UNITED STATES

 SECURITIES
AND EXCHANGE COMMISSION

 Washington,
D.C. 20549

 FORM

 (Mark
One)

 ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 For
the fiscal year ended December 31, 2024

 OR

 TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 FOR
THE TRANSITION PERIOD FROM TO

 Commission
File Number 000-22873

 Oruka
Therapeutics, Inc.

 (Exact
name of Registrant as specified in its Charter)

 Delaware

 36-3855489

 (State or other jurisdiction of
 incorporation or organization)

 (I.R.S. Employer
 Identification No.)

 855 Oak Grove Avenue
 Suite 100
 Menlo Park, California

 94025

 (Address of principal executive offices)

 (Zip Code)

 Registrant's
telephone number, including area code: (650) 606-7910

registered pursuant to Section 12(b) of the Act:

 Title of Each Class

 Trading Symbol(s)

 Name of Each Exchange on Which Registered

 Common Stock, par value $0.001 per share

 ORKA

 The Nasdaq Global Market

registered pursuant to Section 12(g) of the Act: None

by check mark if the Registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes
 No

by check mark if the Registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. Yes
 No

by check mark whether the Registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. Yes No

by check mark whether the Registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the Registrant
was required to submit such files). Yes No

by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company,
or an emerging growth company. See the definitions of "large accelerated filer," "accelerated filer," "smaller
reporting company," and "emerging growth company" in Rule 12b-2 of the Exchange Act.

 Large accelerated filer

 Accelerated filer

 Non-accelerated filer

 Smaller reporting company

 Emerging growth company

 If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

by check mark whether the registrant has filed a report on and attestation to its management's assessment of the effectiveness
of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered
public accounting firm that prepared or issued its audit report.

 If
securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant
included in the filing reflect the correction of an error to previously issued financial statements.

by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation
received by any of the registrant's executive officers during the relevant recovery period pursuant to §240.10D-1(b).

by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes
 No

 The
aggregate market value of the voting and non-voting common equity held by non-affiliates of the Registrant as of June 30, 2024, was approximately
$ 39.7 million based on the closing price of the Registrant's shares of common stock on The Nasdaq Capital Market on such date.

 The
number of the Registrant's Common Stock shares outstanding as of February 28, 2025 was 37,440,510.

 Table
of Contents

 Page

 PART
 I

 Item
 1.

 Business

 Item
 1A.

 Risk
 Factors

 Item
 1B.

 Unresolved
 Staff Comments

 Item
 1C.

 Cybersecurity

 Item
 2.

 Properties

 Item
 3.

 Legal
 Proceedings

 Item
 4.

 Mine
 Safety Disclosures

 PART
 II

 Item
 5.

 Market
 for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities

 Item
 6.

 [Reserved]

 Item
 7.

 Management's
 Discussion and Analysis of Financial Condition and Results of Operations

 Item
 7A.

 Quantitative
 and Qualitative Disclosures About Market Risk

 Item
 8.

 Financial
 Statements and Supplementary Data

 Item
 9.

 in and Disagreements with Accountants on Accounting and Financial Disclosure

 Item
 9A.

 Controls
 and Procedures

 Item
 9B.

 Other
 Information

 Item
 9C.

 Disclosure
 Regarding Foreign Jurisdictions that Prevent Inspections

 PART
 III

 Item
 10.

 Directors,
 Executive Officers and Corporate Governance

 Item
 11.

 Executive

 Item
 12.

 Security
 Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

 Item
 13.

 Relationships and Related Transactions, and Director Independence

 Item
 14.

 Principal
 Accounting Fees and Services

 PART
 IV

 Item
 15.

 Exhibits,
 Financial Statement Schedules

 Item
 16.

 Form
 10-K Summary

 Signatures

 i

 SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS

 This
Annual Report on Form 10-K, or Annual Report, contains "forward-looking statements" within the meaning of Section 27A of
the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act").
These forward-looking statements reflect the current views of Oruka Therapeutics, Inc. ("Oruka", the "Company",
"we", or "us") with respect to future events and are based on assumptions and subject to known and unknown risks
and uncertainties and other factors that may cause our actual results, performance, time frames or achievements to be materially different
from any future results, performance, time frames or achievements expressed or implied by the forward-looking statements. Factors that
might cause such a difference are disclosed in the section titled "Risk Factors" in this Annual Report. We caution readers
that any forward-looking statement is not a guarantee of future performance and that actual results could differ materially from those
contained in the forward-looking statement. These statements are based on current expectations of future events. You should evaluate
all forward-looking statements made in this Annual Report in the context of these risks and uncertainties. We caution you that the risks,
uncertainties and other factors referred to in this Annual Report may not contain all of the risks, uncertainties and other factors that
may affect our future results and operations. Moreover, we operate in a very competitive and rapidly changing environment, and new risks
and uncertainties emerge from time to time.

 All
statements, other than statements of historical facts contained in this Annual Report, including, without limitation, statements regarding:
our future results of operations and financial position, business strategy, the length of time that we believe our existing cash resources
will fund our operations, our market size, our competition, our potential growth opportunities, our clinical development activities and
timeline, the efficacy and safety profile of our product candidates, the potential therapeutic benefits and economic value of our product
candidates, the timing and results of preclinical studies and clinical trials, the expected impact of macroeconomic conditions, including
inflation, increasing interest rates and volatile market conditions, current or potential bank failures, as well as global events, including
military conflicts and geopolitical tensions on our operations, and the receipt and timing of potential regulatory designations, approvals
and commercialization of product candidates, are forward-looking statements. The words "believe," "may," "will,"
"potentially," "estimate," "continue," "anticipate," "predict," "target,"
"intend," "could," "would," "should," "project," "plan," "expect,"
and similar expressions that convey uncertainty of future events or outcomes are intended to identify forward-looking statements, although
not all forward-looking statements contain these identifying words. These forward-looking statements are based on information available
to us as of the date of this Annual Report and are subject to a number of risks, uncertainties and assumptions, including those described
in Item 1A, "Risk Factors" and elsewhere in this Annual Report. Moreover, we operate in a very competitive and rapidly changing
environment, and new risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the
impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ
materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties, and assumptions,
the forward-looking events and circumstances discussed in this Annual Report may not occur and actual results could differ materially
and adversely from those anticipated or implied in the forward-looking statements. While we believe that such information provides a
reasonable basis for these statements, such information may be limited or incomplete. Our statements should not be read to indicate that
we have conducted an exhaustive inquiry into, or review of, all relevant information. These statements are inherently uncertain, and
investors are cautioned not to unduly rely on these statements.

 All
subsequent written or oral forward-looking statements attributable to us or any person acting on our behalf are expressly qualified in
their entirety by the cautionary statements contained or referred to in this section. We do not undertake any obligation to release publicly
any revisions to these forward-looking statements to reflect events or circumstances after the date of this Annual Report or to reflect
the occurrence of unanticipated events, except as may be required under applicable U.S. securities laws. You should read this Annual
Report with the understanding that our actual future results, levels of activity, performance and events and circumstances may be materially
different from what we expect. If we do update one or more forward-looking statements, no inference should be drawn that we will make
additional updates with respect to those or other forward-looking statements.

 Unless
the context indicates otherwise, as used in this Annual Report, the terms "Oruka," "ARCA biopharma, Inc.," "the
Company," "we," "us," and "our" refer to Oruka Therapeutics, Inc., a Delaware corporation,
and its consolidated subsidiaries taken as a whole. "Oruka" and all product candidate names are our common law trademarks.
This Annual Report contains additional trade names, trademarks and service marks of other companies, which are the property of their
respective owners. We do not intend our use or display of other companies' trade names, trademarks or service marks to imply a
relationship with, or endorsement or sponsorship of us by, these other companies.

 All
references to "our product candidates," "our programs" and "our pipeline" in this Annual Report refer
to the research programs with respect to which we have exercised the option to acquire intellectual property license rights to or have
the option to acquire intellectual property license rights to pursuant to those certain antibody discovery and option agreements by and
among the Company, Paragon Therapeutics, Inc. ("Paragon") and Paruka Holding LLC ("Paruka").

 ii

 PART
I

 Item
1. Business.

 Acquisition
of Pre-Merger Oruka

 On
August 29, 2024 (the "Merger Closing"), we completed our acquisition (the "Merger") of Oruka Therapeutics, Inc.
("Pre-Merger Oruka") pursuant to an Agreement and Plan of Merger and Reorganization, dated as of April 3, 2024 (the "Merger
Agreement"). Following the transactions contemplated by the Merger Agreement, Pre-Merger Oruka merged with and into Atlas Merger
Sub Corp., a wholly owned subsidiary of ARCA biopharma, Inc. ("ARCA") and following that, Pre-Merger Oruka then merged with
and into Atlas Merger Sub II, LLC ("Second Merger Sub"), with Second Merger Sub being the surviving entity. Second Merger
Sub changed its corporate name to "Oruka Therapeutics Operating Company, LLC." Pre-Merger Oruka was a pre-clinical stage
biotechnology company that was incorporated on February 6, 2024 under the direction of Peter Harwin, a Managing Member of Fairmount Funds
Management LLC ("Fairmount"), for the purposes of holding rights to certain intellectual property being developed by Paragon
Therapeutics, Inc. ("Paragon"). On August 29, 2024, we changed our name from "ARCA biopharma, Inc." ("ARCA")
to "Oruka Therapeutics, Inc." and our Nasdaq ticker symbol from "ABIO" to "ORKA".

 Company

 We
are a clinical-stage biopharmaceutical company focused on developing novel monoclonal antibody therapeutics for psoriasis ("PsO")
and other inflammatory and immunology ("I&I") indications. Our name is derived from or, for "skin,"
and arukah, for "restoration," and reflects our mission to deliver therapies for chronic skin diseases that provide
patients the most possible freedom from their condition. Our strategy is to apply antibody engineering and format innovations to validated
modes of action, which we believe will enable us to improve meaningfully upon the efficacy and dosing regimens of standard-of-care medicines
while significantly reducing technical and biological risk. Our programs aim to treat and potentially modify disease by targeting mechanisms
with proven efficacy and safety involved in disease pathology and the activity of pathogenic tissue-resident memory T cells ("TRMs").

 Our
lead program, ORKA-001, is designed to target the p19 subunit of interleukin-23 ("IL-23p19") for the treatment of PsO. Our
co-lead program, ORKA-002, is designed to target interleukin-17A and interleukin-17F ("IL-17A/F") for the treatment of PsO,
psoriatic arthritis ("PsA"), and other conditions. These programs each bind their respective targets at high affinity and
incorporate half-life extension technology with the aim to increase exposure and decrease dosing frequency. We believe that our focused
strategy, differentiated portfolio, and deep expertise position us to set a new treatment standard in large I&I markets with continued
unmet need.

 Our
Pipeline

is a high affinity, extended half-life monoclonal antibody ("mAb") designed to target IL-23p19. IL-23 is a pro-inflammatory
cytokine that plays a critical role in the proliferation and development of T helper 17 ("Th17") cells, which are the primary
drivers of several autoimmune and inflammatory disorders, including PsO. IL-23 is composed of two subunits: a p40 subunit that is shared
with IL-12 and a p19 subunit that is specific to IL-23. First-generation IL-23 antibodies bound p40 and inhibited both IL-12 and IL-23
signaling, while more recent IL-23 antibodies targeting the p19 subunit have shown improved efficacy and safety. Based on preclinical
evidence, we believe that ORKA-001 could achieve higher response rates than established therapies in PsO while requiring less frequent
dosing and maintaining the favorable safety profile of therapies targeting IL-23p19. ORKA-001 is engineered with YTE half-life extension
technology, a specific three amino acid change in the fragment crystallizable ("Fc") domain to modify the pH-dependent binding
to the neonatal Fc receptor ("FcRn"). As a result, it has a pharmacokinetic profile designed to support a subcutaneous ("SQ")
injection as infrequently as once or twice a year. In addition, emerging evidence suggests that IL-23 blockade can modify the disease
biology of PsO, possibly leading to durable remissions and preventing the development of PsA. We believe that the expected characteristics
of ORKA-001 increase its potential to deliver these disease-modifying benefits.

 We
initiated dosing of healthy volunteers in a Phase 1 trial of ORKA-001 in the fourth quarter of 2024. We expect to share interim data
from the first-in-human trial in healthy volunteers, including initial pharmacokinetic data, in the second half of 2025 and initial efficacy
on patients with PsO in the second half of 2026. Based on recent precedent for PsO, we anticipate that the entire development program
from first-in-human to biologics license application ("BLA") filing could take as little as six to seven years based
on the averages for recently approved medicines. However, we have no control over the length of time needed for United States Food and
Drug Administration ("FDA") review, and this timeline could vary.

is a high affinity, extended half-life mAb designed to target IL-17A and IL-17F ("IL-17A/F"). IL-17 inhibition has become
central to the treatment of psoriatic diseases, including PsO and PsA, and has also shown efficacy in other I&I indications,
such as hidradenitis suppurativa ("HS") and axial spondyloarthritis ("axSpA"). More recently, the importance
of inhibiting the IL-17F isoform along with IL-17A has become appreciated, and dual blockade with the recently approved therapy Bimzelx
(bimekizumab) has led to higher response rates in patients than blockade of IL-17A alone. ORKA-002 is designed to bind IL-17A/F at similar
epitopes, or binding sites, and affinity ranges as bimekizumab, but incorporates half-life extension technology that could enable more
convenient dosing intervals. We plan to initiate dosing of healthy volunteers in a Phase 1 trial of ORKA-002 in the third quarter
of 2025. We expect to share interim data from the first-in-human trial in healthy volunteers, including initial pharmacokinetic data,
in the first half of 2026.

 We
 view ORKA-002 and ORKA-001 as highly complementary. Patients with moderate-to-severe PsO
 that have purely skin manifestations are most often treated with IL-23 inhibitors due to
 the high efficacy and tolerability of this mechanism. However, for patients who also have
 joint involvement or signs and symptoms of PsA, an IL-17 inhibitor is typically used due
 to its efficacy in addressing both skin and joint symptoms. In addition, IL-17 inhibitors
 are often used in patients with highly resistant skin symptoms that do not adequately resolve
 through treatment with an IL-23 inhibitor. Furthermore, we have the potential opportunity
 to administer ORKA-002 and ORKA-001 sequentially, called ORKA-021, to combine two attractive
 features of each program: the rapid response of an IL-17 inhibitor with the ideal maintenance
 profile of an IL-23 inhibitor. We believe that ORKA-001 and ORKA-002 provide the potential
 to offer a highly compelling product profile for most patients with PsO and/or PsA, as well
 as the opportunity to address additional I&I indications.

Pipeline Program

 We
have a third mAb program, ORKA-003, designed to target an undisclosed pathway. Our strategy as a company is to remain highly focused
on I&I diseases, and specifically on inflammatory dermatology conditions. Our third program provides the potential for indication
expansion beyond PsO and may create combination opportunities with our more advanced programs.

 Our
Team, Investors, and Paragon Collaboration

 We
are led by a management team with significant experience in developing novel treatments for patients at biopharmaceutical companies such
as CRISPR Therapeutics, Celgene, Novartis, CymaBay Therapeutics and Protagonist Therapeutics. Together, our team has a proven track record
of building successful biotech organizations in high-growth environments.

Oruka was founded in February 2024 by leading healthcare investor Fairmount. Fairmount founded Paragon in 2021 to conduct biologics
discovery and optimization, including acting as the firm's discovery engine for biologics that potentially overcome limitations
of existing therapies. We have entered into license agreements with Paragon pursuant to which Paragon granted us a royalty-bearing, world-wide,
exclusive license to develop, manufacture, commercialize or otherwise exploit certain antibodies and products targeting IL-23 outside
of the field of inflammatory bowel disease for ORKA-001 and for ORKA-002, certain antibodies and products targeting IL-17A/F.

 Our
Strategy

 To
achieve our goal of developing leading therapeutic antibodies for patients with inflammatory skin diseases, we are applying antibody
engineering to validated modes of action. We believe this approach will enable us to improve meaningfully upon the efficacy and convenience
of standard-of-care medicines while significantly reducing technical and biological risk. The key elements of our strategy include:

 Employ
 advanced antibody engineering to build biologics that could significantly improve upon existing
 therapies: We and our collaborators at Paragon have optimized
 a variety of parameters using a suite of antibody technologies to develop candidates with
 the potential to improve upon existing therapies. These parameters include extending half-life
 to increase exposure and reduce dosing frequency, enhancing affinity and specificity to maximize
 potency and safety, and optimizing developability to ensure consistency and enable convenient,
 high-dose formulations. Together, we believe these features have the potential to translate
 into more efficacious and convenient medicines for patients.

 Target
 validated mechanisms of action: Our initial targets, IL-23p19
 and IL-17A/F, have established efficacy and safety for the treatment of PsO, PsA, and other
 indications. The FDA has approved four biologics in the IL-23 class, including three targeting
 IL-23p19, and four biologics in the IL-17 class, including one targeting IL-17A/F. While
 these therapies have advanced the standard of care in PsO and PsA, they have not addressed
 these diseases completely, and a significant fraction of patients do not achieve complete
 skin clearance. By applying our advanced antibody engineering to these validated targets,
 we believe we can maximize our chances of developing superior medicines for patients. In
 addition, the reduced technical and biological risk of these validated mechanisms may allow
 us to progress our programs more efficiently and rapidly.

 Leverage
 insights from earlier entrants to optimize our approach: We
 benefit from a large body of clinical evidence generated by prior therapies targeting IL-23
 and IL-17. We continue to extract and apply learnings from this precedent to our programs,
 including in development candidate selection, clinical trial design, dosing regimens, formulations
 and presentations, regulatory pathway, and indication prioritization. For instance, based
 on correlations between affinity and efficacy, we have designed ORKA-001 and ORKA-002 to
 bind to similar epitopes and at similar or greater affinities as the leading antibodies in
 each class: risankizumab and bimekizumab, respectively, with the aim of maximizing efficacy.
 Also, by understanding the exposure-response relationships for efficacy and safety for other
 therapies, we plan to select dose levels and regimens that could maximize efficacy and maintenance
 of response while maintaining safety.

 Pursue
 opportunities with strong prospects of yielding meaningful new medicines as a "base
 case" and the potential to shift the treatment paradigm entirely as an "upside
 case": Our strategy seeks to maximize the potential
 for our programs to reach a base case product profile that could meaningfully advance the
 standard of care—for instance, for ORKA-001, SQ dosing one or twice a year with equal
 or greater efficacy compared to today's standard of care. At the same time, we aim
 to deliver an upside case that dramatically improves outcomes for patients—for instance,
 significantly increasing rates of complete skin clearance via higher antibody exposures or
 offering patients durable remissions free from therapy by introducing patient-specific dosing
 intervals.

 Build
 a preeminent biotechnology company focused on chronic skin disease and other I&I
 indications: We are assembling a team of exceptional people
 and helping them reach their full potential and flourish so that together we can bring forward
 meaningful new medicines for patients.

 We
believe that pursuing the focused strategy outlined above will help us to succeed in our mission of offering patients living with PsO,
PsA, and other dermatologic and inflammatory diseases the greatest possible freedom from their condition.

 Targeting
IL-23 and IL-17 to Treat Multiple I&I Indications

 Our
programs benefit from significant advances in the understanding of the biology of I&I diseases over the past four decades. ORKA-001
and ORKA-002 are designed to target two key cytokines that play a related role in multiple indications. IL-23 is an upstream regulator
of Th17 cells, a pro-inflammatory subset of T helper cells characterized by their production of IL-17. IL-23 has a critical role in maintaining
Th17 cells in the tissue as well as activating these cells to secrete IL-17, which acts downstream to trigger inflammation and other
disease symptoms. Th17 cells are involved in PsO, PsA, HS, axSpA, and many other diseases. They play a particularly central role in PsO
and PsA. The diagram below depicting the immunopathogenesis of PsO provides an example of how Th17 cells can mediate disease and how
blocking IL-23 or IL-17 can break the inflammatory cycle that drives disease.

 Immunopathogenesis
of PsO and the role of IL-23 and IL-17

 PsO
develops when environmental triggers and a genetic predisposition combine to cause activation of an inflammatory cycle in the skin that
leads to the formation of plaques and other disease manifestations. This process begins with the aberrant activation of the dendritic
cells ("DCs"), specifically those producing IL-23 and other cytokines like IL-1, IL-21, TNF-, and IL-12. These
cytokines induce the differentiation of Th17 cells, as well as other cell types, such as T helper type 1 ("Th1") cells that
produce IFN and TNF- and T helper type 22 ("Th22") cells that produce IL-22. IL-23 plays a key role in the
differentiation and activation of Th17 cells to secrete IL-17, as well as Th22 cells to produce IL-22. IL-17 and these other cytokines
induce keratinocyte hyperproliferation leading to plaque formation and a feedforward inflammatory response, with changes in gene expression
in keratinocytes, the production of antimicrobial peptides, and neutrophil recruitment driving further inflammation. While many cytokines
and cell types contribute to the pathogenesis of PsO, the IL-23/IL-17 axis plays an important role, as supported by the success of therapies
targeting this axis.

 While
the successful treatment of PsO — for instance, with mAbs targeting IL-23 or IL-17 — can result in lesional
skin returning to an apparently normal state, disease tends to recur at previously affected sites following cessation of therapy, suggesting
a mechanism of "immunological memory" that predisposes individuals to recurrence in the same locations. Evidence suggests
that pathogenic TRMs play a critical role in this memory. TRMs may arise from the Th17 cells and other cells that drove disease in the
first place and remain in their resident tissue, in this case the epidermis and dermis, for long periods of time. Upon a disease trigger,
these TRMs can actively produce proinflammatory cytokines, causing disease recurrence. IL-23 appears to play an important role in maintaining
and potentiating TRMs, as indicated by the depletion of TRMs following treatment with an IL-23 inhibitor but not an IL-17 inhibitor,
which may explain the longer remissions observed with IL-23 inhibitors following withdrawal of therapy. This type of data has raised
the prospect that efficient IL-23 blockade could modify the disease biology of PsO, possibly leading to durable remissions.

 The
scientific discoveries that refined our understanding of the immunopathogenesis of PsO have led to waves of therapeutic advances, ultimately
leading to today's standard of care. Before the 1980s, PsO was not even thought of as an immunologic disease, but rather a disease
of keratinocyte dysfunction, leading to treatments such as phototherapy, methotrexate, and retinoids. The discovery in the 1980s that
PsO results from immune dysfunction led to the use of broad immunosuppressants like cyclosporine. From 1990 to 2008, it was believed
that Th1 cells were the predominant mediators of the disease, which led to the use of biologics targeting TNF- such as Enbrel
(etanercept) and Humira (adalimumab). Finally, the revelation that PsO is driven principally by Th17 cells resulted in the development
of the primary therapies used today, which target IL-23 and IL-17. This increasingly refined understanding of the disease has narrowed
the standard of care from broad immunosuppressive agents (such as cyclosporine) to more specific immunomodulators (TNF- inhibitors)
to precise biologic therapies targeting the key cytokines involved in disease pathology (IL-23 and IL-17 inhibitors), with each new therapeutic
class raising the bar on both safety and efficacy.

 Biologic
therapies, especially mAbs, are now mainstays in the treatment of a wide variety of I&I diseases, including PsO and PsA. Therapies
that have improved upon efficacy and/or reduced dosing frequency have achieved the most commercial success, even when launched many years
after other biologics. Enbrel was first approved for PsO in 2004 with a weekly maintenance dosing schedule. Four years later, Humira
was approved for PsO with an every-other-week (Q2W) dosing schedule. Stelara (ustekinumab) was approved a year later with similar Phase 3
data to Humira, but with a significantly improved dosing schedule of every twelve weeks (Q12W). Several drugs for PsO have been
approved since 2009 that demonstrated higher efficacy in their pivotal studies compared to Stelara, but with more burdensome dosing schedules,
including Tremfya (guselkumab), which has a dosing schedule of every eight weeks (Q8W), and Cosentyx (secukinumab) and Taltz (ixekizumab),
which have dosing schedules of every four weeks (Q4W). While these therapies have all become generally successful products, the
most commercially successful drug in the PsO market today is Skyrizi (risankizumab), which combines Stelara's Q12W dosing schedule
with improvements in efficacy, as evidenced by a higher psoriasis area severity index (PASI) score of PASI 90 and PASI 100 rates (i.e.,
a 90% improvement in PASI score and a 100% improvement in PASI score (complete clearance), respectively) in clinical trials. In addition,
Bimzelx (bimekizumab), approved by the FDA in 2023, has shown evidence of efficacy that exceeds even Skyrizi, though with a less convenient
Q8W dosing schedule. Although many biologics have entered the PsO market over the past two decades, new entrants have had significant
commercial success when they have improved upon efficacy and/or dosing frequency, and room remains to improve in both areas to set a
new standard for the treatment of PsO.

 Biologics
have raised the bar on the standard of care in PsO, but leave room for improvement

 The
biology driving PsO and PsA is well understood today, and the standard of care has progressed dramatically. We believe that it is unlikely
that a novel mechanism will emerge that is as safe and efficacious as targeting the IL-23/IL-17 axis. Therefore, we believe that innovation
now should be focused on optimizing the product profile that can be offered to patients. While much effort is being directed toward daily
oral formats to inhibit this axis, oral medicines have yet to match the efficacy of biologics. We believe that a better biologic with
a longer dosing interval and the potential for improved efficacy will present a more attractive product profile for most patients.

of Psoriasis (PsO)

 PsO
is a chronic autoimmune skin disorder that affects an estimated 125 million people worldwide with steadily increasing prevalence,
estimated to be around 2 – 3% of the population currently, according to the World Psoriasis Day consortium. It is
the largest pharmaceutical market within dermatology, with annual sales of approximately $25.0 billion in 2022, which is estimated
to grow to $32 billion by 2028. The most common form of PsO is plaque psoriasis. Patients with chronic plaque psoriasis have well-demarcated,
erythematous plaques with overlying, coarse, silvery-scaled patches. These plaques can occur anywhere on the body, though are typically
found on the scalp, extensor areas of the knees and elbows, and gluteal cleft. Involvement of the palms, soles, or nails, and intertriginous
areas, including the genitals, can also occur and can be particularly difficult to treat. Between one-quarter and one-half of PsO patients
have moderate disease, defined as having 3% to 10% of the body surface area ("BSA") involved, or severe disease, defined
as having more than 10% BSA involvement. The chronic inflammation in PsO is associated with multiple comorbidities, including PsA, obesity,
metabolic syndrome, hypertension, diabetes, and atherosclerotic cardiovascular disease.

 As
discussed earlier, PsO is a complex immune-mediated disease driven primarily by Th17 cells and the cytokines IL-23 and IL-17. The interplay
of environmental and behavioral risk factors and genetics is believed to trigger PsO. Multiple lines of evidence support a genetic
component to the disease, including the observation that approximately 40% of patients with PsO and PsA have a family history of the
disease and the identification of multiple susceptibility loci, many containing genes related to the regulation of the immune system,
in genome-wide association studies.

 Current
PsO Treatments and Limitations

 While
patients with mild PsO typically rely on topical corticosteroids or oral therapies like Otezla (apremilast), these agents often do not
provide an adequate response for patients with moderate-to-severe PsO. As a result, the American Academy of Dermatology-National
Psoriasis Foundation recommends biologics as first-line therapy for moderate-to-severe PsO.

 Several
classes of biologic therapies have been approved for PsO over the past 20 years, resulting in progressively more complete symptom
relief. Efficacy in PsO is typically measured via the PASI scoring system. The first biologics approved for PsO were tumor necrosis alpha
("TNF- ") inhibitors such as Enbrel (etanercept), Humira (adalimumab), and Remicade (infliximab), which achieved a
PASI score of PASI 90 at 16 weeks in around 25 – 50% of patients and a PASI score of PASI 100 in around
5 – 20% of patients. Stelara (ustekinumab), which targets the p40 subunit of IL-23 that is shared with IL-12, was approved
next and achieved efficacy on par with Humira. IL-17 inhibitors Cosentyx (secukinumab), Taltz (ixekizumab), and Siliq (brodalumab) followed
and achieved responses of PASI 90 in around 70% of patients and PASI 100 in around 40% of patients with some risk of certain
side effects such as oral candidiasis. Most recently, IL-23p19 inhibitors such as Ilumya (tildrakizumab), Tremfya (guselkumab), and Skyrizi
(risankizumab) have achieved responses of PASI 90 in around 70 – 80% of patients and PASI 100 in around 30 – 50%
of patients with highly tolerable profiles. Finally, IL-17A/F inhibitors such as Bimzelx (bimekizumab) have recently shown even higher
response rates than IL-23 inhibitors, but with slightly less tolerable profiles.

 Treatment
expectations in PsO have evolved progressively with this continued innovation. A 75% improvement in PASI score was previously thought
to be an adequate depth of response, and weekly SQ dosing was viewed as acceptable. With each subsequent generation of innovation, patient
and caregiver expectations have advanced. Today, Skyrizi (risankizumab) is widely viewed as the leader in PsO biologic therapy. In Phase 3
clinical trials, 43% and 58% of patients achieved PASI 100 at 16 and 52 weeks, respectively, with SQ maintenance dosing every three months.
Most recently, Bimzelx (bimekizumab) has shown evidence of efficacy that exceeds even Skyrizi, achieving a 64% PASI 100 rate at 16 weeks
in Phase 3 trials. However, the increased efficacy comes with a less convenient Q8W dosing schedule and an increased risk of certain
side effects, most notably oral candidiasis. While agents like Skyrizi and Bimzelx reflect the remarkable advancement in PsO treatment,
there remains significant unmet need. Approximately half of moderate-to-severe PsO patients do not achieve full skin clarity, and while
early signs are present, the promise of disease modifying therapy remains unrealized. In addition, a continued desire for more convenient
dosing options has driven significant interest in orally delivered medicines targeting these same pathways. However, oral therapies have
yet to match the efficacy and safety profile of biologics. We believe that ORKA-001 and ORKA-002 could represent the next step in biologic
innovation in PsO, with the potential for higher rates of complete skin clearance, more durable remissions, and markedly more convenient
dosing regimens.

of Psoriatic Arthritis (PsA)

 PsA
is a chronic inflammatory condition that affects both the skin and joints, and often coexists with PsO. Around a quarter to a third
of patients with moderate-to-severe PsO also have PsA. Most individuals develop PsO before being diagnosed with PsA, with a median
gap of seven to eight years between the diagnosis of skin and joint disease, though in up to 30% of patients with PsA, joint symptoms
appear before or simultaneously with skin manifestations. Patients with PsA present with joint pain, stiffness, and swelling affecting
the peripheral joints, axial skeleton, or both. Enthesitis, dactylitis, nail lesions, fatigue, and ocular inflammation all occur commonly.
PsA can lead to irreversible joint damage, including bony fusion across a joint (ankylosis). The pathogenesis of PsA is likely to be
closely related to the mechanisms that underlie PsO. Like PsO, the exact cause of PsA remains unknown, but environmental triggers,
including infection and trauma, and genetic factors play a role.

 Current
PsA Treatments and Limitations

 Effective
treatment of PsA requires a coordinated approach to address the unique combination of disease manifestations each patient has, which
can include peripheral and axial arthritis, enthesitis, dactylitis, and skin and nail involvement. Many patients with milder disease
symptoms will start with nonsteroidal anti-inflammatory drugs ("NSAIDs") and/or local treatments to address specific disease
manifestations. However, those with more moderate or severe disease and/or multidomain involvement will typically receive a biologic
therapy targeting TNF- or IL-17, or less commonly an oral Janus kinase ("JAK") inhibitor. Comorbid conditions can
also influence treatment selection. For example, an IL-17 inhibitor would be preferred for a patient with significant skin involvement,
but not for patients with IBD or ocular symptoms, where a TNF- inhibitor would be preferred. The most common endpoint used to
measure the efficacy of TNF- or IL-17 inhibitors in PsA is ACR response, or the proportion of patients achieving a specified percent
improvement in American College of Rheumatology ("ACR") score, which measures peripheral joint disease. Approved TNF-
inhibitors, including Humira (adalimumab) and Cimzia (certolizumab), achieved a placebo-adjusted ACR50 response of around 30 – 35%
at 24 weeks with Q2W dosing. Approved IL-17 inhibitors, including Cosentyx (secukinumab) and Taltz (ixekizumab), achieved a slightly
lower placebo-adjusted ACR50 response of around 25 – 30% at 24 weeks, but with more convenient Q4W dosing.
Bimzelx (bimekizumab), which was recently approved in the United States for PsA, achieved a placebo-adjusted ACR50 response of approximately
35% at 16 weeks with Q4W dosing. A significant fraction of patients with PsA still do not achieve a satisfactory response with available
therapies, and even the most convenient regimens require monthly SQ dosing.

of additional opportunities

 In
addition to PsO and PsA, inhibition of IL-23 or IL-17 has demonstrated efficacy in a number of additional I&I indications, including
HS and axSpA.

 HS
is a chronic inflammatory skin disease characterized by lesions that include deep-seated nodules and abscesses, draining tracts, and
fibrotic scars that occur most commonly in intertriginous areas, such as the armpits and groin. Due to the associated pain, sensitive
locations, drainage, odor, and scarring, this condition can have a particularly negative psychosocial impact on affected individuals.
HS is believed to be underdiagnosed and could have a prevalence well above 1% worldwide. Treatment varies depending on severity and can
include topical and systemic antibiotics, hormone therapy, immune modulators, and surgery. Humira (adalimumab) was the only FDA-approved
medication for the treatment of moderate-to-severe HS from its approval in 2015 until the approval of Cosentyx (secukinumab) in October 2023
and Bimzelx (bimekizumab) in November 2024. Now multiple other biologics are advancing through development and have demonstrated encouraging
data in Phase 2 clinical trials, though a significant fraction of patients still do not achieve adequate responses.

 axSpA
is a chronic inflammatory disease that primarily affects the spine and sacroiliac joints that comprise the axial skeleton. The disease
causes severe pain, stiffness, and fatigue, and can have additional clinical manifestations like uveitis, enthesitis, peripheral arthritis,
and PsO. Patients with axSpA may develop further structural damage in their spine, which can lead to the fusion of vertebra (spinal
ankylosis), which has a massive negative impact on mobility, physical function, and quality of life. The overall prevalence of axSpA
is estimated to be around 1% in the United States. Treatment of axSpA starts with physical therapy and NSAIDs. If patients do not
have an adequate response to NSAIDs, a TNF- inhibitor is typically used, followed by an IL-17 inhibitor, such as Cosentyx (secukinumab),
Taltz (ixekizumab), or Bimzelx (bimekizumab), or less frequently a JAK inhibitor. Patients often need to cycle through therapies over
time due to inadequate responses or loss of response.

 Our
Solution: Half-Life Extension and Antibody Engineering Technologies

 Our
antibody engineering campaigns are designed to optimize multiple attributes in parallel: binding affinity, potency in a variety of assays,
developability, and consistently extended serum half-life in non-human primates ("NHPs"). Half-life extension is possible
by modifying the pH-dependent binding affinity of the antibody Fc domain for FcRn. A primary mechanism of elimination of antibodies from
the serum is through pinocytosis and degradation in the lysosomes of cells. Throughout this process, antibodies can be recycled back
into the serum by binding to FcRn while they are in endosomes. The interior of the endosome is acidic, and therefore the efficiency of
this recycling process depends on the ability of the antibody Fc domain to bind to FcRn at low pH. If this low pH binding is efficient
enough, antibody recycling can be favored over degradation, potentially resulting in a much longer serum half-life.

 Antibody
engineers have discovered methods of modifying the Fc domain to optimize the efficiency of recycling via FcRn binding. Several engineering
strategies have been identified over the past two decades, with the so-called "YTE" mutations (M252Y/S254T/T256E) and "LS"
mutations (M428L/N434S) being the most frequently used. Importantly, while these strategies have been known for some time, it was only
relatively recently that enough clinical precedent was established to provide confidence in how these mutations perform in humans. Two
products incorporating YTE modification were approved in 2023 by the FDA, Beyfortus (nirsevimab) and Evusheld (tixagevimab and cilgavimab),
and several more candidates are in clinical trials. Two products using LS mutations were approved in 2021 and 2022, Xevudy (sotrovima)
and Ultomiris (ravulizumab), respectively, and several more candidates are in clinical trials. Based on clinical data in humans, antibodies
with YTE mutations typically have a half-life that is two to four times longer than wildtype antibodies. In addition, preclinical data
in NHPs can be used to predict the approximate half-life in humans, with the human half-life equaling around two to four times the
NHP half-life.

 Clinical
experience with YTE-modified mAbs predicts significant half-life extension over wildtype mAbs

 While
this increasing body of clinical precedent serves to validate half-life extension, we do not yet have clinical data showing that the
introduction of these amino acid substitutions in our programs leads to a longer serum half-life. However, we aim to establish this favorable
pharmacokinetic profile early in the clinical development of our product candidates.

 Summary

is a high affinity, extended half-life mAb designed to target the p19 subunit of IL-23. Based on preclinical data generated to date,
we believe ORKA-001 has the potential to become the leading IL-23 inhibitor and achieve an optimal product profile in PsO consisting
of the following:

 One
 to two maintenance doses per year. Standard-of-care therapies
 targeting IL-23 require maintenance dosing every eight to twelve weeks. We engineered
 the Fc portion of ORKA-001 to include YTE mutations to increase the half-life of ORKA-001
 in circulation, which may enable dosing every six to twelve months — a
 dosing interval made feasible by half-life extension technology. In preclinical studies,
 serum levels from NHPs indicated an elimination half-life of over 30 days following
 SQ administration of ORKA-001. Based on published scientific literature on other antibodies
 incorporating YTE mutations and pharmacokinetic modeling, we anticipate this half-life in
 NHPs to translate to a half-life in humans that could allow subcutaneous dosing every six
 to twelve months while maintaining high antibody exposures.

 Higher
 PASI 100. ORKA-001 benefits from the robust validation of
 IL-23 inhibition in PsO by multiple approved therapies, such as Skyrizi (risankizumab) and
 Tremfya (guselkumab), while leveraging insights from these therapies to improve upon their
 clinical profile. ORKA-001 is designed to bind a similar epitope to the market-leading anti-IL-23
 antibody, Skyrizi, with similar or greater affinity and could achieve much higher exposures
 in patients due to half-life extension and higher dosing. Skyrizi and Tremfya both have a
 robust exposure-response relationship, with higher drug exposures leading to higher response
 rates. Published data indicates that these therapies have not saturated this exposure-response
 relationship, and ORKA-001 could lead to higher response rates, including higher rates of
 complete skin clearance, or PASI 100, through increased exposure, even while having more
 convenient dosing with as few as one or two maintenance doses per year.

 Validated
 IL-23p19 safety profile. Existing commercially approved antibodies
 targeting IL-23 provide a robust precedent for the safety of IL-23 inhibition. Across thousands
 of patients dosed in dermatology and IBD indications, no correlations have been observed
 at the patient level between exposure and safety. While we are not pursuing IBD, the approved
 Skyrizi regimens for Crohn's disease and ulcerative colitis supports the safety of
 high peak exposures. Peak Skyrizi exposures during the IV induction phase in Crohn's
 disease and ulcerative colitis are multiple times higher than the anticipated peak ORKA-001
 exposures at dose levels we currently plan to evaluate in PsO. In addition, an exposure-response
 analysis for Skyrizi in ulcerative colitis showed no relationship between exposures and evaluated
 safety endpoints in the 12-week induction or 52-week maintenance periods. In this assessment,
 the top quartile of average exposures were significantly higher than the highest anticipated
 exposures with ORKA-001 in the same periods.

 Potential
 to offer longer term remission to some patients. Emerging
 evidence suggests that IL-23 blockade can modify the disease biology of PsO, possibly leading
 to durable remissions and preventing the development of PsA. Dr. Andrew Blauvelt,
 chair of our Scientific Advisory Board, pioneered some of this work by using two- and four-times
 the approved dose levels of risankizumab to achieve best-in-indication response rates. This
 study, called KNOCKOUT, showed a robust depletion of TRMs following high dose IL-23 inhibition,
 which could lead to longer-lasting remissions in some patients. Additional evidence from
 a study of guselkumab, called GUIDE, showed that intervention early in the disease course
 can lead to longer treatment-free remissions. In addition, retrospective claims data suggests
 that treatment with an IL-23 inhibitor could help prevent progression to PsA, though this
 finding has yet to be confirmed by a prospective clinical trial. Given the high antibody
 exposures expected with ORKA-001, we believe that ORKA-001 could lead to durable remissions
 for some patients, especially those with short disease duration. We plan to pursue patient-specific
 dosing intervals to provide each patient the greatest possible freedom from their disease.

 We
believe that this target profile for ORKA-001 could offer improved freedom from disease to many patients affected by PsO and represent
a step forward in the standard of care.

 Preclinical
Data

 We
evaluated ORKA-001 in numerous preclinical studies for several key features:

 Potency
that matches or exceeds Skyrizi (risankizumab) in vitro

 We
have tested the potency of ORKA-001 in vitro in multiple assays, including assays evaluating the inhibition of IL-17 release from
human peripheral mononuclear blood cells, in comparison to risankizumab generated recombinantly based on amino acid sequences from patent
filings. Based on the results of these experiments, we believe ORKA-001 binds a similar epitope as risankizumab with similar potency.

binds to a similar epitope as risankizumab with similar potency

 Significant
half-life extension in NHPs that could enable a maintenance dosing interval of once or twice a year in humans

 We
assessed ORKA-001 in NHPs in comparison to risankizumab generated recombinantly based on amino acid sequences from patent filings. ORKA-001
had a significantly longer half-life, reaching over 30 days with SQ administration. Based on clinical experience with YTE-modified
mAbs and pharmacokinetic modeling, we believe that this half-life extension could enable dosing once or twice per year, as shown in the
figure below.

 The
incorporation of YTE mutations significantly extends half-life in NHPs, which could enable once or twice yearly dosing

 In
addition to enabling less frequent dosing, an extended half-life would increase the exposure of ORKA-001, which has the potential to
increase efficacy. Based on published literature, Skyrizi (risankizumab) demonstrates a clear relationship between antibody exposure
and efficacy, with higher average serum antibody concentration correlating with higher PASI 90 and PASI 100 rates short-term (at 16 weeks)
and long-term (at 52 weeks), as shown for PASI 100 in the figure below. In addition, the KNOCKOUT study, which evaluated two- and
four-times higher doses of Skyrizi than the approved regimen, yielded some of the highest PASI 100 rates observed to date, reaching 67%
at 16 weeks. Based on our pharmacokinetic modeling, ORKA-001 could achieve four-fold higher average exposures than the approved
Skyrizi regimen over the first 16 weeks and over two-fold higher average exposures at steady-state, exceeding even the exposures
in KNOCKOUT. Based on the exposure-response relationship observed with other IL-23 inhibiting antibodies, we believe that these
increased exposures could result in higher efficacy.

is projected to extend the exposure-response relationship established by studies of Skyrizi

 Safety
in vitro and in vivo

 We
have evaluated ORKA-001 in several in vitro and in vivo preclinical studies to assess safety. In addition, we have
a nonclinical program to characterize the toxicology, toxicokinetics, and anti-drug antibody profile of ORKA-001 in NHPs. Our nonclinical
program supported the initiation of our Phase 1 clinical trial for ORKA-001 and our continuing clinical development.

 Characteristics
that support ease of manufacturing and potentially enable high-concentration formulations

 Finally,
we have assessed a variety of attributes essential for manufacturability and high-concentration formulation, including viscosity, solubility,
and stability, among others. ORKA-001 shows evidence of desirable properties across these characteristics, which we believe will enhance
our ability to manufacture ORKA-001 successfully and consistently and to deliver high doses of ORKA-001 subcutaneously using convenient,
low-volume presentations.

 Clinical
Development

 We
dosed the first participants in a Phase 1 clinical trial of ORKA-001 in healthy volunteers in the fourth quarter of 2024. This trial
is a double-blind, placebo-controlled, single ascending dose study evaluating the safety, tolerability, and pharmacokinetics of ORKA-001
in healthy volunteers. The trial is expected to enroll approximately 24 healthy volunteers across three subcutaneous dose cohorts. We
expect to share interim data from this trial in the second half of 2025. We believe this data has the potential to provide key validation
of initial safety and pharmacokinetics data, including half-life, to support extended dosing intervals.

 We
plan to initiate a Phase 2a proof-of-concept study of ORKA-001 in moderate-to-severe PsO in the second half of 2025. We believe that
several aspects of PsO facilitate clinical development, including well-established, reproducible endpoints based on PASI scores, low
placebo rates, particularly with PASI 90 and PASI 100, a rapid efficacy readout at 16 weeks, and potentially rapid enrollment due to
the large patient population. Our Phase 2a clinical trial is anticipated to evaluate the safety and efficacy of a single dose level of
ORKA-001 versus placebo in approximately 80 subjects, followed by randomization to one of two maintenance dosing arms. In one maintenance
arm, subjects will receive ORKA-001 every six months. In the other, subjects will receive only induction dosing to assess the length
of time patients maintain clear skin, which could support once-yearly dosing or even longer-term durability in some patients. The anticipated
primary endpoint is PASI 100 at Week 16. After completing the trial, subjects may have the option to roll over to an open-label extension
study. We expect to share initial data from the Phase 2a trial in the second half of 2026. We believe this data has the potential to
inform efficacy at Week 16, as well as later timepoints, and provide us information on preliminary durability, including the potential
for extended dosing intervals and longer-term remissions.

 Summary

is a high affinity, extended half-life mAb designed to target IL-17A/F. Dual inhibition of both IL-17A and IL-17F has shown superior
efficacy compared to IL-17A inhibition alone in PsO and other indications, as shown by the performance of Bimzelx (bimekizumab) compared
to Cosentyx (secukinumab) and Taltz (ixekizumab) in Phase 3 trials. These therapies all utilize Q4W maintenance dosing in PsO and
PsA, except Bimzelx, where Q8W maintenance dosing in PsO patients <120 kg is recommended. By binding IL-17A/F at similar epitopes
and affinity ranges as Bimzelx while incorporating half-life extension technology to potentially enable dosing two to three times a year
in PsO and PsA, we believe that ORKA-002 could become the leading therapy in the IL-17 class.

 Preclinical
Data

 The
preclinical program we are conducting for ORKA-002 mirrors that for ORKA-001 and spans potency, pharmacokinetics, safety, and manufacturing
characteristics. Based on the results of these experiments, we believe ORKA-002 has the potential for comparable potency to bimekizumab,
but with a significantly longer half-life, which we believe could support dosing two or three times per year based on extrapolation from
clinical precedent and pharmacokinetic modeling.

 Clinical
Development Plans

 We
plan to initiate dosing of healthy volunteers in a Phase 1 trial of ORKA-002 in the third quarter of 2025. As with ORKA-001, initial
data on ORKA-002 in healthy volunteers has the potential to provide key validation of both early safety and pharmacokinetics to support
extended dosing intervals. Though clinical development of ORKA-002 will initially focus on one lead indication, we plan to evaluate ORKA-002
in a range of indications over time. We see ORKA-002 as highly complementary to ORKA-001, with the potential to provide an optimal therapy
for the approximately one-quarter to one-third of moderate-to-severe PsO patients who have PsA, as well as for PsO patients with highly
resistant skin symptoms that do not respond adequately to an IL-23 inhibitor. Furthermore, ORKA-002 could address indications beyond
PsO, including PsA with limited skin involvement, HS, axSpA, and additional I&I diseases.

 ORKA-021

 The
IL-17 and IL-23 classes each have distinct advantages. IL-17 inhibitors tend to have the fastest onset and highest peak response, while
IL-23 inhibitors have less frequent dosing and better durability and safety. Combining the two mechanisms sequentially has the potential
to provide two attractive features of each program: the rapid response of an IL-17 inhibitor with the ideal maintenance profile of an
IL-23 inhibitor. As a result, following ORKA-002 and ORKA-001, we plan to explore a sequential combination regimen of ORKA-002 and ORKA-001,
called "ORKA-021."

Pipeline Program

 We
have a third mAb program, ORKA-003, that targets an undisclosed pathway. A core tenet of our strategy is to remain highly focused on I&I
diseases, and specifically on inflammatory dermatology conditions. ORKA-003 provides the potential for indication expansion beyond PsO
as well as combination opportunities with our more advanced programs. In the future, we may add additional programs to our portfolio
beyond ORKA-001, ORKA-002, ORKA-021 and ORKA-003 that fit our strategic focus.

 Intellectual
Property

 We
strive to protect the proprietary programs and technologies that we believe are important to our business, including seeking and maintaining
patent protection intended to cover the composition of matter of our programs, their methods of use and manufacture, related technologies,
diagnostics, and other inventions.

has filed, on our behalf, provisional patent applications, and we have filed non-provisional patent applications, and may file additional
patent applications directed to antibodies that target IL-23, including applications covering composition of matter, pharmaceutical formulations,
and methods of using such antibodies, including ORKA-001. In addition, Paragon has filed, on our behalf, provisional patent applications,
and we may file additional patent applications directed to antibodies that target IL-17, including applications covering composition
of matter, pharmaceutical formulations, and methods of using such antibodies, including ORKA-002. We have exclusive rights to ORKA-001
and ORKA-002 and the corresponding IL-23 and IL-17 patent applications pursuant to license agreements with Paragon. If the patent applications
mature into one or more issued patents covering ORKA-001 or ORKA-002, we would expect those patents to expire in 2045, absent any applicable
patent term adjustments or extensions.

 Commercial

 Should
any of our product candidates be approved for commercialization, we intend to develop a plan to commercialize them in the United States
and other key markets, through internal infrastructure and/or external partnerships in a manner that will enable us to realize the full
commercial value of our programs. Given our stage of development, we have not yet established a commercial organization or distribution
capabilities. We have exclusive worldwide rights to develop and commercialize ORKA-001 and ORKA-002 pursuant to license agreements with
Paragon.

 Manufacturing

 We
do not currently own or operate facilities for product manufacturing, testing, storage, and distribution. We have contracted and expect
to continue to contract with third parties for the manufacture and distribution of our product candidates. Because we rely on contract
manufacturers, we employ personnel with extensive technical, manufacturing, analytical, and quality experience. Our team has deep knowledge
and understanding of the regulations that govern manufacturing, documentation, quality assurance, and quality control of drug supply
that are required to support our regulatory filings.

 Competition

 The
biotechnology and biopharmaceutical industries are characterized by continuing technological advancement and significant competition.
While we believe that our programs, technology, development experience and scientific knowledge provide us with competitive advantages,
we face competition from major pharmaceutical and biotechnology companies, academic institutions, governmental agencies, and public and
private research institutions, among others. Any product candidates that we successfully develop and commercialize will compete with
existing therapies and therapies that may become available in the future. Many of the companies with which we are currently competing
or will compete against in the future have significantly greater financial resources and expertise in research and development, manufacturing,
preclinical testing, conducting clinical trials, obtaining regulatory approvals, and marketing approved products than we do. Mergers
and acquisitions in the pharmaceutical and biotechnology industry may result in even more resources being concentrated among a smaller
number of our competitors. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative
arrangements with large and established companies. These competitors also compete with us in recruiting and retaining qualified scientific
and management personnel, establishing clinical trial sites, patient enrollment for clinical trials as well as in acquiring technologies
complementary to, or necessary for, our programs.

 Key
competitive factors affecting the success of all our product candidates that we develop, if approved, are likely to be efficacy, safety,
convenience, presentation, price, the level of generic competition, and the availability of reimbursement from government and other third-party
payors. Our competitors may also obtain FDA or other regulatory approval for their products more rapidly than we may obtain approval
for our products, which could result in our competitors establishing a strong market position before we are able to enter the market.

 Specifically,
there are several companies developing or marketing treatments that may be approved for the same indications and/or diseases as our two
most advanced programs, ORKA-001 and ORKA-002, including major pharmaceutical companies. We do not yet have clinical data for any of
our programs and there can be no assurance that our programs will have similar or comparable results.

 There
are several approved biologic therapies for the treatment of moderate-to-severe PsO. These include mAbs targeting IL-23, such as
Skyrizi (risankizumab) from AbbVie, Tremfya (guselkumab) from Janssen, and Ilumya (tildrakizumab) from Sun Pharma, also marketed as Ilumetri
by Almirall in Europe, which all target the p19 subunit, and Stelara (ustekinumab) from Janssen, which targets the p40 subunit; mAbs
targeting IL-17, such as Bimzelx (bimekizumab) from UCB, which targets IL-17A/F, Cosentyx (secukinumab) from Novartis and Taltz (ixekizumab)
from Eli Lilly, which both target IL-17A, and Siliq (brodalumab) from Ortho Dermatologics, also marketed as Kyntheum by LEO Pharma in
Europe, which targets IL-17 receptor/A; and biologics targeting TNF-, such as Humira (adalimumab) from AbbVie, Enbrel (etanercept)
from Amgen, and Remicade (infliximab) from Janssen, and various biosimilar versions of each. In addition, there are several approved
oral medicines in these indications, including the phosphodiesterase-4 (PDE4) inhibitor Otezla (apremilast) from Amgen and the tyrosine
kinase 2 (TYK2) inhibitor Sotyktu (deucravacitinib) from Bristol-Myers Squibb. Many of these therapies also are approved or in development
for PsA, HS, axSpA, and other I&I indications.

 In
addition, we are aware of several product candidates in clinical development for moderate-to-severe PsO, along with PsA, HS, axSpA, and
other indications. These include the biologics picankibart from Innovent Biologics targeting IL-23p19 and sonelokimab from MoonLake Immunotherapeutics
targeting IL-17A/F. Also, there are several oral agents in development, including JNJ-2113 from Janssen targeting the IL-23 receptor,
DC-853 from Eli Lilly targeting IL-17A, and TAK-279 from Takeda and ESK-001 from Alumis, both targeting TYK2.

 Significant
Agreements

Therapeutics – Option Agreements

 In March 2024, we entered
into two antibody discovery and option agreements ("Option Agreements") with Paragon and Paruka Holding, LLC ("Paruka").
Paruka is an entity formed by Paragon as a vehicle to hold equity in our Company in order to share profits with certain employees of Paragon.
Under the terms of each agreement, Paragon identifies, evaluates, and develops antibodies directed against certain mutually agreed therapeutic
targets of interest to us. From time to time, we can choose to add additional targets to the collaboration upon agreement with Paragon
and Paruka. Under the Option Agreements, we have the exclusive option to, on a research program-by-research program basis, be granted
an exclusive, worldwide license to all of Paragon's right, title, and interest in and to the intellectual property resulting from
the applicable research program to develop, manufacture, and commercialize the antibodies and products directed to the selected target(s) (each,
an "Option"). We have initiated certain research programs with Paragon that generally focus on discovering, generating, identifying
and/or characterizing antibodies directed to a particular target (each, a "Research Program"), including for IL-23 and IL-17A/F
for ORKA-001 and ORKA-002, respectively. Our exclusive option with respect to each Research Program is exercisable at our sole discretion
at such time as specified in the Option Agreements (the "Option Period"). There is no payment due upon exercise of an Option
pursuant to the Option Agreements. For each of these agreements, once we enter into the corresponding license agreements, we will be required
to make non-refundable milestone payments to Paragon of up to $12.0 million under each respective agreement upon the achievement of certain
clinical development milestones, up to $10.0 million under each respective agreement upon the achievement of certain regulatory milestones,
as well as a low single-digit percentage royalty for antibody products beginning on the first commercial sale in each program.

 We
 may terminate any Option Agreement or any Research Program at any time for any or no reason
 upon 30 days' prior written notice to Paragon, provided that we must pay certain
 unpaid fees due to Paragon upon such termination, as well as any non-cancellable obligations
 reasonably incurred by Paragon in connection with its activities under any terminated Research
 Program. Paragon may terminate any Option Agreement or a Research Program immediately upon
 written notice to us if, as a result of any action or failure to act by us or our affiliates,
 such Research Program or all material activities under the applicable Research Plan are suspended,
 discontinued or otherwise delayed for a certain consecutive number of months. Each party
 has the right to terminate the Option Agreements or any Research Program upon material breach
 that remains uncured or the other party's bankruptcy.

 Additionally, as part of the
Option Agreements, on December 31, 2024 and December 31, 2025, we granted and will grant, respectively, Paruka a warrant to purchase
a number of shares equal to 1.00% of outstanding shares as of the date of the grant on a fully-diluted basis, with an exercise price equal
to the fair market value of the underlying shares on the grant date.

Therapeutics – License Agreements

 In
September 2024, we exercised the Option to acquire certain rights to ORKA-001, and in December 2024, we entered into the corresponding
license agreement with Paragon (the "ORKA-001 License Agreement"), pursuant to which Paragon granted us a royalty-bearing,
world-wide, exclusive license to develop, manufacture, commercialize or otherwise exploit certain antibodies and products targeting IL-23
in all fields other than the field of inflammatory bowel disease ("ORKA-001 Field"). In December 2024, we exercised the Option
with respect to ORKA-002 for the IL-17A/F program, and in February 2025, we entered into the corresponding license agreement with Paragon
(the "ORKA-002 License Agreement" and together with the ORKA-001 License Agreement, the "License Agreements"),
pursuant to which Paragon granted us a royalty-bearing, world-wide, exclusive license to develop, manufacture, commercialize or otherwise
exploit certain antibodies and products targeting IL-17A/F in all fields ("ORKA-002 Field" and together with the ORKA-001
Field, the "Fields").

 The
License Agreements provide us with exclusive licenses in the Fields to Paragon's patent applications covering the related antibodies,
their method of use and their method of manufacture and Paragon has agreed not to conduct any new campaigns that generate anti-IL-23
monospecific antibodies or anti-IL-17A/F monospecific antibodies for the ORKA-001 Field or the ORKA-002 Field, respectively, for at least
five years. Each of the ORKA-001 and ORKA-002 License Agreements may be terminated on 60 days' notice to Paragon, on material breach
without cure, and on a party's insolvency or bankruptcy to the extent permitted by law.

to the terms of each of the ORKA-001 and ORKA-002 License Agreements, we are obligated to pay Paragon non-refundable milestone payments
of up to $12.0 million under each respective agreement upon the achievement of certain clinical development milestones and up to $10.0
million under each respective agreement upon the achievement of certain regulatory milestones, including a $1.5 million fee for nomination
of a development candidate (or initiation of an investigational new drug ("IND") enabling toxicology study) and a further
milestone payment of $2.5 million upon the first dosing of a human patient in a Phase 1 trial for each of ORKA-001 and ORKA-002. In addition,
we are obligated to pay Paragon a low single-digit percentage royalty for antibody products for each of ORKA-001 and ORKA-002. For each
of the License Agreements, the royalty term ends on the later of (i) the last-to-expire licensed patent or our patent directed to the
manufacture, use or sale of a licensed antibody in the country at issue or (ii) 12 years from the date of first sale of a Company product.
There is also a royalty step-down if there is no Paragon patent in effect during the royalty term for each program.

 Cell
Line License Agreement

 In
March 2024, we entered into the Cell Line License Agreement (the "Cell Line License Agreement") with WuXi Biologics Ireland
Limited ("WuXi Biologics"). Under the Cell Line License Agreement, we received a non-exclusive, worldwide, sublicensable
license to certain of WuXi Biologics' know-how, cell line, biological materials (the "WuXi Biologics Licensed Technology")
and media and feeds to make, have made, use, sell and import certain therapeutic products produced through the use of the cell line licensed
by WuXi Biologics under the Cell Line License Agreement (the "WuXi Biologics Licensed Products"). Specifically, the WuXi
Biologics Licensed Technology is used in certain manufacturing activities in support of the ORKA-001 and ORKA-002 programs.

 In
consideration for the license, we agreed to pay WuXi Biologics a non-refundable license fee of $150,000. Additionally, to the extent
that we manufacture our commercial supplies of bulk drug product with a manufacturer other than WuXi Biologics or its affiliates, we
are required to make royalty payments to WuXi Biologics at a rate of less than one percent of net sales of WuXi Biologics Licensed Products
manufactured by the third-party manufacturer. Pursuant to an amendment to the Cell Line License Agreement effective in November 2024,
a provision was added that permits the royalties owed under the agreement to be bought out on a product-by-product basis for
a lump-sum payment.

 The
Cell Line License Agreement will continue indefinitely unless terminated (i) by us upon six months' prior written notice and our
payment of all undisputed amounts due to WuXi Biologics through the effective date of termination, (ii) by WuXi Biologics for a material
breach by us that remains uncured for 60 days after written notice, (iii) by WuXi Biologics if we fail to make a payment and such failure
continues for 30 days after receiving notice of such failure, or (iv) by either party upon the other party's bankruptcy.

 Government
Regulation

 The
FDA and other regulatory authorities at federal, state and local levels, as well as in foreign countries, extensively regulate, among
other things, the research, development, testing, manufacture, quality control, import, export, safety, effectiveness, labeling, packaging,
storage, distribution, record keeping, approval, advertising, promotion, marketing, post-approval monitoring and post-approval reporting
of biologics such as those we are developing. We, along with our third-party contractors, will be required to navigate the various preclinical,
clinical and commercial approval requirements of the governing regulatory agencies of the countries in which we wish to conduct studies
or seek approval or licensure of our product candidates. Generally, before a new therapeutic product can be marketed, considerable data
demonstrating a biological product candidate's quality, safety, purity and potency, or a small molecule drug candidate's
quality, safety and efficacy, must be obtained, organized into a format specific for each regulatory authority, submitted for review
and approved by the regulatory authority. For biological product candidates, potency is similar to efficacy and is interpreted to mean
the specific ability or capacity of the product, as indicated by appropriate laboratory tests or by adequately controlled clinical data
obtained through the administration of the product in the manner intended, to effect a given result.

to comply with the applicable U.S. requirements at any time during the product development process, approval process or post-marketing
may subject an applicant to administrative or judicial sanctions. These sanctions could include, among other actions, the FDA's
refusal to approve pending applications from the sponsor, withdrawal of an approval, a clinical hold, untitled or warning letters, product
recalls or market withdrawals, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals
of government contracts, restitution, disgorgement and civil or criminal penalties. Any agency or judicial enforcement action could have
a material adverse effect on our company and our products or product candidates.

 United
States Biologics Regulation

 In
the United States, biological products are subject to regulation under the Federal Food, Drug, and Cosmetic Act ("FDCA"),
the Public Health Service Act ("PHSA") and other federal, state, local, and foreign statutes and regulations. The process
of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state, and local statutes and regulations requires
the expenditure of substantial time and financial resources. Failure to comply with the applicable U.S. requirements at any time during
the product development process, approval process or following approval may subject an applicant to administrative action and judicial
sanctions. The process required by the FDA before biologic product candidates may be marketed in the United States generally involves
the following:

 completion
 of preclinical laboratory tests and animal studies performed in accordance with the FDA's
 current Good Laboratory Practices ("GLP") regulation;

 submission
 to the FDA of an IND, which must become effective before clinical trials may begin and must
 be updated annually or when significant changes are made;

 approval
 by an independent institutional review board ("IRB"), or ethics committee at
 each clinical site before the trial is commenced;

 manufacture
 of the proposed biologic candidate in accordance with current Good Manufacturing Practices
 ("cGMPs");

 performance
 of adequate and well-controlled human clinical trials in accordance with current Good Clinical
 Practice ("GCP") requirements to establish the safety, purity and potency of
 the proposed biologic product candidate for its intended purpose;

 preparation
 of and submission to the FDA of a BLA, after completion of all pivotal clinical trials;

 satisfactory
 completion of an FDA Advisory Committee review, if applicable;

 a
 determination by the FDA within 60 days of its receipt of a BLA to file the application for
 review;

 satisfactory
 completion of an FDA pre-approval inspection of the manufacturing facility or facilities
 at which the proposed product is produced to assess compliance with cGMPs, and to assure
 that the facilities, methods and controls are adequate to preserve the biological product's
 continued safety, purity and potency, and of selected clinical investigation sites to assess
 compliance with GCPs; and

 FDA
 review and approval of a BLA to permit commercial marketing of the product for particular
 indications for use in the United States.

 Preclinical
and Clinical Development

 Prior
to beginning any clinical trial with a product candidate in the United States, we must submit an IND to the FDA. An IND is a request
for authorization from the FDA to administer an investigational new drug product to humans. The central focus of an IND submission is
on the general investigational plan and the protocol or protocols for preclinical studies and clinical trials. The IND also includes
results of animal and in vitro studies assessing the toxicology, pharmacokinetics, pharmacology and pharmacodynamic characteristics of
the product, chemistry, manufacturing and controls information, and any available human data or literature to support the use of the
investigational product. An IND must become effective before human clinical trials may begin. The IND automatically becomes effective
30 days after receipt by the FDA, unless the FDA, within the 30-day period, raises safety concerns or questions about the proposed clinical
trial. In such a case, the IND may be placed on clinical hold and the IND sponsor and the FDA must resolve any outstanding concerns or
questions before the clinical trial can begin. Submission of an IND therefore may or may not result in FDA authorization to begin a clinical
trial.

 In
addition to the IND submission process, supervision of human gene transfer trials includes evaluation and assessment by an institutional
biosafety committee ("IBC"), a local institutional committee that reviews and oversees research utilizing recombinant or
synthetic nucleic acid molecules at that institution. The IBC assesses the safety of the research and identifies any potential risk to
public health or the environment and such review may result in some delay before initiation of a clinical trial.

 Clinical
trials involve the administration of the investigational product to human subjects under the supervision of qualified investigators in
accordance with GCPs, which include the requirement that all research subjects provide their informed consent for their participation
in any clinical study. Clinical trials are conducted under protocols detailing, among other things, the objectives of the study, the
parameters to be used in monitoring safety and the effectiveness criteria to be evaluated. A separate submission to the existing IND
must be made for each successive clinical trial conducted during product development and for any subsequent protocol amendments. Furthermore,
an independent IRB for each site proposing to conduct the clinical trial must review and approve the plan for any clinical trial and
its informed consent form before the clinical trial begins at that site, and must monitor the study until completed.

 Regulatory
authorities, the IRB or the sponsor may suspend a clinical trial at any time on various grounds, including a finding that the subjects
are being exposed to an unacceptable health risk or that the trial is unlikely to meet its stated objectives. Some studies also include
oversight by an independent group of qualified experts organized by the clinical study sponsor, known as a data safety monitoring board,
which provides authorization for whether or not a study may move forward at designated check points based on access to certain data from
the study and may halt the clinical trial if it determines that there is an unacceptable safety risk for subjects or other grounds, such
as no demonstration of efficacy. There are also requirements governing the reporting of ongoing preclinical studies and clinical trials
and clinical study results to public registries.

 For
purposes of BLA approval, human clinical trials are typically conducted in three sequential phases that may overlap.

 Phase
 1. The investigational product is initially introduced into healthy human subjects or patients
 with the target disease or condition. These studies are designed to test the safety, dosage
 tolerance, absorption, metabolism and distribution of the investigational product in humans,
 the side effects associated with increasing doses, and, if possible, to gain early evidence
 on effectiveness.

 Phase
 2. The investigational product is administered to a limited patient population with a specified
 disease or condition to evaluate the preliminary efficacy, optimal dosages and dosing schedule
 and to identify possible adverse side effects and safety risks. Multiple Phase 2 clinical
 trials may be conducted to obtain information prior to beginning larger and more expensive
 Phase 3 clinical trials.

 Phase
 3. The investigational product is administered to an expanded patient population to further
 evaluate dosage, to provide statistically significant evidence of clinical efficacy and to
 further test for safety, generally at multiple geographically dispersed clinical trial sites.
 These clinical trials are intended to establish the overall risk/benefit ratio of the investigational
 product and to provide an adequate basis for product approval.

 In
some cases, the FDA may require, or companies may voluntarily pursue, additional clinical trials after a product is approved to gain
more information about the product. These so-called Phase 4 studies may be made a condition to approval of the BLA. Concurrent with clinical
trials, companies may complete additional animal studies and develop additional information about the biological characteristics of the
product candidate and must finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements.
The manufacturing process must be capable of consistently producing quality batches of the product candidate and, among other things,
must develop methods for testing the identity, strength, quality and purity of the final product, or for biologics, the safety, purity
and potency. Additionally, appropriate packaging must be selected and tested, and stability studies must be conducted to demonstrate
that the product candidate does not undergo unacceptable deterioration over its shelf life.

 A
sponsor may choose, but is not required, to conduct a foreign clinical study under an IND. When a foreign clinical study is conducted
under an IND, all IND requirements must be met unless waived. When the foreign clinical study is not conducted under an IND, the sponsor
must ensure that the study complies with certain FDA regulatory requirements in order to use the study as support for an IND or application
for marketing approval or licensure, including that the study was conducted in accordance with GCP, including review and approval by
an independent ethics committee and use of proper procedures for obtaining informed consent from subjects, and the FDA is able to validate
the data from the study through an onsite inspection if the FDA deems such inspection necessary. The GCP requirements encompass both
ethical and data integrity standards for clinical studies.

 BLA
Submission and Review

 Assuming
successful completion of all required testing in accordance with all applicable regulatory requirements, the results of product development,
nonclinical studies and clinical trials are submitted to the FDA as part of a BLA requesting approval to market the product for one or
more indications. The BLA must include all relevant data available from pertinent preclinical studies and clinical trials, including
negative or ambiguous results as well as positive findings, together with detailed information relating to the product's chemistry,
manufacturing, controls, and proposed labeling, among other things. Data can come from company-sponsored clinical studies intended to
test the safety and effectiveness of the product, or from a number of alternative sources, including studies initiated and sponsored
by investigators. The submission of a BLA requires payment of a substantial application user fee to the FDA, unless a waiver or exemption
applies.

 In
addition, under the Pediatric Research Equity Act ("PREA"), a BLA or supplement to a BLA must contain data to assess the
safety and effectiveness of the biological product candidate for the claimed indications in all relevant pediatric subpopulations and
to support dosing and administration for each pediatric subpopulation for which the product is safe and effective. The Food and Drug
Administration Safety and Innovation Act requires that a sponsor who is planning to submit a marketing application for a biological product
that includes a new active ingredient, new indication, new dosage form, new dosing regimen or new route of administration submit an initial
pediatric study plan within sixty days after an end-of-Phase 2 meeting or as may be agreed between the sponsor and FDA. Unless otherwise
required by regulation, PREA does not apply to any biological product for an indication for which orphan designation has been granted.

 Within
60 days following submission of the application, the FDA reviews a BLA submitted to determine if it is substantially complete before
the agency accepts it for filing. The FDA may refuse to file any BLA that it deems incomplete or not properly reviewable at the time
of submission and may request additional information. In this event, the BLA must be resubmitted with the additional information. Once
a BLA has been accepted for filing, the FDA's goal is to review standard applications within ten months after the filing date,
or, if the application qualifies for priority review, six months after the FDA accepts the application for filing. In both standard and
priority reviews, the review process may also be extended by FDA requests for additional information or clarification. The FDA reviews
a BLA to determine, among other things, whether a product is safe, pure and potent and the facility in which it is manufactured, processed,
packed or held meets standards designed to assure the product's continued safety, purity and potency. The FDA may convene an advisory
committee to provide clinical insight on application review questions. The FDA is not bound by the recommendations of an advisory committee,
but it considers such recommendations carefully when making decisions.

 Before
approving a BLA, the FDA will typically inspect the facility or facilities where the product is manufactured. The FDA will not approve
an application unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequate
to assure consistent production of the product within required specifications. Additionally, before approving a BLA, the FDA will typically
inspect one or more clinical sites to assure compliance with GCPs. If the FDA determines that the application, manufacturing process
or manufacturing facilities are not acceptable, it will outline the deficiencies in the submission and often will request additional
testing or information. Notwithstanding the submission of any requested additional information, the FDA ultimately may decide that the
application does not satisfy the regulatory criteria for approval.

 After
the FDA evaluates a BLA and conducts inspections of manufacturing facilities where the investigational product and/or its drug substance
will be produced, the FDA may issue an approval letter or a Complete Response letter. An approval letter authorizes commercial marketing
of the product with specific prescribing information for specific indications. A Complete Response letter will describe all of the deficiencies
that the FDA has identified in the BLA, except that where the FDA determines that the data supporting the application are inadequate
to support approval, the FDA may issue the Complete Response letter without first conducting required inspections, testing submitted
product lots and/or reviewing proposed labeling. In issuing the Complete Response letter, the FDA may recommend actions that the applicant
might take to place the BLA in condition for approval, including requests for additional information or clarification. The FDA may delay
or refuse approval of a BLA if applicable regulatory criteria are not satisfied, require additional testing or information and/or require
post-marketing testing and surveillance to monitor safety or efficacy of a product.

 If
regulatory approval of a product is granted, such approval will be granted for particular indications and may entail limitations on the
indicated uses for which such product may be marketed. For example, the FDA may approve the BLA with a risk evaluation and mitigation
strategy ("REMS") to ensure the benefits of the product outweigh its risks. A REMS is a safety strategy to manage a known
or potential serious risk associated with a product and to enable patients to have continued access to such medicines by managing their
safe use, and could include medication guides, physician communication plans, or elements to assure safe use, such as restricted distribution
methods, patient registries and other risk minimization tools. The FDA also may condition approval on, among other things, changes to
proposed labeling or the development of adequate controls and specifications. Once approved, the FDA may withdraw the product approval
if compliance with pre- and post-marketing requirements is not maintained or if problems occur after the product reaches the marketplace.
The FDA may require one or more Phase 4 post-market studies and surveillance to further assess and monitor the product's safety
and effectiveness after commercialization, and may limit further marketing of the product based on the results of these post-marketing
studies.

 Combination
Therapy

 Combination
therapy is a treatment modality that involves the use of two or more drugs to be used in combination to treat a disease or condition.
If those drugs are combined in one dosage form, such as one pill, that is known as a fixed dose combination product and it is reviewed
pursuant to the FDA's Combination Rule at 21 CFR 300.50. The rule provides that two or more drugs may be combined in a single dosage
form when each component contributes to the claimed effects and the dosage of each component (amount, frequency, duration) is such that
the combination is safe and effective for a significant patient population requiring such concurrent therapy as defined in the labeling
for the drug. But not all combination therapy falls under the category of a fixed dose combination. For example, the FDA recognizes that
two drugs in separate dosage forms and in separate packaging, that otherwise might be administered as monotherapy for an indication,
also may be used in combination for the same indication. In 2013, the FDA issued guidance to assist sponsors that were developing the
range of combination therapies that fall outside the category of fixed dose combinations. That guidance provides recommendations and
advice on such topics as: (1) assessment at the outset whether two or more therapies are appropriate for use in combination; (2) guiding
principles for nonclinical and clinical development of the combination; (3) options for regulatory pathways to seek marketing approval
of the combination; and (4) post-marketing safety monitoring and reporting obligations. Given the wide range of potential combination
therapy variations, the FDA indicated it intends to assess each potential combination on a case-by case basis and encouraged sponsors
to engage in early and regular consultation with the relevant review division at the agency throughout the development process for its
proposed combination.

 Regulation
of Combination Products

therapeutic products are comprised of multiple components, such as drug components, biologic components, and device components, that
would normally be subject to different regulatory frameworks by the FDA and frequently regulated by different centers at the FDA. These
products are known as combination products. Under the FDCA, the FDA is charged with assigning a center with primary jurisdiction, or
a lead center, for review of a combination product. The determination of which center will be the lead center is based on the "primary
mode of action" of the combination product. Thus, if the primary mode of action of drug/biologic-device combination product is
attributable to the drug or biological product, the FDA center responsible for premarket review of the drug or biological product would
have primary jurisdiction for the combination product. The FDA has also established the Office of Combination Products to address issues
surrounding combination products and provide more certainty to the regulatory review process. That office serves as a focal point for
combination product issues for agency reviewers and industry. It is also responsible for developing guidance and regulations to clarify
the regulation of combination products, and for assignment of the FDA center that has primary jurisdiction for review of combination
products where the jurisdiction is unclear or in dispute. A combination product with a primary mode of action attributable to the drug
or biologic component generally would be reviewed and approved pursuant to the drug or biologic approval processes set forth in the FDCA.
In reviewing the new drug application or BLA for such a product, however, FDA reviewers would consult with their counterparts in the
FDA's Center for Devices and Radiological Health to ensure that the device component of the combination product met applicable
requirements regarding safety, effectiveness, durability and performance. In addition, under FDA regulations, combination products are
subject to cGMP requirements applicable to both drugs and devices, including the Quality System Regulation applicable to medical devices.

 Post-Approval
Requirements

 Any
products manufactured or distributed by us pursuant to FDA approvals are subject to pervasive and continuing regulation by the FDA, including,
among other things, requirements relating to record-keeping, reporting of adverse experiences, periodic reporting, product sampling and
distribution, and advertising and promotion of the product. As part of the manufacturing process, the manufacturer is required to perform
certain tests on each lot of the product before it is released for distribution. After a BLA is approved for a biological product, the
product also may be subject to official lot release. If the product is subject to official release by the FDA, the manufacturer submits
samples of each lot of product to the FDA together with a release protocol showing a summary of the history of manufacture of the lot
and the results of all of the manufacturer's tests performed on the lot. The FDA also may perform certain confirmatory tests on
lots of some products before releasing the lots for distribution by the manufacturer. In addition, the FDA conducts laboratory research
related to the regulatory standards on the safety, purity, and potency or effectiveness of biologics. After approval, most changes to
the approved product, such as adding new indications or other labeling claims, are subject to prior FDA review and approval. There also
are continuing user fee requirements, under which the FDA assesses an annual program fee for each product identified in an approved BLA.
Biologic manufacturers and their subcontractors are required to register their establishments with the FDA and certain state agencies,
and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with cGMPs, which impose certain
procedural and documentation requirements upon us and our third-party manufacturers. Changes to the manufacturing process are strictly
regulated, and, depending on the significance of the change, may require prior FDA approval before being implemented. FDA regulations
also require investigation and correction of any deviations from cGMPs and impose reporting requirements upon us and any third-party
manufacturers that we may decide to use. Accordingly, manufacturers must continue to expend time, money and effort in the area of production
and quality control to maintain compliance with cGMPs and other aspects of regulatory compliance.

 The
FDA may withdraw approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product
reaches the market. Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity
or frequency, or with manufacturing processes, or failure to comply with regulatory requirements, may result in revisions to the approved
labeling to add new safety information; imposition of post-market studies or clinical studies to assess new safety risks; or imposition
of distribution restrictions or other restrictions under a REMS program. Other potential consequences include, among other things:

 restrictions
 on the marketing or manufacturing of a product, complete withdrawal of the product from the
 market or product recalls;

 fines,
 warning letters or holds on post-approval clinical studies;

 refusal
 of the FDA to approve pending applications or supplements to approved applications, or suspension
 or revocation of existing product approvals;

 product
 seizure or detention, or refusal of the FDA to permit the import or export of products;

 consent
 decrees, corporate integrity agreements, debarment or exclusion from federal healthcare programs;

 mandated
 modification of promotional materials and labeling and the issuance of corrective information;

 the
 issuance of safety alerts, Dear Healthcare Provider letters, press releases and other communications
 containing warnings or other safety information about the product; or

 injunctions
 or the imposition of civil or criminal penalties.

 The
FDA closely regulates the marketing, labeling, advertising and promotion of biologics. A company can make only those claims relating
to safety and efficacy, purity and potency that are approved by the FDA and in accordance with the provisions of the approved label.
The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses. Failure to comply with
these requirements can result in, among other things, adverse publicity, warning letters, corrective advertising and potential civil
and criminal penalties. Physicians may prescribe legally available products for uses that are not described in the product's labeling
and that differ from those tested by us and approved by the FDA. Such off-label uses are common across medical specialties. Physicians
may believe that such off-label uses are the best treatment for many patients in varied circumstances. The FDA does not regulate the
behavior of physicians in their choice of treatments. The FDA does, however, restrict manufacturer's communications on the subject
of off-label use of their products.

 Biosimilars
and Reference Product Exclusivity

 The
Patient Protection and Affordable Care Act, as amended by the Healthcare and Education Reconciliation Act (the "ACA") includes
a subtitle called the Biologics Price Competition and Innovation Act of 2009 ("BPCIA"), which created an abbreviated
approval pathway for biological products that are highly similar, or "biosimilar," to or interchangeable with an FDA-approved
reference biological product. The FDA has issued several guidance documents outlining an approach to review and approval of biosimilars.

 Biosimilarity,
which requires that there be no clinically meaningful differences between the biological product and the reference product in terms of
safety, purity, and potency, is generally shown through analytical studies, animal studies, and a clinical study or studies. Interchangeability
requires that a product is biosimilar to the reference product and the product must demonstrate that it can be expected to produce the
same clinical results as the reference product in any given patient and, for products that are administered multiple times to an individual,
the biologic and the reference biologic may be alternated or switched after one has been previously administered without increasing safety
risks or risks of diminished efficacy relative to exclusive use of the reference biologic. A product shown to be biosimilar or interchangeable
with an FDA-approved reference biological product may rely in part on the FDA's previous determination of safety and effectiveness
for the reference product for approval, which can potentially reduce the cost and time required to obtain approval to market the product.
Complexities associated with the larger, and often more complex, structures of biological products, as well as the processes by which
such products are manufactured, pose significant hurdles to implementation of the abbreviated approval pathway that are still being worked
out by the FDA. The FDA has issued guidance documents intended to inform prospective applicants and facilitate the development of proposed
biosimilars and interchangeable biosimilars, as well as to describe the FDA's interpretation of certain statutory requirements
added by the BPCIA.

 Under
the BPCIA, an application for a biosimilar product may not be submitted to the FDA until four years following the date that the reference
product was first licensed by the FDA. In addition, the approval of a biosimilar product may not be made effective by the FDA until 12
years from the date on which the reference product was first licensed. During this 12-year period of exclusivity, another company may
still market a competing version of the reference product if the FDA approves a full BLA for the competing product containing that applicant's
own preclinical data and data from adequate and well-controlled clinical trials to demonstrate the safety, purity and potency of its
product. The BPCIA also created certain exclusivity periods for biosimilars approved as interchangeable products. At this juncture, it
is unclear whether products deemed "interchangeable" by the FDA will, in fact, be readily substituted by pharmacies, which
are governed by state pharmacy law.

 A
reference biologic is granted twelve years of exclusivity from the time of first licensure of the reference product. The first biologic
product submitted under the abbreviated approval pathway that is determined to be interchangeable with the reference product has exclusivity
against other biologics submitted under the abbreviated approval pathway for the lesser of (i) one year after the first commercial marketing,
(ii) 18 months after approval if there is no legal challenge, (iii) 18 months after the resolution in the applicant's favor of
a lawsuit challenging the biologics' patents if an application has been submitted, or (iv) 42 months after the application has
been approved if a lawsuit is ongoing within the 42-month period.

 A
biological product can also obtain pediatric market exclusivity in the United States. Pediatric exclusivity, if granted, adds six months
to existing exclusivity periods and patent terms. This six-month exclusivity, which runs from the end of other exclusivity protection
or patent term, may be granted based on the voluntary completion of a pediatric study in accordance with an FDA-issued "Written
Request" for such a study. The BPCIA is complex and continues to be interpreted and implemented by the FDA. In July 2018, the FDA
announced an action plan to encourage the development and efficient review of biosimilars, including the establishment of a new office
within the agency that will focus on therapeutic biologics and biosimilars. On December 20, 2020, Congress amended the PHSA as part of
the COVID-19 relief bill to further simplify the biosimilar review process by making it optional to show that conditions of use proposed
in labeling have been previously approved for the reference product, which used to be a requirement of the application. In addition,
government proposals have sought to reduce the 12-year reference product exclusivity period. Other aspects of the BPCIA, some of which
may impact the BPCIA exclusivity provisions, have also been the subject of recent litigation. As a result, the ultimate impact, implementation,
and impact of the BPCIA is subject to significant uncertainty.

 As
discussed below, the Inflation Reduction Act of 2022 ("IRA") is a significant new law that intends to foster generic and
biosimilar competition and to lower drug and biologic costs.

 Patent
Term Extension

 In
the United States, after a BLA is approved, owners of relevant drug patents may apply for up to a five-year patent extension, which permits
patent term restoration as compensation for the patent term lost during the FDA regulatory process. The allowable patent term extension
is typically calculated as one-half the time between, the latter of the effective date of an IND and issue date of the patent for which
extension is sought, and the submission date of a BLA, plus the time between BLA submission date and the BLA approval date up to a maximum
of five years. The time can be shortened if the FDA determines that the applicant did not pursue licensure with due diligence. The total
patent term after the extension may not exceed 14 years from the date of product licensure. Only one patent applicable to a licensed
biological product is eligible for extension and only those claims covering the product, a method for using it, or a method for manufacturing
it may be extended and the application for the extension must be submitted prior to the expiration of the patent in question. However,
we may not be granted an extension because of, for example, failing to exercise due diligence during the testing phase or regulatory
review process, failing to apply within applicable deadlines, failing to apply prior to expiration of relevant patents or otherwise failing
to satisfy applicable requirements. Some, but not all, foreign jurisdictions possess patent term extension or other additional patent
exclusivity mechanisms that may be more or less stringent and comprehensive than those of the United States.

 Other
Healthcare Laws and Compliance Requirements

 Pharmaceutical
companies are subject to additional healthcare regulation and enforcement by the federal government and by authorities in the states
and foreign jurisdictions in which they conduct their business. Such laws include, without limitation: the federal Anti-Kickback Statute
("AKS"); the federal False Claims Act ("FCA"); the Health Insurance Portability and Accountability Act of 1996
("HIPAA") and similar foreign, federal and state fraud, abuse and transparency laws.

 The
AKS prohibits, among other things, persons and entities from knowingly and willfully soliciting, receiving, offering or paying remuneration,
to induce, or in return for, either the referral of an individual, or the purchase or recommendation of an item or service for which
payment may be made under any federal healthcare program. The term remuneration has been interpreted broadly to include anything of value.

 The
AKS has been interpreted to apply to arrangements between pharmaceutical manufacturers on one hand, and prescribers and purchasers on
the other. The government often takes the position that to violate the AKS, only one purpose of the remuneration need be to induce referrals,
even if there are other legitimate purposes for the remuneration. There are a number of statutory exceptions and regulatory safe harbors
protecting some common activities from AKS prosecution, but they are drawn narrowly and practices that involve remuneration, such as
consulting agreements, that may be alleged to be intended to induce prescribing, purchasing or recommending may be subject to scrutiny
if they do not qualify for an exception or safe harbor. Our practices may not in all cases meet all of the criteria for protection under
a statutory exception or regulatory safe harbor. Failure to meet all of the requirements of a particular applicable statutory exception
or regulatory safe harbor does not make the conduct per se illegal under the AKS. Instead, the legality of the arrangement will be evaluated
on a case-by-case basis based on a cumulative review of all of its facts and circumstances. A person or entity does not need to have
actual knowledge of the statute or specific intent to violate it in order to have committed a violation.

 Civil
and criminal false claims laws, including the FCA, and civil monetary penalty laws, which can be enforced through civil whistleblower
or qui tam actions, prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims
for payment of federal government funds, including in federal healthcare programs, that are false or fraudulent. Pharmaceutical and other
healthcare companies have been prosecuted under these laws for engaging in a variety of different types of conduct that "caused"
the submission of false claims to federal healthcare programs. Under the AKS, for example, a claim resulting from a violation of the
AKS is deemed to be a false or fraudulent claim for purposes of the FCA.

 HIPAA
created additional federal criminal statutes that prohibit, among other things, executing a scheme to defraud any healthcare benefit
program, including private third-party payors, and making false statements relating to healthcare matters. A person or entity does not
need to have actual knowledge of the healthcare fraud statute implemented under HIPAA or specific intent to violate the statute in order
to have committed a violation.

 The
FDCA addresses, among other things, the design, production, labeling, promotion, manufacturing, and testing of drugs, biologics and medical
devices, and prohibits such acts as the introduction into interstate commerce of adulterated or misbranded drugs or devices. The PHSA
also prohibits the introduction into interstate commerce of unlicensed or mislabeled biological products.

 The
U.S. federal Physician Payments Sunshine Act requires certain manufacturers of drugs, devices, biologics and medical supplies for which
payment is available under Medicare, Medicaid or the Children's Health Insurance Program, with specific exceptions, to annually
report to the Centers for Medicaid & Medicare Services ("CMS") information related to payments or other transfers of
value to various healthcare professionals including physicians, physician assistants, nurse practitioners, clinical nurse specialists,
certified nurse anesthetists, certified nurse-midwives, and teaching hospitals, as well as ownership and investment interests held by
physicians and their immediate family members. Beginning on January 1, 2023, California Assembly Bill 1278 requires California physicians
and surgeons to notify patients of the Open Payments database established under the federal Physician Payments Sunshine Act.

 We
are also subject to federal price reporting laws and federal consumer protection and unfair competition laws. Federal price reporting
laws require manufacturers to calculate and report complex pricing metrics to government programs, where such reported prices may be
used in the calculation of reimbursement and/ or discounts on approved products. Federal consumer protection and unfair competition laws
broadly regulate marketplace activities and activities that potentially harm consumers.

 We
are also subject to additional similar U.S. state and foreign law equivalents of each of the above federal laws, which, in some cases,
differ from each other in significant ways, and may not have the same effect, thus complicating compliance efforts. If our operations
are found to be in violation of any of such laws or any other governmental regulations that apply, we may be subject to penalties, including,
without limitation, civil, criminal and administrative penalties, damages, fines, exclusion from government-funded healthcare programs,
such as Medicare and Medicaid or similar programs in other countries or jurisdictions, integrity oversight and reporting obligations
to resolve allegations of non-compliance, disgorgement, individual imprisonment, contractual damages, reputational harm, diminished profits
and the curtailment or restructuring of our operations.

 Data
Privacy and Security

 Numerous
state, federal, and foreign laws govern the collection, dissemination, use, access to, confidentiality, and security of personal information,
including health-related information. In the United States, numerous federal and state laws and regulations, including state data breach
notification laws, state health information privacy laws, and federal and state consumer protection laws and regulations, govern the
collection, use, disclosure, and protection of health-related and other personal information could apply to our operations or the operations
of our partners. For example, HIPAA, as amended by the Health Information Technology for Economic and Clinical Health ("HITECH"),
and their respective implementing regulations imposes data privacy, security, and breach notification obligations on certain health care
providers, health plans, and health care clearinghouses, known as covered entities, as well as their business associates and their covered
subcontractors that perform certain services that involve using, disclosing, creating, receiving, maintaining, or transmitting individually
identifiable protected health information ("PHI") for or on behalf of such covered entities. These requirements imposed by
HIPAA and the HITECH Act on covered entities and business associates include entering into agreements that require business associates
protect PHI provided by the covered entity against improper use or disclosure, among other things; following certain standards for the
privacy of PHI, which limit the disclosure of a patient's past, present, or future physical or mental health or condition or information
about a patient's receipt of health care if the information identifies, or could reasonably be used to identify, the individual;
ensuring the confidentiality, integrity, and availability of all PHI created, received, maintained, or transmitted in electronic form,
to identify and protect against reasonably anticipated threats or impermissible uses or disclosures to the security and integrity of
such PHI; and reporting of breaches of PHI to individuals and regulators. Entities that are found to be in violation of HIPAA may be
subject to significant civil, criminal, and administrative fines and penalties and/or additional reporting and oversight obligations
if required to enter into a resolution agreement and corrective action plan with the U.S. Department of Health and Human Services ("HHS")
to settle allegations of HIPAA non-compliance. A covered entity or business associate is also liable for civil money penalties for a
violation that is based on an act or omission of any of its agents, which may include a downstream business associate, as determined
according to the federal common law of agency. HITECH also increased the civil and criminal penalties applicable to covered entities
and business associates and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts
to enforce HIPAA and seek attorneys' fees and costs associated with pursuing federal civil actions. To the extent that we submit
electronic healthcare claims and payment transactions that do not comply with the electronic data transmission standards established
under HIPAA and HITECH, payments to us may be delayed or denied.

 In
addition, state health information privacy laws, such as California's Confidentiality of Medical Information Act and Washington's
My Health My Data Act, govern the privacy and security of health-related information, specifically, may apply even when HIPAA does not
and impose additional requirements.

 Even
when HIPAA and state health information privacy laws do not apply, according to the FTC and state Attorneys General, violating consumers'
privacy rights or failing to take appropriate steps to keep consumers' personal information secure may constitute unfair acts or
practices in or affecting commerce in violation of Section 5(a) of the Federal Trade Commission Act and state consumer protection laws.

 In
addition, certain state laws, such as the California Consumer Privacy Act of 2018, as amended by the California Privacy Rights Act of
2020 ("CCPA"), govern the privacy and security of personal information, including health-related information in certain circumstances,
some of which are more stringent than HIPAA in various ways. Numerous other states have passed similar laws, but many differ from each
other in significant ways and may not have the same effect, thus complicating compliance efforts. The CCPA applies to personal data of
consumers, business representatives, and employees, and imposes obligations on certain businesses that do business in California, including
to provide specific disclosures in privacy notices, and affords rights to California residents in relation to their personal information.
Health information falls under the CCPA's definition of personal information where it identifies, relates to, describes, or is
reasonably capable of being associated with or could reasonably be linked, directly or indirectly, with a particular consumer or household
- unless it is subject to HIPAA - and is included under a new category of personal information, "sensitive personal information,"
which is offered greater protection. The numerous other comprehensive privacy laws that have passed or are being considered in other
states, as well as at the federal and local levels, also exempt some data processed in the context of clinical trials; but others exempt
covered entities and business associates subject to HIPAA altogether, further complicating compliance efforts, and increasing legal risk
and compliance costs for us and the third parties upon whom we rely. Additionally, our use of artificial intelligence and machine learning
may be subject to laws and evolving regulations regarding the use of artificial intelligence/machine learning, controlling for data bias,
and antidiscrimination.

to comply with these laws, where applicable, can result in the imposition of significant civil and/or criminal penalties and private
litigation. Privacy and security laws, regulations, and other obligations are constantly evolving, may conflict with each other to complicate
compliance efforts, and can result in investigations, proceedings, or actions that lead to significant civil and/or criminal penalties
and restrictions on data processing.

 Coverage
and Reimbursement

 In
the United States and markets in other countries, patients generally rely on third-party payors to reimburse all or part of the costs
associated with their treatment. Adequate coverage and reimbursement from governmental healthcare programs, such as Medicare and Medicaid,
and commercial payors is critical to new product acceptance. Our ability to successfully commercialize our product candidates will depend
in part on the extent to which coverage and adequate reimbursement for these products and related treatments will be available from government
health administration authorities, private health insurers and other organizations. Even if coverage is provided, the approved reimbursement
amount may not be high enough to allow it to establish or maintain pricing sufficient to realize a sufficient return on its investment.
Government authorities and third-party payors, such as private health insurers and health maintenance organizations, decide which medications
they will pay for and establish reimbursement levels.

 Significant
uncertainty exists as to the coverage and reimbursement status of any pharmaceutical or biological product for which we obtain regulatory
approval. Sales of any product, if approved, depend, in part, on the extent to which such product will be covered by third-party payors,
such as federal, state, and foreign government healthcare programs, commercial insurance and managed healthcare organizations, and the
level of reimbursement, if any, for such product by third-party payors. Decisions regarding whether to cover any of our product candidates,
if approved, the extent of coverage and amount of reimbursement to be provided are made on a plan-by-plan basis. Further, no uniform
policy for coverage and reimbursement exists in the United States, and coverage and reimbursement can differ significantly from payor
to payor. Third-party payors often rely upon Medicare coverage policy and payment limitations in setting their own reimbursement rates,
but also have their own methods and approval process apart from Medicare determinations. As a result, the coverage determination process
is often a time-consuming and costly process that will require us to provide scientific and clinical support for the use of our product
candidates to each payor separately, with no assurance that coverage and adequate reimbursement will be applied consistently or obtained
in the first instance. Factors payors consider in determining reimbursement are based on whether the product is:

 a
 covered benefit under its health plan;

 safe,
 effective and medically necessary;

 cost-effective;
 and

 neither
 experimental nor investigational.

 Third-party
payors are increasingly challenging the prices charged for medical products and services, examining the medical necessity and reviewing
the cost effectiveness of pharmaceutical or biological products, medical devices and medical services, in addition to questioning safety
and efficacy. Adoption of price controls and cost-containment measures, and adoption of more restrictive policies in jurisdictions with
existing controls and measures, could further limit sales of any product that receives approval. Decreases in third-party reimbursement
for any product or a decision by a third-party not to cover a product could reduce physician usage and patient demand for the product.

 For
products administered under the supervision of a physician, obtaining coverage and adequate reimbursement may be particularly difficult
because of the higher prices often associated with such drugs. Additionally, separate reimbursement for the product itself or the treatment
or procedure in which the product is used may not be available, which may impact physician utilization. In addition, companion diagnostic
tests require coverage and reimbursement separate and apart from the coverage and reimbursement for their companion pharmaceutical or
biological products. Similar challenges to obtaining coverage and reimbursement, applicable to pharmaceutical or biological products,
will apply to companion diagnostics.

 In
addition, the U.S. government, state legislatures and foreign governments have continued implementing cost-containment programs, including
price controls, restrictions on coverage and reimbursement and requirements for substitution of generic products. The IRA provides CMS
with significant new authorities intended to curb drug costs and to encourage market competition. For the first time, CMS will be able
to directly negotiate prescription drug prices and to cap out-of-pocket costs. Each year, CMS will select and negotiate a preset number
of high-spend drugs and biologics that are covered under Medicare Part B and Part D that do not have generic or biosimilar competition.
On August 29, 2023, HHS announced the list of the first ten drugs subject to price negotiations. These price negotiations occurred in
2024. In January 2025, CMS announced a list of 15 additional Medicare Part D drugs that will be subject to price negotiations. The IRA
also provides a new "inflation rebate" covering Medicare patients that took effect in 2023 and is intended to counter certain
price increases in prescriptions drugs. The inflation rebate provision requires drug manufacturers to pay a rebate to the federal government
if the price for a drug or biologic under Medicare Part B and Part D increases faster than the rate of inflation. To support biosimilar
competition, beginning in October 2022, qualifying biosimilars may receive a Medicare Part B payment increase for a period of five years.
Separately, if a biologic drug for which no biosimilar exists delays a biosimilar's market entry beyond two years, CMS will be
authorized to subject the biologics manufacturer to price negotiations intended to ensure fair competition. Notwithstanding these provisions,
the IRA's impact on commercialization and competition remains largely uncertain.

 In
addition, net prices for drugs may be reduced by mandatory discounts or rebates required by government healthcare programs or private
payors and by any future relaxation of laws that presently restrict imports of drugs from countries where they may be sold at lower prices
than in the United States. Increasingly, third-party payors are requiring that drug companies provide them with predetermined discounts
from list prices and are challenging the prices charged for medical products. We cannot be sure that reimbursement will be available
for any product candidate that we may commercialize and, if reimbursement is available, the level of reimbursement. In addition, many
pharmaceutical manufacturers must calculate and report certain price reporting metrics to the government, such as average sales price
and best price. Penalties may apply in some cases when such metrics are not submitted accurately and timely. Further, these prices for
drugs may be reduced by mandatory discounts or rebates required by government healthcare programs.

 Finally,
in some foreign countries, the proposed pricing for a drug must be approved before it may be lawfully marketed. The requirements governing
drug pricing vary widely from country to country. For example, the European Union ("EU") provides options for its member
states to restrict the range of medicinal products for which their national health insurance systems provide reimbursement and to control
the prices of medicinal products for human use. To obtain reimbursement or pricing approval, some of these countries may require the
completion of clinical trials that compare the cost effectiveness of a particular product candidate to currently available therapies.
A member state may approve a specific price for the medicinal product or it may instead adopt a system of direct or indirect controls
on the profitability of the company placing the medicinal product on the market. There can be no assurance that any country that has
price controls or reimbursement limitations for pharmaceutical products will allow favorable reimbursement and pricing arrangements for
any of our product candidates. Historically, products launched in the EU do not follow price structures of the United States and generally
prices tend to be significantly lower.

 Healthcare
Reform

 The
United States and some foreign jurisdictions are considering or have enacted a number of reform proposals to change the healthcare system.
There is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs, improving
quality or expanding access. In the United States, the pharmaceutical industry has been a particular focus of these efforts and has been
significantly affected by federal and state legislative initiatives, including those designed to limit the pricing, coverage, and reimbursement
of pharmaceutical and biopharmaceutical products, especially under government-funded health care programs, and increased governmental
control of drug pricing.

 The
ACA, which was enacted in March 2010, substantially changed the way healthcare is financed by both governmental and private insurers
in the United States, and significantly affected the pharmaceutical industry. The ACA contains a number of provisions of particular import
to the pharmaceutical and biotechnology industries, including, but not limited to, those governing enrollment in federal healthcare programs,
a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled,
infused, instilled, implanted or injected, and annual fees based on pharmaceutical companies' share of sales to federal health
care programs. Since its enactment, there have been judicial and Congressional challenges to certain aspects of the ACA, and we expect
there will be additional challenges and amendments to the ACA in the future. For example, the IRA, among other things, extends enhanced
subsidies for individuals purchasing health insurance coverage in ACA marketplaces through plan year 2025. The IRA also eliminates the
"donut hole" under the Medicare Part D program beginning in 2025 by significantly lowering the beneficiary maximum out-of-pocket
cost and creating a new manufacturer discount program.

 Other
legislative changes have been proposed and adopted since the ACA was enacted, including automatic aggregate reductions of Medicare payments
to providers of on average 2% per fiscal year as part of the federal budget sequestration under the Budget Control Act of 2011. These
reductions went into effect in April 2013 and, due to subsequent legislative amendments, will remain in effect until 2032 unless additional
action is taken by Congress.

 In
addition, the Bipartisan Budget Act of 2018, among other things, amended the Medicare Act (as amended by the ACA) to increase the point-of-sale
discounts that manufacturers must agree to offer under the Medicare Part D coverage discount program from 50% to 70% off negotiated prices
of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer's outpatient
drugs being covered under Medicare Part D.

there has recently been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products,
which has resulted in several Congressional inquiries and proposed and enacted federal and state measures designed to, among other things,
reduce the cost of prescription drugs, bring more transparency to product pricing, review the relationship between pricing and manufacturer
patient programs, and reform government program reimbursement methodologies for drug products. For example, in May 2019, CMS adopted
a final rule allowing Medicare Advantage Plans the option to use step therapy for Part B drugs, permitting Medicare Part D plans to apply
certain utilization controls to new starts of five of the six protected class drugs, and requiring the Explanation of Benefits for Part
D beneficiaries to disclose drug price increases and lower cost therapeutic alternatives, which went into effect on January 1, 2021.
In response to the Biden administration's October 2022 executive order, on February 14, 2023, HHS released a report outlining three
new models for testing by the CMS Innovation Center which will be evaluated on their ability to lower the cost of drugs, promote accessibility,
and improve quality of care. It is unclear whether the models will be utilized in any health reform measures in the future. Further,
on December 7, 2023, the Biden administration announced an initiative to control the price of prescription drugs through the use of march-in
rights under the Bayh-Dole Act. On December 8, 2023, the National Institute of Standards and Technology published for comment a Draft
Interagency Guidance Framework for Considering the Exercise of March-In Rights which for the first time includes the price of a product
as one factor an agency can use when deciding to exercise march-in rights. While march-in rights have not previously been exercised,
it is uncertain if that will continue under the new framework.

 Notwithstanding
the IRA, continued legislative and enforcement interest exists in the United States with respect to specialty drug pricing practices.
Specifically, we expect regulators to continue pushing for transparency to drug pricing, reducing the cost of prescription drugs under
Medicare, reviewing the relationship between pricing and manufacturer patient programs, and reforming government program reimbursement
methodologies for drugs.

 Individual
states in the United States have also become increasingly active in passing legislation and implementing regulations designed to control
pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain
drug access and marketing cost disclosure and transparency measures, and designed to encourage importation from other countries and bulk
purchasing. Legally mandated price controls on payment amounts by third-party payors or other restrictions could harm our business, financial
condition, results of operations and prospects. In addition, regional healthcare authorities and individual hospitals are increasingly
using bidding procedures to determine what pharmaceutical products and which suppliers will be included in their prescription drug and
other healthcare programs. This could reduce the ultimate demand for its drugs or put pressure on its drug pricing, which could negatively
affect our business, financial condition, results of operations and prospects.

 Other
Government Regulation Outside of the United States

 In
addition to regulations in the United States, we are subject to a variety of regulations in other jurisdictions governing, among other
things, research and development, clinical trials, testing, manufacturing, safety, efficacy, quality control, labeling, packaging, storage,
record keeping, distribution, reporting, export and import, advertising, marketing and other promotional practices involving biological
products as well as authorization, approval as well as post-approval monitoring and reporting of our products. Because biologically sourced
raw materials are subject to unique contamination risks, their use may be restricted in some countries.

 Whether
or not we obtain FDA approval for a product, we must obtain the requisite approvals from regulatory authorities in foreign countries
prior to the commencement of clinical trials or marketing of the product in those countries. Certain countries outside of the United
States have a similar process that requires the submission of a clinical trial application much like the IND prior to the commencement
of human clinical trials.

 The
requirements and process governing the conduct of clinical trials, including requirements to conduct additional clinical trials, product
licensing, safety reporting, post-authorization requirements, marketing and promotion, interactions with healthcare professionals, pricing
and reimbursement may vary widely from country to country. No action can be taken to market any product in a country until an appropriate
approval application has been approved by the regulatory authorities in that country. The current approval process varies from country
to country, and the time spent in gaining approval varies from that required for FDA approval. In certain countries, the sales price
of a product must also be approved. The pricing review period often begins after market approval is granted. Even if a product is approved
by a regulatory authority, satisfactory prices may not be approved for such product, which would make launch of such products commercially
unfeasible in such countries.

 Regulation
in the European Union

 European
Data Laws

 The
collection and use of personal health data and other personal data in the EU is governed by the provisions of the European General Data
Protection Regulation (EU) 2016/679 ("GDPR"), which came into force in May 2018, and related data protection laws in individual
EU Member States. The GDPR imposes a number of strict obligations and restrictions on the ability to process, including collecting, analyzing
and transferring, personal data of individuals, in particular with respect to health data from clinical trials and adverse event reporting.
The GDPR includes requirements relating to the legal basis of the processing (such as consent of the individuals to whom the personal
data relates), the information provided to the individuals prior to processing their personal data, the personal data breaches which
may have to be notified to the national data protection authorities and data subjects, the measures to be taken when engaging processors,
and the security and confidentiality of the personal data. EU Member States may also impose additional requirements in relation to health,
genetic and biometric data through their national legislation.

 In
addition, the GDPR imposes specific restrictions on the transfer of personal data to countries outside of the European Economic Area
("EEA") that are not considered by the European Commission ("EC") to provide an adequate level of data protection.
Appropriate safeguards are required to enable such transfers. Among the appropriate safeguards that can be used, the data exporter may
use the standard contractual clauses ("SCCs"). When relying on SCCs, data exporters are also required to conduct a transfer
risk assessment to verify if anything in the law and/or practices of the third country may impinge on the effectiveness of the SCCs in
the context of the transfer at stake and, if so, to identify and adopt supplementary measures that are necessary to bring the level of
protection of the data transferred to the EU standard of essential equivalence. Where no supplementary measure is suitable, the data
exporter should avoid, suspend or terminate the transfer. With regard to the transfer of data from the EEA to the United States, on July
10, 2023, the EC adopted its adequacy decision for the EU-US Data Privacy Framework. On the basis of the new adequacy decision, personal
data can flow from the EEA to U.S. companies participating in the framework. With regard to the transfer of data from the EU to the United
Kingdom ("UK"), personal data may freely flow from the EEA to the UK since the UK is deemed to have an adequate data protection
level. However, the adequacy decisions include a 'sunset clause' which entails that the decisions will automatically expire
four years after their entry into force, unless renewed.

to comply with the requirements of the GDPR and the related national data protection laws of the EU Member States may result in significant
monetary fines for noncompliance of up to 20 million or 4% of the annual global revenues of the noncompliant company, whichever
is greater, other administrative penalties and a number of criminal offenses for organizations and, in certain cases, their directors
and officers, as well as civil liability claims from individuals whose personal data was processed. Data protection authorities from
the different EU Member States may still implement certain variations, enforce the GDPR and national data protection laws differently,
and introduce additional national regulations and guidelines, which adds to the complexity of processing personal data in the EU.

there are specific requirements relating to processing health data from clinical trials, including public disclosure obligations provided
in the EU Clinical Trials Regulation No. 536/2014 ("CTR"), European Medical Agency ("EMA") disclosure initiatives
and voluntary commitments by industry. Failure to comply with these obligations could lead to government enforcement actions and significant
penalties against us, harm to our reputation, and adversely impact our business and operating results.

 Additionally,
following the UK's withdrawal from the EU and the EEA, companies also have to comply with the UK's data protection laws (including
the UK GDPR (as defined in section 3(10) (as supplemented by section 205(4)) of the Data Protection Act 2018 (the "DPA 2018")),
the DPA 2018, and related data protection laws in the UK). Separate from the fines that can be imposed by the GDPR, the UK regime has
the ability to fine up to the greater of 17.5 million or 4% of global turnover.

 Companies
are subject to specific transfer rules under the UK regime, which broadly mirror the GDPR rules. On February 2, 2022, the UK Secretary
of State laid before the UK Parliament the international data transfer agreement ("IDTA") and the international data transfer
addendum to the EC's standard contractual clauses for international data transfers (Addendum) and a document setting out transitional
provisions. The IDTA and Addendum came into force on March 21, 2022 and replaced the old SCCs for the purposes of the UK regime.

 Regarding
transfers from the UK to the EEA, personal data may flow freely since the EEA is deemed to have an adequate data protection level for
purposes of the UK regime. With regard to the transfer of personal data from the UK to the United States, the UK government has adopted
an adequacy decision for the United States, the UK-US Data Bridge, which came into force on October 12, 2023. The UK-US Data Bridge recognizes
the United States as offering an adequate level of data protection where the transfer is to a U.S. company participating in the EU-US
Data Privacy Framework and the UK Extension.

 Drug
and Biologic Development Process

 Regardless
of where they are conducted, all clinical trials included in applications for marketing authorization ("MA") for human medicines
in the EU/EEA must have been carried out in accordance with EU regulations. This means that clinical trials conducted in the EU/EEA have
to comply with EU clinical trial legislation but also that clinical trials conducted outside the EU/EEA have to comply with ethical principles
equivalent to those set out in the EEA, including adhering to international good clinical practice and the Declaration of Helsinki. The
conduct of clinical trials in the EU is governed by the CTR, which entered into force on January 31, 2022. The CTR replaced the Clinical
Trials Directive 2001/20/EC, ("Clinical Trials Directive") and introduced a complete overhaul of the existing regulation
of clinical trials for medicinal products in the EU.

 Under
the former regime, which will expire after a transition period of three years as outlined below in more detail, before a clinical trial
can be initiated it must be approved in each EU member state where there is a site at which the clinical trial is to be conducted. The
approval must be obtained from two separate entities: the National Competent Authority ("NCA") and one or more Ethics Committees.
The NCA of the EU Member States in which the clinical trial will be conducted must authorize the conduct of the trial, and the independent
Ethics Committee must grant a positive opinion in relation to the conduct of the clinical trial in the relevant EU member state before
the commencement of the trial. Any substantial changes to the trial protocol or other information submitted with the clinical trial applications
must be submitted to or approved by the relevant NCA and Ethics Committees. Under the current regime all suspected unexpected serious
adverse reactions to the investigated drug that occur during the clinical trial must be reported to the NCA and to the Ethics Committees
of the EU member state where they occur.

 A
more unified procedure will apply under the new CTR. A sponsor will be able to submit a single application for approval of a clinical
trial through a centralized EU clinical trials portal (the Clinical Trials Information System or "CTIS"). One national regulatory
authority (the reporting EU member state proposed by the applicant) will take the lead in validating and evaluating the application and
consult and coordinate with the other concerned EU Member States. If an application is rejected, it may be amended and resubmitted through
the EU clinical trials portal. If an approval is issued, the sponsor may start the clinical trial in all concerned EU Member States.
However, a concerned EU member state may in limited circumstances declare an "opt-out" from an approval and prevent the clinical
trial from being conducted in such member state. The CTR also aims to streamline and simplify the rules on safety reporting, and introduces
enhanced transparency requirements such as mandatory submission of a summary of the clinical trial results to the EU Database. The CTR
foresees a three-year transition period. EU Member States will work in CTIS immediately after the system has gone live. Since January
31, 2023, submission of initial clinical trial applications via CTIS is mandatory and CTIS serves as the single entry point for submission
of clinical trial-related information and data. By January 31, 2025, all ongoing trials approved under the former Clinical Trials Directive
will need to comply with the CTR and have to be transitioned to CTIS. On July 19, 2023, the EC published guidance concerning the steps
to be taken in this transition. This guidance provides, among other things, that (i) documentation which was previously assessed will
not be reassessed, (ii) templates that were developed and endorsed by the EU Clinical Trials Expert Group to provide compliance with
the CTR do not need to be updated and (iii) there is no need to retrospectively create a site suitability form, which are only necessary
for new trial sites.

 Under
both the former regime and the new CTR, national laws, regulations, and the applicable GCP and GLP standards must also be respected during
the conduct of the trials, including the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human
Use guidelines on Good Clinical Practice and the ethical principles that have their origin in the Declaration of Helsinki.

 During
the development of a medicinal product, the EMA and national regulators within the EU provide the opportunity for dialogue and guidance
on the development program. At the EMA level, this is usually done in the form of scientific advice, which is given by the Committee
for Medicinal Products for Human Use ("CHMP") on the recommendation of the Scientific Advice Working Party. A fee is incurred
with each scientific advice procedure, but is significantly reduced for designated orphan medicines. Advice from the EMA is typically
provided based on questions concerning, for example, quality (chemistry, manufacturing and controls testing), nonclinical testing and
clinical studies, and pharmacovigilance plans and risk-management programs. Advice is not legally binding with regard to any future Marketing
Authorization Application ("MAA") of the product concerned.

 Drug
Marketing Authorization

 In
the EEA, after completion of all required clinical testing, pharmaceutical products may only be placed on the market after obtaining
a MA. To obtain a MA of a drug under EU regulatory systems, an applicant can submit an MAA through, amongst others, a centralized or
decentralized procedure.

 To
be used or sold in the UK, a drug must have an effective MA obtained by a centralized application through EMA or a national application.
National applications are governed by the Human Medicines Regulations (SI 2012/1916). Applications are made electronically through the
Medicines and Healthcare products Regulatory Agency ("MHRA") Submissions Portal. The process from application to authorizations
generally takes up to 210 days, excluding time taken to provide any additional information or data required by the MHRA.

 On
August 30, 2023, the MHRA published detailed guidance on its recently announced new International Reliance Procedure ("IRP")
for MAAs. The IRP applies since January 1, 2024 and replaces existing EU reliance procedures to apply for authorizations from seven international
regulators (e.g. Health Canada, Swiss Medic, FDA, EMA, among others). The IRP allows medicinal products approved in other jurisdictions
that meet certain criteria to undergo a fast-tracked MHRA review to obtain and/or update a MA in the UK.

 Applicants
can submit initial MAAs to the IRP but the procedure can also be used throughout the lifecycle of a product for post-authorization procedures
including line extensions, variations and renewals.

 Centralized
Authorization Procedure

 The
centralized procedure provides for the grant of a single MA that is issued by the EC following the scientific assessment of the application
by the EMA that is valid for all EU Member States as well as in the three additional EEA Member States (Norway, Iceland and Liechtenstein).
The centralized procedure is compulsory for specific medicinal products, including for medicines developed by means of certain biotechnological
processes, products designated as orphan medicinal products, advanced therapy medicinal products ("ATMP") (gene therapy,
somatic cell therapy or tissue engineered medicines) and medicinal products with a new active substance indicated for the treatment of
certain diseases (HIV/AIDS, cancer, neurodegenerative disorders, diabetes, auto-immune and viral diseases). For medicinal products containing
a new active substance not yet authorized in the EEA before May 20, 2004 and indicated for the treatment of other diseases, medicinal
products that constitute significant therapeutic, scientific or technical innovations or for which the grant of a MA through the centralized
procedure would be in the interest of public health at EU level, an applicant may voluntarily submit an application for a MA through
the centralized procedure.

 Under
the centralized procedure, the CHMP established at the EMA, is responsible for conducting the initial assessment of a drug. The CHMP
is also responsible for several post-authorization and maintenance activities, such as the assessment of modifications or extensions
to an existing MA. Under the centralized procedure, the timeframe for the evaluation of an MAA by the EMA's CHMP is, in principle,
210 days from receipt of a valid MAA. However, this timeline excludes clock stops, when additional written or oral information is to
be provided by the applicant in response to questions asked by the CHMP, so the overall process typically takes a year or more, unless
the application is eligible for an accelerated assessment. Accelerated evaluation might be granted by the CHMP in exceptional cases,
when a medicinal product is expected to be of a major public health interest, particularly from the point of view of therapeutic innovation.
Upon request, the CHMP can reduce the time frame to 150 days if the applicant provides sufficient justification for an accelerated assessment.
The CHMP will provide a positive opinion regarding the application only if it meets certain quality, safety and efficacy requirements.
This opinion is then transmitted to the EC, which has the ultimate authority for granting MA within 67 days after receipt of the CHMP
opinion.

 Decentralized
Authorization Procedure

 Medicines
that fall outside the mandatory scope of the centralized procedure have three routes to authorization: (i) they can be authorized under
the centralized procedure if they concern a significant therapeutic, scientific or technical innovation, or if their authorization would
be in the interest of public health; (ii) they can be authorized under a decentralized procedure where an applicant applies for simultaneous
authorization in more than one EU member state; or (iii) they can be authorized in an EU member state in accordance with that state's
national procedures and then be authorized in other EU countries by a procedure whereby the countries concerned agree to recognize the
validity of the original, national MA (mutual recognition procedure).

 The
decentralized procedure permits companies to file identical MA applications for a medicinal product to the competent authorities in various
EU Member States simultaneously if such medicinal product has not received marketing approval in any EU Member State before. This procedure
is available for pharmaceutical products not falling within the mandatory scope of the centralized procedure. The competent authority
of a single EU Member State, the reference member state, is appointed to review the application and provide an assessment report. The
competent authorities of the other EU Member States, the concerned member states, are subsequently required to grant a MA for their territories
on the basis of this assessment. The only exception to this is where the competent authority of an EU Member State considers that there
are concerns of potential serious risk to public health, the disputed points are subject to a dispute resolution mechanism and may eventually
be referred to the EC, whose decision is binding for all EU Member States.

 Risk
Management Plan

 All
new MAAs must include a Risk Management Plan ("RMP") describing the risk management system that the company will put in place
and documenting measures to prevent or minimize the risks associated with the product. RMPs are continually modified and updated throughout
the lifetime of the medicine as new information becomes available. An updated RMP must be submitted: (i) at the request of EMA or a national
competent authority, or (ii) whenever the risk-management system is modified, especially as the result of new information being received
that may lead to a significant change to the benefit-risk profile or as a result of an important pharmacovigilance or risk-minimization
milestone being reached. The regulatory authorities may also impose specific obligations as a condition of the MA. Since October 20,
2023, all RMPs for centrally authorized products are published by the EMA, subject only to limited redactions.

 MA
Validity Period

 MAs
have an initial duration of five years. After these five years, the authorization may subsequently be renewed on the basis of a reevaluation
of the risk-benefit balance. Once renewed, the MA is valid for an unlimited period unless the EC or the national competent authority
decides, on justified grounds relating to pharmacovigilance, to proceed with only one additional five-year renewal. Applications for
renewal must be made to the EMA at least nine months before the five-year period expires.

 Any
authorization which is not followed by the actual placing of the drug on the EU market (in case of centralized procedure) or on the market
of the authorizing member state within three years after authorization ceases to be valid.

 For
the UK, the period of three years during which the drug has not been marketed in Great Britain will be restarted from the date of conversion
to a Great Britain MA. Conversion refers to the procedure by which, as of January 1, 2021, MAs granted on the basis of a centralized
procedure in the EU are only valid in Northern Ireland but not in Great Britain, whereas, prior EU authorizations have all been automatically
converted into UK MAs effective in Great Britain only.

 On
the other hand, for the EU, in the case the drug has been marketed in the UK, the placing on the UK market before the end of the period
starting when the UK left the EU on January 31, 2020 and ending on December 31, 2020 (the "Brexit Transition Period") will
be taken into account. If, after the end of the Brexit Transition Period, the drug is not placed on any other market of the remaining
EU Member States, the three-year period will start running from the last date the drug was placed on the UK market before the end of
the Brexit Transition Period.

 Advanced
Therapy Medicinal Products

 In
the EU, medicinal products, including ATMPs are subject to extensive pre- and post-market regulation by regulatory authorities at both
the EU and national levels. ATMPs comprise gene therapy products, somatic cell therapy products and tissue engineered products, which
are genes, cells or tissues that have undergone substantial manipulation and that are administered to human beings in order to cure,
diagnose or prevent diseases or regenerate, repair or replace a human tissue. Pursuant to the Regulation (EC) No 1394/2007, the Committee
for Advanced Therapies ("CAT") is responsible in conjunction with the CHMP for the evaluation of ATMPs. The CHMP and CAT
are also responsible for providing guidelines on ATMPs. These guidelines provide additional guidance on the factors that the EMA will
consider in relation to the development and evaluation of ATMPs and include, among other things, the preclinical studies required to
characterize ATMPs. Although such guidelines are not legally binding, compliance with them is often necessary to gain and maintain approval
for product candidates.

 In
addition to the mandatory RMP, the holder of a MA for an ATMP must put in place and maintain a system to ensure that each individual
product and its starting and raw materials, including all substances coming into contact with the cells or tissues it may contain, can
be traced through the sourcing, manufacturing, packaging, storage, transport and delivery to the relevant healthcare institution where
the product is used.

 Exceptional
Circumstances/Conditional Approval

 Similar
to accelerated approval regulations in the United States, conditional MAs can be granted in the EU in exceptional circumstances. A conditional
MA can be granted for medicinal products where, although comprehensive clinical data referring to the safety and efficacy of the medicinal
product have not been supplied, a number of criteria are fulfilled: (i) the benefit/risk balance of the product is positive, (ii) it
is likely that the applicant will be in a position to provide the comprehensive clinical data, (iii) unmet medical needs will be fulfilled
by the grant of the MA and (iv) the benefit to public health of the immediate availability on the market of the medicinal product concerned
outweighs the risk inherent in the fact that additional data are still required. Once a conditional MA has been granted, the MA holder
must fulfil specific obligations within defined timelines. A conditional MA is valid for one year and must be renewed annually, but it
can be converted into a standard MA once the MA holder fulfils the obligations imposed and the complete data confirm that the medicine's
benefits continue to outweigh its risks.

 Data
and Market Exclusivity

 As
in the United States, it may be possible to obtain a period of market and / or data exclusivity in the EU that would have the effect
of postponing the entry into the marketplace of a competitor's generic, hybrid or biosimilar product (even if the pharmaceutical
product has already received a MA) and prohibiting another applicant from relying on the MA holder's pharmacological, toxicological
and clinical data in support of another MA for the purposes of submitting an application, obtaining MA or placing the product on the
market. Innovative medicinal products, referred to as New Chemical Entities ("NCEs") approved in the EU qualify for eight
years of data exclusivity and 10 years of marketing exclusivity.

 An
additional non-cumulative one-year period of marketing exclusivity is possible if during the data exclusivity period (the first eight
years of the 10-year marketing exclusivity period), the MA holder obtains an authorization for one or more new therapeutic indications
that are deemed to bring a significant clinical benefit compared to existing therapies.

 The
data exclusivity period begins on the date of the product's first MA in the EU. After eight years, a generic product application
may be submitted and generic companies may rely on the MA holder's data. However, a generic product cannot launch until two years
later (or a total of 10 years after the first MA in the EU of the innovator product), or three years later (or a total of 11 years after
the first MA in the EU of the innovator product) if the MA holder obtains MA for a new indication with significant clinical benefit within
the eight-year data exclusivity period. Additionally, another non-cumulative one-year period of data exclusivity can be added to the
eight years of data exclusivity where an application is made for a new indication for a well-established substance, provided that significant
pre-clinical or clinical studies were carried out in relation to the new indication.

 Another
year of data exclusivity may be added to the eight years, where a change of classification of a pharmaceutical product has been authorized
on the basis of significant pre-trial tests or clinical trials (when examining an application by another applicant for or holder of MA
for a change of classification of the same substance the competent authority will not refer to the results of those tests or trials for
one year after the initial change was authorized).

 Products
may not be granted data exclusivity since there is no guarantee that a product will be considered by the EU's regulatory authorities
to include an NCE. Even if a compound is considered to be an NCE and the MA applicant is able to gain the prescribed period of data exclusivity,
another company nevertheless could also market another version of the medicinal product if such company can complete a full MAA with
their own complete database of pharmaceutical tests, preclinical studies and clinical trials and obtain MA of its product.

 On
April 26, 2023, the EC submitted a proposal for the reform of the European pharmaceutical legislation. The current draft envisages e.g.,
a shortening of the periods of data exclusivity, however, there is currently neither a final version of this draft nor a date for its
entry into force. While the European Parliament adopted its approving position on the reform on April 10, 2024, no further required legislative
steps have been taken since.

 Pediatric
Development

 In
the EU, companies developing a new medicinal product are obligated to study their product in children and must therefore submit a PIP
together with a request for agreement to the EMA. The EMA issues a decision on the PIP based on an opinion of the EMA's Pediatric
Committee. Companies must conduct pediatric clinical trials in accordance with the PIP approved by the EMA, unless a deferral (e.g. until
enough information to demonstrate its effectiveness and safety in adults is available) or waiver (e.g. because the relevant disease or
condition occurs only in adults) has been granted by the EMA. The MAA for the medicinal product must include the results of all pediatric
clinical trials performed and details of all information collected in compliance with the approved PIP, unless a waiver or a deferral
has been granted, in which case the pediatric clinical trials may be completed at a later date. Medicinal products that are granted an
MA on the basis of the pediatric clinical trials conducted in accordance with the approved PIP are eligible for a six-month extension
of the protection under a supplementary protection certificate (if any is in effect at the time of approval), or, in the case of orphan
medicinal products, a two-year extension of the orphan market exclusivity. This pediatric reward is subject to specific conditions and
is not automatically available when data in compliance with the approved PIP are developed and submitted. An approved PIP is also required
when a MA holder wants to add a new indication, medicinal form or route of administration for a medicine that is already authorized and
covered by intellectual property rights.

 In
the UK, the MHRA has published guidance on the procedures for UK Paediatric Investigation Plans ("PIPs") which, where possible,
mirror the submission format and requirements of the EU system. EU PIPs remain applicable for Northern Ireland and EU PIPs agreed by
the EMA prior to January 1, 2021 have been adopted as UK PIPs.

 Post-Approval
Regulation

 Similar
to the United States, both MA holders and manufacturers of medicinal products are subject to comprehensive regulatory oversight by the
EMA, the EC and/or the competent regulatory authorities of the EU Member States. This oversight applies both before and after grant of
manufacturing licenses and MAs. It includes control of compliance with EU good manufacturing practices rules, manufacturing authorizations,
pharmacovigilance rules and requirements governing advertising, promotion, sale, and distribution, recordkeeping, importing and exporting
of medicinal products.

by us or by any of our third-party partners, including suppliers, manufacturers and distributors to comply with EU laws and the related
national laws of individual EU Member States governing the conduct of clinical trials, manufacturing approval, MA of medicinal products
and marketing of such products, both before and after grant of MA, statutory health insurance, bribery and anti-corruption or other applicable
regulatory requirements may result in administrative, civil or criminal penalties. These penalties could include delays or refusal to
authorize the conduct of clinical trials or to grant MA, product withdrawals and recalls, product seizures, suspension, withdrawal or
variation of the MA, total or partial suspension of production, distribution, manufacturing or clinical trials, operating restrictions,
injunctions, suspension of licenses, fines and criminal penalties.

 The
holder of an MA for a medicinal product must also comply with EU pharmacovigilance legislation and its related regulations and guidelines,
which entail many requirements for conducting pharmacovigilance, or the assessment and monitoring of the safety of medicinal products.

 These
pharmacovigilance rules can impose on holders of MAs the obligation to conduct a labor intensive collection of data regarding the risks
and benefits of marketed medicinal products and to engage in ongoing assessments of those risks and benefits, including the possible
requirement to conduct additional clinical studies or post-authorization safety studies to obtain further information on a medicine's
safety, or to measure the effectiveness of risk-management measures, which may be time consuming and expensive and could impact our profitability.
MA holders must establish and maintain a pharmacovigilance system and appoint an individual qualified person for pharmacovigilance, who
is responsible for oversight of that system. Key obligations include expedited reporting of suspected serious adverse reactions and submission
of Periodic Safety Update Reports ("PSURs") in relation to medicinal products for which they hold MAs. The EMA reviews PSURs
for medicinal products authorized through the centralized procedure. If the EMA has concerns that the risk benefit profile of a product
has varied, it can adopt an opinion advising that the existing MA for the product be suspended, withdrawn or varied. The agency can advise
that the MA holder be obliged to conduct post-authorization Phase 4 safety studies. If the EC agrees with the opinion, it can adopt a
decision varying the existing MA. Failure by the MA holder to fulfill the obligations for which the EC's decision provides can
undermine the ongoing validity of the MA.

 More
generally, non-compliance with pharmacovigilance obligations can lead to the variation, suspension or withdrawal of the MA for the product
or imposition of financial penalties or other enforcement measures.

 The
manufacturing process for pharmaceutical products in the EU is highly regulated and regulators may shut down manufacturing facilities
that they believe do not comply with regulations. Manufacturing requires a manufacturing authorization, and the manufacturing authorization
holder must comply with various requirements set out in the applicable EU laws, regulations and guidance, including Directive 2001/83/EC,
Directive 2003/94/EC (repealed by Directive 2017/1572 on January 31, 2022), Regulation (EC) No 726/2004 and the European Commission Guidelines
for Good Manufacturing Practice ("GMP"). These requirements include compliance with EU GMP standards when manufacturing pharmaceutical
products and active pharmaceutical ingredients, including the manufacture of active pharmaceutical ingredients outside of the EU with
the intention to import the active pharmaceutical ingredients into the EU. Amendments or replacements of at least Directive 2001/83/EC
and Regulation (EC) No 726/2004 are part of the reform proposal for European pharmaceutical legislation. Similarly, the distribution
of pharmaceutical products into and within the EU is subject to compliance with the applicable EU laws, regulations and guidelines, including
the requirement to hold appropriate authorizations for distribution granted by the competent authorities of the EU Member States. The
manufacturer or importer must have a qualified person who is responsible for certifying that each batch of product has been manufactured
in accordance with GMP, before releasing the product for commercial distribution in the EU or for use in a clinical trial. Manufacturing
facilities are subject to periodic inspections by the competent authorities for compliance with GMP.

 Sales
and Marketing Regulations

 The
advertising and promotion of our products is also subject to EU laws concerning promotion of medicinal products, interactions with physicians,
misleading and comparative advertising and unfair commercial practices. In addition, other national legislation of individual EU Member
States may apply to the advertising and promotion of medicinal products and may differ from one country to another. These laws require
that promotional materials and advertising in relation to medicinal products comply with the product's SmPC as approved by the
competent regulatory authorities. The SmPC is the document that provides information to physicians concerning the safe and effective
use of the medicinal product. It forms an intrinsic and integral part of the MA granted for the medicinal product. Promotion of a medicinal
product that does not comply with the SmPC is considered to constitute off-label promotion. All advertising and promotional activities
for the product must be consistent with the approved SmPC and therefore all off-label promotion is prohibited. Direct-to-consumer advertising
of prescription-only medicines is also prohibited in the EU. Violations of the rules governing the promotion of medicinal products in
the EU could be penalized by administrative measures, fines and imprisonment. These laws may further limit or restrict the advertising
and promotion of our products to the general public and may also impose limitations on its promotional activities with healthcare professionals.

 EU
regulation with regards to dispensing, sale and purchase of medicines has generally been preserved in the UK following Brexit, through
the Human Medicines Regulations 2012. However, organizations wishing to sell medicines online need to register with the MHRA. Following
Brexit, the requirements to display the common logo no longer apply to UK-based online sellers, except for those established in Northern
Ireland.

 Anti-Corruption
Legislation

 In
the EU, interactions between pharmaceutical companies and physicians are also governed by strict laws, regulations, industry self-regulation
codes of conduct and physicians' codes of professional conduct both at EU level and in the individual EU Member States. The provision
of benefits or advantages to physicians to induce or encourage the prescription, recommendation, endorsement, purchase, supply, order
or use of medicinal products is prohibited in the EU. The provision of benefits or advantages to physicians is also governed by the national
anti-bribery laws of the EU Member States. Violation of these laws could result in substantial fines and imprisonment.

 Payments
made to physicians in certain EU Member States also must be publicly disclosed. Moreover, agreements with physicians must often be the
subject of prior notification and approval by the physician's employer, his/her regulatory professional organization, and/or the
competent authorities of the individual EU Member States. These requirements are provided in the national laws, industry codes, or professional
codes of conduct, applicable in the individual EU Member States. Failure to comply with these requirements could result in reputational
risk, public reprimands, administrative penalties, fines or imprisonment.

 In
the UK, the pharmaceutical sector is recognized as being particularly vulnerable to corrupt practices, some of which fall within the
scope of the Bribery Act 2010. Due to the Bribery Act 2010's far-reaching territorial application, the potential penalized act
does not have to occur in the UK to become within its scope. If the act or omission does not take place in the UK, but the person's
act or omission would constitute an offense if carried out there and the person has a close connection with the UK, an offense will still
have been committed.

 The
Bribery Act 2010 is comprised of four offenses that cover (i) individuals, companies and partnerships that give, promise or offer bribes,
(ii) individuals, companies and partnerships that request, agree to receive or accept bribes, (iii) individuals, companies and partnerships
that bribe foreign public officials, and (iv) companies and partnerships that fail to prevent persons acting on their behalf from paying
bribes. The penalties imposed under the Bribery Act 2010 depend on the offence committed, harm and culpability and penalties range from
unlimited fines to imprisonment for a maximum term of ten years and in some cases both.

 Regulations
in the UK and Other Markets

 The
UK formally left the EU on January 31, 2020 and EU laws now only apply to the UK in respect of Northern Ireland as laid out in the Protocol
on Ireland and Northern Ireland and as amended by the Windsor Framework sets out a long-term set of arrangements for the supply of medicines
into Northern Ireland. The EU and the UK agreed on a trade and cooperation agreement ("TCA"), which includes provisions affecting
the life sciences sector (including on customs and tariffs). There are some specific provisions concerning pharmaceuticals, including
the mutual recognition of GMP, inspections of manufacturing facilities for medicinal products and GMP issued documents. The TCA does
not, however, contain wholesale mutual recognition of UK and EU pharmaceutical regulations and product standards.

 The
UK government has adopted the Medicines and Medical Devices Act 2021 (the "MMDA") to enable the UK's regulatory frameworks
to be updated following the UK's departure from the EU. The MMDA introduces regulation-making, delegated powers covering the fields
of human medicines, clinical trials of human medicines, veterinary medicines and medical devices. The MHRA has since been consulting
on future regulations for medicines and medical devices in the UK.

 For
other countries outside of the EU, such as countries in Eastern Europe, Latin America or Asia, the requirements governing the conduct
of clinical trials, product licensing, pricing and reimbursement vary from country to country. In all cases, again, the clinical trials
must be conducted in accordance with GCP and the applicable regulatory requirements and the ethical principles that have their origin
in the Declaration of Helsinki.

 If
we fail to comply with applicable foreign regulatory requirements, we may be subject to, among other things, fines, suspension of clinical
trials, suspension or withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions and criminal prosecution.

 Corporate
Information

 We
were formed as a Delaware corporation in 1992 under the name "Nuvelo, Inc." and subsequently, in 2009, we completed a business
combination with ARCA biopharma, Inc. On August 29, 2024, we completed the Merger with Pre-Merger Oruka and changed our name from "ARCA
biopharma, Inc." to "Oruka Therapeutics, Inc." Our corporate headquarters are located at 855 Oak Grove Avenue, Suite
100, Menlo Park, California 94025. The telephone number at our corporate headquarters is (650) 606-7910. Our corporate website address
is www.orukatx.com. We do not incorporate information contained on, or accessible through, our website into this Annual Report
on Form 10-K, and you should not consider it part of this Annual Report.

 Employees
and Human Capital Resources

 As
of December 31, 2024 and as of February 28, 2025, we had 28 full-time employees and 36 full-time employees, respectively. We also engage
temporary employees and consultants to augment our existing workforce. None of our employees are represented by a labor union or covered
under a collective bargaining agreement. We consider our relationship with our employees to be good.

 We
recognize that attracting, motivating, and retaining talent at all levels is vital to continuing our success. We invest in our employees
through high-quality benefits, professional development opportunities, and various health and wellness initiatives and offer competitive
compensation packages (base salary and incentive plans), ensuring fairness in internal compensation practices. The principal purposes
of our incentive plans (bonus and equity) are to align with the long-term interests of our stakeholders and stockholders.

 Item
1A. Risk Factors.

 Risk
Factors Summary

 We
are subject to a number of risks that could harm our business, financial condition, results of operations and/or growth prospects or
cause our actual results to differ materially from those contained in forward-looking statements we have made in this Form 10-K and those
we may make from time to time. The success of our product candidates will depend on a variety of factors. We do not have complete control
over many of these factors, including certain aspects of clinical development and the regulatory submission process, potential threats
to our intellectual property rights and the manufacturing, marketing, distribution and sales efforts of any current or future collaborator.
In addition, some of the factors, events and contingencies discussed below may have occurred in the past, but the disclosures below are
not representations as to whether or not the factors, events or contingencies have occurred in the past and instead reflect our beliefs
and opinions as to the factors, events, or contingencies that could materially and adversely affect us in the future.

 The
following summary is not exhaustive and is qualified by reference to the full set of risk factors set forth in Item 1A "Risk Factors"
of this Form 10-K. Please carefully consider all the information in this Form 10-K, including the full set of risks set forth in the
"Risk Factors" section and in our other filings with the U.S. Securities and Exchange Commission ("SEC"), before
making an investment decision regarding Oruka.

 Risks
Related to Drug Development and Regulatory Approval

 Drug
 development and obtaining and maintaining regulatory approval for drug products is costly,
 time-consuming, and highly uncertain.

 We
 are substantially dependent on the success of our two most advanced programs, ORKA-001 and
 ORKA-002. Our projected development goals, including our clinical trials, may not be successful
 or we may fail to achieve our projected development goals in the time frames we announce
 and expect.

 We
 may not be able to meet requirements for the chemistry, manufacturing and control of our
 programs.

 The
 U.S. Food and Drug Administration ("FDA") and comparable foreign regulatory approval
 processes are lengthy and time consuming and we may not be able to obtain or may be delayed
 in obtaining regulatory approvals for our product candidates. Moreover, even if we obtain
 regulatory approval, we will be subject to ongoing regulatory obligations.

 We
 face competition from entities that have developed or may develop programs for the diseases
 addressed by product candidates developed by us.

 Risks
Related to Our Financial Condition and Capital Requirements

 We
 are a clinical stage biopharmaceutical company with a limited operating history on which
 to assess our business; we have not completed any clinical trials, and have no products approved
 for commercial sale.

 We
 have historically incurred losses and we anticipate that we will continue to incur losses
 for the foreseeable future.

 We
 have never generated revenue from product sales and may never be profitable.

 We
 may not be able to raise the capital that we need to support our business plans.

 Raising
 additional capital may cause dilution to our stockholders, restrict our operations or require
 us to relinquish rights to our technologies or product candidates.

 Risks
Related to Our Intellectual Property

 Our
 ability to obtain and protect our patents and other proprietary rights is uncertain and we
 may fail in obtaining or maintaining necessary rights to our programs.

 We
 may become subject to claims challenging the inventorship or ownership of our intellectual
 property and may be subject to patent infringement claims or may need to file such claims.

 Our
 patents and our ability to protect our products may be impaired by changes to patent laws,
 and our patent protection could be reduced or eliminated for non-compliance with legal requirements.

 We
 may fail to identify or interpret relevant third-party patents.

 Patent
 terms may be inadequate to protect our competitive position of our programs.

 Our technology
 licensed from third parties may be subject to retained rights.

 Risks
Related to Our Reliance on Third Parties

 We
 currently rely on agreements with third parties to develop our product candidates. If we
 are unable to maintain collaborations or licensing arrangements, or if our collaborations
 or licensing arrangements are not successful, our business could be negatively impacted.

 Third
 parties we rely on for the execution of nonclinical studies and clinical trials may fail
 to carry out their contractual duties.

 We
 may be unable to use third-party manufacturing sites, our third-party manufacturers may encounter
 difficulties in production or we may need to switch or create third-party manufacturer redundancies.

 Other
Risk Factors - Risks Related to Employee Matters, Managing Growth, Other Risks Related to Our Business, and Owning Our Common Stock

 Our
 estimates of market opportunity and forecasts of market growth may prove to be inaccurate,
 and even if the markets in which we compete achieve the forecasted growth, our business may
 not grow at similar rates, or at all.

 Our business
 is dependent on key personnel, and we will be harmed if we cannot recruit and retain highly qualified personnel to successfully implement
 our business strategy.

 In
 order to successfully implement our plans and strategies, we will need to grow the size of
 our organization, and we may experience difficulties in managing this growth.

 Significant
 disruptions of information technology systems or breaches of data security could adversely
 affect our business.

 in and failures to comply with United States and foreign privacy and data protection laws,
 regulations and standards may adversely affect our business, operations and consolidated
 financial performance.

 We
 may become exposed to costly and damaging liability claims and our insurance may not cover
 all damages from such claims.

 Our
 business could be adversely affected by macroeconomic or geopolitical conditions.

 We
 do not anticipate paying any dividends in the foreseeable future.

 Future
 sales of shares by existing stockholders could cause our stock price to decline.

 Future
 sales and issuances of equity and debt could result in additional dilution to our stockholders
 and could cause our stock price to decline.

 Risk Factors

 Risks
Related to Our Financial Condition and Capital Requirements

 We
are a clinical stage biopharmaceutical company with a limited operating history on which to assess our business; we have not completed
any clinical trials, have no products approved for commercial sale, have historically incurred losses, and we anticipate that we will
continue to incur significant losses for the foreseeable future. Moreover, we have never generated revenue from product sales and may
never be profitable.

 We
are a clinical stage biopharmaceutical company with a limited operating history. We will need to raise substantial additional capital
to continue to fund our operations in the future. We have based our estimates on assumptions that may prove to be wrong, and could exhaust
our available financial resources sooner than we currently anticipate. We have devoted substantially all of our financial resources to
identify, acquire, and develop our product candidates, organizing and staffing our company, and providing general and administrative
support for our operations.

 Biopharmaceutical
product development is a highly speculative undertaking and involves a substantial degree of risk. We expect our losses to increase as
our product candidates enter advanced clinical trials. It may be several years, if ever, before we complete pivotal clinical trials
or have a product candidate approved for commercialization. We expect to invest significant funds into the research and development of
our programs to determine the potential to advance product candidates to regulatory approval. If we obtain regulatory approval to market
a product candidate, our future revenue will depend upon the size of any markets in which our product candidates may receive approval,
and our ability to achieve sufficient market acceptance, pricing, coverage and adequate reimbursement from third-party payors, and
adequate market share for our product candidates in those markets. Even if we obtain adequate market share for our product candidates,
we may never become profitable despite obtaining such market share and acceptance of our products.

 We
expect to continue to incur significant expenses and increasing operating losses for the foreseeable future and our expenses will increase
substantially if and as we:

 continue
 the clinical development of our product candidates, including advancing our product candidates
 into larger, more expensive trials;

 continue
 efforts to discover and develop new product candidates, including initiating preclinical
 studies or clinical trials;

 progress
 our chemistry, manufacturing and control development, registration, and validation, including
 the manufacture of our product candidates by third parties, including increasing volumes
 manufactured by third parties;

 seek
 regulatory and marketing approvals and reimbursement for our product candidates;

 establish
 a sales, marketing, and distribution infrastructure to commercialize any products for which
 we may obtain marketing approval and market for ourselves;

 make
 milestone, royalty, or other payments under third-party license agreements;

 seek
 to maintain, protect, and expand our intellectual property portfolio; and

 experience
 any delays or encounter issues with the development and potential regulatory approval of
 our product candidates such as safety issues, manufacturing delays, clinical trial delays,
 longer follow-up for planned studies or trials, additional major studies or trials,
 or supportive trials necessary to support marketing approval.

 If
we are unable to raise additional capital when required or on acceptable terms, we may be required to curtail our product development
activities and other activities commensurate with the magnitude of the shortfall and our product development activities may cease altogether,
which could materially harm our business, financial condition, and results of operations. To the extent that the costs of our activities
exceed our current estimates and we are unable to raise sufficient additional capital to cover such costs, we will need to reduce operating
expenses, sell assets, enter into strategic transactions, or effect a combination of the above. No assurance can be given that we will
be able to enter into any of such transactions on acceptable terms, if at all. Any of the following events could have a material adverse
effect on our business, operating results, and prospects:

 a
 delay, scaling back, or discontinuation of the development or commercialization of our product
 candidates;

 seeking
 strategic partnerships, or amending existing partnerships, for research and development programs
 at an earlier stage than otherwise would be desirable or that we otherwise would have sought
 to develop independently, or on terms that are less favorable than might otherwise be available
 in the future;

 disposal
 of technology assets, or the relinquishing or licensing of assets on unfavorable terms, of
 our rights to technologies or any of our product candidates that we otherwise would seek
 to develop or commercialize ourselves;

 pursuing
 the sale of the company to a third party at a price that may result in a loss on investment
 for our stockholders; or

 filing
 for bankruptcy or cease operations altogether.

 Even
if we are successful in raising new capital, we could be limited in the amount of capital we raise due to investor demand restrictions
placed on the amount of capital we raise, or other reasons.

 Raising
additional capital may cause dilution to our stockholders, restrict our operations, or require us to relinquish rights.

 To
the extent that we raise additional capital through the sale of equity securities or convertible debt securities, the ownership interest
of our stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect
the rights of holders of our common stock. Debt financing and preferred equity financing, if available, may involve agreements that include
covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures,
or declaring dividends. For example, in September 2024, we entered into a Securities Purchase Agreement with certain new institutional
and accredited investors, whereby the investors purchased an aggregate of 5,600,000 shares of common stock, 2,439 shares of Series A
Preferred Stock and pre-funded warrants to purchase an aggregate of 680,000 shares of common stock for an aggregate purchase price of
approximately $200.5 million. Each share of Series A Preferred Stock is convertible into 1,000 shares of common stock.

 If
we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third
parties, we may be required to relinquish valuable rights to our research programs or product candidates or grant licenses on terms that
may not be favorable to us. Debt financing, if available, would likely involve agreements that include covenants limiting or restricting
our ability to take specific actions, such as incurring additional debt, making capital expenditures, making additional product acquisitions,
or declaring dividends.

 Risks
Related to Clinical Development, Regulatory Approval and Commercialization

 We
face competition from entities that have developed or may develop programs for the diseases addressed by our product candidates.

 The
development and commercialization of drugs is highly competitive. Product candidates developed by us, if approved, will face significant
competition and our failure to effectively compete may prevent us from achieving significant market penetration. We compete with a variety
of biopharmaceutical companies as well as academic institutions, governmental agencies, and public and private research institutions,
among others. Many of the companies with which we are currently competing or will compete against in the future have significantly greater
financial resources and expertise in research and development, manufacturing, preclinical testing, clinical trials, regulatory approvals,
and marketing than we do. Mergers and acquisitions in the pharmaceutical and biotechnology industry may result in even more resources
being concentrated among a smaller number of our competitors. Smaller or early-stage companies may also prove to be significant
competitors, particularly through collaborative arrangements with large and established companies. These competitors also compete with
us in establishing clinical trial sites, recruiting participants for clinical trials, as well as in acquiring technologies complementary
to, or necessary for, our product candidates.

 Our
competitors have developed, are developing or will develop programs and processes competitive with our programs and processes. Competitive
therapeutic treatments include those that have already been approved and accepted by the medical community and any new treatments. Our
success will depend partially on our ability to develop and commercialize products that have a competitive safety, efficacy, dosing and/or
presentation profile. Our commercial opportunity and success will be reduced or eliminated if competing products are safer, more effective,
have a more attractive dosing profile or presentation or are less expensive than the products we develop, or if biosimilars enter the
market and are able to gain market acceptance more quickly than we do or at wider scale.

 Our
product candidates may fail in development or suffer delays. We depend on the successful initiation and completion of clinical trials
for our product candidates to advance our product development plans.

 We
have no products on the market, and all of our programs are in preclinical or clinical stages of development. As a result, we expect
it will be many years before we can obtain regulatory approval for and commercialize any product candidate, if ever. Clinical testing
is expensive, difficult to design and implement, and can take years to complete and is uncertain as to outcome. A failure of one or more
of our clinical trials can occur at any stage of testing. The outcome of preclinical testing and early clinical trials may not be predictive
of the success of later clinical trials, and interim results of a clinical trial do not necessarily predict final results. Moreover,
preclinical and clinical data are often susceptible to varying interpretations and analyses, and many companies that have believed their
product candidates performed satisfactorily in preclinical studies and clinical trials have nonetheless failed to obtain marketing approval
for their products. It may be difficult for us to raise additional capital if we experience any issues that delay or prevent the regulatory
approval or the ability to commercialize our product candidates.

 We
may experience a number of unforeseen events affecting our product development timeline, including the following:

 our
 clinical trials may fail to show safety or efficacy, produce negative or inconclusive results,
 or our product candidates may have undesirable side effects or unexpected characteristics,
 and we may decide, or regulators may require that we conduct additional preclinical studies
 or clinical trials or we may decide to abandon product development programs;

 the
 supply or quality of our clinical trial materials or other materials necessary to conduct
 clinical trials of our product candidates may be insufficient or inadequate;

 regulators
 or IRBs, the FDA, or ethics committees may not authorize us or our investigators to commence
 or conduct a clinical trial at one or more prospective trial sites; or may require that we
 or our investigators materially modify, suspend or terminate clinical research or trials
 for various reasons, including noncompliance with regulatory requirements or a finding that
 the participants in our trials are being exposed to unacceptable health risks;

 our
 failure to establish an appropriate safety profile for a product candidate based on clinical
 or preclinical data as well as data emerging from other therapies in the same class as our
 product candidates;

 the
 number of subjects required for clinical trials of any product candidates may be larger than
 we anticipate, especially if regulatory bodies require completion of non-inferiority or superiority
 trials; enrollment in these clinical trials may be slower than we anticipate or subjects
 may drop out of these clinical trials or fail to return for post-treatment follow-up at a
 higher rate than we anticipate;

 trial
 conduct or data analysis errors may occur, including, but not limited to, failure by investigators
 or participants to adhere to the study protocol or data entry and/or labeling errors;

 we
 may experience delays in reaching, or fail to reach, agreement on acceptable terms with prospective
 trial sites and/or contract research organizations ("CROs");

 our
 third-party contractors or clinical trial sites may fail to comply with regulatory requirements
 or meet their contractual obligations to us in a timely manner, or at all, or may deviate
 from the clinical trial protocol or drop out of the trial, which may require that we add
 new clinical trial sites or investigators and could potentially complicate the analysis of
 data;

 the
 cost of clinical trials of any of our programs may be greater than we anticipate;

 reports
 from clinical testing of other therapies may raise safety or efficacy concerns about our
 programs; and

 the
 FDA or other regulatory authorities may require us to submit additional data or impose other
 requirements and our product development timeline may be adversely affected.

 If
our clinical trials do not produce favorable results, our ability to obtain regulatory approval for our product candidates will be adversely
impacted. Moreover, the combined data from our trials may be inconclusive or may not be sufficient to ultimately gain marketing approval
from the FDA or other regulatory authorities. There are equivalent processes and risks applicable to clinical trial applications in other
countries outside of the United States.

 In
addition, because of the competitive landscape for immunology and inflammation (commonly referred to as "I&I") indications,
we may also face competition for clinical trial enrollment. Clinical trial enrollment will depend on many factors, including if potential
clinical trial participants choose to undergo treatment with approved products or enroll in competitors' ongoing clinical trials
for programs that are under development for the same indications as our programs. An increase in the number of approved products for
the indications we are targeting with our programs may further exacerbate this competition. Our inability to enroll a sufficient number
of participants could, among other things, delay our development timeline, which may further harm our competitive position and have an
adverse effect on our business and operations.

 We
are substantially dependent on the success of our two most advanced programs, ORKA-001 and ORKA-002, and our clinical trials of such
programs may not be successful.

 Our
future success is substantially dependent on our ability to develop and timely obtain marketing approval for, and then successfully commercialize,
our two most advanced programs, ORKA-001 and ORKA-002. We are investing a majority of our efforts and financial resources into the
research and development of these programs. We have initiated a Phase 1 clinical trial of ORKA-001 in healthy volunteers and anticipate
initiating a Phase 1 clinical trial of ORKA-002 in healthy volunteers in the second half of 2025, subject to the filing of an IND
or foreign equivalent and regulatory approval. Currently, we believe that the success of our programs is dependent on observing a longer
half-life of our product candidates in humans than monoclonal antibodies ("mAbs") currently marketed and in development
as we believe this longer half-life has the potential to result in a more favorable dosing schedule for our product candidates,
assuming they successfully complete clinical development and obtain marketing approval. This is based in part on the assumption that
the longer half-life we have observed in NHPs will translate into an extended half-life of our product candidates in humans.
To the extent we do not observe this extended half-life in humans, it would significantly and adversely affect the clinical and
commercial potential of our product candidates.

 If
we do not achieve our projected development goals in the time frames we announce and expect, the development and potential commercialization
of our product candidates may be delayed and our expenses may increase and, as a result, our business may be materially harmed and our
stock price may decline.

 From
time to time, we estimate the timing of the anticipated accomplishment of various scientific, clinical, regulatory and other product
development goals, which we sometimes refer to as milestones. These milestones may include the commencement or completion of scientific
studies and clinical trials, such as the expected timing of our clinical trials in our target indications, anticipated data analysis
and results from our clinical trials, as well as the submission of regulatory filings. From time to time, we may publicly announce the
expected timing of some of these milestones. All of these milestones are and will be based on numerous assumptions. The actual timing
of these milestones can vary dramatically compared to our estimates, in some cases for reasons beyond our control. If we do not meet
these milestones as publicly announced, or at all, the development and potential commercialization of our product candidates may be delayed
or never achieved and, as a result, our business may be materially harmed and our stock price may decline. Additionally, delays relative
to our projected timelines are likely to cause overall expenses to increase, which may require us to raise additional capital sooner
than expected and prior to achieving targeted development milestones.

 Any
drug delivery device that we may use to deliver our product candidates may have its own regulatory, development, supply and other risks.

 We
expect to deliver our product candidates via a drug delivery device, such as an injector or other delivery system. There may be unforeseen
technical complications related to the development activities required to bring such a product to market, including primary container
compatibility and/or dose volume requirements. If our product candidates are intended to be used with drug delivery devices, we expect
to utilize drug delivery devices authorized for marketing under clearances of approvals held by third parties. Our product candidates
may not be approved or may be substantially delayed in receiving approval if the devices that we choose to develop do not gain and/or
maintain their own regulatory approvals or clearances. Where approval of the drug product and device is sought under a single application,
the increased complexity of the review process may delay approval. In addition, some drug delivery devices are provided by single-source third-party companies.
We may be dependent on the sustained cooperation and effort of those third-party companies both to supply the devices and, in some
cases, to conduct the studies required for approval or other regulatory clearance of the devices. Even if approval is obtained for our
products, we may also be dependent on those third-party companies continuing to maintain such approvals or clearances, if required,
for their drug delivery devices once they have been received. Failure of third-party companies to supply the devices on time and
in accordance with the agreed-upon specifications, to successfully complete studies on the devices in a timely manner, or to obtain or
maintain required approvals or clearances of the devices could result in increased development costs, delays in or failure to obtain
regulatory approval and delays in product candidates reaching patients.

 Our
approach to the discovery and development of our programs is unproven, and we may not be successful in our efforts to build a pipeline
of programs with commercial value.

 Our
approach to the discovery and development of the research programs with respect to which we have signed a license agreement, exercised
the Option to acquire intellectual property license rights to or have the Option to acquire intellectual property license rights to pursuant
to the Option Agreements, leverages clinically validated mechanisms of action and incorporates advanced antibody engineering to optimize
half-life and other properties designed to overcome limitations of existing therapies. Our programs are purposefully designed to
improve upon existing product candidates and products while maintaining the same, well-established mechanisms of action. However,
the scientific research that forms the basis of our efforts to develop programs using half-life extension technologies is ongoing
and may not result in viable programs. There is limited clinical data available on product candidates utilizing half-life extension
technologies, especially in I&I indications, demonstrating whether they are safe or effective for long-term treatment in
humans. The long-term safety and efficacy of these technologies and the extended half-lives and exposure profiles of our programs
compared to currently approved products are unknown.

 We
may ultimately discover that utilizing half-life extension technologies for our specific targets and indications and any programs
resulting therefrom does not possess certain properties required for therapeutic effectiveness. In addition, programs using half-life extension
technologies may demonstrate different chemical and pharmacological properties in human participants than they do in laboratory studies
or preclinical studies. This technology and any programs resulting therefrom may not demonstrate the same chemical and pharmacological
properties in humans and may interact with human biological systems in unforeseen, ineffective or harmful ways.

 In
addition, we may in the future seek to discover and develop programs that are based on novel targets and technologies that are unproven.
If our discovery activities fail to identify novel targets or technologies for drug discovery, or such targets prove to be unsuitable
for treating human disease, we may not be able to develop viable additional programs. We and our existing or future collaborators may
never receive approval to market and commercialize any product candidate. Even if we or an existing or future collaborator obtains regulatory
approval, the approval may be for targets, disease indications or patient populations that are not as broad as we intended or desired
or may require labeling that includes significant use or distribution restrictions or safety warnings. If the products resulting from
the research programs with respect to which we have signed license agreements with Paragon, exercised the Option to acquire intellectual
property license rights to or have the Option to acquire intellectual property license rights to pursuant to the Option Agreements prove
to be ineffective, unsafe or commercially unviable, such programs would have little, if any, value, which would have a material and adverse
effect on our business, financial condition, results of operations and prospects.

 Preclinical
and clinical development involves a lengthy and expensive process that is subject to delays and uncertain outcomes, and results of earlier
studies and trials may not be predictive of future clinical trial results. If our preclinical studies and clinical trials are not sufficient
to support regulatory approval of any of our product candidates, we may incur additional costs or experience delays in completing, or
ultimately be unable to complete, the development of such product candidate.

 Before
obtaining marketing approval from regulatory authorities for the sale of any product candidate, we must complete preclinical studies
and then conduct extensive clinical trials to demonstrate the safety and efficacy of such product candidate in humans. Our clinical trials
may not be conducted as planned or completed on schedule, if at all, and failure can occur at any time during the preclinical study or
clinical trial process.

a failure of one or more clinical trials can occur at any stage of testing. Clinical data is often susceptible to varying interpretations
and analyses, and in addition, we expect to rely on participants to provide feedback on measures such as measures of quality of life,
which are subjective and inherently difficult to evaluate. These measures can be influenced by factors outside of our control, and can
vary widely from day-to-day for a particular participant, and from participant to participant and from site to site within
a clinical trial.

 We
cannot be sure that the FDA, or comparable foreign regulatory authority, as applicable, will agree with our clinical development plan.
We plan to use the data from our Phase 1 trials of our ORKA-001 and ORKA-002 programs in healthy volunteers to support
Phase 2 trials in PsO and potentially other I&I indications. If the FDA and/or comparable foreign regulatory authority
requires us to materially modify our proposed trial designs, conduct additional trials or enroll additional participants, our development
timelines may be delayed. We cannot be sure that submission of an IND, Clinical Trial Application or similar application will result
in the FDA or comparable foreign regulatory authorities, as applicable, allowing clinical trials to begin in a timely manner, if at all.
Moreover, even if these trials begin, issues may arise that could suspend or terminate such clinical trials. Events that may prevent
successful or timely initiation or completion of clinical trials include: inability to generate sufficient preclinical, toxicology or
other in vivo or in vitro data to support the initiation or continuation of clinical trials; delays in reaching a
consensus with regulatory authorities on study design or implementation of the clinical trials; delays or failure in obtaining regulatory
authorization to commence a trial; delays in reaching agreement on acceptable terms with prospective CROs and clinical trial sites; recruiting
and training suitable clinical investigators; delays in obtaining required IRB approval at each clinical trial site; delays in manufacturing,
testing, releasing, validating or importing/exporting sufficient stable quantities of our product candidates for use in clinical trials
or the inability to do any of the foregoing; failure by our CROs, other third parties or us to adhere to clinical trial protocols; failure
to perform in accordance with the FDA's or any other regulatory authority's current GCP requirements or applicable regulatory
guidelines in other countries; changes to the clinical trial protocols; clinical sites deviating from trial protocol or dropping out
of a trial; delays or failure by our third party vendors or us in the manufacturing, packaging, labeling and proper delivery of clinical
trial materials; and third parties being unwilling or unable to satisfy their contractual obligations to us.

 We
could also encounter delays if a clinical trial is required to be materially modified or suspended or terminated by us, the IRBs, by
the Data Safety Monitoring Board, if any, or by the FDA or comparable foreign regulatory authorities. Such authorities may suspend, put
on clinical hold or terminate a clinical trial due to a number of factors, including not aligning with or supporting our clinical trial
designs or our failure to conduct the clinical trial in accordance with regulatory requirements or our clinical trial protocols, inspection
of the clinical trial operations or trial site by the FDA or comparable foreign regulatory authorities resulting in the imposition of
a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from the programs, changes in governmental
regulations or administrative actions or lack of adequate funding to continue the clinical trial. If we are required to conduct additional
clinical trials or other testing of our product candidates beyond those that we currently contemplate, if we are unable to successfully
complete clinical trials of our product candidates, if the results of these trials are not positive or are only moderately positive or
if there are safety concerns, our business and results of operations may be adversely affected and we may need to adjust or abandon our
business plans and we may incur significant additional costs.

 If
we encounter difficulties enrolling participants in our current and future clinical trials, our clinical development activities could
be delayed or otherwise adversely affected. We depend on the successful completion of clinical trials for our product candidates.

 We
may experience difficulties in patient participant enrollment in our clinical trials for a variety of reasons. The timely completion
of clinical trials in accordance with their protocols depends, among other things, on our ability to enroll a sufficient number of participants
who remain in the trial until conclusion. The enrollment of participants in future trials for any of our programs will depend on many
factors, including if participants choose to enroll in clinical trials, rather than using approved products, or if our competitors have
ongoing clinical trials for programs that are under development for the same indications as our programs, and participants instead enroll
in such clinical trials. Even if we are able to enroll a sufficient number of participants for our clinical trials, it may have difficulty
maintaining participants in our clinical trials. Our inability to enroll or maintain a sufficient number of participants would result
in significant delays in completing clinical trials and increased development costs or may require us to abandon one or more clinical
trials altogether.

 Preliminary,
"topline" or interim data from our clinical trials may change as more participant data becomes available and are subject
to audit and verification procedures, and should be viewed with caution until the final data are available.

 From
time to time, we may publicly disclose preliminary or topline data from our preclinical studies and clinical trials, which are based
on a preliminary analysis of then-available data, and the results and related findings and conclusions are subject to change following
a more comprehensive review of the data. We also make assumptions, estimations, calculations and conclusions as part of our analyses
of these data without the opportunity to fully and carefully evaluate complete data. As a result, the preliminary or topline results
that we report may differ from future results of the same studies, or different conclusions or considerations may qualify such results,
once additional data have been received and fully evaluated or subsequently made subject to audit and verification procedures.

 From
time to time, we may also disclose interim data from our preclinical studies and clinical trials. Interim data are subject to the risk
that one or more of the clinical outcomes may materially change as participant enrollment continues and more participant data become
available or as participants from our clinical trials continue other treatments. Further, others, including regulatory agencies, may
not accept or agree with our assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh the importance of
data differently, which could impact the value of the particular product candidate, the approvability or commercialization of the particular
product candidate and our company in general. In addition, the information we choose to publicly disclose regarding a particular preclinical
study or clinical trial is based on what is typically extensive information, and you or others may not agree with what we determine is
material or otherwise appropriate information to include in our disclosure. If the preliminary, topline or interim data that we report
differ from actual results, or if others, including regulatory authorities, disagree with the conclusions reached, our ability to obtain
approval for, and commercialize, our product candidates may be harmed, which could harm our business, operating results, prospects or
financial condition.

 Our
clinical trials may reveal significant adverse events, undesirable side effects or patient intolerance not seen in our preclinical studies
or earlier clinical trials, and may result in a safety profile that could halt clinical development, inhibit regulatory approval or limit
commercial potential or market acceptance of any of our product candidates.

 Results
of our clinical trials could reveal a high and unacceptable severity and prevalence of side effects or patient intolerance, adverse events
or unexpected characteristics, and any of these occurrences could harm our business, financial condition, results of operations and prospects
significantly. If significant adverse events or other side effects are observed in any of our clinical trials, we may have difficulty
recruiting participants to such trials, participants may drop out of the trials, or we may have to suspend, materially modify or abandon
the trials or our development efforts of one or more programs altogether. We, the FDA or other applicable regulatory authorities, or
an IRB, may suspend or require the material modification of any clinical trials of any program at any time for various reasons, including
a belief that participants in such trials are being exposed to unacceptable health risks or adverse side effects. Moreover, negative
or inconclusive results could cause the FDA or other regulatory agencies to require that we repeat or conduct additional clinical trials.
If our clinical trials do not produce favorable results, our ability to obtain regulatory approval for our product candidates may be
adversely impacted.

 Even
if side effects do not preclude the product candidate from obtaining or maintaining marketing approval, undesirable side effects may
inhibit market acceptance of the approved product due to their tolerability versus other therapies. In addition, an extended half-life could
prolong the duration of undesirable side effects, which could also affect our clinical trials or inhibit market acceptance. Potential
side effects associated with our product candidates may not be appropriately recognized or managed by the treating medical staff, as
toxicities resulting from our product candidates may not be normally encountered in the general patient population and by medical personnel.

 In
addition, even if we successfully advance our product candidates through clinical trials, such trials will only include a limited number
of participants and limited duration of exposure to our product candidates. As a result, we cannot be assured that adverse effects of
our product candidates will not be uncovered when a significantly larger number of participants are exposed to the product candidate
after approval. Further, any clinical trials may not be sufficient to determine the effect and safety consequences of using our product
candidates over a multi-year period.

 If
any of the foregoing events occur or if one or more of the research programs with respect to which we have signed a licensed agreement
for or exercised the Option to acquire intellectual property license rights to or have the Option to acquire intellectual property license
rights to pursuant to the Option Agreements prove to be unsafe, our pipeline could be affected, which would have a material adverse effect
on our business, financial condition, results of operations and prospects.

 We
may expend our limited resources to pursue a particular program and fail to capitalize on programs that may be more profitable or for
which there is a greater likelihood of success.

 We
are initially focused on our most advanced programs, ORKA-001 and ORKA-002, and as a result, we may forgo or delay pursuit of opportunities
with other programs that later prove to have greater commercial potential. Our resource allocation decisions may cause us to fail to
capitalize on viable commercial products or profitable market opportunities. Our spending on current and future research and development
programs for specific indications may not yield any commercially viable product candidates. If we do not accurately evaluate the commercial
potential or target market for a particular product candidate, we may be in a position where we may have to relinquish valuable rights
to that product candidate through collaboration, licensing or other arrangements in cases in which we would have been more advantageous
for us to retain sole development and commercialization rights to such product candidate.

 Any
approved products resulting from our programs may not achieve adequate market acceptance among clinicians, patients, healthcare third-party
payors and others in the medical community necessary for commercial success and we may not generate any future revenue from the sale
or licensing of such products.

 Even
if regulatory approval is obtained for a product candidate resulting from one of our current or future programs, it may not gain market
acceptance among physicians, patients, healthcare payors or the medical community. Market acceptance of our product candidates will depend
on many factors, including factors that are not within our control. While there are several approved products and product candidates
in later stages of development for the treatment of PsO, our programs incorporate advanced antibody engineering to optimize the half-life and
formulation of antibodies, and to date, no such antibody has been approved by the FDA for the treatment of PsO. Market participants
with influence over acceptance of new treatments, such as clinicians and third-party payors, may not adopt a biologic that incorporates
half-life extension for our targeted indications, and we may not be able to convince the medical community and third-party payors
to accept and use, or to provide favorable reimbursement for, any programs developed by us or our existing or future collaborators. Moreover,
an extended half-life may make it more difficult for patients to change treatments and there may be a perception that half-life extension
could exacerbate side effects, each of which may adversely affect our ability to gain market acceptance.

 Sales
of medical products also depend on the willingness of healthcare providers to prescribe the treatment, and if any of our product candidates
is approved but does not achieve an adequate level of acceptance, we may not generate or derive sufficient revenue from that product
candidate and may not become or remain profitable.

of our programs may compete with our other programs, which could negatively impact our business and reduce our future revenue.

 We
are developing product candidates for the same indication, PsO, and may in the future develop our programs for other I&I indications.
Each such program targets a different mechanism of action. However, developing multiple programs for a single indication may negatively
impact our business if the programs compete with each other. For example, if multiple programs are conducting clinical trials at the
same time, they could compete for the enrollment of participants. In addition, if multiple product candidates are approved for the same
indication, they may compete for market share, which could limit our future revenue.

 We
may conduct clinical trials for programs at sites outside the United States, and the FDA may not accept data from trials conducted
in such locations. Moreover, conducting clinical trials outside of the U.S. presents additional risks that may delay our clinical trials.

 We
may choose to conduct one or more of our future clinical trials outside the United States. Although the FDA may accept data from
clinical trials conducted outside the United States, acceptance of this data is subject to conditions imposed by the FDA.
If the FDA does not accept the data from any trial that we conduct outside the United States, it would likely result in the need
for additional trials, which would be costly and time-consuming and would delay or permanently halt our development of the applicable
product candidates. Even if the FDA accepted such data, it could impose additional conditions, such as requiring us to modify our planned
clinical trials to receive clearance to initiate such trials in the United States or to continue such trials once initiated.

 Further,
conducting clinical trials outside of the U.S. presents additional risks that may delay completion of our clinical trials. These risks
include the failure of investigators or enrolled participants in foreign countries to adhere to clinical protocol as a result of differences
in healthcare services or cultural customs that could restrict or limit our ability to conduct our clinical trials, the administrative
burdens of conducting clinical trials under multiple sets of foreign regulations, potential restrictions, such as local privacy restrictions,
on data generated from the clinical trial, diminished protection of intellectual property in some countries, as well as political and
economic risks relevant to foreign countries.

 Risks
Related to Government Regulation

 The
regulatory approval processes of the FDA and other comparable foreign regulatory authorities are lengthy, time-consuming and unpredictable.
If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals for our product candidates, we may not
be able to commercialize, or may be delayed in commercializing, our product candidates, and our ability to generate revenue may be materially
impaired.

 The
lengthy regulatory approval process as well as the unpredictability of clinical trial results may result in our failing to obtain or
be delayed in obtaining approval to market our product candidates, which would significantly harm our business, results of operations
and prospects. Of the large number of drugs in development, only a small percentage successfully complete the FDA or foreign regulatory
approval processes and are commercialized. The process of obtaining regulatory approvals, both in the United States and abroad,
is unpredictable, expensive and typically takes many years following commencement of clinical trials. Approval may never be obtained
and the approval process can vary substantially based upon a variety of factors, including the type, complexity and novelty of the product
candidates involved. Before obtaining regulatory approvals for the commercial sale of our product candidates, we must demonstrate through
lengthy, complex and expensive preclinical studies and clinical trials that our product candidates are both safe and effective for each
targeted indication. Securing regulatory approval also requires the submission of information about the drug manufacturing process to,
and inspection of manufacturing facilities by, the relevant regulatory authority. Further, our product candidates may not be effective,
may be only moderately effective or may prove to have undesirable or unintended side effects, toxicities or other characteristics that
may preclude our obtaining marketing approval. The FDA and comparable foreign regulatory authorities have substantial discretion in the
approval process and may refuse to accept any application or may decide that our data are insufficient for approval and require additional
preclinical, clinical or other data. Our product candidates could be delayed in receiving, or fail to receive, regulatory approval for
many reasons, including: the failure to demonstrate that a product candidate's benefits outweigh safety risks; regulatory authorities
may disagree with our interpretation of clinical data or the data collected may not be acceptable or sufficient to support submission;
or the results may not meet the level of statistical significance required for approval by the relevant regulatory authorities or otherwise
considered insufficient by the FDA or comparable foreign regulatory authorities. Regulatory authorities may require the addition of labeling
statements, such as black box or other warnings or contraindications that could diminish the usage of the product or otherwise limit
the commercial success of the affected product.

regulatory authorities may approve any of our product candidates for fewer or more limited indications than we request, including failing
to approve the most commercially promising indications, may grant approval contingent on the performance of costly post-marketing clinical
trials, or may approve a product candidate with a label that does not include the labeling claims necessary or desirable for the successful
commercialization of that product candidate. If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals
for our product candidates, we will not be able to commercialize, or will be delayed in commercializing, our product candidates and our
ability to generate revenue will be materially impaired.

 We
may not be able to meet requirements for the chemistry, manufacturing and control of our programs.

 In
order to receive approval of our products by the FDA and comparable foreign regulatory authorities, we must show that we and our CMO
partners are able to characterize, control and manufacture our drug products safely and in accordance with regulatory requirements. This
includes manufacturing the active ingredient, developing an acceptable formulation, manufacturing the drug product, performing tests
to adequately characterize the formulated product, documenting a repeatable manufacturing process, and demonstrating that our drug products
meet stability requirements. As noted above, we may deliver our product candidates via a drug delivery device, which also requires us
to meet certain chemistry, manufacturing and control requirements set forth by the FDA and other foreign regulatory authorities. Meeting
these chemistry, manufacturing and control requirements is a complex task that requires specialized expertise. If we are not able to
meet the chemistry, manufacturing and control requirements, we may not be successful in getting our products approved.

 Our
product candidates for which we intend to seek approval as biologics may face competition sooner than anticipated.

 The
Patient Protection and Affordable Care Act, as amended by the Healthcare and Education Reconciliation Act (the "ACA"), includes
a subtitle called the BPCIA, which created an abbreviated approval pathway for biological products that are biosimilar to or interchangeable
with an FDA-licensed reference biological product. Under the BPCIA, an application for a highly similar or "biosimilar"
product may not be submitted to the FDA until four years following the date that the reference product was first approved by the
FDA. In addition, the approval of a biosimilar product may not be made effective by the FDA until 12 years from the date on
which the reference product was first approved. During this 12-year period of exclusivity, another company may still market
a competing version of the reference product if the FDA approves a full BLA for the competing product containing the sponsor's
own preclinical data and data from adequate and well-controlled clinical trials to demonstrate the safety, purity and potency of
their product.

 We
believe that any of our product candidates approved as biologics under a BLA should qualify for the 12-year period of exclusivity.
However, there is a risk that this exclusivity could be shortened due to congressional action or otherwise, or that the FDA will not
consider our product candidates to be reference products for competing products, potentially creating the opportunity for competition
sooner than anticipated. Other aspects of the BPCIA, some of which may impact the BPCIA exclusivity provisions, have also been the subject
of recent litigation. Moreover, the extent to which a biosimilar, once approved, will be substituted for any reference products in a
way that is similar to traditional generic substitution for non-biological products is not yet clear, and will depend on a
number of marketplace and regulatory factors that are still developing.

 Even
if we receive regulatory approval of our product candidates, we will be subject to extensive ongoing regulatory obligations and continued
regulatory review and may result in restrictions on the use of the product, which may result in significant additional expense and we
may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our product candidates.

 Any
regulatory approvals that we may receive for our product candidates will require the submission of reports to regulatory authorities
and surveillance to monitor the safety and efficacy of the product candidate, may contain significant limitations related to use restrictions
for specified age groups, warnings, precautions or contraindications, and may include burdensome post-approval study or risk management
requirements. For example, the FDA may require a REMS in order to approve our product candidates. In addition, even if our product candidates
receive approval, our product candidates and the activities associated with their development and commercialization, including their
design, testing, manufacture, safety, efficacy, recordkeeping, labeling, storage, approval, advertising, promotion, sale, distribution,
import and export will be subject to comprehensive regulation by the FDA and other regulatory agencies in the United States and
by comparable foreign regulatory authorities. These requirements include submissions of safety and other post-marketing information
and reports, registration, as well as on-going compliance with current CGMPs and GCPs for any clinical trials that we conduct
following approval. In addition, manufacturers of drug products and their facilities are subject to continual review and periodic, unannounced
inspections by the FDA and other regulatory authorities for compliance with CGMPs.

 If
we or a regulatory authority discover previously unknown problems with a product or problems with the facilities where the product is
manufactured, a regulatory authority may impose restrictions on that product, the manufacturing facility or us, including requiring recall
or withdrawal of the product from the market or suspension of manufacturing, restrictions on our ability to conduct clinical trials,
including full or partial clinical holds on ongoing or planned trials, restrictions on the manufacturing process, warning or untitled
letters, civil and criminal penalties, injunctions, product seizures, detentions or import bans, voluntary or mandatory publicity requirements
and imposition of restrictions on operations, including costly new manufacturing requirements.

 Disruptions
at the FDA, the SEC and other government agencies and regulatory authorities caused by funding shortages or global health concerns could
hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or
commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation
of our business may rely, which could negatively impact our business.

 The
ability of the FDA to review regulatory filings and our ability to commence human clinical trials can be affected by a variety of factors,
including government budget and funding levels, ability to hire and retain key personnel and accept the payment of user fees, and statutory,
regulatory and policy changes. Average review times at the agency have fluctuated in recent years as a result. In addition, government
funding of the SEC, and other government agencies on which our operations may rely, including those that fund research and development
activities is subject to the political process, which is inherently fluid and unpredictable.

 Disruptions
at the FDA and other agencies or comparable foreign regulatory authorities, may also slow the time necessary for the review and approval
of applications for clinical trial or marketing authorization, which would adversely affect our business. For example, in recent years,
including in 2018 and 2019, the U.S. government shut down several times and certain regulatory agencies, such as the FDA and the SEC,
had to furlough critical employees and stop critical activities. Additionally, action by the new Trump Administration to limit federal
agency budgets or personnel may result in reductions to the FDA's budget, employees, and operations, which may lead to slower response
times and longer review periods, potentially affecting our ability to progress development of our product candidates or obtain regulatory
approval for our product candidates. If a prolonged government shutdown occurs, it could significantly impact the ability of the FDA
to timely review and process our regulatory submissions, which could have a material adverse effect on our business. Further, future
government shutdowns could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize
and continue our operations.

 If
a prolonged government shutdown occurs, or if global health concerns prevent the FDA or other regulatory authorities from conducting
their regular inspections, reviews, or other regulatory activities, it could significantly impact the ability of the FDA or other regulatory
authorities to timely review and process our regulatory submissions, which could have a material adverse effect on our business.

 We
may face difficulties from legislative or regulatory reform measures.

 We
may be faced with additional or changing regulatory and governmental regulations that could prevent, limit or delay regulatory approval
of our product candidates. We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation
or administrative or executive action, either in the United States or abroad. For example, the Trump Administration has discussed
several changes to the reach and oversight of the FDA, which could affect its relationship with the pharmaceutical industry, transparency
in decision making and ultimately the cost and availability of prescription drugs. If we are slow or unable to adapt to changes in existing
requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any
marketing approval that we may have obtained and we may not achieve or sustain profitability.

 The
price of pharmaceuticals has been a topic of considerable public discussion that could lead to price controls or other price-limiting
strategies by payors that have the effect of lowering payment and reimbursement rates for drugs or otherwise making the commercialization
of pharmaceuticals less profitable. Many federal and state legislatures have considered, and adopted, healthcare policies intended to
curb rising healthcare costs, such as the IRA. These cost-containment measures may include, among other measures: requirements for pharmaceutical
companies to negotiate prescription drug prices with government healthcare programs; controls on government-funded reimbursement for
drugs; new or increased requirements to pay prescription drug rebates to government healthcare programs, including if drug prices increase
at a higher rate than inflation; controls on healthcare providers; challenges to or limits on the pricing of drugs, including pricing
controls or limits or prohibitions on reimbursement for specific products through other means; requirements to try less expensive products
or generics before a more expensive branded product; and public funding for cost effectiveness research, which may be used by government
and private third-party payors to make coverage and payment decisions. Political, economic and regulatory developments may further complicate
developments in healthcare systems and pharmaceutical drug pricing. These developments could, for example, impact our potential licensing
agreements as commercial and collaborative partners may also consider the impact of these pressures on their licensing strategies.

 Any
new laws or regulations that have the effect of imposing additional costs or regulatory burden on pharmaceutical manufacturers, or otherwise
negatively affect the industry, could adversely affect our ability to successfully commercialize our product candidates. The implementation
of any price controls, caps on prescription drugs or price transparency requirements could adversely affect our business, operating results
and financial condition.

 Our
business operations and current and future arrangements with investigators, healthcare professionals, consultants, third-party payors,
patient organizations and customers will be subject to applicable healthcare regulatory laws, including conflicts of interest rules,
which could expose us to penalties.

 Our
business operations and current and future arrangements with investigators, healthcare professionals, consultants, third-party payors,
patient organizations and customers may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations. These
laws may constrain the business or financial arrangements and relationships through which we conduct our operations, including how we
research, market, sell and distribute our product candidates, if approved. Principal investigators for our clinical trials may serve
as scientific advisors or consultants to us or may be affiliated with our other service providers, including CROs or site management
organizations, and from time to time may receive cash compensation in connection with such services. If these relationships and any related
compensation result in perceived or actual conflicts of interest, the integrity of the data generated at the applicable clinical trial
site or in the applicable trial may be questioned or jeopardized.

 Ensuring
that our internal operations and future business arrangements with third parties comply with applicable healthcare laws and regulations
will involve costs and management attention. If our operations are found to be in violation of any of these laws or any other governmental
laws and regulations that may apply to it, we may be subject to significant penalties, including civil, criminal and administrative penalties,
damages, fines, exclusion from government-funded healthcare programs, integrity oversight and reporting obligations to resolve allegations
of non-compliance, disgorgement, individual imprisonment, contractual damages, reputational harm, diminished profits and the
curtailment or restructuring of our operations. Further, defending against any such actions can be costly and time-consuming and
may require significant personnel resources. Therefore, even if we are successful in defending against any such actions that may be brought
against us, our business may be impaired.

 Even
if we are able to commercialize any product candidates, due to unfavorable pricing regulations and/or third-party coverage and reimbursement
policies, we may not be able to offer such product candidates at competitive prices, which would seriously harm our business.

 We
intend to seek approval to market our product candidates in the United States and in selected foreign jurisdictions, and we will
be subject to rules and regulations in those jurisdictions where we obtain approval. Our ability to successfully commercialize any product
candidates that we may develop will depend in part on the extent to which reimbursement for these product candidates and related treatments
will be available from government health administration authorities, private health insurers and other organizations. In some jurisdictions,
government authorities and other third-party payors decide which medications they will pay for and establish reimbursement levels,
and have attempted to control costs by limiting coverage and the amount of reimbursement for particular medications. These entities may
create preferential access policies for a competitor's product, including a branded or generic/biosimilar product, over our products
in an attempt to reduce their costs, which may reduce our commercial opportunity. Additionally, if any of our product candidates are
approved and we are found to have improperly promoted off-label uses of those product candidates, we may become subject to significant
liability, which would materially adversely affect our business and financial condition.

 We
are subject to U.S. and certain foreign export and import controls, sanctions, embargoes, anti-corruption laws, and anti-money laundering
laws and regulations. We can face criminal liability and other serious consequences for violations, which can harm our business.

 We
are subject to export control and import laws and regulations, including the U.S. Export Administration Regulations, U.S. Customs
regulations, various economic and trade sanctions regulations administered by the U.S. Treasury Department's Office of Foreign
Assets Controls, the U.S. Foreign Corrupt Practices Act of 1977, as amended, the U.S. domestic bribery statute contained
in 18 U.S.C. § 201, the U.S. Travel Act, the USA PATRIOT Act, the U.S. Physician Payments Sunshine Act and other state and
national anti-bribery and anti-money laundering laws in the countries in which we conduct activities. Anti-corruption laws
are interpreted broadly and prohibit companies and their employees, agents, contractors, and other collaborators from authorizing, promising,
offering, or providing, directly or indirectly, improper payments or anything else of value to or from recipients in the public or private
sector. We may engage third parties to sell our products outside the United States, to conduct clinical trials, and/or to obtain
necessary permits, licenses, patent registrations, and other regulatory approvals. We have direct or indirect interactions with officials
and employees of government agencies or government-affiliated hospitals, universities, and other organizations. We can be held liable
for the corrupt or other illegal activities of our employees, agents, contractors, and other collaborators, even if we do not explicitly
authorize or have actual knowledge of such activities. Any violations of the laws and regulations described above may result in substantial
civil and criminal fines and penalties, imprisonment, the loss of export or import privileges, debarment, tax reassessments, breach of
contract and fraud litigation, reputational harm, and other consequences.

 Governments
outside the United States tend to impose strict price controls, which may adversely affect our revenue, if any.

 In
some countries, particularly member states of the EU ("EU Member States"), the pricing of prescription drugs is subject to
governmental control. In these countries, pricing negotiations with governmental authorities can take considerable time after receipt
of marketing approval for a therapeutic. In addition, there can be considerable pressure by governments and other stakeholders on prices
and reimbursement levels, including as part of cost containment measures. Political, economic and regulatory developments may further
complicate pricing negotiations, and pricing negotiations may continue after reimbursement has been obtained. Reference pricing used
by various EU Member States and parallel distribution, or arbitrage between low-priced and high-priced EU Member States,
can further reduce prices. To obtain coverage and reimbursement or pricing approvals in some countries, we or current or future collaborators
may be required to conduct a clinical trial or other studies that compare the cost-effectiveness of our product candidates to other
available therapies in order to obtain or maintain reimbursement or pricing approval. Publication of discounts by third-party payors
or authorities may lead to further pressure on the prices or reimbursement levels within the country of publication and other countries.
If reimbursement of any product candidate approved for marketing is unavailable or limited in scope or amount, or if pricing is set at
unsatisfactory levels, our business, financial condition, results of operations or prospects could be materially and adversely affected.
If the UK or EU Member States were to significantly alter their regulations affecting the pricing of prescription pharmaceuticals, we
could face significant new costs.

 Risks
Related to Our Intellectual Property

 Our
ability to obtain and protect our patents and other proprietary rights is uncertain, exposing us to the possible loss of competitive
advantage.

 We
rely upon a combination of patents, trademarks, trade secret protection, confidentiality agreements and the Option and License Agreements
to protect the intellectual property related to our programs and technologies and to prevent third parties from competing unfairly with
it. Our success depends in large part on our ability to obtain and maintain patent protection for our programs and our product candidates
and their uses, as well as our ability to operate without infringing on or violating the proprietary rights of others. Paragon has filed,
on our behalf, provisional patent applications and we have filed non-provisional patent applications directed to antibodies that target
IL-23, including applications covering composition of matter, pharmaceutical formulations, and methods of using such antibodies, including
ORKA-001. In addition, Paragon has filed, on our behalf, provisional patent applications and we intend to file one or more additional
provisional patent applications directed to antibodies that target IL-17, including applications covering composition of matter, pharmaceutical
formulations, and methods of using such antibodies, including ORKA-002. However, we may not be able to protect our intellectual property
rights throughout the world and the legal systems in certain countries may not favor enforcement or protection of patents, trade secrets
and other intellectual property. Filing, prosecuting and defending patents on programs worldwide is expensive and our intellectual property
rights in some foreign jurisdictions can be less extensive than those in the United States; the reverse may also occur. As such,
we may not have patents in all countries or all major markets and may not be able to obtain patents in all jurisdictions even if we apply
for them. Our competitors may operate in countries where we do not have patent protection and can freely use our technologies and discoveries
in such countries to the extent such technologies and discoveries are publicly known or disclosed in countries where we do have patent
protection or pending patent applications.

 Our
pending and future patent applications may not result in patents being issued. Any issued patents may not afford sufficient protection
of our programs or their intended uses against competitors, nor can there be any assurance that the patents issued will not be infringed,
designed around, invalidated by third parties, or effectively prevent others from commercializing competitive technologies, products
or programs. Even if these patents are granted, they may be difficult to enforce. Further, any issued patents that we may license or
own covering our programs could be narrowed or found invalid or unenforceable if challenged in court or before administrative bodies
in the United States or abroad, including the United States Patent and Trademark Office ("USPTO"). Further, if
we encounter delays in our clinical trials or delays in obtaining regulatory approval, the period of time during which we could market
our product candidates under patent protection would be reduced. Thus, the patents that we may own and license may not afford us any
meaningful competitive advantage.

 In
addition to seeking patents for some of our technology and programs, we may also rely on trade secrets, including unpatented know-how, technology
and other proprietary information, to maintain our competitive position. Any disclosure, either intentional or unintentional, by our
employees, the personnel of third parties with whom we share our facilities or third-party consultants and vendors that we engage
to perform research, clinical trials or manufacturing activities, or misappropriation by third parties (such as through a cybersecurity
breach) of our trade secrets or proprietary information could enable competitors to duplicate or surpass our technological achievements,
thus eroding our competitive position in our market. In order to protect our proprietary technology and processes, we rely in part on
agreements, such as confidentiality agreements, with our vendors, collaborators, employees, consultants, outside scientific collaborators
and sponsored researchers and other advisors. These agreements may not effectively prevent disclosure of confidential information and
may not provide an adequate remedy in the event of unauthorized disclosure of confidential information. We may need to share our proprietary
information, including trade secrets, with future business partners, collaborators, contractors and others located in countries at heightened
risk of theft of trade secrets, including through direct intrusion by private parties or state actors and those affiliated with or controlled
by state actors. In addition, while we undertake efforts to protect our trade secrets and other confidential information from disclosure,
others may independently discover trade secrets and proprietary information, and in such cases, we may not be able to assert any trade
secret rights against such party. Enforcing a claim that a party illegally obtained and is using our trade secrets is challenging and
the outcome is unpredictable. In addition, courts outside of the U.S. may be less willing to protect trade secrets. Costly and time-consuming litigation
could be necessary to enforce and determine the scope of our proprietary rights and failure to obtain or maintain trade secret protection
could adversely affect our competitive business position.

 Lastly,
if our trademarks and trade names are not registered or adequately protected, then we may not be able to build name recognition in our
markets of interest and our business may be adversely affected.

 We
may not be successful in obtaining or maintaining necessary rights to our programs through acquisitions and in-licenses.

 Because
our development programs currently do and may in the future require the use of proprietary rights held by third parties, the growth of
our business may depend in part on our ability to acquire, in-license, or use these third-party proprietary rights. It
is possible that we may be unable to obtain licenses at a reasonable cost or on reasonable terms, if at all. Even if we are able to obtain
a license, it may be non-exclusive, thereby giving our competitors access to the same technologies licensed to us. We may be unable to
acquire or in-license any compositions, methods of use, processes or other third-party intellectual property rights from
third parties that we identify as necessary for our programs. The licensing and acquisition of third-party intellectual property
rights is a competitive area, and a number of more established companies may pursue strategies to license or acquire third-party intellectual
property rights that we may consider attractive or necessary. These established companies may have a competitive advantage over us due
to their size, capital resources and greater clinical development and commercialization capabilities. In addition, companies that perceive
us to be a competitor may be unwilling to assign or license rights to us. We also may be unable to license or acquire third-party intellectual
property rights on terms that would allow us to make an appropriate return on our investment or at all. If we are unable to successfully
obtain rights to required third-party intellectual property rights or maintain the existing intellectual property rights we do obtain,
we may have to abandon development of the relevant program, which could have a material adverse effect on our business, financial condition,
results of operations, and prospects.

 While
we plan to obtain the right to control prosecution, maintenance and enforcement of the patents relating to our programs, there may be
times when the filing and prosecution activities for patents and patent applications relating to our programs are controlled by our current
and future licensors or collaboration partners. If any of our current and future licensors or collaboration partners fail to prosecute,
maintain and enforce such patents and patent applications in a manner consistent with the best interests of our business, we could lose
our rights to the intellectual property or our exclusivity with respect to those rights, our ability to develop and commercialize those
product candidates may be adversely affected and we may not be able to prevent competitors from making, using and selling competing products.
In addition, even where we have the right to control patent prosecution of patents and patent applications we have licensed to and from
third parties, we may still be adversely affected or prejudiced by actions or inactions of our licensees, our future licensors and our
counsel that took place prior to the date upon which we assumed control over patent prosecution. Moreover, if other third parties have
ownership rights to our future in-licensed patents, they may be able to license such patents to our competitors, and our competitors
could market competing products and technology.

to obtain licenses at a reasonable cost or terms may require us to expend significant time and resources to redesign our technology,
programs, or the methods for manufacturing them or to develop or license replacement technology, all of which may not be feasible on
a technical or commercial basis. If we are unable to do so, we may be unable to develop or commercialize the affected product candidates.
This could have a material adverse effect on our competitive position, business, financial condition, results of operations, and prospects.

 Disputes
may arise between us and our future licensors regarding intellectual property subject to a license agreement, including: the scope of
rights granted under the license agreement and other interpretation-related issues; whether and the extent to which our technology
and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement; our right to sublicense
patents and other rights to third parties; our right to transfer or assign the license; the inventorship and ownership of inventions
and know-how resulting from the joint creation or use of intellectual property by our future licensors and us and our partners;
and the priority of invention of patented technology.

 We
may be subject to patent infringement claims or may need to file claims to protect our intellectual property, which could result in substantial
costs and liability and prevent us from commercializing our potential products.

 Because
the intellectual property landscape in the biopharmaceutical industry is rapidly evolving and interdisciplinary, it is difficult to conclusively
assess our freedom to operate and guarantee that we can operate without infringing on or violating third-party rights. Third party
patent rights, if found to be valid and enforceable, could be alleged to render one or more of our product candidates infringing. If
a third party successfully brings a claim against us, we may be required to pay substantial damages, be forced to abandon any affected
product candidate and/or seek a license from the patent holder. Any intellectual property claims brought against us, whether or not successful,
may cause us to incur significant legal expenses and divert the attention of our management and key personnel from other business concerns.
We cannot be certain that patents owned or licensed by us will not be challenged by others in the course of litigation. Some of our competitors
may be able to sustain the costs of complex intellectual property litigation more effectively than we can because they have substantially
greater resources. In addition, any litigation could have a material adverse effect on our business and operations, including our ability
to raise funds.

 Competitors
may infringe or otherwise violate our patents, trademarks, copyrights or other intellectual property. To counter infringement or other
violations, we may be required to file claims, which can be expensive and time-consuming, and any such claims could provoke these parties
to assert counterclaims against us. In addition, in a patent infringement proceeding, a court or administrative body may decide that
one or more of the patents we assert is invalid or unenforceable, in whole or in part, construe the patent's claims narrowly or
refuse to prevent the other party from using the technology at issue on the grounds that our patents do not cover the technology. Similarly,
if we assert trademark infringement claims, a court or administrative body may determine that the marks we have asserted are invalid
or unenforceable or that the party against whom we have asserted trademark infringement has superior rights to the marks in question.
In such a case, we could ultimately be forced to cease use of such marks. In any intellectual property litigation, even if we are successful,
any award of monetary damages or other remedy we receive may not be commercially valuable.

 Further,
we may be required to protect our patents through procedures created to attack the validity of a patent at the USPTO. An adverse
determination in any such submission or proceeding could reduce the scope or enforceability of, or invalidate, our patent rights, which
could adversely affect our competitive position. Because of a lower evidentiary standard in USPTO proceedings compared to the evidentiary
standard in U.S. federal courts necessary to invalidate a patent claim, a third party could potentially provide evidence in a USPTO
proceeding sufficient for the USPTO to hold a claim invalid even though the same evidence would be insufficient to invalidate the claim
if first presented in a district court action.

 In
addition, if our programs are found to infringe the intellectual property rights of third parties, these third parties may assert infringement
claims against our future licensees and other parties with whom we have business relationships and we may be required to indemnify those
parties for any damages they suffer as a result of these claims, which may require us to initiate or defend protracted and costly litigation
on behalf of licensees and other parties regardless of the merits of such claims. If any of these claims succeed, we may be forced to
pay damages on behalf of those parties or may be required to obtain licenses for the products they use.

because of the substantial amount of discovery required in connection with intellectual property litigation or other legal proceedings
relating to our intellectual property rights, there is a risk that some of our confidential information could be compromised by disclosure
during this type of litigation or other proceedings.

 We
may be subject to claims that we have wrongfully hired an employee from a competitor or that our employees, consultants or independent
contractors have wrongfully used or disclosed confidential information of third parties.

 As
is common in the biopharmaceutical industry, in addition to our employees, we engage the services of consultants to assist us in the
development of our programs. Many of these consultants, and many of our employees, were previously employed at, or may have previously
provided or may be currently providing consulting services to, other biotechnology or pharmaceutical companies including our competitors
or potential competitors. We could in the future be subject to claims that we, our employees or our consultants have inadvertently or
otherwise used or disclosed alleged intellectual property, such as trade secrets, or other confidential information of former employers
or competitors. Although we try to ensure that our employees and consultants do not use the intellectual property, proprietary information, know-how or
trade secrets of others in their work for us, we may become subject to claims that we caused an individual to breach the terms of his
or her non-competition or non-solicitation agreement, or that we or these individuals have, inadvertently or otherwise,
used or disclosed the alleged trade secrets or other proprietary information of a former employer or competitor.

 While
we may litigate to defend ourselves against these claims, even if we are successful, litigation could result in substantial costs and
could be a distraction to management. If our defenses to these claims fail, in addition to requiring us to pay monetary damages, a court
could prohibit us from using technologies or features that are essential to our programs, if such technologies or features are found
to incorporate or be derived from the trade secrets or other proprietary information of the former employers. Moreover, any such litigation
or the threat thereof may adversely affect our reputation, our ability to form strategic alliances or sublicense our rights to collaborators,
engage with scientific advisors or hire employees or consultants, each of which would have an adverse effect on our business, results
of operations and financial condition. Even if we are successful in defending against such claims, litigation could result in substantial
costs and be a distraction to management.

to patent laws in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our
ability to protect our products.

in either the patent laws or interpretation of patent laws in the United States and foreign jurisdictions could increase the uncertainties
and costs surrounding the prosecution of our owned and in-licensed patent applications and the maintenance, enforcement or
defense of our owned and in-licensed issued patents. Additionally, there have been proposals for additional changes to the
patent laws of the United States and other countries that, if adopted, could impact our ability to enforce our proprietary technology.
This combination of events has created uncertainty with respect to the validity and enforceability of patents once obtained. Depending
on future actions by the U.S. Congress, the federal courts, the USPTO and the relevant law-making bodies in other countries, the laws
and regulations governing patents could change in unpredictable ways that could have a material adverse effect on our patent rights and
our ability to protect, defend and enforce our patent rights in the future. In addition, geopolitical instability could increase the
uncertainties and costs surrounding the prosecution or maintenance of patent applications and the maintenance, enforcement or defense
of issued patents.

 The
patent positions of companies in the development and commercialization of biologics and pharmaceuticals are particularly uncertain. U.S. Supreme
Court and U.S. Court of Appeals for the Federal Circuit rulings have narrowed the scope of patent protection available in certain
circumstances and weakened the rights of patent owners in certain situations, including in the antibody arts. For example, the United States
Supreme Court in Amgen, Inc. v. Sanofi (Amgen) stated that if patent claims are directed to an entire class of compositions
of matter, then the patent specification must enable a person skilled in the art to make and use the entire class of compositions. This
decision makes it unlikely that we will be granted U.S. patents with composition of matter claims directed to antibodies functionally
defined by their ability to bind a particular antigen. Even if we are granted claims directed to functionally defined antibodies, it
is possible that a third party may challenge our patents, when issued, relying on the reasoning in Amgen or other recent precedential
court decisions.

 In
addition, a European Unified Patent Court ("UPC") entered into force on June 1, 2023. The UPC is a common patent court
that hears patent infringement and revocation proceedings effective for EU Member States. This could enable third parties to seek revocation
of a European patent in a single proceeding at the UPC rather than through multiple proceedings in each of the jurisdictions in which
the European patent is validated.

 Although
we do not currently own any European patents or applications, if we obtain such patents and applications in the future, any such revocation
and loss of patent protection could have a material adverse impact on our business and our ability to commercialize or license our technology
and products. Moreover, the controlling laws and regulations of the UPC will develop over time, and may adversely affect our ability
to enforce or defend the validity of any European patents we may obtain. We may decide to opt out from the UPC any future European patent
applications that we may file and any patents we may obtain. If certain formalities and requirements are not met, however, such European
patents and patent applications could be challenged for non-compliance and brought under the jurisdiction of the UPC. We
cannot be certain that future European patents and patent applications will avoid falling under the jurisdiction of the UPC, if we decide
to opt out of the UPC.

 Obtaining
and maintaining patent protection depends on compliance with various procedural, document submissions, fee payment and other requirements
imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these
requirements.

 Periodic
maintenance fees, renewal fees, annuities fees and various other governmental fees on patents and/or patent applications are due to be
paid to the USPTO and foreign patent agencies in several stages over the lifetime of the patent and/or patent application. The USPTO
and various foreign governmental patent agencies also require compliance with a number of procedural, documentary, fee payment and other
similar provisions during the patent application process. While an inadvertent lapse can in many cases be cured by payment of a late
fee or by other means in accordance with the applicable rules, there are situations in which noncompliance can result in abandonment
or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. Non-compliance events
that could result in abandonment or lapse of a patent or patent application include, but are not limited to, failure to respond to official
actions within prescribed time limits, non-payment of fees and failure to properly legalize and submit formal documents. If
we fail to maintain the patents and patent applications covering our programs, our competitive position would be adversely affected.

 We
may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent,
which might adversely affect our ability to develop and market our products.

 We
cannot guarantee that any of our patent searches or analyses, including the identification of relevant patents, the scope of patent claims
or the expiration of relevant patents, are complete or thorough, nor can we be certain that we have identified each and every third-party patent
and pending application in the United States and abroad that is relevant to or necessary for the commercialization of our product
candidates in any jurisdiction. The scope of a patent claim is determined by an interpretation of the law, the written disclosure in
a patent and the patent's prosecution history. Our interpretation of the relevance or the scope of a patent or a pending application
may be incorrect. For example, we may incorrectly determine that our products are not covered by a third-party patent or may incorrectly
predict whether a third-party's pending application will issue with claims of relevant scope. Our determination of the expiration
date of any patent in the United States or abroad that we consider relevant may be incorrect. Our failure to identify and correctly
interpret relevant patents may negatively impact our ability to develop and market our products.

 In
addition, because some patent applications in the United States may be maintained in secrecy until the patents are issued, patent
applications in the United States and many foreign jurisdictions are typically not published until 18 months after filing,
and publications in the scientific literature often lag behind actual discoveries, we cannot be certain that others have not filed patent
applications for technology covered by our issued patents or our pending applications, or that we were the first to invent the technology.
Our competitors may have filed, and may in the future file, patent applications covering products or technology similar to ours. Any
such patent application may have priority over our patent applications or patents, which could require us to obtain rights to issued
patents covering such technologies.

 We
may become subject to claims challenging the inventorship or ownership of our patents and other intellectual property.

 We
may be subject to claims that former employees, collaborators or other third parties have an interest in our patents or other intellectual
property as an inventor or co-inventor. The failure to name the proper inventors on a patent application can result in the
patents issuing thereon being unenforceable. Inventorship disputes may arise from conflicting views regarding the contributions of different
individuals named as inventors, the effects of foreign laws where foreign nationals are involved in the development of the subject matter
of the patent, conflicting obligations of third parties involved in developing our programs or as a result of questions regarding co-ownership of
potential joint inventions. Litigation may be necessary to resolve these and other claims challenging inventorship and/or ownership.
Alternatively, or additionally, we may enter into agreements to clarify the scope of our rights in such intellectual property. If we
fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights, such as
exclusive ownership of, or right to use, valuable intellectual property. Such an outcome could have a material adverse effect on our
business. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction
to management and other employees.

 Patent
terms may be inadequate to protect the competitive position of our product candidates for an adequate amount of time.

 Patents
have a limited lifespan. In the United States, if all maintenance fees are timely paid, the natural expiration of a patent is generally
20 years from its earliest United States non-provisional filing date. Various extensions may be available, but the
life of a patent, and the protection it affords, is limited. Even if patents covering our product candidates are obtained, once the patent
life has expired, we may be open to competition from competitive products, including generics or biosimilars. Given the amount of time
required for the development, testing and regulatory review of new product candidates, patents protecting such product candidates might
expire before or shortly after such product candidates are commercialized. As a result, our owned and licensed patent portfolio may not
provide us with sufficient rights to exclude others from commercializing products similar or identical to ours.

 Our
technology licensed from various third parties may be subject to retained rights.

 Our
future licensors may retain certain rights under the relevant agreements with us, including the right to use the underlying technology
for noncommercial academic and research use, to publish general scientific findings from research related to the technology, and to make
customary scientific and scholarly disclosures of information relating to the technology. It is difficult to monitor whether our licensors
limit their use of the technology to these uses, and we could incur substantial expenses to enforce our rights to our licensed technology
in the event of misuse.

 In
addition, our future licensors may rely on third-party consultants or collaborators or on funds from third parties, such as the
U.S. government, such that our licensors would not be the sole and exclusive owners of any patents we in-license. If other
third parties have ownership rights or other rights to our in-licensed patents, they may be able to license such patents to
our competitors, and our competitors could market competing products and technology. This could have a material adverse effect on our
competitive position, business, financial conditions, results of operations, and prospects.

 Risks
Related to Our Reliance on Third Parties

 We
currently rely on licensing arrangements with Paragon through the License Agreements. If we are unable to maintain collaborations or
licensing arrangements, or if our collaborations or licensing arrangements are not successful, our business could be negatively impacted.

 We
currently rely on our licensing arrangements with Paragon through the License Agreements for a substantial portion of our in-licenses.

 Collaborations
or licensing arrangements that we enter into may not be successful, and any success will depend heavily on the efforts and activities
of such collaborators or licensors. If any of our current or future collaborators or licensors experience delays in performance of, or
fails to perform our obligations under their agreement with us, disagrees with our interpretation of the terms of such agreement or terminates
their agreement with us, the research programs with respect to which we have the option to acquire intellectual property license rights
to pursuant to the Option Agreements, the licensing agreements we have pursuant to the License Agreements and our development timeline
could be adversely affected. If we fail to comply with any of the obligations under our collaborations or license agreements, including
payment terms and diligence terms, our collaborators or licensors may have the right to terminate such agreements, in which event we
may lose intellectual property rights and may not be able to develop, manufacture, market or sell the products covered by our agreements
or may face other penalties under our agreements. Our collaborators and licensors may also fail to properly maintain or defend the intellectual
property we have licensed from them, if required by our agreement with them, or even infringe upon, our intellectual property rights,
leading to the potential invalidation of our intellectual property or subjecting us to litigation or arbitration, any of which would
be time-consuming and expensive and could harm our ability to commercialize our product candidates. In addition, collaborators could
independently develop, or develop with third parties, products that compete directly or indirectly with our programs and products if
the collaborators believe that the competitive products are more likely to be successfully developed or can be commercialized under terms
that are more economically attractive than ours.

 As
part of our strategy, we plan to evaluate additional opportunities to enhance our capabilities and expand our development pipeline or
provide development or commercialization capabilities that complement ours. We may not realize the benefits of such collaborations, alliances
or licensing arrangements. Any of these relationships may require us to incur non-recurring and other charges, increase our
near and long-term expenditures, issue securities that dilute our existing stockholders or disrupt our management and business.

 We
may face significant competition in attracting appropriate collaborators, and more established companies may also be pursuing strategies
to license or acquire third-party intellectual property rights that we consider attractive. These companies may have a competitive
advantage over us due to their size, financial resources and greater clinical development and commercialization capabilities. In addition,
companies that perceive us to be a competitor may be unwilling to assign or license rights to us. Whether we reach a definitive agreement
for a collaboration will depend upon, among other things, our assessment of the collaborator's resources and expertise, the terms
and conditions of the proposed collaboration and the proposed collaborator's evaluation of a number of factors. Collaborations
are complex and time-consuming to negotiate, document and execute. In addition, consolidation among large pharmaceutical and biotechnology
companies has reduced the number of potential future collaborators. We may not be able to negotiate collaborations on a timely basis,
on acceptable terms or at all. If we fail to enter into collaborations and do not have sufficient funds or expertise to undertake the
necessary development and commercialization activities, we may not be able to further develop our product candidates or bring them to
market.

 We
currently rely, and plan to rely in the future, on third parties to conduct and support our preclinical studies and clinical trials.
If these third parties do not properly and successfully carry out their contractual duties or meet expected deadlines, we may not be
able to obtain regulatory approval of or commercialize our product candidates.

 We
have utilized and plan to continue to utilize and depend upon independent investigators and collaborators, such as medical institutions,
CROs, contract testing labs, CMOs and strategic partners, to supply, conduct and support our preclinical studies and clinical trials
under agreements with us. We will rely heavily on these third parties over the course of our preclinical studies and clinical trials,
and we control only certain aspects of their activities. As a result, we will have less direct control over the conduct, timing and completion
of these preclinical studies and clinical trials and the management of data developed through preclinical studies and clinical trials
than would be the case if we were relying entirely upon our own staff. Nevertheless, we are responsible for ensuring that each of our
studies and trials is conducted in accordance with the applicable protocol, legal, regulatory and scientific standards, and our reliance
on these third parties does not relieve us of our regulatory responsibilities. We and our third-party contractors and CROs are required
to comply with GCP regulations, which are regulations and guidelines enforced by the FDA and comparable foreign regulatory authorities
for all of our programs in clinical development. If we or any of these third parties fail to comply with applicable GCP regulations,
the clinical data generated in our clinical trials may be deemed unreliable and the FDA or comparable foreign regulatory authorities
may require us to perform additional clinical trials before approving our marketing applications or refuse to approve our marketing applications.
We cannot assure you that upon inspection by a given regulatory authority, such regulatory authority will determine that any of our clinical
trials comply with GCP regulations. In addition, our clinical trials must be conducted with products produced under cGMP regulations.
Our failure to comply with these regulations may require us to repeat clinical trials, which would delay the regulatory approval process.
Moreover, our business may be implicated if any of these third parties violate federal or state fraud and abuse or false claims laws
and regulations or healthcare privacy and security laws.

 Any
third parties conducting our clinical trials will not be our employees and, except for remedies available to us under our agreements
with such third parties, we cannot control whether they devote sufficient time and resources to our programs. These third parties may
have relationships with other commercial entities, including our competitors, for whom they may also be conducting clinical trials or
other product development activities, which could negatively affect their performance on our behalf and the timing thereof and could
lead to products that compete directly or indirectly with our product candidates. If these third parties do not successfully carry out
their contractual duties or obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy of the
clinical data they obtain is compromised due to the failure to adhere to our clinical protocols or regulatory requirements or for other
reasons, our clinical trials may be extended, delayed or terminated and we may not be able to complete development of, obtain regulatory
approval of or successfully commercialize our product candidates.

 We
currently rely and expect to rely in the future on the use of manufacturing suites in third-party facilities or on third parties to manufacture
our product candidates, and we may rely on third parties to produce and process our products, if approved. Our business could be adversely
affected if we are unable to use third-party manufacturing suites or if the third-party manufacturers encounter difficulties in production.

 We
do not currently own any facility that may be used as our clinical or commercial manufacturing and processing facility and must currently
rely on CMOs to manufacture our product candidates. We have not yet caused any product candidates to be manufactured on a commercial
scale and may not be able to do so for any of our product candidates, if approved. We currently have a sole source relationship for our
supply of the ORKA-001 and ORKA-002 programs. If there should be any disruption in such supply arrangement, including any adverse
events affecting our sole supplier, it could have a negative effect on the clinical development of our programs and other operations
while we work to identify and qualify an alternate supply source. We may not control the manufacturing process of, and may be completely
dependent on, our contract manufacturing partners for compliance with cGMP requirements and any other regulatory requirements of the
FDA or comparable foreign regulatory authorities for the manufacture of our product candidates. Beyond periodic audits, we have limited
control over the ability of our CMOs to maintain adequate quality control, quality assurance and qualified personnel. If the FDA or a
comparable foreign regulatory authority does not approve these facilities for the manufacture of our product candidates or if it withdraws
any approval in the future, we may need to find alternative manufacturing facilities, which would require the incurrence of significant
additional costs, delays, and materially adversely affect our ability to develop, obtain regulatory approval for or market our product
candidates, if approved. Similarly, our failure, or the failure of our CMOs, to comply with applicable regulations could result in sanctions
being imposed on us, including fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation,
seizures or recalls of product candidates or drugs, operating restrictions and criminal prosecutions, any of which could significantly
and adversely affect supplies of our product candidates or drugs and harm our business and results of operations.

our CMOs may experience manufacturing difficulties due to resource constraints, supply chain issues, proposed or actual legislative changes
or requirements, or as a result of labor disputes or unstable political environments. If any CMOs on which we will rely fail to manufacture
quantities of our product candidates at quality levels necessary to meet regulatory requirements and at a scale sufficient to meet anticipated
demand at a cost that allows us to achieve profitability, our business, financial condition and prospects could be materially and adversely
affected. In addition, our CMOs are responsible for transporting temperature-controlled materials that can be inadvertently
degraded during transport due to several factors, rendering certain batches unsuitable for trial use for failure to meet, among others,
our integrity and purity specifications. We and any of our CMOs may also face product seizure or detention or refusal to permit the import
or export of products. Our business could be materially adversely affected by business disruptions to our third-party providers
that could materially adversely affect our anticipated timelines, potential future revenue and financial condition and increase our costs
and expenses. Each of these risks could delay or prevent the completion of our preclinical studies and clinical trials or the approval
of any of our product candidates by the FDA, result in higher costs or adversely impact commercialization of our product candidates.

 Foreign
CMOs may be subject to U.S. legislation, including the proposed BIOSECURE bill, trade restrictions and other foreign regulatory
requirements, which could increase the cost or reduce the supply of material available to us, delay the procurement or supply of such
material or have an adverse effect on our ability to secure significant commitments from governments to purchase our potential therapies.
We currently rely on foreign CROs and CMOs, including WuXi Biologics (Hong Kong) Limited and its affiliates ("WuXi Biologics")
and will likely continue to rely on foreign CROs and CMOs in the future. WuXi Biologics is identified in the U.S. legislation known as
the BIOSECURE Act, which was proposed in the 118 th Congress, as a "biotechnology company of concern." The version
of the BIOSECURE Act introduced in the U.S. House of Representatives during the 118 th Congress would prohibit federal agencies
from entering into procurement contracts with, as well as providing grants and loans to, an entity that uses biotechnology equipment
or services from a biotechnology company of concern, and includes a grandfathering provision allowing biotechnology equipment and services
provided or produced by named "biotechnology companies of concern" under a contract or agreement entered into before the
effective date until January 1, 2032. The pathway and timing for the BIOSECURE Act or its provisions to become law are uncertain. Depending
on whether the BIOSECURE Act becomes law, what the final language of the BIOSECURE Act includes, and how the law is interpreted by U.S.
federal agencies, we could be potentially restricted from pursuing U.S. federal government business or grants in the future if we continue
to use WuXi or other parties identified as "biotechnology companies of concern" beyond the grandfathering period.

our operations and financial condition may be negatively impacted as a result of any delays or increased costs arising from the trade
restrictions and other foreign regulatory requirements affecting such collaborators. In addition, while we have established relationships
with CROs and CMOs outside of China, moving to those suppliers in the event of geopolitical instability affecting our collaborators in
China could introduce delays into the development program.

 Risks
Related to Employee Matters, Managing Growth and Other Risks Related to Our Business

 In
order to successfully implement our plans and strategies, we will need to grow the size of our organization and we may experience difficulties
in managing this growth.

 We
expect to experience significant growth in the number of our employees and the scope of our operations, particularly in the areas of
preclinical and clinical drug development, technical operations, clinical operations, regulatory affairs and, potentially, sales and
marketing. To manage our anticipated future growth, we must continue to implement and improve our managerial, operational and financial
personnel and systems, expand our facilities and continue to recruit and train additional qualified personnel. Due to our limited financial
resources and the limited experience of our management team working together in managing a company with such anticipated growth, we may
not be able to effectively manage the expansion of our operations or recruit and train additional qualified personnel.

 We
are highly dependent on our key personnel and anticipate hiring new key personnel. If we are not successful in attracting and retaining
highly qualified personnel, we may not be able to successfully implement our business strategy.

 Our
ability to pursue our growth strategy will be limited if we are unable to continue to attract and retain high quality personnel. We have
been and will continue to be highly dependent on the research and development, clinical and business development expertise of our executive
officers, as well as the other principal members of our management, scientific and clinical team. Any of our management team members
may terminate their employment with us at any time. We do not maintain "key person" insurance for any of our executives or
other employees.

 Attracting
and retaining qualified personnel will also be critical to our success, including with respect to any strategic transaction that we may
pursue. The loss of our executive officers or other key employees could impede the achievement of our research, development and commercialization
objectives and seriously harm our ability to successfully implement our business strategy. Furthermore, replacing executive officers
and key employees may be difficult and may take an extended period of time because of the limited number of individuals in our industry
with the breadth of skills and experience required to successfully develop, facilitate regulatory approval of and commercialize product
candidates. Competition to hire from this limited pool is intense, and we may be unable to hire, train, retain or motivate these key
personnel on acceptable terms given the competition among numerous pharmaceutical and biotechnology companies for similar personnel,
as well as from universities and research institutions.

 In
addition, we rely on consultants and advisors to assist us in formulating our discovery and nonclinical and clinical development and
commercialization strategy. Our consultants and advisors may be employed by employers other than us and may have commitments under consulting
or advisory contracts with other entities that may limit their availability to us.

 Our
future growth may depend, in part, on our ability to operate in foreign markets, where we would be subject to additional regulatory burdens
and other risks and uncertainties.

 Our
future growth may depend, in part, on our ability to develop and commercialize our product candidates in foreign markets for which we
may rely on collaboration with third parties. If we fail to comply with the regulatory requirements in foreign markets and receive applicable
marketing approvals, our target market will be reduced and our ability to realize the full market potential of our product candidates
will be harmed and our business will be adversely affected. Moreover, even if we obtain approval of our product candidates and ultimately
commercialize our product candidates in foreign markets, we would be subject to the risks and uncertainties, including the burden of
complying with complex and changing foreign regulatory, tax, accounting and legal requirements and reduced protection of intellectual
property rights in some foreign countries.

 Our
estimates of market opportunity and forecasts of market growth may prove to be inaccurate, and even if the markets in which we compete
achieve the forecasted growth, our business may not grow at similar rates, or at all.

 Our
market opportunity estimates and growth forecasts are subject to significant uncertainty and are based on assumptions and estimates that
may not prove to be accurate. Even if the markets in which we compete meet our size estimates and growth forecasts, our business may
not grow at similar rates, or at all.

 Our
revenue will be dependent, in part, upon the size of the markets in the territories for which we gain regulatory approval, the accepted
price for the product, the ability to obtain coverage and reimbursement and whether we own the commercial rights for that territory.
If the number of our addressable patients is not as significant as we estimate, the indication approved by regulatory authorities is
narrower than we expect or the treatment population is narrowed by competition, physician choice or treatment guidelines, we may not
generate significant revenue from sales of such products, even if approved.

 Our
employees, independent contractors, consultants, commercial collaborators, principal investigators, CROs, CMOs, suppliers and vendors
may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.

 We
are exposed to the risk that our employees, independent contractors, consultants, commercial collaborators, principal investigators,
CROs, CMOs, suppliers and vendors acting for or on our behalf may engage in misconduct or other improper activities. We have adopted
a code of conduct and ethics, but it is not always possible to identify and deter misconduct by these parties and the precautions we
take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us
from governmental investigations or other actions or lawsuits stemming from a failure to comply with these laws or regulations.

 Our
internal information technology systems, or those of any of our third-party service providers, or potential future collaborators, may
fail or suffer security or data privacy breaches or other unauthorized or improper access to, use of, or destruction of our proprietary
or confidential data, employee data or personal data, which could result in additional costs, loss of revenue, significant liabilities,
harm to our brand and material disruption of our operations.

 In
the ordinary course of our business, we and the third parties upon which we rely collect, receive, store, process, generate, use, transfer,
disclose, make accessible, protect, secure, dispose of, transmit, and share (collectively, process) proprietary, confidential, and sensitive
data, including personal data, intellectual property, trade secrets, and other sensitive data (collectively, sensitive information).
If we (or a third party upon whom we rely) experience a security incident or are perceived to have experienced a security incident, we
may experience adverse consequences. While we have implemented security measures designed to protect against security incidents, there
can be no assurance that these measures will be effective. Further, cybersecurity breaches or other cybersecurity incidents may allow
hackers access to our preclinical compounds, strategies, discoveries, trade secrets, and/or other confidential information. Additionally,
sensitive data could be leaked, disclosed, or revealed as a result of or in connection with our employees', personnel's,
vendors' or partners' use of generative AI technologies. Our ability to monitor third parties' information security
practices is limited, and these third parties may not have adequate security measures in place. We may be unable in the future to detect
vulnerabilities in our information technology systems because such threats and techniques change frequently, are often sophisticated
in nature, and may not be detected until after a security incident has occurred. Further, we may experience delays in developing and
deploying remedial measures designed to address any such identified vulnerabilities. Applicable data privacy and security obligations
may require us to notify relevant stakeholders of security incidents. Such disclosures are costly, and the disclosure or the failure
to comply with such requirements could lead to adverse consequences. Moreover, while we may be entitled to damages if our third-party
service providers fail to satisfy their privacy or security-related obligations to us, any award may be insufficient or we may be unable
to recover such award. Security incidents and attendant consequences may negatively impact our ability to grow and operate our business.
The risk of a cybersecurity incident or other informational technology disruption, particularly through cyber-attacks, has generally
increased as the number, intensity and sophistication of attempted attacks and intrusions from around the world have increased.

 To
the extent that any disruption or security breach were to result in loss, destruction, unavailability, alteration or dissemination of,
or damage to, our data (including clinical trial data) or applications, or for it to be believed or reported that any of these occurred,
we could incur liability, including under laws and regulations governing the protection of protected health information and other personal
data, and reputational damage and the development and commercialization of our product candidates could be delayed. Further, our insurance
policies may not be adequate to compensate us for the potential losses arising from any such disruption in, or failure or security breach
of, our systems or third-party systems where information important to our business operations or commercial development is stored.

 Despite
the implementation of security measures in an effort to protect systems that store our information, given their size and complexity and
the increasing amounts of information maintained on our internal information technology systems and those of our third-party CROs,
contractors (including sites performing our clinical trials), third-party service providers and supply chain companies, and consultants,
these systems are potentially vulnerable to breakdown or other damage or interruption from service interruptions, system malfunction,
natural disasters, terrorism, war and telecommunication and electrical failures, as well as security breaches from inadvertent or intentional
actions or from cyber-attacks by malicious third parties, or ransomware attacks, which, in each case, may compromise our system
infrastructure or lead to the loss, destruction, alteration or dissemination of, or damage to, our data.

 Our
hybrid-remote workforce may create additional risks for our information technology systems and data because our employees work remotely
and utilize network connections, computers, and devices working at home, while in transit and in public locations.

 Our
contracts may not contain limitations of liability, and even where they do, there can be no assurance that limitations of liability in
our contracts are sufficient to protect us from liabilities, damages, or claims related to our data privacy and security obligations.
We cannot be sure that our insurance coverage will be adequate or sufficient to protect us from or to mitigate liabilities arising out
of our privacy and security practices, that such coverage will continue to be available on commercially reasonable terms or at all, or
that such coverage will pay future claims.

 We
are subject to stringent and changing laws, regulations and standards, and contractual obligations relating to privacy, data protection,
and data security. The actual or perceived failure to comply with such obligations could lead to government enforcement actions (which
could include civil or criminal penalties), fines and sanctions, private litigation and/or adverse publicity and could negatively affect
our operating results and business.

 We
and third parties who we work with are or may become subject to numerous domestic and foreign laws, regulations, and standards relating
to privacy, data protection, data transfer, and data security, the scope of which is changing, subject to differing applications and
interpretations, and may be inconsistent among countries, or conflict with other rules. We are or may become subject to the terms of
contractual obligations related to privacy, data protection and data security. Our obligations may also change or expand as our business
grows. The actual or perceived failure by us or third parties related to us to comply with such laws, regulations and obligations could
increase our compliance and operational costs, expose us to regulatory scrutiny, actions, fines and penalties, result in reputational
harm, lead to a loss of customers, result in litigation and liability, and otherwise cause a material adverse effect on our business,
financial condition, and results of operations.

 If
we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur
costs that could have a material adverse effect on the success of our business.

 We
are subject to numerous environmental, health and safety laws and regulations, including those governing laboratory procedures and the
handling, use, storage, treatment and disposal of hazardous materials and wastes. Our operations may involve the use of hazardous and
flammable materials, including chemicals and biological and radioactive materials. In addition, we may incur substantial costs in order
to comply with current or future environmental, health and safety laws and regulations. These current or future laws and regulations
may impair our research, development or commercialization efforts. Failure to comply with these laws and regulations also may result
in substantial fines, penalties or other sanctions.

 We
may be subject to adverse legislative or regulatory tax changes that could negatively impact our financial condition.

 The
rules dealing with U.S. federal, state and local income taxation are constantly under review by persons involved in the legislative
process and by the Internal Revenue Service and the U.S. Treasury Department. Changes to tax laws (which may have retroactive application)
could adversely affect our stockholders or us. We continue to assess the impact of various tax reform proposals and modifications to
existing tax treaties in all jurisdictions where we have operations or employees to determine the potential effect on our business and
any assumptions we make about our future taxable income. We cannot predict whether any specific proposals will be enacted, the terms
of any such proposals or what effect, if any, such proposals would have on our business if they were to be enacted. For example, the
United States enacted the IRA, which implements, among other changes, a 1% excise tax on certain stock buybacks. In addition, beginning
in 2022, the Tax Cuts and Jobs Act eliminated the previously available option to deduct research and development expenditures
and requires taxpayers to amortize them generally over five years for research activities conducted in the United States and
over 15 years for research activities conducted outside the United States. Such changes, among others, may adversely affect
our effective tax rate, results of operation and general business condition.

 We
may acquire businesses or products, or form strategic alliances, in the future, and may not realize the benefits of such acquisitions.

 We
may acquire additional businesses or products, form strategic alliances, or create joint ventures with third parties that we believe
will complement or augment our existing business. If we acquire businesses with promising markets or technologies, we may not be able
to realize the benefit of acquiring such businesses if we are unable to successfully integrate them with our existing operations and
company culture. We may encounter numerous difficulties in developing, manufacturing and marketing any new product candidates or products
resulting from a strategic alliance or acquisition that delay or prevent us from realizing their expected benefits or enhancing our business.
There is no assurance that, following any such acquisition, we will achieve the synergies expected in order to justify the transaction,
which could result in a material adverse effect on our business and prospects.

 We
maintain our cash at financial institutions, often in balances that exceed federally-insured limits. The failure of financial institutions
could adversely affect our ability to pay our operational expenses or make other payments.

 Our
cash held in non-interest-bearing and interest-bearing accounts exceeds the Federal Deposit Insurance Corporation insurance
limits. If such banking institutions were to fail, we could lose all or a portion of those amounts held in excess of such insurance limitations.
In addition, even if account holders are ultimately made whole with respect to a future bank failure, account holders' access to
their accounts and assets held in their accounts may be substantially delayed. Any material loss that we may experience in the future
or inability for a material time period to access our cash and cash equivalents could have an adverse effect on our ability to pay our
operational expenses or make other payments, which could adversely affect our business.

Risk Factors

 Our
estimates of market opportunity and forecasts of market growth may prove to be inaccurate, and
even if the markets in which we compete achieve the forecasted growth, our business may not grow at similar rates,
or at all.

 Our
market opportunity estimates and growth forecasts are subject to significant uncertainty and are based on assumptions and estimates that
may not prove to be accurate. Even if the markets in which we compete meet our size estimates and growth forecasts, our business may
not grow at similar rates, or at all. Our growth is subject to many factors, including our success in implementing our business strategy,
which is subject to many risks and uncertainties.

 Our
revenue will be dependent, in part, upon the size of the markets in the territories for which we gain regulatory approval, the accepted
price for the product, the ability to obtain coverage and reimbursement and whether we own the commercial rights for that territory.
If the number of our addressable patients is not as significant as we estimate, the indication approved by regulatory authorities is
narrower than we expect or the treatment population is narrowed by competition, physician choice or treatment guidelines, we may not
generate significant revenue from sales of such products, even if approved.

 We
may become exposed to costly and damaging liability claims, either when testing a product candidate in the clinical or at the commercial
stage, and our insurance may not cover all damages from such claims.

 We
are exposed to potential product liability and professional indemnity risks that are inherent in the research, development, manufacturing,
marketing, and use of pharmaceutical products. The use of a product candidate in clinical trials and the sale of any approved products
in the future may expose us to liability claims. An individual or group of individuals may bring a liability claim against us if one
of our product candidates causes, or merely appears to have caused, an injury. Any claims against us, regardless of their merit, could
be difficult and costly to defend and could materially and adversely affect our business. While we carry product liability insurance
for our clinical trials, it is possible that any liabilities could exceed our insurance coverage or that in the future we may not be
able to maintain insurance coverage at a reasonable cost or obtain insurance coverage that will be adequate to satisfy any liability
that may arise. On occasion, large judgments have been awarded in class action or individual lawsuits. A successful product liability
claim or series of claims brought against us could cause our stock price to decline and, if judgments exceed our insurance coverage,
could decrease our cash and our business operations could be impaired.

 Litigation
costs and the outcome of litigation could have a material adverse effect on our business.

 From
time to time we may be subject to litigation claims through the ordinary course of our business operations
regarding, but not limited to, employment matters, security of patient and employee personal information, contractual relations with
collaborators and intellectual property rights. Litigation to defend ourselves against claims by third parties, or to enforce any rights
that we may have against third parties, may continue to be necessary, which could result in substantial costs and diversion of our resources,
causing a material adverse effect on our business, financial condition, results of operations or cash flows.

 Our
business could be adversely affected by economic downturns, inflation, fluctuation in interest rates, natural disasters, public health
crises, political crises, geopolitical events or other macroeconomic conditions, which could have a material and adverse effect on our
results of operations and financial condition.

 The
global economy, including credit and financial markets, has experienced and may experience in the future extreme volatility and disruptions,
including, among other things, diminished liquidity and credit availability, declines in consumer confidence, declines in economic growth,
supply chain shortages, new or increased tariffs and other barriers to trade, trade and other international disputes, increases in inflation
rates, fluctuation in interest rates, slower growth or recession, tighter credit, volatility in financial markets, high unemployment,
labor availability constraints, public health crises, significant natural disasters, including as a result of climate change, changes
to fiscal and monetary policy or government budget dynamics (particularly in the pharmaceutical and biotech areas), particularly in the
pharmaceutical and biotech areas, political and military conflict, and uncertainty about economic stability. Fluctuation in interest
rates, coupled with reduced government spending and volatility in financial markets, may increase economic uncertainty and affect consumer
spending. Similarly, the ongoing military conflict between Russia and Ukraine and in the Middle East and rising tensions with China have
created extreme volatility in the global capital markets and may have further global economic consequences, including disruptions of
the global supply chain. Any such volatility and disruptions may adversely affect our business or the third parties on whom we rely.
If the equity and credit markets deteriorate, including as a result of political unrest or war, it may make any necessary debt or equity
financing more costly, more dilutive, or more difficult to obtain in a timely manner or on favorable terms, if at all. Increased inflation
rates can adversely affect us by increasing our costs, including materials, operational, labor and employee benefit costs.

 We
may in the future experience disruptions as a result of such macroeconomic conditions, including delays or difficulties in initiating
or expanding clinical trials and manufacturing sufficient quantities of materials. Any one or a combination of these events could have
a material and adverse effect on our results of operations and financial condition.

 Geopolitical
events and global economic conditions may also affect the ability of the FDA and other regulatory authorities to perform routine functions.
If such concerns prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews or other regulatory
activities, it could significantly impact the ability of the FDA or other regulatory authorities to timely review and process our regulatory
submissions, which could have a material adverse effect on our business.

 Risks
Related to Owning Our Stock

 The
market price of our common stock has been, and may continue to be volatile.

 The
market price of our common stock has been and is likely to be highly volatile and is subject to significant fluctuations. Some of the
factors that may cause the market price of our common stock to fluctuate include:

 timing
 and results of clinical trials and preclinical studies of our product candidates, or those
 of our competitors or our existing or future collaborators;

 failure
 to meet or exceed financial and development projections that we may provide to the public;

 announcements
 of significant or potential equity or debt sales by us;

 actions
 taken by regulatory agencies with respect to our product candidates, clinical studies, manufacturing
 process or sales and marketing terms;

 failure
 to meet or exceed the financial and development projections of the investment community or
 if securities or industry analysts do not publish research or reports about our business,
 or if they issue adverse or misleading opinions regarding our business and stock;

 announcements
 of significant acquisitions, strategic collaborations, joint ventures or capital commitments
 by us or our competitors;

 general
 market, macroeconomic or geopolitical conditions or market conditions in the pharmaceutical
 and biotechnology sectors;

 disputes
 or other developments relating to proprietary rights, including patents, litigation matters,
 and our ability to obtain patent protection for our technologies;

 additions
 or departures of key personnel, including scientific or management personnel;

 significant
 lawsuits, including patent or stockholder litigation;

 changes
 in the market valuations of similar companies;

 sales
 of securities by us or our securityholders in the future;

 if
 we fail to raise an adequate amount of capital to fund our operations or continued development
 of our product candidates;

 trading
 volume of our common stock;

 announcements
 by competitors of new products, clinical progress or lack thereof, significant contracts,
 commercial relationships or capital commitments;

 the
 introduction of technological innovations or new therapies that compete with our products;
 and

 period-to-period
 fluctuations in our financial results.

the stock markets in general have experienced substantial volatility that has often been unrelated to the operating performance of individual
companies. These broad market fluctuations may also adversely affect the trading price of our common stock. In addition, a recession,
depression or other sustained adverse market event could materially and adversely affect our business and the value of our common stock.
In the past, following periods of volatility in the market price of a company's securities, stockholders have often instituted
class action securities litigation against such companies.

market volatility may lead to securities litigation or increased stockholder activism if we experience a market valuation that activists
believe is not reflective of our intrinsic value. Activist campaigns that contest or conflict with our strategic direction or seek changes
in the composition of our board of directors could have an adverse effect on our operating results, financial condition and cash flows.

 Our
certificate of incorporation and bylaws, as well as provisions under Delaware law, could make an acquisition of the company more difficult
and may prevent attempts by our stockholders to replace or remove management.

 Provisions
in our certificate of incorporation and bylaws may discourage, delay or prevent a merger, acquisition or other change in control of the
company that stockholders may consider favorable, including transactions in which our common stockholders might otherwise receive a premium
price for their shares. These provisions could also limit the price that investors might be willing to pay in the future for shares of
our common stock, thereby depressing the market price of our common stock. In addition, because our board of directors is responsible
for appointing the members of our management team, these provisions may frustrate or prevent any attempts by our stockholders to replace
or remove current management by making it more difficult for stockholders to replace members of our board of directors. Among other things,
these provisions:

 establish
 a classified board of directors such that all members of the board are not elected at one
 time;

 allow
 the authorized number of our directors to be changed only by resolution of our board of directors;

 limit
 the manner in which stockholders can remove directors from the board;

 establish
 advance notice requirements for nominations for election to the board of directors or for
 proposing matters that can be acted on at stockholder meetings;

 require
 that stockholder actions must be effected at a duly called stockholder meeting and prohibit
 actions by our stockholders by written consent;

 limit
 who may call a special meeting of stockholders;

 authorize
 our board of directors to issue preferred stock without stockholder approval, which could
 be used to institute a "poison pill" that would work to dilute the stock ownership
 of a potential hostile acquirer, effectively preventing acquisitions that have not been approved
 by our board of directors; and

 require
 the approval of the holders of at least 66 2/3% of the votes that all stockholders would
 be entitled to cast to amend or repeal certain provisions of our charter or bylaws.

because we are incorporated in Delaware, we are governed by the provisions of Section 203 of the Delaware General Corporation Law ("DGCL"),
which prohibits stockholders owning more than 15% of our outstanding voting stock from merging or combining with us. Although we believe
these provisions collectively will provide for an opportunity to receive higher bids by requiring potential acquirors to negotiate with
our board of directors, they would apply even if the offer may be considered beneficial by some stockholders.

 Our
governing documents provide that, unless we consent in writing to the selection of an alternative forum, certain designated courts will
be the sole and exclusive forum for certain legal actions between us and our stockholders, which could limit our stockholders'
ability to obtain a favorable judicial forum for disputes with us or our directors, officers, employees or agents.

 Our
governing documents provide that, unless we consent in writing to an alternative forum, the Court of Chancery of the State of Delaware
is the sole and exclusive forum for state law claims for (i) any derivative action or proceeding brought on our behalf, (ii) any action
asserting a claim of or based on a breach of a fiduciary duty owed by any of our current or former directors, officers, or other employees
or our stockholders, (iii) any action asserting a claim arising pursuant to any provision of the DGCL, the certificate of incorporation
or the bylaws, (iv) any action to interpret, apply, enforce or determine the validity of the certificate of incorporation or bylaws,
or (v) any action asserting a claim that is governed by the internal affairs doctrine, in each case subject to the Court of Chancery
having personal jurisdiction over the indispensable parties named as defendants therein, which for purposes of this risk factor refers
to herein as the "Delaware Forum Provision." Our governing documents further provide that, unless we consent in writing to
an alternative forum, the federal district courts of the United States will be the exclusive forum for resolving any complaint asserting
a cause of action arising under the Securities Act, which for purposes of this risk factor refers to herein as the "Federal Forum
Provision." Neither the Delaware Forum Provision nor the Federal Forum Provision will apply to any causes of action arising under
the Exchange Act. In addition, any person or entity purchasing or otherwise acquiring any interest in shares of our capital stock will
be deemed to have notice of and consented to the foregoing Delaware Forum Provision and Federal Forum Provision; provided, however, that
stockholders cannot and will not be deemed to have waived our compliance with the U.S. federal securities laws and the rules and regulations
thereunder.

 The
Delaware Forum Provision and the Federal Forum Provision may impose additional litigation costs on our stockholders in pursuing any such
claims, particularly if such stockholders do not reside in or near the State of Delaware. Additionally, these forum selection clauses
may limit our stockholders' ability to bring a claim in a judicial forum that they find favorable for disputes with us or our directors,
officers or employees, which may discourage such lawsuits against us and our directors, officers and employees even though an action,
if successful, might benefit our stockholders.

 Future
sales of shares by existing stockholders could cause our stock price to decline.

 If
our stockholders sell, or indicate an intention to sell, substantial amounts of our common stock in the public market after legal restrictions
on resale lapse, the trading price of our common stock could decline. In addition, shares of our common stock that are subject to our
outstanding options will become eligible for sale in the public market to the extent permitted by the provisions of various vesting agreements
and Rules 144 and 701 under the Securities Act.

 We
do not anticipate that we will pay any cash dividends in the foreseeable future.

 We
do not anticipate that we will pay any cash dividends in the foreseeable future. The current expectation is that we will retain our future
earnings, if any, to fund the development and growth of our business. As a result, capital appreciation, if any, of our common stock
will be your sole source of gain, if any, for the foreseeable future.

 Our
executive officers, directors and principal stockholders have the ability to control or significantly influence all matters submitted
to our stockholders for approval.

 Our
executive officers, directors and principal stockholders beneficially own a significant percentage of our outstanding common stock. As
a result, if these stockholders were to choose to act together, they would be able to control or significantly influence all matters
submitted to our stockholders for approval, as well as our management and affairs. For example, these stockholders, if they choose to
act together, would control or significantly influence the election of directors and approval of any merger, consolidation or sale of
all or substantially all of our assets. This concentration of voting power could delay or prevent our acquisition on terms that other
stockholders may desire.

 If
equity research analysts do not publish research or reports, or publish unfavorable research or reports about us, our business or our
market, our stock price and trading volume could decline.

 The
trading market for our common stock will be influenced by the research and reports that equity research analysts publish about us and
our business. Equity research analysts may elect to not provide research coverage of our common stock, and such lack of research coverage
may adversely affect the market price of our common stock. If we do have equity research analyst coverage, we will not have any control
over the analysts or the content and opinions included in their reports. The price of our common stock could decline if one or more equity
research analysts downgrade our stock or issue other unfavorable commentary or research. If one or more equity research analysts ceases
coverage of us or fails to publish reports on us regularly, demand for our common stock could decrease, which in turn could cause our
stock price or trading volume to decline.

 Item
1B. Unresolved Staff Comments.

 None.

 Item
1C. Cybersecurity.

 We
collect, use, store, and transmit confidential, sensitive, proprietary, personal, and health-related information in the ordinary course
of our business. As such, we leverage third-party information technology service providers who have implemented and maintain various
information security processes designed to identify, assess, and manage material risks from cybersecurity threats to our information
technology systems, including critical computer networks, third party hosted services, communications systems, hardware and software,
and our data residing on these systems. Our Senior Vice President, Finance is responsible for overseeing these third-party service providers
and processes.

 Cybersecurity
risks are identified by monitoring and evaluating our threat environment, and then assessed by various methods, for example, by manual
and automated tools designed to identify and combat cybersecurity threats, analyzing reports of threats, conducting scans and assessments
of the threat environment and to identify vulnerabilities, the use of detection and response services and conducting reviews of third-party
service providers, among other things. Depending on the threat environment, we implement and maintain various technical, physical, and
organizational measures, processes, standards and policies designed to manage and mitigate material risks from cybersecurity threats
to our information systems and data, including, for example, physical security and access controls, asset management, systems monitoring,
incident detection and response, risk assessment, the implementation of security standards and certifications, encryption of data, network
security controls, and a recovery/business continuity plan, among other mitigation tactics. Our recovery/business continuity plan is
designed to mitigate and remediate identified cybersecurity incidents and escalate certain incidents as appropriate to management and
the Audit Committee. We plan to conduct due diligence on and audits of key technology vendors, contract research organizations, and other
third-party contractors and suppliers. Additionally, we conduct periodic employee training that covers cyber and information security,
among other topics.

 Our assessment and management
of material risks from cybersecurity threats are integrated into the Company's overall risk management process. Our Senior Vice
President, Finance, who reports directly to the Chief Executive Officer, together with our senior management, is responsible for assessing
and managing cybersecurity risks with support from our third-party information technology service providers that employ information technology
consultants with over 20 years of experience managing cybersecurity programs. Our cybersecurity program aligns to the National Institute
of Standards and Technology (NIST) Cybersecurity Framework (CSF) and is consistently updated as NIST recommendations change year over
year. Our Senior Vice President, Finance, together with our senior management and other employees works closely with our information technology
service providers to evaluate material cybersecurity threats against our overall business objectives as part of our cybersecurity incident
response. The Board of Directors, as a whole and at the committee level, has oversight for the most significant risks facing us and for
our processes to identify, prioritize, assess, manage and mitigate those risks. The Audit Committee has been designated by our Board to
oversee cybersecurity risks. The Audit Committee receives regular updates on cybersecurity and information technology matters and related
risk exposures from our Senior Vice President, Finance. The Board also receives updates from management and the Audit Committee on cybersecurity
risks on a regular basis.

 In
the last fiscal year, we have not identified any risks from known cybersecurity threats, including as a result of any prior cybersecurity
incidents, that have materially affected us, but we face certain ongoing cybersecurity risks or threats that, if realized, are reasonably
likely to materially affect us. For a description of the risks from cybersecurity threats that may materially affect the Company and
how they may do so, see our "Risk Factors" under Part 1 Item 1A. Risk Factors, in this Annual Report on Form 10-K.

 Item
2. Properties.

 Our corporate headquarters
are in Menlo Park, California and we have an additional office in Waltham, Massachusetts. Our lease for our Menlo Park headquarters expires
on September 30, 2027 and our lease for our Waltham office expires in 2029. We believe our current facilities are
sufficient for our needs for the foreseeable future.

 Item
3. Legal Proceedings.

 From
time to time, we may become involved in legal proceedings relating to claims arising from the ordinary course of business. Our management
believes that there are currently no claims or actions pending against us, the ultimate disposition of which could reasonably be expected
to have a material adverse effect on our results of operations, financial condition or cash flows.

 Item
4. Mine Safety Disclosures.

 Not
applicable.

 PART
II

 Item
5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.

 Market
Information

 Our
common stock is traded on the Nasdaq Global Market under the symbol "ORKA."

 Holders
of Record

 As of February 28, 2025, there
were approximately 20 stockholders of record of our common stock based on information provided by our transfer agent. The actual number
of stockholders is greater than this number of record holders, and includes stockholders who are beneficial owners, but whose shares are
held in street name by brokers and other nominees. This number of holders of record also does not include stockholders whose shares may
be held in trust by other entities.

 Dividends

 We
have never declared or paid any cash dividends on our capital stock. We currently intend to retain all available funds and any future
earnings to support our operations and finance the growth and development of our business. We do not intend to pay cash dividends on
our common stock for the foreseeable future.

 Recent
Sales of Unregistered Securities

 None.

 Purchases
of Equity Securities by the Issuer and Affiliated Purchasers

 None.

 Performance
Graph

 As
a "smaller reporting company," as defined by Rule 12b-2 of the Exchange Act, and pursuant to Instruction 6 to Item 201(e)
of Regulation S-K, we are not required to provide the stock performance graph.

 Item
6. [Reserved]

 Item
7. Management's Discussion and Analysis of Financial Condition and Results of Operations.

 You
should read the following discussion and analysis of our financial condition and results of operations together with our consolidated
financial statements and the related notes included elsewhere in this Annual Report on Form 10-K for the year ended December 31, 2024
(this "Annual Report"). This discussion contains forward-looking statements that involve risks and uncertainties, such as
statements regarding our plans, objectives, expectations, intentions, hopes, beliefs, strategies or projections regarding the future
of its pipeline and business and words such as "may," "will,", "should," "could," "would,"
"expect," "plan," "anticipate," "believe," "estimate," "project,"
"potential," "seek," "target," "goal," "intend" and variations of such words
and any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying
assumptions, and similar expressions are intended to identify forward-looking statements. You should not place undue reliance on these
forward-looking statements. These forward-looking statements are based on current expectations and beliefs concerning future developments
and their potential effects. There can be no assurance that future developments affecting us will be those that have been anticipated.
These forward-looking statements involve a number of risks, uncertainties (some of which are beyond our control) or other assumptions
that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements.
Factors that could cause or contribute to such differences include, but are not limited to, those discussed in the section of this Annual
Report entitled "Risk Factors" and elsewhere in this Annual Report. These and many other factors could affect our future
financial and operating results. We undertake no obligation to update any forward-looking statement to reflect events after the date
of this Annual Report. As used in this Annual Report, unless the context suggests otherwise, "we," "us," "our,"
"the Company," "Oruka Therapeutics, Inc.," "Oruka," "ARCA biopharma, Inc.," "ARCA,"
refers to Oruka Therapeutics, Inc. and its consolidated subsidiaries, including Oruka Therapeutics Operating Company LLC, taken as a
whole.

 We
are a clinical-stage biotechnology company focused on developing novel monoclonal antibody therapeutics for psoriasis ("PsO")
and other inflammatory and immunology ("I&I") indications. Our name is derived from or, for "skin,"
and arukah, for "restoration," and reflects our mission to deliver therapies for chronic skin diseases that provide
patients the most possible freedom from their condition. Our strategy is to apply antibody engineering and format innovations to validated
modes of action, which we believe will enable us to improve meaningfully upon the efficacy and dosing regimens of standard-of-care medicines
while significantly reducing technical and biological risk. Our programs aim to treat and potentially modify disease by targeting mechanisms
with proven efficacy and safety involved in disease pathology and the activity of pathogenic tissue-resident memory T cells ("TRMs").

 Our
lead program, ORKA-001, is designed to target the p19 subunit of interleukin-23 ("IL-23p19") for the treatment of PsO. Our
co-lead program, ORKA-002, is designed to target interleukin-17A and interleukin-17F ("IL-17A/F") for the treatment of PsO,
psoriatic arthritis ("PsA"), and other conditions. These programs each bind their respective targets at high affinity and
incorporate half-life extension technology with the aim to increase exposure and decrease dosing frequency. We believe that our focused
strategy, differentiated portfolio, and deep expertise position us to set a new treatment standard in large I&I markets with
continued unmet need.

 Since
our inception in February 2024, we have devoted substantially all of our resources to raising capital, organizing and staffing the
company, business and scientific planning, conducting discovery and research activities, establishing arrangements with third parties
for the manufacture of our programs and component materials, and providing general and administrative support for these operations. We
do not have any programs approved for sale and have not generated any revenue from product sales. To date, we have funded our operations
primarily with proceeds from the issuance of convertible preferred stock, common stock, a convertible note, pre-funded warrants, and
the proceeds from the reverse recapitalization and merger with ARCA biopharma, Inc., our Pre-Closing Financing and subsequent PIPE Financing
(as defined and further described in "Recent developments" below).

 Since
our inception, we have incurred significant losses and negative cash flows from our operations. Our ability to generate product revenue
sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of any programs
we may develop. We generated net losses of $83.7 million for the period from February 6, 2024 (inception) to December 31, 2024.
For the period from February 6 (inception) to December 31, 2024, we have used net cash of $57.8 million for our operating activities.

 We
had cash, cash equivalents, and marketable securities of $393.7 million as of December 31, 2024. We expect that our existing cash, cash
equivalents, and marketable securities will be sufficient to fund our operating plans for at least twelve months from the date of filing
of this Annual Report. We expect to continue to incur substantial losses for the foreseeable future, and our transition to profitability
will depend upon successful development, approval and commercialization of our product candidates and upon achievement of sufficient
revenues to support our cost structure.

is a high affinity, extended half-life monoclonal antibody ("mAb") designed to target IL-23p19. IL-23 is a pro-inflammatory
cytokine that plays a critical role in the proliferation and development of T helper 17 ("Th17") cells, which are the primary
drivers of several autoimmune and inflammatory disorders, including PsO. IL-23 is composed of two subunits: a p40 subunit that is
shared with IL-12 and a p19 subunit that is specific to IL-23. First-generation IL-23 antibodies bound p40 and inhibited both IL-12 and
IL-23 signaling, while more recent IL-23 antibodies targeting the p19 subunit have shown improved efficacy and safety. Based on preclinical
evidence, we believe that ORKA-001 could achieve higher response rates than established therapies in PsO while requiring less frequent
dosing and maintaining the favorable safety profile of therapies targeting IL-23p19.

is engineered with YTE half-life extension technology, a specific three amino acid change in the fragment crystallizable ("Fc")
domain to modify the pH-dependent binding to the neonatal Fc receptor. As a result, it has a pharmacokinetic profile designed to support
a subcutaneous ("SQ") injection as infrequently as once or twice a year. In addition, emerging evidence suggests that IL-23
blockade can modify the disease biology of PsO, possibly leading to durable remissions and preventing the development of PsA. We
believe that the expected characteristics of ORKA-001 increase its potential to deliver these disease-modifying benefits.

 We
initiated the dosing of healthy volunteers in a Phase 1 trial of ORKA-001 in the fourth quarter of 2024. We expect to share interim data
from the first-in-human trial in healthy volunteers, including initial pharmacokinetic data, in the second half of 2025 and initial efficacy
data in PsO patients in the second half of 2026. Based on recent precedent for PsO, we anticipate that the entire development program
from first-in-human to biologics license application ("BLA") filing could take as little as six to seven years based
on the averages for recently approved medicines. However, we have no control over the length of time needed for United States Food and
Drug Administration ("FDA") review, and this timeline could vary.

is a high affinity, extended half-life mAb designed to target IL-17A and IL-17F ("IL-17A/F"). IL-17 inhibition has become
central to the treatment of psoriatic diseases, including PsO and PsA, and has also shown efficacy in other I&I indications,
such as hidradenitis suppurativa and axial spondyloarthritis. More recently, the importance of inhibiting the IL-17F isoform along
with IL-17A has become appreciated, and dual blockade with the recently approved therapy Bimzelx (bimekizumab) has led to higher response
rates in patients than blockade of IL-17A alone. ORKA-002 is designed to bind IL-17A/F at similar epitopes, or binding sites, and affinity
ranges as bimekizumab, but incorporates half-life extension technology that could enable more convenient dosing intervals. We plan to
initiate the dosing of healthy volunteers in a Phase 1 trial of ORKA-002 in the third quarter of 2025. We expect to share interim
data from the first-in-human trial in healthy volunteers, including initial pharmacokinetic data, in the first half of 2026.

 We
view ORKA-002 and ORKA-001 as highly complementary. Patients with moderate-to-severe PsO that have purely skin manifestations are most
often treated with IL-23 inhibitors due to the high efficacy and tolerability of this mechanism. However, for patients who also have
joint involvement, or signs and symptoms of PsA, an IL-17 inhibitor is typically used due to its efficacy in addressing both skin and
joint symptoms. In addition, IL-17 inhibitors are often used in patients with highly resistant skin symptoms that do not adequately resolve
through treatment with an IL-23 inhibitor. Furthermore, we have the potential opportunity to administer ORKA-002 and ORKA-001 sequentially,
called ORKA-021, to combine two features of each program: the rapid response of an IL-17 inhibitor with the ideal maintenance profile
of an IL-23 inhibitor. We believe that ORKA-001 and ORKA-002 provide the potential to offer a highly compelling product profile for most
patients with PsO and/or PsA, as well as the opportunity to address additional I&I indications.

Pipeline Program

 We
have a third mAb program, ORKA-003, designed to target an undisclosed pathway. Our strategy as a company is to remain highly focused
on I&I diseases, and specifically on inflammatory dermatology conditions. Our third program provides the potential for indication
expansion beyond PsO and may create combination opportunities with our more advanced programs.

 Recent
Developments

 Acquisition
of Pre-Merger Oruka

 On
August 29, 2024 (the "Merger Closing"), we completed our acquisition (the "Merger") of Oruka Therapeutics, Inc.
("Pre-Merger Oruka") pursuant to an Agreement and Plan of Merger and Reorganization, dated as of April 3, 2024 (the "Merger
Agreement"). Following the transactions contemplated by the Merger Agreement, Pre-Merger Oruka merged with and into Atlas Merger
Sub Corp., a wholly owned subsidiary of ARCA biopharma, Inc. ("ARCA") and following that, Pre-Merger Oruka then merged with
and into Atlas Merger Sub II, LLC ("Second Merger Sub"), with Second Merger Sub being the surviving entity. Second Merger
Sub changed its corporate name to "Oruka Therapeutics Operating Company, LLC." Pre-Merger Oruka was a pre-clinical stage
biotechnology company that was incorporated on February 6, 2024 under the direction of Peter Harwin, a Managing Member of Fairmount Funds
Management LLC ("Fairmount"), for the purposes of holding rights to certain intellectual property being developed by Paragon
Therapeutics, Inc. ("Paragon"). On August 29, 2024, we changed our name from "ARCA biopharma, Inc." ("ARCA")
to "Oruka Therapeutics, Inc." and our Nasdaq ticker symbol from "ABIO" to "ORKA".

 Pre-Closing
Financing

 Immediately
prior to the execution and delivery of the Merger Agreement on April 3, 2024, certain new and existing investors of Pre-Merger Oruka
entered into a subscription agreement with Pre-Merger Oruka (the "Subscription Agreement"), pursuant to which, and on the
terms and subject to the conditions of which, immediately prior to the Closing, those investors purchased shares of common stock of Pre-Merger
Oruka ("Pre-Merger Oruka Common Stock") and Pre-Merger Oruka pre-funded warrants for gross proceeds of approximately $275.0
million (which includes $25.0 million of proceeds previously received from the issuance of the Convertible Note (refer to Note 7 in our
consolidated financial statements included in Part II – Item 8 of this Annual Report for additional details) and accrued interest
on such note which converted to shares of Pre-Merger Oruka Common Stock) (the "Pre-Closing Financing"). We incurred transaction
costs of $20.5 million, which was recorded as a reduction to additional paid-in capital in the consolidated financial statements. At
the Closing, the shares of Pre-Merger Oruka Common Stock and Pre-Merger Oruka pre-funded warrants issued pursuant to the Subscription
Agreement were converted into shares of Company Common Stock and pre-funded warrants of Company Common Stock in accordance with the Exchange
Ratio (defined below).

 In
accordance with an Exchange Ratio determined by terms of the Merger Agreement and upon the effective time of the First Merger (the "First
Effective Time"), (i) each then-issued and outstanding share of Pre-Merger Oruka Common Stock including outstanding and unvested
Pre-Merger Oruka restricted stock and shares of Pre-Merger Oruka Common Stock issued in connection with the Subscription Agreement, were
converted into the right to receive a number of shares of Company Common Stock, equal to the exchange ratio of 6.8569 shares of Company
Common Stock (the "Exchange Ratio"), which were subject to the same vesting provisions as those immediately prior to the
Merger, (ii) each share of Pre-Merger Oruka Series A convertible preferred stock, par value $0.0001 ("Pre-Merger Oruka Series A
Preferred Stock"), outstanding immediately prior to the First Effective Time was converted into the right to receive a number of
shares of ARCA Series B non-voting convertible preferred stock, par value $0.001 per share, which are convertible into shares of Company
Common Stock at a conversion ratio of approximately 83.3332:1 after the reverse stock split discussed below, (iii) each outstanding option
to purchase Pre-Merger Oruka Common Stock was converted into an option to purchase shares of Company Common Stock, (iv) each outstanding
warrant to purchase shares of Pre-Merger Oruka Common Stock was converted into a warrant to purchase shares of Company Common Stock,
and (v) each share of Company Common Stock issued and outstanding at the First Effective Time remain issued and outstanding in accordance
with its terms and such shares. Subsequent to the close of the merger, the common stock shares were then, subject to a reverse stock
split of 1-for-12 effected on September 3, 2024 ("Reverse Stock Split").

 As
part of the Pre-Closing Financing and the Closing, the investors in the Pre-Closing Financing received 22,784,139 shares of Company Common
Stock in exchange for 39,873,706 shares of Pre-Merger Oruka Common Stock (which includes the issuance of 2,722,207 shares of Company
Common Stock in exchange for 4,764,032 shares of Pre-Merger Oruka Common Stock on the conversion of Convertible Note along with the accrued
interest through the conversion date) and 5,522,207 Company pre-funded warrants in exchange for 9,664,208 Pre-Merger pre-funded warrants.

 The
Merger was accounted for as a reverse recapitalization in accordance with U.S. GAAP. Under this method of accounting, Pre-Merger Oruka
was deemed to be the accounting acquirer for financial reporting purposes. This determination was primarily based on the fact that, immediately
following the Merger: (i) Pre-Merger Oruka stockholders own a substantial majority of the voting rights in the combined company; (ii)
Pre-Merger Oruka's largest stockholders retain the largest interest in the combined company; (iii) Pre-Merger Oruka designated
a majority of the initial members of the board of directors of the combined company; and (iv) Pre-Merger Oruka's executive management
team became the management team of the combined company. Accordingly, for accounting purposes: (i) the Merger was treated as the equivalent
of Pre-Merger Oruka issuing stock to acquire the net assets of ARCA; (ii) the reported historical operating results of the combined company
prior to the Merger are those of Pre-Merger Oruka; and (iii) Pre-Merger Oruka was not a variable interest entity as it had sufficient
equity at risk in order to fund its next development milestones at the time of the reverse recapitalization. Additional information regarding
the Merger is included in Note 3 to the consolidated financial statements included in Part II – Item 8 of this Annual Report.

 Reverse
Stock Split

 On
September 3, 2024, we effected the Reverse Stock Split, a 1-for-12 reverse stock split of Company Common Stock. The par value per share
and the number of authorized shares were not adjusted as a result of the Reverse Stock Split. The shares of Company Common Stock underlying
outstanding stock options, common stock warrants and other equity instruments were proportionately reduced and the respective exercise
prices, if applicable, were proportionately increased in accordance with the terms of the agreements governing such securities. All references
to common stock, options to purchase common stock, outstanding common stock warrants, common stock share data, per share data, and related
information contained in the consolidated financial statements have been retrospectively adjusted to reflect the effect of the Reverse
Stock Split for all periods presented, unless otherwise specifically indicated or the context otherwise requires.

 PIPE
Financing

 On
September 11, 2024, we entered into a Securities Purchase Agreement for a private placement (the "PIPE Financing") with certain
institutional and accredited investors. The closing of the PIPE Financing occurred on September 13, 2024.

to the Securities Purchase Agreement, the investors purchased an aggregate of 5,600,000 shares of Company Common Stock at a purchase
price of $23.00 per share, an aggregate of 2,439 shares of the Company's Series A non-voting convertible preferred stock, par value
$0.001 per share ("Company Series A Preferred Stock"), at a purchase price of $23,000.00 per share (each Company Series A
Preferred Stock is convertible into 1,000 shares of Company Common Stock), and pre-funded warrants to purchase an aggregate of 680,000
shares of Company Common Stock at a purchase price of $22.999 per pre-funded warrant, for aggregate net proceeds of approximately $188.7
million (net of issuance costs of $11.9 million).

 Components
of Results of Operations

 Revenue

 To
date, we have not generated revenue from any sources, including product sales, and do not expect to generate any revenue from the sale
of products in the foreseeable future. If our development efforts for our product candidates are successful and result in regulatory
approval, we may generate revenue in the future from product sales or payments from future collaboration or license agreements that we
may enter into with third parties, or any combination thereof. We cannot predict if, when, or to what extent we will generate revenue
from the commercialization and sale of our product candidates. We may never succeed in obtaining regulatory approval for any of our product
candidates.

Expenses

and Development

and development expenses consist primarily of costs incurred in connection with the development and research of our programs. These expenses
include:

 costs
 of funding research performed by third parties, including Paragon, that conduct research
 and development activities on our behalf;

 costs
 incurred, and milestone payments under license and option agreements;

 expenses
 incurred in connection with continuing our current research programs and discovery-phase
 development of any programs we may identify, including under future agreements with third
 parties, such as consultants and contractors;

 expenses
 incurred under agreements with contract research organizations ("CROs"), contract
 manufacturing organizations ("CMOs"), and with clinical trial sites that conduct
 research and development activities on our behalf;

 the
 cost of development and validating our manufacturing process for use in our preclinical studies
 and current and future clinical trials;

 personnel-related
 expenses, including salaries, bonuses, employee benefits, travel, and stock-based compensation
 expense, including stock-based compensation related to the Paruka warrant; and

 allocated
 human resource costs, information technology costs, and facility-related costs, including
 rent, maintenance, utilities, and depreciation for our leased office space.

 We
expense research and development costs as incurred. Non-refundable advance payments that we make for goods or services to be received
in the future for use in research and development activities are recorded as prepaid expenses. The prepaid amounts are expensed as the
related goods are delivered or the services are performed, or when it is no longer expected that the goods will be delivered or the services
rendered. Our primary focus since inception has been the identification and development of our pipeline programs. Our research and development
expenses primarily consist of external costs, such as fees paid to Paragon under the Option Agreements. See "—Contractual
Obligations and Commitments" below for further details on the Option Agreements.

 We
expect our research and development expenses will increase substantially for the foreseeable future as we continue to invest in research
and development activities related to the continued development of our programs, developing any future programs, including investments
in manufacturing, as we advance any program we may identify and continue to conduct clinical trials. The success of programs we may identify
and develop will depend on many factors, including the following:

 timely
 and successful completion of preclinical studies;

 effective
 investigational new drug ("IND") or comparable foreign applications that allow
 commencement of our planned clinical trials or future clinical trials for any programs we
 may develop;

 successful
 enrollment and completion of clinical trials;

 positive
 results from our future clinical trials that support a finding of safety and effectiveness,
 acceptable pharmacokinetics profile, and an acceptable risk-benefit profile in the intended
 populations;

 receipt
 of marketing approvals from applicable regulatory authorities;

 establishment
 of arrangements through our own facilities or with third-party manufacturers for clinical
 supply and, where applicable, commercial manufacturing capabilities; and

 maintenance
 of a continued acceptable safety, tolerability, and efficacy profile of any programs we may
 develop following approval.

 Any
changes in the outcome of any of these variables with respect to the development of programs that we may identify could mean a significant
change in the costs and possible delays in timing associated with the development of such programs. For example, if the FDA or another
regulatory authority were to require us to conduct clinical trials beyond those that we currently anticipate will be required for the
completion of clinical development of a program, or if we experience significant delays in our clinical trials due to patient enrollment
or other reasons, we would be required to expend significant additional financial resources and time on the completion of clinical development.
We may never obtain regulatory approval for any of our programs.

and Administrative

and administrative expenses consist primarily of personnel-related expenses, including salaries, bonuses, employee benefits, travel,
and stock-based compensation, for our executive and other administrative personnel. Other significant general and administrative expenses
include legal services, including intellectual property and corporate matters; professional fees for accounting, auditing, tax, insurance,
and allocated human resource costs, information technology costs, and facility-related costs, including rent, utilities, maintenance,
and depreciation for our leased office space.

 We
expect our general and administrative expenses will increase substantially for the foreseeable future as we anticipate an increase in
our personnel headcount to support the expansion of research and development activities, as well as to support our operations generally.
We also expect to continue to incur significant expenses associated with being a public company, including costs related to accounting,
audit, legal, regulatory, and tax-related services associated with maintaining compliance with applicable Nasdaq and SEC requirements;
director and officer insurance costs; and investor and public relations costs. We also expect to incur additional intellectual property-related
expenses as we file patent applications to protect innovations arising from our research and development activities.

 Other
Income, Net

 Other
income, net consists of interest earned on our cash, cash equivalents, and marketable securities; interest expense on the convertible
note from a related party (see discussion herein); and foreign currency transactions gains and losses. Interest expense relates to a
convertible note (the "Convertible Note") issued to Fairmount Healthcare Fund II, L.P. ("Fairmount"), a
related party, in March 2024. At the effective time of the Merger, the Convertible Note, along with the accrued interest, was automatically
converted into Company Common Stock.

 Income
Taxes

 No
provision for income taxes was recorded for the period from February 6, 2024 (inception) through December 31, 2024. Deferred tax
assets generated from our net operating losses have been fully offset by the valuation allowance as we believe it is not more likely
than not that the benefit will be realized due to our cumulative losses generated to date.

 Results
of Operations for the Period from February 6, 2024 (inception) to December 31, 2024

 The
following table summarizes our results of operations for the period presented (in thousands):

 from February 6,
 2024 (Inception) to
 2024

 Operating expenses

 and development (1)

 $
 75,060

 and administrative (2)

 13,063

 Total
 operating expenses

 88,123

 Loss from operations

 (88,123
)

 Other income (expense)

 Interest income

 5,863

 Interest
 expense (3)

 (1,468
)

 Other
 income, net

 Total
 other income, net

 4,399

 Net loss

 $
 (83,724
)

 (1)
 related party amount of $42,640 for the period from February 6, 2024 (inception) to December

 (2)
 related party amount of $1,364 for the period from February 6, 2024 (inception) to December

 (3)
 related party amount of $1,468 for the period from February 6, 2024 (inception) to December

and Development Expenses

 The
following table summarizes our research and development expenses for the period presented (in thousands):

 from February 6,
 2024 (Inception) to
 2024

 External research
 and development expenses (1)

 $
 57,680

 Other research and development expenses:

 Personnel-related (excluding
 stock-based compensation)

 3,959

 Stock-based compensation (2)

 11,992

 Other

 1,429

 Total
 research and development expenses

 $
 75,060

 (1)
 related party amount of $32,283 for the period from February 6, 2024 (inception) to December

 (2)
 related party amount of $10,357 for the period from February 6, 2024 (inception) to December

and development expenses were $75.1 million for the period from February 6, 2024 (inception) to December 31, 2024 and consisted
primarily of the following:

 $57.7 million
 of research and development expense primarily includes: $18.3 million related to Paragon services rendered under the Option Agreements
 for ORKA-001, including $4.8 million for milestones achieved under the Option and License Agreements upon exercise of the option
 to enter into a license agreement and achievement of development candidate for IL-23 and dosing of the first subject in a Phase 1
 clinical trial; $13.3 million of research and development expense primarily related to Paragon services rendered under the Option
 Agreements for ORKA-002, including $2.3 million for milestones achieved under the Option and License Agreements upon exercise of
 the option to enter into a license agreement and achievement of development candidate for IL-17; $0.7 million of other research and
 development expense due to Paragon; $16.5 million of research and development expense on chemistry, manufacturing, and development
 costs; $5.7 million in toxicology testing with a third-party contract research organization; and $3.2 million of other external research
 and development costs;

 $4.0 million
 of personnel-related costs related to salaries, benefits, and other compensation-related
 costs;

 $12.0
 million of stock-based compensation expense, including $10.4 million of stock-based compensation
 related to the Paruka warrant; and

 $1.4
 million of other expense and allocated human resource costs, information technology costs,
 and facility-related costs, including rent, maintenance, utilities, and depreciation for
 our leased office space.

and Administrative Expenses

 The
following table summarizes our general and administrative expenses for the period presented (in thousands):

 from February 6,

 2024 (Inception) to

 2024

 Personnel-related (including stock-based
 compensation) (1)

 $
 7,981

 Professional and consulting fees (2)

 4,606

 Other (3)

 Total
 general and administrative expenses

 $
 13,063

 (1)
 related party amount of $609 for the period from February 6, 2024 (inception) to December

 (2)
 related party amount of $575 for the period from February 6, 2024 (inception) to December

 (3)
 related party amount of $180 for the period from February 6, 2024 (inception) to December

and administrative expenses were $13.1 million for the period from February 6, 2024 (inception) to December 31, 2024 and consisted
primarily of the following:

 $8.0 million
 of personnel-related costs related to salaries, benefits, other compensation-related costs, recruiting costs, including stock-based
 compensation of $2.9 million, and $0.6 million of personnel-related costs are recruiting costs reimbursed to Paragon for hiring
 of our executive team, legal, and finance and accounting functions;

 $4.6 million
 of professional and consulting fees associated with accounting, audit, and legal fees associated
 with becoming a public company, including $0.6 million of legal fees due to Paragon
 associated with patent-related activities; and

 $0.5
 million of other business expenses and net of allocated human resource costs, information
 technology costs, and facility-related costs, including rent, maintenance, utilities, and
 depreciation for our leased office space to research and development expenses, including
 $0.2 million of other business expenses due to Paragon.

 Total
Other Income, Net

 Interest
income from cash equivalents and marketable securities was $5.9 million for the period from February 6, 2024 (inception) to December

 Interest
expense was $1.5 million for the period from February 6, 2024 (inception) to December 31, 2024 relating to the Convertible Note from
Fairmount.

 Liquidity
and Capital Resources

 As
of December 31, 2024, we had $393.7 million of cash, cash equivalents, and marketable securities.

 Since
our inception, we have incurred significant operating losses and negative cash flow from operations. We expect to incur significant expenses
and operating losses for the foreseeable future as we continue the pre-clinical and clinical development of our programs and our early-stage
research activities. We have not yet commercialized any products, and we do not expect to generate revenue from sales of products for
several years, if at all. Through December 31, 2024, we had funded our operations primarily with proceeds from issuances of convertible
preferred stock, common stock, a convertible note, and pre-funded warrants. In March 2024, we received $2.9 million in net
proceeds from the issuance of Pre-Merger Oruka Series A Preferred Stock and $25.0 million in gross proceeds from the issuance
of the Convertible Note, both of which were related party transactions. In August 2024, we raised approximately $228.0 million in net
proceeds from Pre-Closing Financing and received $4.9 million in cash from ARCA upon consummation of the Merger. In September 2024, we
received approximately $188.7 million in net proceeds from the issuance of common stock, Company Series A Preferred Stock, and pre-funded
warrants in connection with the PIPE Financing.

 Our
primary use of cash is to fund the development of our product candidates and advance our pipeline. This includes both the research and
development costs and the general and administrative expenses required to support those operations. Since we are a clinical stage biotechnology
company, we have incurred significant operating losses since our inception and we anticipate such losses, in absolute dollar terms, to
increase as we continue to pursue clinical development of our product candidates, prepare for the potential commercialization of our
product candidates, and expand our development efforts in our pipeline of nonclinical candidates. We expect that our existing cash, cash
equivalents, and marketable securities will be sufficient to fund our operating plans for at least twelve months from the date of filing
of this Annual Report. We will need to secure additional financing in the future to fund additional research and development, and before
a commercial drug can be produced, marketed, and sold. If we are unable to obtain additional financing or generate license or product
revenue, the lack of liquidity could have a material adverse effect on our company.

 Cash
Flows

 The
following table summarizes our cash flows for the period presented (in thousands):

 from February 6,

 2024 (Inception) to

 2024

 Net cash used in operating activities

 $
 (57,837
)

 Net cash used in investing activities

 (330,127
)

 Net cash provided by
 financing activities

 449,539

 Net
 increase in cash and cash equivalents

 $
 61,575

Activities

 From
February 6, 2024 (inception) to December 31, 2024, net cash used in operating activities was $57.8 million, which was primarily
attributable to a net loss of $83.7 million, offset by net non-cash charges of $14.3 million and net changes in operating activities
of $11.6 million. Non-cash charges primarily consisted of $14.9 million in stock-based compensation expense (including $10.4 million
related to the Paruka warrant) and $1.5 million of non-cash interest expense, partially offset by net accretion of premiums and discounts
on marketable securities of $2.2 million. Net changes in our operating activities primarily consisted of a $3.5 million increase in accounts
payable, a $3.3 million increase in accrued expenses and other current liabilities, a $6.0 million increase in related parties accounts
payable and other current liabilities, partially offset by a $1.1 million increase in prepaid expenses and other current assets. The
increase in amounts due to related parties, accounts payable, and accrued expenses and other current liabilities was primarily due to
an increase in our business activity, as well as vendor invoicing and payments. The increase in prepaid expenses and other current assets
was primarily due to prepaid research and development expenses with our contract research organization.

 Investing
Activities

 From
February 6, 2024 (inception) to December 31, 2024, net cash used in investing activities was $330.1 million, which was primarily
attributable to purchases of marketable securities.

 Financing
Activities

 From
February 6, 2024 (inception) to December 31, 2024, net cash provided by financing activities was $449.5 million, consisting of $228.0
million of net proceeds from the Pre-Closing Financing, $188.7 million of net proceeds from the PIPE Financing, $25.0 million of net
proceeds from the issuance of notes payable to related parties, $4.9 million of cash acquired in connection with the reverse recapitalization
and $2.9 million of net proceeds from issuance of the Pre-Merger Oruka Series A Preferred Stock.

 Contractual
Obligations and Commitments

 We
enter into contracts in the normal course of business with CROs, CMOs and with other vendors for preclinical research studies, clinical
trials, manufacturing, and other services and products for operating purposes. These contracts generally provide for termination on notice
or may have a potential termination fee if a purchase order is cancelled within a specified time, and therefore, are cancelable contracts.
We do not expect any such contract terminations and did not have any non-cancellable obligations under these agreements as of December

Therapeutics - Option Agreements

 In
 March 2024, we entered into two antibody discovery and option agreements ("Option
 Agreements") with Paragon and Paruka Holding, LLC ("Paruka"). Under the
 terms of each agreement, Paragon identifies, evaluates, and develops antibodies directed
 against certain mutually agreed therapeutic targets of interest to us. From time to time,
 we can choose to add additional targets to the collaboration upon agreement with Paragon
 and Paruka. Under the Option Agreements, we have the exclusive option to, on a research program-by-research
 program basis, be granted an exclusive, worldwide license to all of Paragon's right,
 title, and interest in and to the intellectual property resulting from the applicable research
 program to develop, manufacture, and commercialize the antibodies and products directed to
 the selected target(s) (each, an "Option"). We have initiated certain research
 programs with Paragon that generally focus on discovering, generating, identifying and/or
 characterizing antibodies directed to a particular target (each, a "Research Program"),
 including for IL-23 and IL-17A/F for ORKA-001 and ORKA-002, respectively. Our exclusive option
 with respect to each Research Program is exercisable at our sole discretion at such time
 as specified in the Option Agreements (the "Option Period"). There is no payment
 due upon exercise of an Option pursuant to the Option Agreements. For each of these agreements,
 once we enter into the corresponding license agreements, we will be required to make non-refundable
 milestone payments to Paragon of up to $12.0 million under each respective agreement upon
 the achievement of certain clinical development milestones, up to $10.0 million under each
 respective agreement upon the achievement of certain regulatory milestones, as well as a
 low single-digit percentage royalty for antibody products beginning on the first commercial
 sale in each program.

 We
may terminate any Option Agreement or any Research Program at any time for any or no reason upon 30 days' prior written notice
to Paragon, provided that we must pay certain unpaid fees due to Paragon upon such termination, as well as any non-cancellable obligations
reasonably incurred by Paragon in connection with its activities under any terminated Research Program. Paragon may terminate any Option
Agreement or a Research Program immediately upon written notice to us if, as a result of any action or failure to act by us or our affiliates,
such Research Program or all material activities under the applicable Research Plan are suspended, discontinued or otherwise delayed
for a certain consecutive number of months. Each party has the right to terminate the Option Agreements or any Research Program
upon material breach that remains uncured or the other party's bankruptcy.

 Additionally,
as part of the Option Agreements, on December 31, 2024 and December 31, 2025, we granted and will grant, respectively, Paruka a
warrant to purchase a number of shares equal to 1.00% of outstanding shares as of the date of the grant on a fully-diluted basis, with
an exercise price equal to the fair market value of the underlying shares on the grant date.

 The
warrant is liability-classified and after the initial recognition, the liability is adjusted to fair value at the end of each reporting
period, with changes in fair value recorded in the consolidated statement of operations and comprehensive loss as stock-based compensation
expenses under research and development expenses. On issuance of the December 31, 2024 warrant to Paruka, the change in fair value of
the warrant immediately prior to issuance was recorded in the consolidated statement of operations and comprehensive loss and the resultant
carrying value of the liability was reclassified to equity on the consolidated balance sheet as of December 31, 2024.

to the Option Agreements, on a research program-by-research program basis following the finalization of the research plan for each respective
research program, we were required to pay Paragon a one-time, nonrefundable research initiation fee of $0.8 million related to the
ORKA-001 program. This amount was recognized as a research and development expense during the period from February 6, 2024 (inception)
to December 31, 2024. In June 2024, pursuant to the Option Agreements with Paragon, we completed the selection process of our development
candidate for IL-23 antibody for ORKA-001 program. We were responsible for 50% of the development costs incurred through the completion
of the IL-23 selection process. We received the rights to at least one selected IL-23 antibody in June 2024. During the period from February
6, 2024 (inception) to December 31, 2024, we exercised our option for ORKA-001 and recorded a $1.5 million milestone payment related
to the achievement of development candidate as research and development expense in our consolidated statement of operations and comprehensive
loss. In addition, during the period from February 6, 2024 (inception) to December 31, 2024, we recorded a $2.5 million milestone payment
related to the first dosing of a human subject in a Phase 1 trial of ORKA-001 in December 2024 as research and development expense in
our consolidated statement of operations and comprehensive loss. Our share of development costs incurred for the period from February
6, 2024 (inception) to December 31, 2024 was $13.5 million, which was recorded as research and development expenses. An amount of $2.8
million related to ORKA-001 is included in related party accounts payable and other current liabilities as of December 31, 2024.

 We
were also required to reimburse Paragon $3.3 million for development costs related to ORKA-002 incurred by Paragon through December 31,
2023 and certain other development costs incurred by Paragon between January 1, 2024 and March 6, 2024 as stipulated by the
Option Agreements. This amount was recognized as a research and development expense during the period from February 6, 2024 (inception)
to December 31, 2024. We are also responsible for the development costs incurred by Paragon from January 1, 2024 through the completion
of the IL-17 selection process. We recognized an amount of $0.8 million payable to Paragon for the research initiation fee related
to ORKA-002 following the finalization of the ORKA-002 research plan. This was recognized as research and development expenses in the
period from February 6, 2024 (inception) to December 31, 2024. During the period from February 6, 2024 (inception) to December 31, 2024,
we exercised our option for ORKA-002 and recorded a $1.5 million milestone payment related to the achievement of development candidate
as research and development expense in our consolidated statement of operations and comprehensive loss. We accounted for development
costs of $7.8 million for the period from February 6, 2024 (inception) to December 31, 2024 as research and development expenses. An
amount of $2.7 million related to ORKA-002 is included in related party accounts payable and other current liabilities as of December

 We
 expense the service fees as the associated costs are incurred when the underlying services
 are rendered. Such amounts are classified within research and development expenses in the
 accompanying consolidated statement of operations and comprehensive loss.

 We
concluded that the rights obtained under the Option Agreements represent an asset acquisition whereby the underlying assets comprise
in-process research and development assets with no alternative future use. The Option Agreements did not qualify as a business combination
because substantially all of the fair value of the assets acquired was concentrated in the exclusive license options, which represent
a group of similar identifiable assets. The research initiation fee represents a one-time cost on a research program-by-research program
basis for accessing research services or resources with benefits that are expected to be consumed in the near term, therefore the amounts
paid are expensed as part of research and development costs immediately. Amounts paid as reimbursements of on-going development cost,
monthly development cost fee and additional development expenses incurred by Paragon due to work completed for selected targets prior
to the effective date of the Option Agreements that is associated with services being rendered under the related Research Programs are
recognized as research and development expense when incurred.

 For
the period from February 6, 2024 (inception) to December 31, 2024, we recognized $42.0 million of expenses in connection with services
provided by Paragon and Paruka under the Option Agreements.

Therapeutics – License Agreements

 In
September 2024, we exercised the Option to acquire certain rights to ORKA-001, and in December 2024, we entered into the corresponding
license agreement with Paragon (the "ORKA-001 License Agreement"), pursuant to which Paragon granted us a royalty-bearing,
world-wide, exclusive license to develop, manufacture, commercialize or otherwise exploit certain antibodies and products targeting IL-23
in all fields other than the field of inflammatory bowel disease ("ORKA-001 Field"). In December 2024, we exercised the Option
with respect to ORKA-002 for the IL-17A/F program, and in February 2025, we entered into the corresponding license agreement with Paragon
(the "ORKA-002 License Agreement" and together with the ORKA-001 License Agreement, the "License Agreements"),
pursuant to which Paragon granted us a royalty-bearing, world-wide, exclusive license to develop, manufacture, commercialize or otherwise
exploit certain antibodies and products targeting IL-17A/F in all fields ("ORKA-002 Field" and together with the ORKA-001
Field, the "Fields").

 The
License Agreements provide us with exclusive licenses in the Fields to Paragon's patent applications covering the related antibodies,
their method of use and their method of manufacture and Paragon has agreed not to conduct any new campaigns that generate anti-IL-23
monospecific antibodies or anti-IL-17A/F monospecific antibodies for the ORKA-001 Field or the ORKA-002 Field, respectively, for at least
five years. Each of the ORKA-001 and ORKA-002 License Agreements may be terminated on 60 days' notice to Paragon, on material breach
without cure, and on a party's insolvency or bankruptcy to the extent permitted by law.

 to the terms of each of the ORKA-001 and ORKA-002 License Agreements, we are obligated to
 pay Paragon non-refundable milestone payments of up to $12.0 million under each respective
 agreement upon the achievement of certain clinical development milestones and up to $10.0
 million under each respective agreement upon the achievement of certain regulatory milestones,
 including a $1.5 million fee for nomination of a development candidate (or initiation of
 an IND-enabling toxicology study) and a further milestone payment of $2.5 million upon the
 first dosing of a human patient in a Phase 1 trial for each of ORKA-001 and ORKA-002. In
 addition, we are obligated to pay Paragon a low single-digit percentage royalty for antibody
 products for each of ORKA-001 and ORKA-002. For each of the License Agreements, the royalty
 term ends on the later of (i) the last-to-expire licensed patent or our patent directed to
 the manufacture, use or sale of a licensed antibody in the country at issue or (ii) 12 years
 from the date of first sale of a Company product. There is also a royalty step-down if there
 is no Paragon patent in effect during the royalty term for each program.

 Cell
Line License Agreement

 In March 2024, we entered
into the Cell Line License Agreement (the "Cell Line License Agreement") with WuXi Biologics Ireland Limited ("WuXi
Biologics"). Under the Cell Line License Agreement, we received a non-exclusive, worldwide, sublicensable license to certain of
WuXi Biologics' know-how, cell line, biological materials (the "WuXi Biologics Licensed Technology") and media and feeds
to make, have made, use, sell and import certain therapeutic products produced through the use of the cell line licensed by WuXi Biologics
under the Cell Line License Agreement (the "WuXi Biologics Licensed Products"). Specifically, the WuXi Biologics Licensed
Technology is used in certain manufacturing activities in support of the ORKA-001 and ORKA-002 programs.

 In
consideration for the license, we agreed to pay WuXi Biologics a non-refundable license fee of $150,000, which was recognized as a research
and development expense during the period from February 6, 2024 (inception) to December 31, 2024. Additionally, to the extent that
we manufacture our commercial supplies of bulk drug product with a manufacturer other than WuXi Biologics or its affiliates, we are required
to make royalty payments to WuXi Biologics at a rate of less than one percent of net sales of WuXi Biologics Licensed Products manufactured
by the third-party manufacturer. Pursuant to an amendment to the Cell Line License Agreement effective in November 2024, a provision
was added that permits the royalties owed under the agreement to be bought out on a product-by-product basis for a lump-sum payment.

 The
Cell Line License Agreement will continue indefinitely unless terminated (i) by us upon six months' prior written notice and our
payment of all undisputed amounts due to WuXi Biologics through the effective date of termination, (ii) by WuXi Biologics for a material
breach by us that remains uncured for 60 days after written notice, (iii) by WuXi Biologics if we fail to make a payment and such failure
continues for 30 days after receiving notice of such failure, or (iv) by either party upon the other party's bankruptcy.

 Note Payable
with Related Party

 In
March 2024, we entered into a Series A Preferred Stock and Convertible Note Purchase Agreement (the "Purchase Agreement")
with Fairmount, whereby we issued the Convertible Note, with an initial principal amount of $25.0 million that, at the time of issuance,
could be converted into Pre-Merger Oruka Series A Preferred Stock (or a series of preferred shares that is identical in respect
to the shares of preferred shares issued in its next equity financing) or shares of Pre-Merger Oruka Common Stock in exchange for aggregate
proceeds of $25.0 million. The Convertible Note accrued interest at a rate of 12.0% per annum. At issuance, the Convertible Note
required all unpaid interest and principal to mature on December 31, 2025 (the "Maturity Date") and prepayment was not
permitted without prior written consent of Fairmount. At issuance, the principal payment along with the accrued interest on the Convertible
Note was due in full on the Maturity Date. Pursuant to the Purchase Agreement, we had the right to sell and issue additional convertible
notes up to an aggregate principal amount equal to $30.0 million, in addition to the $25.0 million initial principal amount of the Convertible
Note.

 Immediately
prior to the completion of the Merger, the Convertible Note was converted into shares of Pre-Merger Oruka Common Stock based on the aggregate
principal amount of $25.0 million, plus unpaid accrued interest of $1.5 million divided by the conversion price, which was determined
based upon the Company's fully-diluted capitalization immediately prior to the Merger. At the effective time of the Merger, the
Pre-Merger Oruka Common Stock issued upon the conversion of the Convertible Note (including accrued interest) automatically converted
into shares of Company Common Stock. 2,722,207 shares of Company Common Stock were issued on conversion of the Convertible Note and accrued
interest. As of December 31, 2024, there is no note payable to a related party.

 Lease
Agreement

 Our
contractual obligations include minimum lease payments under our operating lease obligation for our headquarters in Menlo Park, California.
See Note 13 to the consolidated financial statements elsewhere in this report for additional information.

 Critical
Accounting Policies and Significant Judgments and Estimates

 Our
management's discussion and analysis of its financial condition and results of operations is based on its financial statements,
which have been prepared in accordance with U.S. GAAP. The preparation of these consolidated financial statements requires us to
make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and
liabilities at the date of the financial statements, as well as the reported revenues recognized and expenses incurred during the reporting
periods. Our estimates are based on its historical experience and on various other factors that we believe are reasonable under the circumstances,
the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent
from other sources. Actual results may differ from these estimates under different assumptions or conditions.

 While
our significant accounting policies are described in more detail in Note 2 to our consolidated financial statements appearing elsewhere
in this Annual Report, we believe the following accounting policies used in the preparation of our financial statements require the most
significant judgments and estimates.

and Development Expenses

and development costs are expensed as incurred. Research and development expenses consist of costs incurred in performing research and
development activities, including salaries and bonuses, overhead costs, contract services and other related costs. The value of goods
and services received from contract research organizations and contract manufacturing organizations in the reporting period are estimated
based on the level of services performed, and progress in the period in cases when we have not received an invoice from the supplier.
In circumstances where amounts have been paid in excess of costs incurred, we record a prepaid expense. When billing terms under these
contracts do not coincide with the timing of when the work is performed, we are required to make estimates of outstanding obligations
to those third parties as of period end. Any accrual estimates are based on a number of factors, including our knowledge of the progress
towards completion of the specific tasks to be performed, invoicing to date under the contracts, communication from the vendors of any
actual costs incurred during the period that have not yet been invoiced and the costs included in the contracts. Significant judgments
and estimates may be made in determining the accrued balances at the end of any reporting period. Actual results could differ from the
estimates made by us.

 Stock-Based

 We
measure stock options granted to employees and non-employees based on the estimated fair values of the awards as of the grant date using
the Black-Scholes option-pricing model. The model requires management to make a number of assumptions, including common stock fair value,
expected volatility, expected term, risk-free interest rate and expected dividend yield. For restricted stock awards and restricted stock
units, the estimated fair value is the fair market value of the underlying stock on the grant date. We expense the fair value of our
equity-based compensation awards on a straight-line basis over the requisite service period, which is the period in which the related
services are received. We account for award forfeitures as they occur. The expense for stock-based awards with performance conditions
is recognized when it is probable that a performance condition is met during the vesting period.

 Determination
of Fair Value of Common Stock

 A
public trading market for Company Common Stock has been established in connection with the completion of the Merger. As such, it is no
longer necessary for our board of directors to estimate the fair value of our stock-based awards in connection with its accounting for
granted stock-based awards or other such awards we may grant, as the fair value of Company Common Stock and share-based awards is determined
based on the quoted market price of Company Common Stock.

 Prior
to the merger, Pre-Merger Oruka's common stock valuations were prepared using a hybrid method, including an option pricing method
("OPM"). The OPM treats common stock and preferred stock as call options on the total equity value of a company, with exercise
prices based on the value thresholds at which the allocation among the various holders of a company's securities changes. Under
this method, the common stock has value only if the funds available for distribution to stockholders exceed the value of the preferred
stock liquidation preferences at the time of the liquidity event, such as a strategic sale or a merger. The hybrid method is a probability-weighted
expected return method ("PWERM"), where the equity value in one or more of the scenarios is calculated using an OPM. The
PWERM is a scenario-based methodology that estimates the fair value of common stock based upon an analysis of future values for the Company,
assuming various outcomes. The common stock value is based on the probability-weighted present value of expected future investment returns
considering each of the possible outcomes available as well as the rights of each class of stock. The future value of the common stock
under each outcome is discounted back to the valuation date at an appropriate risk-adjusted discount rate and probability weighted to
arrive at an indication of value for the common stock. A discount for lack of marketability of the common stock is then applied to arrive
at an indication of value for the common stock.

 The
assumptions underlying these valuations represented management's best estimate, which involved inherent uncertainties and the application
of management's judgment. As a result, if Pre-Merger Oruka had used significantly different assumptions or estimates, the fair
value of Pre-Merger Oruka's incentive shares and its stock-based compensation expense could have been materially different.

 Recently
Issued Accounting Pronouncements

 See
Note 2 to the consolidated financial statements included in Part II - Item 8 of this Annual Report for more information regarding recently
issued accounting pronouncements.

 Off-Balance
Sheet Arrangements

 As
of December 31, 2024, we did not have any off-balance sheet arrangements, as defined in the rules and regulations of the SEC.

 Item
7A. Quantitative and Qualitative Disclosures About Market Risk.

 We
are a smaller reporting company, as defined by Rule 12b-2 under the Securities Exchange Act of 1934, as amended (the "Exchange
Act"), and in Item 10(f)(1) of Regulation S-K, and are not required to provide the information under this item.

 Item
8. Financial Statements and Supplementary Data.

 ORUKA

TO CONSOLIDATED FINANCIAL STATEMENTS

 Page

 Audited Financial Statements:

 Report of Independent Registered Public Accounting Firm (PCAOB ID 238)

 Consolidated Balance Sheets

 Consolidated Statement of Operations and Comprehensive Loss

 Consolidated Statement of Convertible Preferred Stock and Stockholders' Equity

 Consolidated Statement of Cash Flows

 Notes to Consolidated Financial Statements

 F- 1

 REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

 To the Board of Directors and Stockholders of
Oruka Therapeutics, Inc.

 Opinion on the Financial Statements

 We have audited the accompanying
consolidated balance sheets of Oruka Therapeutics, Inc. and its subsidiaries (the "Company") as of December 31, 2024
and February 6, 2024, and the related consolidated statements of operations and comprehensive loss, of convertible preferred stock and
stockholders' equity and of cash flows for the period from February 6, 2024 (inception) to December 31, 2024, including
the related notes (collectively referred to as the "consolidated financial statements"). In our opinion, the consolidated financial
statements present fairly, in all material respects, the financial position of the Company as of December 31, 2024 and February
6, 2024, and the results of its operations and its cash flows for the period from February 6, 2024 (inception) to December 31, 2024
in conformity with accounting principles generally accepted in the United States of America.

 Basis for Opinion

 These consolidated financial
statements are the responsibility of the Company's management. Our responsibility is to express an opinion on the Company's
consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight
Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities
laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

 We conducted our audits of
these consolidated financial statements in accordance with the standards of the PCAOB. Those standards require that we plan and perform
the audits to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether
due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial
reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the
purpose of expressing an opinion on the effectiveness of the Company's internal control over financial reporting. Accordingly, we express
no such opinion.

 Our audits included performing
procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing
procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures
in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates
made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits
provide a reasonable basis for our opinion.

 Critical Audit Matters

 The critical audit matter
communicated below is a matter arising from the current period audit of the consolidated financial statements that was communicated or
required to be communicated to the audit committee and that (i) relates to accounts or disclosures that are material to the consolidated
financial statements and (ii) involved our especially challenging, subjective, or complex judgments. The communication of critical audit
matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating
the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which
it relates.

 External Research and Development Costs

 As described in Note 2 to
the consolidated financial statements, research and development costs are expensed as incurred. Research and development costs include
salaries and bonuses, stock-based compensation, employee benefits, and external costs of vendors and consultants engaged to conduct research
and development activities, as well as allocated human resource costs, information technology costs, and facility-related costs, including
rent, maintenance, utilities, and depreciation. As disclosed by management, the Company's research and development expense for the
period from February 6, 2024 (inception) to December 31, 2024 was $75.1 million, $57.7 million of which relates to external research and
development costs.

 The principal consideration
for our determination that performing procedures relating to external research and development costs is a critical audit matter is a high
degree of auditor effort in performing procedures related to the Company's external research and development costs.

 Addressing the matter involved
performing procedures and evaluating audit evidence in connection with forming our overall opinion on the consolidated financial statements.
These procedures included, among others, testing external research and development costs, on a sample basis, by obtaining and agreeing
the contractual terms of the agreement, amounts incurred to date, and estimates of work performed to date to the (i) underlying agreements
with vendors engaged to conduct research and development; (ii) purchase orders; (iii) invoices received; (iv) underlying payments made
for expenses incurred on the contracts; and (v) external confirmations or communications obtained by management from vendors.

 /s/ PricewaterhouseCoopers LLP

 Boston, Massachusetts

 March 6, 2025

 We have served as the Company's auditor
since 2024.

 F- 2

 ORUKA

 CONSOLIDATED
BALANCE SHEETS

 (In
thousands, except share and per share data)

 2024

 2024

 Assets

 Current assets:

 Cash
 and cash equivalents

 $
 61,575

 $
 —

 securities, current

 —

 Subscription
 receivable

 —

 Prepaid
 expenses and other current assets

 1,221

 —

 Total
 current assets

 376,869

 securities, long-term

 —

 Property
 and equipment, net

 —

 lease right-of-use assets

 —

 Other
 non-current assets

 —

 Total
 assets

 $
 396,019

 $

 Liabilities,
 Convertible Preferred Stock and Stockholders' Equity

 Current
 liabilities:

 Accounts
 payable

 $
 3,462

 $
 —

 Accrued
 expenses and other current liabilities

 3,346

 —

 lease liability, current

 —

 Related
 party accounts payable and other current liabilities

 6,022

 —

 Total
 current liabilities

 13,043

 —

 lease liability, non-current

 —

 Total
 liabilities

 13,798

 —

 Commitments
 and contingencies (Note 13)

 Series A convertible preferred stock, $ 0.0001 par value; no shares and 20,000,000 shares authorized as of December 31, 2024 and February 6, 2024, respectively; none issued and outstanding as of December 31, 2024 and February 6, 2024

 —

 —

 Series A non-voting convertible preferred stock, $ 0.001 par value; none authorized as of December 31, 2024 and February 6, 2024; none issued and outstanding as of December 31, 2024 and February 6, 2024

 —

 —

 Stockholders'
 equity:

 Series B non-voting convertible preferred stock, $ 0.001 par value; 251,504 and no shares authorized as of December 31, 2024 and February 6, 2024, respectively; 137,138 and no shares issued and outstanding as of December 31, 2024 and February 6, 2024, respectively

 2,931

 —

 Common stock, $ 0.001 and $ 0.001 par value as of December 31, 2024 and February 6, 2024, respectively; 545,000,000 and 65,000,000 shares authorized, 37,440,510 and 3,197,975 shares issued and outstanding as of December 31, 2024 and February 6, 2024, respectively

 —

 paid-in capital

 463,018

 Accumulated
 other comprehensive loss

 ( 41
)

 —

 Accumulated
 deficit

)

 —

 Total
 stockholders' equity

 382,221

 Total
 liabilities, convertible preferred stock and stockholders' equity

 $
 396,019

 $

 The
accompanying notes are an integral part of these consolidated financial statements.

 F- 3

 ORUKA

 CONSOLIDATED
STATEMENT OF OPERATIONS AND COMPREHENSIVE LOSS

 (In
thousands, except share and per share data)

 from

 2024

 2024

 Operating expenses

 and development (1)

 $
 75,060

 and administrative (2)

 13,063

 Total
 operating expenses

 88,123

 Loss from operations

 ( 88,123
)

 Other income (expense)

 Interest income

 5,863

 Interest expense (3)

 ( 1,468
)

 Other
 income, net

 Total
 other income, net

 4,399

 Net loss

)

 loss on marketable securities

 ( 41
)

 Comprehensive loss

 $
 ( 83,765
)

 Net loss per share attributable
 to common stockholders, basic and diluted

 $
 ( 3.87
)

 Net
 loss per share attributable to Series A non-voting convertible preferred stockholders, basic and diluted

 $
 ( 3,873.25
)

 Net
 loss per share attributable to Series B non-voting convertible preferred stockholders, basic and diluted

 $
 ( 322.81
)

 Weighted-average
 shares used in computing net loss per share attributable to common stockholders, basic and diluted

 16,789,362

 Weighted-average
 shares used in computing net loss per share attributable to Series A non-voting convertible preferred stockholders, basic and diluted

 Weighted-average
 shares used in computing net loss per share attributable to Series B non-voting convertible preferred stockholders, basic and diluted

 51,946

 (1)
 Includes related party amount of $ 42,640 for the period from February 6, 2024 (inception) to December 31, 2024

 (2)
 Includes related party amount of $ 1,364 for the period from February 6, 2024 (inception) to December 31, 2024

 (3)
 Includes related party amount of $ 1,468 for the period from February 6, 2024 (inception) to December 31, 2024

 The
accompanying notes are an integral part of these consolidated financial statements.

 F- 4

 ORUKA

 CONSOLIDATED
STATEMENT OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY

 (In
thousands, except share data)

 Series
 A
 Convertible
 Preferred Stock

 Series
 A
 Non-Voting
 Convertible
 Preferred Stock

 Series
 B
 Non-Voting
 Convertible
 Preferred Stock

 Stock

 Paid-In

 Accumulated

 Other
 Comprehensive

 Accumulated

 Total

 Stockholders'

 Capital

 Gain
 (Loss)

 Deficit

 Equity

 Balances
 as of February 6, 2024 (inception)

 —

 $
 —

 —

 $
 —

 —

 $
 —

 3,197,975

 $

 $
 ( 2
)

 $
 —

 $
 —

 $

 of common stock

 —

 —

 —

 —

 —

 —

 2,207,553

 ( 2
)

 —

 —

 —

 Issuance of Series A convertible preferred stock, net of issuance costs of $ 69

 20,000,000

 2,931

 —

 —

 —

 —

 —

 —

 —

 —

 —

 —

 Exchange
 of Series A convertible preferred stock for Series B non-voting convertible preferred stock upon the closing of the reverse capitalization

 ( 20,000,000
)

 ( 2,931
)

 —

 —

 137,138

 2,931

 —

 —

 —

 —

 —

 2,931

 Conversion
 of convertible notes (including accrued interest) into common stock upon the closing of the reverse recapitalization

 —

 —

 —

 —

 —

 —

 2,722,207

 26,445

 —

 —

 26,448

 of common stock and pre-funded warrants in the Pre-Closing Financing

 —

 —

 —

 —

 —

 —

 20,061,932

 248,437

 —

 —

 248,457

 costs of Pre-Closing Financing and reverse recapitalization

 —

 —

 —

 —

 —

 —

 —

 —

 ( 20,504
)

 —

 —

 ( 20,504
)

 of common stock to former stockholders of ARCA biopharma, Inc. in connection with the closing of reverse recapitalization

 —

 —

 —

 —

 —

 —

 1,208,883

 4,999

 —

 —

 5,000

 of common stock, Series A non-voting convertible preferred stock, and pre-funded warrants in connection with the PIPE Financing

 —

 —

 2,439

 56,097

 —

 —

 5,600,000

 144,433

 —

 —

 144,439

 costs of PIPE Financing

 —

 —

 —

 ( 3,263
)

 —

 —

 —

 —

 ( 8,592
)

 —

 —

 ( 8,592
)

 Conversion
 of Series A non-voting convertible preferred stock to common stock

 —

 —

 ( 2,439
)

 ( 52,834
)

 —

 —

 2,439,000

 52,832

 —

 —

 52,834

 of common stock under employee stock purchase plan

 —

 —

 —

 —

 —

 —

 2,960

 —

 —

 —

 Reclassification
 of the Paruka warrant from liability to equity

 —

 —

 —

 —

 —

 —

 —

 —

 10,357

 —

 —

 10,357

 Stock-based
 compensation expense

 —

 —

 —

 —

 —

 —

 —

 —

 4,562

 —

 —

 4,562

 loss on marketable securities

 —

 —

 —

 —

 —

 —

 —

 —

 —

 ( 41
)

 —

 ( 41
)

 Net
 loss

 —

 —

 —

 —

 —

 —

 —

 —

 —

 —

)

)

 Balances
 as of December 31, 2024

 —

 $
 —

 —

 $
 —

 137,138

 $
 2,931

 37,440,510

 $

 $
 463,018

 $
 ( 41
)

 $
)

 $
 382,221

 The
accompanying notes are an integral part of these consolidated financial statements.

 F- 5

 ORUKA

 CONSOLIDATED
STATEMENT OF CASH FLOWS

 (In
thousands)

 from

 2024

 2024

 Cash flows from operating activities:

 Net loss

 $
)

 Adjustments to reconcile
 net loss to net cash used in operating activities:

 Stock-based compensation
 expense

 14,919

 Net accretion of premiums
 and discounts on marketable securities

 ( 2,245
)

 Non-cash interest expense

 1,468

 Non-cash lease expense

 Depreciation expense

 Changes in operating
 assets and liabilities:

 Prepaid expenses and
 other current assets

 ( 1,128
)

 Other non-current assets

 ( 43
)

 Accounts payable

 3,462

 Accrued expenses and
 other current liabilities

 3,292

 Operating lease liability

 ( 14
)

 Related
 party accounts payable and other current liabilities

 6,022

 Net
 cash used in operating activities

 ( 57,837
)

 Cash flows from investing
 activities:

 Purchases of property
 and equipment

 ( 189
)

 Purchases
 of marketable securities

 ( 329,938
)

 Net
 cash used in investing activities

 ( 330,127
)

 Cash flows from financing
 activities:

 Proceeds
 from issuance of Pre-Merger Oruka Series A Preferred Stock, net of issuance costs paid

 2,931

 Proceeds
 from issuance of notes payable to related party, net of issuance costs paid

 24,980

 Proceeds from the Pre-Closing
 Financing, net

 227,953

 Proceeds from the PIPE
 Financing, net

 188,681

 Cash acquired in connection
 with the reverse recapitalization

 4,940

 Proceeds
 from issuance of common stock

 Net
 cash provided by financing activities

 449,539

 Net increase in cash and
 cash equivalents

 61,575

 Cash at beginning of period

 —

 Cash and cash equivalents
 at end of period

 $
 61,575

 Supplemental disclosures
 of non-cash operating and financing activities:

 Operating lease liability
 arising from obtaining operating right-of-use asset

 $

 Assets acquired in connection
 with the reverse capitalization

 $

 Other liabilities assumed
 in connection with the reverse recapitalization

 $
 ( 54
)

 Non-cash accrued interest
 on convertible note converted to common stock

 $
 1,468

 Non-cash
 exchange of Pre-Merger Oruka Series A preferred stock for Series B convertible preferred stock

 $
 2,931

 Conversion of Series
 A non-voting convertible preferred stock to common stock

 $
 52,834

 Reclassification of
 the Paruka warrant from liability to equity

 $
 10,357

 The
accompanying notes are an integral part of these consolidated financial statements

 F- 6

 ORUKA

 NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS

 1.
Nature of the Business and Basis of Presentation

 Background
and Basis of Presentation

 Oruka
Therapeutics, Inc., together with its subsidiaries (collectively, the "Company"), formerly known as ARCA biopharma, Inc.
("ARCA"), is a clinical-stage biotechnology company that is the result of the reverse recapitalization discussed below. Prior
to the reverse recapitalization, the private company Oruka Therapeutics, Inc. ("Pre-Merger Oruka") was established and incorporated
under the laws of the state of Delaware on February 6, 2024 (referred to in the Notes as the inception of the Company). The Company
is headquartered in Menlo Park, California. The Company is focused on developing novel monoclonal antibody therapeutics for psoriasis
("PsO") and other inflammatory and immunology ("I&I") indications.

 The
accompanying consolidated financial statements reflect the operations of the Company and its wholly-owned subsidiaries. Intercompany
balances and transactions have been eliminated in consolidation. The accompanying consolidated financial statements have been prepared
in conformity with United States ("U.S.") generally accepted accounting principles ("GAAP"). Any reference in
these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the Accounting Standards Codification ("ASC")
and Accounting Standards Updates ("ASU") of the Financial Accounting Standards Board ("FASB").

 Reverse
Recapitalization and Pre-Closing Financing

 On
August 29, 2024 (the "Merger Closing"), the Company completed the acquisition (the "Merger") of Pre-Merger Oruka
pursuant to an Agreement and Plan of Merger and Reorganization, dated as of April 3, 2024 (the "Merger Agreement"). Following
the transactions contemplated by the Merger Agreement, Pre-Merger Oruka merged with and into Atlas Merger Sub Corp., a wholly owned subsidiary
of ARCA and following that, Pre-Merger Oruka then merged with and into Atlas Merger Sub II, LLC ("Second Merger Sub"), with
Second Merger Sub being the surviving entity. Second Merger Sub changed its corporate name to "Oruka Therapeutics Operating Company,
LLC." On August 29, 2024, the Company changed its name from "ARCA biopharma, Inc." to "Oruka Therapeutics, Inc."
and its Nasdaq ticker symbol from "ABIO" to "ORKA".

 Following
consummation of the Merger, the Company effected a 1-for-12 reverse stock split (the "Reverse Stock Split") of the common
stock, par value $ 0.001 per share, of the Company ("Company Common Stock"), which became effective on September 3, 2024.
The Company Common Stock commenced trading on a post-Reverse Stock Split, post-Merger basis at the opening of trading on September 3,
2024. The Company is led by the Pre-Merger Oruka management team and remains focused on developing biologics to optimize the treatment
of inflammatory skin diseases.

 Immediately
prior to the execution and delivery of the Merger Agreement on April 3, 2024, certain new and existing investors of Pre-Merger Oruka
entered into a subscription agreement with Pre-Merger Oruka (the "Subscription Agreement"), pursuant to which, and on the
terms and subject to the conditions of which, immediately prior to the Closing, those investors purchased shares of common stock of Pre-Merger
Oruka ("Pre-Merger Oruka Common Stock") and Pre-Merger Oruka pre-funded warrants for gross proceeds of approximately $ 275.0
million (which includes $ 25.0 million of proceeds previously received from the issuance of the Convertible Note (as defined in Note 7)
and accrued interest on such note which converted to shares of Pre-Merger Oruka Common Stock) (the "Pre-Closing Financing").
The Company incurred transaction costs of $ 20.5 million which was recorded as a reduction to additional paid-in capital in the consolidated
financial statements. At the Merger Closing, the shares of Pre-Merger Oruka Common Stock and Pre-Merger Oruka pre-funded warrants issued
pursuant to the Subscription Agreement were converted into shares of Company Common Stock and pre-funded warrants of Company Common Stock
in accordance with the Exchange Ratio (defined below).

 F- 7

 In
accordance with an Exchange Ratio determined by terms of the Merger Agreement and upon the effective time of the First Merger (the "First
Effective Time"), (i) each then-issued and outstanding share of Pre-Merger Oruka Common Stock including outstanding and unvested
Pre-Merger Oruka restricted stock and shares of Pre-Merger Oruka Common Stock issued in connection with the Subscription Agreement, were
converted into the right to receive a number of shares of Company Common Stock, equal to the Exchange Ratio of 6.8569 shares of Company
Common Stock, which were subject to the same vesting provisions as those immediately prior to the Merger, (ii) each share of Pre-Merger
Oruka Series A convertible preferred stock, par value $ 0.0001 ("Pre-Merger Oruka Series A Preferred Stock"), outstanding
immediately prior to the First Effective Time was converted into the right to receive a number of shares of ARCA Series B non-voting
convertible preferred stock, par value $ 0.001 per share ("Company Series B Preferred Stock"), which are convertible into
shares of Company Common Stock, at a conversion ratio of approximately 83:3332:1 (iii) each outstanding option to purchase Pre-Merger
Oruka Common Stock was converted into an option to purchase shares of Company Common Stock, (iv) each outstanding warrant to purchase
shares of Pre-Merger Oruka Common Stock was converted into a warrant to purchase shares of Company Common Stock, and (v) each share of
Company Common Stock issued and outstanding at the First Effective Time remain issued and outstanding in accordance with its terms and
such shares. Subsequent to the close of the merger, the common stock shares were then subject to the reverse stock split of 1-for-12
effected on September 3, 2024.

 As
part of the Pre-Closing Financing and the Merger Closing, investors in the Pre-Closing Financing received 22,784,139 shares of Company
Common Stock in exchange for 39,873,706 shares of Pre-Merger Oruka Common Stock (which includes the issuance of 2,722,207 shares of Company
Common Stock in exchange for 4,764,032 shares of Pre-Merger Oruka Common Stock on the conversion of Convertible Note along with the accrued
interest through the conversion date) and 5,522,207 Company pre-funded warrants in exchange for 9,664,208 Pre-Merger pre-funded warrants.

 The
Merger was accounted for as a reverse recapitalization in accordance with U.S. GAAP. Under this method of accounting, Pre-Merger Oruka
was deemed to be the accounting acquirer for financial reporting purposes. This determination was primarily based on the fact that, immediately
following the Merger: (i) Pre-Merger Oruka stockholders own a substantial majority of the voting rights in the combined company; (ii)
Pre-Merger Oruka's largest stockholders retain the largest interest in the combined company; (iii) Pre-Merger Oruka designated
a majority of the initial members of the board of directors of the combined company; and (iv) Pre-Merger Oruka's executive management
team became the management team of the combined company. Accordingly, for accounting purposes: (i) the Merger was treated as the equivalent
of Pre-Merger Oruka issuing stock to acquire the net assets of ARCA, and (ii) the reported historical operating results of the combined
company prior to the Merger are those of Pre-Merger Oruka. Additional information regarding the Merger is included in Note 3.

 Reverse
Stock Split

 On
September 3, 2024, the Company effected the Reverse Stock Split, a 1-for-12 reverse stock split of Company Common Stock. The par value
per share and the number of authorized shares were not adjusted as a result of the Reverse Stock Split. The shares of Company Common
Stock underlying outstanding stock options, common stock warrants and other equity instruments were proportionately reduced and the respective
exercise prices, if applicable, were proportionately increased in accordance with the terms of the agreements governing such securities.
All references to common stock, options to purchase common stock, outstanding common stock warrants, common stock share data, per share
data, and related information contained in the consolidated financial statements have been retrospectively adjusted to reflect the effect
of the Reverse Stock Split for all periods presented, unless otherwise specifically indicated or the context otherwise requires.

 PIPE
Financing

 On
September 11, 2024, the Company entered into a Securities Purchase Agreement for a private placement (the "PIPE Financing")
with certain institutional and accredited investors. The closing of the PIPE Financing occurred on September 13, 2024.

to the Securities Purchase Agreement, the investors purchased an aggregate of 5,600,000 shares of Company Common Stock at a purchase
price of $ 23.00 per share, an aggregate of 2,439 shares of the Company's Series A non-voting convertible preferred stock, par value
$ 0.001 per share ("Company Series A Preferred Stock"), at a purchase price of $ 23,000.00 per share (each Company Series A
Preferred Stock is convertible into 1,000 shares of Company Common Stock), and pre-funded warrants to purchase an aggregate of 680,000
shares of Company Common Stock at a purchase price of $ 22.999 per pre-funded warrant, for aggregate net proceeds of approximately $ 188.7
million (net of issuance costs of $ 11.9 million).

 F- 8

 Liquidity
and Going Concern

 Since
its inception, the Company has devoted substantially all of its resources to advancing the development of its portfolio of programs,
organizing and staffing the Company, business planning, raising capital, and providing general and administrative support for these operations.
Current and future programs will require significant research and development efforts, including preclinical and clinical trials, and
regulatory approvals to commercialization. Until such time as the Company can generate significant revenue from product sales, if ever,
the Company expects to finance its operating activities through a combination of equity offerings and debt financings.

 The
Company has not generated any revenue from product sales or other sources and has incurred significant operating losses and negative
cash flows from operations since inception. For the period from February 6, 2024 (inception) to December 31, 2024, the Company has incurred
a net loss of $ 83.7 million and used net cash of $ 57.8 million for its operating activities.

 As
of December 31, 2024, the Company had cash, cash equivalents, and marketable securities of $ 393.7 million. The Company's management
expects that the existing cash, cash equivalents, and marketable securities will be sufficient to fund the Company's operating
plans for at least twelve months from the date these consolidated financial statements were issued. The Company expects that its research
and development and general and administrative costs will continue to increase significantly, including in connection with conducting
future pre-clinical activities and clinical trials and manufacturing for its existing product candidates and any future product candidates
to support commercialization and providing general and administrative support for its operations, including the costs associated with
operating as a public company. The Company's ability to access capital when needed is not assured and, if capital is not available
to the Company when, and in the amounts needed, the Company may be required to significantly curtail, delay, or discontinue one or more
of its research or development programs or the commercialization of any product candidate, or be unable to expand its operations or otherwise
capitalize on the Company's business opportunities, as desired, which could materially harm the Company's business, financial
condition and results of operations.

 2.
Summary of Significant Accounting Policies

 Use
of Estimates

 The
preparation of the Company's consolidated financial statements in conformity with U.S. GAAP requires management to make estimates,
assumptions, and judgments that affect the reported amounts of assets and liabilities and the disclosure of contingent liabilities at
the date of the consolidated financial statements and the reported amounts of income and expenses during the reporting periods. Significant
estimates and assumptions reflected within these consolidated financial statements include but are not limited to research and development
expenses and related prepaid or accrued costs and the valuation of stock-based compensation awards and related expenses. The Company
bases its estimates on known trends and other market-specific or other relevant factors that it believes to be reasonable under the circumstances.
On an ongoing basis, management evaluates its estimates, as there are changes in circumstances, facts, and experience. Actual results
could differ materially from those estimates or assumptions.

 Concentrations
of Credit Risk and Other Risks and Uncertainties

 Financial
instruments that potentially subject the Company to a concentration of credit risk consist of cash, cash equivalents and marketable securities.
The Company's investment policy limits investments to high credit quality securities issued by the U.S. government, U.S. government-sponsored
agencies, highly rated banks, and corporate issuers, subject to certain concentration limits and restrictions on maturities. The Company's
cash, cash equivalents and marketable securities are held by financial institutions that management believes are of high credit quality.
The financial instruments that potentially subject the Company to a concentration of credit risk consist principally of cash deposits.
Accounts at the Company's U.S. banking institution are insured by the Federal Deposit Insurance Corporation ("FDIC")
up to $ 250,000 per depositor. As of December 31, 2024, the balance at the Company's U.S. banking institution exceeded the FDIC
limits. The Company has not experienced any losses on its deposits of cash and cash equivalents and its accounts are monitored by management
to mitigate risk. The Company is exposed to credit risk in the event of default by the financial institutions holding its cash and cash
equivalents, and bond issuers.

 F- 9

 The
Company is dependent on third-party organizations to research, develop, manufacture, and process its product candidates for its development
programs, including its two most advanced programs, ORKA-001 and ORKA-002. The Company expects to continue to be dependent on a small
number of manufacturers to supply it with its requirements for all products. The Company's research and development programs could
be adversely affected by a significant interruption in the supply of the necessary materials. A significant amount of the Company's
research and development activities are performed under its agreements with Paragon Therapeutics, Inc. ("Paragon") (see Note 12).

 Cash
and Cash Equivalents

 The
Company considers all highly liquid investments with an original maturity of three months or less at the time of initial purchase to
be cash equivalents. The cash equivalents were comprised of investments in money market funds, U. S. treasury securities, U.S. government
agency securities, and debt securities and are stated at fair value.

 The
Company invests in marketable securities, primarily securities issued by the U.S. government and its agencies, commercial paper and corporate
debt securities. The Company's marketable securities are classified as available-for-sale and reported at fair value, with unrealized
gains and losses included as a component of accumulated other comprehensive loss.

 For
available-for-sale debt securities in an unrealized loss position, the Company first assesses whether it intends to sell, or it is more
likely than not that it will be required to sell the security before recovery of its amortized cost basis. If either of the criteria
regarding intent or requirement to sell is met, the security's amortized cost basis is written down to fair value and recognized
in other income (expense) in the results of operations. For available-for-sale debt securities that do not meet the aforementioned criteria,
the Company evaluates whether the decline in fair value has resulted from credit losses or other factors. In making this assessment,
management considers the extent to which fair value is less than amortized cost, any changes to the rating of the security by a rating
agency, and adverse conditions specifically related to the security, among other factors. If this assessment indicates that a credit
loss exists, an allowance is recorded for the difference between the present value of cash flows expected to be collected and the amortized
cost basis of the security. Impairment losses attributable to credit loss factors are charged against the allowance when management believes
an available-for-sale security is uncollectible or when either of the criteria regarding intent or requirement to sell is met.

 Any
unrealized losses from declines in fair value below the amortized cost basis as a result of non-credit loss factors are recognized as
a component of accumulated other comprehensive loss, net of unrealized gains. Realized gains and losses and declines in fair value, if
any, on available-for-sale securities are included in other income, net, in the results of operations.

securities with stated maturities of greater than three months from the date of purchase but less than one year from the consolidated
balance sheet date are classified as current, while marketable securities with maturities in one year or beyond one year from the consolidated
balance sheet date are classified as long-term. The cost of securities sold is determined using the specific-identification method. Interest
earned and adjustments for the amortization of premiums and discounts on investments are included in interest income on the consolidated
statements of operations and comprehensive loss.

 Debt
Issuance Costs

 Debt
issuance costs incurred in connection with the Convertible Note (see Note 7) are recorded as a reduction of the carrying value of
the notes payable liability on the Company's balance sheet and are amortized to interest expense over the term of the loan using
the effective interest method. At the effective time of the Merger the Converted Note was converted to common stock and is no longer
on the balance sheet as of December 31, 2024.

 Subscription
Receivable

 The
Company accounts for any notes received in exchange for common stock as a subscription receivable, provided the note underlying the receivable
is paid prior to the date the financial statement is available to be issued.

 F- 10

 Fair
Value Measurements

assets and liabilities are carried at fair value under U.S. GAAP. Fair value is defined as the exchange price that would be
received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability
in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize
the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are
to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered
observable and the last is considered unobservable:

 Level
 1 — Quoted prices in active markets that are identical assets or liabilities.

 Level 2 — Observable
 inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar
 assets or liabilities, quoted prices in markets that are not active for identical or similar
 assets or liabilities, or other inputs that are observable or can be corroborated by observable
 market data.

 Level 3 — Unobservable
 inputs that are supported by little or no market activity that are significant to determining
 the fair value of the assets or liabilities, including pricing models, discounted cash flow
 methodologies, and similar techniques.

 The
Company's cash equivalents and marketable securities are carried at fair value, determined according to the fair value hierarchy
described above (see Note 4). The carrying values of the Company's prepaid expenses and other current assets, accounts payable
and accrued expenses and other current liabilities approximate their fair values due to their relatively short maturity period.

 Property
and Equipment

 Property
and equipment are stated at cost less accumulated depreciation. Depreciation expense is recognized using the straight-line method over
the estimated useful life of each asset as follows:

 Estimated

 Useful Life

 Furniture and fixtures

 3 - 5 years

 Computer and office equipment

 3 - 5 years

 Classification
of Convertible Preferred Stock

 Prior
to the reverse recapitalization, the Company had classified its Pre-Merger Oruka Series A Preferred Stock outside of stockholders'
equity on the Company's consolidated balance sheet because the holders of such stock have certain liquidation rights in the event
of a deemed liquidation event that, in certain situations, is not solely within the control of the Company and would require the redemption
of the then-outstanding convertible preferred stock.

 Upon
the closing of the Merger, the Company converted its Pre-Merger Oruka Series A Preferred Stock to Company Series B Preferred Stock and
has classified the Company Series B Preferred Stock within stockholders' equity on its consolidated balance sheet because the Company
Series B Preferred Stock is not redeemable or puttable to the Company by the holder under any circumstances.

 In
connection with the PIPE Financing (see Note 1) the Company issued Company Series A Preferred Stock, and has classified the Company Series
A Preferred Stock outside of stockholders' equity on the Company's consolidated balance sheet because the holders of such
stock have certain rights (see Note 8) that, in certain situations, is not solely within the control of the Company and would require
the redemption of the then-outstanding convertible preferred stock. In November 2024, the Company Series A Preferred Stock shares were
converted to common stock, and as of December 31, 2024, there were no shares of Company Series A Preferred Stock outstanding.

 F- 11

 Note Payable
to Related Party

 The
Company accounted for the Convertible Note (as defined in Note 7) at amortized cost. The Company considered if optional conversion features
are required to be bifurcated and separately accounted for as a derivative. Costs related to the issuance of the Convertible Note were
recorded as a debt discount, amortized over the term of the Convertible Note (see Note 7) and were accounted for as interest
expense in other income (expenses) within the consolidated statement of operations and comprehensive loss using the effective interest
method. At the effective time of the Merger, shares of Pre-Merger Oruka Common Stock issued pursuant to the conversion of the Convertible
Note (including accrued interest) automatically converted into shares of Company Common Stock (see Note 1).

and Development Contract Costs Accruals

 The
Company records the costs associated with research studies and manufacturing development as incurred. These costs are a significant component
of the Company's research and development expenses, with a substantial portion of the Company's ongoing research and development
activities conducted by third-party service providers, including contract research organizations ("CROs") and contract manufacturing
organizations ("CMOs"), and the Company's related-party Paragon (see Note 12).

 The
Company accrues for expenses resulting from obligations under its two antibody discovery and option agreements (the "Option Agreements")
(see Note 12), by and among Paragon, Paruka Holding LLC ("Paruka"), an entity formed by Paragon as a vehicle to hold equity
in the Company, and the Company as well as agreements with CROs, CMOs, and other outside service providers for which payment flows do
not match the periods over which materials or services are provided to the Company. Accruals are recorded based on estimates of services
received and efforts expended pursuant to agreements established with Paragon, CROs, CMOs, and other outside service providers. These
estimates are typically based on contracted amounts applied to the proportion of work performed and determined through analysis with
internal personnel and external service providers as to the progress or stage of completion of the services. The Company makes significant
judgments and estimates in determining the accrual balance in each reporting period. If advance payments are made to Paragon, a CRO,
CMO, or outside service provider, the payments will be recorded as a prepaid asset which will be expensed as the contracted services
are performed. Changes in these estimates that result in material changes to the Company's accruals could materially affect the
Company's results of operations. As of December 31, 2024, the Company has not experienced any material deviations between accrued
and actual research and development expenses.

 Leases

 At
the lease commencement date, when control of the underlying asset is transferred from the lessor to the Company, the Company classifies
a lease as either an operating or finance lease and recognizes a right-of-use ("ROU") asset and a current and non-current
lease liability, as applicable, in the balance sheet if the lease has a term greater than one year. Lease terms may include options to
extend or terminate the lease when it is reasonably certain that the Company will exercise its option.

 At
the lease commencement date, operating lease liabilities and their corresponding ROU assets are recorded at the present value of future
minimum lease payments over the expected remaining lease term. The Company determines the present value of lease payments using the implicit
rate, if it is readily determinable, or the risk-free discount rate for a period comparable with that of the lease term. For operating
leases, lease expense for lease payments is recognized on a straight-line basis over the lease term. For finance leases, lease expense
includes amortization expense of the ROU asset recognized on a straight-line basis over the lease term and interest expense recognized
on the finance lease liability. In addition, certain adjustments to the ROU asset may be required for items such as lease prepayments,
incentives received or initial direct costs. As of December 31, 2024, the Company has one operating lease and no finance leases.

 The
Company accounts for lease and non-lease components related to operating leases as a single lease component. The Company has elected
that costs associated with leases having an initial term of 12 months or less are recognized in the consolidated statement of operations
and comprehensive loss on a straight-line basis over the lease term and are not recorded on its consolidated balance sheets. Variable
lease expense is recognized as incurred and consists primarily of real estate taxes, utilities, and other office space related expenses.

 F- 12

 Segment
Reporting

 The Company operates as a
single reportable and operating segment. Its Chief Executive Officer, serving as the Chief Operating Decision Maker ("CODM"),
oversees operations on an aggregated basis to allocate resources effectively. In assessing the Company's financial performance,
the CODM regularly reviews total operating expenses and consolidated net loss.

and Development Costs

and development costs are expensed as incurred. Research and development costs include salaries and bonuses, stock-based compensation,
employee benefits, and external costs of vendors and consultants engaged to conduct research and development activities, as well as allocated
human resource costs, information technology costs, and facility-related costs, including rent, maintenance, utilities, and depreciation.

 Nonrefundable
advance payments for goods or services to be received in the future for use in research and development activities are recorded as prepaid
expenses on the accompanying consolidated balance sheet. The prepaid amounts are expensed as the related goods are delivered or the services
are performed, or when it is no longer expected that the goods will be delivered, or the services rendered. If nonrefundable advance
payments represent a one-time cost for obtaining goods or services, with anticipated benefits to be utilized within a year of period
end, the payment is expensed immediately.

and Administrative Expenses

and administrative expenses consist primarily of salaries and bonuses, stock-based compensation, employee benefits, finance and administration
costs, patent and intellectual property costs, professional fees, as well as allocated human resource costs, information technology costs,
and facility-related costs, including rent, maintenance, utilities and depreciation.

 Commitments
and Contingencies

 The
Company is subject to contingent liabilities, such as legal proceedings and claims, that arise in the ordinary course of business activities.
The Company accrues for loss contingencies when losses become probable and are reasonably estimable. If the reasonable estimate of the
loss is a range and no amount within the range is a better estimate, the minimum amount of the range is recorded as a liability on the
balance sheet. The Company does not accrue for contingent losses that, in its judgment, are considered to be reasonably possible, but
not probable; however, it discloses the range of reasonably possible losses. As of December 31, 2024, no liabilities were recorded for
loss contingencies (see Note 13).

 Stock-Based

 The
Company estimates the fair value of its stock awards using the Black-Scholes option pricing model, which uses as inputs the fair value
of the Company's common stock, and certain management estimates, including the expected stock price volatility, the expected term
of the award, the risk-free interest rate, and expected dividends. Expected volatility is calculated based on reported volatility data
for a representative group of publicly traded companies for which historical information is available. The Company selects companies
with comparable characteristics with historical share price information that approximates the expected term of the equity-based awards.
The Company computes the historical volatility data using the daily closing prices for the selected companies' shares during the
equivalent period that approximates the calculated expected term of the stock options. The Company will continue to apply this method
until a sufficient amount of historical information regarding the volatility of its stock price becomes available. The risk-free interest
rate is based on the U.S. Treasury yield curve in effect at the time of grant commensurate with the expected term assumption. For employee
and non-employee awards (except the Paruka warrant) the Company uses the simplified method, under which the expected term is presumed
to be the midpoint between the vesting date and the end of the contractual term. The Company utilizes this method due to lack of historical
exercise data. For the Paruka warrant, the contractual term is used for the expected term. The expected dividend yield is assumed to
be zero as the Company has no current plans to pay any dividends on common stock.

 The
Company measures restricted common stock awards ("RSAs") using the difference, if any, between the purchase price per share
of the award and the fair value of the Company's common stock at the date of grant.

 F- 13

 The
Company grants stock options, restricted stock awards, and warrants that are subject to service or performance-based vesting conditions.
Compensation expense for awards to employees and directors with service-based vesting conditions is recognized using the straight-line
method over the requisite service period, which is generally the vesting period of the respective award. Compensation expense for awards
to non-employees with service-based vesting conditions is recognized in the same manner as if the Company had paid cash in exchange for
the goods or services, which is generally over the vesting period of the award. Forfeitures are accounted for as they occur. As of each
reporting date, the Company estimates the probability that specified performance criteria will be met and does not recognize compensation
expense until it is probable that the performance-based vesting condition will be achieved.

 The
Company has issued stock options, warrants, and RSAs with service-based and performance-based vesting conditions.

 The
Company recognizes the compensation expense for the option to purchase common stock under the Employee Stock Purchase Plan ("ESPP"),
based on the fair value of the common stock estimated using the closing price of the Company's common stock as reported on the
date of offering, less the purchase discount percentage provided for in the plan.

 The
Company classifies stock-based compensation expense in its consolidated statement of operations and comprehensive loss in the same manner
in which the award recipient's payroll costs are classified or in which the award recipient's service payments are classified,
as applicable.

 Comprehensive
Loss

 Comprehensive
loss includes net loss as well as other changes in stockholders' equity that result from transactions and events other than those
with stockholders. The Company's unrealized gains and losses on marketable securities represent the only component of other comprehensive
loss that are excluded from the reported net loss and that are presented in the consolidated statement of comprehensive loss.

 Net
Loss per Share Attributable to Stockholders

 Basic
and diluted net loss attributable to stockholders per share is presented in conformity with the two-class method required for participating
securities (Pre-Merger Oruka Series A Preferred Stock). Basic earnings per share is computed by dividing net income available to each
class of shares by the weighted-average number of shares of common stock and participating securities outstanding during the period.
Pre-funded warrants were included as the exercise price is negligible and these warrants are fully vested and exercisable. Company Series
A Preferred Stock and Company Series B Preferred Stock share the same characteristics as Common Stock and have no substantive preference
attributed to them and, accordingly, have been considered as classes of Common Stock in the computation of net loss per share regardless
of their legal form.

 Net
loss is allocated to common stock based on its proportional ownership on an as-converted basis. Net loss is not allocated to participating
securities as they do not have an obligation to fund losses. The weighted-average number of shares outstanding of common stock reflects
changes in ownership over the periods presented. See Note 8 — Convertible Preferred Stock and Stockholders' Equity.

 Diluted
net loss per share is computed by dividing the net loss attributable to stockholders adjusted for income (expenses), net of tax, related
to any diluted securities, by the weighted-average number of shares of common stock and potentially dilutive securities outstanding for
the period. For purposes of this calculation, stock options to purchase common stock, employee warrants to purchase common stock, and
unvested RSAs are considered potential dilutive common shares.

 The
Company generated a net loss for the periods presented. Accordingly, basic and diluted net loss per share is the same because the inclusion
of the potentially dilutive securities would be anti-dilutive.

 Other
income, net

 Other
income, net, consists of interest earned on the Company's cash, cash equivalents, and marketable securities; interest expense on
the convertible note from a related party and foreign currency transactions gains and losses.

 F- 14

 Income
Taxes

 The
Company accounts for income taxes using the asset and liability method, which requires the recognition of deferred tax assets and liabilities
for the expected future tax consequences of events that have been recognized in the financial statements or in the Company's tax
returns. Deferred tax assets and liabilities are determined based on the differences between the financial statement basis and tax basis
of assets and liabilities using enacted tax rates in effect for the years in which the differences are expected to reverse. Changes
in deferred tax assets and liabilities are recorded in the provision for income taxes. The Company assesses the likelihood that its deferred
tax assets will be recovered from future taxable income and, to the extent it believes, based upon the weight of available evidence,
that it is more likely than not that all or a portion of the deferred tax assets will not be realized, a valuation allowance is established
through a charge to income tax expense. The potential for recovery of deferred tax assets is evaluated by estimating the future taxable
profits expected and considering prudent and feasible tax planning strategies.

 The
Company accounts for uncertainty in income taxes recognized in the consolidated financial statements by applying a two-step process to
determine the amount of tax benefit to be recognized. First, the tax position must be evaluated to determine the likelihood that it will
be sustained upon external examination by the taxing authorities. If the tax position is deemed more likely than not to be sustained,
the tax position is then assessed to determine the amount of benefit to recognize in the consolidated financial statements. The amount
of the benefit that may be recognized is the largest amount that has a greater than 50% likelihood of being realized upon ultimate settlement.
The provision for income taxes includes the effects of any resulting tax reserves, or unrecognized tax benefits, that are considered
appropriate as well as the related net interest and penalties. The Company had accrued no amounts for interest or penalties related to
uncertain tax positions as of December 31, 2024.

 Recently
Adopted Accounting Pronouncements

 In
November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures ("ASU 2023-07"),
which enhances the segment disclosure requirements for public entities on an annual and interim basis. Under this standard, public entities
will be required to disclose significant segment expenses that are regularly provided to the CODM and included within each reported measure
of segment profit or loss. Additionally, current annual disclosures about a reportable segment's profit or loss and assets will
be required on an interim basis. Entities will also be required to disclose information about the CODM's title and position at
the Company along with an explanation of how the CODM uses the reported measures of segment profit or loss in their assessment of segment
performance and deciding how to allocate resources. Finally, ASU 2023-07 requires all segment disclosures for public entities that
have only a single reportable segment. The amendments in ASU 2023-07 are effective for fiscal years beginning after December 15,
2023, and interim periods within fiscal years beginning after December 15, 2024. Early adoption is permitted. The Company adopted
ASU 2023-07 in 2024 and additional required disclosures have been included in Note 10.

 Recently
Issued Accounting Pronouncements

 In
December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. This ASU
expands disclosures in an entity's income tax rate reconciliation table and disclosures regarding taxes paid both in the U.S. and
foreign jurisdictions. This update is effective beginning with the Company's 2025 fiscal year annual reporting period. The Company
is currently evaluating the impact of the adoption of this ASU on its consolidated financial statements.

 In
November 2024, the FASB issued ASU 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures
(Subtopic 220-40): Disaggregation of Income Statement Expenses. This ASU requires more detailed disclosures, on an annual and interim
basis, about specified categories of expenses (including employee compensation, depreciation, and amortization) included in certain expense
captions presented on the face of the income statement. This ASU is effective for fiscal years beginning after December 15, 2026, and
interim periods within fiscal years beginning after December 15, 2027. Early adoption is permitted. This ASU may be applied either prospectively
or retrospectively. The Company is currently evaluating the impact of the adoption of this ASU on its consolidated financial statements.

 F- 15

 3.
Reverse Recapitalization and Pre-Closing Financing

 As
described within the Reverse Recapitalization and Pre-Closing Financing section in Note 1, on August 29, 2024, the reverse recapitalization
between Pre-Merger Oruka and ARCA was consummated. The Merger was accounted for as a reverse recapitalization in accordance with U.S.
GAAP. At the effective time of the Merger, substantially all of the assets of ARCA consisted of cash and cash equivalents and other nominal
non-operating assets and liabilities. No goodwill or intangible assets were recognized.

 As
part of the recapitalization, the Company acquired the assets and liabilities listed below (in thousands):

 August
 29,

 2024

 Cash and cash equivalents

 $
 4,940

 Other current assets

 Accrued liabilities

 ( 54
)

 Net
 assets acquired

 $
 5,000

 4.
Fair Value Measurements

 The
following tables present the Company's fair value hierarchy for financial assets measured as of December 31, 2024 (in thousands):

 Level

 Level

 Level

 Total

 Cash equivalents

 Money market
 funds

 $
 6,350

 $
 —

 $
 —

 $
 6,350

 —

 19,660

 —

 19,660

 U.S. government agency

 —

 3,988

 —

 3,988

 Commercial
 papers

 —

 22,177

 —

 22,177

 Total
 cash equivalents

 6,350

 45,825

 —

 52,175

 Marketable securities

 Marketable securities,
 current

 —

 190,792

 —

 190,792

 U.S. government agency

 —

 12,966

 —

 12,966

 Commercial papers

 —

 34,811

 —

 34,811

 Corporate
 debt securities

 —

 75,504

 —

 75,504

 Total
 marketable securities, current

 —

 —

 Marketable securities,
 long-term

 —

 —

 U.S.
 government agency securities

 —

 4,462

 —

 4,462

 Total
 marketable securities, long-term

 —

 —

 Total cash equivalents
 and marketable securities

 $
 6,350

 $
 377,967

 $
 —

 $
 384,317

 There were no transfers in
or out of Level 3 during the period from February 6, 2024 (inception) to December 31, 2024.

 F- 16

 5.
Cash equivalents and marketable Securities

 Cash
equivalents and marketable securities, which are classified as available-for-sale, consisted of the following as of December 31, 2024
(in thousands):

 Amortized
 Cost

 Gross
 Unrealized Gains

 Gross
 Unrealized Losses

 Fair
 Value

 Cash equivalents

 Money market
 funds

 $
 6,350

 $
 —

 $
 —

 $
 6,350

 19,656

 —

 19,660

 U.S. government agency

 3,988

 —

 —

 3,988

 Commercial
 papers

 22,180

 —

 ( 3
)

 22,177

 Total
 cash equivalents

 52,174

 ( 3
)

 52,175

 Marketable securities

 Marketable securities,
 current

 190,748

 ( 11
)

 190,792

 U.S. government agency

 12,967

 ( 2
)

 12,966

 Commercial papers

 34,808

 —

 34,811

 Corporate
 debt securities

 75,537

 ( 40
)

 75,504

 Total
 marketable securities, current

 314,060

 ( 53
)

 Marketable securities,
 long-term

 13,639

 —

 ( 32
)

 U.S.
 government agency securities

 4,485

 —

 ( 23
)

 4,462

 Total
 marketable securities, long-term

 18,124

 —

 ( 55
)

 Total cash equivalents
 and marketable securities

 $
 384,358

 $

 $
 ( 111
)

 $
 384,317

 The
following table summarizes the available-for-sale securities in an unrealized loss position, aggregated by major security type and length
of time in a continuous unrealized loss position, for which an allowance for credit losses was not recorded as of December 31, 2024,
(in thousands):

 Less
 than 12 months

 months or longer

 Total

 Fair

 Value

 Losses

 Fair

 Value

 Losses

 Fair

 Value

 Losses

 Cash equivalents

 Commercial
 papers

 $

 18,199

 $

 ( 3

)

 $

 —

 $

 —

 $

 18,199

 $

 ( 3

)

 securities, current

 U.S.
 treasury securities

 49,904

 ( 11

)

 —

 —

 49,904

 ( 11

)

 U.S.
 government agency securities

 4,713

 ( 2

)

 —

 —

 4,713

 ( 2

)

 Corporate
 debt securities

 39,468

 ( 40

)

 —

 —

 39,468

 ( 40

)

 securities, long-term

 —

 —

 U.S.
 treasury securities

 ( 32

)

 —

 —

 ( 32

)

 U.S.
 government agency securities

 4,462

 ( 23

)

 —

 —

 4,462

 ( 23

)

 Total

 $

 130,353

 $

 ( 111

)

 $

 —

 $

 —

 $

 130,353

 $

 ( 111

)

 The
Company evaluated its securities for credit losses and considered the decline in market value to be primarily attributable to current
economic and market conditions and not to a credit loss or other factors. Additionally, the Company does not intend to sell the securities
in an unrealized loss position and it is not more likely than not that the Company will be required to sell the securities before recovery
of the unamortized cost basis, which may be at maturity. There were no material realized gains or realized losses on marketable securities
for the period presented. Given the Company's intent and ability to hold such securities until recovery, and the lack of significant
change in credit risk of these investments, the Company does not consider these marketable securities to be impaired as of December 31,
2024. As of December 31, 2024, the Company did not record an allowance for credit losses.

 F- 17

 The
following table summarizes the contractual maturities of the Company's marketable securities at estimated fair value (in thousands):

 31,

 2024

 Due in one year or less

 $

 Due in 1-2 years

 Total

 $
 332,142

 6.
Accrued Expenses and Other Current Liabilities

 Accrued
expenses and other current liabilities consisted of the following (in thousands):

 31,

 2024

 Accrued employee compensation and
 benefits

 $
 2,041

 Accrued professional and consulting

 Accrued research and
 development

 1,084

 Total

 $
 3,346

 7.
Note Payable with Related Party

 In
March 2024, Pre-Merger Oruka entered into a Series A Preferred Stock and Convertible Note Purchase Agreement (the "Purchase
Agreement") with Fairmount Healthcare Fund II, L.P. ("Fairmount"), whereby Pre-Merger Oruka issued a convertible
note (the "Convertible Note"), with an initial principal amount of $ 25.0 million that, at the time of issuance, could be
converted into Pre-Merger Oruka Series A Preferred Stock (or a series of preferred shares that is identical in respect to the
shares of preferred shares issued in its next equity financing) or shares of Pre-Merger Oruka Common Stock in exchange for aggregate
proceeds of $ 25.0 million. The Convertible Note accrued interest at a rate of 12.0 % per annum. At issuance, the Convertible Note
required all unpaid interest and principal to mature on December 31, 2025 (the "Maturity Date") and prepayment was not
permitted without prior written consent of Fairmount.

 The
Company assessed all terms and features of the Convertible Note in order to identify any potential embedded features that would require
bifurcation. As part of this analysis, the Company assessed the economic characteristics and risks of the embedded features. The Company
determined that the share settled redemption feature was clearly and closely related to the debt host and did not require separate accounting.
The Company determined that the conversion options of the Convertible Note were not clearly and closely associated with a debt host.
However, these features did not meet the definition of a derivative under ASC 815, Derivatives and Hedging, and as a result, did
not require separate accounting as a derivative liability.

 The
Company paid debt issuance costs of less than $ 0.1 million in relation to the Convertible Note. The debt issuance costs were reflected
as a reduction of the carrying value of Convertible Note on the consolidated balance sheet and were being amortized as interest expense
over the term of the Convertible Note using the effective interest method. For the period from February 6, 2024 (inception) to December
31, 2024, the Company recognized interest expenses related to the Convertible Note of $ 1.5 million, which includes non-cash interest
expense related to the amortization of debt issuance.

 F- 18

 Immediately
prior to the completion of the Merger (see Note 1), the Convertible Note was converted into shares of Pre-Merger Oruka Common Stock based
on the aggregate principal amount of $ 25.0 million, plus unpaid accrued interest of $ 1.5 million divided by the conversion price which
was determined based upon the Company's fully-diluted capitalization immediately prior to the Merger. At the effective time of
the Merger, the Pre-Merger Oruka Common Stock issued upon the conversion of the Convertible Note (including accrued interest) automatically
converted into 2,722,207 shares of Company Common Stock. As of December 31, 2024, the Convertible Note is not outstanding.

 8.
Convertible Preferred Stock and Stockholders' Equity

 Pre-Funded

 In
August 2024, pursuant to the Subscription Agreement and immediately prior to the Closing, certain new and current investors purchased
pre-funded warrants, which, at the effective time of the Merger, were exercisable for 5,522,207 shares of Company Common Stock at
a purchase price of approximately $ 9.70 per warrant. After the Merger, there are 5,522,207 pre-funded warrants outstanding and are exercisable
for 5,522,207 shares of the Company Common Stock at an exercise price of $ 0.01 per share.

 In
September 2024, in connection with the PIPE Financing, the Company issued and sold 680,000 pre-funded warrants, at a purchase price of
$ 22.999 per warrant, exercisable for 680,000 shares of Company Common Stock at an exercise price of $ 0.001 per share.

 The
pre-funded warrants were recorded as a component of stockholders' equity within additional paid-in-capital and have no expiration
date. As of December 31, 2024, none of the pre-funded warrants have been exercised and 6,202,207 pre-funded warrants remain outstanding.

 Employee

 In
July 2024, Pre-Merger Oruka entered into a Subscription Agreement that provided for, among other things, the issuance of warrants to
certain of Pre-Merger Oruka's employees and directors immediately prior to the closing of the Merger. During the period from February
6, 2024 (inception) to December 31, 2024, 3,054,358 employee warrants were issued at an exercise price of $ 7.80 per warrant. These warrants
vest over a period of four years. Per the terms of the Employee Warrant Agreement, the holders of the Company's warrants shall
not have any of the rights or privileges of a stockholder of the Company in respect of any shares purchasable upon the exercise of the
warrant or any portion thereof unless and until a certificate or certificates representing such shares have been issued or a book entry
representing such shares has been made and such shares have been deposited with the appropriate registered book-entry custodian. The
Company recognizes compensation cost related to warrants on a straight-line basis over the requisite service period, which is the period
in which the related services are received. As of December 31, 2024, none of the warrants have been exercised and 3,054,358 warrants
remain outstanding.

 Convertible
Preferred Stock

 In
March 2024, Pre-Merger Oruka issued and sold an aggregate of 20,000,000 shares of Pre-Merger Oruka Series A Preferred Stock
to Fairmount (see Note 15), at a purchase price of approximately $ 0.15 per share, for aggregate gross proceeds of $ 3.0 million.
Pre-Merger Oruka incurred less than $ 0.1 million of issuance costs in connection with this transaction. Upon the issuance of the
Pre-Merger Oruka Series A Preferred Stock, the Company assessed the embedded conversion and liquidation features of the securities
as described below and determined that such features did not require the Company to separately account for these features.

 In
August 2024, upon the closing of the Merger, the Company converted the Pre-Merger Oruka Series A Preferred Stock to 137,138 shares of
Company Series B Preferred Stock.

 In
September 2024, in connection with the PIPE Financing, the Company issued and sold an aggregate of 2,439 shares of the Company Series
A Preferred Stock at a purchase price of $ 23,000.00 per share. In November 2024, the 2,439 shares of the Company Series A Preferred
Stock were converted to 2,439,000 shares of Company Common Stock. As of December 31, 2024, there are no outstanding shares of Company
Series A Preferred Stock.

 F- 19

 As
of December 31, 2024, convertible preferred stock consisted of the following (in thousands, except share data):

 Preferred

 Stock

 Authorized

 Preferred

 Stock Issued

 and

 Carrying

 Value

 Stock

 Issuable

 Upon

 Conversion

 Series B convertible preferred
 stock

 251,504

 137,138

 2,931

 11,428,149

to the Certificate of Designation of Preferences, Rights and Limitations of the Series A Non-Voting Convertible Preferred Stock (the
"Series A Certificate of Designation") filed in connection with the PIPE Financing, holders of Company Series A Preferred
Stock were entitled to receive dividends on shares of Company Series A Preferred Stock equal to, on an as-if-converted-to-Company Common
Stock basis, and in the same form as, dividends actually paid on shares of Company Common Stock. Except as provided in the Series A Certificate
of Designation or as otherwise required by law, the Company Series A Preferred Stock did not have voting rights. The Company Series A
Preferred Stock shall rank on parity with the Company Common Stock and Company Series B Preferred Stock upon any liquidation, dissolution
or winding-up of the Company. Subject to the terms and limitations contained in the Series A Certificate of Designation, the Company
Series A Preferred Stock issued in the PIPE Financing will not become convertible until the Company's stockholders approve the
conversion of the Company Series A Preferred Stock into shares of Company Common Stock in accordance with the listing rules of the Nasdaq
Stock Market (the "Stockholder Approval"), which, on issuance, resulted in the Company Series A Preferred Stock being classified
outside of stockholders' equity on the Company's consolidated balance sheet. Following the Stockholder Approval in November
2024, each share of Company Series A Preferred Stock was automatically converted into 1,000 shares of Company Common Stock.

to the Certificate of Designation of Preferences, Rights and Limitations of the Series B Non-Voting Convertible Preferred Stock (the
"Series B Certificate of Designation") filed in connection with the Merger, holders of Company Series B Preferred Stock are
entitled to receive dividends on shares of Company Series B Preferred Stock equal to, on an as-if-converted-to-Company Common Stock basis,
and in the same form as, dividends actually paid on shares of Company Common Stock. Except as provided in the Series B Certificate of
Designation or as otherwise required by law, the Company Series B Preferred Stock does not have voting rights. The Company Series B Preferred
Stock shall rank on parity with the Company Common Stock as to the distribution of assets upon any liquidation, dissolution, or winding-up
of the Company. Each share of Company Series B Preferred Stock is convertible at the option of the holder, at any time, and without the
payment of additional consideration by the holder. As of December 31, 2024, each outstanding share of Company Series B Preferred Stock
was convertible into common stock at a ratio of approximately 83.3332:1.

 Paruka
Warrant

 On
December 31, 2024, the Company settled its 2024 obligations under the Paruka Warrant Obligation (defined below) by issuing Paruka a warrant
to purchase 596,930 shares of Company Common Stock at an exercise price of $ 19.39 per share. The warrant has a term of 10 years, is fully
vested, and is exercisable in part or full at any time during the term of the warrant. As of December 31, 2024, the warrant issued under
the Paruka Warrant Obligation is outstanding and unexercised. See Note 9 for additional information on the Paruka Warrant Obligation.

Stock

 As
of December 31, 2024, the Certificate of Incorporation provides for 545,000,000 authorized shares of Company Common Stock. As of December
31, 2024, 37,440,510 shares of Company Common Stock were issued and outstanding, including 2,207,553 shares of RSAs issued and outstanding.

 F- 20

 As
of December 31, 2024, the Company had common stock reserved for future issuance as follows:

 31,
 2024

 Shares issuable on conversion of
 Company Series B Preferred Stock

 11,428,149

 Shares issuable upon exercise of pre-funded warrants

 6,202,207

 Shares issuable upon exercise of warrant under
 the Paruka Warrant Obligation

 596,930

 Outstanding and issued stock options

 Outstanding and issued employee warrants

 Shares available for grant under 2024 Stock
 Incentive Plan

 4,246,324

 Shares available for
 grant under 2024 Employee Stock Purchase Plan

 460,529

 Total
 shares of common stock reserved

 27,556,257

 9.
Stock-Based Compensation

 2024
Equity Incentive Plan

 The
2024 Equity Incentive Plan ("2024 Plan") was adopted by the board of directors of Pre-Merger Oruka on February 6, 2024.
The 2024 Plan provided for Pre-Merger Oruka to grant stock options, restricted stock awards, restricted stock units, and other stock-based
awards to employees, officers, directors, consultants, and advisors. Equity Incentive Stock options granted under the 2024 Plan generally
vest over four years, subject to the participant's continued service, and expire after ten years, although two non-employee
stock options were granted with vesting terms less than four years. As of December 31, 2024, there are no shares of common
stock available for issuance.

 2024
Stock Incentive Plan

 On
August 22, 2024, the 2024 Stock Incentive Plan ("2024 Stock Plan") was approved by the Company's stockholders and on
August 29, 2024, the board of directors of the Company (the "Board") ratified the 2024 Stock Plan. The 2024 Stock Plan allows
for the grant of stock options, stock appreciation rights, restricted stock awards, restricted stock units, other stockholder-based awards
and incentive bonuses. The 2024 Stock Plan is administered by the Compensation Committee of the Board (the "Compensation Committee")
or another committee designated by the Board to administer the Plan. The initial share pool under the 2024 Stock Plan is 4,634,891 shares
of Company Common Stock. During the period from February 6, 2024 (inception) to December 31, 2024, 388,567 shares were subject to outstanding
stock options, and as of December 31, 2024, there were 4,246,324 shares available in the pool. The shares that may be issued under the
2024 Stock Plan will be automatically increased on January 1 of each year beginning in 2025 and ending with a final increase on January
1, 2034 in an amount equal to 5 % of the diluted stock (including Company Common Stock, preferred stock and unexercised pre-funded warrants)
on the preceding December 31, unless a lower, or no, increase is determined by the Compensation Committee. Current or prospective employees,
officers, non-employee directors, and other independent service providers of the Company and its subsidiaries are eligible to participate
in the 2024 Stock Plan.

 2024
Employee Stock Purchase Plan

 The
2024 Employee Stock Purchase Plan (the "ESPP") became effective on August 29, 2024, at which time 463,489 shares of Company
Common Stock were reserved for issuance. Eligible employees may purchase shares of Company Common Stock under the ESPP at 85 % of
the lower of the fair market value of the Company Common Stock as of the first or the last day of each offering period. Employees are
limited to contributing 15 % of the employee's eligible compensation and may not purchase more than $ 25,000 of stock during
any calendar year. The ESPP will terminate ten years from the first purchase date under the plan, unless terminated earlier
by the board of directors.

 The
shares that may be issued under the ESPP will be automatically increased on January 1 of each year beginning in 2025 and ending with
a final increase on January 1, 2034 in an amount equal to 1 % of the diluted stock (including Company Common Stock, preferred stock and
unexercised pre-funded warrants) on the preceding December 31, unless a lower, or no increase is determined by the Compensation Committee.
During the period from February 6, 2024 (inception) to December 31, 2024, 2,960 shares of Company Common Stock were issued out of the
ESPP and as of December 31, 2024, there were 460,529 shares of Company Common Stock available in the pool.

 For
the period February 6, 2024 (inception) to December 31, 2024, stock-based compensation expense related to the ESPP was less than $ 0.1
million.

 F- 21

 Stock
Option Valuation

 The
following table summarizes the weighted-average assumptions used in calculating the fair value of the awards for the period from February 6,
2024 (inception) to December 31, 2024:

 Period from
 2024
 2024

 Expected term (in years)

 6.1

 Expected volatility

 100.21
 %

 Risk-free interest rate

 4.26
 %

 Expected dividend yield

 —

 Stock
Options

 The
following table summarizes the stock option activities under the 2024 Plan and 2024 Stock Plan for the period of February 6, 2024
(inception) through December 31, 2024:

 Number of
 Stock
 Options

 Exercise
 Price Per
 Share

 Remaining
 Contractual
 Term
 (in Years)

 Aggregate
 Intrinsic
 Value
 (in Thousands)

 Balance as of February 6, 2024 (inception)

 —

 $
 —

 —

 $
 —

 Granted

 $
 11.39

 Exercised

 —

 $
 —

 Forfeited

 —

 $
 —

 Balance as of December 31, 2024

 $
 11.39

 9.4

 $
 15,470

 Vested and expected to vest, December 31, 2024

 $
 11.39

 9.4

 $
 15,470

 Exercisable, December 31, 2024

 —

 $
 —

 —

 $
 —

 The
weighted average grant-date fair value per share of stock options granted during the period from February 6, 2024 (inception) to
December 31, 2024 was $ 9.12 per share. Aggregate intrinsic value represents the difference between the estimated fair value of the underlying
Company Common Stock and the exercise price of outstanding, in-the-money employee stock options.

 Restricted
Stock Awards

 In
February 2024 and March 2024, the Company issued 2,207,553 shares of RSAs to certain employees, directors, and consultants at a
price of $ 0.0001 per share, the then par value of Pre-Merger Oruka Common Stock. Such RSAs have service-based vesting conditions only
and vest over a four-year period, during which time all unvested shares are subject to forfeiture in the event the holder's service
with the Company voluntarily or involuntarily terminates. As of December 31, 2024, none of the RSAs had vested. For the period February
6, 2024 (inception) to December 31, 2024, stock-based compensation expense related to RSAs was less than $ 0.1 million.

 F- 22

 The
following table summarizes the RSA activity for the period from February 6, 2024 (inception) through December 31, 2024:

 of

 RSAs

 Grant Date

 Fair Value

 Unvested balance as of February 6, 2024 (inception)

 —

 $
 —

 Granted

 2,207,553

 $
 —

 Unvested balance as of December 31, 2024

 2,207,553

 $
 —

Agreements and the Paruka Warrant Obligation

 As
part of the Option Agreements, on December 31, 2024 the Company granted and on December 31, 2025, will grant Paruka a warrant
to purchase a number of shares equal to 1.00 % of outstanding shares as of the date of the grant on a fully-diluted basis, with an exercise
price equal to the fair market value of the underlying shares on the grant date (the "Paruka Warrant Obligation").

 The
grant dates for the issuance of warrants were expected to be December 31, 2024 and December 31, 2025 as all terms of the award,
including number of shares and exercise price, will be known by all parties. The Company determined that the 2024 and 2025 grants are
two separate grants, as there would be no obligation for the 2025 grant had the Company exercised or terminated all of the options under
the Option Agreements prior to December 31, 2024. The service inception period for the grant precedes the grant date, with the full award
being vested as of the grant date with no post-grant date service requirement. Accordingly, the warrant expected to be granted to Paruka
was accounted for as a liability on the balance sheet on the service inception date and, after the initial recognition, the liability
is adjusted to fair value at the end of each reporting period, with changes in fair value recorded in the consolidated statement of operations
and comprehensive loss as stock-based compensation expenses under research and development expenses. Accordingly, the Company measured
the grant date fair value of the warrant granted on December 31, 2024 at $ 10.4 million. For the period from February 6, 2024 (inception)
to December 31, 2024, $ 10.4 million was recognized as stock-based compensation expense related to the Paruka Warrant Obligation in the
consolidated statement of operations and comprehensive loss. As of December 31, 2024, there was no unamortized expense related to the
December 31, 2024 Paruka Warrant Obligation. On issuance of the warrant to Paruka, the fair value of the warrant was reclassified from
liability to equity on the consolidated balance sheet as of December 31, 2024.

 Employee

 As stated above, on July
3, 2024, the Subscription Agreement was amended and restated, among other things, for employee warrants to be issued to certain Pre-Merger
Oruka employees and directors immediately prior to the closing of the Merger. Pursuant to this amendment, during the period from February
6, 2024 (inception) to December 31, 2024, the Company issued 3,054,358 warrants at an exercise price of $ 7.80 per warrant, which are accounted
as equity in the consolidated financial statements. The employee warrants were subject to performance and service based vesting requirements
and upon completion of the Merger the performance-based requirements had been achieved.

 The
following table summarizes the warrant activity for the period from February 6, 2024 (inception) through December 31, 2024:

 Number of

Employee

 Exercise
 Price Per
 Share

 Remaining
 Contractual
 Term
 (in Years)

 Aggregate
 Intrinsic
 Value
 (in Thousands)

 Balance as of February 6, 2024 (inception)

 —

 $
 —

 —

 $
 —

 Granted

 $
 7.80

 Exercised

 —

 $
 —

 Forfeited

 —

 $
 —

 Balance as of December 31, 2024

 $
 7.80

 9.5

 $
 35,400

 Vested and expected to vest, December 31, 2024

 $
 7.80

 9.5

 $
 35,400

 Exercisable, December 31, 2024

 —

 $
 —

 —

 $
 —

 The
weighted average grant-date fair value per share of warrants granted during the period from February 6, 2024 (inception) to December
31, 2024 was $ 6.27 per share. Aggregate intrinsic value represents the difference between the estimated fair value of the underlying
Company Common Stock and the exercise price of outstanding, in-the-money warrants.

 F- 23

 The
following table summarizes the weighted-average assumptions used in calculating the fair value of the warrants for the period from February 6,
2024 (inception) to December 31, 2024:

 Period from
 2024
 2024

 Expected term (in years)

 6.1

 Expected volatility

 99.02
 %

 Risk-free interest rate

 4.15
 %

 Expected dividend yield

 —

 Stock-Based
Compensation Expense

 The
following table summarizes the classification of the Company's stock-based compensation expense in the consolidated statement of
operations and comprehensive loss (in thousands):

 from

 2024

 2024

 Research and development

 $
 11,992

 General and administrative

 2,927

 Total

 $
 14,919

 As
of December 31, 2024, total unrecognized compensation cost related to the unvested stock options was $ 12.7 million, which is expected
to be recognized over a weighted average period of approximately 3.2 years. As of December 31, 2024, total unrecognized compensation
cost related to the unvested RSAs was less than $ 0.1 million, which is expected to be recognized over a weighted average period of 3.1
years. As of December 31, 2024, the unrecognized compensation cost related to the employee warrants was $ 16.3 million, which is expected
to be recognized over a weighted average period of 3.3 years.

 The
following table summarizes the award types of the Company's stock-based compensation expense in the consolidated statement of operations
and comprehensive loss (in thousands):

 from

 2024

 2024

 Paruka Warrant Obligation

 $
 10,357

 Employee warrants

 2,899

 Stock options

 1,626

 Employee stock purchase
 plan

 Total

 $
 14,919

 F- 24

 10.
Segment disclosures

 The
Company operates and manages its business activities on a consolidated basis and operates in one reportable segment.

 The Company operates as a single reportable and operating segment.
Its Chief Executive Officer, serving as the Chief Operating Decision Maker ("CODM"), oversees operations on an aggregated
basis to allocate resources effectively. In assessing the Company's financial performance, the CODM regularly reviews total operating
expenses and consolidated net loss.

 The
measure of segment assets is reported on the balance sheet as total consolidated assets. The Company's long-lived assets consist
primarily of property and equipment, net. As of December 31, 2024 all of long-lived assets were in the U.S.

 The
table below is a summary of the segment loss from operations, including significant segment expenses (in thousands):

 from

 2024

 (Inception) to December 31,
 2024

 Research and development personnel-related
 (excluding stock-based compensation)

 $
 3,959

 General and administrative personnel-related
 (excluding stock-based compensation)

 5,054

 Research and development stock-based compensation

 11,992

 General and administrative stock-based compensation

 2,927

 External research and development

 57,680

 Other research and development

 1,429

 General and administrative,
 excluding personnel-related and stock-based compensation

 5,082

 Total
 operating expenses

 88,123

 Loss
 from operations

 $
 ( 88,123
)

 11.
Income Taxes

 No
provision for income taxes was recorded for the period from February 6, 2024 (inception) to December 31, 2024.

 The
following table summarizes the loss before income tax expense by jurisdiction for the periods indicated:

 from

 2024

 2024

 Domestic

 $
)

 Foreign

 —

 Loss
 before income tax expense

 $
)

 For the period from February
6, 2024 (inception) to December 31, 2024, the Company recognized no provision or benefit from income taxes. The difference
between the Company's provision for income taxes and the amounts computed by applying the statutory federal income tax rate to income
before income taxes is as follows:

 Period from
 2024
 2024

 Tax benefit derived by applying the federal statutory rate to income before income taxes

 ( 21.00
)%

 Permanent differences

 ( 0.18
)

 Research and development credits

 ( 3.41
)

 Other

 ( 0.87
)

 Change in the valuation allowance

 25.46

 Income tax (benefit) expense

 0.00
 %

 F- 25

 The
components of the deferred tax assets and liabilities consist of the following (in thousands):

 2024

 Deferred tax assets

 Net operating loss carryforwards

 $
 2,260

 Research and development credits

 3,080

 Stock-based compensation

 3,063

 Accruals and other

 Lease liability

 Intangibles

 1,477

 Capitalized R&D expenses

 10,994

 Total deferred tax assets

 21,501

 Deferred tax liabilities

 Right- of- use asset

 ( 184
)

 Total deferred tax liabilities

 ( 184
)

 Less valuation allowance

 ( 21,317
)

 Deferred tax assets, net

 $
 —

 T he Company has established
a full federal and state valuation allowance equal to the net deferred tax assets due to uncertainties regarding the realization of the
deferred tax asset based on the Company's lack of earnings history. The valuation allowance increased by $ 21.3 million primarily
due to continuing loss from operations.

 2024

 Beginning balance as of February 6, 2024

 $
 —

 Change in valuation allowance

 21,317

 Ending balance as of December 31, 2024

 $
 21,317

 As
of December 31, 2024, the Company had U.S. net operating loss carryforwards ("NOL") of $ 10.8 million. The federal
NOL carryforwards do not expire and can be utilized to offset up to 80 % of the taxable income in any tax year. For the period from February
6, 2024 (inception) to December 31, 2024 the Company had federal tax credit carryforwards and state tax credit carryforwards of
$ 3.8 million and $ 0.4 million, respectively. The federal credits will expire starting in 2044 if not utilized, and the state
research credit can be carried forward indefinitely.

 The
Tax Reform Act of 1986 limits the use of net operating loss carryforwards in certain situations where changes occur in the stock ownership
of a company. The annual limitation may result in the expiration of net operating losses and credits before utilization. The Company
has not performed a Section 382 analysis through December 31, 2024. To the extent that an assessment is completed in the future, the
Company's ability to utilize tax attributes could be restricted on a year-by-year basis and certain attributes could expire before
they are utilized. The Company will examine the impact of any potential ownership changes in the future.

 A
reconciliation of the beginning and ending amount of gross unrecognized tax benefits is as follows (in thousands):

 from

 2024

 2024

 Beginning balance as of February 6, 2024

 $
 —

 related to tax positions taken in the current year

 1,047

 Ending balance
 as of December 31, 2024

 $
 1,047

 F- 26

 The
Company includes penalties and interest expense related to income taxes as a component of income tax expense, as necessary. As of December
31, 2024, the Company had no accrued interest or penalties related to uncertain tax positions.

 The
Company will be filing initial year income tax returns in the United States federal jurisdiction and state jurisdictions. Due to net
operating loss carryforwards, the statute of limitations will remain open for income tax examination.

 12.
Option Agreements and License Agreements

 In
March 2024, the Company entered into two antibody discovery and option agreements ("Option Agreements") with Paragon
and Paruka. Under the terms of each agreement, Paragon identifies, evaluates, and develops antibodies directed against certain mutually
agreed therapeutic targets of interest to the Company. From time to time, the Company can choose to add additional targets to the collaboration
upon agreement with Paragon and Paruka. Under the Option Agreements, the Company has the exclusive option to, on a research program-by-research
program basis, be granted an exclusive, worldwide license to all of Paragon's right, title, and interest in and to the intellectual
property resulting from the applicable research program to develop, manufacture, and commercialize the antibodies and products directed
to the selected target(s) (each, an "Option"). The Company has initiated certain research programs with Paragon that
generally focus on discovering, generating, identifying and/or characterizing antibodies directed to a particular target (each, a "Research
Program"), including for IL-23 and IL-17A/F for ORKA-001 and ORKA-002, respectively. The exclusive option with respect to each
Research Program is exercisable at the Company's sole discretion at such time as specified in the Option Agreements (the "Option
Period"). There is no payment due upon exercise of an Option pursuant to the Option Agreements. For each of these agreements, once
the Company enters into the corresponding license agreements, it will be required to make non-refundable milestone payments to Paragon
of up to $ 12.0 million under each respective agreement upon the achievement of certain clinical development milestones, up to $ 10.0 million
under each respective agreement upon the achievement of certain regulatory milestones, as well as a low single-digit percentage royalty
for antibody products beginning on the first commercial sale in each program.

 The
Company may terminate any Option Agreement or any Research Program at any time for any or no reason upon 30 days' prior written
notice to Paragon, provided that it must pay certain unpaid fees due to Paragon upon such termination, as well as any non-cancellable
obligations reasonably incurred by Paragon in connection with its activities under any terminated Research Program. Paragon may terminate
any Option Agreement or a Research Program immediately upon written notice to the Company if, as a result of any action or failure to
act by the Company or its affiliates, such Research Program or all material activities under the applicable Research Plan are suspended,
discontinued or otherwise delayed for a certain consecutive number of months. Each party has the right to terminate the Option Agreements
or any Research Program upon material breach that remains uncured or the other party's bankruptcy.

Therapeutics – License Agreements

 In
September 2024, the Company exercised the Option to acquire certain rights to ORKA-001, and in December 2024, it entered into the corresponding
license agreement with Paragon (the "ORKA-001 License Agreement"), pursuant to which Paragon granted the Company a royalty-bearing,
world-wide, exclusive license to develop, manufacture, commercialize or otherwise exploit certain antibodies and products targeting IL-23
in all fields other than the field of inflammatory bowel disease ("ORKA-001 Field"). In December 2024, the Company exercised
the Option with respect to ORKA-002 for the IL-17A/F program, and in February 2025, it entered into the corresponding license agreement
with Paragon (the "ORKA-002 License Agreement" and together with the ORKA-001 License Agreement, the "License Agreements"),
pursuant to which Paragon granted the Company a royalty-bearing, world-wide, exclusive license to develop, manufacture, commercialize
or otherwise exploit certain antibodies and products targeting IL-17A/F in all fields ("ORKA-002 Field" and together with
the ORKA-001 Field, the "Fields").

 The
License Agreements provide the Company with exclusive licenses in the Fields to Paragon's patent applications covering the related
antibodies, their method of use and their method of manufacture and Paragon has agreed not to conduct any new campaigns that generate
anti-IL-23 monospecific antibodies or anti-IL-17A/F monospecific antibodies for the ORKA-001 Field or the ORKA-002 Field, respectively,
for at least five years. Each of the ORKA-001 and ORKA-002 License Agreements may be terminated on 60 days' notice to Paragon,
on material breach without cure, and on a party's insolvency or bankruptcy to the extent permitted by law.

to the terms of each of the ORKA-001 and ORKA-002 License Agreements, the Company is obligated to pay Paragon non-refundable milestone
payments of up to $ 12.0 million under each respective agreement upon the achievement of certain clinical development milestones and up
to $ 10.0 million under each respective agreement upon the achievement of certain regulatory milestones, including a $ 1.5 million fee
for nomination of a development candidate (or initiation of an IND-enabling toxicology study) and a further milestone payment of $ 2.5
million upon the first dosing of a human patient in a Phase 1 trial for each of ORKA-001 and ORKA-002. In addition, the Company is obligated
to pay Paragon a low single-digit percentage royalty for antibody products for each of ORKA-001 and ORKA-002. For each of the License
Agreements, the royalty term ends on the later of (i) the last-to-expire licensed patent or our patent directed to the manufacture, use
or sale of a licensed antibody in the country at issue or (ii) 12 years from the date of first sale of a Company product. There is also
a royalty step-down if there is no Paragon patent in effect during the royalty term for each program.

 F- 27

 Additionally,
as part of the Option Agreements, on December 31, 2024 the Company granted and on December 31, 2025, will grant Paruka a warrant
to purchase a number of shares equal to 1.00 % of outstanding shares as of the date of the grant on a fully-diluted basis, with an exercise
price equal to the fair market value of the underlying shares on the grant date.

to the Option Agreements, on a research program-by-research program basis following the finalization of the research plan for each respective
research program, the Company was required to pay Paragon a one-time, nonrefundable research initiation fee of $ 0.8 million related
to the ORKA-001 program. This amount was recognized as a research and development expense during the period from February 6, 2024
(inception) to December 31, 2024. In June 2024, pursuant to the Option Agreements with Paragon, the Company completed the selection process
of its development candidate for IL-23 antibody for ORKA-001 program. The Company was responsible for 50 % of the development costs incurred
through the completion of the IL-23 selection process. The Company received the rights to at least one selected IL-23 antibody in June
2024. During the period from February 6, 2024 (inception) to December 31, 2024, the Company exercised its option for ORKA-001 and recorded
a $ 1.5 million milestone payment related to the achievement of development candidate as research and development expense in the Company's
consolidated statement of operations and comprehensive loss. In addition, during the period from February 6, 2024 (inception) to December
31, 2024, the Company recorded a $ 2.5 million milestone payment related to the first dosing of a human subject in a Phase 1 trial of
ORKA-001 in December 2024 as research and development expense in its consolidated statement of operations and comprehensive loss. The
Company's share of development costs incurred for the period from February 6, 2024 (inception) to December 31, 2024 was $ 13.5 million
(excluding research initiation fee and milestones), which were recorded as research and development expenses. An amount of $ 2.8 million
related to ORKA-001 is included in related party accounts payable and other current liabilities as of December 31, 2024.

 The
Company was also required to reimburse Paragon $ 3.3 million for development costs related to ORKA-002 incurred by Paragon through
December 31, 2023 and certain other development costs incurred by Paragon between January 1, 2024 and March 6, 2024 as
stipulated by the Option Agreements. This amount was recognized as a research and development expense during the period from February 6,
2024 (inception) to December 31, 2024. The Company is also responsible for the development costs incurred by Paragon from January 1,
2024 through the completion of the IL-17 selection process. The Company recognized an amount of $ 0.8 million payable to Paragon
for the research initiation fee related to ORKA-002 following the finalization of the ORKA-002 research plan. This was recognized as
research and development expenses in the period from February 6, 2024 (inception) to December 31, 2024. During the period from February
6, 2024 (inception) to December 31, 2024, the Company exercised its option for ORKA-002 and recorded a $ 1.5 million milestone payment
related to the achievement of development candidate as research and development expense in its consolidated statement of operations and
comprehensive loss. The Company accounted for development costs of $ 7.8 million (excluding research initiation fee, milestone, and reimbursements
of development costs through December 31, 2023) for the period from February 6, 2024 (inception) to December 31, 2024 as research and
development expenses. An amount of $ 2.7 million related to ORKA-002 is included in related party accounts payable and other current liabilities
as of December 31, 2024.

 The
Company expenses the service fees as the associated costs are incurred when the underlying services are rendered. Such amounts are classified
within research and development expenses in the accompanying consolidated statement of operations and comprehensive loss.

 The
Company concluded that the rights obtained under the Option Agreements represent an asset acquisition whereby the underlying assets comprise
in-process research and development assets with no alternative future use. The Option Agreements did not qualify as a business combination
because substantially all of the fair value of the assets acquired was concentrated in the exclusive license options, which represent
a group of similar identifiable assets. The research initiation fee represents a one-time cost on a research program-by-research program
basis for accessing research services or resources with benefits that are expected to be consumed in the near term, therefore the amounts
paid are expensed as part of research and development costs immediately. Amounts paid as reimbursements of ongoing development cost,
monthly development cost fee and additional development expenses incurred by Paragon due to work completed for selected targets prior
to the effective date of the Option Agreements that is associated with services being rendered under the related Research Programs are
recognized as research and development expense when incurred.

 For
the period from February 6, 2024 (inception) to December 31, 2024, the Company recognized $ 42.0 million
of expenses in connection with services provided by Paragon and Paruka under the Option Agreements.

 F- 28

 13.
Commitment and Contingencies

 Leases

 In
April 2024, the Company entered into an operating lease agreement for the Company's headquarters in Menlo Park, California, which
commenced on June 15, 2024 with an initial term of 39.5 months. The Company leases office space under this noncancelable operating lease
agreement. Lease liabilities are based on the net present value of the remaining lease payments over the remaining lease term. In determining
the present value of lease payments, the Company used its incremental borrowing rate when measuring operating lease liabilities as discount
rates were not implicit or readily determinable.

 As
of December 31, 2024, the Company had $ 0.9 million of operating lease right-of-use assets, operating lease liability, current of $ 0.2
million, and operating lease liability, noncurrent of $ 0.8 million on its consolidated balance sheet. As of December 31, 2024, the operating
lease arrangement had a remaining lease term of 33 months and a discount rate of 17.95 %. For the period from February 6, 2024 (inception)
to December 31, 2024, the Company recorded operating and variable lease expense of $ 0.3 million in general and administrative expenses
in its consolidated statement of operations and comprehensive loss.

 The
following table presents the Company's supplemental cash flow information related to leases (in thousands):

 from

 2024

 2024

 Cash paid for amounts included
 in the measurement of lease liabilities

 $

 The
following table summarizes a maturity analysis of the Company's operating lease liabilities showing the aggregate lease payments
as of December 31, 2024 (in thousands):

 Year
 ending December 31,

 2025

 $

 2026

 2027

 Total undiscounted lease
 payments

 1,243

 Less:
 imputed interest

 ( 275

)

 Total discounted lease
 payments

 Less:
 current portion of lease liability

 ( 213

)

 Non-current
 portion of lease liability

 $

 Cell
Line License Agreement

 In March 2024, the Company
entered into the Cell Line License Agreement (the "Cell Line License Agreement") with WuXi Biologics Ireland Limited ("WuXi
Biologics"). Under the Cell Line License Agreement, the Company received a non-exclusive, worldwide, sublicensable license to certain
of WuXi Biologics' know-how, cell line, biological materials (the "WuXi Biologics Licensed Technology") and media and
feeds to make, have made, use, sell and import certain therapeutic products produced through the use of the cell line licensed by WuXi
Biologics under the Cell Line License Agreement (the "WuXi Biologics Licensed Products"). Specifically, the WuXi Biologics
Licensed Technology is used in certain manufacturing activities in support of the ORKA-001 and ORKA-002 programs.

 In
consideration for the license, the Company agreed to pay WuXi Biologics a non-refundable license fee of $ 150,000, which was recognized
as a research and development expense during the period from February 6, 2024 (inception) to December 31, 2024. Additionally, to
the extent that the Company manufactures its commercial supplies of bulk drug product with a manufacturer other than WuXi Biologics or
its affiliates, the Company is required to make royalty payments to WuXi Biologics at a rate of less than one percent of net sales of
WuXi Biologics Licensed Products manufactured by the third-party manufacturer. Pursuant to an amendment to the Cell Line License Agreement
effective in November 2024, a provision was added that permits the royalties owed under the agreement to be bought out on a product-by-product basis
for a lump-sum payment.

 The
 Cell Line License Agreement will continue indefinitely unless terminated (i) by the Company
 upon six months' prior written notice and its payment of all undisputed amounts due
 to WuXi Biologics through the effective date of termination, (ii) by WuXi Biologics for a
 material breach by the Company that remains uncured for 60 days after written notice, (iii)
 by WuXi Biologics if the Company fails to make a payment and such failure continues for 30
 days after receiving notice of such failure, or (iv) by either party upon the other party's
 bankruptcy.

 F- 29

 14.
Net Loss per Share

 Basic
and diluted net loss per share attributable to stockholders were calculated as follows (in thousands, except share and per share data):

 from February 6, 2024

 December 31, 2024

 Loss

 Allocation

 Loss
 Per

 Share,

 Basic and

 Diluted

 Common Stock

 $
 ( 65,037
)

 16,789,362

 $
 ( 3.87
)

 Company Series A Preferred Stock (1)

 ( 1,918
)

 $
 ( 3,873.25
)

 Company Series B Preferred
 Stock (2)

 ( 16,769
)

 51,946

 $
 ( 322.81
)

 Net
 loss

 $
)

 (1)
 The weighted-average number of shares of as-converted Company Series A Preferred Stock used in the loss allocation was 495,191 for the period from February 6, 2024 (inception) to December 31, 2024.

 (2)
 The weighted-average number of shares of as-converted Company Series B Preferred Stock used in the loss allocation was 4,328,844 for the period from February 6, 2024 (inception) to December 31, 2024.

 For
the computation of basic net loss per share attributable to stockholders, the amount of weighted-average shares outstanding excludes
all shares of unvested restricted common stock as such shares are not considered outstanding for accounting purposes until vested. The
amount of weighted-average shares outstanding includes the pre-funded warrants as the exercise price is negligible and these warrants
are fully vested and exercisable.

 The
potential shares of common stock that were excluded from the computation of diluted net loss per share attributable to stockholders for
the periods presented because including them would have had an anti-dilutive effect were as follows:

 31,

 2024

 Outstanding employee warrants to
 purchase common stock

 Outstanding unvested restricted stock awards

 2,207,553

 Outstanding and issued common stock options

 Outstanding and issued
 warrant to Paruka

 596,930

 Total

 7,426,601

 15.
Related Party Transactions

and Paruka each beneficially own less than 5% of the Company's capital stock through their respective holdings of Company Common
Stock.

 Fairmount
beneficially owns more than 5% of the Company's capital, currently has one representative appointed to the Board, and beneficially
owns more than 5% of Paragon. Fairmount appointed Paragon's board of directors and has the contractual right to approve the appointment
of any executive officers of Paragon.

 The
following is a summary of related party accounts payable and other current liabilities (in thousands):

 31,

 2024

 Paragon reimbursable Option Agreements'
 fees

 $
 1,482

 Paragon milestone payments for Option Agreement

 4,000

 Paragon reimbursable other research expenses

 Paragon reimbursable
 patent expenses

 Total

 $
 6,022

 16.
Subsequent Events

 In
February 2025, the Company entered into a lease agreement for an office space located in Waltham, Massachusetts. The lease is for an
initial period of 54 months. The Company expects to pay approximately $ 1.6 million over the lease term.

 F- 30

 Item
9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure.

 None.

 Item
9A. Controls and Procedures.

 Management's
Evaluation of Disclosure Controls and Procedures

 Our
management, with the participation of our Principal Executive Officer and our Principal Financial Officer, evaluated the effectiveness
of our disclosure controls and procedures as of December 31, 2024. Based on the foregoing evaluation, our Principal Executive Officer
and Principal Financial Officer concluded that our disclosure controls and procedures were effective at a reasonable assurance level
as of December 31, 2024. The term "disclosure controls and procedures," as defined in Rules 13a-15(e) and 15d-15(e) under
the Exchange Act means controls and other procedures of a company that are designed to ensure that information required to be disclosed
by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the
time periods specified in the SEC's rules and forms. Disclosure controls and procedures include, without limitation, controls and
procedures designed to ensure that information required to be disclosed by us in the reports we file or submit under the Exchange Act
is accumulated and communicated to our management, including our Principal Executive Officer and Principal Financial Officer, or persons
performing similar functions, as appropriate to allow timely decisions regarding required disclosure.

 Management
recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving
their objectives, and our management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls
and procedures.

 Management's
Report on Internal Control over Financial Reporting

 Our
management is responsible for establishing and maintaining adequate internal control over financial reporting. Internal control over
financial reporting is defined in Rules 13a-15(f) and 15d-15(f) promulgated under the Exchange Act as a process designed by, or under
the supervision of, our principal executive and principal financial officers and effected by our board of directors, management and other
personnel to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with U.S. GAAP. Our internal control over financial reporting includes those policies and procedures
that:

 pertain
 to the maintenance of records that, in reasonable detail, accurately and fairly reflect our
 transactions and dispositions of our assets;

 provide
 reasonable assurance that transactions are recorded as necessary to permit preparation of
 financial statements in accordance with U.S. GAAP, and that our receipts and expenditures
 are being made only in accordance with authorizations of our management and directors; and

 provide
 reasonable assurance regarding prevention or timely detection of unauthorized acquisition,
 use or disposition of our assets that could have a material effect on our financial statements.

 Because
of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of
any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions,
or that the degree of compliance with the policies or procedures may deteriorate.

 Our
management, with the participation of our principal executive officer and principal financial officer, assessed the effectiveness of
our internal control over financial reporting as of December 31, 2024. In making this assessment, management used the criteria set forth
by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) in its 2013 Internal Control – Integrated Framework.
Based on our assessment, our management has concluded that, as of December 31, 2024, our internal control over financial reporting was
effective based on those criteria.

 This
Annual Report on Form 10-K does not include an attestation report of our independent registered public accounting firm regarding internal
control over financial reporting. For as long as we remain a "smaller reporting company" as defined by Rule 12b-2 of the
Exchange Act and report less than $100 million of annual revenues in our most recent fiscal year, we intend to take advantage of the
exemption permitting us not to comply with the requirement that our independent registered public accounting firm provide an attestation
on the effectiveness of our internal control over financial reporting.

in Internal Control over Financial Reporting

 There
were no changes in our internal control over financial reporting during the quarter ended December 31, 2024 that have materially affected,
or are reasonably likely to materially affect, our internal control over financial reporting.

 Item
9B. Other Information.

 During
the quarter ended December 31, 2024, no director or Section 16 officer (as defined in Section 16 of the Securities Exchange Act of 1934,
as amended) adopted or terminated any Rule 10b5-1 trading arrangements or non-Rule 10b5-1 trading arrangements (in each case, as defined
in Item 408(a) of Regulation S-K).

 Item
9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.

 Not
applicable.

 PART
III

 Item
10. Directors, Executive Officers and Corporate Governance.

 Executive
Officers and Directors

 The following table sets
forth the names, ages as of March 6, 2025, and positions of the individuals who currently serve as executive officers and directors of
the Company.

 Name

 Age

 Position

 Executive
 Officers and Employee Director

 Klein, Ph. D.

 President,
 Chief Executive Officer and Director

 Arjun
 Agarwal

 Senior
 Vice President, Finance and Treasurer

 Joana
 Goncalves, MBChB

 Chief
 Medical Officer

 Paul
 Quinlan

 Counsel and Corporate Secretary

 Non-Employee
 Directors

 Samarth
 Kulkarni, Ph. D. (2)(3)

 Chair
 and Director

 Kristine
 Ball (1)(3)

 Carl
 Dambkowski, M.D. (1)

 Peter
 Harwin (2)(3)

 Cameron
 Turtle, D.Phil. (1)(2)

 (1)
 Member
 of the Audit Committee.

 (2)
 Member
 of the Compensation Committee.

 (3)
 Member
 of the Nominating and Governance Committee (the "Governance Committee").

 Our
business affairs are managed under the direction of our Board, which currently consists of six members. Our Board is divided into three
classes, with members of each class holding office for staggered three-year terms. There are currently two Class I directors, who are
up for election at the 2025 Annual Meeting of Stockholders for a term expiring at the 2028 Annual Meeting of Stockholders; two Class
II directors, whose terms expire at the 2026 Annual Meeting of Stockholders; and two Class III directors, whose terms expire at the 2027
Annual Meeting of Stockholders. Each executive officer serves at the discretion of the of the Board and holds office until their successor
is duly appointed and qualified or until their earlier resignation or removal.

 Biographical
and other information regarding our executive officers and directors is set forth below. There are no family relationships among any
of our executive officers or directors.

 Executive
Officers and Employee Director

Klein, Ph. D. Dr. Klein has served as Chief Executive Officer and as a member of the board of directors of the Company since
the Merger Closing and of Pre-Merger Oruka from February 2024 through the Merger Closing. Prior to joining Pre-Merger Oruka, Dr. Klein
was a Partner at Versant Venture Management, LLC, a healthcare and biotechnology venture capital firm, from January 2023 to February 2024,
where he invested in and helped to grow early-stage biotechnology companies. Prior to Versant, Dr. Klein served in various
positions at CRISPR Therapeutics AG (Nasdaq: CRSP), a biopharmaceutical company, including Chief Operating Officer from January 2020
to October 2022, Chief Business Officer from January 2019 to January 2020, Senior Vice President, Business Development
and Strategy from November 2017 to December 2018 and as Vice President, Strategy from February 2016 to November 2017,
where he helped to initiate and execute on several transformative partnerships, establish the strategic direction of the company, oversee
important pipeline programs and led several functions, including program and portfolio management. Before joining CRISPR, Dr. Klein
was an Associate Partner at McKinsey & Company, a global management consulting firm, from October 2014 to February 2016.
Dr. Klein served as a member of the board of directors of Dyne Therapeutics, Inc. (Nasdaq: DYN) from September 2019 to May 2023
and of Jasper Therapeutics, Inc. (Nasdaq: JSPR) from September 2021 to June 2023. Dr. Klein received his B.S. in biochemistry
and physics from the University of Wisconsin-Madison and his Ph. D. in biophysics from Stanford University.

 We
believe Dr. Klein is qualified to serve as a member of the Board because of his business development, operational and senior management
experience in the biotechnology industry and his academic expertise and accomplishments.

 Joana
Goncalves, MBChB. Dr. Goncalves has served as the Chief Medical Officer of the Company since the Merger Closing and of Pre-Merger
Oruka from April 2024 through the Merger Closing. Prior to joining Pre-Merger Oruka, Dr. Goncalves served as Chief Medical
Officer of Cara Therapeutics, Inc. (Nasdaq: CARA), a biopharmaceutical company, from October 2018 to April 2024, where she
was responsible for representing Cara Therapeutics in interactions with regulatory agencies, the investor and scientific communities
and the board of directors, building multifunctional terms and developing the clinical development strategy in dermatological conditions.
Prior to Cara, Dr. Goncalves held various positions at Celgene Corporation, a pharmaceutical company, which was later acquired by
Bristol-Myers Squibb Company, from April 2014 to October 2018, where she most recently served as Vice President, Medical
Affairs for Dermatology and Neurology and was instrumental in planning and executing medical support activities for a number of programs,
including OTEZLA for psoriasis. Prior to Celgene, Dr. Goncalves served as Vice President, Medical Strategy and Scientific Affairs
at LEO Pharma Inc., the U.S. subsidiary of LEO Pharma A/S, a global healthcare company specializing in dermatology and critical
care, from February 2012 to April 2014. She began her pharmaceutical career at Novartis Pharmaceuticals, working on a range
of products across various therapeutic areas from 2001 to 2012. Dr. Goncalves received her MBChB from the University of Cape Town,
South Africa.

 Paul
Quinlan. Mr. Quinlan has served as General Counsel and Corporate Secretary of the Company since the Merger Closing and of
Pre-Merger Oruka since April 2024 through the Merger Closing. Prior to joining Pre-Merger Oruka, Mr. Quinlan served as General
Counsel, Chief Compliance Officer and Corporate Secretary of CymaBay Therapeutics, Inc., a biopharmaceutical company, from October 2020
to March 2024, where he was responsible for the general supervision of the company's legal affairs. From December 2017
to February 2020, he served as General Counsel and Corporate Secretary of CymaBay, where he was responsible for the general supervision
of the company's legal affairs. Prior to CymaBay, Mr. Quinlan served as General Counsel and Secretary, from 2010 to January 2018,
and Chief Legal Officer from 2016 to January 2018, of TerraVia Holdings, Inc., a biotechnology company, where he was responsible
for the general supervision of the company's legal affairs. Prior to joining TerraVia, Mr. Quinlan served as General Counsel
of Metabolex, Inc., a biopharmaceutical company, from 2005 to 2010. Prior to joining Metabolex, Mr. Quinlan held various positions
at Maxygen, Inc., a biopharmaceutical company, from 2000 to 2005. Prior to Maxygen, Mr. Quinlan practiced law at Cooley LLP and
Cravath, Swaine, & Moore LLP. Mr. Quinlan received a law degree from Columbia Law School and an M.Sc. in Medical Biophysics
from the University of Toronto.

 Arjun
Agarwal. Mr. Agarwal has served as the Senior Vice President of Finance of the Company since the Merger Closing and
of Pre-Merger Oruka from March 2024 through the Merger Closing, where he is responsible for overseeing the company's finance
and accounting functions. Prior to joining Pre-Merger Oruka, Mr. Agarwal served as VP of Finance at Jasper Therapeutics, Inc. (Nasdaq:
JSPR), a biotechnology company, from June 2021 to March 2024, including through multiple financings and the company's
successful transition to become a publicly traded entity. Before joining Jasper, Mr. Agarwal served as Vice President, Corporate
Controller at Protagonist Therapeutics, Inc. (Nasdaq: PTGX), a biotechnology company, from August 2019 to June 2021, where
he was responsible for overseeing the company's finance and accounting functions. Prior to joining Protagonist, Mr. Agarwal
served in various roles of increasing responsibility at McKesson Corporation (NYSE: MCK), an international healthcare services
company, from 2009 to 2019. Prior to McKesson, Mr. Agarwal worked at PricewaterhouseCoopers LLP, where he managed a portfolio of
audit clients. He is a graduate of Sydenham College of Commerce and Economics at Mumbai University, India. He is a Certified Public Accountant
(CPA) and a Chartered Accountant accredited by the Institute of Chartered Accountants of India.

 Non-Employee
Directors

 Samarth
Kulkarni, Ph. D. Dr. Kulkarni has served as Chair and a member of the board of directors of the Company since the Merger
Closing and as a member of the board of directors of Pre-Merger Oruka from February 2024 through the Merger Closing. Dr. Kulkarni
has served as the Chief Executive Officer of CRISPR Therapeutics AG (Nasdaq: CRSP), a biopharmaceutical company, since December 2017,
where he has also served as a member and chair of the board of directors since June 2018 and September 2023, respectively.
Previously, Dr. Kulkarni served as CRISPR's President and Chief Business Officer from May 2017 to November 2017
and as Chief Business Officer from August 2015. Prior to joining CRISPR, Dr. Kulkarni was at McKinsey & Company, a
global management consulting firm, from 2006 to 2015, with various titles, his most recent being Partner within the Pharmaceuticals and
Biotechnology practice. Dr. Kulkarni has also served as a member of the boards of directors of Black Diamond Therapeutics, Inc.
(Nasdaq: BDTX), Repare Therapeutics Inc. (Nasdaq: RPTX), and Centessa Pharmaceuticals plc (Nasdaq: CNTA). Dr. Kulkarni received
a Ph. D. in Bioengineering and Nanotechnology from the University of Washington and a B. Tech. from the Indian Institute of Technology.
Dr. Kulkarni has authored several publications in leading scientific and business journals.

 We
believe that Dr. Kulkarni is qualified to serve as a member of the Board because of his experience as a consultant and an executive in
the biopharmaceutical industry and his academic expertise and accomplishments.

 Kristine Ball.
Ms. Ball has served as a member of the board of directors of the Company since the Merger Closing and of Pre-Merger Oruka since May 2024
through the Merger Closing. Ms. Ball has served as President and Chief Executive Officer of Antiva Biosciences, Inc., a private biopharmaceutical
company, since April 2023. Prior to Antiva, Ms. Ball served as Chief Executive Officer of Soteria Biotherapeutics, Inc., a private
biotechnology company, from September 2020 to August 2022. Prior to joining Soteria, Ms. Ball served as Senior Vice President,
Corporate Strategy and Chief Financial Officer of Menlo Therapeutics, Inc., a Nasdaq-listed biopharmaceutical company, which later
became VYNE Therapeutics Inc. (Nasdaq: VYNE), from September 2017 to March 2020, where she was responsible for leading all non-R&D
functions, including strategic planning, corporate development, commercial, human resources, legal, finance and information technology.
Prior to joining Menlo, Ms. Ball served as Chief Financial Officer and Senior Vice President of Relypsa, Inc., a Nasdaq-listed pharmaceutical
company, which was later acquired by Galenica Group, from November 2012 to October 2016. Prior to Relypsa, Ms. Ball held various
other finance roles in the life sciences industry, including Senior Vice President of Finance & Administration and Chief Financial
Officer of KAI Pharmaceuticals, Inc., a biopharmaceutical company, and Vice President of Finance at Exelixis, Inc. (Nasdaq: EXEL), a biotechnology
company. Prior to that, Ms. Ball served as a senior manager in the life sciences audit practice of Ernst & Young LLP. Ms. Ball
has previously served on the boards of directors of Atreca, Inc. (Nasdaq: BCEL), a biopharmaceutical company, from 2020 to 2024, Soteria
from 2020 to 2022 and Forty Seven, Inc. (Nasdaq: FTSV), a Nasdaq-listed biotechnology company, which was acquired by Gilead Sciences,
Inc., from 2018 to 2020. Ms. Ball received a B.S. from Babson College.

 We
believe Ms. Ball is qualified to serve as a member of the Board because of her experience as an executive officer and director of life
sciences companies and her background in finance, corporate development and strategic planning.

 Carl
Dambkowski, M.D. Dr. Dambkowski has served as a member of the board of directors of the Company since the Merger Closing
and of Pre-Merger Oruka from February 2024 through the Merger Closing. Dr. Dambkowski has served as the Chief Medical Officer
of Apogee Therapeutics, Inc. (Nasdaq: APGE), a biotechnology company, since September 2022. Prior to joining Apogee, Dr. Dambkowski
served as a strategic and clinical leader for a variety of companies, including as Chief Medical Officer of QED Therapeutics, Inc., a
private biotechnology company, from July 2021 to September 2022; Chief Strategy Officer and EVP of Operations of Origin Biosciences,
Inc., a private bioecology company, from March 2018 to June 2021; and Chief Medical Officer of Navire Pharma, Inc., a private
biotechnology company, from January 2020 to September 2022, where he served as the clinical lead starting prior to IND for
BBP-398 through the out licensing of the compound to Bristol-Myers Squibb based on initial clinical data and for low-dose infigratinib
in achondroplasia through initial proof-of-concept data. He was part of the core team that brought TRUSELTIQ (infigratinib)
and NULIBRY (fosdenopterin) through regulatory review and FDA approval at QED Therapeutics and Origin Biosciences, respectively.
From July 2016 to March 2018, Dr. Dambkowski was an associate at McKinsey & Company, a global management consulting
firm, where he advised biotech and pharmaceutical companies across the world on a range of research and development activities. Dr. Dambkowski
co-founded Novonate, Inc., a private medical device company focused on building life-saving devices for neonates, in January 2015.
Dr. Dambkowski has coauthored numerous peer-reviewed publications and scientific abstracts and is a named inventor on multiple
published and granted patents. Dr. Dambkowski was trained as a physician at Stanford University, where he also received his M.D.
with a concentration in bioengineering. He also received a B.A. (with honors) from Stanford University and an M.A. from Columbia University.

 We
believe Dr. Dambkowski is qualified to serve as a member of the Board because of his significant experience and innovations in the biotechnology
industry and his academic expertise and accomplishments.

 Peter
Harwin. Mr. Harwin has served as a member of the board of directors of the Company since the Merger Closing and of Pre-Merger
Oruka from February 2024 through the Merger Closing. Mr. Harwin is a Managing Member at Fairmount Funds Management, a healthcare
investment firm he co-founded in April 2016. Prior to Fairmount Funds Management, Mr. Harwin was a member of the investment
team at Boxer Capital, LLC, an investment fund that was part of the Tavistock Group, based in San Diego. Mr. Harwin also serves
as chairman of the board of directors of Cogent Biosciences, Inc. (Nasdaq: COGT) and is a member of the board of directors of Apogee
Therapeutics, Inc. (Nasdaq: APGE), Viridian Therapeutics, Inc. (Nasdaq: VRDN) and Spyre Therapeutics, Inc. (formerly Aeglea BioTherapeutics,
Inc.) (Nasdaq: SYRE). Mr. Harwin received a B.B.A. from Emory University.

 We
believe Mr. Harwin is qualified to serve as a member of the Board because of his experience serving as a director of biotechnology companies
and as a manager of funds specializing in the area of life sciences.

 Cameron
Turtle, D.Phil. Dr. Turtle has served as a member of the board of directors of the Company since the Merger Closing and
of Pre-Merger Oruka from February 2024 through the Merger Closing. Dr. Turtle has served as Chief Executive Officer and a member
of the board of directors of Spyre Therapeutics, Inc. (formerly Aeglea BioTherapeutics, Inc.) (Nasdaq: SYRE), a biotechnology company,
since November 2023 and, before that, as Chief Operating Officer from June 2023 to November 2023. Prior to joining Spyre,
Dr. Turtle was an advisor to Spyre Therapeutics, Inc., a private biotechnology company, from May 2023 to June 2023. Previously,
he served as Venture Partner at Foresite Labs, a life sciences investment firm, from July 2022 to May 2023; Chief Strategy
Officer of BridgeBio Pharma (Nasdaq: BBIO), a biotechnology company, from January 2021 to April 2022; and Chief Business Officer
of Eidos Therapeutics (Nasdaq: EIDX), a biopharmaceutical company, from November 2018 to January 2021, where he led business
development, investor relations, and multiple operational functions as the company advanced an investigational medicine for a form of
heart failure. Prior to joining BridgeBio and Eidos, he was a consultant at McKinsey & Company, a global management consulting
firm, where he worked with pharmaceutical and medical device companies on topics including M&A, growth strategy, clinical trial strategy,
and sales force optimization. Dr. Turtle received his B.S. with honors in Bioengineering from the University of Washington and his
D.Phil. in Cardiovascular Medicine from the University of Oxford, St. John's College. He is the recipient of several awards, including
a Rhodes Scholarship, Goldwater Scholarship, Forbes 30 Under 30, San Francisco Business Times 40 Under 40, and the Biocom Life
Sciences Catalyst Award.

 We
believe Dr. Turtle is qualified to serve as a member of the Board because of his experience as a leader in building, financing, and shaping
biopharmaceutical organizations from preclinical development to late-stage clinical trials and commercialization.

 Code
of Business Conduct and Ethics

 We
have adopted a Code of Business Conduct and Ethics that establishes the standards of ethical conduct applicable to all our directors,
officers and employees, including our principal executive officer, principal financial officer and principal accounting officer, or persons
performing similar functions. It addresses, among other matters, compliance with laws and policies, conflicts of interest, corporate
opportunities, regulatory reporting, external communications, confidentiality requirements, insider trading, proper use of assets and
how to report compliance concerns. A copy of the code is available on our website located at  under
"Governance Documents." We intend to disclose any amendments to the code, or any waivers of its requirements, on our website
to the extent required by applicable rules. The Audit Committee is responsible for applying and interpreting the code in situations where
questions are presented to it. Information contained on, or that can be accessed through, the Company's website is not incorporated
by reference into this report, and you should not consider information on the Company's website to be part of this report.

 Insider
Trading Policy

 We
have adopted insider trading policies and procedures governing the purchase, sale and other transactions in Company securities by our
directors, officers and employees, and other covered persons, as well as the Company itself, that we believe are reasonably designed
to promote compliance with insider trading laws, rules and regulations, and Nasdaq Stock Market ("Nasdaq") listing rules,
as applicable.

 As
part of these policies and procedures, we prohibit any employee, director or other covered person from engaging in short sales, transactions
involving publicly traded options or other derivative securities based on the Company's securities, hedging transactions, margin
accounts, pledges, or other inherently speculative transactions with respect to the Company's securities at any time.

 Audit
Committee and Audit Committee Financial Expert

 We
have a separately designated standing Audit Committee. The members of our Audit Committee are Ms. Ball, Dr. Dambkowski, and Dr. Turtle,
each of whom qualifies as an "independent" director for audit committee purposes as defined under Nasdaq listing rules and
the rules and regulations established by the SEC. Ms. Ball chairs the Audit Committee and qualifies as an "audit committee financial
expert" as that term is defined under the rules and regulations established by the SEC, and all members of the Audit Committee
are financially literate under Nasdaq listing rules.

 Delinquent
Section 16(a) Reports

 Section
16(a) of the Exchange Act requires our directors, officers and persons who beneficially own more than 10% of a registered class of our
equity securities to file with the SEC initial reports of ownership and reports of changes in ownership of our common stock and other
equity securities. To our knowledge, based solely on our review of Forms 3, 4 and 5 filed with the SEC or written representations that
no Form 5 was required, during the year ended December 31, 2024, we believe that all of our directors, officers and persons who beneficially
own more than 10% of a registered class of our equity securities timely filed all reports required under Section 16(a) of the Exchange
Act.

 Stockholder
Proposals and Director Nominations for 2025 Annual Meeting of Stockholders

 We
will hold our 2025 Annual Meeting of Stockholders (the "Annual Meeting") on Monday, June 2, 2025.

to Rule 14a-8 of the Exchange Act, stockholders who wish to submit proposals for inclusion in the proxy statement for the Annual
Meeting must send such proposals to our Corporate Secretary at the address 855 Oak Grove Avenue, Suite 100, Menlo Park, CA 94025. Such
proposals must be received by us a reasonable time before we begin to print and mail our proxy materials and must comply with Rule 14a-8
of the Exchange Act. The submission of a stockholder proposal does not guarantee that it will be included in the proxy statement.

 On August 29, 2024, in connection
with the Merger Closing, the Board adopted an amendment and restatement of our Bylaws, effective as of such date, as described in our
Current Report on Form 8-K filed on September 5, 2024. As set forth in our Bylaws, if a stockholder intends to make a nomination for director
election or present a proposal for other business (other than pursuant to Rule 14a-8 of the Exchange Act) at the Annual Meeting,
the stockholder's notice must be received by our Corporate Secretary at the address 855 Oak Grove Avenue, Suite 100, Menlo Park,
CA 94025 no earlier than the 120th day and no later than the close of business on the 90th day before the anniversary of the last
annual meeting; provided, however, that if the date of the annual meeting is more than 30 days before or more than 60 days after such
anniversary date, the stockholder's notice must be delivered not earlier than the close of business on the 120th day prior to such
annual meeting and not later than the close of business on the later of the 90th day prior to such annual meeting or the 10th day following
the date on which the first public announcement of the date of such annual meeting is made by the Company. Therefore, notice of proposed
nominations or proposals (other than pursuant to Rule 14a-8 of the Exchange Act) must be received by our Corporate Secretary
no later than the close of business on March 16, 2025. Any such director nomination or stockholder proposal must be a proper matter for
stockholder action and must comply with the terms and conditions set forth in our Bylaws (which includes the timing and information required
under Rule 14a-19 of the Exchange Act). If a stockholder fails to meet these deadlines or fails to satisfy the requirements of Rule
14a-4 of the Exchange Act, we may exercise discretionary voting authority under proxies we solicit to vote on any such proposal as we
determine appropriate. We reserve the right to reject, rule out of order or take other appropriate action with respect to any nomination
or proposal that does not comply with these and other applicable requirements.

 Item
11. Executive Compensation.

 This
section provides information regarding the compensation of our principal executive officer (Dr. Klein), and our two other highest
paid executive officers who were serving as executive officers on December 31, 2024 (Dr. Goncalves and Mr. Quinlan). This section
also includes compensation information for certain former executives of the Company (then known as ARCA). The individuals listed below
are collectively referred to herein as the "NEOs" or "Named Executive Officers."

 Name

 Title

 Klein, Ph. D.

 Chief Executive Officer (1)

 Joana Goncalves,
 MBChB

 Chief Medical Officer (1)

 Paul Quinlan

 General Counsel and
 Corporate Secretary (1)

 Michael Bristow,
 M.D.

 Former President
 and Chief Executive Officer (2)

 Thomas A. Keuer

 Former President
 and Chief Operating Officer (3)

 C. Jeffrey Dekker

 Former Chief Financial
 Officer (3)

 (1)
 Drs.
 Klein and Goncalves and Mr. Quinlan were appointed to these positions in connection with
 the consummation of the Merger. Prior to the Merger, they each served in these positions
 at Pre-Merger Oruka.

 (2)
 Dr.
 Bristow's employment with the Company terminated on April 3, 2024. Following his termination,
 Dr. Bristow provided transition services as a consultant.

 (3)
 Mr.
 Keuer's and Mr. Dekker's employment with the Company terminated in connection
 with the Merger. Following the Merger, Mr. Dekker provided transition services as a consultant.

 A
Year of Transition

 2024
was a year of transition for the Company as we completed the Merger, shifted our drug candidate pipeline to focus on novel biologics
designed to set a new standard for the treatment of chronic skin diseases and transformed our management team. Our mission is to offer
patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high
rates of complete disease clearance with dosing as infrequently as once or twice per year. The compensation described below reflects
both compensatory decisions necessary to engage a new leadership team that is critical to lead the advancement of the Company's
pipeline of novel biologics and improve the standard of care for the treatment of chronic skin diseases and compensatory decisions made
by ARCA prior to the consummation of the Merger with respect to the former executive officers.

 2024
Summary Compensation Table

 The
following table shows information regarding the compensation earned by the NEOs during the fiscal years ending December 31, 2024
and 2023, by our named executive officers.

 Name
 and Principal Position (1)

 Year

 Salary

 ($) (2)

 Bonus

 ($) (3)

 Awards
 ($) (4)

 Non-Equity

 Incentive Plan
 ($) (5)

 All
 Other
 ($)

 Total

 ($)

 Klein, Ph. D.

 2024

 203,288

 —

 —

 317,623

 —

 520,911

 Chief
 Executive Officer

 Joana
 Goncalves, MBChB

 2024

 155,854

 —

 —

 162,132

 —

 317,986

 Chief
 Medical Officer

 Paul
 Quinlan

 2024

 155,854

 —

 —

 154,591

 —

 310,445

 Counsel

 Michael
 Bristow, M.D.

 2024

 96,865

 —

 39,676

 —

 373,875
 (6)

 510,416

 Former
 President and Chief Executive Officer

 2023

 345,000

 —

 —

 —

 13,800

 358,800

 Thomas
 A. Keuer

 2024

 235,385

 165,000

 22,484

 —

 430,651
 (7)

 853,520

 Former
 President and Chief Operating Officer

 2023

 340,000

 —

 —

 —

 60,802

 400,802

 C.
 Jeffrey Dekker

 2024

 206,923

 165,000

 24,947

 —

 359,734
 (8)

 756,604

 Former
 Chief Financial Officer

 2023

 270,000

 —

 —

 —

 53,072

 323,072

 (1)
 The
 amounts reflected herein for Drs. Klein and Goncalves and Mr. Quinlan do not include any
 compensation they received from Pre-Merger Oruka prior to the Merger.

 (2)
 $157,595 of consulting fees for Dr. Bristow and $20,000 of consulting fees for Mr. Keuer,
 in each case, pursuant to their respective consulting agreements as described in more detail
 under " Narrative Disclosure to Summary Compensation Table—ARCA Arrangements "
 below.

 (3)
 Amounts
 reported in this column represent retention bonuses, as described in more detail under " Narrative
 Disclosure to Summary Compensation Table—ARCA Arrangements " below.

 (4)
 Amounts
 reported in this column represent the incremental fair value under Accounting Standards Codification
 Topic 718 ("ASC 718") resulting from the acceleration of the Named Executive
 Officer's stock options in the Merger, as described in more detail under "Narrative
 to Summary Compensation Table—ARCA Arrangements" below.

 (5)
 Amounts
 reported in this column represent the annual bonuses earned under the 2024 annual bonus program,
 as described in more detail under " Narrative to Summary Compensation Table—Elements
 of Compensation—Annual Bonus Program " below.

 (6)
 $3,875 of Company contributions under the ARCA 401(k) plan and $370,000 of severance payments
 and benefits, as described in more detail under " Narrative Disclosure to Summary
 Compensation Table—ARCA Arrangements " below.

 (7)
 $16,800 of Company contributions under the ARCA 401(k) plan, $340,000 of severance payments
 and $69,715 in COBRA continuation premiums, as described in more detail under " Narrative
 Disclosure to Summary Compensation Table—ARCA Arrangements " below, and $4,136
 for group term life insurance premiums.

 (8)
 $14,687 of Company contributions under the ARCA 401(k) plan, $270,000 of severance payments
 and $69,715 in COBRA continuation premiums, as described in more detail under " Narrative
 Disclosure to Summary Compensation Table—ARCA Arrangements " below, $2,692
 for group term life insurance premiums and $2,640 for healthcare reimbursements.

 Narrative
Disclosure to Summary Compensation Table

 In
December 2024, our Compensation Committee adopted a compensation philosophy to frame future compensation decisions for the Company. Under
this philosophy, compensation positioning is used to attract and retain key employees for the Company's continued success and growth.
While market data is helpful to the Compensation Committee in setting compensation framework and guiding decisions, other factors such
as Company strategy, stockholder feedback, tenure, performance and criticality are also considered. The compensation philosophy serves
as the foundation to reinforce the Company's business strategy and desired culture, while balancing internal and external alignment.

 Peer
Group

 In
July 2024, Pre-Merger Oruka, in consultation with Alpine, the Compensation Committee's independent compensation consultant, established
a peer group that focuses on U.S.-based, pre-clinical or early clinical biopharma companies (with priority placed on companies with a
similar therapeutic focus) with a market capitalization ranging from $250 million to $2 billion and less than 100 employees. The peer
group, which was used in making compensation decisions in connection with establishing post-Merger executive compensation for 2024, includes
the following companies (the "Peer Group"):

 Apogee

 Astria

 Cabaletta
 Bio

 CARGO

 Celldex

 Contineum

 Entrada

 Janux

 Kymera

 Kyverna

 Lexeo

 Longboard
 Pharmaceuticals

 Lyell
 Immunopharma

 Pliant

 Prime
 Medicine

 Spyre

 Structure

 Third
 Harmonic Bio

 Elements
of Compensation

 Base
Salaries

 Our
Compensation Committee recognizes the importance of base salary as an element of compensation to provide our executive officers with
steady cash flow during the year that is not contingent on short-term variations in our corporate performance. The setting of base salaries
also includes an evaluation of each individual's job duties, responsibilities, performance and experience, as well as internal
pay equity among the executive officer team. The Compensation Committee reviews base salaries at least annually and may recommend adjustment
from time to time based on the results of that review. The Compensation Committee determines salary increases using a combination of
relevant competitive market data, scope of responsibilities and assessment of individual performance.

 For
2024, the annual base salaries of Drs. Klein and Goncalves and Mr. Quinlan were established in connection with the consummation of their
employment with Pre-Merger Oruka as a result of negotiations in the context of a competitive recruitment process. The annual base salaries
as of December 31, 2024 for each of our continuing NEOs were as follows: $600,000 for Dr. Klein and $460,000 for each of Dr. Goncalves
and Mr. Quinlan.

 Annual
Bonus Program

 We
have an annual cash incentive plan under which cash incentives may be paid to each of our employees, including our executive officers,
after the end of each calendar year. The Compensation Committee generally determines target bonuses based on Peer Group practices and
each individual's job duties. For 2024, the target bonuses for each NEO (excluding the former ARCA executive officers), which were
established by Pre-Merger Oruka in connection with the consummation of their employment with Pre-Merger Oruka, were as follows: 50% of
base salary for Dr. Klein and 40% of base salary for each of Dr. Goncalves and Mr. Quinlan, in each case, pro-rated based on their respective
start dates with Pre-Merger Oruka.

Oruka established the corporate goals and targets for the 2024 bonus program, which were heavily weighted towards the preclinical development
of ORKA-001 and ORKA-002, progress towards the commencement of their respective Phase 1 clinical studies and regulatory progress. In
addition, the corporate goals included measures designed to ensure adequate funding for the Company.

 The
Board, upon the recommendation of the Compensation Committee, reviewed our achievement against our 2024 corporate goals and determined
the achievement to have been 125% of target, based on the achievement of substantially all the goals, with overperformance on several
of the goals.

 Based
on our corporate performance, the 2024 annual bonuses awarded to our continuing NEOs were as follows: $317,623 for Dr. Klein, $162,132
for Dr. Goncalves and $154,591 for Mr. Quinlan.

 Long-Term
Incentives

 We
intend our equity incentive program to reward longer-term performance and to align the interests of our executive officers with those
of our stockholders. We also believe that our equity incentive program, which currently consists predominantly of time-based stock options
(or, for certain grants by Pre-Merger Oruka, time-based compensatory warrants), is an important retention tool for our employees, including
our NEOs. The Compensation Committee believes that stock options, which require increased stock price performance for value realization,
create a key connection between the interests of the NEOs and stockholders. Each of the grants described below are presented after giving
effect to the share conversion completed in the Merger and the subsequent 1-for-12 reverse stock split.

 In
connection with his appointment as Chief Executive Officer of Pre-Merger Oruka, Dr. Klein purchased 852,338 shares of restricted stock
at fair market value, which vests as to 25% on February 26, 2025 and in equal monthly installments thereafter through February 26, 2028.
In accordance with the anti-dilution provisions of his offer letter, as described in more detail below, on July 15, 2024, Dr. Klein received
a compensatory warrant to purchase 1,628,513 shares of our common stock, which vests as to 25% on April 3, 2025 and in equal monthly
installments thereafter through April 3, 2028.

 In
connection with her appointment as Chief Medical Officer of Pre-Merger Oruka, Dr. Goncalves was granted stock options to purchase 228,563
shares of our common stock, which vests as to 25% on April 18, 2025 and in equal monthly installments thereafter through April 18, 2028.
On July 15, 2024, Dr. Goncalves was granted a compensatory warrant to purchase 199,992 shares of our common stock, which vests on the
same schedule as her initial stock option grant.

 In
connection with his appointment as General Counsel of Pre-Merger Oruka, Mr. Quinlan was granted stock options to purchase 228,563 shares
of our common stock, which vests as to 25% on April 30, 2025 and in equal monthly installments thereafter through April 30, 2028. On
July 15, 2024, Mr. Quinlan was granted a compensatory warrant to purchase 99,996 shares of our common stock, which vests on the same
schedule as his initial stock option grant.

 None
of the former ARCA executive officers received grants of equity incentive awards during 2024.

 Offer
Letters

 In
connection with their appointments, we entered into offer letters with each of Dr. Klein, Dr. Goncalves and Mr. Quinlan, each of which
was amended and restated as of October 3, 2024 (for Dr. Klein) or October 1, 2024 (for Dr. Goncalves and Mr. Quinlan) following the Merger
(collectively, the "Offer Letters"). The Offer Letters provided for each NEO's initial base salary, target annual bonus
and initial equity incentive award. The Offer Letter with Dr. Klein also provided for periodic grants of stock options sufficient to
maintain Dr. Klein's ownership at approximately 5% on a fully-diluted basis until Oruka raised an aggregate of $200 million
in financing, which obligations were fully satisfied prior to the consummation of the Merger through the warrant issued on July 15, 2024.
The Offer Letter with Dr. Goncalves also provided for a sign-on bonus of $100,000, which is subject to repayment in the event of a termination
for cause or resignation without good reason prior to April 18, 2025.

 Under
the Offer Letters, the NEOs are eligible for certain payments or benefits upon certain terminations of employment, as described under
"Additional Narrative Disclosure—Potential Payments Upon Termination or Change in Control" below. Each of Dr. Klein,
Dr. Goncalves and Mr. Quinlan is also party to our standard employee invention assignment, confidentiality and non-competition agreement,
which, among other things, provides standard protections regarding our ownership of intellectual property, the confidentiality of our
proprietary information, non-competition and non-solicitation.

 ARCA
Arrangements

 Michael
Bristow, M.D. Dr. Bristow served as the Company's President and Chief Executive Officer through April 3, 2024. In connection
with his separation, the Company (then known as ARCA) and Dr. Bristow entered into a separation agreement pursuant to which Dr.
Bristow provided a release of claims in favor of the Company and the Company paid Dr. Bristow a lump sum severance payment of $370,000.

 The
Company and Dr. Bristow also entered into a consulting agreement, effective April 3, 2024, pursuant to which Dr. Bristow
provided certain consulting services to the Company through the Merger. Under the consulting agreement, Dr. Bristow continued to
vest in his outstanding equity awards during the consulting term.

 Thomas
A. Keuer and C. Jeffrey Dekker. Mr. Keuer served as the Company's President and Chief Operating Officer and Mr. Dekker
served as the Company's Chief Financial Officer, in each case, through the consummation of the Merger. Pursuant to retention bonus
letters approved by the ARCA Compensation Committee prior to the Merger, each of Messrs. Keuer and Dekker were paid a retention bonus
upon consummation of the Merger of $165,000.

 As
a result of the Merger and the accompanying termination of their employment, the Company and each of Mr. Keuer and Mr. Dekker entered
into a separation agreement, pursuant to which Mr. Keuer and Mr. Dekker each provided a release of claims in favor of the Company and
the Company provided the following severance payments and benefits, in accordance with the terms of their employment agreement: (i) a
lump sum cash severance payment equal to 12 months of their respective annual base salary ($340,000 and $270,000, respectively) and (ii)
a lump sum cash payment of $69,715 in lieu of 12 months of group health plan continuation premiums.

 Treatment
of ARCA Equity Awards. In connection with the Merger, all outstanding ARCA stock options held by the NEOs were accelerated and cashed
out for an amount equal to the difference between $3.9489 and the applicable per share exercise price; however, any ARCA stock options
having an exercise price in excess of $3.9489 were cancelled for no consideration.

Equity Awards at Fiscal Year End

 The
following table presents information regarding outstanding stock options, compensatory warrants and restricted stock held by each NEO
as of December 31, 2024. The equity awards reflected below give effect to the share conversion completed in the Merger and the subsequent
1-for-12 reverse stock split. None of the former ARCA executive officers held any outstanding equity awards as of December 31, 2024.

 Awards

 Stock
 Awards

 Name

 of

 Underlying

 Unexercised

 Options (#)

 Exercisable

 of

 Underlying

 Unexercised

 Options (#)

 Unexercisable

 Exercise Price

 ($)

 Expiration

 Date

 of

 Shares or

 Units of Stock

 That Have Not

 Vested

 (#)

 Market
 Value

 of Shares or

 Units of Stock

 That Have Not

 Vested

 ($) (1)

 Lawrence Klein, Ph. D.

 —

 1,628,513
 (2)

 7.80

 7/14/2034

 852,338
 (3)

 16,526,834

 Joana Goncalves, MBChB

 —

 228,563
 (4)

 6.84

 10/30/2034

 —

 199,992
 (4)

 7.80

 7/14/2034

 Paul Quinlan

 —

 228,563
 (5)

 6.84

 10/30/2034

 —

 99,996
 (5)

 7.80

 7/14/2034

 Michael Bristow, M.D.

 —

 —

 —

 —

 —

 —

 Thomas A. Keuer

 —

 —

 —

 —

 —

 —

 C. Jeffrey Dekker

 —

 —

 —

 —

 —

 —

 (1)
 The
 market value was determined by multiplying the numbers of shares by $19.39, the closing price
 of our common stock on December 31, 2024.

 (2)
 These
 compensatory warrants vest as to 25% on April 3, 2025 and in equal monthly installments thereafter
 through April 3, 2028, subject to Dr. Klein's continued services to us.

 (3)
 These
 restricted shares vest as to 25% on February 26, 2025 and in equal monthly installments thereafter
 through February 26, 2028, subject to Dr. Klein's continued services to us.

 (4)
 These
 stock options and compensatory warrants vest as to 25% on April 18, 2025 and in equal monthly
 installments thereafter through April 18, 2028, subject to Dr. Goncalves' continued
 services to us.

 (5)
 These
 stock options and compensatory warrants vest as to 25% on April 30, 2025 and in equal monthly
 installments thereafter through April 30, 2028, subject to Mr. Quinlan's continued
 services to us.

Narrative Disclosures

 Employee
Benefits and Perquisites

 Our
NEOs are eligible to participate in our employee benefit plans, including our health and welfare plans, term life insurance, disability
insurance and a 401(k) plan, in each case on the same basis as all our other employees. During 2024, following the Merger, we did not
provide any Company contributions under the 401(k) plan; however, in 2025, the Company will make matching contributions of 100% of the
first 3% of eligible compensation deferred by participants, subject to legal maximum contributions.

 Following
the Merger, we generally do not provide perquisites or personal benefits to our NEOs, except in limited circumstances.

 Potential
Payments Upon Termination or Change in Control

to the terms of the Offer Letters, in the event each NEO that is a current executive officer is terminated by the Company without "cause"
or as a result of a resignation for "good reason" (collectively, an "Involuntary Termination"), such NEO will,
subject to the execution of a release in favor of the Company, receive: (i) severance payments equal to 12 months of base salary; (ii)
Company-paid continuation coverage under the Company's group health plans for up to 12 months; and (iii) in the case of Dr. Klein,
accelerated vesting of 30% of any outstanding time-based equity. However, if the Involuntary Termination is within three months before
or 12 months after a change in control of the Company, the NEO will instead receive: (A) severance payments equal to 1.0 times (or, for
Dr. Klein, 1.5x times) the sum of the NEO's base salary and target bonus; (B) Company-paid continuation coverage under the Company's
group health plans for up to 12 months (or, for Dr. Klein, up to 18 months); and (C) full acceleration of all equity awards. In addition,
upon severance due to the death or disability of the named executive officer, the officer's equity awards shall accelerate in full.

 As
used in the Offer Letters:

 "Cause"
generally means the NEO's (i) dishonest statements or acts with respect to the Company or any affiliate of the Company, or any
current or prospective customers, suppliers, vendors or other third parties with which such entity does business that results in or is
reasonably anticipated to result in material harm to the Company; (ii) conviction or plea of no contest to a felony or misdemeanor involving
moral turpitude, deceit, dishonesty or fraud; (iii) failure to perform his or her duties or responsibilities, subject to a 30-day cure
period; (iv) gross negligence, willful misconduct that results in or is reasonably anticipated to result in material harm to the Company;
or (v) violation of any material provision of any agreement with the Company or any written Company policies.

 "Good
reason" generally means (i) a material diminution in the named executive officer's base salary or target bonus (excluding
across-the-board reductions of less than 10%); (ii) a material geographic relocation or requirement to change the named executive officer's
remote work location; (iii) a material reduction in the named executive officer's duties, authority or responsibilities; (iv) the
failure of the Company to obtain the assumption of the Offer Letter by a successor; or (v) the material breach of any agreement between
the NEO and the Company, in each case, subject to standard notice and cure periods.

 Clawback
Policy

 We
maintain a Compensation Recoupment (Clawback) Policy, which is intended to comply with the requirements of Nasdaq Listing Standard 5608
implementing Rule 10D-1 under the Exchange Act. In the event the Company is required to prepare an accounting restatement of the Company's
financial statements due to material non-compliance with any financial reporting requirement under the federal securities laws, the Company
will recover, on a reasonably prompt basis, the excess incentive-based compensation received by any covered executive, including the
NEOs, during the prior three fiscal years that exceeds the amount that the executive otherwise would have received had the incentive-based
compensation been determined based on the restated financial statements.

 Equity
Grant Practices

 Following
the Merger, we generally grant annual equity awards, including stock options, in January of each year. We also grant stock options as
new hire awards as of their date of employment commencement. Employees, including the NEOs, may enroll to purchase shares under the terms
of our 2024 Employee Stock Purchase Plan, as amended (the "ESPP"), with purchase dates generally occurring during open trading
windows in June and December of each year using payroll deductions accumulated during the prior six-month period. During 2024, the Compensation
Committee did not take material nonpublic information into account when determining the timing and terms of stock options, and the Company
did not time the disclosure of material nonpublic information for the purpose of affecting the value of executive compensation.

 The
following table provides information for the year ended December 31, 2024 regarding all compensation awarded to, earned by or paid to
each person who served as a non-employee director for some portion of 2024. Employees who served on our Board during 2024 did not receive
additional compensation for such service:

 Name (1)(2)

 Fees

 Earned or
 Paid in
 Cash
 ($)

 Awards
 ($) (3)

 Total

 ($)

 Kristine Ball

 20,548

 -

 20,548

 Carl Dambkowski, M.D.

 16,267

 -

 16,267

 Peter Harwin

 19,178

 -

 19,178

 Samarth Kulkarni, Ph. D.

 27,740

 -

 27,740

 Cameron Turtle, D.Phil. (4)

 20,377

 -

 20,377

 Dan Mitchell

 30,810

 -

 30,810

 Raymond Woosley

 27,500

 -

 27,500

 Robert Conway

 197,916

 2,739

 200,655

 James Flynn

 71,042

 12,620

 83,662

 Linda Grais

 168,124

 2,739

 170,863

 Anders Hove

 159,583

 2,739

 162,322

 Jacob Ma-Weaver

 119,167

 8,215

 127,382

 (1)
 The
 amounts reflected herein for directors who served on the Pre-Merger Oruka board of directors
 do not include any compensation they received from Pre-Merger Oruka prior to the Merger.

 (2)
 Messrs.
 Woosley and Mitchell resigned from our Board effective as of February 2, 2024. In connection
 with the Merger on August 29, 2024, Drs. Hove and Grais as well as Messrs. Conway, Ma-Weaver
 and Flynn resigned from our Board and Drs. Turtle, Dambkowski and Kulkarni as well as Ms.
 Ball and Mr. Harwin were appointed to our Board.

 (3)
 In
 connection with the Merger, all outstanding ARCA stock options held by Drs. Hove and Grais
 and Messrs. Conway, Ma-Weaver and Flynn were accelerated and cashed out for an amount equal
 to the difference between $3.9489 and the applicable per share exercise price; however, any
 ARCA stock options having an exercise price in excess of $3.9489 were cancelled for no consideration.
 Amounts reported in this column represent the incremental fair value under ASC Topic 718
 resulting from the acceleration of the stock options in the Merger. As of December 31, 2024,
 each of Drs. Turtle and Dambkowski and Ms. Ball held outstanding options or compensatory
 warrants to purchase 94,282 shares of our common stock (which were assumed by the Company
 in connection with the Merger), Dr. Kulkarni held outstanding options or compensatory warrants
 to purchase 199,992 shares of our common stock (which were assumed by the Company in connection
 with the Merger), and no other non-employee directors held any outstanding options or compensatory
 warrants.

 (4)
 Prior
 to the Merger, Dr. Turtle purchased 85,233 shares (after giving effect to the share conversion
 completed in the Merger and the subsequent 1-for-12 reverse stock split) of restricted common
 stock that vest as to 25% on March 1, 2025 and in and in equal monthly installments thereafter
 through March 1, 2028. All of such restricted shares were outstanding as of December 31,
 2024.

 Non-Employee
Director Compensation Program

 Non-employee
members of the Board are eligible to receive cash and equity compensation in accordance with our non-employee director compensation program.
This program provides for the following annual cash retainers:

 Post-Merger

 Annual Cash Retainer

 $
 40,000

 $
 40,000

 Annual Board Chair Retainer

 $
 30,000

 $
 30,000

 Audit Committee Retainers:

 Chair

 $
 15,000

 $
 15,000

 Non-Chair Member

 $
 7,500

 $
 7,500

 Compensation Committee Retainers:

 Chair

 $
 10,000

 $
 12,000

 Non-Chair Member

 $
 5,000

 $
 6,000

 Nominating and Corporate Governance Committee
 Retainers

 Chair

 $
 10,000

 $
 10,000

 Non-Chair Member

 $
 5,000

 $
 5,000

 In
connection with the Company's annual meeting of stockholders, each member of the Board will receive an annual grant of stock options
to purchase 17,500 shares of common stock, which will vest in equal monthly installments over 12 months so long as such director joined
the Board prior to January 1 of the year in which such annual meeting occurs. Prior to the Merger, the annual grant of stock options
was for 6,000 shares of common stock.

 In
addition, in connection with a non-employee director's initial appointment to the Board, they will receive an initial grant of
stock options to purchase 35,000 shares of common stock, which will vest in equal monthly installments over 36 months. Prior to the Merger,
the initial grant of stock options was for 12,000 shares of common stock.

 All
members of the Board are also reimbursed for reasonable and documented out-of-pocket travel and lodging expenses incurred in connection
with attending meetings and activities of the Board and its committees.

 Item
12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.

 Security
Ownership of Certain Beneficial Owners and Management

 The
following table sets forth information, to the extent known by us or ascertainable from public filings, with respect to the beneficial
ownership of our Common Stock as of February 15, 2025.

 each
 person or group of affiliated persons, who is known by us to be the beneficial owner of more
 than 5% of Common Stock;

 each
 of our directors;

 each
 of our named executive officers; and

 all
 of our current directors and executive officers as a group.

 The
column entitled "Percentage of Shares Outstanding Beneficially Owned" is based on a total of 37,440,510 shares of our Common
Stock outstanding as of February 15, 2025.

 Beneficial
ownership is determined in accordance with the rules and regulations of the SEC and includes voting or investment power with respect
to the Common Stock. Shares of Common Stock subject to options that are currently exercisable or exercisable within 60 days of the date
of this table are considered outstanding and beneficially owned by the person holding the options for the purpose of calculating the
percentage ownership of that person but not for the purpose of calculating the percentage ownership of any other person. Except as otherwise
noted, the persons and entities in this table have sole voting and investing power with respect to all the shares of Common Stock beneficially
owned by them, subject to community property laws, where applicable. Except as otherwise indicated in the table below, addresses of named
beneficial owners are in care of Oruka Therapeutics, Inc., 855 Oak Grove Ave., Suite 100, Menlo Park, CA 94025.

 Name of
 Beneficial Owner

 of Shares
 Beneficially
 Owned

 Percentage

 of Shares
 Beneficially
 Owned

 5% Stockholders:

 Entities affiliated
 with Fairmount Funds Management LLC (1)

 8,511,824

 19.99
 %

 FMR LLC (2)

 5,561,808

 14.86
 %

 Entities affiliated with Venrock
 Healthcare Capital Partners (3)

 4,148,428

 11.08
 %

 Entities affiliated with RTW
 Investments, LP (4)

 2,058,147

 5.50
 %

 Named
 Executive Officers and Directors:

 Lawrence Klein (5)

 1,522,440

 4.02
 %

 Arjun Agarwal (6)

 61,068

 *

 Joana Goncalves (7)

 10,347

 *

 Paul Quinlan (8)

 10,156

 *

 Michael R. Bristow (9)

 *

 Thomas A. Keuer (10)

 3,394

 *

 C. Jeffrey Dekker (11)

 3,333

 *

 Cameron Turtle (12)

 110,579

 *

 Samarth Kulkarni (13)

 35,713

 *

 Peter Harwin (1)

 8,511,824

 19.99
 %

 Carl Dambkowski (14)

 25,058

 *

 Kristine Ball

 —

 *

 All current executive officers
 and directors as a group (9 persons) (15)

 10,287,185

 24.69
 %

 *
 Less
 than 1%.

 (1)
 Consists
 of (i) (A) 798,614 shares of common stock, (B) 409,326 shares of common stock issuable upon
 the exercise of pre-funded warrants and (C) 4,730,576 shares of common stock issuable upon
 conversion of 56,767 shares of Series B Preferred Stock held by Fairmount Healthcare Fund
 II L.P. ("Fairmount Fund II") and (ii) 2,573,308 shares of common stock held
 by Fairmount Healthcare Co-Invest III L.P. ("Fairmount Fund III"). Excludes (i)
 4,888,338 shares of common stock issuable upon the exercise of the pre-funded warrants and
 (ii) 6,697,573 shares of common stock issuable upon the conversion of 80,371 shares of Series
 B Preferred Stock. The pre-funded warrants are subject to a beneficial ownership limitation
 of 9.99% and the shares of Series B Preferred Stock are subject to a beneficial ownership
 limitation of 19.99%, which such limitations restrict Fairmount Funds Management LLC ("Fairmount")
 and its affiliates from exercising that portion of the warrants and converting those shares
 of preferred stock that would result in Fairmount and its affiliates owning, after exercise
 or conversion, a number of shares of common stock in excess of the applicable ownership limitation.
 At such time as Fairmount and its affiliates beneficially own 9.0% or less of the shares
 of common stock, the beneficial ownership limitation applicable to the shares of Series B
 Preferred Stock will automatically reduce to 9.99%. Fairmount serves as investment manager
 for Fairmount Fund II and Fairmount Fund III. Fairmount Fund II and Fairmount Fund III have
 delegated to Fairmount the sole power to vote and the sole power to dispose of all securities
 held in Fairmount Fund II and Fairmount Fund III's portfolios. Because Fairmount Fund
 II and Fairmount Fund III have divested themselves of voting and investment power over the
 securities they hold and may not revoke that delegation on less than 61 days' notice,
 Fairmount Fund II and Fairmount Fund III disclaim beneficial ownership of the securities
 they hold. As managers of Fairmount, Peter Harwin and Tomas Kiselak may be deemed
 to have voting and investment power over the shares held by Fairmount Fund II and Fairmount
 Fund III. Fairmount, Peter Harwin and Tomas Kiselak disclaim beneficial ownership
 of such shares, except to the extent of any pecuniary interest therein. The address of the
 entities and individuals listed is 200 Barr Harbor Drive, Suite 400, West Conshohocken, PA
 19428.

 (2)
 All
 of the shares listed in the table above are owned by funds or accounts managed by direct
 or indirect subsidiaries of FMR LLC, all of which shares are beneficially owned, or may be
 deemed to be beneficially owned, by FMR LLC, certain of its subsidiaries and affiliates,
 and other companies. Abigail P. Johnson is a Director, the Chairman and the Chief Executive
 Officer of FMR LLC. Members of the Johnson family, including Abigail P. Johnson, are the
 predominant owners, directly or through trusts, of Series B voting common shares of FMR LLC,
 representing 49% of the voting power of FMR LLC. The Johnson family group and all other Series
 B shareholders have entered into a shareholders' voting agreement under which all Series
 B voting common shares will be voted in accordance with the majority vote of Series B voting
 common shares. Accordingly, through their ownership of voting common shares and the execution
 of the shareholders' voting agreement, members of the Johnson family may be deemed,
 under the Investment Company Act of 1940, to form a controlling group with respect to FMR
 LLC. The address of FMR LLC is 245 Summer Street, Boston, MA 02210.

 (3)
 Consists
 of (i) 3,205,865 shares of common stock held by Venrock Healthcare Capital Partners EG, L.P.
 ("VHCPEG"), (ii) 856,747 shares of common stock held by Venrock Healthcare Capital
 Partners III, L.P. ("VHCP3"), and (iii) 85,816 shares of common stock held by
 VHCP Co-Investment Holdings III, LLC ("VHCPCo3"). Excludes 405,980, 107,788 and
 10,775 shares of common stock issuable upon the exercise of the pre-funded warrants held
 by VHCPEG, VHCP3 and VHCPCo3, respectively. The pre-funded warrants are subject to a beneficial
 ownership limitation of 9.99%, which such limitations restrict Venrock Healthcare Capital
 Partners and its affiliates from exercising that portion of the warrants that would result
 in Venrock Healthcare Capital Partners and its affiliates owning, after exercise, a number
 of shares of common stock in excess of the applicable ownership limitation. VHCP Management
 III, LLC ("VHCPM3") is the sole general partner of VHCP3 and the sole manager
 of VHCPCo3. VHCP Management EG, LLC ("VHCPM EG") is the sole general partner
 of VHCPEG. As voting members of VHCPM3 and VHCPM EG, Dr. Bong Koh and Nimish Shah may be
 deemed beneficial owners of any securities beneficially owned by VHCPM3 and VHCPM EG. The
 principal business address of each of these persons and entities is 7 Bryant Park, 23rd Floor,
 New York, NY 10018.

 (4)
 Consists
 of 2,058,147 shares of common stock held in the aggregate by RTW Master Fund, Ltd. ("RTW
 Master Fund"), RTW Innovation Master Fund, Ltd. ("RTW Innovation Master Fund"),
 and RTW Biotech Opportunities Operating Ltd. ("RTW Biotech" and together with
 RTW Master Fund and RTW Innovation Fund, the "RTW Funds"). RTW Investments, LP
 ("RTW"), in its capacity as the investment manager of the RTW Funds, has the
 power to vote and the power to direct the disposition of the shares held by the RTW Funds.
 Accordingly, RTW may be deemed to be the beneficial owner of such securities. Roderick Wong,
 M.D., as the Managing Partner of RTW, has the power to direct the vote and disposition of
 the securities held by RTW. Dr. Wong disclaims beneficial ownership of the shares held by
 the RTW Funds, except to the extent of his pecuniary interest therein. The principal business
 address of RTW Investments, LP is 40 10th Avenue, Floor 7, New York, NY 10014, and the address
 of Dr. Wong and each of the RTW Funds is c/o RTW Investments, LP, 40 10th Avenue, Floor 7,
 New York, NY 10014.

 (5)
 (i) 852,338 shares of common stock, (ii) 421,503 shares of common stock issuable upon the
 exercise of options that will vest within 60 days of the date of this table and (iii) 248,599
 shares of common stock issuable upon the vesting of restricted stock awards that will vest
 within 60 days of the date of this table.

 (6)
 61,068 shares of common stock issuable upon the exercise of options that will vest within
 60 days of the date of this table.

 (7)
 (i) 191 shares of common stock and (ii) 10,156 shares of common stock issuable upon the exercise
 of options that will vest within 60 days of the date of this table

 (8)
 10,156 shares of common stock issuable upon the exercise of options that will vest within
 60 days of the date of this table

 (9)
(i) 92 shares owned by Investocor Trust, of which Dr. Bristow is the sole trustee and (ii) 117 shares owned by NFS as Custodian for Michael
Bristow's IRA. Dr. Bristow and ARCA mutually agreed to conclude Dr. Bristow's employment effective April 3, 2024.

 (10)
 Mr.
Keuer resigned as named executive officer at the Merger Closing and his last day of employment was September 1, 2024, which termination
was considered to be without "cause" related to a change in control for purposes of his employment agreement with ARCA.

 (11)
 Mr.
Dekker resigned as named executive officer at the Merger Closing and his last day of employment was September 1, 2024, which termination
was considered to be without "cause" related to a change in control for purposes of his employment agreement with ARCA.

 (12)
(i) 85,233 shares of common stock held by the Turtle Family Trust, for which Mr. Turtle serves as Trustee, (ii) 2,262 shares of common
stock issuable upon the exercise of options that will vest within 60 days of the date of this table and (iii) 23,084 shares of common
stock issuable upon the vesting of restricted stock awards that will vest within 60 days of the date of this table.

 (13)
35,713 shares of common stock issuable upon the exercise of options that will vest within 60 days of the date of this table

 (14)
25,058 shares of common stock issuable upon the exercise of options that will vest within 60 days of the date of this table

 (15)
 See
notes (1), (5), (6), (7), (8), (12), (13) and (14) above.

Authorized for Issuance Under Equity Compensation Plans

 The
following table provides information with respect to all our equity compensation plans in effect as of December 31, 2024.

 Number of

 Securities to be Issued
 upon Exercise of
 Options

 Weighted Average

 Exercise Price of
 Options

 Number of

 Remaining
 Available for
 Future Issuances
 under Equity
 Compensation Plans
 (excluding

 reflected in
 column
 (a))

 Plan Category

 (a)

 (b)

 (c)

 Equity Compensation Plans Approved by Security Holders:

 2024
 Stock Incentive Plan

 388,567

 $
 26.91

 4,246,324
 (1)

 2024
 Employee Stock Purchase Plan

 —

 —

 460,529
 (2)

 2024
 Equity Incentive Plan (3)

 1,179,193

 $
 6.27

 —

 Equity Compensation Plans Not Approved by Security
 Holders:

 Non-Plan
 Compensatory Warrants (4)

 $
 7.80

 —

 Total

 4,622,118

 $
 9.02

 4,706,853

 (1)
 The
 2024 Stock Incentive Plan (the "2024 SIP") provides for an automatic increase
 in the number of shares reserved for issuance thereunder on January 1 of each year through
 and including January 1, 2034 equal to (a) 5% of number of issued and outstanding shares
 of common stock plus outstanding preferred stock and shares underlying unexercised pre-funded
 warrants on an as-converted basis) (collectively, "Shares Outstanding") on December 31
 of the immediately preceding year, or (b) a lesser amount as approved by the Board each
 year. Pursuant to this provision, the number of shares available for issuance under the 2024
 SIP increased by 2,753,543 shares on January 1, 2025.

 (2)
 The
 ESPP provides for an automatic annual increase in the number of shares reserved for issuance
 thereunder on January 1 of each year through and including January 1, 2034 equal to
 (a) 1% of the number of Shares Outstanding on December 31 of the immediately preceding
 year, or (2) a lesser amount as approved by the Board each year. Pursuant to this provision,
 the number of shares available for issuance under the ESPP increased by 550,709 shares on
 January 1, 2025.

 (3)
 Stock
 options granted by Pre-Merger Oruka under the 2024 Equity Incentive Plan were assumed by
 the Company in connection with the Merger. No further awards may be made under the 2024 Equity
 Incentive Plan.

 (4)
 Non-plan
 compensatory warrants granted by Pre-Merger Oruka were assumed by the Company in connection
 with the Merger. No further non-plan compensatory warrants are expected to be granted following
 the Merger.

 Item
13. Certain Relationships and Related Transactions, and Director Independence.

Relationships and Related Transactions

 Other
than the compensation agreements and other arrangements disclosed above under "Executive Compensation," below we describe
the transactions to which we or Pre-Merger Oruka were or are a party since January 1, 2023, in which the amount involved exceeds the
lesser of $120,000 or one percent of the average of our or Pre-Merger Oruka's total assets at year-end for the last two completed
fiscal years and in which our or Pre-Merger Oruka directors, executive officers, holders of more than 5% of our common stock, or members
of their immediate family had a direct or indirect material interest.

 ARCA
Transactions

 Transactions
With ARCA's Former President and Chief Executive Officer

 ARCA
previously entered into unrestricted research grants with its former President and Chief Executive Officer's academic research
laboratory at the University of Colorado. Funding of any unrestricted research grants was contingent upon ARCA's financial condition,
and could be deferred or terminated at ARCA's discretion. There was no expense under these arrangements for the year ended December 31,
2024. Total expense under these arrangements for the year ended December 31, 2023 was $(91,000). In December 2023, ARCA
made a payment of $125,000 for the grant period July 2022 through December 2023 under these arrangements. In April 2024,
the President and Chief Executive Officer resigned.

Oruka Transactions

 Private
Placements of Securities

Oruka Series A Preferred Stock and Convertible Note Financing

 On
March 6, 2024, Oruka entered into a Convertible Note Purchase Agreement with Fairmount Healthcare Fund II, L.P. ("Fairmount
Fund II"), whereby Oruka issued and sold to Fairmount Fund II (i) an aggregate of 20,000,000 shares of Pre-Merger Oruka Series
A Preferred Stock at a purchase price of $0.15 per share and (ii) a convertible note (the "Convertible Note") with an
initial principal amount of $25.0 million at an interest rate of 12% per annum, for aggregate gross proceeds of $28 million. Fairmount
Fund II contributed the aggregate principal amount of $25.0 million and all accrued interest under the Convertible Note (unpaid accrued
interest of $1.5 million divided by the conversion price of $66.62 ($5.55 prior to the impact of the Reverse Stock Split) per share)
in exchange for Pre-Merger Oruka Common Stock and Pre-Merger Oruka pre-funded warrants in connection with the Pre-Merger Closing Financing
(as defined below), immediately prior to the completion of the Merger. Fairmount Funds Management ("Fairmount") is the investment
manager of Fairmount Fund II. Peter Harwin, one of our directors, is a managing member of Fairmount.

Oruka Pre-Merger Closing Financing

 On
April 3, 2024, in connection with the execution of the Merger Agreement, Pre-Merger Oruka entered into the Subscription Agreement
to consummate the Pre-Merger Closing Financing. Pursuant to the Subscription Agreement, the Financing Investors purchased 39,873,706
shares of Pre-Merger Oruka common stock and 9,664,208 Pre-Merger Oruka pre-funded warrants for gross proceeds of approximately $275.0
million (which includes $25.0 million of proceeds previously received from the issuance of the Convertible Note and accrued interest
on such note, which converted to 4,764,032 shares of Pre-Merger Oruka common stock), immediately prior to the Merger Closing and before
the effect of the Reverse Stock Split. Three of the investors or their affiliates were beneficial holders of more than 5% of Pre-Merger
Oruka's capital stock, and the table below sets forth the number of shares of Pre-Merger Oruka common stock and Pre-Merger Oruka
pre-funded warrants purchased by such holders at the closing of the Pre-Merger Closing Financing.

 Participant

 of

 Oruka

 Stock

 Pre-funded

 Warrants of

 Oruka

 Total

 Purchase

 Price

 Entities affiliated with Fairmount

 5,139,797

 9,271,241

 $
 79,907,282
 (1)

 Entities affiliated with Venrock Healthcare
 Capital Partners

 5,011,172

 392,967

 $
 29,996,067

 Entities affiliated with FMR LLC

 4,503,445

 —

 $
 24,999,974

 (1)
 $25.0 million of proceeds previously received by Pre-Merger Oruka from the issuance of the
 Convertible Note and accrued interest on such note, with the remainder of the purchase price
 paid in cash.

 Company
Transactions

 September
2024 Private Placement

 On
September 11, 2024, the Company entered into a Securities Purchase Agreement (the "SPA") with certain selling stockholders
to consummate a private placement (the "Private Placement"). Pursuant to the SPA, the selling stockholders purchased (i)
an aggregate of 5,600,000 shares of Common Stock, at a price per share of $23.00, (ii) an aggregate of 2,439 shares of Series A Preferred
Stock, at a price per share of $23,000.00, and (iii) pre-funded warrants to purchase an aggregate of 680,000 shares of Common Stock at
a purchase price of $22.999 per pre-funded warrant, which represents the per share purchase price of the Private Placement Common Shares
less the $0.001 per share exercise price for each pre-funded warrant, for an aggregate purchase price of approximately $200.5 million.
Three of the selling stockholders or their affiliates were beneficial holders of more than 5% of the Company's capital stock, and
the table below sets forth the number of shares of Common Stock, Series A Preferred Stock and pre-funded warrants purchased by such holders
at the closing of the Private Placement.

 Participant

 of

 Stock

 Series
 A

 Preferred

 Stock

 Pre-Funded

 Total

 Purchase

 Price

 Entities affiliated with FMR LLC

 2,105,000

 —

 $
 67,505,000

 Entities affiliated with Venrock Healthcare
 Capital Partners

 150,000

 300,000

 $
 14,949,700

 Entities affiliated with Fairmount

 275,000

 —

 $
 10,005,000

 Our
Relationship with Paragon and Paruka

 We
are party to a number of agreements with Paragon and Paruka. Paragon and Paruka do not beneficially own more than 5% of our capital stock
through their joint holdings of our Common Stock. Fairmount beneficially owns more than 5% of our capital, one of Fairmount's employees
serves on our Board, and Fairmount beneficially owns more than 5% of Paragon. Fairmount appointed Paragon's board of directors
and has the contractual right to approve the appointment of any executive officers of Paragon, but is not the beneficial owner of Paragon's
securities. Paruka is an entity formed by Paragon as a vehicle to hold equity in our Company in order to share profits with certain employees
of Paragon.

 In
 March 2024, Pre-Merger Oruka entered into the Option Agreements with Paragon and Paruka.
 Under the terms of the Option Agreements, Paragon identifies, evaluates and develops antibodies
 directed against certain mutually agreed therapeutic targets of interest to us. The Option
 Agreements include two selected targets, IL-23 (ORKA-001) and IL-17A/F (ORKA-002). Under
 each of the Option Agreements, we have the exclusive option to, on a research program-by-research
 program basis, be granted an exclusive, worldwide license to all of Paragon's right,
 title and interest in and to the intellectual property resulting from the applicable research
 program to develop, manufacture, and commercialize the antibodies and potential products
 directed to the selected targets (each, an "Option"), with the exception of pursuing
 ORKA-001 for the treatment of inflammatory bowel disease. In September 2024, we exercised
 our Option to acquire the rights to ORKA-001 and executed the corresponding license agreement
 (the "IL-23 License Agreement") on December 17, 2024. In December 2024 we exercised
 our Option to acquire the rights to ORKA-002 and executed the corresponding license agreement
 (the IL-17A/F License Agreement) on February 4, 2025. Under each license agreement we are
 required to make non-refundable milestone payments to Paragon of up to $12.0 million under
 each respective agreement upon the achievement of certain clinical development milestones,
 up to $10.0 million under each respective agreement upon the achievement of certain regulatory
 milestones, as well as a low single-digit percentage royalty for antibody products beginning
 on the first commercial sale in each program. From time to time, we can choose to add additional
 targets to the collaboration by mutual agreement with Paragon. During 2024, we accrued two
 $1.5 million milestone payments related to the achievement of development candidates as research
 and development expense in our consolidated statements of operations and comprehensive loss
 for the year ended December 31, 2024. As of December 31, 2024, this amount is included under
 related party accounts payable and other current liabilities on the consolidated balance
 sheet.

to the terms of the Option Agreements, the parties initiated certain Research Programs. Each Research Program is aimed at discovering,
generating, identifying and/or characterizing antibodies directed to the respective target. For each Research Program, the parties established
a Research Plan (each, a "Research Plan") that sets forth the activities that will be conducted, and the associated research
budget. We and Paragon agreed on initial Research Plans that outlined the services that were performed commencing at inception of the
arrangement related to IL-17 and IL-23. Our exclusive option with respect to each Research Program was exercisable at our sole discretion
at any time during the period beginning on the initiation of activities under the associated Research Program and ending a specified
number of days following the delivery of the data package from Paragon related to the results of the Research Plan activities. There
is no payment due upon exercise of an Option pursuant to the Option Agreements.

to the Option Agreements, on a research program-by-research program basis following the finalization of the Research Plan for each respective
research program, the Company was required to pay Paragon a one-time nonrefundable research initiation fee of $0.8 million related to
the ORKA-001 program. This amount was recognized as a research and development expense during the period from February 6 (inception)
to December 31, 2024. In June 2024, pursuant to the Option Agreements with Paragon, the Company completed the selection process of its
development candidate for IL-23 antibodies for the ORKA-001 program. The Company was responsible for 50% of the development costs incurred
through the completion of the IL-23 selection process. The Company received the rights to at least one selected IL-23 antibody in June
2024. During 2024, the Company exercised its option for ORKA-001 and recorded a $1.5 million milestone payment related to the achievement
of development candidate as research and development expense in the Company's consolidated statement of operations and comprehensive
loss. In addition, during the period from February 6, 2024 (inception) to December 31, 2024, the Company recorded a $2.5 million milestone
payment related to the first dosing of a human subject in a Phase 1 trial of ORKA-001 in December 2024 as research and development expense
in its consolidated statement of operations and comprehensive loss. The Company's share of development costs incurred during the
period from February 6, 2024 (inception) to December 31, 2024 was $13.5 million, which was recorded as research and development expenses.
An amount of $2.8 million related to ORKA-001 is included in related party accounts payable and other current liabilities as of December

 The
Company is also required to reimburse Paragon $3.3 million for development costs related to ORKA-002 incurred by Paragon through December
31, 2023 and certain other development costs incurred by Paragon between January 1, 2024 and March 6, 2024 as stipulated by the Option
Agreements. This amount was recognized as a research and development expense during the period from February 6 (inception) to December
31, 2024. The Company is also responsible for development costs incurred by Paragon from January 1, 2024 through the completion of the
IL-17 selection process. The Company recognized an amount of $0.8 million payable to Paragon for the research initiation fee related
to ORKA-002 following the finalization of the ORKA-002 research plan. This was recognized as research and development expenses in the
period from February 6 (inception) to December 31, 2024. During the period from February 6, 2024 (inception) to December 31, 2024, the
Company exercised its option for ORKA-002 and recorded a $1.5 million milestone payment related to the achievement of development candidate
as research and development expense in its consolidated statement of operations and comprehensive loss. The Company accounted for development
costs of $7.8 million during the period from February 6, 2024 (inception) to December 31, 2024 as research and development expenses.
An amount of $2.7 million related to ORKA-002 is included in related party accounts payable and other current liabilities as of December

the Option Agreements provide for an annual equity grant of warrants to purchase a number of shares equal to 1.00% of the then outstanding
shares of our stock, on a fully diluted basis, on each of December 31, 2024 and December 31, 2025, during the term of the Option Agreements,
at the fair market value determined by our Board.

 Indemnification
Agreements and Insurance

 We
have entered into an indemnification agreement with each of our directors and senior officers and purchased directors' and officers'
liability insurance. The indemnification agreements require us to indemnify our directors and officers to the fullest extent permitted
under Delaware law.

 Review,
Approval or Ratification of Transactions with Related Parties

 Prior
to the Merger Closing, Pre-Merger Oruka did not have a formal policy regarding approval of transactions with related parties. All disclosable
transactions with related parties that occurred prior to the Merger Closing were approved by the directors not interested in such transactions,
pursuant to Section 144(a)(1) of the DGCL.

 Our
Board has adopted a written related person transactions policy. Under this policy, our executive officers, directors, nominees for election
as a director, beneficial owners of more than 5% of our Common Stock, and any members of the immediate family of and any entity affiliated
with any of the foregoing persons, are not permitted to enter into a material related person transaction with us without the review and
approval of our Audit Committee, or a committee composed solely of independent directors in the event it is inappropriate for our Audit
Committee to review such transaction due to a conflict of interest. The policy provides that, subject to limited exceptions, any transaction,
arrangement or relationship or series of similar transactions, arrangements or relationships in which (1) the aggregate amount involved
since the beginning of the Company's last completed fiscal year exceeds or is expected to exceed $120,000, (2) the Company or any
of our subsidiaries is a participant, and (3) any related person has or will have a direct or indirect interest, will be presented to
our Audit Committee for review, consideration and approval. In approving or rejecting any such proposal, our Audit Committee will consider
the material facts and other factors it deems appropriate, including, but not limited to, whether the transaction is on terms no less
favorable than terms generally available to an unaffiliated third party under the same or similar circumstances and the extent of the
related person's interest in the transaction.

Independence

 Our
Board has reviewed the independence of all directors in light of each director's (or any family member's, if applicable)
affiliations with the Company and members of management, as well as significant holdings of our securities and all other facts and circumstances
that the Board has deemed relevant in determining the independence of each director. The Board has determined that each of the directors
other than Lawrence Klein, our current President and Chief Executive Officer, including Kristine Ball, Carl Dambkowski, Peter Harwin,
Samarth Kulkarni and Cameron Turtle, qualify as "independent directors" as defined by the Nasdaq listing rules.

 Nasdaq
listing rules have objective tests and a subjective test for determining who is an "independent director." The subjective
test states that an independent director must be a person who lacks a relationship that, in the opinion of the Board, would interfere
with the exercise of independent judgment in carrying out the responsibilities of a director. The Board has not established categorical
standards or guidelines to make these subjective determinations but considers all relevant facts and circumstances.

 In
addition, ARCA's board of directors determined that former directors Drs. Linda Grais, Anders Hove and Raymond Woosley, and Messrs.
Robert Conway, Daniel Mitchell and James Flynn were independent during the period each served on the Board in 2024. ARCA's board
of directors determined Dr. Michael R. Bristow, ARCA's former President and Chief Executive Officer, was not an independent director
in 2024 by virtue of his employment relationship with ARCA.

 Item
14. Principal Accountant Fees and Services.

 Principal
Accountant Fees and Services

 The
following is a summary of the audit fees billed and expected to be billed for the indicated fiscal year to Oruka by PricewaterhouseCoopers
LLP ("PwC"), Pre-Merger Oruka's independent registered public accounting firm and Oruka's independent registered
public accounting firm on and after August 30, 2024, and the fees billed by PwC for all other services rendered during the indicated
fiscal year. All services associated with such fees on and after August 30, 2024 were pre-approved by our Audit Committee in accordance
with the "Pre-Approval Policies and Procedures" described below.

 Fiscal
 Year ended
 2024

 Audit Fees (1)

 $
 1,928,000

 Audit-Related Fees

 —

 Tax Fees

 —

 All
 Other Fees (2)

 2,000

 Total

 $
 1,930,000

 (1)
 Audit
 Fees consisted of fees and expenses covering the audit of our consolidated financial statements,
 reviews of our interim quarterly reports, accounting and financial reporting consultations,
 and the issuance of consents and comfort letters in connection with registration statement
 filings with the Securities and Exchange Commission (the "SEC").

 (2)
 All
 Other Fees consist of all other services and fees billed for an annual subscription to PwC's
 online resource library.

 Pre-Approval
Policies and Procedures

 In
connection with the Merger Closing, our Board and Audit Committee adopted a policy and procedures for the pre-approval of audit
and non-audit services performed by our independent registered public accounting firm. These procedures generally approve the
performance of specific services subject to a cost limit for all such services. This general approval is reviewed, and if necessary modified,
at least annually. Management must obtain the specific prior approval of the Audit Committee for each engagement of our independent registered
public accounting firm to perform other audit-related or non-audit services. The Audit Committee does not delegate its responsibility
to pre-approve services performed by our independent registered public accounting firm to any member of management. The Audit Committee
has delegated authority to the Audit Committee chair to pre-approve audit and non-audit services to be provided to us by our independent
registered public accounting firm provided that the fees for such services do not exceed $100,000. Any pre-approval of services by the
Audit Committee chair pursuant to this delegated authority must be reported to the Audit Committee at its next regularly scheduled meeting.

 PART
IV

 Item
15. Exhibits, Financial Statement Schedules.

 (a)
 The
 following documents are filed as part of this Annual Report:

 (1)
 Financial
 Statements

 See
Index to Financial Statements included in Part II, Item 8 of this Annual Report.

 (2)
 Financial
 Statement Schedules

 All
schedules are omitted because they are not applicable or the required information is shown in the financial statements or notes thereto.

 (3)
 List
 of Exhibits required by Item 601 of Regulation S-K

 Incorporation
 By Reference

 Exhibit

 Description

 Form

 Exhibit

 No.

 Filing
 Date

 2.1

 Agreement
 and Plan of Merger and Reorganization, dated as of April 3, 2024, by and among ARCA biopharma, Inc., Atlas Merger Sub Corp., Atlas
 Merger Sub II, LLC and Oruka Therapeutics, Inc.

 2.1

 4/3/2024

 3.1

 Second
 Amended and Restated Certificate of Incorporation

 3.5

 3.2

 and Restated Bylaws

 3.6

 3.3

 Form
 of Certificate of Designation of Preferences, Rights and Limitations of Series A Convertible Preferred Stock

 S-1/A

 3.1(b)

 5/24/2013

 3.4

 Certificate
 of Elimination of Series A Convertible Preferred Stock, dated August 29, 2024

 3.8

 3.5

 Certificate
 of Designation of Preferences, Rights and Limitations of Series B Non-Voting Convertible Preferred Stock

 3.9

 3.6

 Certificate
 of Designation of Preferences, Rights and Limitations of Series A Non-Voting Convertible Preferred Stock

 3.1

 9/13/2024

 4.1

 Description
 of Securities

 Filed

 4.2

 Investors'
 Rights Agreement by and among Oruka Therapeutics, Inc. and certain investors, dated March 6, 2024

 S-4

 4.3

 4.3

 Form
 of Pre-Funded Warrant, dated August 29, 2024

 Filed

 4.4

 Form
 of Pre-Funded Warrant, dated September 13, 2024

 4.1

 9/13/2024

 10.1#

 Oruka
Therapeutics, Inc. 2024 Stock Incentive Plan

 10.10

 10.2#

 Oruka
Therapeutics, Inc. 2024 Employee Stock Purchase Plan

 10.11

 10.3#

 and Restated 2024 Equity Incentive Plan

 S-4

 10.40

 10.4#

 Second
 Amendment to the Oruka Therapeutics, Inc. Amended and Restated 2024 Equity Incentive Plan

 10.13

 10.5#

 Form
 of Employee Warrant Agreement

 10.16

 10.6#

 Form
 of Grant Notice for Nonqualified Stock Option and Standard Terms and Conditions for Stock Options (Directors)

 S-8

 99.2

 11/14/2024

 10.7#

 Form
 of Grant Notice for Stock Option and Standard Terms and Conditions for Stock Options (Employees)

 S-8

 99.3

 11/14/2024

 10.8#

 Form
 of Stock Option Agreement under the Oruka Therapeutics, Inc. Amended and Restated 2024 Equity Incentive Plan

 S-4

 10.42

 10.9#

 Separation
 Agreement and Release by and between Michael Bristow and ARCA biopharma, Inc., dated April 3, 2024

 10.1

 4/4/2024

 10.10#

 Second
 Amendment to Retention Bonus Letter by and between ARCA biopharma, Inc. and Thomas A. Keuer, dated April 22, 2024

 10.1

 4/23/2024

 10.11#

 Second
 Amendment to Retention Bonus Letter by and between ARCA biopharma, Inc. and C. Jeffrey Dekker

 10.2

 4/23/2024

 10.12 #

 Consulting
 Agreement, effective as of August 30, 2024, by and between the Company and Jeff Dekker

 10.25

 10.13#

 and Restated Director Offer Letter, dated March 22, 2024, by and between Oruka Therapeutics, Inc. and Samarth Kulkarni

 S-4

 10.43

 10.14#

 Offer Letter, dated April 24, 2024, by and between Oruka Therapeutics, Inc. and Kristine Ball

 S-4

 10.44

 10.15#

 and Restated Employment Letter Agreement by and between Oruka Therapeutics, Inc. and Lawrence Klein, dated October 3, 2024

 10.1

 10/4/2024

 10.16#

 and Restated Employment Letter Agreement by and between Oruka Therapeutics, Inc. and Arjun Agarwal, dated October 3, 2024

 10.2

 10/4/2024

 10.17*#

 Amended and Restated Employment Letter Agreement by and between Oruka Therapeutics, Inc. and Paul Quinlan, dated October 1, 2024

 Filed

 10.18*#

 Amended and Restated Employment Letter Agreement by and between Oruka Therapeutics, Inc. and Joana Goncalves, dated October 1, 2024

 Filed

 10.19*#

 Form of Indemnification Agreement

 Filed

 10.20*

 Non-Employee Directors Compensation Program

 Filed

 10.21

 Form
 of Lock-Up Agreement

 10.4

 4/3/2024

 10.22

 Form
 of Amendment to Subscription Agreement

 10.1

 7/9/2024

 10.23

 Form
 of Amended & Restated Subscription Agreement

 10.2

 7/9/2024

 10.24

 Form
 of Registration Rights Agreement, dated August 29, 2024

 10.4

 11/13/2024

 10.25

 Purchase Agreement by and between Oruka Therapeutics, Inc. and each of the entities listed on Exhibit A thereto, dated September
 11, 2024

 10.1

 9/13/2024

 10.26

 Form
 of Registration Rights Agreement, dated as of September 13, 2024

 10.2

 9/13/2024

 10.27

 Asset
 Purchase Agreement, dated August 14, 2024, by and between ARCA biopharma, Inc. and Genvara Biopharma, Inc.

 10.1

 8/15/2024

 10.28

 and Restated Antibody Discovery and Option Agreement (IL-17) by and among Paragon Therapeutics, Inc., Paruka Holding, LLC, and Oruka
 Therapeutics, Inc. dated March 28, 2024

 S-4/A

 10.50

 6/18/2024

 10.29*

 IL-17 License Agreement by and between Paragon Therapeutics, Inc. and Oruka Therapeutics, Inc., dated February 4, 2025

 Filed

 10.30

 and Restated Antibody Discovery and Option Agreement (IL-23) by and among Paragon Therapeutics, Inc., Paruka Holding, LLC, and Oruka
 Therapeutics, Inc. dated March 28, 2024

 S-4/A

 10.51

 6/18/2024

 10.31*

 IL-23 License Agreement by and between Paragon Therapeutics, Inc. and Oruka Therapeutics, Inc., dated December 17, 2024

 Filed

 10.32*

 Cell
 Line License Agreement by and between WuXi Biologics Ireland Limited and Oruka Therapeutics, Inc., dated March 4,
 2024

 Filed

 10.33*

 Amendment
 No. 1 to the Cell Line License Agreement by and between WuXi Biologics Ireland Limited and Oruka Therapeutics, Inc., dated November
 20, 2024

 Filed

 14.1

 Code
 of Business Conduct and Ethics

 14.1

 16.1

 Letter
 from KPMG LLP, dated September 5, 2024

 16.1

 19.1*

 Insider Trading Policy

 Filed

 21.1*

 List of subsidiaries of the Registrant

 Filed

 23.1*

 Consent of Independent Registered Public Accounting Firm

 Filed

 24.1*

 Power of Attorney (Incorporated by reference to the signature page of this Annual Report on Form 10-K)

 Filed herewith

 31.1*

 Certification
 of the Principal Executive Officer pursuant to Rule 13a-14(a) or 15d-14(a) promulgated under the Securities Exchange Act of 1934

 Filed

 31.2*

 Certification
 of the Principal Financial Officer pursuant to Rule 13a-14(a) or 15d-14(a) promulgated under the Securities Exchange Act of 1934

 Filed

 32.1**

 Certification
 of the Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. Section 1350 and Rule 13a-14(B) promulgated
 under the Securities Exchange Act of 1934

 Furnished

 97.1*

 Incentive
 Compensation Clawback Policy

 Filed

 101.INS*

 Document

 Filed

 101.SCH *

 Extension Schema with Embedded Linkbases Document

 Filed

 101.CAL *

 Inline

 Filed

 101.DEF*

 Inline

 Filed

 101.LAB *

 Inline

 Filed

 101.PRE *

 Inline

 Filed

 Cover Page Interactive

 *
 Filed
 herewith.

 **
 Furnished
 herewith. The certifications on Exhibit 32.1 hereto are deemed not "filed" for
 purposes of Section 18 of the Exchange Act or otherwise subject to the liability of that
 Section. Such certifications will not be deemed incorporated by reference into any filing
 under the Securities Act or the Exchange Act.

 #
 Indicates
 management contract or compensatory plan.

 Exhibits
 and/or schedules have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The Company
 hereby undertakes to furnish supplementally copies of any of the omitted exhibits and schedules
 upon request by the SEC; provided, however, that the Company may request confidential treatment
 pursuant to Rule 24b-2 under the Exchange Act for any exhibits or schedules so furnished.
 Certain portions of this exhibit (indicated by "[***]") have been omitted because
 they are both (i) not material and (ii) is the type of information that the registrant both
 customarily and actually treats as private and confidential.

 Item
16. Form 10-K Summary

 None.

 SIGNATURES

to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this Report
to be signed on its behalf by the undersigned, thereunto duly authorized.

 Oruka
 Therapeutics, Inc.

 Date:
 March 6, 2025

 By:

 /s/
 Lawrence Klein

 Klein

 President
 and Chief Executive Officer

 (Principal
 Executive Officer)

 POWER
OF ATTORNEY

 KNOW
ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Dr. Lawrence Klein and Mr. Arjun
Agarwal, jointly and severally, his or her attorneys-in-fact, each with the power of substitution, for him or her in any and all capacities,
to sign any amendments to this Report on Form 10-K and to file same, with exhibits thereto and other documents in connection therewith,
with the Securities and Exchange Commission, hereby ratifying and confirming all that each of said attorneys-in-fact, or his substitutes,
may do or cause to be done by virtue hereof.

to the requirements of the Securities Exchange Act of 1934, as amended, this Report has been signed below by the following persons on
behalf of the Registrant in the capacities and on the dates indicated.

 Signature

 Title

 Date

 /s/
 Lawrence Klein

 Chief
 Executive Officer & Director

 March

 Klein

 (Principal
 Executive Officer)

 /s/
 Arjun Agarwal

 Senior
 Vice President, Finance and Treasurer

 March

 Arjun
 Agarwal

 (Principal
 Financial Officer and Principal Accounting Officer)

 /s/
 Samarth Kulkarni

 Chairman
 of the Board

 March

 Samarth
 Kulkarni

 /s/
 Kristine Ball

 March

 Kristine
 Ball

 /s/
 Carl Dambkowski

 March

 Carl
 Dambkowski

 /s/
 Peter Harwin

 March

 Peter
 Harwin

 /s/
 Cameron Turtle

 March

 Cameron
 Turtle

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