UNITED
STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 FORM

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

 For
the fiscal year ended: December 31, 2023

 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: 001-34673

INC.

(Exact name of Registrant as Specified in Its Charter)

 Delaware

 20-5894890

 (State or Other Jurisdiction of
 Incorporation or Organization)

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

 300 Connell Drive, Suite 4200, Berkeley Heights, NJ

 07922

 (Address of Principal Executive Offices)

 (Zip Code)

 Registrant's
telephone number, including area code: (908) 517-9500

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

 Title of each class

 Trading Symbol

 Name of each exchange on which registered

 Common Stock, $0.001 Par Value

 CRMD

 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 Section 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 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, a 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 news 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 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 Act).

 Yes
 No

 The
aggregate market value of the registrant's voting common equity held by non-affiliates of the registrant, based upon the closing
price of the registrant's common stock on the last business day of the registrant's most recently completed second fiscal
quarter was approximately $ 180.0 million.

 The number of outstanding shares of the registrant's
common stock was 54,981,102 as of March 7, 2024.

 DOCUMENTS
INCORPORATED BY REFERENCE

 None.

INC.

 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

 Item 5.

 Market
 for the 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.

 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

 Item 10.

 Directors,
 Executive Officers, and Corporate Governance

 Item 11.

 Compensation

 Item 12.

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

 Item 13.

 Certain
 Relationships and Related Transactions and Director Independence

 Item 14.

 Principal
 Accounting Fees and Services

 Item 15.

 Exhibits,
 Financial Statement Schedules

 Item 16.

 Form
 10-K Summary

 SIGNATURES

 i

 Forward-Looking
Statements

 This
Annual Report on Form 10-K contains "forward-looking statements" that involve risks and uncertainties, as well as assumptions
that, if they never materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such
forward-looking statements. The statements contained in this Annual Report on Form 10-K that are not purely historical are forward-looking
statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E
of the Securities Exchange Act of 1934, as amended (the "Exchange Act"). Forward-looking statements are often identified
by the use of words such as, but not limited to, "anticipate," "believe," "can," "continue,"
"could," "estimate," "expect," "intend," "may," "will," "plan,"
"project," "seek," "should," "target," "will," "would," and similar
expressions or variations intended to identify forward-looking statements. These statements are based on the beliefs and assumptions
of our management based on information currently available to management, including, but not limited to, statements regarding our commercial
launch efforts, our ability to obtain coverage and reimbursement for use of DefenCath
 by third party payors, the timing and qualification of our contract manufacturing organization alternative manufacturing
site, and our future financial position, financing plans, future revenues, projected costs and sufficiency of our cash and short term
investments to fund our operations which should be considered forward-looking. Such forward-looking statements are subject to risks,
uncertainties and other important factors that could cause actual results and the timing of certain events to differ materially from
future results expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include,
but are not limited to, those identified below in the Risk Factor Summary and section titled "Item 1A. Risk Factors." Furthermore,
such forward-looking statements speak only as of the date of this Annual Report on Form 10-K. Except as required by law, we undertake
no obligation to update any forward-looking statements to reflect events or circumstances after the date of such statements. In addition,
with respect to all our forward-looking statements, we claim the protection of the safe harbor for forward-looking statements contained
in the Private Securities Litigation Reform Act of 1995.

 Risk Factor
Summary

 The
following is a summary of material risks that could affect our business. This summary may not contain all of our material risks, and
it is qualified in its entirety by the more detailed risk factors set forth in Item 1.A "Risk Factors."

 Risks
Related to our Financial Position and Need for Additional Capital

 We
 have a history of operating losses, expect to incur additional operating losses in the future
 and may never be profitable

 We
may need to finance our future cash needs through public or private equity offerings, debt financings or corporate collaboration and
licensing arrangements, which may not be on terms favorable to us or our stockholders and may require us to relinquish valuable rights

 Risks
Related to the Commercialization of DefenCath

 We
 are highly dependent on the successful commercialization of our only approved product, DefenCath

 The successful commercialization of
 DefenCath will depend on obtaining coverage and reimbursement for use of DefenCath from third-party payors.

 The Company has applied for a HCPCS code and TDAPA for DefenCath.
While CMS has advised it is working toward a July 1, 2024 implementation date, there is no guarantee that the applications will be approved
or that TDAPA implementation will take place on or before July 1, 2024

 The
 expected outpatient demand for DefenCath is highly concentrated, with two large customers
 accounting for more than 70% of total outpatient dialysis treatments. The failure of one or both
 of these large dialysis providers to utilize DefenCath could adversely impact the commercial
 launch of DefenCath

 Risks
Related to the Development and Commercialization of our Other Products

 Successful
 development and commercialization of our product candidates is uncertain

 Final
 approval by regulatory authorities of our product candidates for commercial use may be delayed,
 limited or prevented, any of which would adversely affect our ability to generate operating
 revenues

 Risks
Related to Healthcare Regulatory and Legal Compliance Matters

 DefenCath,
 and our product candidates (if approved), will be subject to extensive post-approval regulation

 Current
 healthcare laws and regulations in the U.S. and future legislative or regulatory reforms
 to the U.S. healthcare system may affect our ability to commercialize DefenCath and future
 marketed products profitably

 We
 are subject to laws and regulations relating to privacy, data protection and the collection
 and processing of personal data. Failure to maintain compliance with these regulations could
 create additional liabilities for us

 ii

 Clinical
 trials required for our new product candidates or for expanded uses of DefenCath may be expensive
 and time-consuming, and their outcome is uncertain

 If
 we are unable to effectively recruit, train, retain and equip our sales force, our ability
 to successfully commercialize DefenCath will be harmed

 Risks
Related to Our Business and Industry

 institutions, physicians and patients may not accept and use our products

 Competition
 and technological change may make our products and technologies less attractive or obsolete

 policy changes, including reimbursement policies for drugs and medical devices, may have
 an adverse effect on our business, financial condition and results of operations

 If
 we lose key management or scientific personnel, cannot recruit qualified employees, directors,
 officers, or other personnel or experience increases in compensation costs, our business
 may materially suffer

 in funding for the FDA and other government agencies or future government shutdowns or disruptions
 could cause delays in the submission and regulatory review of marketing applications, including
 supplements, which could negatively impact our business or prospects

 If
 we are unable to hire additional qualified personnel, our ability to grow our business may
 be harmed

 We
 may not successfully manage our growth

 We
 face the risk of product liability claims and the amount of insurance coverage we hold now
 or in the future may not be adequate to cover all liabilities we might incur

 We
 may be exposed to liability claims associated with the use of hazardous materials and chemicals

 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 harm our business

 Negative
 U.S. and global economic conditions may pose challenges to our business strategy, which relies
 on funding from the financial markets or collaborators

 Risks
Related to Our Intellectual Property

 If
 we materially breach or default under our License and Assignment Agreement (the "ND
 License Agreement") with ND Partners, LLC ("NDP"), NDP would have the right
 to terminate the ND License Agreement, which would materially harm our business

 If
 we do not obtain protection for and successfully defend our respective intellectual property
 rights, competitors may be able to take advantage of our research and development efforts
 to develop competing products

 Intellectual
 property disputes could require us to spend time and money to address such disputes and could
 limit our intellectual property rights

 If
 we infringe the rights of third parties we could be prevented from selling products and forced
 to pay damages and defend against litigation

 Risks
Related to Dependence on Third Parties

 If
 we or our collaborators are unable to manufacture our products in sufficient quantities or
 experience quality or manufacturing problems, we may be unable to meet demand for our products
 and we may lose potential revenues

 We
 depend on third party suppliers and contract manufacturers for the manufacturing of DefenCath
 and all key active pharmaceutical ingredients ("APIs"), which subjects us to
 potential cost increases and manufacturing delays that are not within our control

 iii

 We
 currently have one FDA approved supplier for each of our key APIs, taurolidine and heparin,
 respectively, as well as one currently FDA approved manufacturing site for DefenCath finished
 dosage. We are actively working to qualify an alternative manufacturing site for finished
 dosage as well as making preparations to qualify alternative sources of both APIs. There
 is no guarantee we will be successful in these endeavors.

 Corporate
 and academic collaborators may take actions that delay, prevent, or undermine the success
 of new development products or expanded uses of DefenCath

 Data
 provided by collaborators and others upon which we rely that has not been independently verified
 could turn out to be false, misleading or incomplete

 We may rely on third parties to conduct our clinical trials and pre-clinical
studies. If those parties do not successfully carry out their contractual duties or meet expected deadlines, our product candidates may
not advance in a timely manner or at all

 Risks
Related to Our Common Stock

 Our
 executive officers and directors may sell shares of their stock, and these sales could adversely
 affect our stock price

 Our
 common stock price has fluctuated considerably and is likely to remain volatile, and you
 could lose all or a part of your investment

 A
 significant number of additional shares of our common stock may be issued at a later date,
 and their sale could depress the market price of our common stock

 Provisions
 in our corporate charter documents and under Delaware law could make an acquisition of us,
 which may be beneficial to our stockholders, more difficult

 If
 we fail to comply with the continued listing standards of the Nasdaq Global Market, it may
 result in a delisting of our common stock from the exchange

 Laws,
 rules and regulations relating to public companies may be costly and impact our ability to
 attract and retain directors and executive officers

 Our
 internal control over financial reporting and our disclosure controls and procedures may
 not prevent all possible errors that could occur

 Security
 breaches and other disruptions could compromise our information and expose us to liability,
 which would cause our business and reputation to suffer

 We do not currently pay dividends on our common stock so any returns
on our common stock may be limited to the value of our common stock

 We
 are a "smaller reporting company" and we cannot be certain if the reduced reporting
 requirements applicable to such companies could make our common stock less attractive to
 investor.

 iv

 PART
I

Item 1. Business

 Overview

 We
are a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening
diseases and conditions.

 Our
primary focus is on the commercialization of our lead product, DefenCath in the United States. We have in-licensed the
worldwide rights to develop and commercialize DefenCath. The name DefenCath is the U.S. proprietary name approved by the U.S. Food and
Drug Administration, or FDA.

 DefenCath is an antimicrobial
catheter lock solution ("CLS") (a formulation of taurolidine 13.5 mg/mL, and heparin 1000 USP Units/mL) indicated to reduce
the incidence of catheter-related bloodstream infections ("CRBSI") in adult patients with kidney failure receiving chronic
hemodialysis through a central venous catheter ("CVC"). It is indicated for use in a limited and specific population of patients.
CRBSIs can lead to treatment delays and increased costs to the healthcare system when they occur due to hospitalizations, need for IV
antibiotic treatment, long-term anticoagulation therapy, removal/replacement of the CVC, related treatment costs, as well as increased
mortality. We believe DefenCath can address a significant unmet medical need.

 DefenCath
– United States

 On November 15, 2023, we announced
that the FDA approved the new drug application ("NDA") for DefenCath to reduce the incidence of CRBSI in adult patients with
kidney failure receiving chronic hemodialysis through a CVC. DefenCath is indicated for use in a limited and specific population of patients.
DefenCath is the first and only FDA-approved antimicrobial CLS in the U.S. and was shown to reduce the risk of CRBSI by up to 71% in a
Phase 3 clinical study. As a result of the November 2023 FDA approval, we are currently preparing for the commercial launch of DefenCath.

 DefenCath is listed in the
Orange Book as having New Chemical Entity or NCE exclusivity (5 years) expiring on November 15, 2028, and the Generating Antibiotic Incentives
Now or GAIN exclusivity extension of the NCE exclusivity (an additional 5 years) expiring on November 15, 2033. The GAIN exclusivity extension
of 5 years is the result of the January 2015 designation of DefenCath as a Qualified Infectious Disease Product ("QIDP").

 As part of the DefenCath approval
letter, the FDA communicated the existence of a required pediatric assessment under the Pediatric Research Equity Act ("PREA").
PREA requires sponsors to conduct pediatric studies for, among other things, NDAs for a new active ingredient, such as taurolidine in
DefenCath, unless a waiver or deferral is obtained from the FDA. A deferral acknowledges that a pediatric assessment is required but permits
the applicant to submit the pediatric assessment after the submission of an NDA. FDA deferred submission of the pediatric study for DefenCath
because the product is ready for approval for use in adults and the pediatric study has not been completed. We are obligated to conduct
the study communicated in the approval letter: an open-label, two-arm (DefenCath vs. standard of care) study to assess safety and time
to CRBSI in subjects from birth to less than 18 years of age with kidney failure receiving hemodialysis via a central venous catheter.
Because this is a required post-marketing study, we must make annual reports to the FDA. Pediatric studies for an approved product conducted
under PREA may qualify for pediatric exclusivity, which, if granted, provides an additional six months of exclusivity that attaches to
the end of existing marketing exclusivity and patent periods for DefenCath. Depending on the timing of final report submission, DefenCath
could potentially receive a total marketing exclusivity period of 10.5 years. However, there are factors that could affect whether this
exclusivity is received or the duration of exclusivity, and DefenCath may or may not ultimately be eligible for the additional 0.5 years
of exclusivity associated with this pediatric study.

 We announced on April 26,
2023 that following the submission of a duplicate New Technology Add-On Payment ("NTAP") application in the fourth quarter
of 2022 to the Centers for Medicare & Medicaid Services ("CMS"), CMS has subsequently issued the Inpatient Prospective
Payment System ("IPPS") 2024 proposed rule that includes a NTAP of up to $17,111 per hospital stay for DefenCath. This NTAP
represents reimbursement to inpatient facilities of 75% of the anticipated wholesaler acquisition cost ("WAC") price of $1,170
per 3 mL vial, and an average utilization of 19.5 vials per hospital stay. The final IPPS rule was published in early August 2023 and
confirmed this payment amount in that final rule. This NTAP was conditioned upon the DefenCath NDA obtaining final FDA approval prior
to July 1, 2024. As the NTAP was calculated by CMS based upon an anticipated WAC price of $1,170, and following FDA approval of the DefenCath
NDA, an actual WAC of $249.99 per 3ml vial was established, we anticipate that CMS will revise the amount of the NTAP payment to reflect
the actual WAC price in the next IPPS rulemaking, effective October 1, 2024. Upon the listing in the compendia of the actual WAC price
of $249.99 per 3ml vial, we notified CMS of the new lower WAC pricing and recommended that CMS make an off-cycle adjustment to the NTAP
to reflect the current lower WAC pricing amount. CMS subsequently communicated to us that they do not intend to update the NTAP reimbursement
amount until the next review cycle in October 2024.

 On January 25, 2024, CMS determined
that DefenCath should be classified as a renal dialysis service that is subject to the Medicare end-stage renal disease prospective payment
system ("ESRD PPS"). The ESRD PPS provides bundled payment for renal dialysis services, but also affords a transitional drug
add-on payment adjustment, or TDAPA, which provides temporary, additional payments for certain new drugs and biologicals. We submitted
an application for TDAPA on January 26, 2024, and CMS has confirmed receipt. We also submitted a HCPCS application for a J-code to CMS
on December 8, 2023, for DefenCath, which is relevant to billing and the TDAPA application. CMS has confirmed the coding application is
under review. TDAPA reimbursement is calculated based on 100 percent of the average selling price ("ASP") (or 100 percent
of WAC or else manufacturers' list price, respectively, if such data is unavailable). If CMS grants TDAPA and post-TDAPA add-on
payment adjustments for DefenCath, collective payments would be for five years (with such post-TDAPA add-on payments applying to all ESRD
PPS payments for years three through five). CMS confirmed to us that, assuming a favorable review, CMS is working towards a July 1, 2024
implementation date for TDAPA.

 We may pursue additional indications
for DefenCath use as a CLS in populations with unmet medical needs that may also represent potentially significant market opportunities.
While we are continuing to assess these areas, potential future indications may include use as a CLS to reduce CRBSIs in total parenteral
nutrition patients using a central venous catheter and in certain oncology patients using a central venous catheter. In 2024, we anticipate
discussing with the FDA potential pathways for expanded indications.

 We
announced on May 1, 2023 that the United States Patent and Trademark Office ("USPTO") allowed our patent application directed
to a locking solution composition for treating and reducing infection and flow reduction in central venous catheters. This application
was granted on August 29, 2023 as U.S. Patent No. 11,738,120. Our newly granted U.S. Patent reflects the unique and proprietary
formulation of our product, DefenCath, for which we received FDA approval on November 15, 2023. This patent supplements the coverage
of our existing licensed U.S. Patent No. 7,696,182, and has the potential to provide an additional layer of patent protection for DefenCath
through 2042.

 Neutrolin
– International

 Neutrolin
was previously sold in the European Union, or EU, and other territories where we received CE-Mark approval for the commercial distribution
of Neutrolin as a CLS. We have elected to discontinue sales of Neutrolin for lack of commercial viability. The winding down of our operations
in the EU is nearly complete and Neutrolin sales in both the EU and the Middle East have been discontinued since 2022.

 Additional
Development Possibilities

 In
addition to DefenCath, we have sponsored a pre-clinical research collaboration for the use of taurolidine as a possible treatment for
rare pediatric tumors. In February 2018, the FDA granted orphan drug designation to taurolidine for the treatment of neuroblastoma in
children. We may seek one or more strategic partners or other sources of capital to help us develop and commercialize taurolidine for
the treatment of neuroblastoma in children.

 License
Agreement with NDP Partners

 On January 30, 2008, we entered
into a License and Assignment Agreement, or the ND License Agreement, with ND Partners LLC, or NDP. Pursuant to the ND License Agreement,
NDP granted us exclusive, worldwide licenses for certain antimicrobial catheter lock solutions, processes for treating and inhibiting
infections, a biocidal lock system and a taurolidine delivery apparatus, and the corresponding United States and foreign patents and applications
(the "NDP Technology"). NDP also granted us exclusive licenses, with the right to grant sublicenses, to use and display certain
trademarks in connection with the NDP Technology. As consideration in part for the rights to the NDP Technology, we paid NDP an initial
licensing fee of $325,000 and granted NDP an equity interest in our Company consisting of 73,107 shares of common stock as of December
31, 2010. In addition, we are required to make cash payments to NDP upon the achievement of certain milestones. The maximum aggregate
amount of cash payments upon achievement of milestones is $3,000,000, with $2,000,000 remaining at December 31, 2023.

 During the year ended December
31, 2013, a milestone payment of $500,000 was earned by NDP upon the first issuance of the CE Mark for Neutrolin. On April 11, 2013, we
entered into an amendment to the ND License Agreement which extended the milestone payment from within 30 days after such issuance to
within twelve months after the achievement of such issuance. As consideration for the amendment, we issued NDP a five-year warrant to
purchase 25,000 shares of our common stock at an exercise price of $7.50 per share. The warrant, which was exercisable immediately upon
issuance, expired in April 2018. In January 2014, the $500,000 milestone payment due to NDP was converted into 10,000 Series C-3 non-voting
preferred stock and a warrant to purchase 50,000 shares of our common stock at an exercise price of $4.50 per share. These warrants expired
and were unexercised during the year ended December 31, 2020.

 During the year ended December
31, 2014, a certain milestone was achieved resulting in the release of 7,277 shares held in escrow. The terms of the escrow agreement
provide that if, as of December 31, 2022, any shares remain in escrow, such shares will be returned to the Company and cancelled. There
were no milestones achieved in 2023 or 2022.

 The ND License Agreement will
expire on a country-by-country basis upon the earlier of (i) the expiration of the last patent claim under the ND License Agreement in
a given country, or (ii) the payment of all milestone payments. Upon the expiration of the ND License Agreement in each country, we will
have an irrevocable, perpetual, fully paid-up, royalty-free exclusive license to the NDP Technology in such country. The ND License Agreement
also may be terminated by NDP if we materially breach or default under the ND License Agreement and that breach is not cured within 60
days following the delivery of written notice to us, or by us on a country-by-country basis upon 60 days prior written notice. If the
ND License Agreement is terminated by either party, our rights to the NDP Technology will revert back to NDP.

 We announced on May 1, 2023
that the USPTO allowed our patent claims directed to a locking solution composition for treating and reducing infection and flow reduction
in central venous catheters. Our newly issued U.S. Patent 11,738,120 reflects the unique and proprietary formulation of our product, DefenCath,
for which we received FDA approval on November 15, 2023. The newly issued patent provides patent coverage that supplements our existing
licensed U.S. Patent No. 7,696,182, and has the potential to provide an additional layer of patent protection for DefenCath through 2042.

 We believe that the patents
and patent applications we have licensed pursuant to the ND License Agreement cover effective solutions to the various medical problems
discussed previously when using taurolidine in clinical applications, and specifically in hemodialysis applications. The foregoing summary
of the ND License Agreement does not purport to be complete and is qualified in its entirety by reference to the ND License Agreement,
attached as an exhibit hereto and which is incorporated by reference herein.

 DefenCath

 Market
Opportunity

 Central
venous catheters, or CVCs, and peripherally inserted central catheters, or Central Catheters, are an important and frequently used method
for accessing the vasculature for hemodialysis (a form of dialysis where the patient's blood is circulated through a dialysis filter),
administering chemotherapy and basic fluids in cancer patients and for cancer chemotherapy, administering long term antibiotic therapy,
and administering total parenteral nutrition (complete or partial dietary support via intravenous nutrients).

 Bloodstream
infections resulting from the use of central catheters known as CRBSIs can result in significant morbidity and increased rates of hospital
admissions, readmissions and mortality. One of the major and common risk factors for all patients requiring CVCs is CRBSI and the clinical
complications associated with them. The total annual cost for treating CRBSI episodes and their related complications in the U.S. is
up to $2.3 billion, with approximately 250,000 CRBSI episodes per year (Becker's Hospital Review).

 According
to the 2022 United States Renal Disease System, reporting data from 2020, there were nearly 808,000 End-Stage-Renal-Disease, or ESRD,
patients on permanent hemodialysis in the U.S. Of these, nearly 108,000 hemodialysis patients were new patients diagnosed with ESRD during
the year they were receiving dialysis through a CVC. Patients are typically treated in various care settings including inpatient hospitals
and outpatient dialysis clinics. Kidney failure patients can include ESRD, Acute Kidney Injury, or AKI and Chronic Kidney Disease, or
CKD, populations that progress into dialysis. Patients that present in the hospital have an average length of stay of 13.3 days and additionally
high 30-day readmission rates both for same diagnosis and all-cause with the all-cause readmissions being higher.

 Biofilm
build up is the pathogenesis of both infections and thrombotic complications in central venous catheters. Prevention of CRBSI and inflammatory
complications requires both removal of pathogens from the internal surface of the catheter to prevent the systemic dissemination of organisms
contained within the biofilm as well as an anticoagulant to retain blood flow during dialysis. Biofilm forms when bacteria adhere to
surfaces in aqueous environments and begin to excrete a slimy, glue-like substance that can anchor them to various types of materials,
including intravenous catheters. The presence of biofilm has many adverse effects, including the ability to release bacteria into the
blood stream. The current standard of catheter care is to instill a heparin lock solution at a concentration of 1000 u/mL into each catheter
lumen immediately following treatment, in order to prevent clotting between dialysis treatments. However, a heparin lock solution provides
no protection from the risk of infection.

 Other than DefenCath, there
are no pharmacologic drug products approved in the U.S. for the prevention or reduction of CRBSIs in CVCs. We believe there is a significant
need for reduction or prevention of CRBSIs in the hemodialysis patient population as well as for other patient populations utilizing central
venous catheters and peripherally inserted central catheters, such as oncology/chemotherapy, and total parenteral nutrition.

 DefenCath, our FDA-approved
product, is a non-antibiotic, broad-spectrum antibacterial, antifungal and anticoagulant combination that is active against common microbes
including antibiotic-resistant strains and in addition may prevent biofilm formation. We believe that using DefenCath as an anti-infective
catheter-lock solution will significantly reduce the incidence of life-threatening catheter-related blood stream infections, thus reducing
the need for local and systemic antibiotics while prolonging catheter function. We are unaware of any drug products other than DefenCath
approved by the FDA with an indication for use as a catheter lock solution.

 Competitive
Landscape

 The drug and medical device industries are highly
competitive and subject to rapid and significant technological change. DefenCath's potential competitors could include large as
well as specialty pharmaceutical and biotechnology companies and large and specialty medical device companies. Many of our potential competitors
have substantially greater financial, technical and human resources than we do and significantly more experience in the development and
commercialization of drugs and medical devices. Further, the development of new treatment methods could render DefenCath non-competitive
or obsolete.

 We believe that the key competitive
factors that will affect the commercial success of DefenCath are efficacy and safety, as well as pricing and reimbursement. Given that
DefenCath is the only approved catheter lock solution with antimicrobial properties in the U.S., we believe that with adequate reimbursement
there is an opportunity for DefenCath to become the new standard of care as a CLS in the U.S. market. We are not aware of any potentially
competitive CLS which are approved or under development by other companies in the U.S. As a means to reduce infections, some dialysis
providers may be using anti-infective infused catheter caps and/or compounded unapproved antibiotic catheter lock solutions.

 Manufacturing/Supply
Chain

 We
do not own or operate any manufacturing facilities related to the production of our products. All our manufacturing processes currently
are, and we expect them to continue to be, outsourced to third parties. We rely on third-party manufacturers to produce sufficient quantities
of drug product for use both commercially and in clinical trials. We intend to continue this practice in the future.

 We currently have one FDA
approved source for each of our two key active drug ingredients ("APIs") for DefenCath, taurolidine and heparin sodium, respectively.
With regards to taurolidine, we have a Drug Master File ("DMF") filed with the FDA. There is a master commercial supply agreement
between a third-party manufacturer and us in place from August 2018. We are currently in the process of identifying and qualifying an
alternate third-party manufacturer for taurolidine under our existing DMF. With respect to heparin sodium API, we have identified an alternate
third party supplier and intend to qualify such supplier under the DefenCath NDA over the next twelve months.

 We received FDA approval of
DefenCath with finished dosage production from our European based CMO Rovi Pharma Industrial Services. We believe this CMO has adequate
capacity to produce the volumes needed to meet near term projected demand for the commercial launch of DefenCath.

 We previously announced commercial
arrangements with additional finished dosage CMOs, Alcami Corporation and Siegfried Hameln, that provide for the manufacture of commercial
sterile parenteral drug products. The Company anticipates the submission to the FDA of a supplement adding Siegfreid Hameln as an alternate
manufacturing site in the second fiscal quarter of 2024. The Company will also discontinue its relationship with Alcami as a potential
alternate manufacturing site for DefenCath.

 We
note that CMOs and our API suppliers are subject to FDA oversight and inspection regarding compliance with cGMP, and if deemed non-compliant
with cGMP by FDA, we could face shortages or risk with respect to producing sufficient quantities of drug product or drug substance.

 United
States Government Regulation

 The
research, development, testing, manufacture, labeling, promotion, advertising, distribution, and marketing, among other things, of our
products are extensively regulated by governmental authorities in the U.S. and other countries. DefenCath is an FDA-approved drug, and
our other product candidates may be classified by the FDA as a drug or a medical device (or combination product) depending upon the indications
for use or claims, and/or how the product affects the structure or function of the body. Because certain of our product candidates are
considered as medical devices and others are considered as drugs for regulatory purposes, we intend to submit applications to regulatory
agencies for approval or clearance of medical device and pharmaceutical product candidates, or combination products, as appropriate.

 In
the U.S., the FDA regulates drugs and medical devices under the Federal Food, Drug, and Cosmetic Act ("FDCA") and the Agency's
implementing regulations. If we fail to comply with the applicable U.S. requirements at any time during the product development process,
clinical testing, and during the approval process or after approval, we may become subject to administrative or judicial sanctions. These
sanctions could include the FDA's refusal to approve pending applications, withdrawal of an approval, warning letters, adverse
publicity, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, civil penalties
or criminal prosecution, among other actions. Any agency enforcement action and/or any related impact could have a material adverse effect
on us.

 Drug
Approval Process

 The
research, development, and approval process in the U.S. and elsewhere is intensive and rigorous and generally takes many years to complete.
The typical process required by the FDA before a therapeutic drug may be marketed in the U.S. includes:

 Pre-clinical
 laboratory and animal tests performed under the FDA's Good Laboratory Practices, or
 GLP, regulations;

 submission
 to the FDA of an investigational new drug application, or IND, which must become effective
 before human clinical trials may commence;

 human
 clinical studies to evaluate the drug's safety and effectiveness for its intended uses;

 FDA
 review of whether the facility in which the drug is manufactured, processed, packaged, or
 held meets standards designed to assure the product's continued quality and compliance
 with cGMPs, and FDA review of clinical trial sites to determine whether the clinical trials
 were conducted in accordance with Good Clinical Practices, or GCPs; and

 submission
 of a new drug application, or NDA, to the FDA, and approval of the application by the FDA
 to allow sales of the drug.

pre-clinical testing, studies are performed with respect to the chemical and physical properties of candidate formulations. These studies
are subject to GLP requirements. Biological testing is typically done in animal models to demonstrate the activity of the compound against
the targeted disease or condition and to assess the apparent effects of the new product candidate on various organ systems, as well as
its relative therapeutic effectiveness and safety. An IND application must be submitted to the FDA and become effective before studies
in humans may commence.

 Clinical
trial programs in humans generally follow a three-phase process. Typically, Phase 1 studies are conducted in small numbers of healthy
volunteers or, on occasion, in patients afflicted with the target disease. Phase 1 studies are conducted to determine the metabolic and
pharmacological action of the product candidate in humans and the side effects associated with increasing doses, and, if possible, to
gain early evidence of effectiveness. In Phase 2, studies are generally conducted in larger groups of patients having the target disease
or condition in order to validate clinical endpoints, and to obtain preliminary data on the effectiveness of the product candidate and
optimal dosing. This phase also helps determine further the safety profile of the product candidate. In Phase 3, large-scale clinical
trials are generally conducted in patients having the target disease or condition to provide sufficient data for the statistical proof
of effectiveness and safety of the product candidate as required by United States and foreign regulatory agencies. Typically, two Phase
3 trials are required for marketing approval, though one such trial, plus confirmatory evidence, may be acceptable.

 Post-approval
trials, sometimes referred to as Phase 4 clinical trials, may be conducted after initial marketing approval. These trials are used to
gain additional experience from the treatment of patients in the intended therapeutic indication and are commonly intended to generate
additional safety data regarding use of the product in a clinical setting. In certain instances, the FDA may mandate the performance
of Phase 4 clinical trials as a condition of approval of an NDA or post-approval.

 Additionally,
some clinical trials are overseen by an independent group of qualified experts organized by the clinical trial sponsor, known as a data
safety monitoring board or committee. This group regularly reviews accumulated data and advises the study sponsor regarding the continuing
safety of trial subjects, and the continuing validity and scientific merit of the clinical trial. The data safety monitoring board receives
special access to unblinded data during the clinical trial and may advise the sponsor to halt the clinical trial if it determined there
is an unacceptable safety risk for subjects or on other grounds, such as no demonstration of efficacy. The committee can also stop a
clinical trial for an overwhelming demonstration of efficacy, based on pre-defined, stringent statistical parameters and ethical considerations.

 IND
sponsors are required to submit a number of reports to the FDA during the course of a development program. For instance, sponsors are
required to make annual reports to the FDA concerning the progress of their clinical trial programs as well as more frequent reports
for certain serious adverse events. Sponsors must submit a protocol for each clinical trial, and any subsequent protocol amendments to
the FDA. Investigators must also provide certain information to the clinical trial sponsors to allow the sponsors to make certain financial
disclosures to the FDA. Information about certain clinical trials, including a description of the study and study results, must be submitted
within specific timeframes to the National Institutes of Health, or NIH, for public dissemination on their clinicaltrials.gov website.
Moreover, under the 21st Century Cures Act, manufacturers or distributors of investigational drugs for the diagnosis, monitoring, or
treatment of one or more serious diseases or conditions must have a publicly available policy concerning expanded access to investigational
drugs.

 The
clinical trial process for a new compound can take ten years or more to complete. The FDA may prevent clinical trials from beginning
or may place clinical trials on hold at any point in this process if, among other reasons, it concludes that study subjects are being
exposed to an unacceptable health risk. Trials may also be prevented from beginning or may be terminated by institutional review boards,
or IRBs, who must review and approve all research involving human subjects and amendments thereto. The IRB must continue to oversee the
clinical trial while it is being conducted. This includes the IRB receiving information concerning unanticipated problems involving risk
to subjects. Side effects or adverse events that are reported during clinical trials can delay, impede, or prevent marketing authorization.
Similarly, adverse events that are reported after marketing authorization can result in additional limitations being placed on a product's
use and, potentially, withdrawal of the product from the market.

 Following
the completion of a clinical trial, the data are analyzed by the sponsoring company to determine whether the trial successfully demonstrated
safety and effectiveness and whether a product approval application may be submitted. In the United States, if the product is regulated
as a new drug, an NDA must be submitted and approved by the FDA before commercial marketing may begin. The NDA must include a substantial
amount of data and other information concerning the safety and effectiveness of the compound from laboratory, animal, and human clinical
testing, as well as data and information on manufacturing, product quality and stability, and proposed product labeling.

 Each
domestic and foreign manufacturing establishment, including any contract manufacturers, must be listed in the NDA and must be registered
with the FDA. The application generally will not be approved until the FDA conducts a manufacturing inspection, approves the applicable
manufacturing process for the drug product, and determines that the facility is in compliance with current cGMP requirements. Moreover,
FDA will also typically inspect one or more clinical trial sites to confirm that the applicable clinical trials were conducted in accordance
with GCPs.

 Under the Prescription Drug
User Fee Act ("PDUFA"), as amended, the FDA assesses and receives application user fees for reviewing an NDA, as well as annual
program fees for commercial manufacturing establishments and for approved products. These fees can be significant. Fee waivers, reductions
or refunds are available in certain circumstances. One basis for a waiver or refund of the application user fee is if the applicant is
a "small business" generally defined as employing fewer than 500 employees, including employees of affiliates, no approved
marketing application for a product that has been introduced or delivered for introduction into interstate commerce, and the applicant,
including its affiliates, is submitting its first marketing application. Product candidates that are designated as orphan drugs, which
are further described below, are also not subject to application user fees unless the application includes an indication other than the
orphan indication. Under certain circumstances, orphan products may also be exempt from product and establishment fees.

 Each
NDA submitted for FDA approval is usually reviewed for administrative completeness and reviewability. Following this review, the FDA
may request additional information rather than accept an NDA for filing. In this event, the application must be resubmitted with the
additional information. The resubmitted application is also subject to review before the FDA accepts it for filing.

 Once
accepted for filing, the FDA's review of an application may involve review and recommendations by an independent FDA advisory committee.
The FDA must refer applications for drugs that contain active ingredients, including any ester or salt of the active ingredients that
have not previously been approved by the FDA to an advisory committee or provide in an action letter a summary for not referring it to
an advisory committee. The FDA may also refer drugs to advisory committees when it is determined that an advisory committee's expertise
would be beneficial to the regulatory decision-making process, including the evaluation of novel products and the use of new technology.
An advisory committee is typically a panel that includes clinicians and other experts, which review, evaluate, and make a recommendation
as to whether the application should be approved and under what conditions. The FDA is not bound by the recommendations of an advisory
committee, but it considers such recommendations carefully when making decisions.

 After
evaluating the NDA and all related information, including the advisory committee recommendation, if any, and inspection reports regarding
the manufacturing facilities and clinical trial sites, the FDA may issue an approval letter, or, in some cases, a Complete Response Letter,
or CRL. If a CRL is issued, the applicant may either resubmit the NDA, addressing all the deficiencies identified in the letter; withdraw
the application; or request an opportunity for a hearing. A CRL indicates that the review cycle of the application is complete, and the
application is not ready for approval and describes all the specific deficiencies that the FDA identified in the NDA. A CRL generally
contains a statement of specific conditions that must be met in order to secure final approval of the NDA and may require additional
clinical or pre-clinical testing in order for the FDA to reconsider the application. The deficiencies identified may be minor, for example,
requiring labeling changes; or major, for example, requiring additional clinical trials. Even with submission of this additional information,
the FDA ultimately may decide that the application does not satisfy the regulatory criteria for approval. If and when those conditions
have been met to the FDA's satisfaction, the FDA may issue an approval letter. An approval letter authorizes commercial marketing
of the drug with specific prescribing information for specific indications.

 Even
if the FDA approves a product, it may limit the approved therapeutic uses for the product as described in the product labeling, require
that warning statements be included in the product labeling, require that additional studies be conducted following approval as a condition
of the approval, impose restrictions and conditions on product distribution, prescribing, or dispensing in the form of a Risk Evaluation
and Mitigation Strategy, or a REMS, or otherwise limit the scope of any approval.

 In addition, under the Pediatric
Research Equity Act, or PREA, an NDA or supplement to an NDA for a new active ingredient, indication, dosage form, dosage regimen, or
route of administration must contain data that are adequate to assess the safety and effectiveness of the drug 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 FDA may, on its own initiative or at the request of the applicant, grant deferrals for submission of some or
all pediatric data until after approval of the product for use in adults, or full or partial waivers from the pediatric data requirements.
Such deferred studies become required post-marketing studies upon approval of the product.

 Special
FDA Expedited Review and Approval Programs

 The
FDA has various programs, including Fast Track designation, priority review and breakthrough designation, that are intended to expedite
or simplify the process for the development and FDA review of certain drug products that are intended for the treatment of serious or
life-threatening diseases or conditions, and demonstrate the potential to address unmet medical needs or present a significant improvement
over existing therapy. The purpose of these programs is to provide important new drugs to patients earlier than under standard FDA review
procedures.

 To
be eligible for a Fast Track designation, the FDA must determine, based on the request of a sponsor, that a product is intended to treat
a serious or life-threatening disease or condition and demonstrates the potential to address an unmet medical need. The FDA will determine
that a product will fill an unmet medical need if the product will provide a therapy where none exists or provide a therapy that may
be potentially superior to existing therapy based on efficacy, safety, or public health factors. If Fast Track designation is obtained,
drug sponsors may be eligible for more frequent development meetings and correspondence with the FDA. In addition, the FDA may initiate
review of sections of an NDA before the application is complete. This "rolling review" is available if the applicant provides
and the FDA approves a schedule for the remaining information. A Fast Track product is also eligible to apply for accelerated approval
and priority review.

 The
FDA may give a priority review designation to drugs that are intended to treat serious conditions and, if approved, would provide significant
improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions. A priority review means
that the goal for the FDA is to review an application within six months, rather than the standard review of ten months under current
PDUFA guidelines, of the 60-day filing date for new molecular entities.

 A
sponsor can also request designation of a product candidate as a "breakthrough therapy." A breakthrough therapy is defined
as a drug that is intended, alone or in combination with one or more other drugs, to treat a serious or life-threatening disease or condition,
and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more
clinically significant endpoints, such as substantial treatment effects observed early in clinical development. Drugs designated as breakthrough
therapies are eligible for the Fast Track designation features as described above, intensive guidance on an efficient drug development
program beginning as early as Phase 1 trials, and a commitment from the FDA to involve senior managers and experienced review staff
in a proactive collaborative, cross-disciplinary review.

 Even
if a product qualifies for one or more of these programs, the FDA may later decide that the product no longer meets the conditions for
qualification or decide that the time period for FDA review or approval will not be shortened.

 A
new program to expedite the development of drug products is the Limited Population Pathway for Antibacterial and Antifungal Drugs, or
LPAD, which was passed as part of the 21 st Century Cures Act. LPAD allows for the FDA's determination of safety and
effectiveness to reflect the risk-benefit profile of the drug in the intended limited population, taking into account the severity, rarity,
or prevalence of the infection and the availability of alternative treatments in the limited population. Under LPAD, a sponsor may request
drug approval for an antibacterial or antifungal drug if the drug is intended to treat a serious life-threatening infection in a limited
population of patients with unmet needs. The drug may be approved for the limited population notwithstanding a lack of evidence to fully
establish a favorable benefit-risk profile in a broader population. The FDA must provide prompt advice to sponsors seeking approval under
LPAD to enable them to plan a development program. If approved under LPAD, certain post-marketing requirements would apply, such as required
labeling and advertising statements and pre-distribution submission of promotional materials to FDA. If after approval for a limited
population, a product receives a broader approval, the FDA may remove such post-marketing restrictions. While a drug may only be approved
for a limited population under this program, the 21 st Century Cures Act states that it is not intended to restrict the prescribing
of antimicrobial drugs or other products by healthcare professionals.

 Exclusivity

 For
approved drug products, market exclusivity provisions under the FDCA provide periods of exclusivity, which gives the holder of an approved
NDA limited protection from new competition in the marketplace for the innovation represented by its approved drug.

 Section 505
of the FDCA describes three types of marketing applications that may be submitted to the FDA to request marketing authorization for a
new drug. A Section 505(b)(1) NDA is an application that contains full reports of investigations of safety and efficacy. A Section 505(b)(2)
NDA is an application in which the applicant, in part, relies on investigations that were not conducted by or for the applicant and for
which the applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted. Section 505(j)
establishes an abbreviated approval process for a generic version of approved drug products through the submission of an Abbreviated
New Drug Application, or ANDA. An ANDA provides for marketing of a generic drug product that has the same active ingredients, dosage
form, strength, route of administration, labeling, performance characteristics, and intended use, among other things, to a previously
approved product. Limited changes must be pre-approved by the FDA via a suitability petition.

 Five
years of exclusivity are available to New Chemical Entities, or NCEs. A NCE is a drug that contains no active moiety that has been approved
by the FDA in any other NDA submitted under Section 505 of the FDCA. An active moiety is the molecule or ion, excluding those appended
portions of the molecule, that cause the drug to be an ester, salt, including a salt with hydrogen or coordination bonds, or other noncovalent
derivatives, such as a complex, chelate, or clathrate, of the molecule, responsible for the physiological or pharmacological action of
the drug substance. During the exclusivity period, the FDA may not accept for review an ANDA or a 505(b)(2) NDA application submitted
by another company that contains the previously approved active moiety, except that an ANDA or 505(b)(2) that contains a certification
that the patents listed by the NCE sponsor in FDA's list of Approved Drug Products with Therapeutic Equivalence Evaluations, or
Orange Book, are invalid or will not be infringed by the manufacture, use, or sale of the drug product for which approval is sought,
may be submitted one year before NCE exclusivity expires. Five-year exclusivity will also not delay the submission or approval of a 505(b)(1)
NDA; however, an applicant submitting a 505(b)(1) NDA would be required to conduct or obtain a right of reference to all the pre-clinical
studies and adequate and well-controlled clinical trials necessary to demonstrate safety and efficacy.

 The
FDCA also provides three years of marketing exclusivity for an NDA, 505(b)(2) NDA or supplement to an existing NDA if new clinical investigations,
other than bioavailability studies, that were conducted or sponsored by the applicant are deemed by the FDA to be essential to the approval
of the application, for example, new indications, dosages or strengths of an existing drug. This three-year exclusivity covers only the
conditions of use associated with the new clinical investigations and does not prohibit the FDA from approving NDAs or ANDAs for drugs
containing the original active agent.

 Pediatric
exclusivity is another type of non-patent marketing exclusivity in the United States and, if granted, provides for the attachment
of an additional six months of exclusivity to the term of any existing exclusivity for the product, such as NCE exclusivity. This six-month
exclusivity may be granted if an NDA sponsor submits pediatric data that fairly respond to a written request from the FDA for such data.
The data do not need to show the product to be effective in the pediatric population studied; rather, if the clinical trial is deemed
to fairly respond to the FDA's request, the additional protection is granted. If reports of requested pediatric studies are submitted
to and accepted by the FDA within the required time frames, whatever statutory or regulatory periods of exclusivity that cover the drug
are extended by six months. For patent protection, pediatric exclusivity does not extend the term of the patent or the term a patent
extension, but rather the period during which FDA cannot approve an ANDA or 505(b)(2) NDA that certifies to a patent listed in the Orange
Book. Moreover, pediatric exclusivity attaches to all formulations, dosage forms, and indications for products with existing marketing
exclusivity or patent life that contain the same active moiety as that which was studied.

 The
Orphan Drug Act also provides incentives for the development of drugs intended to treat rare diseases or conditions, which generally
are diseases or conditions affecting fewer than 200,000 individuals annually in the United States, or affecting more than 200,000 in
the United States and for which there is no reasonable expectation that the cost of developing and making the drug available in the United
States will be recovered from sales in the United States. Additionally, sponsors must present a plausible hypothesis for clinical superiority
to obtain orphan designation if there is a drug already approved by the FDA that is intended for the same indication and that is considered
by the FDA to be the same drug as the already approved drug. This hypothesis must be demonstrated to obtain orphan drug exclusivity.
If granted, prior to product approval, Orphan Drug Designation entitles a party to financial incentives such as opportunities for grant
funding towards clinical study costs, tax advantages, and user-fee waivers. In addition, if a product receives FDA approval for the indication
for which it has orphan designation, the product is generally entitled to orphan drug exclusivity, which means the FDA may not approve
any other application to market the same drug for the same indication for a period of seven years, except in limited circumstances, such
as a showing of clinical superiority over the product with orphan exclusivity.

 For
certain infectious disease products, the above discussed exclusivity periods may be further extended if the product is designated as
a QIDP and receives GAIN Act exclusivity. A qualified infectious disease product, or QIDP, is an antibacterial or antifungal drug for
human use intended to treat serious or life-threatening infections, including those caused by an antibacterial or antifungal resistant
pathogen, including novel or emerging infectious pathogens; or qualifying pathogens designated by the FDA that have the potential to
pose a serious threat to public health. Subject to the specified statutory limitations, a drug that is designated as a QIDP and is approved
for the use for which the QIDP designation was granted will receive a 5-year extension to any exclusivity for which the application qualifies
upon approval. For example, if the FDA approves an NDA for a drug designated as a QIDP, the NCE exclusivity period is extended to ten
years and the FDA may not accept applications for nine years. Moreover, if a product is designated as a QIDP and an orphan product, the
orphan product exclusivity period is extended to twelve years. These extensions are in addition to any extension that an application
may be entitled to under the pediatric exclusivity provisions. To receive a QIDP designation, the sponsor must request that the FDA designate
the product as such prior to the submission of an NDA. This designation may not be withdrawn except if the FDA finds that the request
for designation contained an untrue statement of material fact. QIDPs are also eligible for Fast Track status and priority review.

 Post
Approval Requirements

 Significant
legal and regulatory requirements also apply after FDA approval to market under an NDA. These include, among other things, requirements
related to adverse event and other reporting, product tracking and tracing, suspect and illegitimate product investigations and notifications,
product advertising and promotion and ongoing adherence to cGMPs, as well as the need to submit appropriate new or supplemental applications
and obtain FDA approval for certain changes to the approved product, product labeling, or manufacturing process. FDA can also require
the completion of studies post-approval, such as required studies under PREA. The FDA also enforces the requirements of the Prescription
Drug Marketing Act which, among other things, imposes various requirements in connection with the distribution of product samples to
physicians. The FDA enforces these requirements through, among other ways, review of promotional material submissions, review of adverse
events, review of annual reports, periodic announced and unannounced facility inspections.

 The
FDA also strictly regulates marketing, labeling, advertising, and promotion of products that are placed on the market. Physicians, in
their independent professional medical judgment, may prescribe legally available products for unapproved indications that are not described
in the product's labeling and that differ from those tested and approved by the FDA. Pharmaceutical companies, however, are allowed
to promote their drug products only for the approved indications and in accordance with the provisions of the approved label; off-label
promotion is prohibited, as is false and misleading promotion. The FDA and other agencies actively enforce the laws and regulations prohibiting
the promotion of off-label uses, and a company that is found to have improperly promoted off-label uses may be subject to significant
liability, including, but not limited to, criminal and civil penalties under the FDCA and the civil False Claims Act, or FCA, exclusion
from participation in federal healthcare programs, mandatory compliance programs under corporate integrity agreements, debarment, and
refusal of government contracts.

 FDA
regulations require that products be manufactured in specific approved facilities and in accordance with cGMP regulations. We rely, and
expect to continue to rely, on third parties for the production of clinical and commercial quantities of our products in accordance with
cGMP regulations. These manufacturers must comply with cGMP regulations that require, among other things, quality control and quality
assurance, the maintenance of records and documentation and the obligation to investigate and correct any deviations from cGMP. Manufacturers
and other entities involved in the manufacture and distribution of approved drugs or biologics 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 cGMP requirements and other laws. Accordingly, manufacturers must continue to expend time, money and effort in the area
of production and quality control to maintain cGMP compliance. The discovery of violative conditions, including failure to conform to
cGMP regulations, could result in enforcement actions, and the discovery of problems with a product after approval may result in restrictions
on a product, manufacturer or holder of an approved NDA or BLA, including recall.

 After
approval of a drug is granted, FDA may withdraw the 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 mandatory revisions to the approved labeling to add new safety information, or imposition of additional post-market surveillance
or clinical trials to assess new safety risks. Other potential consequences include, among other things: restrictions on the marketing
or manufacturing of the product, complete withdrawal of the product from the market or product recalls fines, warning letters or
other enforcement-related letters or clinical holds on investigational or post-approval clinical trials refusal by FDA to approve
pending NDAs or supplements to approved NDAs, or suspension or revocation of product approvals product seizure or detention, or
refusal to permit the import or export of products injunctions or the imposition of civil or criminal penalties and consent
decrees, corporate integrity agreements, debarment, or exclusion from federal health care programs or mandated modification of
promotional materials and labeling and the issuance of corrective information.

 Moreover,
individual states may have laws and regulations that we must comply with, such as laws and regulations concerning licensing, promotion,
sampling, distribution, and reporting.

 Pricing
and Reimbursement

 We
expect to sell DefenCath primarily to inpatient acute-care hospitals and outpatient dialysis clinics.

 Inpatient
Reimbursement

 For Medicare, inpatient acute-care
hospitals are paid under the inpatient prospective payment system (referred to herein as the "IPPS"). The IPPS pays a
flat rate based on the average charges across all hospitals for a specific diagnosis, regardless of whether that particular patient costs
more or less. Under the IPPS, each case is categorized into a diagnosis-related group, or DRG, which is weighted and multiplied by a standardized
amount (updated each year for inflation and other factors), to yield a fixed payment for that DRG and adjusted for hospital-specific factors
(e.g., wages, teaching hospitals) to cover care furnished during the inpatient stay. Additional, temporary payment is available for new
medical services and technologies called New Technology Add-on Payment, or NTAP, if certain criteria are met. There are three criteria
required for new technologies to be eligible to receive NTAP:

 1.
Product must meet "newness" criteria;

 2.
Product must meet "substantial clinical improvement" over existing technologies; and

 3.
Product must meet certain cost thresholds.

 CMS created several alternative
NTAP approval pathways for certain devices that obtain breakthrough designation and drugs that obtain Qualified Infectious Disease
Product, or QIDP, designation from the FDA. Under these alternative pathways, the new technology need only meet the cost criterion because
CMS assumes that those products meet the newness and substantial clinical improvement criteria.

 We submitted an NTAP application
under the alternative pathway for fiscal year ("FY") 2024 IPPS and received conditional approval from CMS pending FDA marketing
authorization for DefenCath before July 1, 2024. Based on the information available at the time of the FY 2024 IPPS final rule, CMS determined
the cost per case of DefenCath was $22,815. Under CMS' regulations, NTAPs are limited to the lesser of 75% of the average cost of
the technology, or 75% of the costs in excess of the MS-DRG payment for the case. Accordingly, CMS finalized for FY 2024 $17,111.25 as
the maximum NTAP for a case involving the use of DefenCath. This NTAP represents reimbursement to inpatient facilities of 75% of the anticipated
wholesaler acquisition cost price of $1,170 per 3 mL vial, and an average utilization of 19.5 vials per hospital stay. Given that FDA
approval of the NDA was obtained on November 15, 2023 and prior to the July 1, 2024 deadline, the NTAP for cases involving the technology
will be effective beginning January 1, 2024. As the NTAP was calculated by CMS based upon an anticipated WAC price of $1,170, and following
FDA approval of the DefenCath NDA an actual WAC of $249.99 per 3ml vial was established, we anticipate that CMS will revise the amount
of the NTAP payment to reflect the actual WAC price in the next IPPS rulemaking, effective October 1, 2024. Upon the listing in the compendia
of the actual WAC price of $249.99 per 3ml vial, we notified CMS of the new lower WAC pricing and recommended that CMS make an off-cycle
adjustment to the NTAP to reflect the current lower WAC pricing amount. CMS subsequently communicated to us that CMS does not intend to
update the NTAP reimbursement amount until the next review cycle in October 2024.

 NTAP is granted for a period
of 2-3 years after the date of FDA approval. Although NTAP is intended to identify and ensure adequate payment for qualifying new technologies,
it may have a limited effect depending on the DRG assignment after the NTAP period ends. With established reimbursement in the inpatient
setting, we plan to launch DefenCath in hospitals first while outpatient reimbursement is expected to be effective July 1, 2024 (assuming
TDAPA approval as discussed below).

 Outpatient
Reimbursement

 On January 25, 2024, CMS determined
that DefenCath should be classified as a renal dialysis service within an existing functional category, and is therefore subject to the
Medicare end-stage renal disease prospective payment system (referred to herein as the "ESRD PPS"). The ESRD PPS does afford,
however, a transitional drug add-on payment adjustment, or TDAPA, followed by post-TDAPA add-on payment adjustments. If CMS grants TDAPA
and post-TDAPA add-on payment adjustments for DefenCath, collective payments would be for five years (with such add-on payments applying
to all ESRD PPS payments for years three through five). New renal dialysis drugs or biological products that fall within an ESRD PPS functional
category are paid TDAPA unless certain exclusion criteria apply (related to the FDA approval or the NDA classification type). To be considered
a new renal drug or biologic, the product must be:

 Used
 to treat or manage a condition(s) associated with ESRD

 Approved
 by the FDA pursuant to Section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act or section
 351 of the Public Health service Act;

 Commercially
 available;

 Assigned a Healthcare Common Procedure Coding System ("HCPCS") code (or have an application submitted); and

 Designated
 by CMS as a renal dialysis service.

 We
believe that DefenCath would meet the criterion of being a new renal dialysis product based upon communications received from CMS. We
submitted a HCPCS application for a J-code to CMS on December 8, 2023 for DefenCath and CMS has confirmed the application is under review.
We submitted an application for TDAPA on January 26, 2024. CMS confirmed receipt and advised us in writing that CMS is working toward
a July 1, 2024 effective date for TDAPA, assuming a favorable review. CMS reserves the right to request more information, and does not
guarantee that the TDAPA application will be approved or will be effective by July 1, 2024.

 TDAPA
reimbursement is calculated based on 100 percent ASP (or 100 percent of wholesale acquisition price or else manufacturers' list
price, respectively, if such data is unavailable). CMS has recently adopted policies related to the submission of ASP data making TDAPA
conditional in certain circumstances on the continued submission of such data. Accordingly, it is possible that the duration of TDAPA
could be shortened if the submission requirements of the ASP policy are not met. When TDAPA ends for new products for which there is
a functional category, CMS does not make any adjustments to the ESRD PPS rate.

 Although
we cannot anticipate changes in reimbursement requirements and mechanisms in the coming years, CMS has acknowledged TDAPA payment mechanisms
may be adjusted to encourage innovation for this patient population. Beginning with calendar year 2024, CMS adopted a new payment adjustment
that follows the TDAPA period which is applied to all ESRD PPS payments for three years. Following such additional ESRD PPS payment adjustments,
DefenCath would be paid as part of the bundled ESRD PPS rate.

 In anticipation that payers
will require that we demonstrate the cost effectiveness of DefenCath as part of the reimbursement review and approval process, we have
submitted posters and abstracts to support our health economic analysis and continue to commission and develop health economic evaluations
to support this review in the context of the prospective use of DefenCath in dialysis.

 We may seek CMS reimbursement
for DefenCath in other catheter indications, such as oncology patients and total parenteral nutrition patients, including through (i)
relevant hospital inpatient DRGs, (ii) additional NTAP payments, (iii) outpatient ambulatory payment classifications, or APCs, (iv) the
End-Stage Renal Disease Prospective Payment System, or ESRD PPS, base payment, or (v) under the Durable Medical Equipment, Prosthetics,
Orthotics, and Supplies, or DMEPOS, Fee Schedule, depending on the setting of care. Coverage and payment under these Medicare benefit
categories is not guaranteed for these additional potential indications.

Regulation

 Federal and state healthcare
laws, including fraud and abuse and health information privacy and security laws, also govern our business. If we fail to comply with
those laws, we could face substantial penalties and our business, results of operations, financial condition and prospects could be adversely
affected. Such laws include, but are not limited to: the federal Anti-Kickback Statute ("AKS"); federal pricing transparency
and reporting laws and regulations; federal Physician Payments Sunshine Act and Open Payments requirements to track and report certain
payments and other transfers of value; federal and state civil and criminal false claims laws, including the civil False Claims Act. Additionally,
we are subject to state and local law equivalents of the above federal laws, which may be broader in scope and apply regardless of whether
the payer is a governmental healthcare program. We may also be subject to certain state healthcare laws that may not have a federal parallel,
such as pharmaceutical detailing and disclosure laws and requirements.

 We are subject to federal
government price reporting, such as those applicable to the Medicare Part B program, those under the Medicaid Drug Rebate Program ("MDRP"),
the 340 Drug Pricing Program and individual state laws relating to pricing and sales and marketing practices. Manufacturers report Average
Sales Price (ASP) data for Part B-covered drugs and biologicals and related items, services, supplies, and products that are paid as drugs
or biologicals. We also participate in the MDRP and report ASP, Best Price and other metrics related to our participation in such program.
We pay rebates to state Medicaid agencies based on those metrics on Medicaid beneficiary utilization of products. In addition, we are
required to sell our covered outpatient drugs at or below the 340B Ceiling Price to 340B Covered Entities. We are also required to discount
our products to authorized users of the Federal Supply Schedule, under which additional laws and requirements apply. Each of these programs
require submission of pricing data and calculation of discounts and/or rebates pursuant to complex statutory formulas and regulatory guidance,
as well as the entry into government procurement contracts governed by the Federal Acquisition Regulations, and the guidance governing
such calculations is not always clear. Compliance with such requirements can require significant investment in personnel, systems and
resources. Failure to properly calculate prices, or to offer required discounts or rebates could subject us to substantial penalties including,
but not limited to, potential False Claims Act liability. CMS continues to issue guidance and rulemaking governing our participation in
the MDRP, and we cannot predict how future guidance or rules would affect our profitability (including the potential for increases in
our overall Medicaid rebate liability and the obligation to charge greatly reduced prices to 340B Covered Entities).

 In
the U.S., the federal and state governments are considering proposals or have enacted legislative and regulatory changes to the healthcare
system that could affect our ability to sell our products profitably. Among policy makers and payers in the U.S., there is significant
interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs, improving quality and/or expanding
access.

 There
has been increasing legislative and enforcement interest in the U.S. with respect to drug pricing practices. In particular, there have
been several recent U.S. Congressional inquiries, hearings and proposed and enacted federal legislation and rules, as well as executive
orders and sub-regulatory guidance that may impact pricing for pharmaceutical products. These initiatives include, among others:

 efforts
 to reevaluate, reduce or limit the prices of drugs and make them more affordable for patients;

 implementation
 of additional data collection and transparency reporting regarding drug pricing, rebates,
 fees and other remuneration provided by drug manufacturers;

 revisions
 to rules associated with ESRD PPS Transitional Drug Add-on Payment Adjustment;

 potential
 revisions to rules associated with the calculation of average sales price;

 revisions
 to rules associated with the calculation of average manufacturer price and best price under
 Medicaid;

 changes
 to the MDRP, including through a May 2023 CMS-proposed rulemaking for this program, that
 could significantly increase manufacturer rebate liability;

 implementation
 of the inflation Reduction Act of 2022 (Inflation Reduction Act), including provisions that
 generally require manufacturers of Medicare Part B and Part D drugs to pay inflation rebates
 to the Medicare program if pricing metrics associated with their products increase faster
 than the rate of inflation;

 potential
 elimination of the AKS discount safe harbor protection for manufacturer rebate arrangements
 with Medicare Part D plan sponsors; and

 reevaluation
 of safe harbors under the AKS.

 In
addition, at the state level, legislatures have increasingly passed legislation and implemented regulations similar to those under consideration
at the federal level, as well as laws designed to control pharmaceutical and biotherapeutic product pricing, including restrictions on
pricing or reimbursement at the state government level, limitations on discounts to patients, marketing cost disclosure and transparency
measures, restrictions or other limitations on patient assistance, and, in some cases, policies to encourage importation from other countries
(subject to federal approval) and bulk purchasing.

 In
addition, the U.S. Foreign Corrupt Practices Act and similar worldwide anti-bribery laws generally prohibit companies and their intermediaries
from making improper payments for the purpose of obtaining or retaining business.

 These
laws and regulations may affect our sales, marketing, and other promotional activities by imposing administrative and compliance burdens
on us. In addition, given the lack of clarity with respect to these laws and their implementation, our reporting actions could be subject
to the penalty provisions of the pertinent state and federal authorities.

Regulatory Requirements

 We
have not made any filings seeking approval for DefenCath outside of the United States. In order to market any product outside of the
United States, we would need to comply with numerous and varying regulatory requirements of other countries regarding safety and efficacy
and governing, among other things, clinical trials, marketing authorization, commercial sales and distribution of our products. Even
though we have obtained FDA approval for DefenCath, and more generally, whether or not with FDA approval for a product, we would need
to obtain the necessary approvals by the comparable regulatory authorities of foreign countries before we can commence clinical trials
or marketing of the product in those countries. The approval process varies from country to country and can involve additional product
testing and additional administrative review periods. The time required to obtain approval in other countries might differ from and be
longer than that required to obtain FDA approval. Regulatory approval in one country does not ensure regulatory approval in another,
but a failure or delay in obtaining regulatory approval in one country may negatively impact the regulatory process in others.

 Employees
and Human Capital Resources

 As of March 7, 2024, we employed
82 full-time employees and one part-time employee, who work out of our corporate offices in Berkeley Heights, NJ or work remotely in
various locations throughout the United States and Europe. We are committed to diversity, equity and inclusion, regardless of gender
or race/ethnicity, or any protected status, and conduct training to reflect our commitment as an organization and build awareness.

 We
invest in our workforce by offering competitive salaries and benefits. We endeavor to foster a strong sense of ownership by offering
stock options under our stock incentive program. We also offer comprehensive and benefits for all eligible employees. We recognize and
support the growth and development of our employees and we provide performance feedback and conduct employee goal and development discussions.

 None
of our employees are subject to a collective bargaining agreement. We emphasize organizational communication and consider our relationship
with our employees to be strong.

 Corporate
Information

 We
were organized as a Delaware corporation on July 28, 2006 under the name "Picton Holding Company, Inc." and we changed our
corporate name to "CorMedix Inc." on January 18, 2007. Our principal executive offices are located at 300 Connell Drive,
Suite 4200, Berkeley Heights, New Jersey 07922. Our telephone number is (908) 517-9500.

 Available
Information

 We
maintain our websites at www.cormedix.com, www.defencath.com. and www.crbis.com. This Annual Report on Form 10-K and all of our filings
under the Exchange Act, including copies of annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K,
and any amendments to those reports, are available free of charge through our website on the date we file those materials with, or furnish
them to, the Securities and Exchange Commission (the "SEC"). Such filings are also available to the public on the internet
at the SEC's website at www.sec.gov. The information contained on, or that can be accessed through, the websites referenced
in this Annual Report on Form 10-K is not a part of, nor shall it be deemed to be, incorporated by reference into this filing or any
of our other filings with the SEC. Further, the Company's references to website URLs are intended to be inactive textual references
only.

Item 1A. Risk Factors

 Risks
Related to Our Financial Position and Need for Additional Capital

 We
have a history of operating losses, expect to incur additional operating losses in the future and may never be profitable.

 Our prospects must be considered in light of the uncertainties, risks,
expenses and difficulties frequently encountered by companies in the early stages of operation. We incurred net losses of approximately
$46.3 million and $29.7 million for the years ended December 31, 2023 and 2022, respectively. As of December 31, 2023, we had an accumulated
deficit of approximately $321.7 million. We expect to incur substantial additional operating expenses over the next several years as our
research, development, pre-clinical testing, clinical trial and commercialization activities increase as we commercialize DefenCath and
develop our other product candidates. As a result, we expect to experience negative cash flow as we fund our operating losses and capital
expenditures. The amount of future losses and when, if ever, we will achieve profitability are uncertain. We have not generated any significant
commercial revenue and our ability to generate revenue and achieve profitability will depend on, among other things, the following: successfully
launching and marketing DefenCath in the US; obtaining necessary regulatory approvals for our other product candidates from the FDA and,
if sought, international regulatory agencies; establishing additional manufacturing, sales, and marketing arrangements, either alone or
with third parties; and raising sufficient funds to finance our activities if we are unable to generate sufficient revenue from the commercialization
of DefenCath in the U.S. We might not succeed at any of these undertakings. If we are unsuccessful at some or all of these undertakings,
our business, prospects, and results of operations may be materially adversely affected.

 We
may need to finance our future cash needs through public or private equity offerings, debt financings or corporate collaboration and
licensing arrangements. Any additional funds that we obtain may not be on terms favorable to us or our stockholders, may dilute our stockholders,
and may require us to relinquish valuable rights.

 To date, our commercial operations have not generated
sufficient revenues to enable profitability. We estimate that we have sufficient cash to fund (i) operations for at least twelve months
from the date of issuance of this Annual Report on Form 10-K and (ii) the commercial launch of DefenCath. These estimates are based upon
the assumption of commercial launch in the second quarter of 2024, and other base case assumptions for market penetration, average selling
price, R&D expense and commercial infrastructure cost.

 We
may need additional financing to the extent we are unable to generate sufficient revenue from the commercialization of DefenCath in the
U.S. We can provide no assurances that any financing or strategic relationships will be available to us on acceptable terms, or at all.
We expect to continue to use significant cash to fund our operations as we commercialize DefenCath in the U.S, pursue development of
our other product candidates and other business development activities, and incur additional legal costs to defend our intellectual property.

 To raise needed
capital, we may sell additional equity or debt securities, obtain a bank credit facility, or enter into a corporate collaboration or licensing
arrangement. The sale of additional equity or debt securities, if convertible, could result in dilution to our stockholders. The incurrence
of indebtedness would result in fixed obligations and could also result in covenants that would restrict our operations. Raising additional
funds through collaboration or licensing arrangements with third parties may require us to relinquish valuable rights to our technologies,
future revenue streams, research programs or product candidates, or to grant licenses on terms that may not be favorable to us or our
stockholders.

 To
the extent we raise additional capital by issuing equity securities, our stockholders may experience substantial dilution. We may, as
we have in the past, sell common stock, convertible securities or other equity securities in one or more transactions at prices and in
a manner we determine from time to time. If we sell common stock, convertible securities or other equity securities in more than one transaction,
investors may be further diluted by subsequent sales. Such sales may also result in material dilution to our existing stockholders, and
new investors could gain rights superior to existing stockholders.

 Risks
Related to the Commercialization of DefenCath

 We
are highly dependent on the successful commercialization of our only approved product, DefenCath.

 Our ability to generate operating
revenue will be severely limited until we successfully commercialize DefenCath in the U.S., and we may experience unforeseen events during
scale up and/or manufacturing. DefenCath was approved by FDA on November 15, 2023, and is indicated to reduce the incidence of CRBSIs
in adult patients with kidney failure receiving chronic hemodialysis through a central venous catheter. This drug is indicated for use
in a limited and specific population of patients. The safety and effectiveness of DefenCath have not been established for use in populations
other than adult patients with kidney failure receiving chronic hemodialysis through a central venous catheter.

 We
have not commercialized any other product candidates other than DefenCath. Successful commercialization of DefenCath is subject to many
risks, including but not limited to:

 failure to maintain regulatory approvals;

 failure to receive TDAPA and post-TDAPA add-on adjustment payments;

 emergence
 of superior or equivalent products;

 inability to manufacture our product candidates on a commercial scale
on our own or in collaboration with third parties;

 failure to comply with a broad range of post-marketing requirements including those related to labeling,
promotion and advertising, manufacturing and quality, pharmacovigilance and adverse event reporting, commercial distribution and supply
chain requirements, and pediatric post-marketing study requirements; and

 to achieve market acceptance or significant adoption.

 There
is no guarantee that our commercial launch of DefenCath or our future commercialization efforts will be successful, or that we will be
able to successfully launch and commercialize any other product candidates that receive regulatory approval.

 The
successful commercialization of DefenCath will depend on obtaining coverage and reimbursement for use of DefenCath from third-party payors.

 Sales of pharmaceutical products
largely depend on the reimbursement of patients' medical expenses by government health care programs, such as Medicare, Medicaid
and/or private health insurers. Further, significant uncertainty exists as to the reimbursement status of newly approved health care products.
We initially expect to sell DefenCath directly to hospitals and key dialysis center operators, but also may expand its usage into oncology
and total parenteral nutrition patients requiring catheters if those indications can be secured from the FDA. All of these potential customers
are healthcare providers who depend upon reimbursement by government and commercial insurance payors for dialysis and other treatments.
Depending on the treatment setting, we believe that DefenCath would be eligible for coverage under various reimbursement programs, such
as the IPPS and ESRD PPS, including certain temporary or transitional add-on payment adjustments (e.g., NTAP, TDAPA); however, payment
under these payment systems could later be modified or decreased under future regulations. Further, CMS, which administers Medicare, and
works with states to administer Medicaid, has adopted and will continue to adopt and/or amend rules governing reimbursement for specific
treatments. We anticipate that insurers may increasingly demand that manufacturers demonstrate the cost effectiveness of their products
as part of the reimbursement review and approval process. Rising healthcare costs have also led many European and other foreign countries
to adopt healthcare reform proposals and medical cost containment measures. Similar legislation could be introduced in the U.S. Any measures
affecting the reimbursement programs of these governmental and private insurance payors, including any uncertainty in the medical community
regarding their nature and effect on reimbursement programs, could have an adverse effect on purchasing decisions regarding DefenCath,
as well as limit the prices we may charge for DefenCath. The failure to obtain or maintain reimbursement coverage for DefenCath or any
other products could materially harm our operations.

 In anticipation that payers may increasingly demand that we demonstrate
the cost effectiveness of DefenCath as part of the reimbursement review and approval process, we have submitted posters and abstracts
to support our health economic analysis and continue to commission and develop health economic evaluations to support this review in the
context of the utilization of DefenCath in dialysis. We are pursuing opportunities to work with healthcare systems to demonstrate the
clinical and economic effectiveness of DefenCath; however, our studies might not be sufficient to support coverage or reimbursement at
levels that allow providers to use DefenCath.

 The Company submitted to CMS an HCPCS application for a J-code on December
8, 2023, and a TDAPA application on January 26, 2024, in each case for DefenCath. While CMS has advised it is working toward a July 1,
2024 implementation date for TDAPA, there is no guarantee that it will be approved or that implementation will take place on or before
July 1, 2024. Any delay or failure in the approval of such applications would have an adverse impact on the commercial launch of DefenCath.
See Item 1 for additional detail regarding TDAPA and the implementation thereof.

 The
expected outpatient demand for DefenCath is highly concentrated, with two large customers accounting for more than 70% of total outpatient dialysis treatments.

 The
market for outpatient dialysis clinics is highly concentrated, with two large dialysis providers accounting for more than 70% of the
total outpatient dialysis treatments. The failure of one or both of these providers to utilize DefenCath could adversely
impact the commercial launch of DefenCath, and there can be no assurance that either or both of such providers will agree to utilize
DefenCath on favorable terms or at all. To the extent we are successful in our efforts to enter into agreements with either or both of
these providers, any failure of these providers to meet purchase commitments, or any reduction or cessation in their purchasing or utilization
of DefenCath, could adversely impact the commercial launch of DefenCath and harm our business.

 Risks
Related to the Development and Commercialization of our Other Products

 Successful
development and commercialization of our product candidates is uncertain.

 Our
development and commercialization of our products, including future product candidates, is subject to the risks of failure and delay
inherent in the development of new pharmaceutical products, including but not limited to the following:

 inability
 to produce positive data in pre-clinical and clinical trials;

 delays
 in product development, pre-clinical and clinical testing, or manufacturing;

 unplanned
 expenditures in product development, clinical testing, or manufacturing;

 challenges
 with securing the heparin supply chain;

 uncertainties
 relating to, or changes in FDA view of, the appropriate product approval pathway;

 to obtain treatment of a drug or application under expedited development and review programs
 or to obtain marketing exclusivities;

 to receive or maintain regulatory approvals;

 emergence
 of superior or equivalent products;

 inability
 to manufacture our product candidates on a commercial scale on our own, or in collaboration
 with third parties;

 to comply with a broad range of post-marketing requirements including those related to labeling,
 promotion and advertising, manufacturing and quality, pharmacovigilance and adverse event
 reporting, commercial distribution and supply chain requirements, and drug sample distribution
 requirements; and

 to achieve market acceptance.

 Because
of these risks, our development efforts may not result in any future commercially viable products. If a significant portion of these
development efforts are not successfully completed, required regulatory approvals are not obtained or any approved products are not commercialized
successfully, our business, financial condition, and results of operations will be materially harmed.

 Final
approval by regulatory authorities of our product candidates for commercial use may be delayed, limited or prevented, any of which would
adversely affect our ability to generate operating revenues.

 The
clinical development, manufacturing, labeling, packaging, storage, recordkeeping, export, marketing, promotion and distribution, and
other possible activities relating to our product candidates are subject to extensive regulation by the FDA and other regulatory agencies.
Failure to comply with applicable regulatory requirements may, either before or after product approval, subject us to administrative
or judicially imposed sanctions that may negatively impact the approval of one or more of our product candidates or otherwise negatively
impact our business. Compliance with such regulations may consume substantial financial and management resources and expose us and our
collaborators to the potential for other adverse circumstances. For example, a regulatory authority can place restrictions on the sale
or marketing of a drug in order to manage the risks identified during initial clinical trials or after the drug is on the market. A regulatory
authority can condition the approval for a drug on costly post-marketing follow-up studies. Based on these studies, if a regulatory authority
does not believe that the drug demonstrates a clinical benefit to patients or an acceptable safety profile, it could limit the indications
for which a drug may be sold or revoke the drug's marketing approval. In addition, identification of certain side effects either
during clinical trials or after a drug is on the market may result in reformulation of a drug, additional pre-clinical and clinical trials,
labeling changes, termination of ongoing clinical trials or withdrawal of approval. Any of these events could delay or prevent us from
generating revenue from the commercialization of these drugs and cause us to incur significant additional costs.

 We
are not permitted to market a product candidate in the United States until the particular product candidate is approved for marketing
by the FDA. Specific pre-clinical data, chemistry, manufacturing and controls data, a proposed clinical trial protocol and other information
must be submitted to the FDA as part of an IND application, and clinical trials may commence only after the IND application becomes effective.
To market a new drug in the United States, we must submit to the FDA and obtain FDA approval of an NDA. An NDA must be supported by extensive
clinical and pre-clinical data, as well as extensive information regarding chemistry, manufacturing and controls, to demonstrate the
safety and effectiveness of the product candidate, and the FDA will also assess whether the manufacturing processes and facilities are
suitable to support the application. Approval of an NDA may be delayed due to delays in FDA's review of the manufacturing facility,
which may require an onsite inspection.

 Obtaining
approval of an NDA can be a lengthy, expensive and uncertain process. Review time can be impacted by the quality of the information included
in the application, FDA's internal resources such as the availability of reviewers, or requests from the FDA for additional information.
Regulatory approval of an NDA is not guaranteed. The number and types of pre-clinical studies and clinical trials that will be required
for FDA approval varies depending on the product candidate, the disease or condition that the product candidate is designed to target
and the regulations applicable to any particular product candidate. Despite the time and expense exerted in pre-clinical and clinical
studies, failure can occur at any stage, and we could encounter problems that delay our product candidate development or that cause us
to abandon clinical trials or to repeat or perform additional pre-clinical studies and clinical trials. The FDA can delay, limit or deny
approval of a product candidate for many reasons, and product candidate development programs may be delayed or may not be successful
for many reasons including but not limited to, the following:

 The
 FDA or IRBs may not authorize us to commence, amend, or continue clinical studies;

 we
 may not be able to enroll a sufficient number of qualified patients for clinical trials in
 a timely manner or at all, patients may drop out of our clinical trials or be lost to follow-up
 at a higher rate than we anticipate, patients may not follow the clinical trial procedures,
 or the number of patients required for clinical trials may be larger than we anticipate;

 the
 FDA may not accept an NDA or other submission due to, among other reasons, the content or
 formatting of the submission;

 a
 product candidate may not be deemed adequately safe or effective for an intended use;

 the
 FDA may not find the data from pre-clinical studies and clinical trials sufficient;

 the
 FDA may require that we conduct additional pre-clinical or clinical studies, change our manufacturing
 process, or gather additional manufacturing information above what we currently have planned
 for;

 the
 FDA's interpretation and our interpretation of data from pre-clinical studies and clinical
 trials or chemistry, manufacturing and controls data may differ significantly;

 the
 FDA may not agree with our intended indications, the design of our clinical or pre-clinical
 studies, or there may be a flaw in the design that does not become apparent until the studies
 are well advanced;

 we
 may not be able to establish agreements with contractors or collaborators or they or we may
 fail to comply with applicable FDA and other regulatory requirements, including those identified
 in other risk factors;

 the
 FDA may not accept aspects of our proposed labeling, or may impose specific limitations in
 the labeling and require post-marking commitments or Phase 4 clinical trials before the labeling
 can be expanded;

 the
 FDA may determine that the manufacturing processes and facilities for our product candidate
 do not have sufficient good manufacturing practice ("GMP") controls in place to support approval;
 or

 the
 FDA may change its approval policies or adopt new regulations.

 Our
pre-clinical and clinical data, other information and procedures relating to a product candidate may not be sufficient to support approval
by the FDA or any other U.S. or foreign regulatory authority, or regulatory interpretation of these data and procedures may be unfavorable.
Failure to conduct required post-approval studies, or confirm a clinical benefit, will allow the FDA to withdraw the drug from the market
on an expedited basis. Our business and reputation may be harmed by any failure or significant delay in receiving regulatory approval
for the sale of any drugs resulting from our product candidates. As a result, we cannot predict when or whether regulatory approval will
be obtained for any drug we develop.

 Additionally,
other factors may serve to delay, limit or prevent the final approval by regulatory authorities of our product candidates for commercial
use, including, but not limited to:

 we
 or our licensees will need to conduct significant clinical testing and development work to
 demonstrate the quality, safety, and efficacy of these product candidates before applications
 for marketing can be filed with the FDA, or with the regulatory authorities of other countries;

 development
 and testing of product formulation, including identification of suitable excipients, or chemical
 additives intended to facilitate delivery of our product candidates;

 it
 may take us many years to complete the testing of our product candidates, and failure can
 occur at any stage of this process;

 negative
 or inconclusive results or adverse medical events during a clinical trial could cause us
 to delay or terminate our development efforts; and

 inspection
 delay given the FDA's current backlog of foreign inspections.

 The
successful development of any of these product candidates is uncertain and, accordingly, we may never commercialize any of these product
candidates or generate significant revenue.

 Risks
Related to Healthcare Regulatory and Legal Compliance Matters

 DefenCath,
and our other product candidates (if approved), will be subject
to extensive post-approval regulation.

 Once a product is approved, numerous post-approval requirements apply
in the United States. These include, among other things, requirements related to pharmacovigilance and adverse event and other reporting,
supply chain security requirements, suspect and illegitimate product investigations and notifications, limitations on product advertising
and promotion and on the distribution of product samples, required post-marketing studies, and ongoing adherence to cGMPs, as well as
the need to submit appropriate new or supplemental applications and obtain FDA approval for certain changes to the approved product, product
labeling, or manufacturing process. Establishing and maintaining systems and procedures for compliance with these requirements, and for
training and monitoring personnel relative to their compliance, is expensive, time consuming, and an ongoing effort. Depending on the
circumstances, failure to meet post-approval requirements can result in criminal prosecution, fines, injunctions, recall or seizure of
products, total or partial suspension of production, denial or withdrawal of pre-marketing product approvals, or refusal to allow us to
enter into supply contracts, including government contracts. In addition, even if we comply with FDA, foreign and other requirements,
new information regarding the safety or effectiveness of a product could lead the FDA or a foreign regulatory body to modify or withdraw
product approval. Failure to complete a PREA post-marketing study can result in a PREA non-compliance letter, which is publicly posted
on FDA's website, and could result in the product being considered misbranded and subject to additional enforcement.

 Current
healthcare laws and regulations in the U.S. and future legislative or regulatory reforms to the U.S. healthcare system may affect our
ability to commercialize DefenCath and future marketed products profitably.

 Federal
and state governments in the U.S. are considering legislative and regulatory proposals to change the U.S. healthcare system in ways that
could affect our ability to commercialize DefenCath and future marketed products profitably. Similarly, among payors and other third-parties,
there is significant interest in promoting such changes through legislation and regulation (in additional to through restrictions introduced
via contracting and other methods). The life sciences industry and specifically the market for the sale, insurance coverage and distribution
of pharmaceuticals has been a particular focus of these efforts and would likely be significantly affected by any major legislative or
regulatory initiatives. In addition, there have been, and may in the future be, initiatives at both the federal and state level that
could significantly modify the terms and scope of government-provided health insurance coverage, ranging from changes to some or all
of the provisions of existing law, to establishing a single-payer, national health insurance system, to more limited "buy-in"
options to existing public health insurance programs, any of which could have a significant impact on the healthcare industry. It is
possible that additional legislative, executive and judicial activities in the future could have a material adverse impact on our business,
financial condition and results of operations.

 We
are subject to healthcare laws, regulations and enforcement; our failure to comply with those laws could have a material adverse impact
on our business, financial condition and results of operations.

 Should our compliance controls prove ineffective at preventing or mitigating
the risk and impact of improper business conduct or inaccurate reporting in connection with applicable federal and state healthcare laws
and regulations, we could be subject to enforcement actions and substantial penalties. If our operations are found, or even alleged, to
be in violation of any of these laws and regulations, we, or our officers or employees, may be subject to significant penalties, including
administrative civil and criminal penalties, damages, fines, regulatory penalties, the curtailment or restructuring of our operations,
exclusion from participation in Medicare, Medicaid and other federal and state healthcare programs, imprisonment, reputational harm, additional
reporting requirements and oversight through a Corporate Integrity Agreement or other monitoring agreement, any of which would adversely
affect our ability to sell our products and operate our business and also adversely affect our financial results.

 Risks
relating to data privacy could create additional liabilities for us.

 We
are subject to data privacy and protection laws and regulations that apply to the collection, transmission, storage and use of personally-identifying
information. Failure to comply with applicable privacy and data security laws and regulations could result in enforcement actions against
us, including possible fines, imprisonment of company officials and public censure, claims for damages by affected individuals, damage
to our reputation and loss of goodwill, any of which could have a material adverse effect on our business, financial condition, results
of operations or prospects.

 The
legislative and regulatory landscape for privacy and data protection continues to evolve in jurisdictions worldwide. There are numerous
U.S. federal and state laws and regulations related to the privacy, data protection and security of personal information. At the federal
level, regulations promulgated pursuant to HIPAA establish privacy and security standards for "covered entities" (group health
plans and most healthcare providers) that limit the use and disclosure of individually identifiable health information those entities
and their service providers receive or create ("protected health information"). Although we generally are not subject to
the HIPAA privacy or security regulations, we do business with various entities (including clinical trial investigators) that are subject
those regulations, and we have to expend resources to understand their obligations, adjust contractual terms in light of those obligations,
or otherwise modify our business practices. Congress is currently considering adopting legislation to regulate the collection, use, and
disclosure of personal health information more broadly than the HIPAA privacy and security regulations. Such legislation might require
us to make substantial expenditures and would likely create additional liability risks.

 The
Federal Trade Commission ("FTC") Act, while not focused on data privacy or security, has proven to be a significant federal
enforcement tool with respect to protection of personal information, and recently, personal health information in particular. The FTC
has used its authority under Section 5 of the FTC Act, which prohibits unfair and deceptive practices affecting consumers, to bring numerous
cases against companies for failing to protect the privacy or security of personal information in a manner that is reasonable and fully
consistent with stated privacy policies, notices, or other representations. Particularly because the FTC has taken these actions based
on theories that are not codified in regulations, the optimal means to mitigate the risk of such an action are uncertain.

 In
addition, many U.S. states in which we operate have laws that protect the privacy and security of personal information. Certain state
laws may be more stringent or broader in scope, or offer greater individual rights, with respect to personal information than federal,
international or other state laws, and such laws may differ from each other, which complicates compliance efforts. For example, the California
Confidentiality of Medical Information Act (the "CMIA") imposes stringent data privacy and security requirements and obligations
with respect to the personal health information of California residents. The CMIA authorizes administrative fines and civil penalties
of up to $25,000 for willful violations and up to $250,000 if the violation is for purposes of financial gain, as well as criminal fines.
Other states, including Colorado, Connecticut, Delaware, Indiana, Iowa, Montana, New Hampshire, New Jersey, Oregon, Tennessee, Texas,
Utah, and Virginia, have recently adopted broadly applicable privacy laws, and both Nevada and Washington State have enacted laws specifically
to protect the privacy of personal health information. Violations of the Washington State law can result in civil penalties of up to
$7,500 per violation, up to $25,000 in treble damages at the sole discretion of the court, and injunctive relief. Consumers also may
bring their own actions to recover (i) actual damages, (ii) treble damages; and (iii) attorney's fees. Violations of the Nevada
law can result in up to $10,000 civil penalties per violation and injunctive relief.

 New
legislation anticipated to be enacted in various other states will continue to shape the data privacy environment nationally. The effects
on our business of this growing body of privacy and data protection laws are potentially significant, and may require us to modify our
data processing practices and policies and to incur substantial costs and expenses in an effort to comply.

 If we or our third-party service providers are unable to properly protect
the privacy and security of personal information, or other confidential data we process in our business, we could be found to have breached
our contracts. Further, if we fail to comply with applicable privacy laws, we could face civil and criminal penalties. Enforcement activity
by regulatory authorities in relation to privacy and cybersecurity matters can result in financial liability and reputational harm, and
responses to such enforcement activity can consume significant internal resources. The threat of class action lawsuits based on data security
breaches or alleged unfair practices further increases the risk to our business. We cannot be sure how these privacy laws and regulations
will be interpreted, enforced or applied to our operations. In addition to the risks associated with enforcement activities and potential
contractual liabilities, our ongoing efforts to comply with evolving laws and regulations at the federal and state level may be costly
and require ongoing modifications to our policies, procedures and systems.

 Clinical
trials required for our product candidates, including, but not limited to, new uses or formulations of DefenCath and the required DefenCath
PREA study, may be expensive and time-consuming, and their outcome is uncertain.

 In order to obtain FDA or foreign approval to market a new drug or
device product, we must demonstrate proof of safety and effectiveness in humans. Foreign regulations and requirements are similar to those
of the FDA. To meet FDA requirements, we are obligated to conduct "adequate and well-controlled" clinical trials. Conducting
clinical trials is a lengthy, time-consuming, and expensive process. The length of time may vary substantially according to the type,
complexity, novelty, and intended use of the product candidate, and often can be several years or more per trial. Delays associated with
the development plans for our product candidates may cause us to incur additional operating expenses. The commencement and rate of completion
of clinical trials may be delayed by many factors, including, for example:

 inability
 to manufacture sufficient quantities of qualified materials under the FDA's cGMP requirements
 for use in clinical trials;

 slower
 than expected rates of patient recruitment;

 to recruit a sufficient number of patients;

 modification
 of clinical trial protocols;

 changes
 in regulatory requirements for clinical trials;

 lack
 of effectiveness during clinical trials;

 emergence
 of unforeseen safety issues;

 delays,
 suspension, or termination of clinical trials due to the IRB responsible for overseeing the
 study at a particular study site; and

 government
 or regulatory delays or "clinical holds" requiring suspension or termination
 of the trials.

 Further,
the results from early pre-clinical and clinical trials are not necessarily predictive of results to be obtained in later clinical trials.
Accordingly, even if we obtain positive results from early pre-clinical or clinical trials, we may not achieve the same success in later
clinical trials. Moreover, comparisons of results across different studies should be viewed with caution as such comparisons are limited
by a number of factors, including differences in study designs and populations. Such comparisons also will not provide a sufficient basis
for any comparative claims following product approval. Clinical results are frequently susceptible to varying interpretations that may
delay, limit or prevent regulatory approvals or commercialization. Negative or inconclusive results or adverse medical events during
a clinical trial could cause a clinical trial to be delayed, repeated or terminated, or a clinical program to be abandoned.

 Our
clinical trials may be conducted in patients with serious or life-threatening diseases for whom conventional treatments have been unsuccessful
or for whom no conventional treatment exists, and in some cases, our product is expected to be used in combination with approved therapies
that themselves have significant adverse event profiles. During the course of treatment, these patients could suffer adverse medical
events or die for reasons that may or may not be related to our products. We cannot ensure that safety issues will not arise with respect
to our products in clinical development.

 Clinical
trials may not demonstrate statistically significant safety and effectiveness to obtain the requisite regulatory approvals for product
candidates. The failure of clinical trials to demonstrate safety and effectiveness for the desired indications could harm the development
of our product candidates. Such a failure could cause us to abandon a product candidate and could delay development of other product
candidates. Any delay in, or termination of, our clinical trials would delay the filing of any NDA or any Premarket Approval Application,
or PMA, or De Novo application, with the FDA and, ultimately, our ability to commercialize our product candidates and generate product
revenues. Any change in, or termination of, our clinical trials could materially harm our business, financial condition, and results
of operations.

 If
we are unable to effectively recruit, train, retain and equip our sales force, our ability to successfully commercialize DefenCath
will be harmed.

 None
of the members of our sales force has promoted DefenCath prior to its launch, and we are required to, and will continue to be required
to, expend significant time and effort to recruit and train our sales force to be credible, persuasive, and compliant with applicable
laws in marketing DefenCath for its approved indication. We must train our sales force to ensure that a consistent and appropriate message
about DefenCath is being delivered to our customers. If we are unable to successfully train our sales force and provide them with appropriate
materials, including medical and sales literature to help them educate and inform customers about the benefits and risks of DefenCath,
our efforts to successfully commercialize DefenCath may be challenged and it may present risk to our ability to generate product revenue.

 Risks
Related to Our Business and Industry

institutions, physicians and patients may not accept and use our products.

 Even
though we have received FDA approval for DefenCath, healthcare institutions, physicians and patients may not accept and use our products.
Acceptance and use of our products will depend upon a number of factors including the following:

 perceptions
 by members of the health care community, including physicians, about the safety and effectiveness
 of our drug or device product;

 prevalence
 of the disease to be treated or prevented;

 prevalence
 and severity of any side effects;

 cost-effectiveness
 of our product relative to current standard of care;

 availability
 of coverage and reimbursement from government and other third-party payers;

 timing
 of market introduction of our drugs and competitive drugs;

 effectiveness
 of marketing and distribution efforts by us and our licensees and distributors, if any;

 potential
 or perceived advantages or disadvantages over alternative treatments;

 potential
 post-marketing commitments imposed by regulatory authorities, such as patient registries;

 price
 of our future products, both in absolute terms and relative to alternative treatments; and

 the
 effect of current and future healthcare laws and regulations on our product candidates.

 Because
we expect sales of DefenCath to generate substantially all of our product revenues for the foreseeable future, the failure of DefenCath
to find market acceptance would harm our business and would require us to seek additional financing.

 Competition
and technological change may make DefenCath, as well as our other product candidates or indications, less attractive or obsolete.

 We
compete with established pharmaceutical and medical device companies that are pursuing other forms of prevention or treatment for the
same or similar indications we are pursuing, and that have greater financial and other resources. Other companies may succeed in developing
products earlier than we do, may develop products that are more effective than our product candidates. Research and development by others
may render our technology or product candidates obsolete or noncompetitive, or result in processes, treatments or cures superior to any
therapy we develop. We face competition from companies that develop competing technology internally, or acquire competing technology
through acquisitions of other companies, or from universities and other research institutions. As these competitors develop their technologies,
they may develop competitive positions that may prevent, make futile, or limit our product commercialization efforts, which would result
in a decrease in the revenue we would be able to derive from the sale of DefenCath or our other product candidates if any of such other
product candidates receive marketing approval.

policy changes, including reimbursement policies for drugs and medical devices, may have an adverse effect on our business, financial
condition and results of operations.

 Our
future revenues, profitability and access to capital will be affected by the continuing efforts of governmental and private third-party
payors to manage, contain or reduce the costs of health care through various means, such as capping prices, limiting price increases,
reducing reimbursement, and requiring rebates. Market acceptance and sales of DefenCath or any other product candidates that we develop,
will depend on reimbursement policies and may be affected by health care reform measures in the U.S. and abroad. Government authorities
and other third-party payors, such as private health insurers, decide which drugs they will pay for and establish reimbursement levels.
While we have some indication that Medicare will provide reimbursement in certain settings and benefits, we cannot be sure that reimbursement
will be available for DefenCath by other payers. That uncertainty applies for any other product candidates that we develop. Also, we
cannot be sure that the amount of reimbursement that is available will not reduce the demand for, or the price of, our products. If reimbursement
is not available by certain payors or is available only at limited levels, we may not be able to successfully commercialize DefenCath
or any other product candidates that we develop.

 In
the U.S. there has been, and we expect there will continue to be, a number of legislative and regulatory changes to the health care system
that could affect our ability to profit from our approved products. The U.S. government and other governments have shown significant
interest in pursuing healthcare reform. In particular, the Medicare Modernization Act of 2003 revised the payment methodology for many
products under the Medicare program in the United States. This has resulted in lower rates of reimbursement. In 2010, the Patient Protection
and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act (collectively, the "Affordable Care Act"),
was enacted. The Affordable Care Act substantially changed the way healthcare is financed by both governmental and private insurers.
Such government-adopted reform measures may adversely affect the pricing of healthcare products and services in the U.S. or internationally
and the amount of reimbursement available from governmental agencies or other third-party payors.

 In
recent years, the U.S. Congress has sought to repeal and has significantly amended the Affordable Care Act. We expect that there will
continue to be proposals by legislators at both the federal and state levels, regulators and third-party payors to keep healthcare costs
down while expanding individual healthcare benefits. Certain of these changes could impose limitations on the prices we will be able
to charge for any products that are approved or the amounts of reimbursement available for these products from governmental agencies
or other third-party payors or may increase the tax requirements for life sciences companies such as ours. Any such legislation could
have an adverse effect on our business, financial condition and results of operations.

 There
has been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products, which have resulted
in several recent congressional inquiries and proposed and enacted bills by Congress and the states designed to, among other things,
bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government
program reimbursement methodologies for products. In addition, the U.S. government, state legislatures, and foreign governments have
shown significant interest in implementing cost containment programs, including price-controls, restrictions on reimbursement and requirements
for substitution of generic products for branded prescription drugs to limit the growth of government paid health care costs. For example,
the U.S. government has passed legislation requiring pharmaceutical manufacturers to provide rebates and discounts to certain entities
and governmental payors to participate in federal healthcare programs. The U.S. government enacted the Inflation Reduction Act of 2022
(Inflation Reduction Act or IRA), the implementation and scope of which is subject to change through ongoing and future regulatory processes
and rulemaking. The IRA brings sweeping changes to Medicare coverage and reimbursement for prescription drugs that could negatively impact
us and other pharmaceutical manufacturers. Of note, beginning January 1, 2025 the IRA alters the current structure of the Medicare Part
D standard benefit by eliminating the coverage gap. The IRA reduces a beneficiary's out-of-pocket maximum to $2,000 beginning in
2025. The existing coverage gap discount program for pharmaceutical manufacturers will be replaced by a new manufacturer discount program
effective in 2025. Under the new program, manufacturers will provide a 10 percent discount off the negotiated price for applicable drugs
(branded drugs and biologics manufactured by companies that have Part D discount agreements) after the deductible is satisfied through
the catastrophic phase of the benefit. In the catastrophic phase, manufacturers will provide a 20 percent discount off negotiated price.

 In
addition to restructuring the Medicare Part D benefit, under the IRA the CMS will negotiate directly with manufacturers the price that
Medicare will pay for certain high-cost drugs via establishment of the Drug Price Negotiation Program (or the Program). The Program will
apply to drugs administered or dispensed under both Medicare Parts B and D, although for the first two years of the Program, only Medicare
Part D qualifying drugs will be impacted. The Program officially began in 2023 with CMS selecting 10 drugs for direct price negotiation
from a list of drugs representing the highest Medicare Part D spend. The newly negotiated prices for the first tranche of Part D drugs
will not be applicable until 2026. If a manufacturer of a selected drug does not negotiate a Maximum Fair Price (MFP) with the CMS, the
manufacturer must pay an excise tax of 65 to 95 percent of Medicare utilization based on the prior year. Manufacturers that agree on
an MFP, but do not honor it, will be subject to civil monetary penalties equal to 10 times the amount of the product dispensed or administered
that year, as well as the difference between the reimbursed price and the MFP. Even if a manufacturer's drug is not selected for
negotiation under the Program, its Medicare coverage could be impacted as a drug with a MFP automatically receives placement on Part
D plan formularies and could usurp coverage of another therapeutic alternative in the same class of drugs as the general rule is that
Medicare Part D plan formularies have at least 2 drugs per each therapeutic class outside of the 6 protected classes. While none of our
drug products have currently been selected for negotiation, we continue to monitor the process for potential impact to our business.
The Program and resulting excise tax have been challenged as unconstitutional in various lawsuits. In the event that the Program and
resulting excise tax are struck down as unconstitutional, the Medicare Part D marketplace could be disturbed by insurers exiting the
Medicare Part D market and premiums increasing. If this occurs, it could negatively impact reimbursement and coverage for our self-administered
drugs.

 Lastly,
the IRA imposed additional rebates on manufacturers including CorMedix to the extent certain drug pricing metrics are rising faster than
inflation. These new inflation rebates are similar to those imposed on manufacturers under Medicaid and could result in additional rebates
due from us on Medicare utilization of our products. Inflation rebates are accruing on Medicare Part D utilization from October 1, 2022
and on Medicare Part B utilization from January 1, 2023 forward, though the CMS has deferred collection of such rebates until 2025.

 Any
reduction in reimbursement rates under Medicare, Medicaid, or private insurers or foreign health care programs could negatively affect
the pricing of our products. If we are not able to charge a sufficient amount for our products, then our margins and our profitability
will be adversely affected.

 If
we lose key management or scientific personnel, cannot recruit qualified employees, directors, officers, or other personnel or experience
increases in compensation costs, our business may materially suffer.

 We are highly dependent on the principal members of our management
and scientific staff, specifically, Joseph Todisco, our Chief Executive Officer, Dr. Matthew David, our Executive Vice President and Chief
Financial Officer, Beth Zelnick Kaufman, our Executive Vice President, Chief Legal Officer and Corporate Secretary, Elizabeth Hurlburt,
our Executive Vice President and Chief Clinical Strategy & Operations Officer and Erin Mistry, our Executive Vice President and Chief
Commercial Officer. Our future success will depend in part on our ability to identify, hire, and retain current and additional personnel.
We experience intense competition for qualified personnel and may be unable to attract and retain the personnel necessary for the development
of our business. Because of this competition, our compensation costs may increase significantly. In addition, we have only limited ability
to prevent former employees from competing with us.

in funding for the FDA and other government agencies or future government shutdowns or disruptions could cause delays in the submission
and regulatory review of marketing applications, including supplements, which could negatively impact our business or prospects.

 The
ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding
levels, ability to hire and retain key personnel and accept submission, applications, and the payment of user fees, and statutory, regulatory,
and policy changes. In addition, government funding of other government agencies that fund research and development activities is subject
to the political process, which is inherently fluid and unpredictable. The impact of global events, including terrorism, natural disasters
and pandemics, or other health emergencies, may also cause disruptions in the normal functioning of the FDA or other government agencies.

 If
we are unable to hire additional qualified personnel, our ability to grow our business may be harmed.

 We
have established field based commercial and medical teams to support the launch of DefenCath. We compete for qualified individuals with
numerous pharmaceutical companies, universities and other research institutions. Competition for such individuals is intense, and we
cannot be certain that our search for such personnel will be successful. Attracting and retaining such qualified personnel will be critical
to our success.

 We
may not successfully manage our growth.

 Our
success will depend upon the expansion of our operations to commercialize DefenCath and the effective management of any growth, which
could place a significant strain on our management and our administrative, operational and financial resources. To manage this growth,
we may need to expand our facilities, augment our operational, financial and management systems and hire and train additional qualified
personnel. If we are unable to manage our growth effectively, our business may be materially harmed.

 We
face the risk of product liability claims and the amount of insurance coverage we hold now or in the future may not be adequate to cover
all liabilities we might incur.

 Our
business exposes us to the risk of product liability claims that are inherent in the development of drugs. If the use of one or more
of our or our collaborators' drugs or devices harms people, we may be subject to costly and damaging product liability claims brought
against us by clinical trial participants, consumers, health care providers, pharmaceutical companies or others selling our products.

 We
currently carry product liability insurance. We cannot predict all of the possible harms or side effects that may result and, therefore,
the amount of insurance coverage we hold may not be adequate to cover all liabilities we might incur. Our insurance covers bodily injury
and property damage arising from our clinical trials, subject to industry-standard terms, conditions and exclusions. Our coverage also
includes the sale of commercial products.

 If
we are unable to obtain insurance at an acceptable cost or otherwise protect against potential product liability claims, we may be exposed
to significant liabilities, which may materially and adversely affect our business and financial position. If we are sued for any injury
allegedly caused by our or our collaborators' products and do not have sufficient insurance coverage, our liability could exceed
our total assets and our ability to pay the liability. A successful product liability claim or series of claims brought against us would
decrease our cash and could cause the value of our capital stock to decrease.

 We
may be exposed to liability claims associated with the use of hazardous materials and chemicals.

 Our
research, development and manufacturing activities and/or those of our third-party contractors may involve the controlled use of hazardous
materials and chemicals. Although we believe that our safety procedures for using, storing, handling and disposing of these materials
comply with federal, state and local, as well as foreign, laws and regulations, we cannot completely eliminate the risk of accidental
injury or contamination from these materials. In the event of such an accident, we and the third-party could be held liable for any resulting
damages and any liability could materially adversely affect our business, financial condition and results of operations. In addition,
the federal, state and local, as well as foreign, laws and regulations governing the use, manufacture, storage, handling and disposal
of hazardous or radioactive materials and waste products may require us to incur substantial compliance costs that could materially adversely
affect 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 harm our business.

 From
time to time and in the future, our operations may involve the use of hazardous and flammable materials, including chemicals and biological
materials, and may also produce hazardous waste. Even if we contract with third parties for the disposal of these materials and waste,
we cannot completely eliminate the risk of contamination or injury resulting from these materials. In the event of contamination or injury
resulting from the use or disposal of our hazardous materials, we could be held liable for any resulting damages, and any liability could
exceed our resources. We also could incur significant costs associated with civil or criminal fines and penalties for failure to comply
with such laws and regulations.

 In
addition, we may incur substantial costs in order to comply with current or future environmental, health and safety laws and regulations.
Current or future environmental laws and regulations may impair our research, development or production efforts. In addition, failure
to comply with these laws and regulations may result in substantial fines, penalties or other sanctions.

 Negative
U.S. and global economic conditions may pose challenges to our business strategy, which relies on funding from the financial markets
or collaborators.

 Negative
conditions in the U.S. or global economy, including financial markets, may adversely affect our business and the business of current
and prospective vendors, licensees and collaborators, and others with whom we do or may conduct business. The U.S. or global economy
may experience disruptions as the result of international hostilities, natural disasters, pandemics, other international health emergencies,
or weather-related or similar events (such as fires, hurricanes, earthquakes, floods, landslides and other natural conditions including
the effects of climate change), political instability, labor strikes or turmoil, or terrorist attacks. We continue to assess the potential
impact on our counterparties and customers of such events, and what impact, if any, these events could have on our business.

 The
duration and severity of these conditions is uncertain. If negative economic conditions occur, we may be unable to secure funding on
terms satisfactory to us to sustain our operations or to find suitable collaborators to advance our internal programs, even if we achieve
positive results from our drug development programs.

 Risks
Related to Our Intellectual Property

 If
we materially breach or default under the ND License Agreement, NDP will have the right to terminate the ND License Agreement, which
termination may materially harm our business.

 Our
commercial success will depend in part on the maintenance of the ND License Agreement. The ND License Agreement provides NDP with a right
to terminate the license agreement for our uncured material breach or default under the agreement, including the failure to make any
required milestone or other payments. Should NDP exercise such a termination right following an uncured material breach by us, we would
lose our right to the intellectual property under the ND License Agreement, which loss would materially harm our business.

 If
we and our licensors do not obtain protection for and successfully defend our respective intellectual property rights, competitors may
be able to take advantage of our research and development efforts to develop competing products.

 Our
commercial success will depend in part on obtaining further patent protection for our products, product candidates and other technologies
and successfully defending any patents that we currently have or will obtain against third-party challenges. The patents which we currently
believe are most material to our business are as follows:

 U.S. Patent No. 8,541,393 (expiring November 2, 2024);

 U.S.
 Patent No. 9,339,036 (expiring November 2, 2024);

 U.S. Patent No. 7,696,182 (expiring May 16, 2025); and

 U.S.
 Patent No. 11,738,120 (expiring April 15, 2042).

 We
may seek further patent protection for our compounds and methods of treating diseases. However, the patent process is subject to numerous
risks and uncertainties, and there can be no assurance that we will be successful in protecting our products by obtaining and defending
patents. These risks and uncertainties include the following:

 patents
 that may be issued or licensed may be challenged, invalidated, or circumvented, or otherwise
 may not provide any competitive advantage;

 our
 competitors, many of which have substantially greater resources than we have and many of
 which have made significant investments in competing technologies, may seek, or may already
 have obtained, patents that will limit, interfere with, or eliminate our ability to make,
 use, and sell our potential products either in the United States or in international markets;

 there
 may be significant pressure on the United States government and other international governmental
 bodies to limit the scope of patent protection both inside and outside the United States
 for treatments that prove successful as a matter of public policy regarding worldwide health
 concerns; and

 countries
 other than the United States may have less restrictive patent laws than those upheld by United
 States courts, allowing foreign competitors the ability to exploit these laws to create,
 develop, and market competing products.

 In addition, the USPTO and patent offices in other jurisdictions have
often required that patent applications concerning pharmaceutical and/or biotechnology-related inventions be limited or narrowed substantially
to cover only the specific innovations exemplified in the patent application, thereby limiting the scope of protection against competitive
challenges. Thus, even if we or our licensors are able to obtain patents, the patents may be substantially narrower than anticipated. Additionally,
the breadth of claims allowed in biotechnology and pharmaceutical patents or their enforceability cannot be predicted. We cannot be sure
that, should any patents issue, we will be provided with adequate protection against potentially competitive products. Furthermore, we
cannot be sure that should patents issue, they will be of commercial value to us, or that private parties, including competitors, will
not successfully challenge our patents or circumvent our patent position in the U.S. or abroad.

 The
above-mentioned patents are exclusively licensed to or owned by us. To support our patent strategy, we have engaged in a review of patentability
and certain freedom to operate issues, including performing certain searches. However, patentability and certain freedom to operate issues
are inherently complex, and we cannot provide assurances that a relevant patent office and/or relevant court will agree with our conclusions
regarding patentability issues or with our conclusions regarding freedom to operate issues, which can involve subtle issues of claim
interpretation and/or claim liability. Furthermore, we may not be aware of all patents, published applications or published literature
that may affect our business either by blocking our ability to commercialize our product candidates, preventing the patentability of
our product candidates to us or our licensors, or covering the same or similar technologies that may invalidate our patents, limit the
scope of our future patent claims or adversely affect our ability to market our product candidates. Additionally, it is also possible
that prior art of which we are aware, but which we do not believe affects the validity or enforceability of a claim, may, nonetheless,
ultimately be found by a court of law or an administration panel to affect the validity or enforceability of a claim. If a third party
were to prevail on a legal assertion of invalidity and/or unenforceability, we would lose at least part, and perhaps all, of the patent
protection on our product candidates. Such loss of patent protection could have a material adverse impact on our business. Additionally,
since patent applications in the United States are maintained in secrecy until published or issued and as publication of discoveries
in the scientific or patent literature often lag behind the actual discoveries, we cannot be certain that we were the first to make the
inventions covered by the pending patent applications or issued patents referred to above or that we were the first to file patent applications
for such inventions.

 In
addition to patents, we also rely on trade secrets and proprietary know-how. Although we take measures to protect this information by
entering into confidentiality and inventions agreements with our employees, and some but not all of our scientific advisors, consultants,
and collaborators, we cannot provide any assurances that these agreements will not be breached, that we will be able to protect ourselves
from the harmful effects of disclosure or dispute ownership if they are breached, or that our trade secrets will not otherwise become
known or be independently discovered by competitors. We may also be unsuccessful in executing such an agreement with each party who in
fact develops intellectual property that we regard as our own, which may result in claims by or against us related to the ownership of
such intellectual property. If any of these events occurs, or we otherwise lose protection for our trade secrets or proprietary know-how,
the value of our intellectual property may be greatly reduced. Even if we are successful in prosecuting or defending against
such claims, litigation could result in substantial costs and be a distraction to our senior management and scientific personnel.

 Intellectual
property disputes could require us to spend time and money to address such disputes and could limit our intellectual property rights.

 The biotechnology and pharmaceutical industries have been characterized
by extensive litigation regarding patents and other intellectual property rights, and companies have employed intellectual property litigation
to gain a competitive advantage. We may initiate or become subject to infringement claims or litigation arising out of patents and pending
applications of our competitors, or we may become subject to proceedings initiated by our competitors or other third parties or the PTO
or applicable foreign bodies to reexamine the patentability of our licensed or owned patents. In addition, litigation may be necessary
to enforce our issued patents, to protect our trade secrets and know-how, or to determine the enforceability, scope, and validity of the
proprietary rights of others. If we are required to defend patent infringement actions brought by third parties, or if we sue to protect
our own patent rights, we may be required to pay substantial litigation costs and managerial attention may be diverted from business operations
even if the outcome is not adverse to us. In addition, any legal action that seeks damages or an injunction to stop us from carrying on
our commercial activities relating to the affected technologies could subject us to monetary liability and require us or any third party
licensors to obtain a license to continue to use the affected technologies. We cannot predict whether we would prevail in any of these
types of actions or that any required license would be made available on commercially acceptable terms or at all. Furthermore, to the
extent that we or our consultants or research collaborators use intellectual property owned by others in work performed for us, disputes
may also arise as to the rights in such intellectual property or in resulting know-how and inventions. An adverse claim could subject
us to significant liabilities to such other parties and/or require disputed rights to be licensed from such other parties. See Note
6, Commitments and Contingencies, of this Annual Report on Form 10-K for additional detail on the Company's legal proceedings.

 If
we infringe the rights of third parties we could be prevented from selling products and forced to pay damages and defend against litigation.

 If
our products, methods, processes and other technologies infringe the proprietary rights of other parties, we could incur substantial
costs and we may have to do one or more of the following:

 obtain
 licenses, which may not be available on commercially reasonable terms, if at all;

 abandon
 an infringing product candidate;

 redesign
 our products or processes to avoid infringement;

 stop
 using the subject matter claimed in the patents held by others;

 pay
 damages; or

 defend
 litigation or administrative proceedings, which may be costly whether we win or lose, and
 which could result in a substantial diversion of our financial and management resources.

 Risks
Related to Dependence on Third Parties

 We
depend on third party suppliers and contract manufacturers for the supply and manufacture of DefenCath and our product candidates, as
well as our APIs, which subjects us to potential cost increases and manufacturing delays that are not within our control.

 We do not manufacture DefenCath or any of its raw materials or components
ourselves, and we rely on third parties for our drug supplies both for clinical trials and for commercial quantities. All of our manufacturing
processes currently are, and we expect them to continue to be, outsourced to third parties, some of which are single-source suppliers.
We have made the strategic decision not to manufacture APIs for DefenCath or our other product candidates, as these can be more economically
supplied by third parties with particular expertise in this area. We have engaged contract facilities that are registered with the FDA,
have a track record of large-scale API manufacture, and have already invested in capital and equipment.

 We currently have one FDA approved source for each of our two key APIs
for DefenCath, taurolidine and heparin sodium, respectively. With regards to taurolidine, we have a DMF filed with the FDA. There is a
master commercial supply agreement between a third-party manufacturer and us in place from August 2018. We are currently in the process
of identifying and qualifying an alternate third-party manufacturer for taurolidine under our existing DMF. With respect to heparin sodium
API, we have identified an alternate third party supplier and intend to qualify such supplier under the DefenCath NDA over the next twelve
months.

 We received FDA approval of DefenCath
with finished dosage production from our European based CMO Rovi Pharma Industrial Services. We believe this CMO has adequate capacity
to produce the volumes needed to meet near term projected demand for the commercial launch of DefenCath.

 We previously announced commercial arrangements with additional finished
dosage CMOs, Alcami Corporation and Siegfried Hameln, that provide for the manufacture of commercial sterile parenteral drug products.
The Company anticipates the submission to the FDA of a supplement adding Siegfreid Hameln as an alternate manufacturing site in the second
fiscal quarter of 2024. The Company will also discontinue its relationship with Alcami as a potential alternate manufacturing site for
DefenCath.

 We
have no direct control over the manufacturing of DefenCath or our product candidates. If the contract manufacturers are unable to produce
sufficient quantities of DefenCath or our product candidates, as a result of a lack of available materials or otherwise, then we would
need to identify and contract with additional or replacement third-party manufacturers. If we are unable to identify suitable additional
or replacement third-party manufacturers, or are only able to do so on unfavorable terms, our ability to commercialize DefenCath and
our future profitability would be adversely affected.

 In
addition, we have no direct control over manufacturing costs of DefenCath or our product candidates. If the cost of manufacturing increases,
or if the cost of the materials used increases, these costs will be passed on to us, making the cost of clinical trials and commercializing
DefenCath and our product candidates more expensive. Increases in manufacturing costs could adversely affect our future profitability
if we are unable to pass all of the increased costs along to our customers.

 Our
continuing reliance on third parties for manufacturing entails a number of additional risks, including reliance on third parties for
legal and regulatory compliance and quality assurance, the possible breach of the manufacturing or supply agreement by such third parties,
and the possible termination or nonrenewal of the agreement by such third parties at a time that is costly or inconvenient for the Company.
Further, we, along with our contract manufacturers, are required to comply with FDA requirements for cGMPs, related to product testing,
quality assurance, manufacturing and documentation. Our contract manufacturers may fail to comply with the applicable FDA regulatory
requirements, which could result in delays to our product development programs, result in adverse regulatory actions against them or
us, and prevent us from ultimately receiving product marketing approval. They also generally must pass an FDA preapproval inspection
for conformity with cGMPs before we can obtain approval to manufacture our product candidates and will be subject to ongoing, periodic,
unannounced inspection by the FDA and corresponding state agencies to ensure strict compliance with cGMP and other applicable government
regulations and corresponding foreign standards. Not complying with FDA requirements could result in a product recall or prevent commercialization
of our product candidates and delay our business development activities. In addition, such failure could be the basis for the FDA to
issue a warning or untitled letter or take other regulatory or legal enforcement action, including recall or seizure, total or partial
suspension of production, suspension of ongoing clinical trials, refusal to approve pending applications or supplemental applications,
and potentially civil and/or criminal penalties depending on the matter. Similarly, we, along with our contract manufacturers, are required
to comply with all applicable healthcare laws and regulations, such as, without limitation, the federal AKS, the civil False Claims Act,
and civil monetary penalty laws, as well as similar state laws. Violation of any such laws by a contract manufacturer could materially
impact our operations.

 Corporate
and academic collaborators may take actions that delay, prevent, or undermine the success of our products.

 Our
operating and financial strategy for the development, clinical testing, manufacture, and commercialization of our product candidates
is heavily dependent on our entering into collaborations with corporations, academic institutions, licensors, licensees, and other parties.
Our current strategy assumes that we will successfully establish and maintain these collaborations or similar relationships. However,
there can be no assurance that we will be successful establishing or maintaining such collaborations. Some of our existing collaborations,
such as the ND License Agreement, are, and future collaborations may be, terminable at the sole discretion of the collaborator in certain
circumstances. Replacement collaborators might not be available on attractive terms, or at all.

 In
addition, the activities of any collaborator will not be within our control and may not be within our power to influence. There can be
no assurance that any collaborator will perform its obligations to our satisfaction or at all, that we will derive any revenue or profits
from such collaborations, or that any collaborator will not compete with us. If any collaboration is not pursued, we may require substantially
greater capital to undertake on our own the development and marketing of our product candidates and may not be able to develop and market
such products successfully, if at all. In addition, a lack of development and marketing collaborations may lead to significant delays
in introducing product candidates into certain markets and/or reduced sales of products in such markets.

 Data
provided by collaborators and others upon which we rely that has not been independently verified could turn out to be false, misleading,
or incomplete.

 We
rely on third-party vendors, scientists, and collaborators to provide us with significant data and other information related to our projects,
clinical trials, and business. If such third parties provide inaccurate, misleading, or incomplete data, our business, prospects, and
results of operations could be materially adversely affected.

 We
rely on third parties to conduct our clinical trials and pre-clinical studies. If those parties do not successfully carry out their contractual
duties or meet expected deadlines, our product candidates may not advance in a timely manner or at all.

 In
the course of our pre-clinical and clinical trials, we may rely on third parties, including laboratories, investigators, clinical contract
research organizations ("CROs"), and manufacturers, to perform critical services for us, many of which are required to be
conducted consistent with regulations on Good Laboratory Practice ("GLP"). CROs and study sites are responsible for many
aspects of the trials, including finding and enrolling subjects for testing and administering the trials. Although we may rely on these
third parties to conduct our pre-clinical and clinical trials, we are responsible for ensuring that each of our trials is conducted in
accordance with its investigational plan and protocol and that the integrity of the studies and resulting data is protected. Moreover,
the FDA and foreign regulatory authorities require us to comply with regulations and standards, commonly referred to as Good Clinical
Practices ("GCPs"), for conducting, monitoring, recording, and reporting the results of clinical trials to ensure that the
data and results are scientifically credible and accurate, and that the trial subjects are adequately informed of the potential risks
of participating in such trials. Our reliance on third parties does not relieve us of these responsibilities and requirements. These
third parties may not be available when we need them or, if they are available, may not comply with all regulatory and contractual requirements
or may not otherwise perform their services in a timely or acceptable manner, and we may need to enter into new arrangements with alternative
third parties and our clinical trials may be extended, delayed or terminated. These independent third parties may also have relationships
with other commercial entities, some of which may compete with us. In addition, if such third parties fail to perform their obligations
in compliance with our protocols or the applicable regulatory requirements, our trials may not meet regulatory requirements or may need
to be repeated, we may not receive marketing approvals, or we or such third parties may face regulatory enforcement. As a result of our
dependence on third parties, we may face delays, failures or cost increases outside of our direct control. These risks also apply to
the development activities of collaborators, and we do not control their research and development, clinical trial or regulatory activities.

 Risks
Related to our Common Stock

 Our
executive officers and directors may sell shares of their stock, and these sales could adversely affect our stock price.

 Sales
of our common stock by our executive officers and directors, or the perception that such sales may occur, could adversely affect the
market price of our common stock. Our executive officers and directors may sell stock in the future, either as part, or outside, of trading
plans under Rule 10b5-1 under the Exchange Act.

 Our
common stock price has fluctuated considerably and is likely to remain volatile, in part due to the limited market for our common stock
and you could lose all or a part of your investment.

 From
December 31, 2022, through December 31, 2023, the high and low sales prices for our common stock were $6.09 and $2.57, respectively.

 The
market price of our common stock has fluctuated considerably and may continue to fluctuate significantly in response to a number of factors,
some of which are beyond our control, including the following:

 our
 need for additional capital;

 results
 of clinical trials of our product candidates;

 our
 entry into or the loss of a significant collaboration, or expiration or termination of licenses;

 regulatory
 or legal developments in the United States and other countries, including changes in the
 healthcare payment systems;

 changes
 in financial estimates or investment recommendations by securities analysts relating to our
 common stock;

 future
 sales or anticipated sales of our securities by us or our stockholders;

 changes
 in key personnel;

 variations
 in our financial results or those of companies that are perceived to be similar to us;

 actual
 or anticipated variations in operating results;

 market
 conditions in the pharmaceutical and medical device sectors and issuance of new or changed
 securities analysts' reports or recommendations;

 instability
 in the stock market as a result of current or future domestic and global events;

 liquidity
 of any market for our securities;

 threatened
 or actual delisting of our common stock from a national stock exchange;

 general
 economic, industry and market conditions;

 developments
 or disputes concerning patents or other proprietary rights; and

 any
 other factors described in this "Risk Factors" section.

 In
addition, the stock markets in general, and the stock of pharmaceutical and medical device companies in particular, have experienced
extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies.
In addition, changes in economic conditions in the U.S., the European Union or globally, particularly in the context of current global
events, could impact upon our ability to grow profitably. Adverse economic changes are outside our control and may result in material
adverse impacts on our business or our results of operations. Broad market and industry factors may negatively affect the market price
of our common stock, regardless of our actual operating performance. In the past, following periods of volatility in the market price
of a company's securities, securities class-action litigation has often been instituted against that company. Such litigation,
if instituted against us, could cause us to incur substantial costs and divert management's attention and resources.

 For
these reasons and others, an investment in our securities is risky and you should invest only if you can withstand wide fluctuations
in and a significant or complete loss of the value of your investment.

 A
significant number of additional shares of our common stock may be issued at a later date, and their sale could depress the market price
of our common stock.

 As
of December 31, 2023, we had outstanding the following securities that are convertible into or exercisable for shares of our common stock:

 options
 to purchase an aggregate of 930,490 shares of our common stock issued to our officers, directors
 and non-employee consultants under our 2013 Stock Plan, with a weighted average exercise
 price of $9.87 per share;

 options
 to purchase an aggregate of 5,281,018 shares of our common stock issued to our officers,
 directors and non-employee consultants under our 2019 Stock Plan and Amended and Restated
 2019 Stock Plan, with a weighted average exercise price of $4.66 per share;

 153,735
 shares of restricted stock units issuable into 153,735 shares of common stock;

 pre-funded
 warrants to purchase an aggregate of 2,500,625 shares of common stock at an exercise price
 of $0.001 per share;

 2,000
 shares of Series C-3 Preferred Stock, which are convertible into 4,000 shares of common stock;

 89,623
 shares of Series E Preferred Stock, which are convertible into 391,953 shares of common stock;

 89,999
 shares of Series G Preferred Stock, which are convertible into 5,004,069 shares of common
 stock; and

 48,909
 shares of common stock issuable for payment of deferred board compensation.

 Additionally,
there are 3,108,929 shares of common stock available for grants under the Amended and Restated 2019 Omnibus Stock Plan (adopted on October
13, 2022).

 The
possibility of the issuance of these shares, as well as the actual sale of such shares, could substantially reduce the market price for
our common stock and impede our ability to obtain future financing.

 Provisions
in our corporate charter documents and under Delaware law could make an acquisition of us, which may be beneficial to our stockholders,
more difficult.

 Provisions
in our Amended and Restated Certificate of Incorporation, as amended, and our Amended and Restated Bylaws, as well as provisions of the
General Corporation Law of the State of Delaware, or DGCL, may discourage, delay or prevent a merger, acquisition or other change in
control of our company, even if such a change in control would be beneficial to our stockholders. These provisions include the following:

 authorizing
 the issuance of "blank check" preferred stock, the terms of which may be established
 and shares of which may be issued without stockholder approval;

 prohibiting
 our stockholders from fixing the number of our directors; and

 establishing
 advance notice requirements for stockholder proposals that can be acted on at stockholder
 meetings and nominations to our Board of Directors.

 These
provisions may frustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult
for stockholders to replace members of our board of directors, which is responsible for appointing the members of our management. In
addition, we are subject to Section 203 of the DGCL, which generally prohibits a Delaware corporation from engaging in any of a broad
range of business combinations with an interested stockholder for a period of three years following the date on which the stockholder
became an interested stockholder, unless such transactions are approved by the board of directors. This provision could have the effect
of discouraging, delaying or preventing someone from acquiring us or merging with us, whether or not it is desired by, or beneficial
to, our stockholders. Any provision of our Amended and Restated Certificate of Incorporation, as amended, or Amended and Restated Bylaws
or Delaware law that has the effect of delaying or deterring a change in control could limit the opportunity for our stockholders to
receive a premium for their shares of our common stock and could also affect the price that some investors are willing to pay for our
common stock.

 If
we fail to comply with the continued listing standards of the Nasdaq Global Market, it may result in a delisting of our common stock
from the exchange.

 Our
common stock is currently listed for trading on the Nasdaq Global Market under the symbol "CRMD", and the continued listing
of our common stock on the Nasdaq Global Market is subject to our compliance with a number of listing standards. If we fail to satisfy
the continued listing requirements of the Nasdaq Global Market such as the corporate governance requirements, the stockholder's
equity requirement or the minimum closing bid price requirement, the Nasdaq Global Market may take steps to delist our common stock.
Such a delisting or even notification of failure to comply with such requirements would likely have a negative effect on the price of
our common stock and would impair our stockholders ability to sell or purchase our common stock when they wish to do so. In addition,
the delisting of our common stock could materially adversely impact our ability to raise capital on acceptable terms or at all. Delisting
from Nasdaq could also have other negative results, including the potential loss of confidence by our current or prospective third-party
providers and collaboration partners, the loss of institutional investor interest, and fewer licensing and partnering opportunities.
In the event of a delisting, we would take actions to restore our compliance with the Nasdaq Global Market's listing requirements,
but we can provide no assurance that any such action taken by us would allow our common stock to become listed again, stabilize the market
price or improve the liquidity of our common stock.

 If
our common stock were no longer listed on the Nasdaq Global Market, investors might only be able to trade on the over-the-counter markets,
including the OTC Bulletin Board or in the Pink Sheets (a quotation medium operated by Pink Sheets
LLC). This would impair the liquidity of our common stock not only in the number of shares that could be bought and sold at a given price,
which might be depressed by the relative illiquidity, but also through delays in the timing of transactions and reduction in media coverage.

 Laws,
rules and regulations relating to public companies may be costly and impact our ability to attract and retain directors and executive
officers.

 Laws
and regulations affecting public companies, including rules adopted by the SEC and by the Nasdaq Global Market, may result in increased
costs to us. These laws, rules and regulations could make it more difficult or costly for us to obtain certain types of insurance, including
director and officer liability insurance, and we may be forced to accept reduced policy limits and coverage or incur substantially higher
costs to obtain the same or similar coverage. The impact of these events could make it more difficult for us to attract and retain qualified
persons to serve on our board of directors, on our board committees or as executive officers.

 Our
internal control over financial reporting and our disclosure controls and procedures may not prevent all possible errors that could occur.

 Our
management is responsible for establishing and maintaining adequate internal control over financial reporting to provide reasonable assurance
regarding the reliability of our financial reporting and the preparation of financial statements for external purposes in accordance
with GAAP. Failure on our part to have effective internal financial and accounting controls would cause our financial reporting to be
unreliable, could have a material adverse effect on our business, operating results, and financial condition, and could cause the trading
price of our common stock to fall dramatically.

 A
control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the control system's
objectives will be satisfied. Internal control over financial reporting and disclosure controls and procedures are designed to give a
reasonable assurance that they are effective to achieve their objectives. We cannot provide absolute assurance that all of our possible
future control issues will be detected. These inherent limitations include the possibility that judgments in our decision making can
be faulty, and that isolated breakdowns can occur because of simple human error or mistake. The design of our system of controls is based
in part upon assumptions about the likelihood of future events, and there can be no assurance that any design will succeed absolutely
in achieving our stated goals under all potential future or unforeseeable conditions. Because of the inherent limitations in a cost-effective
control system, misstatements due to error could occur and not be detected. This and any future failures could cause investors to lose
confidence in our reported financial information, which could have a negative impact on our financial condition and stock price.

 In
future periods, if the process required by Section 404 of the Sarbanes-Oxley Act reveals any material weaknesses or significant deficiencies,
the correction of any such material weaknesses or significant deficiencies could require remedial measures which could be costly and
time-consuming. In addition, in such a case, we may be unable to produce accurate financial statements on a timely basis. Any associated
accounting restatement could create a significant strain on our internal resources and cause delays in our release of quarterly or annual
financial results and the filing of related reports, increase our costs and cause management distraction. Any of the foregoing could
cause investors to lose confidence in the reliability of our financial statements, which could cause the market price of our common stock
to decline and make it more difficult for us to finance our operations and growth.

 Security
breaches and other disruptions could compromise our information and expose us to liability, which would cause our business and reputation
to suffer.

 In
the ordinary course of our business, we collect and store sensitive data, including intellectual property, our proprietary business information
and that of our suppliers, as well as personally identifiable information of clinical trial participants and employees. Similarly, our
third-party providers possess certain of our sensitive protected health data. The secure maintenance of this information is critical
to our operations and business strategy. Despite our security measures, our information technology and infrastructure may be vulnerable
to attacks by hackers or breached due to employee error, malfeasance or other disruptions. Attacks of this nature are increasing in their
frequency, levels of persistence, sophistication and intensity, and are being conducted by sophisticated and organized groups and individuals
with a wide range of motives and expertise. Although we develop and maintain systems and controls designed to prevent these events from
occurring, and we have a process to identify and mitigate threats, the development and maintenance of these systems, controls and processes
is costly and requires ongoing monitoring and updating particularly because technologies and techniques used to overcome security measures
are increasingly sophisticated and constantly evolving, and such systems, controls and processes may not be successful in preventing
a breach. For example, as artificial intelligence continues to evolve, cyber-attackers could also use artificial intelligence to develop
malicious code and sophisticated phishing attempts. Any such breach could compromise our networks and the information stored there could
be accessed, publicly disclosed, lost or stolen. We could be required to expend significant amounts of money and other resources to repair
or replace information systems or networks. We maintain cyber liability insurance, but we cannot be certain that our coverage will be
adequate for liabilities actually incurred or that insurance will continue to be available to us on economically reasonable terms, or
at all.

 See
Part I, Item 1C, Cybersecurity, in this Annual Report on Form 10-K for more information regarding our cybersecurity risk management,
strategy, and governance.

 Each
of U.S. state has adopted legislation requiring notification of a breach in the security of certain personal information. Such breaches
trigger requirements for notification not only to affected individuals, but also state authorities and sometimes the media. In addition,
they often prompt class action litigation and can have serious reputational consequences. For breaches involving personal data subject
to the EU or UK GDPR, there can be substantial fines. Guarding against such breaches requires us to put in place and consistently monitor
the effectiveness of data security controls, including technical mechanisms, physical safeguards, and administrative standards. It will
increase our responsibility and potential liability in relation to personal data that we process, and we will be required to put in place
additional mechanisms ensuring compliance with the new European Union data protection rules. There is significant uncertainty related
to the manner in which data protection authorities will seek to enforce compliance with GDPR. For example, it is not clear if the authorities
will conduct random audits of companies doing business in the European Union, or if the authorities will wait for complaints to be filed
by individuals who claim their rights have been violated. Enforcement uncertainty and the costs associated with ensuring GDPR compliance
may be onerous and adversely affect our business, operating results, prospects and financial condition.

 Any
access, disclosure or other loss of information, including our data being breached at our partners or third-party providers, could result
in legal claims or proceedings and liability under laws that protect the privacy of personal information, disrupt our operations and
damage our reputation, which could adversely affect our business.

 We do not currently pay dividends on our
common stock so any returns on our common stock may be limited to the value of our common stock.

 We have never declared dividends on our common stock, and currently
do not plan to declare dividends on shares of our common stock in the foreseeable future. We currently expect to retain future earnings,
if any, for use in the operation and expansion of our business. The payment of cash dividends in the future, if any, will be at the discretion
of our Board of Directors and will depend upon such factors as earnings levels, capital requirements, our overall financial condition
and any other factors deemed relevant by our Board of Directors. Any return to holders of our common stock will be limited to the value
of their common stock.

 We
are a "smaller reporting company" and we cannot be certain if the reduced reporting requirements applicable to such companies
could make our common stock less attractive to investors.

 We
are a "smaller reporting company", as defined in the Exchange Act. For as long as we continue to be a smaller reporting company,
we may take advantage of exemptions from various reporting requirements, including exemption from compliance with the auditor attestation
requirements of Section 404 of the Sarbanes-Oxley Act of 2002 (Sarbanes-Oxley Act), only being required to provide two years of audited
financial statements in annual reports and reduced disclosure obligations regarding executive compensation in periodic reports and proxy
statements.

 We
cannot predict if investors will find our common stock less attractive because we may rely on these exemptions. If some investors find
our common stock less attractive as a result, there may be a less active trading market for our common stock and our stock price may
be more volatile.

Item 1B. Unresolved Staff Comments

 None.

Item 1C. Cybersecurity

 Management
and Strategy

 The
Company has processes in place for assessing, identifying, preventing, and managing material risks from cybersecurity threats, including
related to the use of third party service providers. In addition, the Company leverages the security and monitoring tools of third party
service providers. These processes are integrated into the Company's overall risk management program and systems, as overseen by
the Board, primarily through the Audit Committee.

 We
maintain physical, technical and administrative safeguards to prevent and identify cybersecurity risks, and have implemented practices
and procedures to address cybersecurity risks. To this end, among other things, we:

 provide
 annual mandatory training for our employees regarding cybersecurity threats as a means to
 equip them with effective tools to address cybersecurity threats, and to communicate our
 evolving information security policies, standards, processes and practices;

 conduct
 regular simulation modules for all employees to enhance awareness and responsiveness to possible
 threats;

 conduct
 cybersecurity management and incident training for employees involved in our systems and
 processes that handle sensitive data; and

 carry
 cyber liability insurance that is intended to provide protection against the potential losses
 arising from a cybersecurity incident.

 We
are currently working with outside counsel to further develop a formal cybersecurity incident response plan.

 While
we are regularly exposed to malicious technology-related events and threats, none of these threats or incidents, either individually
or in the aggregate of related occurrences, have materially affected the Company in the period covered by this Annual Report on Form
10-K. In determining materiality, cybersecurity incidents are reviewed not only for potential financial impacts, which could include
potential legal and regulatory penalties, stolen assets or funds, system damage, forensic and remediation costs, lost revenue or litigation
costs, but also the breadth and sensitivity of data exposure, data exfiltration, impacts on the ability to operate our business or provide
our services and loss of investor confidence.

 Governance

 The
Board executes its oversight responsibility for risk management both directly and through delegating oversight of certain of these risks
to its committees, and the Board has authorized the Audit Committee to oversee risks related to cybersecurity threats. Our Audit Committee
has primary oversight responsibility for cybersecurity and information security risk management and controls. As part of its oversight
function, the Audit Committee oversees the Company's risk assessment and risk management policies, including related to cybersecurity
and the overall data protection program.

 Our senior management is responsible for assessing and managing the
Company's various exposures to risk, including those related to cybersecurity, on a day-to-day basis, including the identification
of risks through an enterprise risk management framework and the creation of appropriate risk management programs and policies to address
such risks. The Company's Senior Manager, IT, has 24 years of experience in enterprise IT and has primary responsibility for managing
our cybersecurity program and efforts, and our finance and IT teams are responsible for the testing and audit of our information-technology
related internal controls.

 See
 Item 1A, Risk Factors, for additional information on the Company's cybersecurity risk profile, in particular the risk factors
under the headings entitled " Risks relating to data privacy could create additional liabilities for us " and " Security
breaches and other disruptions could compromise our information and expose us to liability, which would cause our business and reputation
to suffer ".

Item 2. Properties

 In
March 2020, we entered into a seven-year operating lease agreement for an office space at 300 Connell Drive, Berkeley Heights, New Jersey
07922. The lease agreement, with a monthly average cost of approximately $17,000, commenced on September 16, 2020.

 Our
subsidiary leases its offices in Fulda, Germany pursuant to a three-month lease agreement which commenced in June 2017, renewable every
three months for a base monthly payment of 400.

 We
believe that our existing facilities are adequate to meet our current needs.

Item 3. Legal Proceedings

 From time to time, we may
be involved in various claims and legal proceedings relating to claims arising out of our operations. We are not currently a party to
any legal proceedings that, in the opinion of our management, are likely to have a material adverse effect on our business. Regardless
of outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and
other factors. For information regarding our legal proceedings, see Note 6, Commitments and Contingencies, included in the Financial
Statements in this Annual Report on Form 10-K, which is incorporated into this item by reference.

Item 4. Mine Safety Disclosures

 Not
applicable.

 PART
II

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

 Market
for Common Equity

 Our
common stock is listed on the Nasdaq Global Market under the symbol "CRMD."

 Based
upon information furnished by our transfer agent, at March 7, 2024, we had approximately 65
 holders of record of our common stock.

 Dividend
Policy

 We
have never declared dividends on our equity securities, and currently do not plan to declare dividends on shares of our common stock
in the foreseeable future. We expect to retain our future earnings, if any, for use in the operation and expansion of our business. Subject
to applicable law and the Company's charter and bylaws and the terms of any preferred stock, the payment of cash dividends in the
future, if any, will be at the discretion of our Board of Directors and will depend upon such factors as earnings levels, capital requirements,
our overall financial condition and any other factors deemed relevant by our Board of Directors.

Compensation Plan Information

 A
table with information about our common stock that may be issued upon the exercise of options, warrants and rights under all our existing
equity compensation plans is found in Item 12 of the report under the heading "Equity Compensation Plan Information."

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 together with our audited consolidated financial statements and the accompanying notes
contained elsewhere in this report. This discussion contains forward-looking statements, within the meaning of Section 27A of Securities
Act, Section 21E of the Exchange Act, and the Private Securities Litigation Reform Act of 1995, including statements regarding our
expected financial condition, business and financing plans. These statements involve risks and uncertainties. Our actual results could
differ materially from the results described in or implied by these forward-looking statements as a result of various factors, including
those discussed below and elsewhere in this Annual Report on Form 10-K, particularly under the heading "Risk Factors."

 Overview

Inc. and our wholly owned subsidiaries (collectively, with our wholly owned subsidiaries, referred to herein as "we," "us,"
"our" or the "Company") is a biopharmaceutical company focused on developing and commercializing therapeutic
products for the prevention and treatment of life-threatening diseases and conditions.

 Our primary focus is on the
commercialization of our lead product, DefenCath, in the U.S. The name DefenCath is the U.S. proprietary name that was approved by the
FDA.

 DefenCath is an antimicrobial
catheter lock solution ("CLS") (a formulation of taurolidine 13.5 mg/mL, and heparin 1000 USP Units/mL) indicated to reduce
the incidence of catheter-related bloodstream infections ("CRBSI") in adult patients with kidney failure receiving chronic
hemodialysis through a central venous catheter ("CVC"). It is indicated for use in a limited and specific population of patients.
CRBSIs can lead to treatment delays and increased costs to the healthcare system when they occur due to hospitalizations, need for IV
antibiotic treatment, long-term anticoagulation therapy, removal/replacement of the CVC, related treatment costs, as well as increased
mortality. We believe DefenCath can address a significant unmet medical need.

 On November 15, 2023, we announced
that the FDA approved the NDA for DefenCath to reduce the incidence of CRBSI in adult patients with kidney failure receiving chronic hemodialysis
through a CVC. DefenCath is indicated for use in a limited and specific population of patients. DefenCath is the first and only FDA-approved
antimicrobial CLS in the U.S. and was shown to reduce the risk of CRBSI by up to 71% in a Phase 3 clinical study. As a result of
the November 2023 FDA approval, we are currently preparing for the commercial launch of DefenCath.

 DefenCath is listed in the
Orange Book as having NCE exclusivity (5 years) expiring on November 15, 2028, and the Generating Antibiotic Incentives Now or GAIN exclusivity
extension of the NCE exclusivity (an additional 5 years) expiring on November 15, 2033. The GAIN exclusivity extension of 5 years is the
result of the January 2015 designation of DefenCath as a Qualified Infectious Disease Product ("QIDP").

 We announced on April 26,
2023 that following the submission of a duplicate New Technology Add-On Payment ("NTAP") application in the fourth quarter
of 2022 to CMS, CMS has subsequently issued the Inpatient Prospective Payment System ("IPPS") 2024 proposed rule that includes
a NTAP of up to $17,111 per hospital stay for DefenCath. This NTAP represents reimbursement to inpatient facilities of 75% of the anticipated
wholesaler acquisition cost price of $1,170 per 3 mL vial, and an average utilization of 19.5 vials per hospital stay. The final IPPS
rule was published in early August 2023 and confirmed this payment amount in that final rule. This NTAP was conditioned upon the DefenCath
NDA obtaining final FDA approval prior to July 1, 2024. As the NTAP was calculated by CMS based upon an anticipated WAC price of $1,170,
and following FDA approval of the DefenCath NDA, an actual WAC of $249.99 per 3ml vial was established, we anticipate that CMS will revise
the amount of the NTAP payment to reflect the actual WAC price in the next IPPS rulemaking, effective October 1, 2024. Upon the listing
in the compendia of the actual WAC price of $249.99 per 3ml vial, the Company notified CMS of the new lower WAC pricing and recommended
that CMS make an off-cycle adjustment to the NTAP to reflect the current lower WAC pricing amount. CMS subsequently communicated to the
Company that they do not intend to update the NTAP reimbursement amount until the next review cycle in October 2024.

 On January 25, 2024, CMS determined
that DefenCath should be classified as a renal dialysis service that is subject to the Medicare end-stage renal disease prospective payment
system ( "ESRD PPS"). The ESRD PPS provides bundled payment for renal dialysis services, but also affords a transitional drug
add-on payment adjustment, or TDAPA, which provides temporary, additional payments for certain new drugs and biologicals. We submitted
an application for TDAPA on January 26, 2024, and CMS has confirmed receipt. We also submitted a HCPCS application for a J-code to CMS
on December 8, 2023, for DefenCath, which is relevant to billing and the TDAPA application. CMS has confirmed the coding application is
under review. TDAPA reimbursement is calculated based on 100 percent ASP (or 100 percent of wholesale acquisition price or else manufacturers'
list price, respectively, if such data is unavailable). If CMS grants TDAPA and post-TDAPA add-on payment adjustments for DefenCath, collective
payments would be for five years (with such add-on payments applying to all ESRD PPS payments for years three through five). CMS confirmed
to the Company that, assuming a favorable review, CMS is working towards a July 1, 2024 implementation date for TDAPA.

 We may pursue additional indications
for DefenCath use as a CLS in populations with unmet medical needs that may also represent potentially significant market opportunities.
While we are continuing to assess these areas, potential future indications may include use as a CLS to reduce CRBSIs in total parenteral
nutrition patients using a central venous catheter and in certain oncology patients using a central venous catheter. In 2024, the company
anticipates discussing with the FDA potential pathways for expanded indications.

 We currently have one FDA
approved source for each of our two key APIs for DefenCath, taurolidine and heparin sodium, respectively. With regards to taurolidine,
we have a DMF filed with the FDA. There is a master commercial supply agreement between a third-party manufacturer and us in place from
August 2018. We are currently in the process of identifying and qualifying an alternate third-party manufacturer for taurolidine under
our existing DMF. With respect to heparin sodium API, we have identified an alternate third party supplier and intend to qualify such
supplier under the DefenCath NDA over the next twelve months.

 We received FDA approval of
DefenCath with finished dosage production from our European based CMO Rovi Pharma Industrial Services. We believe this CMO has adequate
capacity to produce the volumes needed to meet near term projected demand for the commercial launch of DefenCath.

 We previously announced commercial
arrangements with additional finished dosage CMOs, Alcami Corporation and Siegfried Hameln, that provide for the manufacture of commercial
sterile parenteral drug products. The Company anticipates the submission to the FDA of a supplement adding Siegfreid Hameln as an alternate
manufacturing site in the second fiscal quarter of 2024. The Company will also discontinue its relationship with Alcami as a potential
alternate manufacturing site for DefenCath.

 We announced on May 1, 2023
that the USPTO allowed our patent application directed to a locking solution composition for treating and reducing infection and flow
reduction in central venous catheters. This application was granted on August 29, 2023 as U.S. Patent No. 11,738,120. Our newly
granted U.S. Patent reflects the unique and proprietary formulation of our product, DefenCath, for which we received FDA approval on November
15, 2023. This patent supplements the coverage of our existing licensed U.S. Patent No. 7,696,182, and has the potential to provide an
additional layer of patent protection for DefenCath through 2042.

 As part of the DefenCath approval
letter, the FDA communicated the existence of a required pediatric assessment under the Pediatric Research Equity Act, or PREA. PREA requires
sponsors to conduct pediatric studies for, among other things, NDAs for a new active ingredient, such as taurolidine in DefenCath, unless
a waiver or deferral is obtained from the FDA. A deferral acknowledges that a pediatric assessment is required but permits the applicant
to submit the pediatric assessment after the submission of an NDA. FDA deferred submission of the pediatric study for DefenCath because
the product is ready for approval for use in adults and the pediatric study has not been completed. We are obligated to conduct the study
communicated in the approval letter: an open-label, two-arm (DefenCath vs. standard of care) study to assess safety and time to CRBSI
in subjects from birth to less than 18 years of age with kidney failure receiving hemodialysis via a central venous catheter. Because
this is a required post-marketing study, we must make annual reports to the FDA. Pediatric studies for an approved product conducted under
PREA may qualify for pediatric exclusivity, which, if granted, provides an additional six months of exclusivity that attaches to the end
of existing marketing exclusivity and patent periods for DefenCath. Depending on the timing of final report submission, DefenCath could
potentially receive a total marketing exclusivity period of 10.5 years. However, there are factors that could affect whether this exclusivity
is received or the duration of exclusivity, and DefenCath may or may not ultimately be eligible for the additional 0.5 years of exclusivity
associated with this pediatric study.

 Neutrolin was previously sold
in the EU and other territories where we received CE-Mark approval for the commercial distribution of Neutrolin as a CLS. The Company
has elected to discontinue sales of Neutrolin for lack of commercial viability. The winding down of our operations in the EU is nearly
complete and Neutrolin sales in both the EU and the Middle East have been discontinued since 2022.

 In addition to DefenCath,
we have sponsored a pre-clinical research collaboration for the use of taurolidine as a possible treatment for rare pediatric tumors.
In February 2018, the FDA granted orphan drug designation to taurolidine for the treatment of neuroblastoma in children. We may seek one
or more strategic partners or other sources of capital to help us develop and commercialize taurolidine for the treatment of neuroblastoma
in children.

Operations Overview

 Revenue

 We
have not generated substantial revenue since our inception. Through December 31, 2023, we have funded our operations primarily through
debt and equity financings.

 Research
and Development Expense

 Research and development,
or R&D, expense consists of: (i) internal costs associated with our development activities; (ii) payments we make to third party contract
research organizations, contract manufacturers, investigative sites, and consultants; (iii) technology and intellectual property license
costs; (iv) manufacturing development costs; (v) personnel related expenses, including salaries, stock–based compensation expense,
benefits, travel and related costs for the personnel involved in drug development; (vi) activities relating to regulatory filings and
pre-clinical studies and clinical trials; (vii) facilities and other allocated expenses, which include direct and allocated expenses for
rent, facility maintenance, as well as laboratory and other supplies; and (viii) manufacturing-related costs, including previously expensed
pre-NDA approval inventory amounting to approximately $6,400,000. All R&D is expensed as incurred.

 The
process of conducting pre-clinical studies and clinical trials necessary to obtain regulatory approval is costly and time consuming.
The probability of success for each product candidate and clinical trial may be affected by a variety of factors, including, among others,
the quality of the product candidate's early clinical data, investment in the program, competition, manufacturing capabilities
and commercial viability. As a result of the uncertainties associated with clinical trial enrollments and the risks inherent in the development
process, we are unable to determine the duration and completion costs of future clinical stages of our product candidates or when, or
to what extent, we will generate revenues from the commercialization and sale of any of our future product candidates.

 Development
timelines, probability of success and development costs vary widely. We are currently focused on the commercialization of DefenCath in
the U.S.

 Selling,
General and Administrative Expense

 Selling,
general and administrative, or SG&A, expense includes costs related to commercial personnel, medical education professionals, marketing
and advertising, salaries and other related costs, including stock-based compensation expense, for persons serving in our executive,
sales, finance and accounting functions. Other SG&A expense includes facility-related costs not included in R&D expense, promotional
expenses, costs associated with industry and trade shows, and professional fees for legal services and accounting services.

Currency Exchange Transaction Gain (Loss)

currency exchange transaction gain (loss) is the result of re-measuring transactions denominated in a currency other than our functional
currency and is reported in the consolidated statement of operations as a separate line item within other income (expense). The intercompany
loans outstanding between our Company based in New Jersey and our subsidiary based in Germany are not expected to be repaid in the foreseeable
future and the nature of the funding advanced is of a long-term investment nature. As such, unrealized foreign exchange movements related
to long-term intercompany loans are recorded in other comprehensive income (loss).

Income

income consists of interest earned on our cash equivalents and short-term investments.

Expense

expense consists of interest incurred on financing of expenditures.

 Results
of Operations

 Comparison
of the Years Ended December 31, 2023 and 2022

 The
following is a tabular presentation of our consolidated operating results for the years ended December 31, 2023 and 2022 (in thousands):

 2023

 2022

 % of

Change

 (Decrease)

 Revenue

 $
 -

 $

 (100
)%

 Cost of sales

 -

 (4
)

 (100
)%

 Gross profit

 -

 (100
)%

 Operating Expenses:

 Research and development

 (13,155
)

 (10,680
)

 %

 Selling, general and administrative

 (35,803
)

 (20,006
)

 %

 Total operating expenses

 (48,958
)

 (30,686
)

 %

 Loss from operations

 (48,958
)

 (30,625
)

 %

 Interest income

 2,682

 %

 Foreign exchange transaction (loss) income

 (29
)

 (178
)%

 Interest expense

 (34
)

 (26
)

 %

 Total other income

 2,619

 %

 Loss before income taxes

 (46,339
)

 (30,288
)

 %

 Tax benefit

 -

 (100
)%

 Net loss

 (46,339
)

 (29,702
)

 %

 Other comprehensive gain (loss)

 (4
)

 (359
)%

 Comprehensive loss

 $
 (46,328
)

 $
 (29,706
)

 %

 Revenue.
 Revenue for the year ended December 31, 2023 was $0 as compared to $65,000 for the same period in 2022, attributable to the winding
down of our operations in the EU and the discontinuance of Neutrolin sales in both the EU and the Middle East.

 Cost
of Sales. Cost of sales for the year ended December 31, 2023 was $0 as compared to $4,000 for the same period in 2022, attributable
to the winding down of our operations in the EU and the discontinuance of Neutrolin sales in both the EU and the Middle East.

 Research
and Development Expense. R&D expense for the year ended December 31, 2023 was $13,155,000, an increase of $2,475,000 from $10,680,000
for the same period in 2022. The increase was driven by an increase in personnel expenses of $1,177,000 as a result of higher R&D
headcount in 2023 as compared to 2022, net increases in costs related to medical affairs activities of $941,000, and an increase in costs
related to the technical and quality operations for the manufacturing of DefenCath prior to its marketing approval in November 2023 of
$311,000.

 Selling, General and Administrative
Expense. SG&A expense for the year ended December 31, 2023 was $35,803,000, an increase of $15,797,000 from $20,006,000 for the
same period in 2022. The increase was primarily attributable to an increase in costs related to market research studies and pre-launch
activities for DefenCath of $12,248,000, and an increase in personnel expenses of $3,693,000 as a result of additional SG&A hires
in 2023 in preparation for the marketing launch of DefenCath. These increases were partially offset, among others of lesser significance,
a decrease in legal fees of $1,120,000.

Income. Interest income for the year ended December 31, 2023 was $2,682,000, an increase of $2,356,000 from $326,000 for the same
period in 2022. The increase was attributable to higher interest-bearing balances and higher interest rates this year as compared to
the same period last year.

Exchange Transaction Income (Loss). Foreign exchange transaction income (losses) for the years ended December 31, 2023 and 2022 were
due to the re-measuring of transactions denominated in a currency other than our functional currency.

 Interest Expense. Interest
expense for the year ended December 31, 2023 was $34,000 as compared to $26,000 for the same period in 2022. The increase of $8,000 was
due primarily to higher interest rates on expenses that were financed this year as compared to the same period last year.

 Tax Benefit. Tax benefits
for the year ended December 31, 2022 of $586,000, was an income tax benefit due to the sale of our unused NOL for the state fiscal year
2021, which was sold in fiscal year 2022, through the NJEDA Program. There was no tax benefit from the sale of unused net operating losses
for fiscal year 2023.

 Other
Comprehensive Income (Loss). Unrealized foreign exchange movements related to long-term loans and the translation of the foreign
affiliate financial statements to U.S. dollars and unrealized movements related to short term investment are recorded in other comprehensive
income (loss) which resulted in a gain of $11,000 and a loss $(4,000) for the years ended December 31, 2023 and 2022, respectively.

 Liquidity
and Capital Resources

 Sources
of Liquidity

 As
a result of our R&D and SG&A expenditures and the lack of substantial product sales revenue, our ongoing operations have not
been profitable since our inception. During the year ended December 31, 2023, we received net proceeds of $42,878,000 from the issuance
of 9,000,093 shares of common stock and pre-funded warrants to purchase 2,500,625 shares of common stock in connection with a public
offering. In addition, during the year ended December 31, 2023, we received net proceeds of $12,949,000 from the issuance of 2,977,637
shares of common stock under our at-the-market-issuance sales agreement, or ATM program, as compared to $17,770,000 net proceeds for
the same period in 2022 from the issuance of 4,704,259 shares of common stock. We may need to raise additional capital through various
potential sources, such as equity and/or debt financings, strategic relationships, potential strategic transactions or out-licensing
of our products until profitability is achieved, if ever.

 Net
Cash Used in Operating Activities

 Net cash used in operating
activities for the year ended December 31, 2023 was $38,409,000 as compared to $24,357,000 in 2022, an increase in net cash use of $14,052,000.
The increase is primarily driven by an increase in net loss of $16,637,000, attributable to a net increase in operating expenses of $18,272,000,
primarily due to increased pre-launch commercial activities for DefenCath.

 Net Cash Used in Investing Activities

 Cash
used in investing activities for the year ended December 31, 2023 was $17,062,000 as compared to $3,709,000 of cash provided in the same
period in 2022. The net cash used during the year ended December 31, 2023, was mainly driven by the higher amount invested in short-term
investments as compared to the same period in 2022.

 Net
Cash Provided by Financing Activities

 Net
cash provided by financing activities for the year ended December 31, 2023 was $55,917,000 as compared to $17,898,000 for the same period
in 2022, an increase of $38,019,000, primarily attributable to net proceeds we received from the sale of our common stock and pre-funded
warrants in the public offering during 2023. Additionally, during the year ended December 31, 2023, we generated net proceeds of $12,949,000
from the sale of our common stock in our ATM program, as compared to $17,770,000 in the same period last year.

 Funding
Requirements and Liquidity

 Our total cash and cash equivalents and short-term
investments as of December 31, 2023 and 2022, excluding restricted cash of $181,000 and $226,000, respectively, was $76,031,000 and $58,792,000,
respectively. During the year ended December 31, 2023, we realized net proceeds of $42,878,000 of net proceeds from the public offering
and exercise of the underwriters' option and an aggregate of $12,949,000 of net proceeds from the issuance of 2,977,637 shares of
common stock under our ATM program. As of December 31, 2023, we have $104,400,000 available under our shelf registration statement filed
in August 2021 for the issuance of equity, debt or equity-linked securities.

 Because
our business has not generated positive operating cash flow and if we do not raise significant revenue, we may need to raise additional
capital in order to continue to fund our research and development activities, as well as to fund operations generally. Our continued
operations are focused on the commercial launch of DefenCath and we can provide no assurances that financing or strategic relationships
will be available on acceptable terms, or at all, if additional funds are needed.

 We expect to continue to fund
operations from cash on hand and through capital raising sources as previously described, which may be dilutive to existing stockholders,
through revenues from the licensing of our products, or through strategic alliances. We may seek to sell additional equity or debt securities
through one or more discrete transactions, or enter into a strategic alliance arrangement, but can provide no assurances that any such
financing or strategic alliance arrangement will be available on acceptable terms, or at all. Moreover, the incurrence of indebtedness
would result in increased fixed obligations and could contain covenants that would restrict our operations. Raising additional funds through
strategic alliance arrangements with third parties may require significant time to complete and could force us to relinquish valuable
rights to our technologies, future revenue streams, research programs or product candidates, or to grant licenses on terms that may not
be favorable to us or our stockholders. Our actual cash requirements may vary materially from those now planned due to a number of factors,
including any change in the timing of the commercial launch of DefenCath or the focus and direction of our research and development programs,
any acquisition or pursuit of development of new product candidates, competitive and technical advances, the costs of commercializing
any of our product candidates, and costs of filing, prosecuting, defending and enforcing any patent claims and any other intellectual
property rights.

 We
expect to generate product sales for DefenCath in the U.S. In the absence of significant revenue, we are likely to continue generating
operating cash flow deficits. We will continue to use cash as we increase other activities leading to the commercialization of DefenCath,
pursue business development activities, and incur additional legal costs to defend our intellectual property.

 We currently estimate that
as of December 31, 2023, we have sufficient cash, cash equivalents and short-term investments to fund operations for at least twelve months
from the issuance of this Annual Report on Form 10-K, and will enable us to fund the launch of DefenCath through to anticipated profitability.
These estimates are based upon the assumption of commercial launch in the second quarter of 2024, and other base case assumptions for
market penetration, average selling price, R&D expense and commercial infrastructure cost. Additional financing may be needed to build
out our commercial infrastructure and to continue our operations. If we are unable to raise additional funds when needed, we may be forced
to slow or discontinue the commercial launch of DefenCath. We may also be required to delay, scale back or eliminate some or all of our
research and development programs. Each of these alternatives would likely have a material adverse effect on our business.

 Contractual
Obligations

 We
entered into a seven-year operating lease agreement in March 2020 for an office space at 300 Connell Drive, Berkeley Heights, New Jersey
07922. The lease agreement, with a monthly average cost of approximately $17,000, commenced on September 16, 2020.

 Critical
Accounting Estimates

 Our management's discussion and analysis of our financial condition
and results of operations is based on our consolidated financial statements, which have been prepared in accordance with accounting principles
generally accepted in the United States, or GAAP. The preparation of these consolidated financial statements requires us to make estimates
and judgments that affect the reported amounts of assets, liabilities and expenses. On an ongoing basis, we evaluate these estimates and
judgments. We base our estimates on our historical experience and on various other assumptions that we believe to be reasonable under
the circumstances. These estimates and assumptions form the basis for making judgments about the carrying values of assets and liabilities
that are not readily apparent from other sources. Actual results and experiences may differ materially from these estimates. Our significant
accounting policies are more fully described in Note 3 to our financial statements included with this report.

Item 7A. Quantitative and Qualitative Disclosures About Market Risk

 N/A.

Item 8. Financial Statements and Supplementary Data

 The
information required by this Item 8 is included in Part IV, Item 15, and is incorporated by reference.

Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure

 None.

Item 9A. Controls and Procedures

 As
of the end of the period covered by this Annual Report on Form 10-K, we carried out an evaluation, under the supervision and with the
participation of our management, including our Chief Executive Officer and our Chief Financial Officer, of the effectiveness of the design
and operation of our disclosure controls and procedures (as defined in the Exchange Act Rules 13a-15(e) and 15d-15(e)) (the "Exchange
Act"). Based on the foregoing evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that our disclosure
controls and procedures are effective to ensure that information required to be disclosed by us in the reports we file or submit under
the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the rules and forms of the SEC,
and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial
Officer, to allow timely decisions regarding required disclosures.

in Internal Control Over Financial Reporting

 There
were no changes in our internal control over financial reporting during our year ended December 31, 2023, or in other factors that could
significantly affect these controls, that materially affected, or are reasonably likely to materially affect, our internal control over
financial reporting.

 Management's
Annual Report on Internal Controls Over Financial Reporting

 Our
management is responsible for establishing and maintaining adequate internal control over financial reporting and for the assessment
of the effectiveness of internal control over financial reporting. As defined by the Securities and Exchange Commission, internal control
over financial reporting is 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 the consolidated financial statements in accordance with U.S. generally accepted accounting
principles.

 Our internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records
that, in reasonable detail, accurately and fairly reflect our transactions and dispositions of our assets; (2) provide reasonable assurance
that transactions are recorded as necessary to permit preparation of the consolidated financial statements in accordance with generally
accepted accounting principles, and that our receipts and expenditures are being made only in accordance with authorizations of our management
and directors; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition
of our assets that could have a material effect on the consolidated 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.

 In
connection with the preparation of our annual consolidated financial statements, management, including, our Principal Executive and Financial
Officer, has undertaken an assessment of the effectiveness of our internal control over financial reporting as of December 31, 2023,
based on the criterial established in Internal Control—Integrated Framework (2013) issued by the Committee of Sponsoring Organizations
of the Treadway Commission ("COSO"). Management's assessment included an evaluation of the design of our internal control
over financial reporting and testing of the operational effectiveness of those controls.

 Based
on this evaluation, management has concluded that our internal control over financial reporting was effective as of December 31,
2023.

 Item
9B. Other Information

 Not
applicable.

 Item
9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections

 Not
applicable.

 PART
III

 Item 10.
Directors, Executive Officers, and Corporate Governance

 We
have adopted a written Code of Conduct and Ethics that applies to our directors, executive officers and all employees. We intend to disclose
any amendments to, or waivers from, our code of ethics and business conduct that are required to be publicly disclosed pursuant to rules
of the SEC by filing such amendment or waiver with the SEC. This code of ethics and business conduct can be found in the "Investors
- Corporate Governance" section of our website, www.cormedix.com.

 Directors

 The
following table sets forth the name, age and position of each of our directors as of February 15, 2024:

 Name

 Age

 Director Since

 Position(s) with CorMedix

 March 2022

 Director and Chief Executive Officer

 Janet Dillione

 August 2015

 Gregory Duncan

 November 2020

 Alan W. Dunton

 March 2019

 Myron Kaplan

 April 2016

 Director and Chairman of the Board

 Steven Lefkowitz

 June 2017

 Robert Stewart

 April 2023

became a director of CorMedix in March 2022. He was a senior executive at Amneal Pharmaceuticals for 11 years prior to joining CorMedix.
He held various roles at Amneal Pharmaceuticals, most recently as Executive Vice President, Chief Commercial Officer where he was responsible
for Amneal Specialty, a growing branded products business. During his tenure at Amneal, Mr. Todisco held roles overseeing corporate development
and international operations, leading commercial teams in several international markets including the UK, Australia and Germany, as well
as leading Amneal's merger integration with Impax Laboratories in 2018. He was previously Co-Founder and managing executive of Gemini
Laboratories, a specialty pharmaceutical company focused on the sales and marketing for niche branded products in the US Market. Gemini
Laboratories was established as an affiliate of Amneal Pharmaceuticals and was subsequently acquired by Amneal in 2018. Prior to joining
Amneal, Mr. Todisco was Vice President, Business Development & Licensing at Ranbaxy, Inc. where he was responsible for developing
and executing Ranbaxy's North American commercial business strategy. Prior to Ranbaxy, he held various roles at Par Pharmaceutical,
and in his earlier career held positions at Oppenheimer & Company and Marsh & McLennan Companies. Mr. Todisco obtained his MBA
in finance from Fordham Graduate School of Business and his BA in Economics from Georgetown University. Among other qualifications, attributes
and skills, Mr. Todisco's business expertise and significant executive management experience in the pharmaceutical industry led
to the conclusion of our Board that he should serve as a director of our Company in light of our business and structure.

 Janet
Dillione has been a director of CorMedix since August 2015. Since November 2020, Ms. Dillione has served as the Chief Executive
Officer of Connect America, a nationally recognized leader in comprehensive telehealth and remote patient monitoring solutions. Prior
to joining Connect America and starting in May 2014, she served as Chief Executive Officer of Bernoulli Enterprise, Inc., a real-time
connected healthcare information technology company. Previously, she was at Nuance Communications, Inc., a leading provider of voice
and language solutions for businesses and consumers around the world, having joined Nuance in April 2010 as Executive Vice President
and General Manager of the Healthcare Division and serving as an executive officer from March 2010 until May 2014. From June 2000 to
March 2010, Ms. Dillione held several senior level management positions at Siemens Medical Solutions, a global leader in medical imaging,
laboratory diagnostics, and healthcare information technology, including President and CEO of the global healthcare IT division. Ms.
Dillione currently serves as a director of Vizient, Inc., a private health care performance improvement company. Ms. Dillione received
her B.A. from Brown University in 1981 and completed the Executive Program at The Wharton School of Business of the University of Pennsylvania
in 1998. She has over 25 years of experience leading global teams in the development and delivery of healthcare technology and services.
Among other qualifications, attributes and skills, Ms. Dillione's financial and IT expertise and significant executive management
experience with medical device and healthcare companies led to the conclusion of our Board that she should serve as a director of our
Company in light of our business and structure.

 Gregory
Duncan has been a director of CorMedix since November 2020. Mr. Duncan currently serves as the Chairman and CEO of Virios Therapeutics,
a clinical-stage biopharmaceutical company developing and commercializing innovative antiviral therapies to treat diseases associated
with a viral triggered abnormal immune response, such as fibromyalgia (FM), and has served since April 2020. From 2014 and prior to joining
his current company, Mr. Duncan served as President and CEO of Celtaxsys, a privately held biotechnology company focused on cystic fibrosis
and other rare, inflammatory diseases. Mr. Duncan has spent the majority of his career in senior leadership roles in commercial stage
pharmaceutical companies. From 2007 to 2013, he served as a senior executive at UCB, including as President of its North America business,
as well as an executive committee member. Prior to his roles with UCB, Mr. Duncan spent approximately 17 years at Pfizer where he gained
significant experience across sales and marketing functions including serving as SVP of US Marketing and later as President of Pfizer's
Latin America business from 2005 to 2007. Mr. Duncan received his undergraduate degree from the State University of New York, Albany,
and earned an MBA degree from Emory University. Among other experience, qualifications, attributes and skills, Mr. Duncan's significant
depth of experience in the pharmaceutical industry led to the conclusion of our Board that he should serve as a director of our Company
in light of our business and structure.

 Alan
W. Dunton, M.D. has been a director of CorMedix since March 2019. He is the founder and principal consultant of Danerius,
LLC, a biotechnology and pharmaceutical consulting business which he started in 2006. From 1994, he served in senior positions in Research
and Development in the Pharmaceutical Division of Johnson and Johnson including President and Managing Director of the Janssen, the major
research, development and regulatory arm of the pharmaceuticals division at Johnson & Johnson. From January 2007 through March 2009,
Dr. Dunton served as President and Chief Executive Officer of Panacos Pharmaceuticals, Inc. From November 2015 through March 2018, Dr.
Dunton was the Head/Senior Vice President of Research, Development and Regulatory Affairs of Purdue Pharma L.P., a private pharmaceutical
company. In addition to CorMedix, Dr. Dunton currently serves on the boards of three public companies, as a Director at Palatin Technologies,
Inc. and Oragenics, Inc. he chairs the Compensation Committees of both companies. He also serves as a member of the Audit Committees
of these companies. Additionally, Dr. Dunton is a member of the board of Recce Pharma Ltd., an Australian public biotechnology company
focused on developing novel anti-infectives for serious and life-threatening diseases. Dr. Dunton received his Bachelor of Science degree
in biochemistry, magna cum laude, from State University of New York at Buffalo, and received his M.D. from New York University School
of Medicine. Among other qualifications, Dr. Dunton's significant depth of experience in the pharmaceutical industry, including
service as a director of public pharmaceutical companies, led to the conclusion of our Board that he should serve as a director of our
Company in light of our business and structure.

 Myron
Kaplan became a director of CorMedix in April 2016 and became Chairman of the Board in August 2017. He is a founding partner
of Kleinberg, Kaplan, Wolff & Cohen, P.C., a New York City general practice law firm, where he has practiced corporate and securities
law for more than fifty years. In 2012, Mr. Kaplan became a trustee of the Lehman Brothers Plan Holding Trust. Previously, he served
as a member of the board of directors of SAirGroup Finance (USA) Inc., a subsidiary of SAirGroup that had publicly issued debt securities,
Trans World Airlines, Inc. and Kitty Hawk, Inc. Among his business and civic involvements, Mr. Kaplan currently serves on the boards
of directors of a number of private companies and has been active for many years on the boards of trustees and various board committees
of The Children's Museum of Manhattan and JBI International (formerly The Jewish Braille Institute of America). Mr. Kaplan graduated
from Columbia College and holds a Juris Doctor from Harvard Law School. Among other experience, qualifications, attributes and skills,
Mr. Kaplan's experience in a broad range of corporate and securities matters and service as a director of public companies led
to the conclusion of our Board that he should serve as a director of our Company in light of our business and structure.

 Steven
Lefkowitz was a director of CorMedix from August 2011 to June 2016. He was reappointed to the Board in June 2017. He also served
as our acting Chief Financial Officer from August 2013 to July 2014. Mr. Lefkowitz has been the President and Founder of Wade Capital
Corporation, a financial advisory services company since June 1990. Mr. Lefkowitz has been a director of both public and private companies.
Mr. Lefkowitz received his A.B. from Dartmouth College in 1977 and his M.B.A. from Columbia University in 1985. Among other experience,
qualifications, attributes and skills, Mr. Lefkowitz's education, experience and financial expertise led to the conclusion of our
Board that he should serve as a director of our Company in light of our business and structure.

 Robert
Stewart became a director of CorMedix in April 2023. Mr. Stewart is the current Chief Executive Officer of Theramex, a global
specialty pharmaceutical company dedicated to women's health, and has served in this role since March 2020. Prior to this, Mr.
Stewart served as Chief Executive Officer of Amneal Pharmaceuticals Inc. from 2018 to 2019, and from 2009 through 2018 Mr. Stewart served
in senior roles with Allergan, formerly Watson and Actavis, most notably as Chief Operating Officer (2015 – 2018) and President,
Global Operations (2009 – 2015). Mr. Stewart has also previously held management roles with Abbott Laboratories, Knoll Pharmaceutical
Company, and Hoffmann La Roche, Inc. Mr. Stewart currently sits on the Board of Directors of Cipla Ltd and serves on the Board of Trustees
for Fairleigh Dickinson University. Mr. Stewart obtained his bachelor's degree in Finance & Business Management from Fairleigh
Dickinson University. Among other qualifications, Mr. Stewarts significant depth of experience in the pharmaceutical industry, including
service as an executive director of other pharmaceutical companies, led to the conclusion of our Board that he should serve as a director
of our Company in light of our business and structure.

 Board
Independence

 Our
common stock is listed on the Nasdaq Global Market. Under the rules of Nasdaq, independent directors must comprise a majority of a listed
company's board of directors. In addition, the rules of Nasdaq require that, subject to specified exceptions, each member of a
listed company's audit, compensation and nominating and corporate governance committees be independent. Under the rules of Nasdaq,
a director will only qualify as an "independent director" if, in the opinion of that company's board of directors,
that person does not have a relationship that would interfere with the exercise of independent judgment in carrying out the responsibilities
of a director. Additionally, compensation committee members must not have a relationship with us that is material to the director's
ability to be independent from management in connection with the duties of a compensation committee member.

 Audit
committee members must also satisfy the independence criteria set forth in Rule 10A-3 under the Exchange Act. In order to be considered
independent for purposes of Rule 10A-3, a member of an audit committee of a listed company may not, other than in his or her capacity
as a member of the audit committee, the board of directors or any other board of directors committee: (i) accept, directly or indirectly,
any consulting, advisory or other compensatory fee from the listed company or any of its subsidiaries; or (ii) be an affiliated
person of the listed company or any of its subsidiaries.

 Our
Board has undertaken a review of the independence of our directors and has determined that (i) all current directors other than Mr. Todisco
are independent within the meaning of Section 5605(b) of the Nasdaq Marketplace Rules, (ii) all members of our Audit Committee meet the
additional test for independence for audit committee members imposed by SEC regulation and Section 5605(c) of the Nasdaq Marketplace
Rules, (iii) all of the members of our Compensation Committee are independent within the meaning of Section 5605(d) of the Nasdaq Marketplace
Rules, and (iv) all of the members of our Nominating and Governance Committee are independent within the meaning of Section 5605(e) of
the Nasdaq Marketplace Rules.

 Board
Committees

 Our
Board has established an Audit Committee, a Compensation Committee and a Nominating and Governance Committee. Our Audit Committee currently
consists of Mr. Lefkowitz (Chair), Dr. Dunton and Mr. Duncan. Our Compensation Committee currently consists of Ms. Dillione (Chair),
Dr. Dunton and Mr. Duncan. Our Nominating and Governance Committee currently consists of Mr. Kaplan (Chair), Ms. Dillione, and Mr. Stewart.
The membership of these committees may be changed after our next annual meeting.

 Each
of the above-referenced committees operates pursuant to a formal written charter. The charters for each committee, which have been adopted
by our Board, contain a detailed description of the respective committee's duties and responsibilities and are available on our
website at www.cormedix.com under the "Investor Relations—Corporate Governance" tab.

 From time to time, the Board
also conducts business through other duly appointed committees, such as the Strategy Committee, that are established on an ad hoc basis.
The Strategy Committee was formed by the Board to evaluate and oversee certain of the Company's strategic planning activities. In
2023, the Strategy Committee acted by unanimous written consent on one occasion and held no committee meetings. The Strategy Committee
consists of Steve Lefkowitz, Myron Kaplan and Rob Stewart.

 Audit
Committee

 The
Audit Committee assists the Board in its oversight of our corporate financial statements and reporting and our external audits, including,
among other things, our internal controls and audit functions, the results and scope of the annual audit and other services provided
by our independent registered public accounting firm and our compliance with legal matters that have a significant impact on our financial
statements. The Audit Committee also consults with our management and our independent registered public accounting firm prior to the
presentation of financial statements to stockholders and, as appropriate, initiates inquiries into aspects of our financial affairs.
The Audit Committee is responsible for establishing procedures for the receipt, retention and treatment of complaints regarding accounting,
internal accounting controls or auditing matters, and for the confidential, anonymous submission by our employees of concerns regarding
questionable accounting or auditing matters. In addition, the Audit Committee is directly responsible for the appointment, retention,
compensation and oversight of the work of our independent registered public accounting firm, including approving services and fee arrangements.
All related party transactions will be approved by the Audit Committee before we enter into them.

 Both
our independent registered public accounting firm and internal financial personnel regularly meet with, and have unrestricted access
to, the Audit Committee.

 The
Board has determined that each of Mr. Lefkowitz, Dr. Dunton and Mr. Duncan qualifies as an "audit committee financial expert"
as that term is defined in the rules and regulations of the SEC. The designation of each of Mr. Lefkowitz, Dr. Dunton and Mr. Duncan
as an "audit committee financial expert" does not impose on them any duties, obligations or liability that are greater than
those that are generally imposed on them as a member of the Audit Committee and the Board, and their designation as an "audit committee
financial expert" pursuant to this SEC requirement does not affect the duties, obligations or liability of any other member of
the Audit Committee or the Board.

 Compensation
Committee

 The
Compensation Committee reviews and approves our compensation policies and all forms of compensation to be provided to our executive officers,
including, among other things, annual salaries, bonuses, and other incentive compensation arrangements. The Compensation Committee also
reviews and makes recommendations to our Board regarding changes in director compensation. In addition, the Compensation Committee administers
our equity compensation plans, including granting stock options to our executive officers. The Compensation Committee also reviews and
approves employment agreements with executive officers and other compensation policies and matters. Pursuant to its charter, the Compensation
Committee has the power to form and delegate authority to subcommittees and to delegate authority to one or more members of the Compensation
Committee.

 Since
2016, the Company and the Compensation Committee have periodically engaged Frederic W. Cook & Co., an independent compensation consultant,
for input on the compensation of our Named Executive Officers and directors. The Compensation Committee assessed the independence of
Frederic W. Cook & Co., considering the factors required by the Nasdaq Global Market Listing Rules and concluded that no conflict
of interest exists that would prevent Frederic W. Cook & Co. from independently representing our Company. In the future, we, or the
Compensation Committee, may engage or seek the advice of Frederic W. Cook & Co., or another compensation consultant.

 Each
member of the Compensation Committee is a non-employee director, as defined pursuant to Rule 16b-3 promulgated under the Exchange Act.

 Nominating
and Governance Committee

 The
Nominating and Governance Committee identifies, evaluates and recommends nominees to the Board and committees of the Board, conducts
searches for appropriate directors and evaluates the performance of the Board and of individual directors. The Nominating and Governance
Committee also is responsible for reviewing developments in corporate governance practices, evaluating the adequacy of our corporate
governance practices and reporting and making recommendations to the Board concerning corporate governance matters.

Officers

 The
following table sets forth the name, age and position of each of our executive officers as of December 31, 2023:

 Name

 Age

 Position(s) with CorMedix

 Chief Executive Officer

 Executive Vice President and Chief Financial Officer

 Beth Zelnick Kaufman

 Executive Vice President and Chief Legal Officer and Corporate Secretary

 Erin Mistry

 Executive Vice President and Chief Commercial Officer

 Elizabeth Hurlburt

 Executive Vice President and Head, Clinical and Medical Affairs

 Phoebe Mounts

 Former Executive Vice President and General Counsel and Head of Regulatory, Compliance and Legal

 See
the biography for Joseph Todisco under "Directors."

David. M.D., became our Executive Vice President and Chief Financial Officer in May 2020. From October 4, 2021 through
May 10, 2022, Dr. David also served as our interim Chief Executive Officer in addition to his role as Chief Financial Officer.
Prior to joining us, he most recently served as Head of Strategy at Ovid Therapeutics Inc, a late-stage clinical biopharmaceutical company
focused on developing treatments for rare neurological disorders, where he was responsible for financing strategy and investor relations,
and joined in October 2018. Prior to Ovid, Dr. David was a Strategic Advisor to Frequency Therapeutics, advising on financing, investor
relations and strategic initiatives from 2017 to early 2019. Prior to Frequency, Dr. David spent the majority of his career as an investment
banker specialized in the life sciences sectors, including at Piper Jaffray, Thomas Weisel Partners, Ferghana Partners and most recently
at Bank of America Merrill Lynch. As part of his experience as an investment banker, Dr. David has advised on a broad range of capital
raising and strategic transactions. Earlier in his career, Dr. David was part of the equity research team at Lehman Brothers, focusing
on Large Pharma. Dr. David began his career as a surgical resident at Beth Israel Hospital, after receiving an M.D. from NYU School of
Medicine. Dr. David earned his Bachelor of Arts degree in Chemistry, magna cum laude, from Dartmouth College.

 Beth Zelnick Kaufman
became our Executive Vice President and Chief Legal Officer and Corporate Secretary on December 12, 2023. She has more than two decades
of legal, compliance and operations experience in the life sciences industry. Prior to joining CorMedix, she most recently served as Chief
Legal and Administrative Officer and Corporate Secretary of Akorn Pharmaceuticals, a specialty and generic pharmaceuticals company. Ms.
Zelnick Kaufman also served in several roles at Amneal Pharmaceuticals, a publicly traded global generics, biosimilars and branded pharmaceuticals
company, including roles as Assistant General Counsel, Vice President, Legal Affairs, and Head of Government Affairs. During her tenure
at these and other pharmaceutical companies, Ms. Zelnick Kaufman gained deep experience in the pharmaceutical industry across legal, regulatory,
government affairs, and other operational areas. Earlier in her career, Ms. Zelnick Kaufman held roles at Actavis, Alpharma and Topcon
America and spent time as an Associate in the law firm Brown, Rudnick.

 Erin
Mistry became our Senior Vice President of Payer Strategy, Government Affairs and Trade in March 2020. Her current role is Executive
Vice President and Chief Commercial Officer, effective January 2023. Prior to joining CorMedix, Erin held roles as VP market access at
Intarcia therapeutics as well as Senior Managing Director of the global Value and Access practice at Syneos Health. During her career,
Erin has worked with emerging, mid-size, and large biopharma companies with a focus on pricing, access and reimbursement. She currently
serves on the boards of Incubate Coalition and the AntiMicrobial Working Group, both in Washington, DC. Erin holds a B.S. in Industrial
Engineering (healthcare) and an M.S. in Biomechanical Engineering from North Carolina State University.

 Elizabeth
Hurlburt became our Executive Vice President and Head of Clinical Operations in March 2018. Her current role is Executive Vice
President and Head of Clinical and Medical Affairs, effective May 2022. Prior to her employment, Ms. Hurlburt had been providing us clinical
operations expertise as a consultant since late November 2017. Before she began her consulting career, she held several progressive management
roles in clinical operations, most recently at Gemphire Therapeutics, as a Senior Director, Clinical Operations from April 2015 to October
2016, then as Vice President, Clinical Operations from October 2016 to March 2018. Ms. Hurlburt received her B.A. in Leadership and Organizational
Management from Bay Path College and a M.S. in Management and Leadership from Western Governors University.

 On
December 31, 2023, Phoebe Mounts, our former Executive Vice President and General Counsel and Head of Regulatory, Compliance and Legal,
voluntarily resigned effective December 31, 2023. See Item 11, Executive Compensation, for further detail on the terms of Ms.
Mounts' separation with the Company.

 Item 11.
Executive Compensation

 DIRECTOR
COMPENSATION

Compensation in Fiscal 2023

 The
following table shows the compensation earned by each of our non-employee directors for the year ended December 31, 2023:

 Name

 Fees
 Earned or Paid in Cash ($)

 Awards (1)(2)
 ($)

 Total

 ($)

 Paulo F. Costa (3)

 65,242

 134,662

 Janet Dillione

 78,000

 147,420

 Gregory Duncan

 72,000

 141,420

 Alan W. Dunton

 72,000

 141,420

 Myron Kaplan

 122,543

 191,963

 Steven Lefkowitz

 93,000

 162,420

 Robert Stewart

 43,587

 158.995

 202,582

 (1)
 The
 amounts included in this column are the dollar amounts representing the full grant date fair
 value of each stock option award calculated in accordance with FASB ASC Topic 718 and do
 not represent the actual value that may be recognized by the directors upon option exercise.
 For information on the valuation assumptions used in calculating these amounts, see Note
 7 to our audited financial statements included in this Annual Report on Form 10-K.

 (2)
 As
 of December 31, 2023, the number of shares underlying options held by each non-employee director
 was as follows: 83,750 shares for Mr. Costa; 145,000 shares for Ms. Dillione; 82,500 for
 Mr. Duncan; 112,500 shares for Dr. Dunton; 126,000 shares for Mr. Kaplan; 108,000 shares
 for Mr. Lefkowitz; and 39,200 shares for Mr. Stewart.

 (3)
 Effective
 October 15, 2023, Mr. Costa ceased as a member of the Company's board of directors.

Compensation Plan

 The
Board, following the recommendation of the Compensation Committee and, based on advice of Frederic W. Cook & Co., determined that
no adjustment was needed with regard to Board and committee cash compensation for 2023.

 The 2023 compensation program
is set forth below in the table. Each year we make an annual grant of stock options to each non-employee director with respect to 20,000
shares and we make an initial grant of stock options to new non-employee directors with respect to 25,000 shares, prorated as appropriate.
On March 5, 2024, the Board approved an increase in the annual and initial grant of stock options to non-employee directors, whereby
such directors will receive an annual option grant with respect to 30,000 shares (from 20,000 shares) and new non-employee directors
will receive an initial option grant with respect to 30,000 shares (from 25,000 shares). All stock options are subject to continued service
on the Board through the vesting date. The exercise price per share of each stock option granted to our non-employee directors is equal
to the fair market value of our common stock as determined based upon the closing sales price for our stock on the date of grant.

 Cash

 ($)

 Stock

 Options (#)

 Annual Fee

 55,000

 First Election to Board

 25,000
 (1)

 Annual Grant, Prorated in First Year Following Election to the Board

 20,000
 (2)

 Additional Annual Fee - Board Chair

 45,000

 Additional Annual Fee - Audit Chair

 23,000

 Additional Annual Fee - Compensation Chair

 18,000

 Additional Annual Fee - Nomination and Governance Chair

 14,000

 Additional Annual Fee - Audit Committee Non-Chair Members

 10,000

 Additional Annual Fee - Compensation Committee Non-Chair Members

 7,000

 Additional Annual Fee - Nomination and Governance Committee Non-Chair Members

 5,000

 Additional Annual Fee - Strategic Committee Members

 15,000

 (1)
 Vests
 one third each on the date of grant and the first and second anniversary date of grant.

 (2)
 Vests
 monthly over one year after the grant date.

 We
maintain a Deferred Compensation Plan for Directors, pursuant to which our non-employee directors may defer all of their cash director
fees and restricted stock units. Any cash fees due to a participating director will be converted into a number of shares of our common
stock by dividing the dollar amount of fees payable by the closing price of our common stock on the date such fees would be payable,
and the director's unfunded account is credited with the shares. The shares that accumulate in a director's account will
be paid to the director on the tenth business day in January following the year in which the director's service terminates for
whatever reason, other than death, in which case the account will be paid within 30 days of the date of death to the designated beneficiary,
as applicable. In the event of a change in control of our Company, the director would receive cash in an amount equal to the number of
shares in the account multiplied by the fair market value of our common stock on the change in control date, and the payment would be
accelerated to five business days after the effective date of the change in control.

 EXECUTIVE
COMPENSATION

 Summary
Compensation Table

 The
following table sets forth information with respect to compensation earned by our Named Executive Officers in the years ended December
31, 2023 and 2022:

 Name
 and Principal Position

 Year

 Salary

 ($)

 Stock
 Awards (1)
 ($)

 Awards (1)
 ($)

 Non-equity
 Incentive Plan Compensation
 ($)

 All
 Other Compensation ($)

 Total

 ($)

 Todisco

 2023

 616,962

 --

 1,388,400

 401,700

 52,370
 (2)

 2,459,342

 Chief
 Executive Officer

 2022

 378,461

 701,245

 1,273,500

 305,760

 32,223

 2,691,189

 David

 2023

 389,135

 --

 433,875

 156,000

 52,140
 (2)

 1,031,150

 Chief
 Financial Officer

 2022

 393,462

 --

 305,900

 389,485

 47,697

 1,136,544

 Erin
 Mistry (3)

 2023

 389,577

 --

 694,200

 156,800

 --

 1,240,577

 Vice President and Chief Commercial Officer

 Phoebe
 Mounts (4)

 2023

 375,000

 --

 433,875

 112,500

 333,207
 (5)

 1,254,582

 Former
 Executive Vice President and General Counsel and Head of Regulatory, Compliance and Legal

 2022

 375,000

 --

 428,260

 195,075

 12,146

 1,010,481

 (1)
 The
 amounts included in this column are the dollar amounts representing the full grant date fair
 value of each award calculated in accordance with FASB ASC Topic 718 and do not represent
 the actual value that may be recognized by the Named Executive Officers upon option exercise.

 (2)
 Represents
 premiums paid by us for health benefits and 401(k) plan employer match.

 (3)
 Ms.
 Mistry became our Chief Commercial Officer on January 15, 2023. Ms. Mistry was not an executive
 officer during 2022.

 (4)
 Dr.
 Mounts' service as an executive officer ceased on December 12, 2023, but her employment
 continued through December 31, 2023.

 (5)
 Represents
 premiums paid by us for health benefits, Dr. Mounts' 401(k) employer match for 2023,
 Dr. Mounts' cash severance and accrued but unpaid paid time off through her termination
 date.

 Narrative
Disclosure to Summary Compensation Table

 Employment
Agreements with Named Executive Officers

Todisco

 On
March 16, 2022, we entered into an employment agreement with Mr. Todisco, our Chief Executive Officer. The term of the employment agreement
will automatically renew for additional successive one-year periods on March 16 th of each calendar year, unless either party
notifies the other in writing at least 90 days before the expiration of the then-current term that the term will not be renewed. Mr.
Todisco is entitled to an annual salary of $618,000 (effective January 2023), and his target annual bonus is 65% of his base salary,
with the actual bonus entitlement based on the achievement of specified Company objectives.

David

 On May 11, 2020, we entered into an employment agreement with Dr. David
to serve as our Executive Vice President and Chief Financial Officer. The term will automatically renew for additional successive one-year
periods on May 11 th of each calendar year, unless either party notifies the other in writing at least 90 days before the expiration
of the then-current term that the term will not be renewed. Dr. David is entitled to an annual salary of $390,000 (effective January 2023),
and his target annual bonus is 40% of his base salary, with the actual bonus entitlement based on the achievement of specified Company
objectives.

 Erin
Mistry

 On
January 15, 2023, we entered into an employment agreement with Ms. Mistry to serve as Executive Vice President and Chief Commercial Officer.
After the initial three-year term of the employment agreement, the term will automatically renew for additional successive one-year periods,
unless either party notifies the other in writing at least 90 days before the expiration of the then-current term that the term will
not be renewed. Ms. Mistry receives an annual salary of $392,000, and her target annual bonus is 40% of her base salary, with the actual
bonus entitlement based on the achievement of specified Company objectives.

 Phoebe
Mounts

 Until
December 12, 2023, Dr. Mounts served as our Executive Vice President and General Counsel and Head of Regulatory, Compliance and Legal
and received an annual salary of $375,000, with a target annual bonus of 30% of her base salary, with the actual bonus entitlement based
on the achievement of specified Company objectives.

 In
connection with her departure, the Company and Dr. Mounts entered into a separation agreement which provided for severance benefits,
including continued payment of her base salary for nine months, payment of her 2023 target annual bonus, and accelerated vesting of her
time-based stock options that were otherwise scheduled to vest on or before the first anniversary of her termination date. For additional
information regarding Dr. Mounts' separation agreement, please see the section titled " Potential Payments on a Qualifying
Termination."

 Potential
Payments Upon Termination or Change in Control

 The
following provisions of the employment agreements with our Named Executive Officers are identical except where noted.

 In the event that a Named
Executive Officer's employment is terminated during the term of his or her employment agreement by the Company other than for Cause
(other than as a result of death or disability), or by the Named Executive Officer for Good Reason (as defined in the employment agreement),
the Named Executive Officer will, subject to execution of a general release of claims, be entitled to: (i) a continuation of base salary
for a period of nine months; except that Mr. Todisco's base salary will continue for 12 months (or 18 months if such termination
occurs within 24 months following a corporate transaction (as defined in the employment agreement)); (ii) payment on a prorated basis
for any target bonus for the year of termination based on the actual achievement of the specified bonus objectives (or in the case of
Mr. Todisco only, for 18 months, if such termination occurs within 24 months following a corporate transaction); (iii) subsidized
COBRA premiums for up to nine months (or in the case of Mr. Todisco only, for 18 months, if such termination occurs within 24 months following
a corporate transaction); and (iv) one year of additional time vesting of the Named Executive Officer's then-outstanding equity
awards (and in the case of Mr. Todisco, accelerated vesting of the restricted stock units granted to him on May 10, 2022), or full
vesting if such termination occurs within 24 months following a corporate transaction.

 Dr.
Mounts' separation agreement provides for severance benefits consistent with the terms of her employment agreement in connection
with a termination without "cause" prior to a corporate transaction. Specifically, in exchange for a general release of claims
in favor of the Company and its affiliates, Dr. Mounts' cooperation with the transition of her position, and continued compliance
with certain restrictive covenants, the Company agreed to provide Dr. Mounts with (i) a continuation of base salary ($31,250 per
month) for a period of nine months, (ii) payment of her full 2023 target annual bonus (as reflected in the " Non-equity
Incentive Plan Compensation " column of the Summary Compensation Table), and (iii) one year of additional time vesting of her
then-outstanding options.

 Non-Compete
Covenants

 Each
of our Named Executive Officers is prohibited from engaging in any business involving the development or commercialization of a preventive
anti-infective product that would be a direct competitor of DefenCath/Neutrolin or a product containing taurolidine or any other product
being actively developed or produced by us within the United States and the European Union (or in the case of Dr. David and Mr. Todisco,
worldwide) on the date of termination of his or her employment for a period of 12 months following any termination of employment.

Plan

 The
Company maintains the CorMedix Inc. Amended and Restated 2019 Omnibus Stock Incentive Plan pursuant to which it has granted equity awards
to the Named Executive Officers, as well as other employees and service providers.

 2023
Equity Awards

 Mr.
Todisco was granted stock options to purchase 400,000 shares of the Company's Common Stock on January 14, 2023. The options granted
to Mr. Todisco are scheduled to vest over a period of three years (with the first 25% vesting on the date of the grant, and the remainder
scheduled to vest in equal annual installments over the next three years thereafter, subject to continued employment).

 Dr.
David was granted stock options to purchase 125,000 shares of the Company's Common Stock on January 14, 2023. The options granted
to Dr. David are scheduled to vest over a period of three years (with the first 25% vesting on the date of the grant, and the remainder
scheduled to vest in equal annual installments over the next three years thereafter, subject to continued employment).

 Ms. Mistry was granted stock
options to purchase 200,000 shares of the Company's Common Stock on January 14, 2023. The options granted to Ms. Mistry are scheduled
to vest over a period of three years (with the first 25% vesting on the date of the grant, and the remainder scheduled to vest in equal
annual installments over the next three years thereafter, subject to continued employment).

 Dr.
Mounts was granted stock options to purchase 125,000 shares of the Company's Common Stock on January 14, 2023. The options granted
to Dr. Mounts were scheduled to vest over a period of three years (with the first 25% vesting on the date of the grant, and the remainder
scheduled to vest in equal annual installments over the next three years thereafter, subject to continued employment).

 Outstanding
Equity Awards at Fiscal Year-End 2023

 The
following table contains certain information concerning unexercised options for the Named Executive Officers as of December 31, 2023.

 Awards

 Stock
 Awards

 Name

 of Shares Underlying Unexercised Options (#)

 Exercisable

of Shares Underlying Unexercised Options (#) Unexercisable (1)

 Incentive Plan Awards: Number of Shares Underlying Unexercised Unearned Options

 # (2)

 Exercise Price

 ($)

 Expiration Date

 Incentive Plan Awards: Number of Unearned Shares, Units or Other Rights That Have Not Vested

#

 Incentive Plan Awards: FMV or Payout Value of Unearned Shares, Units or Other Rights That Have Not Vested

$ (3)

 125,000

 375,000

 --

 3.38

 05/09/2032

 103,735
 (4)

 390,044

 100,000

 300,000

 --

 4.43

 01/14/2033

 --

 --

 101,917

 20,750

 --

 5.63

 05/11/2030

 --

 --

 101,917

 20,750

 --

 4.08

 05/11/2030

 --

 --

 30,000

 10,000

 --

 8.32

 01/10/2031

 --

 --

 93,750

 31,250

 --

 5.56

 10/31/2031

 --

 --

 --

 4.03

 02/17/2032

 --

 --

 31,250

 93,750

 --

 4,43

 01/14/2033

 Erin Mistry

 77,500

 2,500

 --

 3.57

 04/13/2030

 --

 --

 7,500

 2,500

 --

 8.32

 01/10/2031

 --

 --

 10,500

 10,500

 --

 4.03

 02/17/2032

 --

 --

 60,000

 60,000

 --

 5.45

 07/20/2032

 --

 --

 150,000

 --

 4.43

 01/14/2033

 --

 --

 Phoebe Mounts (5)

 60,000

 --

 --

 7.92

 --

 --

 24,764

 --

 --

 5.63

 --

 --

 --

 --

 4.08

 --

 --

 --

 --

 5.63

 --

 --

 70,000

 --

 --

 8.32

 --

 --

 100,000

 --

 --

 5.56

 --

 --

 105,000

 --

 --

 4.03

 --

 --

 62,500

 --

 --

 4.43

 (1)
 Vesting
 based on continued employment over four years.

 (2)
 Options
 vest based on achievement of specific milestones and continued employment and become exercisable
 if and when a milestone is achieved.

 (3)
 Fair
 market value of the shares that could be acquired based on the closing sale price per share
 of our common stock on the Nasdaq Global Market on December 31, 2023, which was $3.76.

 (4)
 Each
 restricted stock unit represents the right to receive one share of our common stock. The
 restricted stock units vest as follows: 50% on the first anniversary of the grant date, 30%
 on the second anniversary of the grant date, and the remaining 20% on the third anniversary
 of the grant date, subject to continued service through the applicable vesting date.

 (5)
 Dr.
 Mounts ceased serving as our General Counsel and Head of Regulatory, Compliance and Legal
 effective December 12, 2023, but her employment continued through December 31, 2023.

 Potential
Payments on a Qualifying Termination

 If
the severance payments called for in our employment agreements for Mr. Todisco, Dr. David and Ms. Mistry had been triggered on December
31, 2023, we would have been obligated to make the following payments as described in more detail under the " Potential Payments
Upon Termination or Change in Control " summary above:

 Name

 Cash
 Severance
 ($)

 COBRA
 Subsidy
 ($)

 Accelerated
 Equity Vesting
 ($) (1)

 Total

 ($)

 Todisco (no Corporate Transaction)

 618,000

 42,831

 437,544

 1,098,375

 Todisco (within 24 months following a Corporate Transaction)

 927,000

 64,246

 532,544

 1,230,790

 David (no Corporate Transaction)

 292,500

 31,863

 324,363

 David (within 24 months following a Corporate Transaction)

 292,500

 31,863

 324,363

 Erin
 Mistry (no Corporate Transaction)

 294,003

 294,578

 Erin
 Mistry (within 24 months following a Corporate Transaction)

 294,003

 294,578

 (1)
 With
 respect to outstanding stock options, represents the difference between the fair market value
 of the shares that could be acquired based on the closing sale price per share of our common
 stock on the Nasdaq Global Market on December 31, 2023, which was $3.76, and the exercise
 prices of the applicable stock options. With respect to restricted stock units, represents
 the fair market value of the shares that could be acquired based on the closing sale price
 per share of our common stock on the Nasdaq Global Market on December 31, 2023, which was
 $3.76.

to Dr. Mounts' separation agreement, her departure was treated as a termination by the Company without Cause and she will be entitled
to receive the severance benefits and payments described under the " Potential Payments Upon Termination or Change in Control "
summary above. Dr. Mounts is subject to a noncompete covenant that runs through September 30, 2024, consistent with the terms described
above under " Non-Compete Covenants ".

 Item 12.
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

 Beneficial
Ownership

 The
following table shows the number of shares of our common stock beneficially owned as of March 7, 2024 by:

 each
 person known by us to own beneficially more than 5% of the outstanding shares of our common
 stock;

 each
 director;

 each
 of our Named Executive Officers; and

 all
 of our current directors and executive officers as a group.

 This
table is based upon the information supplied by our Named Executive Officers, directors and principal stockholders and from
Schedules 13D and 13G filed with the SEC. Except as indicated in footnotes to this table, the persons named in this table have sole
voting and investment power with respect to all shares of common stock shown, and their address is c/o CorMedix Inc., 300 Connell
Drive, Suite 4200, Berkeley Heights, New Jersey 07922. As March 7, 2024 we had 54,981,102 shares of common stock outstanding.
Beneficial ownership in each case also includes shares issuable upon vesting of restricted stock units within 60 days from March 7,
2024 and exercise of outstanding options that can be exercised within 60 days after March 7, 2024 for purposes of computing the
percentage of common stock owned by the person named. Options owned by a person are not included for purposes of computing the
percentage owned by any other person.

 Common
 Stock

 Beneficially Owned (1)

 Name and
 Address of Beneficial Owner

 %

 5% or
 Greater Stockholders

 Blackrock,
 Inc. (2)

 3,507,695

 6.4
 %

 Nomura
 Global Financial Products, Inc. (3)

 2,946,531

 5.4
 %

 Directors:

 Janet
 Dillione (4)

 198,473

 *

 Gregory
 Duncan (5)

 82,500

 *

 Alan
 W. Dunton (6)

 127,750

 *

 Myron
 Kaplan (7)

 307,034

 *

 Steven
 Lefkowitz (8)

 215,650

 *

 Robert
 Stewart (9)

 41,866

 *

 Named
 Executive Officers:

 Todisco (10)

 527,210

 *

 David (11)

 510,518

 *

 Beth
 Kaufman

 *

 Elizabeth
 Hurlburt (12)

 415,041

 *

 Erin
 Mistry (13)

 303,761

 *

 Phoebe
 Mounts (14)

 514,464

 *

 All
 executive officers and directors as a group (11 persons) (15)

 2,729,803

 4.8
 %

 *
 Less
 than 1%

 (1)
 Based
 upon 54,981,102 shares of our common stock outstanding on March 7, 2024 and, with respect
 to each individual holder, rights to acquire our common stock exercisable within 60 days
 of March 7, 2024.

 (2)
 Based
 solely on information contained in the Statement on Schedule 13G filed with the SEC
 on January 29, 2024 by Blackrock, Inc. Blackrock, Inc. reported has sole voting power with
 respect to 3,480,288 shares of our common stock, has shared voting power with respect to
 0 shares of our common stock, has sole dispositive power with respect to 3,507,695 shares
 of our common stock and has shared dispositive power with respect to 0 shares of our common
 stock. The business address of Blackrock, Inc. is 50 Hudson Yards, New York, NY 10001.

 (3)
 Based
 solely on information contained in Amendment No. 2 to the Statement on Schedule 13G filed
 with the SEC on February 14, 2024 by Nomura Global Financial Products, Inc. ("NGFP").
 NGFP is a wholly owned subsidiary of Nomura Holdings, Inc., which accordingly may be deemed
 to beneficially own the shares beneficially owned by NGFP. NGFP reported has sole voting
 power with respect to 0 shares of our common stock, shared voting power with respect to 2,946,531
 shares of our common stock, sole dispositive power with respect to 0 shares of our common
 stock and shared dispositive power with respect to 2,946,531 shares of our common stock.
 The business address of NGFP is Worldwide Plaza, 309 West 49th Street, New York, NY 10019.
 The business address of Nomura Holdings, Inc. is 13-1, Nihonbashi 1-chome, Chuo-ku, Tokyo
 103-8645, Japan.

 (4)
 of (i) 53,473 shares of our common stock, and (ii) 145,000 shares of our common stock issuable
 upon exercise of stock options. Ms. Dillione also holds 48,909 shares of common stock deferred
 under Director's Compensation Plan, which is excluded for purposes of calculating the
 number of shares of our common stock beneficially owned as of February 15, 2024.

 (5)
 of 82,500 shares of our common stock issuable upon exercise of stock options.

 (6)
 of (i) 15,250 shares of our common stock, and (ii) 112,500 shares of our common stock issuable

 (7)
 of (i) 151,034 shares of our common stock held directly, (ii) 30,000 shares of our common
 stock held by Mr. Kaplan's wife, 20,000 of which are held by her individually and 10,000
 of which are held as a custodian for two of Mr. Kaplan's grandchildren, and (iii) 126,000
 shares of our common stock issuable upon exercise of stock options.

 (8)
 of (i) 75,498 shares of our common stock held directly, (ii) 2,000 shares of our common stock
 held by Mr. Lefkowitz's wife, (iii) 30,152 shares of our common stock held by Wade
 Capital Corporation Money Purchase Plan, an entity for which Mr. Lefkowitz has voting and
 investment control, and (iv) 108,000 shares of our common stock issuable upon exercise of
 stock options.

 (9)
 of (i) 11,000 shares of our common stock, and (ii) 30,866 shares of our common stock issuable

 (10)
 of (i) 135,543 shares of our common stock, and (ii) 391,667 shares of our common stock issuable

 (11)
 of (i) 10,434 shares of our common stock, (ii) 500,084 shares of our common stock issuable

 (12)
 of (i) 7,897 shares of our common stock, and (ii) 407,144 shares of our common stock issuable

 (13)
 of (i) 13,011 shares of our common stock, and (ii) 290,750 shares of our common stock issuable

 (14)
 (i) 7,200 shares of our common stock, and (ii) 507,264 shares of our common stock issuable

 (15)
 Consists of the following held by our directors and executive officers
(i) 535,292 shares of our common stock, and (ii) 2,151,177 shares of our common stock issuable upon exercise of stock options.

Compensation Plan Information

 The
following table provides information as of December 31, 2023 about our common stock that may be issued upon the exercise of options,
warrants and rights under all of our existing equity compensation plans (including individual arrangements):

 Plan
 Category

 of securities to be issued upon exercise of outstanding options, warrants and rights
 (a)

 Weighted-average
 exercise price of outstanding options, warrants and rights
 (b)

 of
 securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column
 (a)
 (c))

 Equity compensation plans approved
 by security holders (1)

 6,365,243 (2)

 $ 5.44 (3)

 3,108,929

 (1)
 Our
 2013 Stock Incentive Plan was approved by our stockholders on July 30, 2013. Our 2019 Omnibus
 Stock Incentive Plan was approved by our stockholders on November 26, 2019. Our Amended and
 Restated 2019 Omnibus Stock Incentive Plan was approved by our stockholders on October 13,
 2022.

 (2)
 Consist
 of 6,211,508 underlying stock options and 153,735 underlying restricted stock units.

 (3)
 Applicable
 to shares underlying outstanding stock options only.

 Item 13.
Certain Relationships and Related Transactions and Director Independence

 Related
Party Transactions

 No
related party transactions occurred during the fiscal year ended December 31, 2023.

 Procedures
for Review and Approval of Transactions with Related Persons

to the Audit Committee Charter, the Audit Committee is responsible for reviewing and approving all related party transactions as defined
under Item 404 of Regulation S-K, after reviewing each such transaction for potential conflicts of interests and other improprieties.
Our policies and procedures for review and approval of transactions with related persons are in writing in our Code of Conduct and Ethics
available on our website at www.cormedix.com under the "Investor Relations—Corporate Governance" tab.

 The
information on Board independence is found in Item 10 of this Report under the heading "Board Independence."

 Item 14.
Principal Accounting Fees and Services

 Fees
Paid to the Independent Registered Public Accounting Firm

 The following table sets forth
fees billed to us by Friedman LLP and Marcum LLP, our independent registered public accounting firms for the years ended December 31,
2023 and 2022, for services relating to: auditing our annual financial statements; reviewing our financial statements included in our
quarterly reports on Form 10-Q; reviewing registration statements during 2023 and 2022; and financing activities in 2023 and 2022.

 2023

 2022

 Audit Fees (Friedman LLP)

 $
 -

 $
 42,400

 Audit Fees (Marcum LLP)

 $
 225,225

 $
 127,000

 Audit Related Fees

 -

 -

 Tax Fees

 -

 -

 All Other Fees

 $
 -

 -

 Total

 $
 225,225

 $
 169,400

 Audit
Committee Pre-Approval Policies and Procedures

to its charter, the Audit Committee is responsible for reviewing and approving in advance any audit and any permissible non-audit engagement
or relationship between us and our independent registered public accounting firm. The Audit Committee may delegate to one or more designated
members of the Audit Committee the authority to grant pre-approvals, provided such approvals are presented to the Audit Committee at
a subsequent meeting. If the Audit Committee elects to establish pre-approval policies and procedures regarding non-audit services, the
Audit Committee must be informed of each non-audit service provided by our independent registered public accounting firm. Audit Committee
pre-approval of audit and non-audit services will not be required if the engagement for the services is entered into pursuant to pre-approval
policies and procedures, provided the policies and procedures are detailed as to the particular service, the Audit Committee is informed
of each service provided and such policies and procedures do not include delegation of the Audit Committee's responsibilities under
the Exchange Act to our management. Audit Committee pre-approval of non-audit services (other than review and attestation services) also
will not be required if such services fall within available exceptions established by the SEC. All services performed by our independent
registered public accounting firm during 2023 were pre-approved by the Audit Committee.

 PART
IV

 Item
15. Exhibits, Financial Statement Schedules

 1.
 Financial Statements. The following consolidated financial statements of CorMedix Inc. are filed as part of this Annual Report
on Form 10-K:

 Report
 of Independent Registered Public Accounting Firm (PCAOB ID # 688)

 Consolidated Balance Sheets as of December 31, 2023 and 2022

 Consolidated Statements of Operations and Comprehensive Income (Loss) Years Ended December 31, 2023 and 2022

 Consolidated Statements of Changes in Stockholders' Equity Years Ended December 31, 2023 and 2022

 Consolidated Statements of Cash Flows Years Ended December 31, 2023 and 2022

 Notes to Consolidated Financial Statements

 2.
Financial Statement Schedules. The Financial Statement Schedules have been omitted because of the absence of conditions under which they
are required or because the required information, where material, is shown in the financial statements or notes thereto.

 3.
 Exhibit Index. The following is a list of exhibits filed as part of this Annual Report on Form 10-K:

 Description
 of Document

 Registrant's

 Form

 Dated

 Filed
 or

 Furnished

 Herewith

 1.1

 At-the-Market
Issuance Sales Agreement, dated August 12, 2021, by and among CorMedix Inc., Truist Securities, Inc. and JMP Securities LLC

 08/12/2021

 1.1

 1.2

 Underwriting
 Agreement, dated June 28, 2023, by and among CorMedix Inc., BC Capital Markets, LLC and Truist Securities, Inc.

 06/30/2023

 1.1

 3.1

 Form
 of Amended and Restated Certificate of Incorporation

 S-1/A

 3/01/2010

 3.3

 3.2

 of Amendment to Amended and Restated Certificate of Incorporation, dated February 24, 2010

 S-1/A

 3/19/2010

 3.5

 3.3

 Second
 Amended and Restated Bylaws as amended October 8, 2020

 10/14/2020

 3.1

 3.4

 of Amendment to Amended and Restated Certificate of Incorporation, dated December 3, 2012

 3/27/2013

 3.3

 3.5

 of Amendment to Amended and Restated Certificate of Incorporation, dated August 9, 2017

 8/10/2017

 3.1

 3.6

 of Amendment to Amended and Restated Certificate of Incorporation, dated March 25, 2019

 3/25/2019

 3.1

 Description
 of Document

 Registrant's

 Form

 Dated

 Filed
 or

 Furnished

 Herewith

 3.7

 Amended
 and Restated Certificate of Designation of Series C-3 Non-Voting Convertible Preferred Stock of CorMedix Inc., filed with the Delaware
 Secretary of State on September 15, 2014

 9/16/2014

 3.16

 3.8

 Second
 Amended and Restated Certificate of Designation of Series E Convertible Preferred Stock of CorMedix Inc., filed with the Delaware
 Secretary of State on September 5, 2019

 9/11/2019

 3.2

 3.9

 of Designation of Series G Convertible Preferred Stock of CorMedix Inc., filed with the Delaware Secretary of State on September
 5, 2019

 9/11/2019

 3.1

 4.1

 Specimen
 of Common Stock Certificate

 S-1/A

 3/19/2010

 4.1

 4.2

 Form
 of Warrant issued on January 8, 2014.

 1/09/2014

 4.23

 4.3

 Form
 of Series B Warrant to Purchase Common Stock of CorMedix Inc. issued on May 3, 2017

 5/03/2017

 4.2

 4.4

 Form
 of Underwriter's Warrant to Purchase Common Stock of CorMedix Inc., issued May 3, 2017

 5/03/2017

 4.3

 4.5

 Description of Capital Stock of CorMedix Inc.

 03/16/2020

 4.5

 4.6

 Form of Pre-Funded Warrant issued June 28, 2023

 06/30/2023

 4.1

 10.1*

 License and Assignment Agreement, dated as of January 30, 2008, between CorMedix Inc. and ND Partners LLC

 03/16/2020

 10.1

 10.2+

 Form of Indemnification Agreement between CorMedix Inc. and each of its directors and executive officers

 5/15/2023

 10.1

 10.3**+

 Employment Agreement, dated and effective May 11, 2020, between CorMedix Inc. and Matthew David

 3/30/2021

 10.10

 10.4+

 Letter
 Agreement, dated and effective October 26, 2021, between CorMedix Inc. and Matthew David, M.D.

 10/29/2021

 10.1

 10.5

 Form
 of Securities Purchase Agreement, dated November 17, 2017, between CorMedix Inc. and the investors signatory thereto

 11/13/2017

 10.1

 10.6

 Backstop
 Agreement, dated November 9, 2017, between CorMedix Inc. and the investor named therein

 11/13/2017

 10.2

 10.7

 Form
 of Registration Rights Agreement, dated November 9, 2017, by and between CorMedix Inc. and the investor named therein

 11/13/2017

 10.3

 10.8

 Amendment
 No. 1, dated as of December 11, 2017, to Registration Rights Agreement, dated November 9, 2017, by and between CorMedix Inc. and
 the investor named therein

 12/11/2017

 10.1

 10.9**+

 Employment Agreement, dated and effective March 10, 2021, between CorMedix Inc. and Elizabeth Hurlburt

 3/12/2021

 10.1

 10.10

 Purchase Agreement, dated December 31, 2018, between CorMedix Inc. and the investor named therein

 1/03/2019

 10.1

 Description
 of Document

 Registrant's

 Form

 Dated

 Filed
 or

 Furnished

 Herewith

 10.11*

 Employment
 Agreement, dated as of March 19, 2019, between CorMedix Inc. and Phoebe Mounts

 5/13/19

 10.1

 10.12

 Exchange Agreement, dated August 14, 2019, by and among CorMedix Inc. and the Existing Security holders listed on the Schedule of
 Holders thereto

 8/15/2019

 10.1

 10.13

 Amended
 and Restated Registration Rights Agreement, dated as of September 6, 2019, by and among CorMedix Inc. and Manchester Securities Corp.,
 and Elliot International, L.P. and Elliot Associates, L.P.

 9/11/2019

 10.1

 10.14

 Amended and Restated 2019 Omnibus Stock Incentive Plan

 S-8

 10/26/2022

 99.1

 10.15+

 2021 Executive Bonus Plan

 12/23/2021

 10.1

 10.16+

 Executive Employment Agreement, dated March 16, 2022, between CorMedix Inc. and Joseph Todisco.

 03/21/2022

 10.2

 10.17+

 Separation Agreement, effective December 14, 2023, between CorMedix Inc. and Phoebe Mounts.

 X

 21.1

 List
 of Subsidiaries

 3/27/2013

 21.1

 23.1

 Consent of Independent Registered Public Accounting Firm

 X

 31.1

 Certification of Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

 X

 31.2

 Certification of Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

 X

 32.1***

 Certification of Principal Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

 X

 32.2***

 Certification of Principal Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

 X

 97.1

 Board Policy on Recouping Incentive Compensation

 X

 101.INS

 X

 101.SCH

 Inline

 X

 101.CAL

 X

 101.DEF

 X

 101.LAB

 X

 101.PRE

 X

 Cover

 X

 *

 Confidential treatment has been granted
 for portions of this document. The omitted portions of this document have been filed separately with the SEC.

 **

 Portions of the exhibit have been omitted
 in reliance on Item 601(b)(10)(iv) of Regulation S-K.

 ***

 These certifications are furnished.

 +

 Indicates management contract or compensation
 plan.

 Item
16. Form 10-K Summary

 Not
applicable.

 SIGNATURES

to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by
the undersigned thereunto duly authorized.

 CORMEDIX INC.

 By:

 /s/

 Chief Executive Officer

 (Principal Executive Officer)

 By:

 /s/

 Chief Financial Officer

 (Principal Financial and Accounting Officer)

to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the
Registrant and in the capacities and on the dates indicated:

 Signature

 Title

 Date

 /s/ Joseph Todisco

 Chief Executive Officer and Director

 (Principal Executive Officer)

 /s/

 Executive Vice President and Chief Financial Officer

 (Principal Financial and Accounting Officer)

 /s/ Myron Kaplan

 Director and Chairman of the Board

 Myron Kaplan

 /s/ Janet Dillione

 Janet Dillione

 /s/ Gregory Duncan

 Gregory Duncan

 /s/ Alan Dunton

 Alan Dunton

 /s/ Steven Lefkowitz

 Steven Lefkowitz

 /s/
 Robert Stewart

 March
 12, 2024

 Robert Stewart

INC. AND SUBSIDIARIES

 FINANCIAL
STATEMENTS

Statements Index

 Report of Independent Registered Public Accounting Firm (PCAOB ID # 688)

 Consolidated Balance Sheets as of December 31, 2023 and 2022

 Consolidated Statements of Operations and Comprehensive Income (Loss) Years Ended December 31, 2023 and 2022

 Consolidated Statements of Changes in Stockholders' Equity Years Ended December 31, 2023 and 2022

 Consolidated Statements of Cash Flows Years Ended December 31, 2023 and 2022

 Notes to Consolidated Financial Statements

 F- 1

 REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

 To the Sh areh olders
and Board of Directors of

Inc.

 Opinion
on the Financial Statements

 We have audited the accompanying
consolidated balance sheets of CorMedix Inc. and Subsidiaries (the "Company") as of December 31, 2023 and 2022, and the
related consolidated statements of operations and comprehensive income (loss), changes in stockholders' equity and cash flows
for each of the two years in the period ended December 31, 2023, and the related notes (collectively referred to as the
"financial statements"). In our opinion, the financial statements present fairly, in all material respects, the
financial position of the Company as of December 31, 2023 and 2022, and the results of its operations and its cash flows for each of
the two years in the period ended December 31, 2023, in conformity with accounting principles generally accepted in the United
States of America.

 Basis
for Opinion

 These
financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on the Company's
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 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 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 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 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 financial statements. We believe that our audits provide a reasonable basis for our opinion.

 Critical
Audit Matters

 Critical
audit matters are matters arising from the current period audit of the financial statements that were communicated or required to be
communicated to the audit committee and that: (1) relate to accounts or disclosures that are material to the financial statements and
(2) involved our especially challenging, subjective, or complex judgments. We determined that there are no critical audit matters.

 /s/ Marcum llp

 Marcum llp

 We have served as the Company's auditor
since 2014.

 Marlton,
New Jersey

 F- 2

Inc. And Subsidiaries

 CONSOLIDATED
BALANCE SHEETS

31, 2023 and 2022

 31,

 2023

 2022

 ASSETS

 Current assets

 Cash
 and cash equivalents

 $
 43,642,684

 $
 43,148,323

 Restricted
 cash

 77,453

 124,102

 Short-term
 investments

 32,388,130

 15,644,062

 Inventories,
 net

 2,106,345

 -

 Prepaid
 research and development expenses

 353,574

 11,016

 Other
 prepaid expenses and current assets

 882,214

 623,672

 Total
 current assets

 79,450,400

 59,551,175

 Property
 and equipment, net

 1,866,224

 1,609,679

 Restricted
 cash, long term

 103,055

 102,320

 lease right-of-use assets

 640,278

 775,085

 TOTAL
 ASSETS

 $
 82,059,957

 $
 62,038,259

 LIABILITIES
 AND STOCKHOLDERS' EQUITY

 Current
 liabilities

 Accounts
 payable

 $
 4,279,679

 $
 2,202,149

 Accrued
 expenses

 6,970,217

 3,973,941

 lease liabilities, short-term

 150,619

 134,801

 Total
 current liabilities

 11,400,515

 6,310,891

 lease liabilities, net of current portion

 517,013

 667,632

 TOTAL
 LIABILITIES

 11,917,528

 6,978,523

 COMMITMENTS
 AND CONTINGENCIES (Note 6)

 STOCKHOLDERS'
 EQUITY

 Preferred stock - $ 0.001 par value: 2,000,000 shares authorized; 181,622 shares issued and outstanding at December 31, 2023 and 2022

 Common stock - $ 0.001 par value: 160,000,000 shares authorized at December
31, 2023 and 2022; 54,938,258 and 42,815,196 shares issued and outstanding at December 31, 2023 and 2022, respectively

 54,938

 42,815

 Accumulated
 other comprehensive gain

 94,108

 82,743

 Additional
 paid-in capital

 391,693,214

 330,294,782

 Accumulated
 deficit

 ( 321,700,013

)

 ( 275,360,786
)

 TOTAL
 STOCKHOLDERS' EQUITY

 70,142,429

 55,059,736

 TOTAL
 LIABILITIES AND STOCKHOLDERS' EQUITY

 $
 82,059,957

 $
 62,038,259

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

 F- 3

Inc. and Subsidiaries

 CONSOLIDATED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)

 Years
Ended December 31, 2023 and 2022

 December 31,

 2023

 2022

 Revenue:

 Net sales

 $
 -

 $
 65,408

 Cost of sales

 -

 ( 3,734
)

 Gross profit

 -

 61,674

 Operating Expenses:

 Research and development

 ( 13,155,125
)

 ( 10,679,549
)

 Selling, general and administrative

 ( 35,802,663
)

 ( 20,006,093
)

 Total operating expenses

 ( 48,957,788
)

 ( 30,685,642
)

 Loss From Operations

 ( 48,957,788
)

 ( 30,623,968
)

 Other Income (Expense):

 Interest income

 2,681,851

 326,016

 Foreign exchange transaction (loss) income

 ( 28,994
)

 37,145

 Interest expense

 ( 34,296
)

 ( 26,515
)

 Total other income

 2,618,561

 336,646

 Net Loss Before Income Taxes

)

 ( 30,287,322
)

 Tax benefit

 -

 585,617

 Net Loss

)

 ( 29,701,705
)

 Other Comprehensive Income (Loss):

 Unrealized gain from investments

 9,683

 5,055

 Foreign currency translation gain (loss)

 1,682

 ( 9,442
)

 Total other comprehensive gain (loss)

 11,365

 ( 4,387
)

 Comprehensive Loss

 $
 ( 46,327,862
)

 $
 ( 29,706,092
)

 Net Loss Per Common Share – Basic and Diluted

 $
 ( 0.91
)

 $
 ( 0.74
)

 Weighted Average Common Shares Outstanding – Basic and Diluted

 50,902,931

 40,274,273

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

 F- 4

INC. AND SUBSIDIARY

 CONSOLIDATED
STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY (DEFICIENCY)

 Years
Ended December 31, 2023 and 2022

 Common
 Stock

 Preferred
 Stock – Series C-3, Series E, Series F and Series G

 Accumulated
 Other Comprehen-sive

 Additional

 Paid-in

 Accumulated

 Total
 Stockholders'

 Amount

 Amount

 Gain (Loss)

 Capital

 Deficit

 Balance
 at December 31, 2021

 38,086,437

 $
 38,086

 181,622

 $

 $
 87,130

 $
 308,331,750

 $
 ( 245,659,081
)

 $
 62,798,067

 Stock
 issued in connection with ATM sale of common stock, net

 4,704,259

 4,705

 -

 -

 -

 17,764,911

 -

 17,769,616

 Stock
 issued in connection with warrants exercised, cash

 24,500

 -

 -

 -

 128,601

 -

 128,625

 Stock-based
 compensation

 -

 -

 -

 -

 -

 4,069,520

 -

 4,069,520

 Other
 comprehensive loss

 -

 -

 -

 -

 ( 4,387
)

 -

 -

 ( 4,387
)

 Net
 loss

 -

 -

 -

 -

 -

 -

 ( 29,701,705
)

 ( 29,701,705
)

 Balance
 at December 31, 2022

 42,815,196

 $
 42,815

 181,622

 $

 $
 82,743

 $
 330,294,782

 $
 ( 275,360,786
)

 $
 55,059,736

 Stock
 issued in connection with ATM sale of common stock, net

 2,977,637

 2,978

 -

 -

 -

 12,946,132

 -

 12,949,110

 Stock
 and pre-funded warrants issued in connection with public offering, net

 9,000,093

 9,000

 -

 -

 -

 42,869,399

 -

 42,878,399

 Stock
 issued in connection with options exercised

 79,041

 -

 -

 -

 287,659

 -

 287,738

 Issuance
 of vested restricted stock, net of shares withheld for employee withholding taxes

 66,291

 -

 -

 -

 ( 198,509
)

 -

 ( 198,443
)

 Stock-based
 compensation

 -

 -

 -

 -

 -

 5,493,751

 -

 5,493,751

 Other
 comprehensive loss

 -

 -

 -

 -

 11,365

 -

 -

 11,365

 Net
 loss

 -

 -

 -

 -

 -

 -

)

)

 Balance
 at December 31, 2023

 54,938,258

 $
 54,938

 181,622

 $

 $
 94,108

 $
 391,693,214

 $
 ( 321,700,013

)

 $
 70,142,429

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

 F- 5

INC. AND SUBSIDIARIES

 CONSOLIDATED
STATEMENTS OF CASH FLOWS

 Years
Ended December 31, 2023 and 2022

 31,

 2023

 2022

 CASH
 FLOWS FROM OPERATING ACTIVITIES:

 Net
 loss

 $

)

 $
 ( 29,701,705
)

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

 Stock-based
 compensation

 5,493,751

 4,069,520

 Change
 in right-of-use assets

 134,807

 124,420

 Depreciation

 70,755

 84,618

 in operating assets and liabilities:

 Decrease
 (Increase) in trade receivables

 -

 42,143

 (Increase)
 Decrease in inventory

 ( 2,106,345
)

 3,008

 (Increase)
 Decrease in prepaid expenses and other current assets

 ( 600,983
)

 187,235

 (Decrease) in accounts payable

 2,077,479

 ( 6,566
)

 in accrued expenses

 2,995,084

 961,963

 Decrease
 in operating lease liabilities

 ( 134,801
)

 ( 121,368
)

 Net
 cash used in operating activities

 ( 38,409,480
)

 ( 24,356,732
)

 CASH
 FLOWS FROM INVESTING ACTIVITIES:

 Purchase
 of short-term investments

 ( 77,084,385
)

 ( 31,140,004
)

 Maturity
 of short-term investments

 60,350,000

 27,650,000

 Purchase
 of equipment

 ( 327,300
)

 ( 219,360
)

 Net
 cash used in investing activities

 ( 17,061,685
)

 ( 3,709,364
)

 CASH
 FLOWS FROM FINANCING ACTIVITIES:

 Proceeds
 from sale of common stock from at-the-market program, net

 12,949,110

 17,769,616

 Proceeds
 from public offering of common stock and pre-funded warrants, net

 42,878,399

 -

 Payment
 of employee withholding taxes on vested restricted stock units

 ( 198,443
)

 -

 Proceeds from exercise
 of warrants

 -

 128,625

 Proceeds
 from exercise of stock options

 287,738

 -

 Net
 cash provided by financing activities

 55,916,804

 17,898,241

 exchange effects on cash

 2,808

 ( 8,677
)

 NET
 INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS

 448,447

 ( 10,176,532
)

 CASH
 AND CASH EQUIVALENTS AND RESTRICTED CASH – BEGINNING OF YEAR

 43,374,745

 53,551,277

 CASH
 AND CASH EQUIVALENTS AND RESTRICTED CASH – END OF YEAR

 $
 43,823,192

 $
 43,374,745

 Cash
 paid for interest

 $
 34,296

 $
 26,516

 Supplemental
 Disclosure of Non-Cash and Investing Activities:

 Unrealized
 gain (loss) from investments

 $
 9,683

 $
 5,055

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

 F- 6

 Note
1 — Organization, Business and Basis of Presentation:

 Organization
and Business:

Inc. ("CorMedix" or the "Company") was incorporated in the State of Delaware on July 28, 2006. The Company is
a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious
and inflammatory diseases.

 The
Company's primary focus is on the commercialization of our lead product, DefenCath in the United States. We have
in-licensed the worldwide rights to develop and commercialize DefenCath. The name DefenCath is the U.S. proprietary name approved by
the U.S. Food and Drug Administration, or FDA.

 DefenCath
is an antimicrobial solution (a formulation of taurolidine 13.5 mg/mL, and heparin 1000 USP Units/mL) indicated to reduce the incidence
of catheter-related bloodstream infections (CRBSI) in adult patients with kidney failure receiving chronic hemodialysis (HD) through
a central venous catheter (CVC). It is indicated for use in a limited and specific population of patients. CRBSI can lead to treatment
delays and increased costs to the healthcare system when they occur due to hospitalizations, need for IV antibiotic treatment, long-term
anticoagulation therapy, removal/replacement of the CVC, related treatment costs, as well as increased mortality. We believe DefenCath
can address a significant unmet medical need.

 On January 30, 2008, we entered
into a License and Assignment Agreement, or the ND License Agreement, with ND Partners LLC, or NDP. Pursuant to the ND License Agreement,
NDP granted us exclusive, worldwide licenses for certain antimicrobial catheter lock solutions, processes for treating and inhibiting
infections, a biocidal lock system and a taurolidine delivery apparatus, and the corresponding United States and foreign patents and applications
(the "NDP Technology"). NDP also granted us exclusive licenses, with the right to grant sublicenses, to use and display certain
trademarks in connection with the NDP Technology. As consideration in part for the rights to the NDP Technology, we paid NDP an initial
licensing fee of $ 325,000 and granted NDP an equity interest in our Company consisting of 73,107 shares of common stock as of December
31, 2010. In addition, we are required to make cash payments to NDP upon the achievement of certain milestones. The maximum aggregate
amount of cash payments upon achievement of milestones is $ 3,000,000, with $ 2,000,000 remaining at December 31, 2023.

 On November 15, 2023, we announced
that the FDA approved the NDA for DefenCath to reduce the incidence of CRBSI in adult patients with kidney failure receiving chronic hemodialysis
through a CVC. DefenCath is indicated for use in a limited and specific population of patients. DefenCath is the first and only FDA-approved
antimicrobial CLS in the U.S. and was shown to reduce the risk of CRBSI by up to 71 % in a Phase 3 clinical study. As a result of
the November 2023 FDA approval, we are currently preparing for the commercial launch of DefenCath.

 DefenCath is listed in the
Orange Book as having NCE exclusivity (5 years) expiring on November 15, 2028, and the Generating Antibiotic Incentives Now or GAIN exclusivity
extension of the NCE exclusivity (an additional 5 years) expiring on November 15, 2033. The GAIN exclusivity extension of 5 years is the
result of the January 2015 designation of DefenCath as a Qualified Infectious Disease Product ("QIDP").

 We announced on April 26,
2023 that following the submission of a duplicate New Technology Add-On Payment ("NTAP") application in the fourth quarter
of 2022 to CMS, CMS has subsequently issued the Inpatient Prospective Payment System ("IPPS") 2024 proposed rule that includes
a NTAP of up to $ 17,111 per hospital stay for DefenCath. This NTAP represents reimbursement to inpatient facilities of 75 % of the anticipated
wholesaler acquisition cost price of $ 1,170 per 3 mL vial, and an average utilization of 19.5 vials per hospital stay. The final IPPS
rule was published in early August 2023 and confirmed this payment amount in that final rule. This NTAP was conditioned upon the DefenCath
NDA obtaining final FDA approval prior to July 1, 2024. As the NTAP was calculated by CMS based upon an anticipated WAC price of $ 1,170,
and following FDA approval of the DefenCath NDA, an actual WAC of $ 249.99 per 3ml vial was established, we anticipate that CMS will revise
the amount of the NTAP payment to reflect the actual WAC price in the next IPPS rulemaking, effective October 1, 2024. Upon the listing
in the compendia of the actual WAC price of $ 249.99 per 3ml vial, the Company notified CMS of the new lower WAC pricing and recommended
that CMS make an off-cycle adjustment to the NTAP to reflect the current lower WAC pricing amount. CMS subsequently communicated to the
Company that they do not intend to update the NTAP reimbursement amount until the next review cycle in October 2024.

 F- 7

 On January 25, 2024, CMS determined
that DefenCath should be classified as a renal dialysis service that is subject to the Medicare end-stage renal disease prospective payment
system ("ESRD PPS"). The ESRD PPS provides bundled payment for renal dialysis services, but also affords a transitional drug
add-on payment adjustment, or TDAPA, which provides temporary, additional payments for certain new drugs and biologicals. We submitted
an application for TDAPA on January 26, 2024, and CMS has confirmed receipt. We also submitted a HCPCS application for a J-code to CMS
on December 8, 2023, for DefenCath, which is relevant to billing and the TDAPA application. CMS has confirmed the coding application is
under review. TDAPA reimbursement is calculated based on 100 percent ASP (or 100 percent of wholesale acquisition price or else manufacturers'
list price, respectively, if such data is unavailable). If CMS grants TDAPA and post-TDAPA add-on payment adjustments for DefenCath, collective
payments would be for five years (with such add-on payments applying to all ESRD PPS payments for years three through five). CMS confirmed
to the Company that, assuming a favorable review, CMS is working towards a July 1, 2024 implementation date for TDAPA.

 We may pursue additional indications
for DefenCath use as a CLS in populations with unmet medical needs that may also represent potentially significant market opportunities.
While we are continuing to assess these areas, potential future indications may include use as a CLS to reduce CRBSIs in total parenteral
nutrition patients using a central venous catheter and in certain oncology patients using a central venous catheter. In 2024, the company
anticipates discussing with the FDA potential pathways for expanded indications.

 We currently have one FDA
approved source for each of our two key APIs for DefenCath, taurolidine and heparin sodium, respectively. With regards to taurolidine,
we have a DMF filed with the FDA. There is a master commercial supply agreement between a third-party manufacturer and us in place from
August 2018. We are currently in the process of identifying and qualifying an alternate third-party manufacturer for taurolidine under
our existing DMF. With respect to heparin sodium API, we have identified an alternate third party supplier and intend to qualify such
supplier under the DefenCath NDA over the next twelve months.

 We received FDA approval of
DefenCath with finished dosage production from our European based CMO Rovi Pharma Industrial Services. We believe this CMO has adequate
capacity to produce the volumes needed to meet near term projected demand for the commercial launch of DefenCath.

 We previously announced commercial
arrangements with additional finished dosage CMOs, Alcami Corporation and Siegfried Hameln, that provide for the manufacture of commercial
sterile parenteral drug products. The Company anticipates the submission to the FDA of a supplement adding Siegfreid Hameln as an alternate
manufacturing site in the second fiscal quarter of 2024. The Company will also discontinue its relationship with Alcami as a potential
alternate manufacturing site for DefenCath.

 We announced on May 1, 2023
that the USPTO allowed our patent application directed to a locking solution composition for treating and reducing infection and flow
reduction in central venous catheters. This application was granted on August 29, 2023 as U.S. Patent No. 11,738,120. Our newly
granted U.S. Patent reflects the unique and proprietary formulation of our product, DefenCath, for which we received FDA approval on November
15, 2023. This patent supplements the coverage of our existing licensed U.S. Patent No. 7,696,182, and has the potential to provide an
additional layer of patent protection for DefenCath through 2042.

 As part of the DefenCath approval
letter, the FDA communicated the existence of a required pediatric assessment under the Pediatric Research Equity Act, or PREA. PREA requires
sponsors to conduct pediatric studies for, among other things, NDAs for a new active ingredient, such as taurolidine in DefenCath, unless
a waiver or deferral is obtained from the FDA. A deferral acknowledges that a pediatric assessment is required but permits the applicant
to submit the pediatric assessment after the submission of an NDA. FDA deferred submission of the pediatric study for DefenCath because
the product is ready for approval for use in adults and the pediatric study has not been completed. We are obligated to conduct the study
communicated in the approval letter: an open-label, two-arm (DefenCath vs. standard of care) study to assess safety and time to CRBSI
in subjects from birth to less than 18 years of age with kidney failure receiving hemodialysis via a central venous catheter. Because
this is a required post-marketing study, we must make annual reports to the FDA. Pediatric studies for an approved product conducted under
PREA may qualify for pediatric exclusivity, which, if granted, provides an additional six months of exclusivity that attaches to the end
of existing marketing exclusivity and patent periods for DefenCath. Depending on the timing of final report submission, DefenCath could
potentially receive a total marketing exclusivity period of 10.5 years. However, there are factors that could affect whether this exclusivity
is received or the duration of exclusivity, and DefenCath may or may not ultimately be eligible for the additional 0.5 years of exclusivity
associated with this pediatric study.

 F- 8

 Neutrolin was previously sold
in the EU and other territories where we received CE-Mark approval for the commercial distribution of Neutrolin as a CLS. The Company
has elected to discontinue sales of Neutrolin for lack of commercial viability. The winding down of our operations in the EU is nearly
complete and Neutrolin sales in both the EU and the Middle East have been discontinued since 2022.

 In
addition to DefenCath, we have sponsored a pre-clinical research collaboration for the use of taurolidine as a possible treatment for
rare pediatric tumors. In February 2018, the FDA granted orphan drug designation to taurolidine for the treatment of neuroblastoma in
children. We may seek one or more strategic partners or other sources of capital to help us develop and commercialize taurolidine for
the treatment of neuroblastoma in children.

 Note
2 — Liquidity and Uncertainties:

 The consolidated financial statements have been
prepared in conformity with generally accepted accounting principles which contemplate continuation of the Company as a going concern.
To date, the Company's commercial operations have not generated sufficient revenues to enable profitability. As of December 31,
2023, the Company had an accumulated deficit of $ 321.7 million, and incurred net losses of $ 46.3 million and $ 29.7 million for the years
ended December 31, 2023 and 2022, respectively. Based on the Company's current development plans for DefenCath and its other operating
requirements, the Company's existing cash and cash equivalents and short-term investments at December 31, 2023 are expected to fund
its operations for at least twelve months from the issuance of this Annual Report on Form 10-K.

 The
Company may raise additional capital through various potential sources, such as equity and/or debt financings, strategic relationships,
potential strategic transactions and/or out-licensing. Management can provide no assurances that such financing or strategic relationships
will be available on acceptable terms, or at all. As of December 31, 2023, the Company has $ 104.4 million available under its current
shelf registration for the issuance of equity, debt or equity-linked securities (see Note 7).

 The
Company's operations are subject to a number of other factors that can affect its operating results and financial condition. Such
factors include, but are not limited to: the results of clinical testing and trial activities of the Company's product candidates;
the ability to market the Company's products; ability to manufacture successfully; competition from products manufactured and sold
or being developed by other companies; the price of, and demand for, Company products; the Company's ability to negotiate favorable
licensing or other manufacturing and marketing agreements for its products; and the Company's ability to raise capital to support
its operations.

 Note
3 — Summary of Significant Accounting Policies:

 Use
of Estimates

 The preparation of financial statements in conformity with accounting
principles generally accepted in the United States of America ("GAAP") requires
management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets
and liabilities at the date of the financial statements and reported amounts of revenue and expenses during the reporting period. Actual
results could differ from those estimates.

 Basis
of Consolidation

 The
consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All significant intercompany
accounts and transactions have been eliminated in consolidation.

Instruments

instruments that potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents and
short-term investments. The Company maintains its cash and cash equivalents in bank deposit and other interest-bearing accounts, the
balances of which, at times, may exceed federally insured limits.

 F- 9

 The
following table is the reconciliation of the accounting standard that modifies certain aspects of the recognition, measurement, presentation
and disclosure of financial instruments as shown on the Company's consolidated statement of cash flows:

 31,

 2023

 2022

 Cash and cash equivalents

 $
 43,642,684

 $
 43,148,323

 Restricted cash, short-term
 and long-term

 180,508

 226,422

 Total cash, cash equivalents
 and restricted cash

 $
 43,823,192

 $
 43,374,745

 The
appropriate classification of marketable securities is determined at the time of purchase and reevaluated as of each balance sheet date.
Investments in marketable debt and equity securities classified as available-for-sale are reported at fair value. Fair value is determined
using quoted market prices in active markets for identical assets or liabilities or quoted prices for similar assets or liabilities or
other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
Changes in fair value that are considered temporary are reported net of tax in other comprehensive income (loss). Realized gains and
losses, amortization of premiums and discounts and interest and dividends earned are included in income (expense). For declines in the
fair value of equity securities that are considered other-than-temporary, impairment losses are charged to other (income) expense, net.
The Company considers available evidence in evaluating potential impairments of its investments, including the duration and extent to
which fair value is less than cost. There were no deemed permanent impairments at December 31, 2023 or 2022.

 The
Company's marketable securities are highly liquid and consist of U.S. government agency securities, high-grade corporate obligations
and commercial paper with original maturities of more than 90 days. As of December 31, 2023 and 2022, all of the Company's investments
had contractual maturities which were less than one year. The following table summarizes the amortized cost, unrealized gains and losses
and the fair value at December 31, 2023 and 2022:

 31, 2023:

 Amortized

 Cost

 Gross

 Unrealized

 Losses

 Gross

 Unrealized

 Gains

 Fair
 Value

 Money
 Market Funds and Cash Equivalents

 $

 32,541,862

 $

 -

 $

 -

 $

 32,541,862

 U.S. Government
 Agency

 29,701,677

 -

 10,506

 29,712,183

 Commercial
 Paper

 2,676,740

 ( 1,425

)

 -

 2,675,315

 Subtotal

 32,378,417

 ( 1,425

)

 10,506

 32,387,498

 Total
 December 31, 2023

 $

 64,920,279

 $

 ( 1,425

)

 $

 10,506

 $

 64,929,360

 December 31,
 2022:

 Money
 Market Funds and Cash Equivalents

 $

 7,311,327

 $

 -

 $

 $

 7,311,899

 U.S. Government
 Agency

 12,072,127

 ( 3,184

)

 2,056

 12,070,999

 Corporate Securities

 2,684,235

 ( 183

)

 2,684,961

 Commercial
 Paper

 888,875

 ( 773

)

 -

 888,102

 Subtotal

 15,645,237

 ( 4,140

)

 2,965

 15,644,062

 Total
 December 31, 2022

 $

 22,956,564

 $

 ( 4,140

)

 $

 3,537

 $

 22,955,961

 Fair
Value Measurements

 The
Company's financial instruments recorded in the consolidated balance sheets include cash and cash equivalents, accounts receivable,
investment securities, accounts payable and accrued expenses. The carrying value of certain financial instruments, primarily cash
and cash equivalents, accounts receivable, accounts payable, and accrued expenses approximate their estimated fair values based upon
the short-term nature of their maturity dates.

 F- 10

 The
Company categorizes its financial instruments into a three-level fair value hierarchy that prioritizes the inputs to valuation techniques
used to measure fair value, which is set out below. The fair value hierarchy gives the highest priority to quoted prices in active markets
for identical assets (Level 1) and the lowest priority to unobservable inputs (Level 3). If the inputs used to measure fair value fall
within different levels of the hierarchy, the category level is based on the lowest priority level input that is significant to the fair
value measurement of the instrument.

 Level
 inputs—Observable
 inputs that reflect quoted prices (unadjusted) for identical assets or liabilities in active
 markets.

 Level
 inputs—
 Significant other observable inputs (e.g., quoted prices for similar items in active markets,
 quoted prices for identical or similar items in markets that are not active, inputs other
 than quoted prices that are observable such as interest rate and yield curves, and market-corroborated
 inputs).

 Level
 inputs—Unobservable
 inputs for the asset or liability, which are supported by little or no market activity and
 are valued based on management's estimates of assumptions that market participants
 would use in pricing the asset or liability.

 The
following table provides the carrying value and fair value of the Company's financial assets measured at fair value as of December
31, 2023 and 2022:

 December 31, 2023:

 Carrying Value

 Level

 Level

 Level

 Money Market
 Funds and Cash Equivalents

 $
 32,541,230

 $
 32,541,230

 $
 -

 $
 -

 U.S. Government Agency

 29,712,183

 29,712,183

 -

 -

 Commercial Paper

 2,675,947

 -

 2,675,947

 -

 Subtotal

 32,388,130

 29,712,183

 2,675,947

 -

 Total December 31, 2023

 $
 64,929,360

 $
 62,253,413

 $
 2,675,947

 $
 -

 December 31, 2022:

 Money Market Funds and
 Cash Equivalents

 $
 7,311,899

 $
 7,311,899

 $
 -

 $
 -

 U.S. Government Agency

 12,070,999

 12,070,999

 -

 -

 Corporate Securities

 2,684,961

 -

 2,684,961

 -

 Commercial Paper

 888,102

 -

 888,102

 -

 Subtotal

 15,644,062

 12,070,999

 3,573,063

 -

 Total
 December 31, 2022

 $
 22,955,961

 $
 19,382,898

 $
 3,573,063

 $
 -

Currency Translation and Transactions

 The
consolidated financial statements are presented in U.S. Dollars (USD), the reporting currency of the Company. For the financial statements
of the Company's foreign subsidiaries, whose functional currency is the EURO, foreign currency asset and liability amounts, if
any, are translated into USD at end-of-period exchange rates. Foreign currency income and expenses are translated at average exchange
rates in effect during the year. Translation gains and losses are included in other comprehensive income (loss). The Company had a foreign
currency translation gain of $ 1,682 and a loss of $ 9,442 for the year ended December 31, 2023 and 2022, respectively.

currency exchange transaction gain (loss) is the result of re-measuring transactions denominated in a currency other than the functional
currency of the entity recording the transaction.

 F- 11

 Restricted
Cash

 As of December 31, 2023, and 2022 the Company has restricted cash in
connection with the patent and utility model infringement proceedings against TauroPharm (see Note 6). The Company was required
by the District Courts of Mannheim to provide security deposit to cover legal fees in the event TauroPharm is entitled to reimbursement
of these costs. The Company furthermore had to provide a deposit for the first and second instances, respectively, in connection with
the unfair competition proceedings in Cologne. During the year ended December 31, 2023, approximately a total of $ 47,000 was released
by the court for the reimbursement of legal fees and other costs which was removed from restricted cash. As of December 31, 2023 and 2022,
restricted cash in connection with the patent and utility model infringement proceedings were approximately
$ 77,000 and approximately $ 124,000, respectively.

 As of December 31, 2023 and 2022, the Company had $ 103,000 in long-term
restricted cash for a lease security deposit.

 Prepaid
Research and Development and Other Prepaid Expenses

 Prepaid
expenses consist of payments made in advance to vendors relating to service contracts for clinical trial development, manufacturing,
pre-clinical development and insurance policies. These advanced payments are amortized to expense either as services are performed or
over the relevant service period using the straight-line method.

 Inventories,
net

 The Company engages third parties to manufacture and package inventory
held for sale and warehouse such goods until packaged for final distribution and sale. Costs related to the manufacturing of the product
incurred prior to FDA approval in order to support the preparation for commercial launch of its product were expensed as R&D as incurred.
Upon FDA approval, costs related to the manufacturing of inventory are stated at the lower of cost or net realizable value with cost determined
on a first-in, first-out basis. Inventories previously expensed as R&D prior to FDA approval amounted to $ 6,407,266.

 Inventories
consist of raw materials (including labeling and packaging), work-in-process, and finished goods, if any, for the DefenCath product.
Inventories consist of the following:

 31,

 2023

 2022

 Raw materials

 $
 1,525,420

 $
 -

 Work in progress

 580,925

 -

 Total

 $
 2,106,345

 $
 -

 Property
and Equipment

 Property
and equipment consist primarily of furnishings, fixtures, leasehold improvements, office equipment and computer equipment all of
which are recorded at cost. Depreciation is provided for by the straight-line method over the estimated useful lives of the related
assets. Leasehold improvements are amortized using the straight-line method over the remaining lease term or the life of
the asset, whichever is shorter. Property and equipment, as of December 31, 2023 and 2022 were $ 1,866,224 and $ 1,609,679,
respectively, net of accumulated depreciation of $ 520,542 and $ 449,787, respectively. Depreciation and amortization of property and
equipment is included in selling, general and administrative expenses.

 Description

 Estimated
 Useful Life

 Office equipment and furniture

 5 years

 Leasehold improvements

 7 years or remaining
 term of the lease

 Computer equipment

 5 years

 Computer software

 3 years

 Leases

 The
Company determines if an arrangement is a lease at inception. Operating leases are included in operating lease right-of-use ("ROU")
assets, current portion of operating lease liabilities (included in accrued expenses), and operating lease liabilities, net of current
portion, on the consolidated balance sheet (see Note 8).

 F- 12

lease ROU assets and operating lease liabilities are recognized based on the present value of the future minimum lease payments over
the lease term at commencement date. As the Company's leases do not provide an implicit rate, the Company uses its incremental
borrowing rate based on the information available at commencement date in determining the present value of future payments. The Company's
lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option.
Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term.

 The
Company has elected, as an accounting policy, not to apply the recognition requirements in ASC 842 to short-term leases. Short-term leases
are leases that have a term of 12 months or less and do not include an option to purchase the underlying asset that the
Company is reasonably certain to exercise. The Company recognizes the lease payments for short-term leases on a straight-line basis
over the lease term.

 The
Company has also elected, as a practical expedient, by underlying class of asset, not to separate lease components from non-lease components
and, instead, account for them as a single component.

 Revenue
Recognition

 The
Company uses Accounting Standards Codification ("ASC") 606, " Revenue from Contracts with Customers," issued
by the Financial Accounting Standards Board ("FASB"), that prescribes a five-step model for recognizing revenue which includes
(i) identifying contracts with customers; (ii) identifying performance obligations; (iii) determining the transaction price; (iv) allocating
the transaction price; and (v) recognizing revenue.

 The
Company recognizes net sales upon shipment of product to the dialysis centers and upon meeting the five-step model prescribed by ASC
606 outlined above.

 Loss
Per Common Share

 Basic
loss per common share excludes dilution and is computed by dividing net loss by the weighted average number of common shares outstanding
during the period. The weighted average number of common shares outstanding during the period included 2,500,625 shares underlying outstanding
pre-funded warrants. Diluted loss per common share reflects the potential dilution that could occur if securities or other contracts
to issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that then shared in the
earnings of the Company.

 The
Company's outstanding shares of Series E preferred stock entitle the holders to receive dividends on a basis equivalent to the
dividends paid to holders of common stock. As a result, the Series E preferred stock meet the definition of participating securities
requiring the application of the two-class method. Under the two-class method, earnings available to common shareholders, including both
distributed and undistributed earnings, are allocated to each class of common stock and participating securities according to dividends
declared and participating rights in undistributed earnings, which may cause diluted earnings per share to be more dilutive than the
calculation using the treasury stock method. No loss has been allocated to these participating securities since they do not have contractual
obligations that require participation in the Company's losses.

 Since
the Company has only incurred losses, basic and diluted loss per share are the same as potentially dilutive shares have been excluded
from the calculation of diluted net loss per share as their effect would be anti-dilutive. The shares outstanding at the end of the respective
periods presented below were excluded from the calculation of diluted net loss per share due to their anti-dilutive effect:

 of Shares of

 Common Stock Issuable At

 31,

 2023

 2022

 Series C non-voting preferred stock

 4,000

 4,000

 Series E voting preferred stock

 391,953

 391,953

 Series G voting preferred stock

 5,004,069

 5,004,069

 Shares issuable for payment of deferred board
 compensation

 48,909

 48,909

 Shares underlying outstanding stock options

 6,211,508

 4,454,369

 Restricted stock units

 153,735

 207,469

 Total potentially dilutive
 shares

 11,814,174

 10,110,769

 F- 13

 Stock-Based
Compensation

 Share-based
compensation cost is measured at grant date, based on the estimated fair value of the award using the Black-Scholes option pricing model
for options with service or performance-based conditions. Stock-based compensation is recognized as expense over the requisite service
period on a straight-line basis or when the achievement of the performance condition is probable. For options with market-based vesting,
share-based compensation cost is measured at grant date using the Monte Carlo option pricing model and the expense is recognized over
the derived service period.

 Research
and Development

 Research
and development costs are charged to expense as incurred. Research and development include fees associated with operational consultants,
contract clinical research organizations, contract manufacturing organizations, clinical site fees, contract laboratory research organizations,
contract central testing laboratories, licensing activities, and allocated executive, human resources and facilities expenses. The Company
accrues for costs incurred as the services are being provided by monitoring the status of the trial and the invoices received from its
external service providers. As actual costs become known, the Company adjusts its accruals in the period when actual costs become known.
Costs related to the acquisition of technology rights and patents for which development work is still in process are charged to operations
as incurred and considered a component of research and development expense.

 Income
Taxes

 Deferred
tax assets and liabilities are recognized for the future tax consequences attributable to temporary differences between the financial
statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are
measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to
be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period
that includes the enactment date. Valuation allowances are established when it is more likely than not that some or all of the deferred
tax assets will not be realized.

 Legal
Costs

 The
Company records legal costs associated with loss contingencies when they are probable and reasonably estimable.

 Recent
Authoritative Pronouncements

 In
October 2023, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") 2023-06,
" Codification Amendments in Response to the SEC's Disclosure Update and Simplification Initiative," which modifies
the disclosure or presentation requirements of various FASB topics in the Codification. The date on which this guidance is effective
for the Company will be the date on which the SEC's removal of that related disclosure from Regulation S-X or Regulation S-K becomes
effective, with early adoption prohibited. The Company does not expect the adoption of this guidance to have an impact on its consolidated
financial statements.

 In November 2023, the FASB
issued ASU 2023-07, " Improvements to Reportable Segment Disclosures," which improves reportable segment disclosure
requirements, primarily through enhanced disclosures about significant segment expenses. The guidance is effective for the Company beginning
in the annual reporting period ending December 31, 2024 and interim periods beginning in fiscal year 2025. Early adoption is permitted.
The Company is assessing the impact of adopting this guidance on its consolidated financial statements.

 In December 2023, the FASB issued ASU
2023-09, " Improvements to Income Tax Disclosures," which enhances the transparency and decision usefulness of income
tax disclosures. The guidance is effective for the Company's annual reporting period ending December 31, 2025. Early adoption is
permitted. The Company is assessing the impact of adopting this guidance on its consolidated financial statements.

 Note
4 — Accrued Expenses:

 Accrued
Expenses

 Accrued
expenses consist of the following:

 31,

 2023

 2022

 Professional and consulting fees

 $
 2,270,022

 $
 514,354

 Accrued payroll and payroll taxes

 2,718,770

 2,180,581

 Manufacturing related

 1,835,101

 1,214,550

 Other

 146,324

 64,456

 Total

 $
 6,970,217

 $
 3,973,941

 F- 14

 Note 5 — Income
Taxes:

 The
Company's U.S. and foreign loss before income taxes are set forth below:

 December 31,

 2023

 2022

 United States

 $

 ( 45,946,020

)

 $

 ( 29,973,763

)

 ( 393,207

)

 ( 313,559

)

 Total

 $

)

 $

 ( 30,287,322

)

 There
were no current or deferred income tax provision for the years ended December 31, 2023 and 2022 because the Company has incurred operating
losses since inception.

 The
Company's deferred tax assets consist of the following:

 December 31,

 2023

 2022

 Net operating loss carryforwards – Federal

 $

 53,614,000

 $

 47,683,000

 Net operating loss carryforwards – State

 4,603,000

 1,592,000

 Net operating loss carryforwards – Foreign

 6,000

 10,000

 Capitalized licensing fees

 165,000

 304,000

 Stock-based compensation

 6,151,000

 5,270,000

 Accrued compensation

 720,000

 172,000

 Section 174 capitalization

 5,522,000

 2,702,000

 Other

 ( 4,000

)

 28,000

 Totals

 70,777,000

 57,761,000

 Less valuation allowance

 ( 70,777,000

)

 ( 57,761,000

)

 Deferred tax assets

 $

 -

 $

 -

 A
valuation allowance is provided when it is more likely than not that some portion or all of the deferred tax assets will not be realized.
The net change in the total valuation allowance for the year ended December 31, 2023 was $ 13,016,000.

 The
Company had the following potentially utilizable net operating loss tax carryforwards:

 31,

 2023

 2022

 Federal

 $
 255,306,000

 $
 227,068,000

 State

 $
 64,738,000

 $
 23,389,000

 $
 25,000

 $
 38,000

 Approximately $ 113,600,000 of net operating losses generated will expire
in 2026 through 2037 for Federal purposes whereas the operating losses for state purposes will expire between 2039 and 2044. The Tax Cuts
and Jobs Act of 2017 (the "Act") limits the net operating loss deduction to 80 % of taxable income for losses arising in tax
years beginning after December 31, 2017. However, the net operating losses now have an indefinite carryforward as opposed to the
former 20-year carryforward. The foreign net operating loss tax carryforwards do not expire. Our federal and state operating loss
carryforwards include windfall tax deductions from stock option exercises.

 The Company's foreign
net operating loss carryforward relates to the Company's Spanish subsidiary.

 During 2021, the Company's
German subsidiary was audited by the German taxing authorities for the years 2013-2015. It was determined that the amount of German income
was not sufficient, so the taxing authorities made adjustments accordingly. Further, amended returns were filed for the subsequent years
to provide the German subsidiary sufficient income. As a result of these changes, the German subsidiary's net operating losses were
fully utilized and no longer have a carryforward attribute. Such adjustments do not have a material effect on the Company's financial
statements.

 The Company's foreign
earnings are derived from its German and Spanish subsidiaries. The Company does not expect any foreign earnings to be repatriated in
the U.S. in the near future. The winding down of its operations in the EU is ongoing and there was no income during the year ended December
31, 2023.

 F- 15

 The
Company's effective tax rate varied from the statutory rate as follows:

 31,

 2023

 2022

 Statutory federal tax rate

 21.0
 %

 21.0
 %

 State income tax rate (net of federal)

 8.7
 %

 ( 4.3
) %

 Change in foreign NOL

 ( 0.2
)%

 ( 0.2
)%

 NJ NOL adjustment

 0.0
 %

 1.9
 %

 Other permanent differences

 ( 1.4
)%

 ( 0.8
)%

 Effect of valuation
 allowance

 ( 28.1
)%

 ( 15.7
)%

 Effective
 tax rate

 0.0
 %

 1.9
 %

 In
assessing the realizability of deferred tax assets, management considers whether it is more-likely-than-not that some portion or all
of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of
future taxable income of the appropriate character during the periods in which those temporary differences become deductible and the
loss carryforwards are available to reduce taxable income. In making its assessment, the Company considered all sources of taxable income
including carryback potential, future reversals of existing deferred tax liabilities, prudent and feasible tax planning strategies, and
lastly, objectively verifiable projections of future taxable income exclusive of reversing temporary differences and carryforwards. At
December 31, 2023 and 2022, the Company maintained a full valuation allowance against its net deferred tax assets. The Company will continue
to assess all available evidence during future periods to evaluate the realization of its deferred tax assets.

 The
following table presents the changes in the deferred tax asset valuation allowance for the periods indicated:

 Year Ended

 Balance at

Beginning of

Year

(Decrease)

Charged

(Credited) to

Income Taxes

(Benefit)

(Decrease)

Charged

(Credited)

to OCI

 Balance at

End of Year

 December 31, 2023

 $

 57,761,000

 $

 13,050,000

 $

 ( 34,000

)

 $

 70,777,000

 December 31, 2022

 $

 52,989,000

 $

 4,804,000

 $

 ( 32,000

)

 $

 57,761,000

 Accounting
for uncertainty in income taxes requires uncertain tax positions to be classified as non-current income tax liabilities unless they are
expected to be paid within one year. The Company has concluded that there are no uncertain tax positions requiring recognition in its
consolidated financial statements as of December 31, 2023 and 2022. The Company recognizes interest and penalties related to uncertain
tax positions if any as a component of income tax expense.

 The Company files U.S. federal and state returns. The Company's
foreign subsidiary also files a local tax return in their local jurisdiction. From a U.S. federal, state and local perspective the years
that remain open to examination are consistent with each jurisdiction's statute of limitations. From a foreign perspective, tax
years 2016 to 2022 remain open to examination.

the year ended December 31, 2023 the Company did not sell any of its unused New Jersey net operating losses ("NOL") eligible
for sale under the State of New Jersey's Economic Development Authority's New Jersey Technology Business Tax Certificate
Transfer program ("NJEDA Program"). The NJEDA Program allowed the Company to sell $ 626,000 of its total $ 626,000 in available
NOL tax benefits for the state fiscal year 2021, which the Company received net proceeds of approximately $ 586,000 during the year ended
December 31, 2022.

 F- 16

 Note
6 — Commitments and Contingencies:

 Contingency
Matters

 In
re CorMedix Inc. Securities Litigation, Case No. 2:21-cv-14020 (D.N.J.)

 On
October 13, 2021, the United States District Court for the District of New Jersey consolidated into In re CorMedix Inc. Securities Litigation,
Case No. 2:21-cv 14020-JXN-CLW, two putative class action lawsuits filed on or about July 22, 2021 and September 13, 2021, respectively,
and appointed lead counsel and lead plaintiff, a purported stockholder of the Company. The lead plaintiff filed a consolidated amended
class action complaint on December 14, 2021, alleging violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934,
as amended, or the Exchange Act, along with Rule 10b-5 promulgated thereunder, and Sections 11 and 15 of the Securities Act of 1933,
as amended, or the Securities Act. On October 10, 2022, the lead plaintiff filed a second amended consolidated complaint that superseded
the original complaints in In re CorMedix Securities Litigation. In the second amended complaint, the lead plaintiff seeks to represent
 two classes of shareholders: (i) shareholders who purchased or otherwise acquired CorMedix securities between October 16, 2019 and August
8, 2022, inclusive; and (ii) shareholders who purchased CorMedix securities pursuant or traceable to the Company's November 27,
2020 offering pursuant to CorMedix's Form S-3 Registration Statement, its Prospectus Supplement, dated November 27, 2020, and its
Prospectus Supplement, dated August 12, 2021. The second amended complaint names as defendants the Company and twelve (12) current and
former directors and officers of CorMedix, namely Khoso Baluch, Robert Cook, Matthew David, Phoebe Mounts, John L. Armstrong, and Joseph
Todisco (the "Officer Defendants" and collectively with CorMedix, the "CorMedix Defendants") as well as Janet
Dillione, Myron Kaplan, Alan W. Dunton, Steven Lefkowitz, Paulo F. Costa, Greg Duncan (the "Director Defendants"). The second
amended complaint alleges that the CorMedix Defendants violated Section 10(b) of the Exchange Act (and Rule 10b-5), the Officer Defendants
violated Section 20(a), the Director Defendants, CorMedix, Baluch, and David violated Section 11 of the Securities Act, and that the
Director Defendants, Baluch, and David violated Section 15. In general, the purported bases for these claims are allegedly false and
misleading statements and omissions related to the NDA submissions to the FDA for DefenCath, subsequent complete response letters, as
well as communications from the FDA related and directed to the Company's contract manufacturing organization and heparin supplier.
The Company intends to vigorously contest such claims. The Company and the other Defendants filed their motion to dismiss the second
amended complaint on November 23, 2022 and briefing was complete as of February 6, 2023. The motion to dismiss is currently pending.

 In re
CorMedix Inc. Derivative Litigation, Case No. 2:21-cv-18493-JXN-LDW (D.N.J.)

 On
or about October 13, 2021, a purported shareholder, derivatively and on behalf of the Company, filed a shareholder derivative complaint
in the United States District Court for the District of New Jersey, in a case entitled Voter v. Baluch, et al., Case No. 2:21-cv-18493-JXN-LDW
(the "Derivative Litigation"). The complaint names as defendants Khoso Baluch, Janet Dillione, Alan W. Dunton, Myron Kaplan,
Steven Lefkowitz, Paulo F. Costa, Greg Duncan, Matthew David, and Phoebe Mounts along with the Company as Nominal Defendant. The complaint
alleges breaches of fiduciary duties, abuse of control, and waste of corporate assets against the defendants and a claim for contribution
for purported violations of Sections 10(b) and 21D of the Exchange Act against certain defendants. The individual defendants intend to
vigorously contest such claims. On January 21, 2022, pursuant to a stipulation between the parties, the Court entered an order staying
the case while the motion to dismiss the class action lawsuit described in the foregoing paragraph is pending. The stay may be terminated
before the motion to dismiss is resolved according to certain circumstances described in the stipulation available on the Court's
public docket.

 On
or about January 13, 2023, another purported shareholder, derivatively and on behalf of the Company, filed a shareholder derivative complaint
in the United States District Court for the District of New Jersey, in a case entitled DeSalvo v. Costa, et al., Case No. 2:23-cv-00150-JXN-CLW.
Defendants Paulo F. Costa, Janet D. Dillione, Greg Duncan, Alan Dunton, Myron Kaplan, Steven Lefkowitz, Joseph Todisco, Khoso Baluch,
Robert Cook, Matthew David, Phoebe Mounts, and John L. Armstrong along with the Company as Nominal Defendant. The complaint alleges breaches
of fiduciary duty and unjust enrichment against the individual defendants.

 On
or about January 25, 2023, another purported shareholder, derivatively and on behalf of the Company, filed a shareholder derivative complaint
in the United States District Court for the District of New Jersey, in a case entitled Scullion v. Baluch, et al., Case No. 2:23-cv-00406-ES-ESK.
Defendants Khoso Baluch, Janet Dillione, Alan W. Dunton, Myron Kaplan, Steven Lefkowitz, Paulo F. Costa, Gregory Duncan, Matthew David,
and Phoebe Mounts, along with the Company as Nominal Defendant. The complaint alleges breaches of fiduciary duties.

 On
or about April 18, 2023, the Court entered an order consolidating the above-mentioned shareholder derivative complaints for all purposes,
including pretrial proceedings, trial and appeal. The consolidated derivative action is entitled, In re CorMedix Inc. Derivative Litigation,
C.A. No. 2:21-cv-18493-JXN-LDW. The provisions of the Order to Stay entered in the Voter Action on January 21, 2022, apply to
the consolidated derivative action. The consolidated derivative action was then administratively terminated and removed from the Court's
docket until the motion to dismiss the class action is resolved. The individual defendants intend to vigorously contest the claims set
forth in the consolidated derivative action when the case moves forward.

 F- 17

 Demand
Letter

 On
or about June 23, 2022, the Company's Board received a letter demanding it investigate and pursue causes of action, purportedly
on behalf of Company, against certain current and former directors, officers, and/or other employees of the Company (the "Letter"),
which the Board believes are duplicative of the claims already asserted in the Derivative Litigation. As set forth in the Board's
response to the Letter, the Board will consider the Letter at an appropriate time, as circumstances warrant, as it continues to monitor
the progress of the Derivative Litigation.

 Commitments

 In-Licensing

 In
2008, the Company entered into the ND License Agreement with NDP. Pursuant to the ND License Agreement, NDP granted the Company exclusive,
worldwide licenses for certain antimicrobial catheter lock solutions, processes for treating and inhibiting infections, a biocidal lock
system and a taurolidine delivery apparatus, and the corresponding United States and foreign patents and applications(the "NDP
Technology"). As consideration in part for the rights to the NDP Technology, the Company paid NDP an initial licensing fee of $ 325,000
and granted NDP a 5 % equity interest in the Company, consisting of 7,996 shares of the Company's common stock.

 The Company is required to make cash payments to NDP upon the achievement
of certain milestones. In 2014, a certain milestone was achieved resulting in the release of 7,277 shares held in escrow. The maximum
aggregate amount of cash payments due upon achievement of milestones is $ 3,000,000, with the balance being $ 2,000,000 as of December 31,
2023 and 2022. Events that trigger milestone payments include achieving certain worldwide net sales amounts. There were no milestones
achieved during the years ended December 31, 2023 and 2022.

 The ND License Agreement will expire on a country-by-country basis
upon the earlier of (i) the expiration of the last patent claim under the ND License Agreement in a given country, or (ii) the payment
of all milestone payments. Upon the expiration of the ND License Agreement in each country, we will have an irrevocable, perpetual, fully
paid-up, royalty-free exclusive license to the NDP Technology in such country. The ND License Agreement also may be terminated by NDP
if we materially breach or default under the ND License Agreement and that breach is not cured within 60 days following the delivery of
written notice to us, or by us on a country-by-country basis upon 60 days prior written notice. If the ND License Agreement is terminated
by either party, our rights to the NDP Technology will revert back to NDP.

 Other

 The
Company entered into a seven-year operating lease agreement in March 2020 for an office space at 300 Connell Drive, Berkeley Heights,
New Jersey 07922. The lease agreement, with a monthly average cost of approximately $ 17,000, commenced on September 16, 2020.

 Note
7 — Stockholders' Equity:

 Common
Stock:

 In
November 2020, the Company filed a shelf registration statement, (the "2020 Shelf Registration"), under which the Company
could issue and sell up to an aggregate of $ 100,000,000 of shares of its common stock, $ 0.001 par value per share. In November 2020,
the Company allocated to its at-the-market program ("ATM program"), an aggregate of $ 50,000,000 out of the $ 100,000,000 total
under the 2020 Shelf Registration, which has been fully sold.

 In
August 2021, the Company entered into an at-the-market issuance sales agreement with Truist Securities, Inc. and JMP Securities LLC,
as sales agents, pursuant to which the Company may sell, from time to time, an aggregate of up to $ 50,000,000, which was the remaining
balance under the 2020 Shelf Registration, of its common stock through the sales agents under its ATM program, subject to limitations
imposed by the Company and subject to the sales agents' acceptance, such as the number or dollar amount of shares registered under
the 2020 Shelf Registration to which the offering relates. The sales agents are entitled to a commission of up to 3 % of the gross proceeds
from the sale of common stock sold under the ATM program. During the year ended December 31, 2023 and 2022, the Company sold 2,977,637
and 4,704,259 shares of its common stock under the ATM program, respectively, and realized net proceeds of $ 12,900,000 and $ 17,800,000,
respectively. The remaining balance of approximately $ 18,300,000 under the ATM program related to the 2020 Shelf Registration expired
in November 2023.

 Also,
in August 2021, the Company filed a new shelf registration statement (the "2021 Shelf Registration") for the issuance of
up to $ 150,000,000 of shares of its common stock of which $ 104,400,000 is currently available for the issuance of equity, debt or equity-linked
securities.

 On
June 28, 2023, the Company entered into an underwriting agreement (the "Underwriting Agreement") with RBC Capital Markets,
LLC and Truist Securities, Inc., as representatives of the several underwriters named therein, relating to the issuance and sale of an
aggregate of 7,500,000 shares of the Company's common stock, and, in lieu of common stock to certain investors, pre-funded warrants
to purchase 2,500,625 shares of common stock to the underwriters. Pursuant to the Underwriting Agreement, the Company also granted the
underwriters a 30-day option to purchase up to 1,500,093 additional shares of common stock.

 F- 18

 The
offering, pursuant to the 2021 Shelf Registration, closed on July 3, 2023. Upon closing, the Company issued and sold an aggregate of
 7,500,000 shares of its common stock at a public offering price of $ 4.00 per share and, in lieu of common stock to certain investors,
pre-funded warrants to purchase up to an aggregate of 2,500,625 shares of its commons stock at a price of $ 3.999 per pre-funded warrant
(see Pre-Funded Warrants below). The Company realized net proceeds of approximately $ 37,300,000 from the sale of its common stock and
the pre-funded warrants. On July 26, 2023, the underwriters' representatives fully exercised the option to purchase additional
shares of the Company's common stock, and on July 28, 2023, the Company issued and sold an aggregate of 1,500,093 shares of its
common stock at the public offering price of $ 4.00 per share, less underwriting discounts and commissions, and the Company realized net
proceeds of approximately $ 5,600,000.

the year ended December 31, 2023, the Company issued an aggregate of 79,041 shares of its common stock upon exercise of stock options,
resulting in net proceeds to the Company of approximately $ 288,000.

the year ended December 31, 2022, the Company issued an aggregate of 24,500 shares of its common stock, upon cash exercise of warrants,
resulting in net proceeds to the Company of approximately $ 129,000.

 Restricted
Stock Units

 In
May 2022, the Company granted 207,469 restricted stock units ("RSUs") to its Chief Executive Officer under its Amended and
Restated 2019 Omnibus Stock Incentive Plan with a weighted average grant date fair value of $ 3.38 per share. The fair market value of
the RSUs was estimated to be the closing price of the Company's common stock on the date of grant. These RSUs vest as to 50 % on
the first anniversary of the grant date, as to 30 % on the second anniversary of the grant date, and as to 20 % on the third anniversary
of the grant date, subject to continued service as an employee or consultant through the applicable vesting date.

 In
May 2023, 103,734 RSUs vested pursuant to a grant made to its Chief Executive Officer, of which 66,291 shares of common stock were issued
by the Company and 37,443 shares were withheld in lieu of withholding taxes.

 In December 2023, the Company granted 50,000 RSUs to its Chief Legal
Officer under its Amended and Restated 2019 Omnibus Stock Incentive Plan with a weighted average grant date fair value of $ 3.30 per share.
The fair market value of the RSUs was estimated to be the closing price of the Company's common stock on the date of grant. These
RSUs vest over four years in four equal installments on the first four anniversaries of the applicable grant date, subject to continued
service as an employee or consultant through the applicable vesting date.

the year ended December 31, 2023 and 2022, compensation expense recorded for the RSUs was $ 262,000 and $ 226,000, respectively. Unrecognized
compensation expense for these RSUs amounted to $ 378,000. The expected weighted average period for the expense to be recognized is 1.6
years. As of December 31, 2023, the Company had 153,735 outstanding RSUs.

 Preferred
Stock

 The
Company is authorized to issue up to 2,000,000 shares of preferred stock in one or more series without stockholder approval. The Company's
board of directors has the discretion to determine the rights, preferences, privileges and restrictions, including voting rights, dividend
rights, conversion rights, redemption privileges and liquidation preferences, of each series of preferred stock. Of the 2,000,000 shares
of preferred stock authorized, the Company's board of directors has designated (all with par value of $ 0.001 per share) the following:

 As of December 31, 2023 and 2022

 Preferred
 Outstanding

 Preference
 (Per Share)

 Total
 Preference

 Series C-3

 2,000

 $
 10.00

 $
 20,000

 Series E

 89,623

 $
 49.20

 $
 4,409,452

 Series G

 89,999

 $
 187.36

 $
 16,862,213

 Total

 181,622

 $
 21,291,665

 F- 19

 The
following rights, privileges, terms and condition apply to the outstanding preferred stock at December 31, 2023:

 Series
C-3 Non-Voting Preferred Stock

 Rank.
 The Series C-3 non-voting preferred stock will rank senior to our common stock; senior to any class or series of capital
stock created after the issuance of the Series C-3 non-voting preferred stock; and junior to the Series E voting convertible preferred
stock in each case, as to dividends or distributions of assets upon our liquidation, dissolution or winding up whether voluntarily or
involuntarily.

 Conversion.
 Each share of Series C-3 preferred stock is convertible into 2 shares of our common stock (subject to adjustment in the event of
stock dividends and distributions, stock splits, stock combinations, or reclassifications affecting our common stock) at a per share
price of $ 5.00 at any time at the option of the holder, except that a holder will be prohibited from converting shares of Series C-3
preferred stock into shares of common stock if, as a result of such conversion, such holder, together with its affiliates, would beneficially
own more than 9.99 % of the total number of shares of our common stock then issued and outstanding.

Preference. In the event of our liquidation, dissolution or winding up, holders of Series C-3 preferred stock will receive a payment
equal to $ 10.00 per share of Series C-3 preferred stock before any proceeds are distributed to the holders of our common stock. After
the payment of this preferential amount, and subject to the rights of holders of any class or series of our capital stock hereafter created
specifically ranking by its terms senior to the Series C-3 preferred stock and holders of Series C-3 preferred stock will participate
ratably in the distribution of any remaining assets with the common stock and any other class or series of our capital stock hereafter
created that participates with the common stock in such distributions.

 Voting
Rights. Shares of Series C-3 preferred stock will generally have no voting rights, except as required by law and except that the
consent of holders of two thirds of the outstanding Series C-3 preferred Stock will be required to amend the terms of the Series C-3
preferred stock or the certificate of designation for the Series C-3 preferred stock.

 Dividends.
 Holders of Series C-3 preferred stock are entitled to receive, and we are required to pay, dividends on shares of the Series C-3
preferred stock equal (on an as-if-converted-to-common-stock basis) to and in the same form as dividends (other than dividends in the
form of common stock) actually paid on shares of the common stock when, as and if such dividends (other than dividends in the form of
common stock) are paid on shares of the common stock.

 Redemption.
 We are not obligated to redeem or repurchase any shares of Series C-3 preferred stock. Shares of Series C-3 preferred stock are not
otherwise entitled to any redemption rights, or mandatory sinking fund or analogous fund provisions.

 Listing.
 There is no established public trading market for the Series C-3 preferred stock, and we do not expect a market to develop. In addition,
we do not intend to apply for listing of the Series C-3 preferred stock on any national securities exchange or trading system.

 Fundamental
Transactions. If, at any time that shares of Series C-3 preferred stock are outstanding, we effect a merger or other change of control
transaction, as described in the certificate of designation and referred to as a fundamental transaction, then a holder will have the
right to receive, upon any subsequent conversion of a share of Series C-3 preferred stock (in lieu of conversion shares) for each issuable
conversion share, the same kind and amount of securities, cash or property as such holder would have been entitled to receive upon the
occurrence of such fundamental transaction if such holder had been, immediately prior to such fundamental transaction, the holder of
a share of common stock.

 Series
E Voting Convertible Preferred Stock

 Rank.
 The Series E voting preferred stock will rank senior to our common stock; senior to any class or series of capital stock created
after the issuance of the Series E voting convertible preferred stock; senior to the Series C-3 non-voting convertible preferred stock;
and on parity with the Series G voting convertible preferred stock in each case, as to dividends or distributions of assets upon our
liquidation, dissolution or winding up whether voluntarily or involuntarily.

 Conversion.
 Each share of Series E preferred stock is convertible into 4.3733 shares of our common stock (subject to adjustment as provided in
the certificates of designation for the Series E preferred stock) at a per share price of $ 3.75 at any time at the option of the holder,
except that a holder will be prohibited from converting shares of Series E preferred stock into shares of common stock if, as a result
of such conversion, such holder, together with its affiliates, would beneficially own more than 4.99 % of the total number of shares of
our common stock then issued and outstanding.

 F- 20

Preference. In the event of our liquidation, dissolution or winding up, holders of Series E preferred stock will receive a payment
equal to $ 49.20 per share of Series E preferred stock on parity with the payment of the liquidation preference due the Series G preferred
stock, but before any proceeds are distributed to the holders of common stock, and the Series C-3 non-voting convertible preferred stock.
After the payment of this preferential amount, holders of Series E preferred stock will participate ratably in the distribution of any
remaining assets with the common stock and any other class or series of our capital stock that participates with the common stock in
such distributions.

 Voting
Rights. Shares of Series E preferred stock are entitled to vote on an as-converted basis, based upon an assumed conversion price
of $ 7.93.

 Dividends.
 Holders of Series E preferred stock are entitled to receive, and we are required to pay, dividends on shares of the Series E preferred
stock equal (on an as-if-converted-to-common-stock basis) to and in the same form as dividends (other than dividends in the form of common
stock) actually paid on shares of the common stock when, as and if such dividends (other than dividends in the form of common stock)
are paid on shares of the common stock.

 Redemption.
 We are not obligated to redeem or repurchase any shares of Series E preferred stock. Shares of Series E preferred stock are not otherwise
entitled to any redemption rights, or mandatory sinking fund or analogous fund provisions.

 Listing.
 There is no established public trading market for the Series E preferred stock, and we do not expect a market to develop. In addition,
we do not intend to apply for listing of the Series E preferred stock on any national securities exchange or trading system.

 Fundamental
Transactions. If, at any time that shares of Series E preferred stock are outstanding, we effect a merger or other change of control
transaction, as described in the certificate of designation and referred to as a fundamental transaction, then a holder will have the
right to receive, upon any subsequent conversion of a share of Series E preferred stock (in lieu of conversion shares) for each issuable
conversion share, the same kind and amount of securities, cash or property as such holder would have been entitled to receive upon the
occurrence of such fundamental transaction if such holder had been, immediately prior to such fundamental transaction, the holder of
a share of common stock.

 Debt
Restriction. As long as any of the Series E preferred stock is outstanding, we cannot create, incur, guarantee, assume or suffer
to exist any indebtedness, other than (i) trade payables incurred in the ordinary course of business consistent with past practice, and
(ii) up to $ 10 million aggregate principal amount of indebtedness with a maturity less than twelve months outstanding at any time, which
amount may include up to $ 5 million of letters of credit outstanding at any time.

 Other
Covenants. In addition to the debt restrictions above, as long as any of the Series E preferred stock is outstanding, we cannot,
among others things: create, incur, assume or suffer to exist any encumbrances on any of our assets or property; redeem, repurchase or
pay any cash dividend or distribution on any of our capital stock (other than as permitted, which includes the dividends on the Series
E preferred stock and Series G preferred stock); redeem, repurchase or prepay any indebtedness (other than as permitted); or engage in
any material line of business substantially different from our current lines of business.

 Purchase
Rights. In the event we issue any options, convertible securities or rights to purchase stock or other securities pro rata to the
holders of common stock, then a holder of Series E preferred stock will be entitled to acquire, upon the same terms a pro rata amount
of such stock or securities as if the Series E preferred stock had been converted to common stock.

 Series
G Voting Convertible Preferred Stock

 Rank.
The Series G voting convertible preferred stock will rank senior to our common stock; senior to any class or series of capital stock
created after the issuance of the Series G voting convertible preferred stock; junior to the Series C-3 non-voting convertible preferred
stock, pending the consent of the holders of such series to the subordination thereof; and on parity with the Series E voting convertible
preferred stock in each case, as to dividends or distributions of assets upon our liquidation, dissolution or winding up whether voluntarily
or involuntarily.

 F- 21

 Conversion.
Each share of Series G preferred stock is convertible into approximately 55.5978 shares of our common stock (subject to adjustment as
provided in the certificate of designation for the Series G preferred stock) at a per share price of $ 3.37 at any time at the option
of the holder, except that a holder will be prohibited from converting shares of Series G preferred stock into shares of common stock
if, as a result of such conversion, such holder, together with its affiliates, would beneficially own more than 4.99 % of the total number
of shares of our common stock then issued and outstanding.

Preference. In the event of our liquidation, dissolution or winding up, holders of Series E preferred stock will receive a payment
equal to $ 187.36452 per share of Series G preferred stock on parity with the payment of the liquidation preference due the Series E preferred
stock, but before any proceeds are distributed to the holders of Series C-3 preferred stock (pending the consent of the holders of such
series to the subordination thereof) and any proceeds are distributed to the holders of common stock. After the payment of this preferential
amount, holders of Series G preferred stock will participate ratably in the distribution of any remaining assets with the common stock
and any other class or series of our capital stock that participates with the common stock in such distributions.

 Voting
Rights. Shares of Series G preferred stock are entitled to vote on an as-converted basis, based upon an assumed conversion price
of $ 7.93.

 Dividends.
Holders of Series G Preferred stock are entitled to receive, and we are required to pay, dividends on shares of the Series G preferred
stock equal (on an as-if-converted-to-common-stock basis) to and in the same form as dividends (other than dividends in the form of common
stock) actually paid on shares of the common stock when, as and if such dividends (other than dividends in the form of common stock)
are paid on shares of the common stock.

 Redemption.
We are not obligated to redeem or repurchase any shares of Series G preferred stock. Shares of Series G preferred stock are not otherwise
entitled to any redemption rights, or mandatory sinking fund or analogous fund provisions.

 Listing.
There is no established public trading market for the Series G preferred stock, and we do not expect a market to develop. In addition,
we do not intend to apply for listing of the Series G preferred stock on any national securities exchange or trading system.

 Fundamental
Transactions. If, at any time that shares of Series G preferred stock are outstanding, we effect a merger or other change of control
transaction, as described in the certificate of designation and referred to as a fundamental transaction, then a holder will have the
right to receive, upon any subsequent conversion of a share of Series G preferred stock (in lieu of conversion shares) for each issuable
conversion share, the same kind and amount of securities, cash or property as such holder would have been entitled to receive upon the
occurrence of such fundamental transaction if such holder had been, immediately prior to such fundamental transaction, the holder of
a share of common stock.

 Debt
Restriction. As long as any of the Series G preferred stock is outstanding, we cannot create, incur, guarantee, assume or suffer
to exist any indebtedness, other than (i) trade payables incurred in the ordinary course of business consistent with past practice, and
(ii) up to $ 10 million aggregate principal amount of indebtedness with a maturity less than twelve months outstanding at any time, which
amount may include up to $ 5 million of letters of credit outstanding at any time.

 Other
Covenants. In addition to the debt restrictions above, as long as any of the Series G preferred stock is outstanding, we cannot,
among others things: create, incur, assume or suffer to exist any encumbrances on any of our assets or property; redeem, repurchase or
pay any cash dividend or distribution on any of our capital stock (other than as permitted, which includes the dividends on the Series
E preferred stock and the Series G preferred stock); redeem, repurchase or prepay any indebtedness (other than as permitted); or engage
in any material line of business substantially different from our current lines of business.

 Purchase
Rights. In the event we issue any options, convertible securities or rights to purchase stock or other securities pro rata to the
holders of common stock, then a holder of Series G preferred stock will be entitled to acquire, upon the same terms a pro rata amount
of such stock or securities as if the Series G preferred stock had been converted to common stock.

 F- 22

 Stock
Options:

 On
October 13, 2022, the Company's shareholders approved the CorMedix Inc. Amended and Restated 2019 Omnibus Stock Incentive Plan
(the "2022 Plan"), pursuant to which the Company may issue as additional 4,800,000 shares of its common stock, plus any shares
that remain available for grant under its existing plan as of the effective date, as long-term equity incentives to the Company's
employees, consultants, and directors. The long-term incentives may be in the form of stock options, stock appreciation rights, restricted
stock, restricted stock units, dividend equivalent rights, or other rights or benefits (collectively, "stock rights") to
employees, consultants, and directors of the Company or a related entity (collectively, "participants"). The Company believes
that the effective use of long- term equity incentives is essential to attract, motivate, and retain employees, consultants and directors,
to further align participants' interests with those of the Company's stockholders, and to provide participants incentive
compensation opportunities that are competitive with those offered by other companies in the same industry and locations as the Company.

 The 2022 Plan amends and
restates the 2019 Stock Incentive Plan. The 2013 Stock Incentive Plan and the Amended and Restated 2006 Stock Incentive Plan are referred
to collectively as the "Prior Plans". No further awards will be granted under the Prior Plans. Awards outstanding under the
Prior Plans will remain outstanding in accordance with their terms and the Prior Plans.

the years ended December 31, 2023 and 2022, the Company granted ten-year qualified and non-qualified stock options to its officers, directors,
employees and consultants covering an aggregate of 2,536,200 and 1,627,850 shares of the Company's common stock under the 2019
Plan, respectively. The weighted average exercise price of these options is $ 4.18 and $ 3.83 per share, respectively.

the year ended December 31, 2023, the Company issued 79,041 shares of common stock as a result of the exercise of stock options. The
Company realized net proceeds of $ 288,000 from the exercise of stock options with a weighted average exercise price of $ 3.64 per share.

 During the years ended December 31, 2023 and 2022, total compensation
expense for stock options issued to employees, directors, officers and consultants was $ 5,232,000 and $ 3,843,000, respectively. As of
December 31, 2023, there was $ 6,145,000 total unrecognized compensation expense related to unvested stock options granted which expense
is expected to be recognized over an expected remaining weighted average period of 1.6 years. All share-based awards are recognized on
a straight-line method, assuming all awards granted will vest. Forfeitures of share-based awards are recognized in the period in which
they occur.

 The
fair value at grants dates of the grants issued subject to service and performance-based vesting conditions were determined using the
Black-Scholes option pricing model with the following assumptions:

 Year
 Ended December 31,

 2023

 2022

 Risk-free
 interest rate

 3.45 % - 4.81 %

 1.76 % - 4.31 %

 Expected
 volatility

 92.2 % - 105.7 %

 89.68 % - 107.2 %

 Expected
 term (years)

 5 years

 2.75 – 5 years

 Expected
 dividend yield

 0.0 %

 0.0 %

 Weighted-average
 grant date fair value of options granted during the period

 $ 3.24

 $ 2.90

 The Company estimated the
expected term of the stock options granted based on anticipated exercises in future periods. The expected term of the stock options granted
to consultants is based upon the full term of the respective option agreements. The expected stock price volatility for the Company's
stock options is calculated based on the historical volatility of the Company's common stock. The expected dividend yield of 0.0 %
reflects the Company's current and expected future policy for dividends on the Company's common stock. To determine the risk-free
interest rate, the Company utilized the U.S. Treasury yield curve in effect at the time of grant with a term consistent with the expected
term of the Company's awards which is 5 years for employees and 10 years for non-employees.

 F- 23

 The following table summarizes
the Company's stock options activity and related information for the year ended December 31, 2023:

 Underlying

 Stock

 Options

 Weighted-

 Average
 Exercise
 Price

 Weighted-

 Average
 Remaining

 Contractual

 Term

 (Years)

 Aggregate

 Intrinsic

 Value

 Outstanding at December 31, 2022

 4,454,369

 $
 6.21

 6.6

 $
 1,113,050

 Granted

 2,536,200

 $
 4.18

 -

 $
 231,850

 Exercised

 ( 79,041
)

 $
 3.64

 -

 $
 27,583

 Expired/Canceled

 ( 287,900
)

 $
 6.40

 -

 $
 3,820

 Forfeited

 ( 412,120
)

 $
 5.74

 -

 $
 35,592

 Outstanding at December 31, 2023

 6,211,508

 $
 5.44

 6.4

 $
 700,241

 Vested at December 31, 2023

 3,645,020

 $
 6.41

 4.7

 $
 281,080

 Expected to vest in the
 future

 2,566,488

 $
 4.06

 9.0

 $
 419,161

 The
aggregate intrinsic value is calculated as the difference between the exercise prices of the underlying options and the quoted closing
price of the common stock of the Company at the end of the reporting period for those options that have an exercise price below the quoted
closing price.

 Warrants

 During the year ended December
31, 2022, the Company issued an aggregate of 24,500 shares of its common stock upon cash exercise of warrants, resulting in net proceeds
to the Company of $ 129,000. Except for the pre-funded warrants described below, there were no outstanding warrants at December 31, 2023
and 2022.

 Pre-Funded
Warrants

 On July 3, 2023, pursuant to the Underwriting Agreement, the Company's
issued pre-funded warrants to purchase 2,500,625 shares of its common stock to certain investors. The pre-funded warrants to purchase
up to an aggregate of 2,500,625 shares of the Company's commons stock had a price of $ 3.999 per pre-funded warrant, which represents
the per share public offering price for the common stock less the $ 0.001 per share exercise price for each such pre-funded warrant pursuant
to the Underwriting Agreement. The Company realized net proceeds of approximately $ 9,400,000 from the sale of the pre-funded warrants.

 Stock-based
Deferred Compensation Plan for Non-Employee Directors

 In 2014, the Company established an unfunded stock-based deferred compensation
plan, providing non-employee directors the opportunity to defer up to one hundred percent of fees and compensation, including restricted
stock units. The amount of fees and compensation deferred by a non-employee director is converted into stock units, the number of
which is determined based on the closing price of the Company's common stock on the date such compensation would have otherwise
been payable. At all times, the plan participants are one hundred percent vested in their respective deferred compensation accounts.
On the tenth business day of January in the year following a director's termination of service, the director will receive a number
of common shares equal to the number of stock units accumulated in the director's deferred compensation account. The Company
accounts for this plan as stock-based compensation under ASC 718. During the years ended December 31, 2023 and 2022 no compensation
was deferred under this plan.

 Note
8 — Leases:

 The
Company entered into a seven-year operating lease agreement in March 2020 for an office space at 300 Connell Drive, Berkeley Heights,
New Jersey 07922. The lease agreement, with a monthly average cost of approximately $ 17,000 commenced on September 16, 2020.

 The
Company entered into an operating lease for office space in Germany that began in July 2017. The rental agreement has a three-month term
which automatically renews and includes a monthly cost of 400 Euros. The Company elected to apply the short-term practical expedient
to the office lease. The Company also has an operating lease for office equipment.

 F- 24

lease expense in the Company's consolidated statements of operations and comprehensive loss for the year ended December 31, 2023
and 2022 was approximately $ 207,000 and $ 208,000, respectively, which includes costs associated with leases for which ROU assets have
been recognized as well as short-term leases.

 At
December 31, 2023, the Company has a total operating lease liability of $ 668,000, of which approximately $ 151,000 and $ 517,000 were classified
as operating lease liabilities, short-term and operating lease liabilities, net of current portion, respectively, on the consolidated
balance sheet. At December 31, 2022, the Company's total operating lease liability was $ 803,000, of which $ 135,000 was classified
as operating lease liabilities, short-term and $ 668,000 was classified as operating lease liabilities, net of current portion, on the
condensed consolidated balance sheet. Operating ROU assets as of December 31, 2023 and 2022 are $ 640,000 and $ 775,000, respectively.

 For
the year ended December 31, 2023 and 2022, cash paid for amounts included in the measurement of lease liabilities in operating cash flows
from operating leases was $ 201,000 and $ 199,000, respectively.

 As
of December 31, 2023 and 2022, the weighted average remaining lease term were 3.8 years and 4.8 years, respectively and the weighted
average discount rate of 9 % and 9 % at December 31, 2023 and 2022, respectively.

 As
of December 31, 2023, maturities of lease liabilities were as follows:

 2024

 $
 205,000

 2025

 208,000

 2026

 211,000

 2027 and thereafter

 169,000

 Total future minimum lease payments

 793,000

 Less imputed interest

 ( 125,000
)

 Total

 $
 668,000

 Note
9 — Subsequent Events:

 TDAPA. On January 25,
2024 CMS notified the Company that the agency has determined DefenCath will be eligible for reimbursement in accordance with the ESRD
PPS, allowing the Company to submit a TDAPA application, which currently allows for two years of additional payment for certain products
to outpatient renal dialysis providers, and CMS recently adopted a three-year post-TDAPA add-on payment adjustment. The Company
submitted its TDAPA application on January 26, 2024 after receiving the CMS notification. As a result of CMS' determination
that DefenCath is within the scope of the ESRD PPS and eligible for TDAPA, the Company established a WAC of $ 249.99 per 3ml vial, to account
for the market dynamics and functionality of the TDAPA framework. In addition, as discussed above, the Company previously applied for
and received conditional NTAP from CMS for inpatient reimbursement of DefenCath for the FY 2024 IPPS. As a result of the Company having
established a WAC price for commercialization, the NTAP reimbursement payment to inpatient facilities may also be adjusted. NTAP was conditioned
upon the DefenCath NDA obtaining final FDA approval prior to July 1, 2024. The Company intends to work closely with CMS on obtaining TDAPA
and the TDAPA implementation process.

 NOLs. On March 6,
2024, the Company received net proceeds of approximately $ 1,395,000 from the sale of its remaining unused New Jersey state NOL that was
eligible for sale under the NJEDA Program for the state fiscal year 2023. The NJEDA Program allowed the Company to sell approximately
$ 1,529,000 of its total $ 1,529,000 in available NOL tax benefits for state fiscal year 2023.

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