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 utr:sqft

 UNITED
STATES

 SECURITIES
AND EXCHANGE COMMISSION

 Washington,
D.C. 20549

 FORM
 10-K/A

 Amendment No. 1

 (Mark
One)

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

 FOR
THE FISCAL YEAR ENDED DECEMBER 31, 2023

 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 001-37603

 (Exact
name of registrant as specified in its charter)

 Nevada

 30-1341024

 (State
 or other jurisdiction

 of
 incorporation or organization)

 (I.R.S.
 Employer

 Identification
 No.)

 Marcus Drive, Suite 1, Melville, New York

 11747

 (Address
 of principal executive offices)

 (Zip
 Code)

 (631) 760-8100

 (Registrant's
telephone number, including area code)

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

 Title
 of each class

 Trading
 Symbol(s)

 Name
 of each exchange on which registered

 Stock $0.0001 par value

 BRTX

 Nasdaq
 Capital Market

 Securities
registered pursuant to Section 12(g) of the Act:

 None

 (Title
of Class)

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 Exchange 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 new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

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

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

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

by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).

 Yes
 No

 State
the aggregate market value of the voting and non-voting common equity held by non-affiliates computed by reference to the price at which
the common equity was last sold, or the average bid and asked price of such common equity, as of the last business day of the registrant's
most recently completed second fiscal quarter.

 As
of June 30, 2023, the aggregate market value of the registrant's common stock held by non-affiliates of the registrant was $ 13,663,719
based on the closing sale price as reported on the Nasdaq Capital Market.

 APPLICABLE
ONLY TO REGISTRANTS INVOLVED IN BANKRUPTCY

 PROCEEDINGS
DURING THE PRECEDING FIVE YEARS:

by check mark whether the registrant has filed all documents and reports required to be filed by Section 12, 13 or 15(d) of the Securities
Exchange Act of 1934 subsequent to the distribution of securities under a plan confirmed by a court. Yes No

 As
of March 28, 2024, there were 6,769,919 shares of common stock outstanding.

 DOCUMENTS
INCORPORATED BY REFERENCE

 None

 Page

 No.

 Forward-Looking Statements

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

 Item
 6.

 [Reserved].

 Item
 7.

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

 Item
 7A.

 Quantitative and Qualitative Disclosures About Market Risk.

 Item
 8.

 Financial Statements and Supplementary Data.

 Item
 9.

 Changes 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.

 Executive 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 Accountant Fees and Services.

 Item
 15.

 Exhibits and Financial Statement Schedules.

 Item
 16.

 Form 10-K Summary.

 Signatures

 EXPLANATORY
NOTE

of Previously Issued Consolidated Financial Statements

 On
May 23, 2024, BioRestorative Therapies, Inc. (the "Company"), in consultation with its Audit Committee, concluded that its
previously issued (i) consolidated financial statements as of and for the two years ended December 31, 2023 included in the Company's
Annual Report on Form 10-K for the year ended December 31, 2023 (the "Annual Periods") and (ii) unaudited interim condensed
consolidated financial statements as of and for the quarters ended March 31, 2022 through September 30, 2023 included in the Company's
quarterly reports on Form 10-Q for the periods ended March 31, 2023, June 30, 2023 and September 30, 2023 (the "Interim Periods",
and, together with the Annual Periods, the "Affected Periods") should be restated because of a misapplication in the guidance
around the accounting for certain warrants, as discussed below, and should no longer be relied upon.

 The
warrants at issue are the following:

 (i)
the warrants to purchase an aggregate of 2,645,000 shares of the Company's common stock, issued in November 2021 pursuant to
an underwritten public offering, which warrants provide for an exercise price of $10.00 per share (the "Public
Warrants");

 (ii)
the warrants to purchase an aggregate of 1,856,938 shares of the Company's common stock, issued in November 2021 pursuant to a
private offering, which warrants provide for an exercise price of $10.00 per share (the "Private Warrants");
and

 (iii)
the warrants to purchase an aggregate of 235,970 shares of the Company's common stock, issued in November 2021 to the
underwriter of the public offering, which warrants provide for an exercise price of $12.50 per share (together with the Public
Warrants and the Private Warrants, the "Warrants").

 Historically,
the Warrants were included as a component of stockholders' equity on the balance sheet. It has now been determined, in accordance
with Accounting Standards Codification 815, that the Warrants should be included as a component of liabilities on the balance sheets
and the statements of operations should include the effect of subsequent changes in the estimated fair value of the Warrants (the
"Restatement"). This Amendment No. 1 to the Annual Report on Form 10-K includes restated consolidated financial statements for the
Affected Periods.

 Refer
to Note 2 – Summary of Significant Accounting Policies – Restatement of Previously Issued Consolidated Financial Statements
and Note 3 – Restatement of Previously Issued Unaudited Interim Condensed Consolidated Financial Statements in the accompanying
consolidated financial statements included in Part II, Item 8 for additional information.

 Internal
Control Considerations

 In connection with the Restatement,
management has re-evaluated its disclosure controls and procedures and internal control over financial reporting as of December 31, 2023.
As a result of that assessment, management has concluded that an additional material weakness existed as of December 31, 2023 related
to the lack of design and implementation of effective controls over the accounting for warrants issued in connection with
equity financings. For a discussion of management's consideration of disclosure controls and procedures, internal controls over
financial reporting, and the material weaknesses identified, see Part II, Item 9A.

 Items
Restated in this Form 10-K/A

 The
following items have been restated, as appropriate, to correct the errors noted above:

 Part
 I, Item 1A. Risk Factors

 Part
 II, Item 7. Management's Discussion and Analysis of Financial Condition and Results
 of Operation

 Part
 II, Item 8. Financial Statements and Supplementary Data

 Part
 II, Item 9A. Controls and Procedures.

 Except
as described above, no other changes have been made to the original filing of the Company's Annual Report on Form 10-K for the
year ended December 31, 2023 (the "Original Filing"). The Original Filing continues to speak as of the date of the Original
Filing, and we have not updated the disclosures contained therein to reflect any events which occurred after the filing of the Original
Filing. Accordingly, this Amendment No. 1 should be read in conjunction with our filings with the SEC after the date of the Original
Filing.

 The
Company has not filed, and does not intend to file, amendments to the Quarterly Reports on Form 10-Q for any of the quarters for the
years ended December 31, 2022 and 2023. Accordingly, investors should rely only on the financial information and other disclosures regarding
the restated periods in this Form 10-K/A or in future filings with the SEC (as applicable), and not on any previously issued or filed
reports, earnings releases or similar communications relating to these periods.

 In
addition, as required by Rule 12b-15 under the Securities Exchange Act of 1934, as amended (the "Exchange Act"), new certifications
by the Company's principal executive officer and principal financial officer are filed herewith as exhibits to this Amendment No.
1 pursuant to Rule 13a-14(a) of the Exchange Act and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. 1350).

 PART
I

 Forward-Looking
Statements

 This
Annual Report contains forward-looking statements as that term is defined in the federal securities laws. The events described in forward-looking
statements contained in this Annual Report may not occur. Generally, these statements relate to business plans or strategies, projected
or anticipated benefits or other consequences of our plans or strategies, projected or anticipated benefits from acquisitions to be made
by us, or projections involving anticipated revenues, earnings or other aspects of our operating results. The words "may,"
"will," "expect," "believe," "anticipate," "project," "plan,"
"intend," "estimate," and "continue," and their opposites and similar expressions are intended to
identify forward-looking statements. We caution you that these statements are not guarantees of future performance or events and are
subject to a number of uncertainties, risks and other influences, many of which are beyond our control, that may influence the accuracy
of the statements and the projections upon which the statements are based. Factors which may affect our results include, but are not
limited to, the risks and uncertainties discussed in Item 1A of this Annual Report ("Risk Factors").

 Any
one or more of these uncertainties, risks and other influences could materially affect our results of operations and whether forward-looking
statements made by us ultimately prove to be accurate. Our actual results, performance and achievements could differ materially from
those expressed or implied in these forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking
statements, whether from new information, future events or otherwise.

 Intellectual

 This
Annual Report includes references to our federally registered trademarks, BioRestorative Therapies and Dragonfly design,
 BRTX-100, ThermoStem and BRTX. The Dragonfly logo is also registered with the U.S. Copyright Office. This
Annual Report also includes references to trademarks, trade names and service marks that are the property of other organizations. Solely
for convenience, trademarks and trade names referred to in this Annual Report appear without the, SM or symbols, and copyrighted
content appears without the use of the symbol, but the absence of use of these symbols does not reflect upon the validity or enforceability
of the intellectual property owned by us or third parties.

 ITEM
 1.

 BUSINESS.

 (a)
 Business Development

 As
used in this Annual Report on Form 10-K, or the Annual Report, references to the "Company", "we", "us",
or "our" refer to BioRestorative Therapies, Inc.

 We
were incorporated in Nevada on June 13, 1997. On August 15, 2011, we changed our name from "Stem Cell Assurance, Inc." to
"BioRestorative Therapies, Inc." Effective January 1, 2015, we reincorporated in Delaware. Effective December 31, 2022, we
reincorporated in Nevada.

 We
develop therapeutic products and medical therapies using cell and tissue protocols, primarily involving adult stem cells.

 We
are currently pursuing our Disc/Spine Program with our initial investigational therapeutic product being called BRTX-100.
In March 2022, a United States patent issued in our Disc/Spine Program. We submitted an IND application to the U.S. Food and Drug
Administration, or the FDA, to obtain authorization to commence a Phase 2 clinical trial investigating the use of BRTX-100 in
the treatment of chronic lower back pain arising from degenerative disc disease. We have received such authorization from the FDA and
have commenced such clinical trial.

 We
have obtained an exclusive license to use technology for investigational adult stem cell treatment of disc and spine conditions, including
protruding and bulging lumbar discs. The technology is an advanced stem cell injection procedure that may offer relief from lower back
pain, buttock and leg pain, and numbness and tingling in the leg and foot.

 We
are also developing our ThermoStem Program. This pre-clinical program involves the use of brown adipose (fat) in connection with
the cell-based treatment of type 2 diabetes and obesity as well as hypertension, other metabolic disorders and cardiac deficiencies.
Patents related to the ThermoStem Program have been issued in the United States and other jurisdictions.

we are seeking to develop a biologics-based cosmetic products business. Pursuant to such business, we would manufacture and sell cosmetics
and hair growth products designed for cosmetic and aesthetic uses.

Events During 2023

 In
April 2023, we entered into a Capital On Demand Sales Agreement, or the Sales Agreement, with JonesTrading Institutional Services
LLC, or the Agent, pursuant to which we may offer and sell, from time to time, through or to the Agent, shares of our common stock having
an aggregate offering price of up to $6,109,000. To date, we have sold approximately $622,000 of our shares pursuant to the Sales Agreement.

 In
April 2023, we announced that we had completed enrollment for the safety run-in component of our Phase 2 clinical study of BRTX-100.

 In
May 2023, we announced that we had signed a clinical trial agreement with Northwell Health, New York State's largest health care
provider and private employer, pursuant to which Northwell Health is participating in our Phase 2 clinical study of BRTX-100.

 In
May 2023, we announced that we had received a license from the New York State Department of Health to act as a tissue bank for the processing
of mesenchymal stem cells from autologous donors.

 In
June 2023, we announced that the final subject in our BRTX-100 Phase 2 clinical trial safety cohort had been dosed.

 In
June 2023, we announced that the independent Data Safety Monitoring Board, which is overseeing our Phase 2 clinical trial, unanimously
recommended the continuation of our study in accordance with the version of the protocol with no changes.

 In
June 2023, a Japanese patent related to our ThermoStem Program was issued to us.

 In
June 2023, a United States patent related to our ThermoStem Program was issued to us.

 In
July 2023, a European patent related to our ThermoStem Program was issued to us.

 In
July 2023, we sold 685,033 shares of our common stock in a registered direct public offering. We received gross proceeds of approximately
$2,100,000 from the offering.

 In
September 2023, we entered into a supply agreement with a supplier of biologic-based cosmetics. Pursuant to the supply agreement, using
our cGMP ISO-7 certified clean room, we manufactured tissue-based biologics for cosmetic and aesthetic applications. In December 2023,
we terminated the supply agreement.

 In
December 2023, a United States patent related to our ThermoStem Program was issued to us.

Events During 2024

 In
February 2024, we issued 2,000,000 shares of our common stock pursuant to the exercise of warrants. In connection with the issuance,
we issued warrants for the purchase of 2,513,686 shares of our common stock and are obligated to issue an additional 1,351,580 shares
of our common stock, which additional shares have been fully paid for but have not yet been issued due to a maximum beneficial ownership
limitation for one of the warrant holders. We received gross proceeds of approximately $8,100,000 from the warrant exercise.

 (b)
 Business

 We
develop therapeutic products, using cell and tissue protocols, primarily involving adult stem cells. Our two core programs, as described
below, relate to the treatment of disc/spine disease and metabolic disorders:

 Disc/Spine
 Program (brtxDisc). Our lead cell therapy candidate, BRTX-100, is a product formulated from autologous (or a person's
 own) cultured mesenchymal stem cells, or MSCs, collected from the patient's bone marrow. We intend that the product will be
 used for the non-surgical treatment of painful lumbosacral disc disorders or as a complimentary therapeutic to a surgical procedure.
 The BRTX-100 production process utilizes proprietary technology and involves collecting a patient's bone marrow, isolating
 and culturing stem cells from the bone marrow and cryopreserving the cells. In an outpatient procedure, BRTX-100 is to be
 injected by a physician into the patient's damaged disc. The treatment is intended for patients whose pain has not been alleviated
 by non-surgical procedures and who potentially face the prospect of surgery. We have received authorization from the FDA to commence
 a Phase 2 clinical trial using BRTX-100 to treat chronic lower back pain arising from degenerative disc disease. We have commenced
 such clinical trial through the execution of a CRO agreement with PRC Clinical, the execution of clinical trial site agreements,
 patient enrollment, the commencement of patient procedures, the purchase of manufacturing equipment and the expansion of our laboratory
 to include capabilities for clinical production. In March 2022, a United States patent related to our Disc/Spine Program was
 issued. We have been granted exclusive license rights with regard to the patent. See "Disc/Spine Program" below.

 Metabolic
 Program (ThermoStem). We are developing a cell-based therapy candidate to target obesity and metabolic disorders using brown
 adipose (fat) derived stem cells, or BADSC, to generate brown adipose tissue, or BAT. We refer to this as our ThermoStem Program.
 BAT is intended to mimic naturally occurring brown adipose depots that regulate metabolic homeostasis in humans. Initial preclinical
 research indicates that increased amounts of brown fat in animals may be responsible for additional caloric burning as well as reduced
 glucose and lipid levels. Researchers have found that people with higher levels of brown fat may have a reduced risk for obesity
 and diabetes. Patents related to the ThermoStem Program have been issued in the United States and other jurisdictions. See
 "Metabolic Brown Adipose (Fat) Program" below.

 We
have also licensed an investigational curved needle device designed to deliver cells and/or other therapeutic products or material to
the spine and discs (and other parts of the body). We anticipate that FDA approval or clearance will be necessary for this device prior
to commercialization. We do not intend to utilize this device in connection with our Phase 2 clinical trial with regard to BRTX-100.
See "Curved Needle Device" below.

 The
patents and patent applications for the Disc/Spine Program, the ThermoStem Program and the curved needle device are listed
below under "Technology; Research and Development."

 We
are also seeking to develop a biologics-based cosmetic products business. Pursuant to such business, we would manufacture and sell cosmetics
and hair growth products designed for cosmetic and aesthetic uses.

 Overview

 Every
human being has stem cells in his or her body. These cells exist from the early stages of human development until the end of a person's
life. Throughout our lives, our body continues to produce stem cells that regenerate to produce differentiated cells that make up various
aspects of the body such as skin, blood, muscle and nerves. These are generally referred to as adult (non-embryonic) stem cells. These
cells are important for the purpose of medical therapies aiming to replace lost or damaged cells or tissues or to otherwise treat disorders.

 Regenerative
cell therapy relies on replacing diseased, damaged or dysfunctional cells with healthy, functioning ones or repairing damaged or diseased
tissue. A great range of cells can serve in cell therapy, including cells found in peripheral and umbilical cord blood, bone marrow and
adipose (fat) tissue. Physicians have been using adult stem cells from bone marrow to treat various blood cancers for more than 65 years
(the first successful bone marrow transplant was performed in 1956). Recently, physicians have begun to use stem cells to treat various
other diseases. We intend to develop cell and tissue products and regenerative therapy protocols, primarily involving adult stem cells,
to allow patients to undergo cellular-based treatments.

 We
are concentrating initially on therapeutic areas in which risk to the patient is low, recovery is relatively easy, results can be demonstrated
through sufficient clinical data, and patients and physicians will be comfortable with the procedure. We believe that there will be readily
identifiable groups of patients who will benefit from these procedures. We also believe that these procedures will be significantly less
expensive than the most common surgical procedure alternatives and will compare favorably, over the long-term, to conservative treatment
costs which may persist for years.

 Accordingly,
we have focused our initial developmental efforts on cellular-based therapeutic products and clinical development programs in selective
areas of medicine for which the treatment protocol is minimally invasive. Such areas include the treatment of the disc and spine and
metabolic-related disorders. Upon regulatory approval, we will seek to obtain third party reimbursement for our products and procedures;
however; if we are not successful, patients may be required to pay for our products and procedures out of pocket in full and without
the ability to be reimbursed by any governmental and other third party payers, which would adversely impact our prospects.

 We
have undertaken research and development efforts in connection with the development of investigational therapeutic products and medical
therapies using cell and tissue protocols, primarily involving adult stem cells. See "Disc/Spine Program," "Metabolic
Brown Adipose (Fat) Program" and "Curved Needle Device" below. As a result of these programs, we have seven United
States patents, thirteen foreign patents, one United States patent application, and four foreign patent applications related to research
regarding our ThermoStem Program. We have also obtained licenses for four United States patent applications related to our Disc/Spine
Program, one United States patent related to our Disc/Spine Program, and a license for one United States patent related to
a curved needle device.

 We
have established a research laboratory facility with current Good Manufacturing Practice, or cGMP, capabilities to produce clinical grade
products and we will seek to further develop cellular-based treatments, products and protocols, stem cell-related intellectual property,
or IP, and translational research applications. See "Laboratory" below.

 We
have not generated any significant revenues to date. In November 2021, we completed a $23,000,000 public offering of our securities.
In 2023, we raised approximately $2,680,000 in additional gross proceeds through public offerings of our securities. In February 2024,
we also received approximately $8,100,000 in gross proceeds pursuant to the exercise of warrants. Such aggregate funds are sufficient
for us to complete our Phase 2 clinical trial investigating the use of BRTX - 100 in the treatment of chronic lower back
pain arising from degenerative disc disease, as further described in this section, as well as to continue our pre-clinical research and
development efforts with respect to our ThermoStem Program and to satisfy our current working capital needs; however, the implementation
of our business plan, as discussed below, will require the receipt of additional financing to fund our research and development efforts,
including our contemplated Phase 3 clinical trial with regard to BRTX-100 and our contemplated clinical trials relating to our
 ThermoStem Program, and otherwise fund our operations. We intend to seek to raise capital through investment bankers and from
biotech funds, strategic partners and other financial institutions. We will require significant additional financing to complete our
contemplated Phase 3 clinical trial investigating the use of BRTX-100. We will also require a substantial amount of additional
funding to implement our other programs described in this section, and fund general operations. No assurance can be given that the amount
of funding that we anticipate may be required for such purposes is correct or that we will be able to accomplish our goals within the
timeframes projected. In addition, no assurance can be given that we will be able to obtain any required financing on commercially reasonable
terms or otherwise. If we are unable to obtain adequate funding, we may be required to significantly curtail or discontinue our proposed
operations.

 Disc/Spine
Program

 Among
the initiatives that we are currently pursuing is our Disc/Spine Program, with our initial product candidate being called BRTX-100.
We have obtained an exclusive license (see " Exclusive License " below) that permits us to use technology for adult
stem cell treatment of disc and spine conditions. The technology is an advanced stem cell culture and injection procedure into the intervertebral
disc, or IVD, that may offer relief from lower back pain, buttock and leg pain, and numbness and tingling in the leg and foot.

 Lower
back pain is the most common, most disabling, and most costly musculoskeletal ailment faced worldwide. According to a 2016 market report
from Trinity Partners, a global life sciences consulting firm, of the 250 million American adults, nearly 25 million have chronic lower
back pain of which approximately 12 million have been diagnosed with and treated for disc degeneration and approximately 5.6 million
have pain caused by a protruding or injured disc. We believe that between 500,000 and one million invasive surgical procedures are performed
each year to try to alleviate the pain associated with these lower back conditions and that such procedures cost approximately $40 billion.
Clinical studies have documented that the source of the pain is most frequently damage to the IVD. This can occur when forces, whether
a single load or repetitive microtrauma, exceed the IVD's inherent capacity to resist those loads. Aging, obesity, smoking, lifestyle,
and certain genetic factors may predispose one to an IVD injury. Current surgical approaches to back pain are extremely invasive (often
altering the spine's biomechanics unfavorably and predisposing it to further disc degeneration) and are associated with unacceptably
low success rates (with a second operation occurring 10% to 20% of the time). In addition, current surgical approaches are costly with
spinal fusion surgery costing approximately $110,000, discectomy costing approximately $20,000 to $50,000 and disc replacement surgery
costing approximately $80,000 to $150,000. Even conservative treatments can be costly, with oral medications costing between $1,000 and
$2,000 per year, injection treatments costing approximately $8,000 per year and physical therapy costing approximately $20,000 annually.
We anticipate that the cost of a single treatment using BRTX-100 will compare favorably to conservative treatments which may continue
for years and will be less expensive than the most common surgical procedures.

 While
once thought to be benign, the natural history of lower back pain is often one of chronic recurrent episodes of pain leading to progressive
disability. This is believed to be a direct result of the IVD's poor healing capacity after injury. The IVD is the largest avascular
(having few or no blood vessels) structure in the body and is low in cellularity. Therefore, its inherent capacity to heal after injury
is poor. The clinical rationale of BRTX-100 is to deliver a high concentration of the patient's own cultured MSCs into the
site of pathology to promote healing and relieve pain.

 We
have developed a mesenchymal stem cell product candidate, BRTX-100, derived from autologous (or a person's own) human bone
marrow, cultured and formulated, in a proprietary method, specifically for introduction into a painful lumbar disc. The product candidate
was developed utilizing in part the exclusive license described below under " Exclusive License." As described below
under " BRTX-100 " and " Production and Delivery," BRTX-100 is a hypoxic (low oxygen) stem
cell product developed through a culturing process. In order to enhance the survivability of our bone marrow-derived MSCs in the avascular
environment of the damaged disc, BRTX-100 is designed to expand under hypoxic conditions. This process is intended to result in
a large cell count population with enhanced viability and therapeutic potential following injection into the injured disc.

 In
February 2017, pursuant to an IND application, we received authorization from the FDA to commence a Phase 2 clinical trial investigating
the use of BRTX-100, our lead cell therapy candidate, in the treatment of chronic lower back pain arising from degenerative disc
disease. We have commenced our Phase 2 clinical trial through the execution of a CRO agreement with PRC Clinical, the execution of clinical
trial site agreements, patient enrollment, the commencement of patient procedures, the purchase of manufacturing equipment and the expansion
of our laboratory to include capabilities for clinical production. We believe that, based upon our periodic reports to the FDA as to
the commencement of the clinical trial, the existing IND remains effective.

 In
addition to developing BRTX-100, we may also seek to sublicense the technology to a strategic third party, who may assist in gaining
FDA approval for a lumbar disc indication, or third parties for use in connection with cellular-based developmental programs with regard
to disc and spine related conditions.

 We
have established a laboratory, which includes a clean room facility, to perform the production of cell products (including BRTX-100)
for use in our clinical trials, for third party cell products or for general research purposes. We may also use this laboratory to develop
our pipeline of future products and expand our stem cell-related IP. See "Laboratory" and "Technology; Research and
Development" below.

 In
March 2022, a United States patent related to BRTX-100 was issued. We have been granted exclusive license rights with respect
to the patent. See " Exclusive License " below.

 BRTX-100

 Our
lead product candidate, BRTX-100, is an autologous hypoxic (low oxygen) cultured mesenchymal stem cell product derived from a
patient's own bone marrow and formulated with a proprietary biomaterial carrier (platelet lysate) to increase potency, viability
and survivability. We have designed the cryopreserved sterile cellular product candidate to be provided in vials for injection into painful
lumbar discs. We anticipate the product candidate will be delivered using a standard 20 gauge 3.5 inch introducer needle and a 25 gauge
6 inch needle that will extend into the disc center upon delivery. Upon regulatory approval, we plan to provide training to medical practitioners
with regard to the approved injection procedure. It is anticipated that the delivery of the product candidate will be a 30 minute procedure.

 Mesenchymal
stem cells used in BRTX-100 are similar to other MSCs under development by others; however, in order to enhance the survivability
of our bone marrow-derived MSCs in the avascular environment of the damaged disc, BRTX-100 is designed to expand under hypoxic
conditions for a period of approximately three weeks. This process is intended to result in an approximate 40 million cell count population
with enhanced viability and therapeutic potential following injection locally into injured spinal discs. Publications and scientific
literature have indicated that MSCs preconditioned in hypoxic environment show enhanced skeletal muscle regeneration properties and improved
impacts upon circulation and vascular formation compared to MSCs cultured under normoxic (normal oxygen) conditions.

 In
August 2018, the Journal of Translational Medicine published the results of our study evaluating the benefits of long-term hypoxic
culturing of human bone marrow-derived MSCs.

 In
September 2021, we were awarded a National Institutes of Health Small Business Technology Transfer (STTR) Phase 1 grant for $256,000
to evaluate the therapeutic effects on our hypoxic cultured bone marrow derived mesenchymal stem cells ( BRTX-100) after encapsulation
with a PEG-peptide hydrogel. The work is being done in collaboration with Washington University of St. Louis.

 Since
June 2022, we have entered into clinical trial agreements with 16 sites to conduct our Phase 2 clinical trial targeting chronic lumbar
disc disease.

 Production
and Delivery

 The
production of our product candidate, BRTX-100, begins with the physician collecting bone marrow from the patient under local anesthesia.
Peripheral blood is also collected from the patient. The physician will then send the patient's bone marrow and blood samples to
our laboratory (or a contract laboratory) for culturing and formulation. The hypoxic culturing process is intended to result in the selection
of a cell population that is suitable for an improved possibility of survival in the internal disc environment. We anticipate that the
cell culturing process and product formulation will take approximately three weeks, with an additional two weeks required for quality
control testing required to meet product release criteria. We will then send the therapeutic cryopreserved stem cells ( BRTX-100)
in a sterile vial back to the physician's offices where it will undergo a controlled thaw prior to the procedure. The price structure
for the procedure and our services has not been determined and no assurances can be given as to the effect that such price structure
will have on the marketability of such procedure and services. The following illustrates the process:

 Exclusive
License

to our license agreement with Regenerative Sciences, LLC, or Regenerative, that became effective in April 2012, or the Regenerative License
Agreement, we have obtained, among other things, a worldwide (excluding Asia and Argentina), exclusive, royalty-bearing license from
Regenerative to utilize or sublicense a certain method for culturing cells for use in our developmental program involving disc and spine
conditions, including protruding or painful discs and the treatment of avascular zones. The investigational technology that has been
licensed is an advanced stem cell culture and injection procedure that may offer relief from lower back pain, buttock and leg pain, and
numbness and tingling in the leg and foot. Pursuant to the Regenerative License Agreement, we have also obtained a worldwide, exclusive,
royalty-bearing license from Regenerative to utilize or sublicense a certain investigational curved needle device for the administration
of specific cells and/or cell products to the disc and/or spine (and other parts of the body). It will be necessary to advance the design
of this investigational device to facilitate the delivery of substances, including living cells, to specific locations within the body
and minimize the potential for damage to nearby structures.

 The
patents that are the subject of the Regenerative License Agreement have been assigned to Regenexx, LLC which we have been advised by
Regenerative is an affiliate of Regenerative.

 Animal
Study

 The
efficacy and safety of our product candidate, BRTX-100, has been tested in a degenerative intervertebral rabbit disc model. In
this study, 80 rabbits underwent surgery to create a puncture in the discs. Four weeks post-surgery, each rabbit had either contrast,
a biomaterial carrier or BRTX-100 injected into the discs. In order to study the biodistribution and efficacy of BRTX-100,
the rabbits were evaluated at day 56 and day 120.

 The
key safety findings of the animal study are as follows:

 There
 was no evidence or observation of gross toxicity related to the administration of BRTX-100 at either time point. The clinical
 pathology across both groups and time points were within expected normal historical ranges and under the conditions of the test.
 No abnormalities (including fractures or overt signs of lumbar disc disease) were identified after review of the radiographic images
 taken at both endpoints for both groups. No toxicity or adverse finding was evident in the systemic tissues or the discs of animals
 receiving BRTX-100.

 There
 was no detectable presence of human cells ( BRTX-100) observed at the day 56 interim time point. This is consistent with the
 proposed mechanism of action that BRTX-100 acts through a paracrine effect of secreted growth and immunomodulation factors.

 The
key efficacy findings of the animal study are as follows:

 BRTX-100
 showed a statistically significant DHI (disc height increase) over the control group at day 120.

 BRTX-100
 showed a statistically significant improvement in disc histology over the control group at day 120 as graded by a validated histology
 scale. BRTX-100 showed a significant improvement in the cellularity and matrix of the disc when compared to the control at
 day 120.

Trial

to an IND application we submitted to the FDA, we have obtained authorization to commence a Phase 2 clinical trial investigating the
use of BRTX-100, our lead cell therapy candidate, in the treatment of chronic lower back pain arising from degenerative disc disease.
We have commenced our Phase 2 clinical trial through the execution of a CRO agreement with PRC Clinical, the execution of clinical trial
agreements with 16 sites, patient enrollment, the commencement of patient procedures, the purchase of manufacturing equipment and the
expansion of our laboratory to include capabilities for clinical production.

 The
following describes the Phase 2 clinical trial authorized by the FDA:

 A
Phase 2 Prospective, Double-Blinded, Placebo Controlled, Randomized Study

 patients; randomized 2:1, BRTX-100 to control, 40 million cells/dose

 10-20
 clinical trial sites (we intend to utilize 15 clinical trial sites)

 Primary
 efficacy endpoint at 12 months

 Patient
 safety and efficacy follow up at 24 months

 Included
 subjects must have only one symptomatic diseased disc

 Included
 subjects must have current diagnosis of chronic lumbar disc disease typical pain with degeneration of a single disc confirmed by
 history, exam, radiography, or other acceptable means

 Included
 subjects must have exhausted previous conservative non-operative therapies

 Primary
 Efficacy Endpoint

 Responder
 endpoint - percentage of patients that meet the improvement in function and reduction in pain threshold

 Improvement
 in function defined as at least a 30% increase in function based on the Oswestry questionnaires (ODI)

 Reduction
 of pain defined as at least a 30% decrease in pain as measured using the Visual Analogue Scale (VAS)

 or Secondary Endpoints

 response at 12 months

 from baseline in pain as assessed with the VAS score and ODI at weeks 2, 12, 26, 52 and 104

 from baseline in function as assessed with the ODI at weeks 2, 12, 26, 52 and 104

 from baseline in function as assessed by Roland Morris Disability Questionnaire (RMDQ) at weeks 26, 52 and 104

 from baseline function as assessed by Functional Rating Index (FRI) at weeks 12, 52 and 104

 from baseline Quality of Life assessment (SF-12 questionnaire) scores at weeks 2, 12, 26, 52 and 104

 In
December 2021, we entered into a Master Service Agreement with Professional Research Consulting Inc. d/b/a PRC Clinical, a contract research
organization, or CRO, specializing in clinical trial management, to conduct our Phase 2 clinical trial.

 In
April 2023, we announced that we had completed enrollment for the safety run-in component of our Phase 2 clinical study of BRTX-100.

 In
May 2023, we announced that we had signed a clinical trial agreement with Northwell Health, New York State's largest health care
provider and private employer, pursuant to which Northwell Health is participating in our Phase 2 clinical study of BRTX-100.

 In
June 2023, we announced that the final subject in our BRTX-100 Phase 2 clinical trial safety cohort had been dosed.

 In
June 2023, we announced that the independent Data Safety Monitoring Board, which is overseeing our Phase 2 clinical trial, unanimously
recommended the continuation of our study in accordance with the version of the protocol with no changes.

 The
FDA approval process can be lengthy, expensive and uncertain and there is no guarantee that the clinical trial(s) will be completed or
that the product will ultimately receive approval or clearance.

 As
an alternative to undertaking any necessary clinical trials ourselves, we may explore the licensing of our rights with respect to our
product candidate, BRTX-100, to a strategic partner. Such an arrangement could possibly eliminate or significantly reduce the
need to raise the substantial capital needed to commence and complete the clinical trials and undertake the commercialization of BRTX-100
 and would provide licensing-related revenue to us in lieu of product sales revenue. No assurance can be given that any licensing
agreement will be entered into, whether upon commercially reasonable terms or otherwise.

 Defined
Health Report

 In
March 2018, we engaged Defined Health, a business development and strategy consulting firm, to conduct an independent review of BRTX-100.
Defined Health has worked with many of the leading companies in the pharmaceutical, biotech and healthcare industries for over 25 years.

 The
review was intended to collect informed, independent opinions regarding BRTX-100 among key opinion leaders, or KOLs (i.e., orthopedic
surgeons specializing in back and spine surgery with experience in stem cell therapy), who, upon studying applicable clinical material,
could offer opinions regarding the future therapeutic potential of BRTX-100.

 As
noted in the Defined Health report, the KOLs indicated that stem cell therapies have great potential to treat chronic lumbar disc disease
and other therapeutic areas. The KOLs reacted positively to the value proposition of our product candidate, BRTX-100, and were
optimistic that the clinical data presented to date is likely to be mirrored in future clinical investigations. Given the opportunity,
the KOLs indicated that they would likely participate in a clinical trial should it be offered at their center and that they would recommend
the study to appropriately eligible patients. The report indicated that, if BRTX-100 were to be granted FDA approval, the KOLs
anticipate that it would be integrated into the standard of care for eligible chronic lumbar disc disease patients.

 Similar
Therapies

 Human
data from studies of therapies comparative to BRTX-100 have shown reduced pain, increased function, and an absence of significant
safety issues with a durable response, as shown below:

 Impact
on Public Health

 The
United States is the world's leading consumer of hydrocodone (99%) and oxycodone (83%) and leads the world in per capital consumption
of such drugs (twice as much as second ranked Canada). In 2020, 91,000 persons in the United States died from overdoses.

 Total
annual healthcare and lost productivity costs in the United States related to pain, including headache, back pain and neck pain, are
estimated to be $600 billion, which is twice the annual costs related to heart disease and greater than the combined annual costs related
to cancer and diabetes.

 Metabolic
Brown Adipose (Fat) Program

 Since
June 2011, we have been engaging in pre-clinical research efforts with respect to an investigational platform technology utilizing brown
adipose (fat) derived stem cells, or BADSCs, for therapeutic purposes. We have labeled this initiative our ThermoStem Program.

 Brown
fat is a specialized adipose (fat) tissue found in the human body that plays a key role in the evolutionarily conserved mechanisms underlying
thermogenesis (generation of non-shivering body heat) and energy homeostasis in mammals - long known to be present at high levels in
hibernating mammals and human newborns. Recent studies have demonstrated that brown fat is present in the adult human body and may be
correlated with the maintenance and regulation of healthy metabolism, thus potentially being involved in caloric regulation. The pre-clinical
 ThermoStem Program involves the use of a cell-based (brown adipose tissue construct) treatment for metabolic disease, such as
type 2 diabetes, obesity, hypertension and other metabolic disorders, as well as cardiac deficiencies. The diseases, disorders and syndromes
that may be targeted by our ThermoStem Program are as follows:

 We
have had initial success in transplanting the brown adipose tissue construct in animals, and we are currently exploring ways to deliver
into humans. Even though present, BAT mass is very low in healthy adults and even lower in obese populations. Therefore, it may not be
sufficient to either naturally impact whole body metabolism, or to be targeted by drugs intended to increase its activity in the majority
of the population. Increasing BAT mass is crucial in order to benefit from its metabolic activity and this is what our ThermoStem
Program seeks to accomplish. We may also identify other naturally occurring biologics and chemically engineered molecules that may
enhance brown adipose tissue performance and activity.

 Obesity,
the abnormal accumulation of white fat tissue, leads to a number of metabolic disorders and is the driving force behind the rise of type
2 diabetes and cardiovascular diseases worldwide. Pharmacological efforts to alter metabolic homeostasis through modulating central control
of appetite and satiety have had limited market penetration due to significant psychological and physiological safety concerns directly
attributed to modulating these brain centers. Adipose tissue is one of the largest organs in the human body and plays a key role in central
energy balance and lipid homeostasis. White and brown adipose tissues are found in mammals. White adipose tissue's function is
to store energy, whereas BAT specializes in energy expenditure. As discussed in a 2020 article published in the International Journal
of Molecular Sciences, recent advancements in unraveling the mechanisms that control the induction, differentiation, proliferation,
and thermogenic activity of BAT, along with the application of imaging technologies for human BAT visualization, have generated optimism
that these advances may provide novel strategies for targeting BAT activation/thermogenesis, leading to efficacious and safe obesity
targeted therapies.

 We
are developing a cell-based product candidate to target obesity and metabolic disorders using BADSCs. Our goal is to develop a bioengineered
implantable brown adipose tissue construct intended to mimic ones naturally occurring in the human body. We have isolated and characterized
a human multipotent stem cell population that resides within BAT depots. We have expanded these stem cells to clinically relevant numbers
and successfully differentiated them into functional brown adipocytes. We intend to use adult stem cells that may be differentiated into
progenitor or fully differentiated brown adipocytes, or a related cell type, which can be used therapeutically in patients. We are focusing
on the development of treatment protocols that utilize allogeneic cells (i.e., stem cells from a genetically similar but not identical
donor).

 In
order to deliver these differentiated cells into target locations in vivo, we seeded BADSCs onto 3-dimensional biological scaffolds.
Pre-clinical animal models of diet-induced obesity, that were transplanted with differentiated BADSCs supported by a biological scaffold,
presented significant reductions in weight and blood glucose levels compared to scaffold only controls. We are identifying technology
for in vivo delivery in small animal models. Having completed our proof of concept using our BAT in small animals, we are currently
developing our next generation BAT. It is anticipated that this next version will contain a higher purity of BADSC and a greater percent
of functional brown adipocytes, which is expected to increase the therapeutic effect compared to our first generation product. In addition,
we are exploring the delivery of the therapeutic using encapsulation technology, which will only allow for reciprocal exchange of small
molecules between the host circulation and the BAT implant. We expect that encapsulation may present several advantages over our current
biological scaffolds, including prevention of any immune response or implant rejection that might occur in an immunocompetent host and
an increase in safety by preventing the implanted cells from invading the host tissues. We have developed promising data on the loading
of human stem cell-derived tissue engineered brown fat into an encapsulation device to be used as a cell delivery system for our metabolic
platform program for the treatment of type 2 diabetes, obesity, hyperlipidemia and hypertension. This advancement may lead to successful
transplantation of brown fat in humans. We are evaluating the next generation of BAT constructs that will first be tested in small animal
models. No assurance can be given that this delivery system will be effective in vivo in animals or humans. Our allogeneic brown
adipose derived stem cell platform potentially provides a therapeutic and commercial model for the cell-based treatment of obesity and
related metabolic disorders.

 In
February 2014, our research with regard to the identification of a population of brown adipose derived stem cells was published in Stem
Cells, a respected stem cell journal.

 In
March 2014, we entered into a Research Agreement with Pfizer Inc., a global pharmaceutical company. Pursuant to the Research Agreement
with Pfizer, we were engaged to provide research and development services with regard to a joint study of the development and validation
of a human brown adipose cell model. The Research Agreement with Pfizer provided for an initial payment to us of $250,000 and the payment
of up to an additional $525,000 during the two-year term of the Agreement, all of which has been received. The Research Agreement expired
upon completion of the services provided for therein.

 In
August 2015, we entered into a one year research collaboration agreement with the University of Pennsylvania with regard to the understanding
of brown adipose biology and its role in metabolic disorders. In September 2018, we entered into a one year research collaboration agreement
with the University of Pennsylvania pursuant to which the university was provided access to our proprietary brown adipose tissue cells
for research purposes. No amounts were payable by or to us pursuant to either agreement.

 In
September 2015, a United States patent related to the ThermoStem Program was issued to us.

 In
April 2017, an Australian patent related to the ThermoStem Program was issued to us.

 In
December 2017, a Japanese patent related to the ThermoStem Program was issued to us.

 In
January 2019, a United States patent related to the ThermoStem Program was issued to us.

 In
October 2019, an Australian patent related to the ThermoStem Program was issued to us.

 In
October 2019, an Israeli patent related to the ThermoStem Program was issued to us.

 In
March 2020, a United States patent related to our ThermoStem Program was issued to us.

 In
March 2020, our collaboration with the University of Pennsylvania resulted in a publication in Cell Reports, a respected peer
reviewed journal, with regard to our ThermoStem Program.

 In
April 2020, a European patent related to our ThermoStem Program was issued to us. This European patent was validated in Belgium,
France, Germany, Italy, Poland, Spain, Sweden, Switzerland, and the United Kingdom.

 In
May 2020, an Israeli patent related to our ThermoStem Program was issued to us.

 In
January 2021, a European patent related to our ThermoStem Program was issued to us. This European patent was validated in France,
Germany, Italy, Spain, and the United Kingdom.

 In
March 2021, a United States patent related to our ThermoStem Program was issued to us.

 In
June 2021, a Japanese patent related to our ThermoStem Program was issued to us.

 In
July 2021, a United States patent related to our ThermoStem Program was issued to us.

 In
August 2021, an Australian patent related to our ThermoStem Program was issued to us.

 In
February 2022, a Japanese patent related to our ThermoStem Program was issued to us.

 In
March 2022, an Israeli patent related to our ThermoStem Program was issued to us.

 In
December 2022, we announced that we were awarded a Small Business Innovation Research (SBIR) Phase 1 grant from Eunice Kennedy Shriver
National Institute of Child Health & Human Development of the National Institutes of Health to enable the development and the evaluation
of our ThermoStem Program for the treatment of polycystic ovary syndrome (PCOS). The work is to be done in collaboration with
Dr. Sheng Wu, Associate Professor, Center for Metabolic Disease Research at Temple University.

 In
June 2023, a Japanese patent related to our ThermoStem Program was issued to us.

 In
June 2023, a United States patent related to our ThermoStem Program was issued to us.

 In
July 2023, a European patent related to our ThermoStem Program was issued to us. This European patent was validated in
France, Germany, Italy, Spain, and the United Kingdom.

 In
December 2023, a United States patent related to our ThermoStem Program was issued to us.

 We
have completed proof of concept preclinical animal studies using our first generation brown adipose derived stem cells. We intend to
undertake additional preclinical animal studies in order to optimize delivery and explore the feasibility of targeting additional indications.
Such studies are planned to begin in 2024. Following the completion of such studies, if successful, we intend to file an IND with the
FDA and initiate a clinical trial. The FDA approval process can be lengthy, expensive and uncertain and there is no guarantee of ultimate
approval or clearance.

 We
anticipate that much of our development work in this area will take place at our laboratory facility, outside core facilities at academic,
research or medical institutions, or contractors. See "Laboratory" below.

 Curved
Needle Device

to the Regenerative License Agreement discussed under "Disc/Spine Program- Exclusive License " above, we have licensed
and further developed an investigational curved needle device, or CND, that is a needle system with a curved inner cannula to allow access
to difficult-to-locate regions for the delivery or removal of fluids and other substances. The investigational CND is intended to deliver
stem cells and/or other therapeutic products or material to the interior of a human intervertebral disc, the spine region, or potentially
other areas of the body. The device is designed to rely on the use of pre-curved nested cannulae that allow the cells or material to
be deposited in the posterior and lateral aspects of the disc to which direct access is not possible due to outlying structures such
as vertebra, spinal cord and spinal nerves. We anticipate that the use of the investigational CND will facilitate the delivery of substances,
including living cells, to specific locations within the body and minimize the potential for damage to nearby structures. The investigational
device may also have more general use applications. In August 2015, a United States patent for the CND was issued to the licensor, Regenerative.
We anticipate that FDA approval or clearance will be necessary for the investigational CND prior to commercialization. We do not intend
to utilize the CND in connection with our Phase 2 clinical trial with regard to BRTX-100. The FDA review and approval process
can be lengthy, expensive and uncertain and there is no guarantee of ultimate approval or clearance.

 Laboratory

 We
have established a laboratory in Melville, New York for research purposes and have built a cleanroom within the laboratory for the production
of cell-based product candidates, such as BRTX-100, for use in a clinical trial, for third party cell products or for general
research purposes.

 We
have expanded our laboratory to include capabilities for the clinical production of our pipeline of clinical and investigational cell
therapy candidates. Our expanded cGMP facility includes process development space, ISO 7 cleanrooms and state-of-the-art equipment. We
have expanded our research and development operations to include clinical manufacturing, a necessary step for our Phase 2 clinical trial
for BRTX-100. The new facility has been designed to provide cGMP manufacturing according to FDA and European Medicines Agency
regulations and guidelines to support clinical grade cell production. In May 2023, we announced that we had received a license from the
New York State Department of Health to act as a tissue bank for the processing of mesenchymal stem cells from autologous donors.

 As
we develop our business and our stem cell product candidates, and we obtain regulatory approval, we will seek to establish ourselves
as a key provider of adult stem cells for therapies and expand to provide cells in other market areas for stem cell therapy. We may also
use outside laboratories specializing in cell therapy services and manufacturing of cell products.

 Technology;
Research and Development

 We
intend to utilize our laboratory or a third party laboratory in connection with cellular research activities. We also intend to obtain
cellular-based therapeutic technology licenses and increase our IP portfolio. We intend to seek to develop potential stem cell delivery
systems or devices. The goal of these specialized delivery systems or devices is to deliver cells into specific areas of the body, control
the rate, amount and types of cells used in a treatment, and populate these areas of the body with sufficient stem cells so that there
is a successful therapeutic result.

 We
also intend to perform research to develop certain stem cell optimization compounds, media designed to enhance cellular growth and regeneration
for the purpose of improving pre-treatment and post-treatment outcomes.

 In
our Disc/Spine Program, thirteen patent applications have been filed with regard to technology that is the subject of the Regenerative
License Agreement (see "Disc/Spine Program- Exclusive License " above). Regenerative has been issued a patent from one
of these applications with regard to its curved needle therapeutic delivery device. This patent expires in March 2031. In addition, in
March 2022, a United States patent related to BRTX- 100 was issued. This patent expires in December 2029. Of the other eleven applications
that were filed, four applications remain pending. The patents that are the subject of the Regenerative License Agreement have been assigned
to Regenexx, LLC which we have been advised is an affiliate of Regenerative.

 In
our ThermoStem Program, we have one pending United States patent application and seven United States patents within three patent
families. Four of the patents expire in June 2032 and three of the patents expire in April 2034. With regard to the first patent family
in the ThermoStem Program, patent applications have been filed in five foreign jurisdictions (of which four applications have
been granted as foreign patents and one application has lapsed). The patents expire in June 2032. With regard to the second patent family
in the ThermoStem Program, patent applications have been filed in four foreign jurisdictions (of which four applications have
been granted as foreign patents). The patents expire in April 2034. With regard to the third patent family in the ThermoStem Program,
patent applications have been filed in four foreign jurisdictions.

 Our
patent applications and those of Regenexx, LLC are currently in prosecution (i.e., we and Regenexx, LLC are seeking issued patents).

 In
March 2014, we entered into a Research and Development Agreement with Rohto Pharmaceutical Co., Ltd., a Japanese pharmaceutical company,
or Rohto. Pursuant to the Research and Development Agreement with Rohto, we were engaged to provide research and development services
with regard to stem cells. The agreement with Rohto expired upon the completion of the services provided for therein.

 We
have secured registrations in the U.S. Patent and Trademark Office for the following trademarks:

 BRTX-100

 THERMOSTEM

 BRTX

 The
 Dragonfly Logo is also registered with the U.S. Copyright Office.

 We
also have federal common law rights in the trademark BioRestorative Therapies and other trademarks and trade names used in the
conduct of our business that are not registered.

 Our
success will depend in large part on our ability to develop and protect our proprietary technology. We intend to rely on a combination
of patent, trade secret and know-how, copyright and trademark laws, as well as confidentiality agreements, licensing agreements, non-compete
agreements and other agreements, to establish and protect our proprietary rights. Our success will also depend upon our ability to avoid
infringing upon the proprietary rights of others, for if we are judicially determined to have infringed such rights, we may be required
to pay damages, alter our services, products or processes, obtain licenses or cease certain activities.

the years ended December 31, 2023 and 2022, we incurred $4,034,591 and $3,513,352, respectively, in research and development expenses.

 Scientific
Advisors

 We
have established a Scientific Advisory Board whose purpose is to provide advice and guidance in connection with scientific matters relating
to our business. The Scientific Advisory Board has established a Disc Advisory Committee which focuses on matters relating to our Disc/Spine
Program. Our Scientific Advisory Board members are Dr. Wayne Marasco (Chairman), Dr. Jason Lipetz, Dr. Wayne Olan, Dr. Joy Cavagnaro,
Dr. Harvinder Sandhu and Dr. Christopher Plastaras. The Disc Advisory Committee members are Dr. Lipetz (Chairman), Dr. Olan, Dr. Sandhu
and Dr. Plastaras. See Item 10 of this Annual Report ("Directors, Executive Officers and Corporate Governance – Scientific
Advisory Board") for a listing of the principal positions for Drs. Marasco, Lipetz, Olan, Cavagnaro, Sandhu and Plastaras.

 Competition

 We
will compete with many pharmaceutical, biotechnology and medical device companies, as well as other private and public stem cell companies
involved in the development and commercialization of cell-based medical technologies and therapies.

 Regenerative
medicine is rapidly progressing, in large part through the development of cell-based therapies or devices designed to isolate cells from
human tissues. Most efforts involve cell sources, such as bone marrow, adipose tissue, embryonic and fetal tissue, umbilical cord and
peripheral blood and skeletal muscle.

 Companies
working in the area of regenerative medicine with regard to the disc and spine include, among others, Mesoblast, SpinalCyte, DiscGenics
and Isto Biologics. Companies that are developing products and therapies to combat obesity and diabetes include Novo Nordisk, Sanofi,
Merck, Eli Lilly, Roche, Pfizer, Regeneron and Altimmune. The recent extensive use of both FDA-approved and compounded versions of glucagon-like
peptide-1 (GLP-1) receptor agonist drug products, such as Wegovy and Ozempic (semaglutide) for the treatment of obesity has significantly
increased the competition in the obesity market.

 Many
of our competitors and potential competitors have substantially greater financial, technological, research and development, marketing
and personnel resources than we do. We cannot, with any accuracy, forecast when or if these companies are likely to bring their products
and therapies to market in competition with those that we are pursuing.

 The
Biologics Price Competition and Innovation Act, or the BPCIA, sets forth an abbreviated pathway for the approval of biosimilar and interchangeable
biological products that could be used by future competitors, if any, of our product candidates that are approved by the FDA as a biologic.
For the FDA to approve a biosimilar product, it must find that there are no clinically meaningful differences between the reference product
and the proposed biosimilar product. Interchangeability requires that a product is biosimilar to the reference product, and the product
must be expected to produce the same clinical results as the reference product and, for products administered multiple times, the biologic
and the reference biologic may be switched after one has been previously administered without increasing safety risks or risks of diminished
efficacy relative to exclusive use of the reference biologic. Under the BPCIA, an application for a biosimilar product cannot be submitted
to the FDA until four years following approval of the reference product, and it may not be approved by the FDA until 12 years after the
original branded product is approved under a biologics license application, or BLA.

 We
believe that, if any of our product candidates are approved as a biological product under a BLA, it should qualify for the 12-year period
of exclusivity. However, there is a risk that the FDA could permit biosimilar applicants to reference approved biologics other than our
therapeutic candidates, thus circumventing our exclusivity and potentially creating the opportunity for competition sooner than anticipated.
Additionally, this period of regulatory exclusivity does not apply to companies pursuing regulatory approval via their own traditional
BLA, rather than via the abbreviated pathway. Moreover, it is possible that a biosimilar product could be approved as "interchangeable"
with our product and therefore substitutable for our product by a healthcare professional under applicable state laws.

 We
may also face increased competition from stem cell therapies performed by treatment centers that do not require FDA premarket approval.
In August 2022, a federal District Court in the case of United States v. California Stem Cell Treatment Center, Inc. held that
certain autologous adipose stem cell treatments were not "biological products" and therefore did not require FDA approval.
The FDA has appealed the decision but, should it be upheld, we could face competition from stem cell clinics that would not be required
to undergo the costly and time-consuming FDA approval process.

 Set
forth below is a comparison of BRTX-100 to Mesoblast's adult stem cell biologic:

 We
believe that BRTX-100 has competitive advantages to Mesoblast's product for the following reasons:

 The
 use of autologous cells results in low to no risk of rejection, greater safety profile (introduction of viral/genetic) and a streamlined
 regulatory path

 Hypoxic
 culturing creates increased cell proliferation, greater plasticity, increased paracrine effect and increased cell survival after
 application

 Autologous
 platelet lysate provides growth factors that interact with the cells, allowing for better cell survival

 Low
 to no risk of safety concerns related to immunological and zoonotic (animal to human) transmission

 Customers

 Upon
regulatory approval, our cell product candidates are intended to be marketed to physicians, other health care professionals, hospitals,
research institutions, pharmaceutical companies and the military. It is anticipated that physicians who are trained and skilled in performing
spinal injections will be the physicians most likely to treat discs with injections of BRTX-100 upon regulatory approval. These
physicians would include interventional physiatrists (physical medicine physicians), pain management anesthesiologists, interventional
radiologists and neurosurgeons.

 Governmental
Regulation

 U.S.
Government Regulation

 The
health care industry is highly regulated in the United States. The federal government, through various departments and agencies, state
and local governments, and private third-party accreditation organizations, regulate and monitor the health care industry, associated
products, and operations. The FDA and comparable regulatory agencies in state and local jurisdictions and in foreign countries impose
substantial requirements upon the clinical development, approval, manufacture, distribution and marketing of medical products, including
drugs, biologics, and medical devices. These agencies and other federal, state and local entities regulate research and development activities
and the testing, manufacture, quality control, safety, effectiveness, labeling, packaging, storage, distribution, record keeping, approval,
post-approval monitoring, advertising, promotion, sampling and import and export of medical products. The following is a general overview
of the laws and regulations pertaining to our business.

 FDA
Regulation of Stem Cell Treatment and Products

 The
FDA regulates the manufacture of human stem cell treatments and associated products under the authority of the Public Health Service
Act, or PHSA, and the Federal Food, Drug, and Cosmetic Act, or FDCA. Stem cells can be regulated under the FDA's Human Cells, Tissues,
and Cellular and Tissue-Based Products Regulations, or HCT/Ps, or may also be subject to the FDA's drug, biologic, or medical device
regulations, each as discussed below.

 Human
Cells, Tissues, and Cellular and Tissue-Based Products Regulation

 Under
Section 361 of the PHSA, the FDA issued specific regulations governing the use of HCT/Ps in humans. Pursuant to Part 1271 of Title 21
of the Code of Federal Regulations, or CFR, or the HCT/P Regulations, the FDA established a unified registration and listing system for
establishments that manufacture and process HCT/Ps. The regulations also include provisions pertaining to donor eligibility determinations;
current good tissue practices covering all stages of production, including harvesting, processing, manufacture, storage, labeling, packaging,
and distribution; and other procedures to prevent the introduction, transmission, and spread of communicable diseases.

 The
HCT/P Regulations define HCT/Ps as articles "containing or consisting of human cells or tissues that are intended for implantation,
transplantation, infusion or transfer into a human recipient." The HCT/P Regulations strictly constrain the types of products that
may be regulated solely as HCT/P. Factors considered include the degree of manipulation, whether the product is intended for a homologous
function, whether the product has been combined with noncellular or non-tissue components, and the product's effect or dependence
on the body's metabolic function. In those instances where cells, tissues, and cellular and tissue-based products have been only
minimally manipulated, are intended strictly for homologous use, have not been combined with noncellular or nontissue substances, and
do not depend on or have any effect on the body's metabolism, the manufacturer is only required to register with the FDA, submit
a list of manufactured products, and adopt and implement procedures for the control of communicable diseases. If one or more of the above
factors has been exceeded, the product would be regulated as a drug, biological product, or medical device rather than an HCT/P.

 Because
we are an enterprise in the early stages of operations and have not generated significant revenues from operations, it is difficult to
anticipate the likely regulatory status of the array of products and services that we may offer. We believe that some of the adult autologous
(self-derived) stem cells that will be used in our cellular therapy products and services, including the brown adipose (fat) tissue that
we intend to use in our ThermoStem Program, may be regulated by the FDA as HCT/Ps under the HCT/P Regulations. However, the FDA
may disagree with this position or conclude that some or all of our stem cell therapy products or services do not meet the applicable
definitions and exemptions to the regulation. In July 2020, the FDA issued an updated guidance document entitled "Regulatory Considerations
for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use" that provides additional
guidance on how FDA interprets the HCT/P Regulations, particularly the definition of the terms "minimally manipulated" and
"homologous use." In the guidance, the FDA stated it would exercise enforcement discretion until May 31, 2021 for products
that do not comply with the HCT/P Regulations. As of that date, manufacturers of products marketed as HCT/Ps that do not comply with
the HCT/P Regulations are subject to immediate FDA enforcement action. If we are not regulated solely under the HCT/P Regulations, we
would need to expend significant resources to comply with the FDA's broad regulatory authority under the FDCA. Historically, the
U.S. federal courts have upheld the FDA's authority to regulate stem cell products under the FDCA that do not comply with the FDA's
interpretations of the HCT/P Regulations. However, in August 2022, a federal District Court in the case of United States v. California
Stem Cell Treatment Center, Inc. held that certain autologous adipose stem cell treatments that the FDA alleged were biological products
were instead within the HCT/P definition and therefore did not require FDA approval. The FDA has appealed the decision but, should it
be upheld, it could expand the types of stem cell products that are regulated solely under the HCT/P Regulations.

 If
regulated solely under the FDA's HCT/P statutory and regulatory provisions, once our laboratory in the United States becomes operational,
it will need to satisfy the following requirements, among others, to process and store stem cells:

 registration
 and listing of HCT/Ps with the FDA;

 donor
 eligibility determinations, including donor screening and donor testing requirements;

 current
 good tissue practices, specifically including requirements for the facilities, environmental controls, equipment, supplies and reagents,
 recovery of HCT/Ps from the patient, processing, storage, labeling and document controls, and distribution and shipment of the HCT/Ps
 to the laboratory, storage, or other facility;

 tracking
 and traceability of HCT/Ps and equipment, supplies, and reagents used in the manufacture of HCT/Ps;

 adverse
 event reporting;

 FDA
 inspection; and

 abiding
 by any FDA order of retention, recall, destruction, and cessation of manufacturing of HCT/Ps.

 Non-reproductive
HCT/Ps and non-peripheral blood stem/progenitor cells that are offered for import into the United States and regulated solely under Section
361 of the PHSA must also satisfy the requirements under 21 C.F.R. § 1271.420. Section 1271.420 requires that the importer of record
of HCT/Ps notify the FDA prior to, or at the time of, importation and provide sufficient information for the FDA to make an admissibility
decision. In addition, the importer must hold the HCT/P intact and under conditions necessary to prevent transmission of communicable
disease until an admissibility decision is made by the FDA.

 If
the FDA determines that we have failed to comply with applicable regulatory requirements, it can impose a variety of enforcement actions
including public warning letters, fines, consent decrees, orders of retention, recall or destruction of product, orders to cease manufacturing,
and criminal prosecution. If any of these events were to occur, it could materially adversely affect us.

 To
the extent that our cellular therapy activities are limited to developing products and services outside the United States, as described
in detail below, the products and services would not be subject to FDA regulation, but will be subject to the applicable requirements
of the foreign jurisdiction. We intend to comply with all applicable foreign governmental requirements.

 Drug
and Biological Product Regulation

 An
HCT/P product that does not meet the criteria for being solely regulated under Section 361 of the PHSA will be regulated as a drug, device
or biological product under the FDCA and/or Section 351 of the PHSA, and applicable FDA regulations. The FDA has broad regulatory authority
over drugs and biologics marketed for sale in the United States. The FDA regulates the research, clinical testing, manufacturing, safety,
effectiveness, labeling, storage, recordkeeping, promotion, distribution, and production of drugs and biological products. The FDA also
regulates the export of drugs and biological products manufactured in the United States to international markets in certain situations.

 The
process required by the FDA before a drug or biologic may be marketed in the United States generally involves the following:

completion of non-clinical laboratory tests, animal studies and formulation studies conducted according to Good Laboratory Practice,
or GLP, or other applicable regulations;

submission of an IND, which allows clinical trials to begin unless the FDA objects within 30 days;

performance of adequate and well-controlled human clinical trials to establish the safety and efficacy of the proposed drug or biologic
for its intended use or uses conducted in accordance with FDA regulations and Good Clinical Practices, or GCP, which are international
ethical and scientific quality standards meant to ensure that the rights, safety and well-being of trial participants are protected and
that the integrity of the data is maintained;

registration of clinical trials of FDA-regulated products and certain clinical trial information;

preparation and submission to the FDA of a new drug application, or NDA, in the case of a drug or BLA in the case of a biologic;

review of the product by an FDA advisory committee, where appropriate or if applicable;

satisfactory completion of pre-approval inspection of manufacturing facilities and clinical trial sites at which the product, or components
thereof, are produced to assess compliance with cGMP requirements and of selected clinical trial sites to assess compliance with GCP
requirements; and

FDA approval of an NDA or BLA which must occur before a drug or biologic can be marketed or sold.

 Approval
of an NDA requires a showing that the drug is safe and effective for its intended use and that the methods, facilities, and controls
used for the manufacturing, processing, and packaging of the drug are adequate to preserve its identity, strength, quality, and purity.
To obtain a BLA, a manufacturer must show that the proposed product is safe, pure, and potent and that the facility in which the product
is manufactured, processed, packed, or held meets established quality control standards.

 For
purposes of an NDA or BLA approval by the FDA, human clinical trials are typically conducted in the following phases (which may overlap):

Phase 1: The investigational product is initially given to healthy human subjects or patients and tested for safety, dosage tolerance,
absorption, metabolism, distribution and excretion. These trials may also provide early evidence on effectiveness. During Phase 1 clinical
trials, sufficient information about the investigational product's pharmacokinetics and pharmacologic effects may be obtained to
permit the design of well-controlled and scientifically valid Phase 2 clinical trials.

Phase 2: These clinical trials are conducted in a limited number of human subjects in the target population to identify possible adverse
effects and safety risks, to determine the efficacy of the investigational product for specific targeted diseases and to determine dosage
tolerance and dosage levels. Multiple Phase 2 clinical trials may be conducted by the sponsor to obtain information prior to beginning
larger and more costly Phase 3 clinical trials.

Phase 3: Phase 3 clinical trials are undertaken after Phase 2 clinical trials demonstrate that a dosage range of the investigational
product appears effective and has a tolerable safety profile. The Phase 2 clinical trials must also provide sufficient information for
the design of Phase 3 clinical trials. Phase 3 clinical trials are conducted to provide statistically significant evidence of clinical
efficacy and to further test for safety risks in an expanded human subject population at multiple clinical trial sites. These clinical
trials are intended to further evaluate dosage, effectiveness and safety, to establish the overall benefit-risk profile of the investigational
product and to provide an adequate basis for product labeling and approval by the FDA. In most cases, the FDA requires two adequate and
well-controlled Phase 3 clinical trials to demonstrate the efficacy of an investigational drug or biologic.

 All
clinical trials must be conducted in accordance with FDA regulations, GCP requirements and their protocols in order for the data to be
considered reliable for regulatory purposes. Progress reports detailing the results of the clinical trials must be submitted at least
annually to the FDA and more frequently if serious adverse events occur. Phase 1, Phase 2 and Phase 3 clinical trials may not be completed
successfully within any specified period, or at all. These government regulations may delay or prevent approval of product candidates
for a considerable period of time and impose costly procedures upon our business operations.

 The
FDA may require, or companies may pursue, additional clinical trials, referred to as Phase 4 clinical trials, after a product is approved.
Such trials may be made a condition to be satisfied for continuing drug approval. The results of Phase 4 clinical trials can confirm
the effectiveness of a product candidate and can provide important safety information. In addition, the FDA has authority to require
sponsors to conduct post-marketing trials to specifically address safety issues identified by the agency.

 Under
the Pediatric Research Equity Act, or PREA, certain NDAs and BLAs and certain supplements to an NDA or BLA must contain data to assess
the safety and efficacy 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 grant deferrals for submission of pediatric
data or full or partial waivers. A sponsor who is planning to submit a marketing application for a drug that includes a new active ingredient,
new indication, new dosage form, new dosing regimen, or new route of administration submit an initial Pediatric Study Plan, or PSP, to
the FDA within 60 days of an end-of-Phase 2 meeting or, if there is no such meeting, as early as practicable before the initiation of
the Phase 3 or Phase 2/3 study. The initial PSP must include an outline of the pediatric study or studies that the sponsor plans to conduct,
including study objectives and design, age groups, relevant endpoints and statistical approach, or a justification for not including
such detailed information, and any request for a deferral of pediatric assessments or a full or partial waiver of the requirement to
provide data from pediatric studies along with supporting information. The FDA and the sponsor must reach an agreement on the PSP. A
sponsor can submit amendments to an agreed-upon initial PSP at any time if changes to the pediatric plan need to be considered based
on data collected from preclinical studies, early phase clinical trials, and/or other clinical development programs.

to some of the conditions established in an approved application, including changes in indications, labeling, manufacturing processes
or facilities, require submission and FDA approval of a new NDA or BLA, or an NDA or BLA supplement, before the change can be implemented.
An NDA or BLA supplement for a new indication typically requires clinical data similar to that in the original application, and the FDA
uses the same procedures and actions in reviewing NDA and BLA supplements as it does in reviewing NDAs and BLAs.

 Drug
and biological products must also comply with applicable requirements, including monitoring and recordkeeping activities, manufacturing
requirements, reporting to the applicable regulatory authorities of adverse experiences with the product, providing the regulatory authorities
with updated safety and efficacy information, product sampling and distribution requirements, and complying with promotion and advertising
requirements, which include, among others, standards for direct-to-consumer advertising, restrictions on promoting drugs for uses or
in patient populations that are not described in the drug's approved labeling, or off-label use, limitations on industry-sponsored
scientific and educational activities and requirements for promotional activities involving the internet. Although physicians may, in
their independent professional medical judgment, prescribe legally available drugs for off-label uses, manufacturers typically may not
market or promote such off-label uses.

 We
have determined that, under the FDA's current interpretation of the applicable law, our BRTX-100 product candidate will
be regulated as a biological product under the PHSA. Therefore, we will need to expend significant resources to ensure regulatory compliance.
There is no assurance as to whether or when we will receive FDA approval of the BRTX-100 product candidate. The process of designing,
conducting, compiling and submitting the non-clinical and clinical studies required for BLA approval is time-consuming, expensive and
unpredictable. The process can take many years, depending on the product and the FDA's requirements.

 In
addition, even if a product candidate receives regulatory approval, the approval may be limited to specific disease states, patient populations
and dosages, or might contain significant limitations on use in the form of warnings, precautions or contraindications, or in the form
of onerous risk management plans, restrictions on distribution or use, or post-marketing trial requirements. Further, even after regulatory
approval is obtained, later discovery of previously unknown problems with a product may result in restrictions on the product, including
safety labeling or imposition of a Risk Evaluation and Mitigation Strategy, or REMS, the requirement to conduct post-market studies or
clinical trials or even complete withdrawal of the product from the market. Delay in obtaining, or failure to obtain, regulatory approval
for our products, or obtaining approval but for significantly limited use, would harm our business. Further, we cannot predict what adverse
governmental regulations may arise from future United States or foreign governmental action.

 If
the FDA determines that we have failed to comply with applicable regulatory requirements, it can impose a variety of enforcement actions
from public warning letters, fines, injunctions, consent decrees and civil penalties to suspension or delayed issuance of approvals,
seizure of our products, total or partial shutdown of our production, withdrawal of approvals, and criminal prosecutions. If any of these
events were to occur, it could materially adversely affect us.

 FDA
Expedited Review Programs

 The
FDA is authorized to expedite the review of NDAs and BLAs in several ways. Under the Fast Track program, the sponsor of a drug or biologic
product candidate may request the FDA to designate the product for a specific indication as a Fast Track product concurrent with or after
the filing of the IND. Drug and biologic products are eligible for Fast Track designation if they are intended to treat a serious or
life-threatening condition and demonstrate the potential to address unmet medical needs for the condition. Fast Track designation applies
to the combination of the product candidate and the specific indication for which it is being studied.

 In
addition to other benefits, such as the ability to have greater interactions with the FDA, the FDA may initiate review of sections of
a Fast Track NDA or BLA before the application is complete, a process known as rolling review.

 Any
product submitted to the FDA for marketing, including under a Fast Track program, may also be eligible for the following other types
of FDA programs intended to expedite development and review:

Breakthrough therapy designation. To qualify for the breakthrough therapy program, product candidates must be intended to treat a serious
or life-threatening disease or condition, and preliminary clinical evidence must indicate that such product candidates may demonstrate
substantial improvement on one or more clinically significant endpoints over existing therapies. The FDA will seek to ensure the sponsor
of a breakthrough therapy product candidate receives intensive guidance on an efficient drug development program, intensive involvement
of senior managers and experienced staff on a proactive, collaborative and cross-disciplinary review, and rolling review.

Priority review. A product candidate is eligible for priority review if it treats a serious condition and, if approved, it would be a
significant improvement in the safety or effectiveness of the treatment, diagnosis or prevention of a serious condition compared to marketed
products. The FDA aims to complete its review of priority review applications within six months as opposed to ten months for standard
review.

Accelerated approval. Drug or biologic products studied for their safety and effectiveness in treating serious or life-threatening illnesses
and that provide meaningful therapeutic benefit over existing treatments may receive accelerated approval. Accelerated approval means
that a product candidate may be approved on the basis of adequate and well-controlled clinical trials establishing that the product candidate
has an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit, or on the basis of an effect on a clinical
endpoint other than survival or irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity
and prevalence of the condition and the availability or lack of alternative treatments. As a condition of approval, the FDA may require
that a sponsor of a drug or biologic product candidate receiving accelerated approval perform adequate and well-controlled post-marketing
clinical trials. In addition, the FDA currently requires as a condition for accelerated approval pre-approval of promotional materials.
As a result of the FDA's controversial use of the accelerated approval pathway for an Alzheimer's drug (aducanumab), Congress
revised the accelerated approval process as a part of the Food and Drug Omnibus Reform Act of 2022 to provide the FDA with additional
authorities to enforce the post-approval study requirements and to withdraw approvals when those requirements are not met.

 Fast
Track designation, breakthrough therapy designation, priority review and accelerated approval do not change the standards for approval
but may expedite the development or approval process.

the FDA is authorized to accelerate review and approval of products designated as regenerative advanced therapies. A product is eligible
for this designation if it is a regenerative medicine advanced therapy, or RMAT (which may include a cell therapy), that is intended
to treat, modify, reverse or cure a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that
the drug has the potential to address unmet medical needs for such disease or condition. The benefits of a RMAT designation include early
interactions with the FDA to expedite development and review, benefits available to breakthrough therapies, potential eligibility for
priority review and accelerated approval based on surrogate or intermediate endpoints.

 Medical
Device Regulation

 The
FDA also has broad authority over the regulation of medical devices marketed for sale in the United States. The FDA regulates the research,
clinical testing, manufacturing, safety, labeling, storage, recordkeeping, premarket clearance or approval, promotion, distribution,
and production of medical devices. The FDA also regulates the export of medical devices manufactured in the United States to international
markets.

 Under
the FDCA, medical devices are classified into one of three classes, Class I, Class II, or Class III, depending upon the degree of risk
associated with the medical device and the extent of control needed to ensure safety and effectiveness. Class I devices are subject to
the lowest degree of regulatory scrutiny because they are considered low risk devices and need only comply with the FDA's General
Controls. The General Controls include compliance with the registration, listing, adverse event reporting requirements, and applicable
portions of the Quality System Regulation as well as the general misbranding and adulteration prohibitions.

 Class
II devices are subject to the General Controls as well as certain Special Controls such as 510(k) premarket notification. Class III devices
are subject to the highest degree of regulatory scrutiny and typically include life supporting and life sustaining devices and implants.
They are subject to the General Controls and Special Controls that include a premarket approval application, or PMA. "New"
devices are automatically regulated as Class III devices unless they are shown to be low risk, in which case they may be subject to de
novo review to be moved to Class I or Class II. Clinical research of an investigational device is subject to the FDA's Investigational
Device Exemption, or IDE, regulations. Nonsignificant risk devices are subject to abbreviated requirements that do not require a submission
to the FDA but must have Institutional Review Board (IRB) approval and comply with other requirements pertaining to informed consent,
labeling, recordkeeping, reporting, and monitoring. Significant risk devices require the submission of an IDE application to the FDA
and the FDA's approval of the IDE application.

 The
FDA premarket clearance and approval process can be lengthy, expensive and uncertain. It generally takes three to twelve months from
submission to obtain 510(k) premarket clearance, although it may take longer. Approval of a PMA could take one to four years, or more,
from the time the application is submitted and there is no guarantee of ultimate clearance or approval. Securing FDA clearances and approvals
may require the submission of extensive clinical data and supporting information to the FDA. Additionally, the FDA actively enforces
regulations prohibiting marketing and promotion of devices for indications or uses that have not been cleared or approved by the FDA.
In addition, modifications or enhancements of products that could affect the safety or effectiveness or effect a major change in the
intended use of a device that was either cleared through the 510(k) process or approved through the PMA process may require further FDA
review through new 510(k) or PMA submissions.

 In
the event we develop processes, products or services which qualify as medical devices subject to FDA regulation, we intend to comply
with such regulations. If the FDA determines that our products are regulated as medical devices and we have failed to comply with applicable
regulatory requirements, it can impose a variety of enforcement actions from public warning letters, application integrity proceedings,
fines, injunctions, consent decrees and civil penalties to suspension or delayed issuance of approvals, seizure of our products, total
or partial shutdown of our production, withdrawal of approvals, and criminal prosecutions. If any of these events were to occur, it could
materially adversely affect us.

Good Manufacturing Practices and other FDA Regulations of Cellular Therapy Products

 Products
that fall outside of the HCT/P regulations and are regulated as drugs, biological products, or devices must comply with applicable cGMP
regulations. These cGMPs and related quality standards are designed to ensure the products that are processed at a facility meet the
FDA's applicable requirements for identity, strength, quality, sterility, purity, and safety. In the event that our domestic United
States operations are subject to the FDA's drug, biological product, or device regulations, we intend to comply with the applicable
cGMPs and quality regulations.

 If
the FDA determines that we have failed to comply with applicable regulatory requirements, it can impose a variety of enforcement actions
from public warning letters, fines, injunctions, consent decrees and civil penalties to suspension or delayed issuance of approvals,
seizure of our products, total or partial shutdown of our production, withdrawal of approvals, and criminal prosecutions. If any of these
events were to occur, it could materially adversely affect us.

 Promotion
of Foreign-Based Cellular Therapy Treatment— "Medical Tourism"

 We
may establish, or license technology to third parties in connection with their establishment of, adult stem cell therapy facilities outside
the United States. We also intend to work with hospitals and physicians to make the stem cell-based therapies available for patients
who travel outside the United States for treatment. "Medical tourism" is defined as the practice of traveling across international
borders to obtain health care.

 The
Federal Trade Commission, or the FTC, has the authority to regulate and police advertising of medical treatments, procedures, and regimens
in the United States under the Federal Trade Commission Act, or the FTCA. The FTC has regulatory authority to prevent unfair and deceptive
practices and false advertising. Specifically, the FTC requires advertisers and promoters to have a reasonable basis to substantiate
and support claims. The FTC has many enforcement powers, one of which is the power to order disgorgement by promoters deemed in violation
of the FTCA of any profits made from the promoted business and can order injunctions from further violative promotion. Advertising that
we may utilize in connection with our medical tourism operations will be subject to FTC regulatory authority, and we intend to comply
with such regulatory r gime. Similar laws and requirements are likely to exist in other countries and we intend to comply with
such requirements.

 Federal
Regulation of Clinical Laboratories

 The
federal Clinical Laboratory Improvement Amendments, or CLIA, provides the Centers for Medicare and Medicaid Services, or CMS, authority
over all laboratory testing, except research, that is performed on humans in the United States. The Division of Laboratory Services,
within the Survey and Certification Group, under the Center for Medicaid and State Operations, or CMSO, has the responsibility for implementing
the CLIA program.

 The
CLIA program is designed to establish quality laboratory testing by ensuring the accuracy, reliability, and timeliness of patient test
results. Under CLIA, a laboratory is a facility that does laboratory testing on specimens derived from humans and used to provide information
for the diagnosis, prevention, treatment of disease, or impairment of, or assessment of health. Laboratories that handle stem cells and
other biologic matter are, therefore, included under the CLIA program. Under the CLIA program, laboratories must be certified by the
government, satisfy governmental quality and personnel standards, undergo proficiency testing, be subject to inspections, and pay fees.
To the extent that our business activities require CLIA certification, we intend to obtain and maintain such certification. If we are
subject to CLIA, the failure to comply with CLIA standards could result in suspension, revocation, or limitation of a laboratory's
CLIA certificate. In addition, fines or criminal penalties could also be levied. If any of these events were to occur, it could impact
our business operations.

 Health
Insurance Portability and Accountability Act—Protection of Patient Health Information

 We
may be subject to data privacy and security regulation by both the federal government and the states in which we conduct our business.
The Health Insurance Portability Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and Clinical Health
Act, or HITECH, and their respective implementing regulations imposes specified requirements relating to the privacy, security and transmission
of individually identifiable health information on certain types of individuals and organizations. In addition, certain state laws govern
the privacy and security of health information in certain circumstances, many of which differ from each other and from HIPAA in significant
ways and may not have the same effect, thus complicating compliance efforts. Further, we may need to also comply with additional federal
or state privacy laws and regulations that may apply to certain diagnoses, such as HIV/AIDS, to the extent that they apply to us.

 The
Department of Health and Human Services, or HHS, through its Office for Civil Rights, investigates breach reports and determines whether
administrative or technical modifications are required and whether civil or criminal sanctions should be imposed. Companies failing to
comply with HIPAA and the implementing regulations may also be subject to civil money penalties or in the case of knowing violations,
potential criminal penalties, including monetary fines, imprisonment, or both. In some cases, the State Attorneys General may seek enforcement
and appropriate sanctions in federal court.

 Other
Applicable U.S. Laws

 In
addition to the above-described regulation by United States federal and state government, the following are other federal and state laws
and regulations that could directly or indirectly affect our ability to operate the business:

 state
 and local licensure, registration, and regulation of the development of pharmaceuticals and biologics;

 state
 and local licensure of medical professionals;

 state
 statutes and regulations related to the corporate practice of medicine;

 laws
 and regulations administered by U.S. Customs and Border Protection related to the importation of biological material into the United
 States;

 other
 laws and regulations administered by the FDA;

 other
 laws and regulations administered by HHS;

 state
 and local laws and regulations governing human subject research and clinical trials;

 the
 federal physician self-referral prohibition, also known as Stark Law, and any state equivalents to Stark Law;

 the
 federal False Claims Act, or FCA;

 the
 federal Anti-Kickback Statute, or AKS, and any state equivalent statutes and regulations;

 federal
 and state coverage and reimbursement laws and regulations;

 state
 and local laws and regulations for the disposal and handling of medical waste and biohazardous material;

 Occupational
 Safety and Health Administration, or OSHA, regulations and requirements;

 the
 Intermediate Sanctions rules of the IRS providing for potential financial sanctions with respect to "excess benefit transactions"
 with tax-exempt organizations;

 the
 Physician Payments Sunshine Act (in the event that our products are classified as drugs, biologics, devices or medical supplies and
 are reimbursed by Medicare, Medicaid or the Children's Health Insurance Program);

 state
 and other federal laws addressing the privacy of health information; and

 state
 and foreign law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items
 or services reimbursed by any third-party payer, including commercial insurers, state laws that require pharmaceutical companies
 to comply with the pharmaceutical industry's voluntary compliance guidelines and the relevant compliance guidance promulgated
 by the federal government or otherwise restrict payments that may be made to healthcare professionals and other potential referral
 sources, state laws that require drug manufacturers to report information related to payments and other transfers of value to physicians
 and other healthcare professionals or marketing expenditures, and state laws governing the privacy and security of health information
 in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating
 compliance efforts.

 Violation
of any of the laws described above or any other governmental laws and regulations may result in penalties, including civil and criminal
penalties, damages, fines, the curtailment or restructuring of operations, the exclusion from participation in federal and state healthcare
programs and imprisonment. Furthermore, efforts to ensure that business activities and business arrangements comply with applicable healthcare
laws and regulations can be costly for manufacturers of branded prescription products.

 Foreign
Government Regulation

 In
general, we will need to comply with the government regulations of each individual country in which our therapy centers are located and
products are to be distributed and sold. These regulations vary in complexity and can be as stringent, and on occasion even more stringent,
than FDA regulations in the United States. Due to the fact that there are new and emerging cell therapy regulations that have recently
been drafted and/or implemented in various countries around the world, the application and subsequent implementation of these new and
emerging regulations have little to no precedence. Therefore, the level of complexity and stringency is not always precisely understood
for each country, creating greater uncertainty for the international regulatory process. Furthermore, government regulations can change
with little to no notice and may result in up-regulation of our product(s), thereby creating a greater regulatory burden for our cell
processing technology products. We have not yet thoroughly explored the applicable laws and regulations that we will need to comply with
in foreign jurisdictions. It is possible that we may not be permitted to expand our business into one or more foreign jurisdictions.

 We
do not have any definitive plans or arrangements with respect to the establishment by us of stem cell therapy clinics in any country.
We intend to explore any such opportunities as they arise.

 Offices

 Our
principal executive offices are located at 40 Marcus Drive, Suite One, Melville, New York, and our telephone number is (631) 760-8100.
Our website is www.biorestorative.com. Our internet website and the information contained therein or connected thereto are not intended
to be incorporated by reference into this Annual Report.

 Employees

 We
currently have 11 employees, all of whom are full-time employees. We believe that our employee relations are good.

 ITEM
 1A.

 RISK
 FACTORS.

 The
risk factors listed in this section provide examples of risks, uncertainties and events that may cause our actual results to differ materially
from the expectations we describe in our forward-looking statements. Readers should be aware that the occurrence of any of the events
described in these risk factors could have a material adverse effect on our business, results of operations and financial condition.
We undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future
events, or otherwise.

 Preceding
the full risk factors is a list of certain of the risk factors that follow. Reference is made to the complete risk factors for a full
description of the risks involved.

 Risks
Related to Our Business Generally

 We
 have a limited operating history; we have incurred substantial losses since inception; we expect to continue to incur losses for
 the near term.

 We
 will need to obtain a significant amount of financing to complete our clinical trials and implement our business plan.

 We
 will need to enter into agreements in order to implement our business strategy.

 We
 depend on our executive officers and on our ability to attract and retain additional qualified personnel.

 Risks
Relating to Change in Accounting Treatment of Our Securities and Restatement of Our Previously Issued Financial Statements in Connection
Therewith

 Our
 warrants are accounted for as a liability and the change in the fair value of our warrants or any other similar derivative liabilities
 could have a material effect on our financial results.

 Our
 failure to prepare and timely file our Quarterly Report on Form 10-Q for the period ended March 31, 2024 with the SEC limits our
 access to the public markets to raise debt or equity capital.

 We identified certain misstatements
 to our previously issued financial statements and have restated the financial statements described below, which has exposed us to
 a number of additional risks and uncertainties.

 Risks
Related to Our Cell Therapy Product Development Efforts

 Our
 future success is significantly dependent on the timely and successful development and commercialization of BRTX-100, our lead product
 candidate for the treatment of chronic lumbar disc disease; if we encounter delays or difficulties in the development of this product
 candidate, as well as any other product candidates, our business prospects would be significantly harmed.

 We
 may experience delays and other difficulties in enrolling a sufficient number of patients in our clinical trials which could delay
 or prevent the receipt of necessary regulatory approvals.

 The
 development of our cell therapy product candidates is subject to uncertainty because autologous cell therapy is inherently variable.

 Any
 disruption to our access to the media (including cell culture media) and reagents we are using in the clinical development of our
 cell therapy product candidates could adversely affect our ability to perform clinical trials and seek future regulatory submissions.

 Our
 clinical trials may fail to demonstrate adequately the safety and efficacy of our product candidates, which would prevent or delay
 regulatory approval and commercialization.

 Even
 if we complete the necessary clinical trials, we cannot predict when, or if, we will obtain regulatory approval to commercialize
 a product candidate, and the approval may be for a narrower indication than we seek.

 We
 may never obtain FDA approval for any of our product candidates in the United States and, even if we do, we may never obtain approval
 for or commercialize any of our product candidates in any foreign jurisdiction, which would limit our ability to realize our full
 market potential.

 We
 presently lack manufacturing capabilities to produce our product candidates at commercial scale quantities and do not have an alternate
 manufacturing supply at this time, which could negatively impact our ability to meet any future demand for the products.

 The
 commercial potential and profitability of our products are unknown and subject to significant risk and uncertainty.

 We
 may have difficulties in sourcing brown adipose (fat) tissue.

 If
 safety problems are encountered by us or others developing new stem cell-based therapies, our stem cell initiatives could be materially
 and adversely affected.

 We
 are vulnerable to competition and technological change, and also to physicians' inertia.

 We
 have limited experience in the development and marketing of cell therapies and may be unsuccessful in our efforts to establish a
 profitable business.

 Our
 cell therapy business is based on novel technologies that are inherently expensive, risky and may not be understood by or accepted
 in the marketplace, which could adversely affect our future value.

 Our
 cell therapy product candidates for which we intend to seek approval as biologic products may face competition sooner than anticipated.

 We
 may be subject to significant product liability claims and litigation, including potential exposure from the use of our product candidates
 in human subjects, and our insurance may be inadequate to cover claims that may arise.

 Our
 internal computer systems, or those that are expected to be used by our clinical investigators, clinical research organizations or
 other contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of development
 programs for our product candidates.

 Our
 inability to obtain reimbursement for our products and services from private and governmental insurers could negatively impact demand
 for our products and services.

 Risks
Related to Our Intellectual Property

 We
 may not be able to protect our proprietary rights.

 to United States patent law may have a material adverse effect on our intellectual property rights.

 In
 certain countries, patent holders may be required to grant compulsory licenses, which would likely have a significant and detrimental
 effect on any future revenues in such country.

 Risks
Related to Government Regulation

 Even
 if we obtain regulatory approval for a product candidate, our products will remain subject to regulatory oversight.

 We
 may be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, false claims laws and health information
 privacy and security laws. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties.

 The
 failure to receive regulatory approvals for our cell therapy product candidates would likely have a material and adverse effect on
 our business and prospects.

 If
 we are unable to conduct clinical studies in accordance with regulations and accepted standards, we may be delayed in receiving,
 or may never receive, regulatory approvals of our product candidates from the FDA and other regulatory authorities.

 Health
 care companies have been the subjects of federal and state investigations, and we could become subject to investigations in the future.

 It
 is uncertain to what extent the government, private health insurers and third-party payors will approve coverage or provide reimbursement
 for the therapies and products to which our services relate. Availability for such reimbursement may be further limited by reductions
 in Medicare, Medicaid and other federal healthcare program funding in the United States.

 Competitor
 companies or hospitals in the EU may be able to take advantage of EU rules permitting sales of unlicensed medicines for individual
 patients to sell competing products without a marketing authorization.

 Risks
Related to Our Common Stock

 We
 pay no dividends.

 Stockholders
 who hold unregistered shares of our common stock are subject to resale restrictions pursuant to Rule 144 due to our former status
 as a "shell company."

 weaknesses in our internal control over financial reporting may cause us to fail to timely and accurately report our financial results
 or result in a material misstatement of our consolidated financial statements.

 There
 may be significant future issuances or resales of our common stock which may materially and adversely dilute stockholders'
 ownership interest and affect the market price of our securities.

 Anti-takeover
 provisions and the regulations to which we may be subject may make it more difficult for a third party to acquire control of us,
 even if the change in control would be beneficial to our securityholders.

 Risks
Associated with Our Nasdaq Listing

 We
 cannot assure you that we will be able to continue to comply with the minimum bid price requirement of Nasdaq.

 The
 market price of our common stock may not attract new investors, including institutional investors, and may not satisfy the investing
 requirements of those investors. Consequently, the trading liquidity of our common stock may not improve.

 Risks
Related to Our Business Generally

 We
have a limited operating history; we have incurred substantial losses since inception; we expect to continue to incur losses for the
near term.

 We
have a limited operating history. Since our inception, we have incurred net losses. As of December 31, 2023, our accumulated deficit
was $146,699,334.

 We
will need to obtain a significant amount of financing to complete our clinical trials and implement our business plan.

 Since
our inception, we have not generated revenues from our operations and have funded our operations through the sale of our equity securities
and debt securities. The implementation of our business plan, as discussed in this Annual Report under Item 1 ("Business"),
will require the receipt of sufficient equity and/or debt financing to purchase necessary equipment, technology and materials, fund our
clinical trials and other research and development efforts and otherwise fund our operations. We will require significant additional
funding to complete our clinical trials using BRTX-100. We will also require a substantial amount of additional funding to implement
our other programs described in this Annual Report under Item 1 ("Business"), including our metabolic ThermoStem Program,
 and fund general operations. No assurance can be given that the amount of funding that we anticipate may be required for such purposes
is correct or that we will be able to accomplish our goals within the timeframes projected. In addition, no assurance can be given that
we will be able to obtain any required financing on commercially reasonable terms or otherwise. In the event we do not obtain the financing
required for the above purposes, we may have to curtail our development, marketing and promotional activities, which would have a material
adverse effect on our business, financial condition and results of operations, and ultimately we could be forced to discontinue our operations
and liquidate.

 Our
business strategy is high risk.

 We
are focusing our resources and efforts primarily on the development of cellular-based products and services which will require extensive
cash for research, development and commercialization activities. This is a high-risk strategy because there is no assurance that our
products and services, including our Disc/Spine Program and our ThermoStem metabolic brown fat research initiative, will
ever become commercially viable (commercial risk), that we will prevent other companies from depriving us of market share and profit
margins by offering services and products based on our inventions and developments (legal risk), that we will successfully manage a company
in a new area of business, regenerative medicine, and on a different scale than we have operated in the past (operational risk), that
we will be able to achieve the desired therapeutic results using stem and regenerative cells (scientific risk), or that our cash resources
will be adequate to develop our products and services until we become profitable, if ever (financial risk). We are using our cash in
one of the riskiest industries in the economy (strategic risk). This may make our securities an unsuitable investment for many investors.

 We
will need to enter into agreements in order to implement our business strategy.

 Except
for a certain license agreement with Regenerative Sciences, LLC and agreements relating to the conduct of our Phase 2 clinical trial,
we do not have any material agreements or understandings in place with respect to the implementation of our business strategy. No assurances
can be given that we will be able to enter into any necessary agreements with respect to the development of our business. Our inability
to enter into any such agreements would have a material adverse effect on our results of operations and financial condition.

 We
depend on our executive officers and on our ability to attract and retain additional qualified personnel.

 Our
performance is substantially dependent on the performance of Lance Alstodt, our Chief Executive Officer. We rely upon him for strategic
business decisions and guidance. We are also dependent on the performance of Francisco Silva, our Vice President of Research and Development.
Each of Messrs. Alstodt and Silva is subject to an employment agreement with us. We do not have any key-man insurance policies on the
lives of either of our executive officers. We believe that our future success in developing marketable products and services and achieving
a competitive position will depend in large part upon whether we can attract and retain additional qualified management and scientific
personnel. Competition for such personnel is intense, and there can be no assurance that we will be able to attract and retain such personnel.
The loss of the services of Mr. Alstodt and/or Mr. Silva or the inability to attract and retain additional personnel and develop expertise
as needed would have a substantial negative effect on our results of operations and financial condition.

 The
impact of COVID-19 and related risks could materially affect our results of operations and prospects.

 Beginning
in March 2020, the global pandemic related to the novel coronavirus COVID-19 began to impact the global economy. Because of the size
and breadth of this pandemic, all of the direct and indirect consequences of COVID-19 are not yet known and may not emerge for some time.
Risks presented by the ongoing effects of COVID-19 include, among others, the following:

Trials. We anticipate that the COVID-19 pandemic may negatively impact our clinical trials. Due to the worldwide efforts being taken
to combat COVID-19 and the increased clinical work being done in this respect, we believe that it may be difficult for certain needed
laboratory supplies, equipment and other materials to be obtained in order to conduct our clinical trials. We also anticipate that, due
to a fear of COVID-19 transmission, there may be a hesitancy on the part of certain individuals to become clinical trial participants.
We believe that these possible negative effects have lessened as more of the population has become vaccinated; however, the impact that
the vaccinations will have is uncertain at this time.

 Adverse
Legislative and/or Regulatory Action. Federal, state and local government actions to address and contain the impact of COVID-19 may
adversely affect us. For example, we may be subject to legislative and/or regulatory action that negatively impacts the manner in which
the clinical trials may be conducted.

 Operational
Disruptions and Heightened Cybersecurity Risks. Our operations could be disrupted if key members of our senior management or a significant
percentage of our workforce are unable to continue to work because of illness, government directives or otherwise. In addition, in connection
with increased remote working arrangements, we face a heightened risk of cybersecurity attacks or data security incidents and are more
dependent on internet and telecommunications access and capabilities.

 Risks
Relating to Change in Accounting Treatment of Our Securities and Restatement of Our Previously Issued Financial Statements in Connection
Therewith

 Our
Warrants are accounted for as a liability and the change in the fair value of our Warrants or any other similar derivative
liabilities could have a material effect on our financial results.

the preparation of our financial statements for the quarter ended March 31, 2024, our management reevaluated certain warrants issued
in 2021 under Accounting Standards Codification ("ASC") Subtopic 815-40, Contracts in Entity's Own Equity. ASC Section
815-40-15 addresses equity versus liability treatment and classification of equity-linked financial instruments, including warrants,
and states that a warrant may be classified as a component of equity only if, among other things, the warrant is indexed to the issuer's
common stock. Based on its reevaluation, in consultation with our Audit Committee, and after discussion with our independent registered
public accounting firm, management concluded that, for certain of our Warrants, we do not control the occurrence of events, such
as a tender offer or exchange, that may trigger cash settlement of the Warrants and not result in a change of control of the Company.
As a result, such Warrants do not meet the criteria for equity treatment and the Warrants must be recorded as a derivative liability.
Additionally, certain other Warrants contain adjustments to the settlement amount based on a variable that is not an input to the fair
value of a "fixed-for-fixed" option as defined under ASC 815-40 and, accordingly, such Warrants are not considered indexed
to our own stock and are not eligible for an exception from derivative accounting. As a result, we should have classified the Warrants
as derivative liabilities in our previously issued financial statements as of and for the years ended December 31, 2023 and 2022 and
as of and for the quarters ended March 31, 2022 through September 30, 2023. Under this accounting treatment, we are required to measure
the fair value of our Warrants at the end of each reporting period and recognize changes in the fair value from the
prior period in our operating results for the current period. As a result of the recurring fair value measurement of our Warrants
and any subsequent changes in fair value from a prior period, our results of operations in our financial statements may fluctuate
quarterly based on factors which are outside of our control. Due to this recurring fair value measurement, we expect that we
will recognize non-cash gains or losses on our Warrants each reporting period and that the amount of such gains or losses could be material.

 Our
failure to prepare and timely file our Quarterly Report on Form 10-Q for the period ended March 31, 2024 with the SEC limits our access
to the public markets to raise debt or equity capital.

 We
have not yet filed our Quarterly Report on Form 10-Q for the period ended March 31, 2024 with the SEC; therefore, we have not remained
current in our reporting requirements with the SEC. We are not currently eligible, without receiving a waiver from the SEC, to use a
short-form registration statement on Form S-3, or to use "shelf" registration statements to conduct offerings, until approximately
one year from the date we regained and maintain status as a current filer. If we wish to pursue an offering now, we would be required
to conduct the offering on an exempt basis or file a registration statement on Form S-1. Using a Form S-1 registration statement for
a public offering could take significantly longer than using a registration statement on Form S-3 and increase our transaction costs,
and could, to the extent we are not able to conduct offerings using alternative methods, adversely impact our ability to raise capital
or complete acquisitions of other companies in a timely manner.

 We
identified certain misstatements to our previously issued financial statements and have restated the financial statements described below,
which has exposed us to a number of additional risks and uncertainties.

 As
discussed in the Explanatory Note and Notes 2 and 3 of our consolidated financial statements, we have restated our previously issued
audited financial statements as of and for the years ended December 31, 2022 and 2023 and our interim financial statements as of and
for the quarterly periods ended March 31, 2022 through September 30, 2023.

 As
a result of the misstatements discussed and the Restatement, we have become subject to a number of additional risks and uncertainties
and unanticipated costs for accounting, legal and other fees and expenses, including risks of lawsuit relating to securities offered
by us in public and private offerings as well as claims by purchasers of our shares of common stock in the public market. Any actions,
lawsuits or other legal proceedings related to the misstatements or the Restatement could result in liabilities, reputational harm and
defense and other costs, regardless of the outcome of the lawsuit or proceeding.

 We
cannot ensure that litigation or other claims by stockholders will not be brought in the future arising out of the Restatement. We may
also be subject to further examinations, investigations, proceedings and orders by regulatory authorities as a result of the Restatement.
Any such further actions could be expensive and damaging to our business, results of operations and financial condition.

 Risks
Related to Our Cell Therapy Product Development Efforts

 Our
future success is significantly dependent on the timely and successful development and commercialization of BRTX-100, our lead product
candidate for the treatment of chronic lumbar disc disease; if we encounter delays or difficulties in the development of this product
candidate, as well as any other product candidates, our business prospects would be significantly harmed.

 We
are dependent upon the successful development, approval and commercialization of our product candidates. Before we are able to seek regulatory
approval of our product candidates, we must conduct and complete extensive clinical trials to demonstrate their safety and efficacy in
humans. Our lead product candidate, BRTX-100, is in early stages of development and we have just recently commenced a Phase 2
clinical trial using BRTX-100 to treat chronic lower back pain due to degenerative disc disease related to protruding/bulging
discs.

testing is expensive, difficult to design and implement, and can take many years to complete. Importantly, a failure of one or more of
these or any other clinical trials can occur at any stage of testing. We may experience numerous unforeseen events during, or as a result
of, clinical trials that could delay or prevent our ability to complete our clinical studies, receive regulatory approval or commercialize
our cell therapy product candidates, including the following:

 suspensions,
 delays or changes in the design, initiation, enrollment, implementation or completion of required clinical trials; adverse changes
 in our financial position or significant and unexpected increases in the cost of our clinical development program; changes or uncertainties
 in, or additions to, the regulatory approval process that require us to alter our current development strategy; clinical trial results
 that are negative, inconclusive or less than desired as to safety and/or efficacy, which could result in the need for additional
 clinical studies or the termination of the product's development; delays in our ability to manufacture the product in quantities
 or in a form that is suitable for any required clinical trials;

 intellectual
 property constraints that prevent us from making, using, or commercializing any of our cell therapy product candidates;

 the
 supply or quality of our product candidates or other materials necessary to conduct clinical trials of these product candidates may
 be insufficient or inadequate; the inability to generate sufficient pre-clinical, toxicology, or other in vivo or in vitro data,
 to support the initiation of clinical studies;

 in reaching agreement on acceptable terms with prospective clinical study sites, the terms of which can be subject to extensive negotiation
 and may vary significantly among different clinical study sites;

 in obtaining required Institutional Review Board, or IRB, approval at each clinical study site;

 imposition
 of a temporary or permanent clinical hold by regulatory agencies for a number of reasons, including after review of an IND application
 or amendment, or equivalent application or amendment; as a result of a new safety finding that presents unreasonable risk to clinical
 trial participants; a negative finding from an inspection of our clinical study operations or study sites; developments on trials
 conducted by competitors or approved products post-market for related technology that raise FDA concerns about risk to patients of
 the technology broadly; or if the FDA finds that the investigational protocol or plan is clearly deficient to meet its stated objectives;

 difficulty
 collaborating with patient groups and investigators;

 failure
 by our CRO, other third parties, or us to adhere to clinical study requirements;

 failure
 to perform in accordance with the FDA's current Good Clinical Practices, or GCP, requirements, or applicable regulatory guidelines
 in other countries;

 in having patients qualify for or complete participation in a study or return for post-treatment follow-up;

 patients
 dropping out of a study;

 occurrence
 of adverse events associated with the product candidate that are viewed to outweigh its potential benefits;

 changes
 in the standard of care on which a clinical development plan was based, which may require new or additional trials;

 transfer
 of manufacturing processes from any academic collaborators to larger-scale facilities operated by either a contract manufacturing
 organization, or CMO, or by us, and delays or failure by our CMOs or us to make any necessary changes to such manufacturing process;

 in our clinical trials caused by the COVID-19 pandemic or other health emergencies;

 in manufacturing, testing, releasing, validating, or importing/exporting sufficient stable quantities of our product candidates for
 use in clinical studies or the inability to do any of the foregoing;

 the
 FDA not accepting clinical data from trials that are conducted at clinical sites in countries where the standard of care is potentially
 different from the United States; and

 failure
 to raise sufficient funds to complete our clinical trials.

 Any
inability to successfully complete pre-clinical and clinical development could result in additional costs to us or impair our ability
to generate revenue. In addition, if we make manufacturing or formulation changes to our product candidates, we may be required, or we
may elect, to conduct additional studies to bridge our modified product candidates to earlier versions. Clinical study delays could also
shorten any periods during which our products have patent protection and may allow our competitors to bring products to market before
we do, which could impair our ability to successfully commercialize our product candidates and may harm our business and results of operations.

 Even
if we are able to successfully complete our clinical development program for our product candidates, and ultimately receive regulatory
approval to market one or more of the products, we may, among other things:

 obtain
 approval for indications that are not as broad as the indications we sought;

 have
 the product removed from the market after obtaining marketing approval;

 encounter
 issues with respect to the manufacturing of commercial supplies;

 be
 subject to additional post-marketing testing requirements; and/or

 be
 subject to restrictions on how the product is distributed or used.

 We
anticipate that we will not be able to commercialize our BRTX-100 product candidate for at least five years.

 We
may experience delays and other difficulties in enrolling a sufficient number of patients in our clinical trials which could delay or
prevent the receipt of necessary regulatory approvals.

 We
may not be able to initiate or complete as planned any clinical trials if we are unable to identify and enroll a sufficient number of
eligible patients to participate in the clinical trials required by the FDA or other regulatory authorities. We also may be unable to
engage a sufficient number of clinical trial sites to conduct our trials.

 We
may face challenges in enrolling patients to participate in our clinical trials due to the novelty of our cell-based therapies, the size
of the patient populations and the eligibility criteria for enrollment in the trial. In addition, some patients may have concerns regarding
cell therapy that may negatively affect their perception of therapies under development and their decision to enroll in the trials. Furthermore,
patients suffering from diseases within target indications may enroll in competing clinical trials, which could negatively affect our
ability to complete enrollment of our trials. Enrollment challenges in clinical trials often result in increased development costs for
a product candidate, significant delays and potentially the abandonment of the clinical trial.

 We
may have other delays in completing our clinical trials and we may not complete them at all.

 We
have just recently commenced the clinical trials necessary to obtain FDA approval to market our product candidate, BRTX-100. Since
we lack significant experience in completing clinical trials and bringing a drug through commercialization, we have hired outside consultants
with such experience. Clinical trials for BRTX-100 and other product candidates in development may be delayed or terminated as
a result of many factors, including the following:

 patients
 failing to complete clinical trials due to dissatisfaction with the treatment, side effects, or other reasons;

 failure
 by regulators to authorize us to commence a clinical trial;

 suspension
 or termination by regulators of clinical research for many reasons, including concerns about patient safety, the failure of study
 sites and/or investigators in our clinical research program to comply with GCP requirements, or our failure, or the failure of our
 contract manufacturers, to comply with current cGMP requirements;

 or failure to obtain clinical supply for our products necessary to conduct clinical trials from contract manufacturers;

 treatment
 candidates demonstrating a lack of efficacy during clinical trials;

 treatment
 candidates demonstrating significant safety signals; and/or

 inability
 to continue to fund clinical trials or to find a partner to fund the clinical trials.

 Any
delay or failure to complete clinical trials and obtain FDA approval for our product candidates could have a material adverse effect
on our cost to develop and commercialize, and our ability to generate revenue from, a particular product candidate.

 The
development of our cell therapy product candidates is subject to uncertainty because autologous cell therapy is inherently variable.

 When
manufacturing an autologous cell therapy, the number and composition of the cell population varies from patient to patient. Such variability
in the number and composition of these cells could adversely affect our ability to manufacture autologous cell therapies in a cost-effective
or profitable manner and meet acceptable product release specifications for use in a clinical trial or, if approved, for commercial sale.
As a consequence, the development and regulatory approval process for autologous cell therapy products could be delayed or may never
be completed.

 Any
disruption to our access to the media (including cell culture media) and reagents we are using in the clinical development of our cell
therapy product candidates could adversely affect our ability to perform clinical trials and seek future regulatory submissions.

 Certain
media (including cell culture media) and reagents, as well as devices, materials and systems, that we intend to use in our clinical trials,
and that we may need or use in commercial production, are provided by unaffiliated third parties. Any lack of continued availability
of these media, reagents, devices, materials and systems for any reason would have a material adverse effect on our ability to complete
these studies and could adversely impact our ability to achieve commercial manufacture of our planned therapeutic products. Although
other available sources for these media, reagents, devices, materials and systems may exist in the marketplace, we have not evaluated
their cost, effectiveness, or intellectual property foundation and therefore cannot guarantee the suitability or availability of such
other potential sources.

 Products
that appear promising in research and development may be delayed or may fail to reach later stages of clinical development.

 The
successful development of cellular based products is highly uncertain. Product candidates that appear promising in preclinical and early
research and development may be delayed or fail to reach later stages of development. Decisions regarding the further development of
product candidates must be made with limited and incomplete data, which makes it difficult to ensure or even accurately predict whether
the allocation of limited resources and the expenditure of additional capital on specific product candidates will result in desired outcomes.
Pre-clinical and clinical data can be interpreted in different ways, and negative or inconclusive results or adverse events during a
clinical trial could delay, limit or prevent the development of a product candidate. Positive preclinical data may not continue or occur
for future subjects in our clinical studies and may not be repeated or observed in ongoing or future studies involving our product candidates.
Furthermore, our product candidates may also fail to show the desired safety and efficacy in later stages of clinical development despite
having successfully advanced through initial clinical studies. In addition, regulatory delays or rejections may be encountered as a result
of many factors, including changes in regulatory policy during the period of product development.

 Our
clinical trials may fail to demonstrate adequately the safety and efficacy of our product candidates, which would prevent or delay regulatory
approval and commercialization.

 The
clinical trials of our product candidates are, and the manufacturing and marketing of our products will be, subject to extensive and
rigorous review and regulation by numerous government authorities in the United States and in other countries where we intend to test
and market our product candidates. Before obtaining regulatory approvals for the commercial sale of any of our product candidates, we
must demonstrate through lengthy, complex and expensive preclinical testing and clinical trials that our product candidates are both
safe and effective for use in each target indication. In particular, because some of our product candidates are subject to regulation
as biological drug products, we will need to demonstrate that those products are safe, pure, and potent for use in their target indications.
Each product candidate must demonstrate an adequate risk versus benefit profile in its intended patient population and for its intended
use. The risk/benefit profile required for product licensure will vary depending on these factors and may include decrease or elimination
of pain, adequate duration of response, a delay in the progression of the disease, an improvement in function and/or decrease in disability.

 In
addition, even if such trials are successfully completed, we cannot guarantee that the FDA will interpret the results as we do, and more
trials could be required before we submit our product candidates for approval. To the extent that the results of the trials are not satisfactory
to the FDA for support of a marketing application, we may be required to expend significant resources, which may not be available to
us, to conduct additional trials in support of potential approval of our product candidates.

 Even
if we complete the necessary clinical trials, we cannot predict when, or if, we will obtain regulatory approval to commercialize a product
candidate, and the approval may be for a narrower indication than we seek.

 We
cannot commercialize a product candidate until the appropriate regulatory authorities have reviewed and approved the product candidate.
Even if our product candidates meet their safety and efficacy endpoints in clinical trials, the regulatory authorities may not complete
their review processes in a timely manner, or we may not be able to obtain regulatory approval. Additional delays may result if an FDA
Advisory Committee or other regulatory authority recommends non-approval or restrictions or conditions on approval. In addition, we may
experience delays or rejections based upon additional government regulation from future legislation or administrative action, or changes
in regulatory authority policy during the period of product development, clinical trials and the review process. Regulatory authorities
also may approve a product candidate for more limited indications than requested or they may impose significant limitations in the form
of narrow indications, contraindications or a Risk Evaluation and Mitigation Strategy, or REMS. These regulatory authorities may require
warnings or precautions with respect to conditions of use or they may grant approval subject to the performance of costly post-marketing
clinical trials. In addition, regulatory authorities may not approve the labeling claims or allow the promotional claims that are necessary
or desirable for the successful commercialization of our product candidates. Any of the foregoing scenarios could materially harm the
commercial prospects for our product candidates and materially and adversely affect our business, financial condition, results of operations
and prospects.

 We
may never obtain FDA approval for any of our product candidates in the United States and, even if we do, we may never obtain approval
for or commercialize any of our product candidates in any foreign jurisdiction, which would limit our ability to realize our full market
potential.

 In
order to eventually market any of our product candidates in any particular foreign jurisdiction, we must establish and comply with numerous
and varying regulatory requirements regarding safety and efficacy on a jurisdiction-by-jurisdiction basis. Approval by the FDA in the
United States, if obtained, does not ensure approval by regulatory authorities in other countries or jurisdictions. In addition, preclinical
studies and clinical trials conducted in one country may not be accepted by regulatory authorities in other countries, and regulatory
approval in one country does not guarantee regulatory approval in any other country.

 Approval
processes vary among countries and can involve additional product testing and validation and additional administrative review periods.
Seeking foreign regulatory approval could result in difficulties and costs for us and require additional preclinical studies or clinical
trials which could be costly and time consuming. Regulatory requirements can vary widely from country to country and could delay or prevent
the introduction of our product candidates in those countries. The foreign regulatory approval process involves similar risks to those
associated with FDA approval. We do not have any product candidates approved for sale in any jurisdiction, including international markets,
nor have we attempted to obtain such approval. If we fail to comply with regulatory requirements in international markets or to obtain
and maintain required approvals, or if regulatory approvals in international markets are delayed, our target market will be reduced and
our ability to realize the full market potential of our products may be unrealized.

 We
presently lack manufacturing capabilities to produce our product candidates at commercial scale quantities and do not have an alternate
manufacturing supply at this time, which could negatively impact our ability to meet any future demand for the products.

 We
have utilized our laboratory to provide the cell processing services necessary for clinical production of BRTX-100 for our Phase
2 disc clinical trial. We believe that we have sufficient laboratory capacity to provide such services with regard to the balance of
the Phase 2 trial; however, we would need to significantly expand our manufacturing capabilities to provide such cell processing services
to meet potential commercial demand for BRTX-100 and any other of our product candidates, if approved, as well as any of our other
product candidates that might attain regulatory approval. Such expansion would require additional regulatory approvals. Even if we increase
our manufacturing capabilities, it is possible that we may still lack sufficient capacity to meet demand. Ultimately, if we are unable
to supply our products to meet commercial demand, whether because of processing constraints or other disruptions, delays or difficulties
that we experience, sales of the products and their long-term commercial prospects could be significantly damaged.

 We
may seek to utilize a third-party manufacturer for BRTX-100 or any of our other product candidates; however, we do not have any
arrangements in place with a third-party manufacturer. If our facilities at which these product candidates would be manufactured or our
equipment were significantly damaged or destroyed, or if there were other disruptions, delays or difficulties affecting manufacturing
capacity, our planned and future clinical studies and commercial production for these product candidates would likely be significantly
disrupted and delayed. It would be both time consuming and expensive to replace this capacity with third parties, particularly since
any new facility would need to comply with the regulatory requirements.

 Ultimately,
if we are unable to supply our cell therapy product candidates to meet commercial demand (assuming commercial approval is obtained),
whether because of processing constraints or other disruptions, delays or difficulties that we experience, our production costs could
dramatically increase and sales of the product and its long-term commercial prospects could be significantly damaged.

 The
commercial potential and profitability of our products are unknown and subject to significant risk and uncertainty.

 Even
if we successfully develop and obtain regulatory approval for our cell therapy product candidates, the market may not understand or accept
the products, which could adversely affect both the timing and level of future sales. Ultimately, the degree of market acceptance of
our product candidates (or any of our future product candidates) will depend on a number of factors, including:

 the
 clinical effectiveness, safety and convenience of the product particularly in relation to alternative treatments;

 our
 ability to distinguish our products (which involve adult cells) from any ethical and political controversies associated with stem
 cell products derived from human embryonic or fetal tissue; and

 the
 cost of the product, the reimbursement policies of government and third-party payors and our ability to obtain sufficient third-party
 coverage or reimbursement.

 Even
if we are successful in achieving sales of our product candidates, it is not clear to what extent, if any, the products will be profitable.
The costs of goods associated with production of cell therapy products are significant. In addition, some changes in manufacturing processes
or procedures generally require FDA or foreign regulatory authority review and approval prior to implementation. We may need to conduct
additional pre-clinical studies and clinical trials to support approval of any such changes. Furthermore, this review process could be
costly and time-consuming and could delay or prevent the commercialization of product candidates.

 We
may have difficulties in sourcing brown adipose (fat) tissue.

 We
use brown adipose (fat) tissue to identify and characterize brown adipose derived stem cells for use in our pre-clinical ThermoStem
Program. There is no certainty that we will be able to continue to collect brown adipose samples through any relationships that we
have, have had or may establish with potential sources of brown adipose tissue. The inability to procure brown fat tissue would have
a material adverse effect upon our ability to advance our ThermoStem Program.

 If
safety problems are encountered by us or others developing new stem cell-based therapies, our stem cell initiatives could be materially
and adversely affected.

 The
use of stem cells for therapeutic indications is still in the very early stages of development. If an adverse event occurs during clinical
trials related to one of our proposed products and/or services or those of others, the FDA and other regulatory authorities may halt
clinical trials or require additional studies. The occurrence of any of these events would delay, and increase the cost of, our development
efforts and may render the commercialization of our proposed products and/or services impractical or impossible.

 We
are vulnerable to competition and technological change, and also to physicians' inertia.

 We
will compete with many domestic and foreign companies in developing our technology and products, including biotechnology, medical device
and pharmaceutical companies. Many current and potential competitors have substantially greater financial, technological, research and
development, marketing, and personnel resources. There is no assurance that our competitors will not succeed in developing alternative
products and/or services that are more effective, easier to use, or more economical than those which we may develop, or that would render
our products and/or services obsolete and non-competitive. In general, we may not be able to prevent others from developing and marketing
competitive products and/or services similar to ours or which perform similar functions or which are marketed before ours.

 Competitors
may have greater experience in developing products, therapies or devices, conducting clinical trials, obtaining regulatory clearances
or approvals, manufacturing and commercialization. It is possible that competitors may obtain patent protection, approval or clearance
from the FDA or achieve commercialization earlier than we can, any of which could have a substantial negative effect on our business.

 We
will compete against cell-based therapies derived from alternate sources, such as bone marrow, adipose tissue, umbilical cord blood and
potentially embryos. Doctors historically are slow to adopt new technologies like ours, whatever the merits, when older technologies
continue to be supported by established providers. Overcoming such inertia often requires very significant marketing expenditures or
definitive product performance and/or pricing superiority.

 We
expect that physicians' inertia and skepticism will also be a significant barrier as we attempt to gain market penetration with
our future products and services. We may need to finance lengthy time-consuming clinical studies (so as to provide convincing evidence
of the medical benefit) in order to overcome this inertia and skepticism.

 We
may form or seek collaborations or strategic alliances or enter into additional licensing arrangements in the future, and we may not
realize the benefits of such alliances or licensing arrangements.

 We
may form or seek strategic alliances, create joint ventures or collaborations, or enter into additional licensing arrangements with third
parties that we believe will complement or augment our development and commercialization efforts with respect to our product candidates
and any future product candidates that we may develop. Any of these relationships may require us to incur non-recurring and other charges,
increase our near and long-term expenditures, issue securities that dilute the shares of our existing stockholders, or disrupt our management
and business. In addition, we face significant competition in seeking appropriate strategic partners and the negotiation process is time-consuming
and complex. Moreover, we may not be successful in our efforts to establish a strategic partnership or other alternative arrangements
for our product candidates because they may be deemed to be at too early of a stage of development for collaborative effort and third
parties may not view our product candidates as having the requisite potential to demonstrate safety and efficacy. To date, such efforts
have not been successful.

collaborations involving our product candidates, such as our collaborations with third-party research institutions, are subject to numerous
risks, which may include the following:

 have significant discretion in determining the efforts and resources that they will apply to a collaboration;

 may not pursue development and commercialization of our product candidates or may elect not to continue or renew development or commercialization
 programs based on clinical trial results, changes in their strategic focus due to the acquisition of competitive products, availability
 of funding, or other external factors, such as a business combination that diverts resources or creates competing priorities;

 may delay clinical trials, provide insufficient funding for a clinical trial, stop a clinical trial, abandon a product candidate,
 repeat or conduct new clinical trials, or require a new formulation of a product candidate for clinical testing;

 could independently develop, or develop with third parties, products that compete directly or indirectly with our products or product
 candidates;

 a
 collaborator with marketing and distribution rights to one or more products may not commit sufficient resources to their marketing
 and distribution;

 may not properly maintain or defend our intellectual property rights or may use our intellectual property or proprietary information
 in a way that gives rise to actual or threatened litigation that could jeopardize or invalidate our intellectual property or proprietary
 information or expose us to potential liability;

 disputes
 may arise between us and a collaborator that cause the delay or termination of the research, development or commercialization of
 our product candidates, or that result in costly litigation or arbitration that diverts management attention and resources;

 collaborations
 may be terminated and, if terminated, may result in a need for additional capital to pursue further development or commercialization
 of the applicable product candidates; and

 may own or co-own intellectual property covering our products that results from our collaborating with them, and in such cases, we
 would not have the exclusive right to commercialize such intellectual property.

 As
a result, if we enter into collaboration agreements and strategic partnerships or license our products or businesses, we may not be able
to realize the benefit of such transactions if we are unable to successfully integrate them with our existing operations and company
culture, which could delay our timelines or otherwise adversely affect our business. We also cannot be certain that, following a strategic
transaction or license, we will achieve the revenue or specific net income that justifies such transaction. Any delays in entering into
new collaborations or strategic partnership agreements related to our product candidates could delay the development and commercialization
of our product candidates in certain geographies for certain indications, which would harm our business prospects, financial condition,
and results of operations.

 We
have limited experience in the development and marketing of cell therapies and may be unsuccessful in our efforts to establish a profitable
business.

 Our
business plan has been focused historically on capturing a piece of the burgeoning field of cell therapy. We have limited experience
in the areas of cell therapy product development and marketing, and in the related regulatory issues and processes. Although we have
recruited a team that has experience with designing and conducting clinical trials and have hired FDA consultants, as a company, we have
limited experience in conducting clinical trials and no experience in conducting clinical trials through to regulatory approval of any
product candidate. In part because of this lack of experience, we cannot be certain that planned clinical trials will begin or be completed
on time, if at all. We cannot assure that we will successfully achieve our clinical development goals or fulfill our plans to capture
a piece of the cell therapy market.

 Our
cell therapy business is based on novel technologies that are inherently expensive, risky and may not be understood by or accepted in
the marketplace, which could adversely affect our future value.

 The
clinical development, commercialization and marketing of cell and tissue-based therapies are at an early-stage, substantially research-oriented,
and financially speculative. To date, very few companies have been successful in their efforts to develop and commercialize a cell therapy
product. In general, cell-based or tissue-based products may be susceptible to various risks, including undesirable and unintended side
effects, unintended immune system responses, inadequate therapeutic efficacy, or other characteristics that may prevent or limit their
approval or commercial use. In addition, BRTX-100 is a cell-based candidate that is produced by using a patient's own stem
cells derived from bone marrow. Regulatory approval of novel product candidates such as BRTX-100, which is manufactured using
novel manufacturing processes, can be more complex and expensive and take longer than other, more well-known or extensively studied pharmaceutical
or biopharmaceutical products, due to the FDA's lack of experience with them. To our knowledge, the FDA has not yet approved a
disc related stem cell therapy product. This lack of experience may lengthen the regulatory review process, require us to conduct additional
studies or clinical trials, which would increase our development costs, lead to changes in regulatory positions and interpretations,
delay or prevent approval and commercialization of these product candidates or lead to significant post-approval limitations or restrictions.
Furthermore, the number of people who may use cell or tissue-based therapies is difficult to forecast with accuracy. Our future success
is dependent on the establishment of a large global market for cell- and tissue-based therapies and our ability to capture a share of
this market with our product candidates.

 Our
cell therapy product candidates for which we intend to seek approval as biologic products may face competition sooner than anticipated.

 The
enactment of the Biologics Price Competition and Innovation Act of 2009, or BPCIA, created an abbreviated regulatory pathway for the
approval of products demonstrated to be biosimilar, or "highly similar," to or "interchangeable" with an FDA-approved
innovator (original) biologic product. The abbreviated regulatory pathway establishes legal authority for the FDA to review and approve
biosimilar biologics, including the possible designation of a biosimilar as "interchangeable" based on its similarity to
an existing reference product. Under the BPCIA, an application for a biosimilar product cannot be approved by the FDA until 12 years
after the original branded product is approved under a biologics license application, or BLA. The FDA has developed considerable experience
with the biosimilar and interchangeable biosimilar processes since the enactment of the BPCIA in 2009. Should any of our product candidates
be approved via the BLA pathway, we expect that biosimilar applicants will seek approval of biosimilar, and/or interchangeable, versions
of our product that could result in lower prices for our products.

 We
believe that, if any of our product candidates are approved as a biological product under a BLA, it should qualify for the 12-year period
of exclusivity. However, there is a risk that the FDA could approve biosimilar applicants for other reference products that no longer
have such exclusivity, thus potentially creating the opportunity for greater competition sooner than anticipated.

 We
may also face increased competition from stem cell therapies performed by treatment centers that do not require FDA premarket approval.
In August 2022, a federal District Court in the case of United States v. California Stem Cell Treatment Center, Inc. held that
certain autologous adipose stem cell treatments were not "biological products" and therefore did not require FDA approval.
The FDA has appealed the decision but, should it be upheld, we could face competition from stem cell clinics that would not be required
to undergo the costly and time-consuming FDA approval process.

 The
FDA's regulation of regenerative medicine products remains unpredictable and we are not certain what impact this will have on the
potential approval of our products

 The
FDA's regulation of therapies derived from stem cell products and technologies is evolving and may continue to evolve. In December
2016, the 21st Century Cures Act, or the Cures Act, was signed into law in the United States to advance access to medical innovations.
Among other things, the Cures Act established a new FDA regenerative medicine advanced therapy, or RMAT, designation. This designation
offers a variety of benefits to product candidates, including enhanced FDA support during clinical development, priority review on application
filing, accelerated approval based on potential surrogate endpoints, and the potential use of patient registry data and other forms of
real world evidence for post-approval confirmatory studies. There is no certainty that any of our product candidates will receive RMAT
designation or any other type of expedited review program designation from the FDA. In any event, the receipt of an FDA RMAT designation
or other expedited review program designation may not result in a faster development process, review or approval compared to products
considered for approval under conventional FDA procedures and does not assure ultimate approval by the FDA.

 We
may be subject to significant product liability claims and litigation, including potential exposure from the use of our product candidates
in human subjects, and our insurance may be inadequate to cover claims that may arise.

 Our
business exposes us to potential product liability risks inherent in the testing, processing and marketing of cell therapy products.
Such liability claims may be expensive to defend and result in large judgments against us. We face an inherent risk of product liability
exposure related to the testing of our current and any future product candidates in human clinical trials and will face an even greater
risk with respect to any commercial sales of our products should they be approved. No product candidate has been widely used over an
extended period of time, and therefore safety data is limited. Cell therapy companies derive the raw materials for manufacturing of product
candidates from human cell sources, and therefore the manufacturing process and handling requirements are extensive, which increases
the risk of quality failures and subsequent product liability claims.

 We
will need to maintain insurance coverage adequate to cover our clinical trials and increase that coverage before commercializing product
candidates, if ever. At any time during our clinical trials or after commercialization, if that occurs, we may not be able to obtain
or maintain product liability insurance on acceptable terms with adequate coverage or at all, or if claims against us substantially exceed
our coverage, then our financial position could be significantly impaired.

 Whether
or not we are ultimately successful in any product liability litigation that may arise, such litigation could consume substantial amounts
of our financial and managerial resources, result in decreased demand for our products and injure our reputation.

 We
seek to maintain errors and omissions, directors and officers, workers' compensation and other insurance at levels we believe to
be appropriate to our business activities. If, however, we were subject to a claim in excess of this coverage or to a claim not covered
by our insurance and the claim succeeded, we would be required to pay the claim from our own limited resources, which could have a material
adverse effect on our financial condition, results of operations and business. Additionally, liability or alleged liability could harm
our business by diverting the attention and resources of our management and damaging our reputation.

 Our
internal computer systems, or those that are expected to be used by our clinical investigators, clinical research organizations or other
contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of development programs
for our product candidates.

 We
rely on information technology systems to keep financial records, maintain laboratory and corporate records, communicate with staff and
external parties and operate other critical functions. Any significant degradation or failure of these computer systems could cause us
to inaccurately calculate or lose data. Despite the implementation of security measures, these internal computer systems and those used
by our clinical investigators, clinical research organizations, and other contractors and consultants are vulnerable to damage from computer
viruses, unauthorized access, natural disasters, terrorism, war, and telecommunication and electrical failures. The techniques that could
be used by criminal elements or foreign governments to attack these computer systems are sophisticated, change frequently and may originate
from less regulated and remote areas of the world. While we have not experienced any such system failure, theft of information, accident
or security breach to date, if such an event were to occur and cause interruptions in our operations, it could result in a material disruption
of our clinical development activities. For example, the loss of clinical trial data from historical or future clinical trials could
result in delays in regulatory approval efforts and significantly increase costs to recover or reproduce the data. To the extent that
any disruption, theft of information, or security breach were to result in a loss of or damage to data or applications, or inappropriate
disclosure of confidential or proprietary information, we could incur liability and the clinical development and the future development
of our product candidates could be delayed.

 To
operate and sell in international markets carries great risk.

 We
intend to market our products and services both domestically and in foreign markets. A number of risks are inherent in international
transactions. In order for us to market our products and services in non-U.S. jurisdictions, we need to obtain and maintain required
regulatory approvals or clearances in these countries and must comply with the country specific regulations regarding safety, manufacturing
processes and quality. These regulations, including the requirements for approvals or clearances to market, may differ from the FDA regulatory
scheme. International operations and sales also may be limited or disrupted by political instability, price controls, trade restrictions
and changes in tariffs. Additionally, fluctuations in currency exchange rates may adversely affect demand for our services and products
by increasing the price of our products and services in the currency of the countries in which the products and services are offered.

 There
can be no assurance that we will obtain regulatory approvals or clearances in all of the countries where we intend to market our products
and services, that we will not incur significant costs in obtaining or maintaining foreign regulatory approvals or clearances, or that
we will be able to successfully commercialize our products and services in various foreign markets. Delays in receipt of approvals or
clearances to market our products and services in foreign countries, failure to receive such approvals or clearances or the future loss
of previously received approvals or clearances could have a substantial negative effect on our results of operations and financial condition.

 Our
inability to obtain reimbursement for our products and services from private and governmental insurers could negatively impact demand
for our products and services.

 Market
acceptance and sales of our product candidates may depend on coverage and reimbursement policies and health care reform measures. Decisions
about formulary coverage as well as levels at which government authorities and third-party payors, such as private health insurers and
health maintenance organizations, reimburse patients for the price they pay for our product candidates, as well as levels at which these
payors pay directly for our product candidates, where applicable, could affect whether we are able to successfully commercialize these
products. We cannot guarantee that reimbursement will be available for any of our product candidates. We also cannot guarantee that coverage
or reimbursement amounts will not reduce the demand for, or the price of, our product candidates.

 If
coverage and reimbursement are not available or are available only at limited levels, we may not be able to successfully commercialize
our products. The Patient Protection and Affordable Care Act, or PPACA, as well as the Inflation Reduction Act, passed in August 2022,
and other health reforms include measures that would limit or prohibit payments for certain medical treatments or subject the pricing
of drugs and biologics to government control. In addition, in many foreign countries, particularly the countries of the European Union,
or the EU, the pricing of drugs and biologics is subject to government control. If our products are or become subject to government regulation
that limits or prohibits payment for our products, or that subjects the price of our products to government control, we may not be able
to generate revenue, attain profitability or commercialize our products.

 In
addition, third-party payors are increasingly limiting both coverage and the level of reimbursement of new drugs and biologics. They
may also impose strict prior authorization requirements and/or refuse to provide any coverage of uses of approved products for medical
indications other than those for which the FDA has granted market approvals. As a result, significant uncertainty exists as to whether
and how much third-party payors will reimburse patients for their use of newly-approved drugs and biologics. If we are unable to obtain
adequate levels of reimbursement for our product candidates, our ability to successfully market and sell our product candidates will
be harmed.

 Risks
Related to Our Intellectual Property

 We
may not be able to protect our proprietary rights.

 Our
commercial success will depend in large part upon our ability to protect our proprietary rights. There is no assurance, for example,
that any additional patents will be issued based on our or our licensor's pending applications or, if issued, that such patents
will not become the subject of a re-examination, will provide us with competitive advantages, will not be challenged by any third parties,
or that the patents of others will not prevent the commercialization of products and services incorporating our technology. Furthermore,
there can be no guarantee that others will not independently develop similar products and services, duplicate any of our products and
services, or design around any patents we obtain.

 Our
commercial success will also depend upon our ability to avoid infringing patents issued to others. If we were judicially determined to
be infringing on any third-party patent, we could be required to pay damages, alter our products, services or processes, obtain licenses,
or cease certain activities. If we are required in the future to obtain any licenses from third parties for some of our products and/or
services, there can be no guarantee that we would be able to do so on commercially favorable terms, if at all. United States and foreign
patent applications are not immediately made public, so we might be surprised by the grant to someone else of a patent on a technology
we are actively using. Although we conducted a freedom to operate, or FTO, search years ago on the licensed technology associated with
our Disc/Spine Program, modifications made, and/or further developments that may be made, to that technology may not be covered
by the initial FTO. No FTO has been undertaken with respect to our ThermoStem brown fat initiative.

 Litigation,
which would result in substantial costs to us and the diversion of effort on our part, may be necessary to enforce or confirm the ownership
of any patents issued or licensed to us, or to determine the scope and validity of third-party proprietary rights. If our competitors
claim technology also claimed by us and prepare and file patent applications in the United States, we may have to participate in interference
proceedings declared by the U.S. Patent and Trademark Office, or the Patent Office, or a foreign patent office to determine priority
of invention, which could result in substantial costs and diversion of effort, even if the eventual outcome is favorable to us. Any such
litigation or interference proceeding, regardless of outcome, could be expensive and time-consuming.

 Successful
challenges to our patents through oppositions, re-examination proceedings or interference proceedings could result in a loss of patent
rights in the relevant jurisdiction. If we are unsuccessful in actions we bring against the patents of other parties, and it is determined
that we infringe upon the patents of third parties, we may be subject to litigation, or otherwise prevented from commercializing potential
products and/or services in the relevant jurisdiction, or may be required to obtain licenses to those patents or develop or obtain alternative
technologies, any of which could harm our business. Furthermore, if such challenges to our patent rights are not resolved in our favor,
we could be delayed or prevented from entering into new collaborations or from commercializing certain products and/or services, which
could adversely affect our business and results of operations.

 Furthermore,
because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some
of our confidential or sensitive information could be compromised by disclosure in the event of litigation. In addition, during the course
of litigation there could be public announcements of the results of hearings, motions or other interim proceedings or developments. If
securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of our
common stock.

 In
addition to patents, we rely on unpatented trade secrets and proprietary technological expertise. Some of our intended future cell-related
therapeutic products and/or services may fit into this category. We also rely, in part, on confidentiality agreements with our partners,
employees, advisors, vendors, and consultants to protect our trade secrets and proprietary technological expertise. There can be no guarantee
that these agreements will not be breached, or that we will have adequate remedies for any breach, or that our unpatented trade secrets
and proprietary technological expertise will not otherwise become known or be independently discovered by competitors.

 Failure
to obtain or maintain patent protection, failure to protect trade secrets, third-party claims against our patents, trade secrets, or
proprietary rights or our involvement in disputes over our patents, trade secrets, or proprietary rights, including involvement in litigation,
could divert our efforts and attention from other aspects of our business and have a substantial negative effect on our results of operations
and financial condition.

 We
may not be able to protect our intellectual property in countries outside of the United States.

 Intellectual
property law outside the United States is uncertain and, in many countries, is currently undergoing review and revisions. The laws of
some countries do not protect our patent and other intellectual property rights to the same extent as United States laws. Third parties
may attempt to oppose the issuance of patents to us in foreign countries by initiating opposition proceedings. Opposition proceedings
against any of our patent filings in a foreign country could have an adverse effect on our corresponding patents that are issued or pending
in the United States. It may be necessary or useful for us to participate in proceedings to determine the validity of our patents or
our competitors' patents that have been issued in countries other than the United States. This could result in substantial costs,
divert our efforts and attention from other aspects of our business, and could have a material adverse effect on our results of operations
and financial condition.

to United States patent law may have a material adverse effect on our intellectual property rights.

 The
Leahy-Smith America Invents Act, or AIA, which was signed into law in 2011, significantly changes United States patent law. It may take
some time to establish what the law means, since it is just being interpreted by the lower courts, Federal Circuit Courts of Appeal,
and the Supreme Court. The effects of these decisions are still not known. The first major change is that AIA switches the United States
patent system from a "first to invent" system to a "first to file" system. Now that the first to file system
is in effect, there is a risk that another company may independently develop identical or similar patents at approximately the same time,
and be awarded the patents instead of us. Further, for the second major change, AIA abolished interference proceedings, and establishes
derivation proceedings to replace interference proceedings in all cases in which the time period for instituting an interference proceeding
has not lapsed where an inventor named in an earlier application derived the claimed invention from a named inventor. Now that the derivation
proceedings are in effect, there is a risk that the inventorship of any pending patent application can be challenged for reasons of derivation.
The third major change is that AIA established post-grant opposition proceedings that will apply only to patent applications filed after
"first to file" became effective. Post-grant opposition will enable a person who is not the patent owner to initiate proceedings
in the Patent Office within nine months after the grant of a patent that can result in cancellation of a patent as invalid. In addition
to AIA, recent court decisions have created uncertainty with regard to our ability to obtain and maintain patents. Therefore there is
a risk that any of our patents once granted may be subject to post-grant opposition, which will increase uncertainty on the validity
of any newly granted patent or may ultimately result in cancellation of the patent.

 In
addition, the Supreme Court has recently taken more limiting positions as to what constitutes patentable subject matter. As a result,
many patents covering what were previously patentable inventions are now determined to cover inventions which are deemed non-statutory
subject matter and are now invalid. As a result of this and subsequent opinions by the Court of Appeals for the Federal Circuit, the
Patent Office is now applying more stringent limitations to claims in patent applications and is refusing to grant patents in areas of
technology where patents were previously deemed available. Therefore there is a risk that we will be unable to acquire patents to cover
our products and if such patents are granted they may subsequently be found to be invalid.

 In
certain countries, patent holders may be required to grant compulsory licenses, which would likely have a significant and detrimental
effect on any future revenues in such country.

 Many
countries, including some countries in Europe, have compulsory licensing laws under which a patent owner may be compelled to grant licenses
to third parties. In addition, most countries limit the enforceability of patents against government agencies or government contractors.
In these countries, the patent owner may be limited to monetary relief and may be unable to enjoin infringement, which could materially
diminish the value of the patent. Compulsory licensing of life-saving products is also becoming increasingly common in developing countries,
either through direct legislation or international initiatives. Such compulsory licenses could be extended to our product candidates,
which may limit our potential revenue opportunities, including with respect to any future revenues that may result from our product candidates.

 Risks
Related to Government Regulation

 Even
if we obtain regulatory approval for a product candidate, our products will remain subject to regulatory oversight.

 Our
product candidates for which we obtain regulatory approval will be subject to ongoing regulatory requirements for manufacturing, labeling,
packaging, storage, advertising, promotion, record-keeping and submission of safety and other post-market information. Any regulatory
approvals that we receive for our product candidates also may be subject to a REMS or the specific obligations imposed as a condition
for marketing authorization by equivalent authorities in a foreign jurisdiction, limitations on the approved indicated uses for which
the product may be marketed or to the conditions of approval, or contain requirements for potentially costly post-marketing testing,
including Phase 4 clinical trials, and surveillance to monitor the quality, safety and efficacy of the product. For example, in the United
States, the holder of an approved new drug application, or NDA, or BLA is obligated to monitor and report adverse events and any failure
of a product to meet the specifications in the NDA or BLA. The holder of an approved NDA or BLA also must submit new or supplemental
applications and obtain FDA approval for certain changes to the approved product, product labeling or manufacturing process. Advertising
and promotional materials must comply with the Federal Food, Drug and Cosmetic Act, or FDCA, and implementing regulations and are subject
to FDA oversight and post-marketing reporting obligations, in addition to other potentially applicable federal and state laws.

 In
addition, product manufacturers and their facilities may be subject to payment of application and program fees and are subject to continual
review and periodic inspections by the FDA and other regulatory authorities for compliance with cGMP requirements and adherence to commitments
made in the NDA, BLA or foreign marketing application. If we or a regulatory authority discover previously unknown problems with a product,
such as adverse events of unanticipated severity or frequency, or problems with the facility where the product is manufactured, or if
a regulatory authority disagrees with the promotion, marketing or labeling of our product, a regulatory authority may impose restrictions
relative to that product, the manufacturing facility or us, including requiring recall or withdrawal of the product from the market or
suspension of manufacturing.

 If
we fail to comply with applicable regulatory requirements for any product candidate following approval, a regulatory authority may:

 issue
 a warning or untitled letter asserting that we are in violation of the law;

 seek
 an injunction or impose administrative, civil or criminal penalties or monetary fines;

 suspend
 or withdraw regulatory approval;

 suspend
 any ongoing clinical trials;

 refuse
 to approve a pending BLA or comparable foreign marketing application (or any supplements thereto) submitted by us or our strategic
 partners;

 restrict
 the marketing or manufacturing of the product;

 seize
 or detain the product or otherwise demand or require the withdrawal or recall of the product from the market;

 refuse
 to permit the import or export of products;

 request
 and publicize a voluntary recall of the product; or

 refuse
 to allow us to enter into supply contracts, including government contracts.

 Any
government enforcement action or investigation of alleged violations of law could require us to expend significant time and resources
in response and could generate negative publicity. The occurrence of any event or penalty described above may inhibit our ability to
commercialize our product candidates and adversely affect our business, financial condition, results of operations and prospects.

 We
may be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, false claims laws and health information
privacy and security laws. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties.

 In
the United States, the research, manufacturing, distribution, sale, and promotion of drugs and biologic products are subject to regulation
by various federal, state, and local authorities, including the FDA, the Centers for Medicare and Medicaid Services, or CMS, other divisions
the Department of Health and Human Services, or HHS (e.g., the Office of Inspector General), the United States Department of Justice
offices of the United States Attorney, the Federal Trade Commission and state and local governments. Our operations are directly, or
indirectly through our prescribers, customers and purchasers, subject to various federal and state fraud and abuse laws and regulations,
including the federal Anti-Kickback Statute, or AKS, the federal civil and criminal False Claims Act, or FCA, the Physician Payments
Sunshine Act and regulations and equivalent provisions in other countries. In addition, we may be subject to patient privacy laws by
both the federal government and the states in which we conduct our business.

 State
and federal regulatory and enforcement agencies continue actively to investigate violations of health care laws and regulations, and
the United States Congress continues to strengthen the arsenal of enforcement tools. For example, the Bipartisan Budget Act of 2018 increased
the criminal and civil penalties that can be imposed for violating certain federal health care laws, including the AKS. Enforcement agencies
also continue to pursue novel theories of liability under these laws. Government agencies have recently increased regulatory scrutiny
and enforcement activity with respect to programs supported or sponsored by pharmaceutical companies, including reimbursement and co-pay
support, funding of independent charitable foundations and other programs that offer benefits for patients. Several investigations into
these programs have resulted in significant civil and criminal settlements.

 Because
of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available, it is possible that some of our
business activities could be subject to challenge under one or more of such laws. If our operations are found to be in violation of any
of the laws described above or any other government regulations that apply to us, we may be subject to penalties, including civil and
criminal penalties, damages, fines, exclusion from participation in government health care programs, such as Medicare and Medicaid, imprisonment
and the curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our
results of operations. Even if we are not determined to have violated these laws, government investigations into these issues typically
require the expenditure of significant resources and generate negative publicity, which could harm our financial condition and divert
the attention of our management from operating our business.

in the event we determine to operate in foreign jurisdictions, including conducting clinical trials, we will need to comply with the
United States Foreign Corrupt Practices Act of 1977, or the FCPA. The FCPA prohibits a corporation, including its subsidiaries, third-party
contractors, distributors, consultants and employees, from corruptly making or offering to make payments to foreign officials for the
purpose of obtaining or enhancing business. Under the law, "foreign officials" include employees of health systems operated
by government entities. The FCPA also establishes specific record-keeping and internal accounting controls. Violations of the FCPA can
result in the imposition of civil penalties or criminal prosecution. Failure to comply with the FCPA will adversely affect our business.

 In
addition to the FCPA, we will also need to comply with the foreign government laws and regulations of each individual country in which
any therapy centers that we may establish are located and products are to be distributed and sold. These regulations vary in complexity
and can be as stringent, and on occasion even more stringent, than FDA regulations in the United States. Due to the fact that there are
new and emerging stem cell and cell therapy regulations that have recently been drafted and/or implemented in various countries around
the world, the application and subsequent implementation of these new and emerging regulations have little to no precedence. Therefore,
the level of complexity and stringency is not always precisely understood today for each country, creating greater uncertainty for the
international regulatory process. Furthermore, there can be no guarantee that laws and regulations will not be implemented, amended and/or
reinterpreted in a way that will negatively affect our business. Likewise, there can be no assurance that we will be able, or will have
the resources, to maintain compliance with all such healthcare laws and regulations. Failure to comply with such healthcare laws and
regulations, as well as the costs associated with such compliance or with enforcement of such healthcare laws and regulations, may have
a material adverse effect on our operations or may require restructuring of our operations or impair our ability to operate profitably.

 Our
current and future employees, consultants and advisors and our future principal investigators, medical institutions and commercial partners
may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements.

 We
are exposed to the risk of fraud or other misconduct by our current and future employees, consultants, advisors, principal investigators,
medical institutions and commercial partners, including contract laboratories, and CROs. Misconduct by these parties could include intentional
failures to comply with FDA regulations or the regulations applicable in other jurisdictions, provide accurate information to the FDA
and other regulatory authorities, comply with healthcare fraud and abuse laws and regulations in the United States and abroad, report
financial information or data accurately or disclose unauthorized activities to us.

 We
currently do not and in the future may not independently conduct all aspects of our product candidate research and preclinical and clinical
testing and product candidate manufacturing. If we rely on third parties, including CROs, medical institutions, and contract laboratories
to monitor and manage data for our ongoing preclinical and clinical programs, we will still maintain responsibility for ensuring their
activities are conducted in accordance with the applicable study protocol, legal, regulatory and scientific standards. We and our third-party
vendors will be required to comply with current cGMP, GCP, and Good Laboratory Practice, or GLP, requirements, which are a collection
of laws and regulations enforced by the FDA, the EU and comparable foreign authorities for all of our product candidates in clinical
development.

 In
addition, sales, marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations intended
to prevent fraud, misconduct, kickbacks, self-dealing and other abusive practices. These laws and regulations restrict or prohibit a
wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements.
Such misconduct also could involve the improper use of information obtained in the course of clinical trials or interactions with the
FDA or other regulatory authorities, which could result in regulatory sanctions and cause serious harm to our reputation.

 The
precautions we take to detect and prevent employee and third-party misconduct may not be effective in controlling unknown or unmanaged
risks or losses or in protecting us from government investigations or other actions or lawsuits stemming from a failure to comply with
these laws or regulations. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting
our rights, those actions could have a significant impact on our business, financial condition, results of operations and prospects,
including the imposition of significant fines or other sanctions.

 The
failure to receive regulatory approvals for our cell therapy product candidates would likely have a material and adverse effect on our
business and prospects.

 To
date, we have not received regulatory approval to market any of our product candidates in any jurisdiction. If we seek approval of any
of our cell therapy product candidates, we will be required to submit to the FDA and potentially other regulatory authorities extensive
pre-clinical and clinical data supporting its safety and efficacy, as well as information about the manufacturing process and to undergo
inspection of our manufacturing facility or other contract manufacturing facilities, if utilized, among other things. The process of
obtaining FDA and other regulatory approvals is expensive, generally takes many years and is subject to numerous risks and uncertainties,
particularly with complex and/or novel product candidates such as our cell-based product candidates. Changes in regulatory approval requirements,
policies, or court decisions may cause delays in the approval or rejection of an application, make it easier for our competitors to gain
regulatory approval to enter the marketplace, or allow competitors to enter the market without having to obtain FDA approval. Ultimately,
the FDA and other regulatory agencies have substantial discretion in the approval process and may refuse to accept any application or
may decide that our product candidate data are insufficient for approval without the submission of additional preclinical, clinical or
other studies. In addition, varying agency interpretations of the data obtained from preclinical and clinical testing could delay, limit
or prevent regulatory approval of a product candidate. Any difficulties or failures that we encounter in securing regulatory approval
for our product candidates would likely have a substantial adverse impact on our ability to generate product sales, and could make any
search for a collaborative partner more difficult. Similarly, any regulatory approval we ultimately obtain may be limited or subject
to restrictions or post-approval commitments that render the approved product not commercially viable.

 If
we are unable to conduct clinical studies in accordance with regulations and accepted standards, we may be delayed in receiving, or may
never receive, regulatory approvals of our product candidates from the FDA and other regulatory authorities.

 To
obtain marketing approvals for our product candidates in the United States and abroad, we must, among other requirements, complete adequate
and well-controlled clinical trials sufficient to demonstrate to the FDA and other regulatory bodies that the product candidate is safe
and effective for each indication for which approval is sought. If the FDA finds that patients enrolled in the trial are or would be
exposed to an unreasonable and significant risk of illness or injury, due to, among other things, occurrence of a serious adverse event
in an ongoing clinical trial, the FDA can place one or more of our clinical trials on hold. If safety concerns develop, we may, or the
FDA or an institutional review board may require us to, stop the affected trials before completion.

 The
completion of our clinical trials also may be delayed or terminated for a number of other reasons, including if:

 third-party
 clinical investigators do not perform the clinical trials on the anticipated schedule or consistent with the clinical trial protocol,
 good clinical practices required by the FDA and other regulatory requirements, or other third parties do not perform data collection
 and analysis in a timely or accurate manner;

 inspections
 of clinical trial sites by the FDA or other regulatory authorities reveal violations that require us to undertake corrective action,
 suspend or terminate one or more sites, or prohibit use of some or all of the data in support of marketing applications; or

 the
 FDA or one or more institutional review boards suspends or terminates the trial at an investigational site, or precludes enrollment
 of additional subjects.

 Our
development costs will increase if there are material delays in our clinical trials, or if we are required to modify, suspend, terminate
or repeat a clinical trial. If we are unable to conduct our clinical trials properly, we may never receive regulatory approval to market
our product candidates.

 Health
care companies have been the subjects of federal and state investigations, and we could become subject to investigations in the future.

 Both
federal and state government agencies have heightened civil and criminal enforcement efforts. There are numerous ongoing investigations
of health care companies, as well as their executives and managers. In addition, amendments to the federal FCA, including under healthcare
reform legislation, have made it easier for private parties to bring " qui tam " (or whistleblower) lawsuits against
companies under which the whistleblower may be entitled to receive a percentage of any money paid to the government. The FCA provides,
in part, that an action can be brought against any person or entity that has knowingly presented, or caused to be presented, a false
or fraudulent request for payment from the federal government, or who has made a false statement or used a false record to get a claim
approved. The government has taken the position that claims presented in violation of the federal AKS, Stark Law or other healthcare-related
laws, including laws enforced by the FDA, may be considered a violation of the FCA. Penalties include substantial fines for each false
claim, plus three times the amount of damages that the federal government sustained because of the act of that person or entity and/or
exclusion from the Medicare and Medicaid programs. In addition, a majority of states have adopted similar state whistleblower and false
claims provisions.

 We
are not aware of any government investigations involving any of our facilities or management. While we believe that we are in compliance
with applicable governmental healthcare laws and regulations, any future investigations of our business or executives could cause us
to incur substantial costs, and result in significant liabilities or penalties, as well as damage to our reputation.

 It
is uncertain to what extent the government, private health insurers and third-party payors will approve coverage or provide reimbursement
for the therapies and products to which our services relate. Availability for such reimbursement may be further limited by reductions
in Medicare, Medicaid and other federal healthcare program funding in the United States.

 To
the extent that health care providers cannot obtain coverage or reimbursement for our products and therapies, they may elect not to provide
such products and therapies to their patients and, thus, may not need our services. Further, as cost containment pressures are increasing
in the health care industry, government and private payors may adopt strategies designed to limit the amount of reimbursement paid to
health care providers.

 Similarly,
the trend toward managed health care and bundled pricing for health care services in the United States, could significantly influence
the purchase of healthcare products and services, resulting in lower prices and reduced demand for our therapeutic products under development.

 We
may directly or indirectly receive revenues from federal health care programs, such as Medicare. Federal health care programs are subject
to changes in coverage and reimbursement rules and procedures, including retroactive rate adjustments. These contingencies could materially
decrease the range of services covered by such programs or the reimbursement rates paid directly or indirectly for our products and services.
To the extent that any health care reform favors the reimbursement of other therapies over our therapeutic products under development,
such reform could affect our ability to sell our services, which may have a material adverse effect on our revenues.

 The
limitation on reimbursement available from private and government payors may reduce the demand for, or the price of, our products and
services, which could have a material adverse effect on our revenues. Additional legislation or regulation relating to the health care
industry or third-party coverage and reimbursement may be enacted in the future which could adversely affect the revenues generated from
the sale of our products and services.

 Furthermore,
there has been a trend in recent years towards reductions in overall funding for Medicare, Medicaid and other federal health care programs.
The reduced funding of governmental programs could have a negative impact on the demand for our services to the extent it relates to
products and services which are reimbursed by government and private payors.

 Unintended
consequences of healthcare reform in the United States may adversely affect our business.

 The
healthcare industry is undergoing fundamental changes resulting from political, economic and regulatory influences. In the United States,
the PPACA was signed into law in 2010 under the Obama administration. By implementing comprehensive reforms, the law seeks to, among
other things, increase access to healthcare for the uninsured and control the escalation of healthcare expenditures within the economy.

 In
addition, other legislative changes have been adopted since the PPACA was enacted. These changes include aggregate reductions in Medicare
payments to providers of 2% per fiscal year, which went into effect in April 2013 and, following passage of the Bipartisan Budget Act
of 2018, will remain in effect through 2030 unless additional Congressional action is taken. In January 2013, President Obama signed
into law the American Taxpayer Relief Act of 2012, which, among other things, further reduced Medicare payments to several types of providers
and increased the statute of limitations period for the government to recover overpayments to providers from three to five years. Congress
has since considered additional reductions in Medicare reimbursement for drugs and devices as part of legislation to reduce the budget
deficit. Similar legislation could be enacted in the future. The Medicare regulations and interpretive determinations that determine
how drugs, devices and services are covered and reimbursed also are subject to change. These laws, regulations, and interpretive determinations
may result in additional reductions in Medicare and other health care funding, which could impact our business.

 In
August 2022, President Biden signed the Inflation Reduction Act, or the IRA, which provides for (i) the government to set or negotiate
prices for select high-cost Medicare Part D (beginning in 2026) and Medicare Part B drugs (beginning in 2028) that are more than nine
years (for small-molecule drugs) or 13 years (for biological products) from their FDA approval, (ii) manufacturers to pay a rebate for
Medicare Part B and Part D drugs when prices increase faster than inflation beginning in 2022 for Medicare Part D and 2023 for Medicare
Part B drugs, and (iii) Medicare Part D redesign which replaces the current coverage gap provisions and establishes a $2,000 cap for
out-of-pocket limits costs for Medicare beneficiaries beginning in 2025, with manufacturers being responsible for 10% of costs up to
the $2,000 cap and 20% after that cap is reached. Implementation of the IRA is expected to be carried out through upcoming actions by
regulatory authorities, the outcome of which is uncertain.

 Healthcare
reform measures that may be adopted in the future, may result in more rigorous coverage criteria and decreased reimbursement. The implementation
of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability or
commercialize our product candidates. It is difficult to predict how enforcement initiatives under the PPACA, the IRA, and/or additional
legislation or regulation enacted in the future may impact our business. If the PPACA, the IRA, and/or additional legislation or regulation
enacted in the future cause such unintended consequences or indirect impact, they could have a material adverse effect on our business,
financial condition and results of operations.

 Competitor
companies or hospitals in the EU may be able to take advantage of EU rules permitting sales of unlicensed medicines for individual patients
to sell competing products without a marketing authorization.

 The
EU medicines rules allow individual member states to permit the supply of a medicinal product without a marketing authorization to fulfill
special needs, where the product is supplied in response to a bona fide unsolicited order, formulated in accordance with the specifications
of a healthcare professional and for use by an individual patient under his direct personal responsibility. This may, in certain countries,
also apply to products manufactured in a country outside the EU and imported to treat specific patients or small groups of patients.
In addition, advanced therapy medicinal products do not need a marketing authorization if they are prepared on a non-routine basis and
are used within the same EU member state in a hospital in accordance with a medical prescription for an individual patient.

 These
exemptions could allow our competitors to make sales in the EU without having obtained a marketing authorization and without undergoing
the expense of clinical trials, especially if those competitors have cell processing facilities in the relevant EU member state. Similarly,
certain hospitals may be able to compete with us on the basis of these rules.

 Risks
Related to Our Common Stock

 We
pay no dividends.

 We
have never paid cash dividends in the past, and currently do not intend to pay any cash dividends in the foreseeable future. We intend
to retain earnings, if any, to finance the development and expansion of our business. Our future dividend policy will be subject to the
discretion of our Board of Directors and will be contingent upon future earnings, if any, our financial condition, capital requirements,
general business conditions, and other factors. Therefore, we can give no assurance that any dividends of any kind will ever be paid
to holders of our common stock.

 There
is no assurance that an active trading market for our common stock will be sustained.

 Our
common stock is listed on Nasdaq. However, no assurance can be given that an active market for our common stock will be sustained. In
addition, although there have been market makers in our common stock, we cannot assure that these market makers will continue to make
a market in our securities or that other factors outside of our control will not cause them to stop market making in our securities.
Making a market in securities involves maintaining bid and ask quotations and being able to effect transactions in reasonable quantities
at those quoted prices, subject to various securities laws and other regulatory requirements. Furthermore, the development and maintenance
of a public trading market depends upon the existence of willing buyers and sellers, the presence of which is not within our control
or that of any market maker. Market makers are not required to maintain a continuous two-sided market, are required to honor firm quotations
for only a limited number of securities, and are free to withdraw firm quotations at any time. Even with a market maker, factors such
as our past losses from operations and the small size of our company mean that there can be no assurance of an active and liquid market
for our securities developing in the foreseeable future. Even if there is a market for our securities, we cannot assure that securityholders
will be able to resell their securities at any price.

 Stockholders
who hold unregistered shares of our common stock are subject to resale restrictions pursuant to Rule 144 due to our former status as
a "shell company."

 We
previously were a "shell company" pursuant to Rule 144, promulgated under the Securities Act, or Rule 144, and, as such,
sales of our securities pursuant to Rule 144 cannot be made unless, among other things, we continue to remain subject to Section 13 or
15(d) of the Exchange Act, and we file all of our required periodic reports with the SEC under the Exchange Act. Because our unregistered
securities cannot be sold pursuant to Rule 144 unless we continue to meet such requirements, any unregistered securities we sell in the
future or issue to consultants or employees, in consideration for services rendered or for any other purpose, will have no liquidity
unless we continue to comply with such requirements. As a result, it may be more difficult for us to obtain financing to fund our operations
and pay our consultants and employees with our securities instead of cash.

 We
have incurred, and will continue to incur, increased costs as a result of being an SEC reporting company.

 The
Sarbanes-Oxley Act of 2002, or the Sarbanes-Oxley Act, as well as a variety of related rules implemented by the SEC, have required changes
in corporate governance practices and generally increased the disclosure requirements of public companies. As a reporting company, we
incur significant legal, accounting and other expenses in connection with our public disclosure and other obligations. Based upon SEC
regulations currently in effect, we are required to establish, evaluate and report on our internal control over financial reporting.
We believe that compliance with the myriad of rules and regulations applicable to reporting companies and related compliance issues will
continue to require a significant amount of time and attention from our management.

weaknesses in our internal control over financial reporting have caused and may cause us to fail to timely and accurately report our
financial results or result in a material misstatement of our consolidated financial statements.

 We
identified control deficiencies in the design and operation of our internal
control over financial reporting that constituted material weaknesses, as further described in Item 9A of this Annual Report ("Controls
and Procedures"). A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting
such that there is a reasonable possibility that a material misstatement of our consolidated financial statements will not be prevented
or detected on a timely basis. Our material weaknesses related to the following control deficiencies:

 Lack
 of adherence to formal policies and procedures;

 Lack
 of risk assessment procedures on internal controls to detect financial reporting risks on a timely manner;

 Lack
 of sufficient formal management testing over documented formal procedures and controls, and time to evaluate continuous effectiveness
 of controls to achieve complete and accurate financial reporting and disclosures, including documented controls over the preparation
 and review of journal entries and account reconciliations; and

 Lack of design and implementation of effective controls over the accounting for warrants issued in connection with
equity financings.

 The
deficiencies described above have resulted and, if not remedied, could
result in a misstatement of one or more account balances or disclosures in our annual or interim consolidated financial statements that
would not be prevented or detected, and, accordingly, we determined that these control deficiencies constituted material weaknesses.

 To
address our material weaknesses, we have engaged an external financial consulting firm to assist us with implementing enhancements
and controls within our accounting systems, and further evolving our accounting and quarterly and annual close processes. We will
not be able to remediate these control deficiencies until these steps have been completed and have been operating effectively for a
sufficient period of time and Management has concluded, through testing, that the controls are operating effectively. The redesign
and implementation of improvements to our accounting and proprietary systems and controls may be costly and time consuming and the
cost to remediate may impair our results of operations in the future.

 If
we fail to remediate our material weakness, identify future material weaknesses in our internal control over financial reporting or fail
to meet the demands that have been placed upon us as a public company, including the requirements of the Sarbanes-Oxley Act, we may be
unable to accurately report our financial results or report them within the timeframes required by law or stock exchange regulations.
Failure to comply with Section 404 of the Sarbanes-Oxley Act could also potentially subject us to sanctions or investigations by the
SEC or other regulatory authorities. If additional material weaknesses exist or are discovered in the future, and we are unable to remediate
any such material weakness, our reputation, results of operations and financial condition could suffer.

 Our
stock price may fluctuate significantly and be highly volatile and this may make it difficult for a securityholder to resell our securities
at the volume, prices and times the securityholder finds attractive.

 The
market price of our common stock may be subject to significant fluctuations and be highly volatile, which may make it difficult for a
securityholder to resell our securities at the volume, prices and times the securityholder finds attractive. There are many factors that
will impact our stock price and trading volume, including, but not limited to, the factors listed above under "Risks Related to
Our Business Generally," "Risks Related to Our Cell Therapy Product Development Efforts," "Risks Related to Our
Intellectual Property," "Risks Related to Government Regulation," "Risks Related to Our Common Stock" and
"Risks Associated with Our Nasdaq Listing."

 Stock
markets, in general, experience significant price and volume volatility, and the market price of our securities may continue to be subject
to such market fluctuations that may be unrelated to our operating performance and prospects. Increased market volatility and fluctuations
could result in a substantial decline in the market price of our securities.

 There
may be significant future issuances or resales of our common stock which may materially and adversely dilute stockholders' ownership
interest and affect the market price of our securities.

 We
currently have authorization to issue up to 75,000,000 shares of common stock of which, as of March 20, 2024, 6,769,919 shares were issued
and outstanding. In addition, as discussed in Item 1 ("Business – Business Development – Material Events During 2024"),
we are obligated to issue an additional 1,351,580 shares of common stock. We are not restricted from issuing additional shares of our
common stock in the future, including securities convertible into, or exchangeable or exercisable for, shares of our common stock. In
addition, there are 1,398,158 shares of Series B preferred stock issued and outstanding. Such shares are convertible under certain circumstances
into an equal number of shares of common stock.

to our November 2021 public offering of securities, we issued warrants for the purchase of an aggregate of 2,645,000 shares of common
stock (of which warrants for the purchase of an aggregate of 1,675,000 shares of common stock have been exercised) as well as underwriter
warrants for the purchase of 235,970 shares of common stock. We have an effective registration statement on Form S-3 under the Securities
Act registering the issuance of such shares. The shares issuable pursuant to the registration statement on Form S-3 will be freely tradable
in the public market, except for shares held by affiliates. In addition, in connection with the public offering and pursuant to exchange
agreements entered into with holders of convertible notes and warrants, we issued an aggregate of 313,789 shares of common stock and
warrants for the purchase of an aggregate of 1,856,938 shares of common stock (of which warrants for the purchase of an aggregate of
1,676,580 shares of common stock have been exercised). The shares of common stock issued to such holders are eligible for resale in the
open market (subject to Rule 144 volume limitations applicable to affiliates), potentially causing sales in the market to increase and
our stock price to decline. We have registered the resale of the shares of common stock issuable upon exercise of such warrants. The
issuance of shares of common stock upon exercise of the above warrants would dilute the ownership of our stockholders.

 In
addition, in February 2024, in connection with the warrant exercises discussed in Item 1 ("Business – Business Development
– Material Events During 2024"), we issued warrants for the purchase of an aggregate of 2,513,686 shares of common stock.
We have agreed to file a registration statement with the SEC to register the resale of the shares of common stock underlying such warrants.

 We
also have effective registration statements on Form S-8 under the Securities Act registering an aggregate of 3,850,000 shares of our
common stock issuable under our 2021 Stock Incentive Plan, or the 2021 Plan (of which 319,797 shares have been issued). As of March 20,
2024, options to purchase 3,401,608 shares of our common stock were outstanding under the 2021 Plan. The shares issued and issuable pursuant
to the registration statements on Form S-8 will be freely tradable in the public market, except for shares held by affiliates. We may
include a resale prospectus in a registration statement on Form S-8 with regard to the 2021 Plan covering the resale of the shares issuable
to Messrs. Alstodt and Silva (and other affiliates) upon their exercise of options held by them and the vesting of the above described
RSUs. The resale of such shares will be currently subject to the volume limitations imposed by Rule 144.

we have an effective shelf registration statement on Form S-3 under the Securities Act registering $75,000,000 of our equity and debt
securities. Pursuant to the requirements of Form S-3, we currently may sell pursuant to such Form S-3, during any 12 month period, securities
having an aggregate market value of no more than one-third of the aggregate market value of the shares of our common stock held by non-affiliates.

 The
sale of a substantial number of shares of our common stock or securities convertible into, or exchangeable or exercisable for, shares
of our common stock, whether directly by us in future offerings or by our existing stockholders in the secondary market, the perception
that such issuances or resales could occur or the availability for future issuances or resale of shares of our common stock or securities
convertible into, or exchangeable or exercisable for, shares of our common stock could materially and adversely affect the market price
of our securities and our ability to raise capital through future offerings of equity or equity-related securities on attractive terms
or at all.

 In
addition, our Board of Directors is authorized to designate and issue 18,456,842 shares of preferred stock without further stockholder
approval, containing such rights and preferences as our Board of Directors shall determine. We may also issue other equity and equity-related
securities that are senior to our common stock in the future for a number of reasons, including, without limitation, to support operations
and growth, and to comply with any future changes in regulatory standards.

 Anti-takeover
provisions and the regulations to which we may be subject may make it more difficult for a third party to acquire control of us, even
if the change in control would be beneficial to our securityholders.

 We
are incorporated in Nevada. Anti-takeover provisions in Nevada law and our articles of incorporation and bylaws could make it more difficult
for a third party to acquire control of us and may prevent stockholders from receiving a premium for their securities. Our certificate
of incorporation provides that our Board of Directors may issue up to 20,000,000 shares of preferred stock, in one or more series, without
stockholder approval and with such terms, preferences, rights and privileges as the Board of Directors may deem appropriate. Of such
20,000,000 authorized shares, 1,398,158 shares of Series B preferred stock are issued and outstanding. These provisions and other factors
may hinder or prevent a change in control, even if the change in control would be perceived as beneficial to, or sought by, our other
stockholders.

 Risks
Associated with Our Nasdaq Listing

 We
cannot assure you that we will be able to continue to comply with the minimum bid price requirement of Nasdaq.

 Although
the market price of our common stock satisfied the initial listing minimum bid price requirement for Nasdaq, there can be no assurance
that the market price of our common stock will remain at the $1.00 per share level required for continuing compliance with that requirement.
There are many factors, such as negative financial or operational results, that could adversely affect the market price of our common
stock and jeopardize our ability to maintain Nasdaq's minimum bid price requirement.

 The
market price of our common stock may not attract new investors, including institutional investors, and may not satisfy the investing
requirements of those investors. Consequently, the trading liquidity of our common stock may not improve.

 Although
we believe that our Nasdaq listing has helped generate greater and broader investor interest, including institutional investors, there
can be no assurances in that regard. In addition, there can be no assurance that the market price of our common stock will satisfy the
investing requirements of those investors. As a result, the trading liquidity of our common stock may not necessarily improve.

 ITEM
 1B.

 UNRESOLVED
 STAFF COMMENTS.

 Not

 ITEM
 1C.

 CYBERSECURITY.

 We
recognize the critical importance of cybersecurity in safeguarding sensitive information, maintaining operational resilience, and protecting
stakeholders' interests.

 We
are in the process of establishing a cybersecurity policy designed to establish a comprehensive framework for identifying, assessing,
mitigating, and responding to cybersecurity risks across the organization and implement protocols to evaluate, recognize, and address
significant risks, including those posed by cybersecurity threats. This strategy will encompass the utilization of standard traffic monitoring
tools, educating personnel to identify and report abnormal activities, and partnering with reputable service providers capable of upholding
security standards equivalent to or exceeding our own.

 These
measures are to be integrated into our broader operational risk management framework aimed at minimizing exposure to unnecessary risks
across our operations. For cybersecurity, we collaborate with consultants and third-party service providers to implement industry-standard
strategies aimed at identifying and mitigating potential threats or vulnerabilities within our systems. Additionally, the policy strategy
will have a comprehensive cybersecurity crisis response plan to manage high severity security incidents, ensuring efficient coordination
across the organization.

 Cybersecurity
threats have not significantly impacted our operations, and we do not anticipate such risks materially affecting our business, strategy,
financial condition, or results of operations. However, given the escalating sophistication of cybersecurity threats, our preventive
measures may not always suffice. Despite well-designed controls, we acknowledge the inability to foresee all security breaches, including
those stemming from third-party misuse of AI technologies, and the potential challenges in implementing timely preventive measures. See
Item 1A ("Risk Factors - Our internal computer systems, or those that are expected to be used by our clinical investigators, clinical
research organizations or other contractors or consultants, may fail or suffer security breaches, which could result in a material disruption
of development programs for our product candidates.") for further insights into cybersecurity attack-related risks that we may
face.

 Our
Chief Financial Officer will oversee our information security programs, including cybersecurity initiatives, and our cybersecurity incident
response process. The Audit Committee of the Board oversees cybersecurity risk management activities, supported by our management, the
Board of Directors, and external consultants. We assess and prioritize risks based on potential impact, implement technical controls,
and monitor third-party vendors' security practices.

 ITEM
 2.

 PROPERTIES.

 Our
principal executive offices and laboratory are located at 40 Marcus Drive, Suite One, Melville, New York. We occupy 6,800 square feet
of space at the premises pursuant to a lease that expires in December 2024. The lease provides for a current annual base rental of $173,060.
Our premises are suitable and adequate for our current operations.

 ITEM
 3.

 LEGAL
 PROCEEDINGS.

 None.

 ITEM
 4.

 MINE
 SAFETY DISCLOSURES.

 Not

 PART
II

 ITEM
 5.

 MARKET
 FOR REGISTRANT'S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES.

 Market
Information

 Transactions
in our common stock are currently reported under the symbol "BRTX" on the Nasdaq Capital Market.

 Holders

 As
of March 28, 2024, there were 352 record holders of our shares of common stock.

 Dividends

 Not

 Recent
Sales of Unregistered Securities

 None.

 Issuer
Purchases of Equity Securities

 None.

 ITEM
 6.

 [RESERVED]

 ITEM
 7.

 MANAGEMENT'S
 DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.

 The
following discussion and analysis of the consolidated results of operations and financial condition of BioRestorative Therapies, Inc.
as of December 31, 2023 and 2022 and for the years ended December 31, 2023 and 2022 should be read in conjunction with our financial
statements and the notes to those financial statements that are included elsewhere in this Annual Report following Item 16 ("Form
10-K Summary"). References in this "Management's Discussion and Analysis of Financial Condition and Results of Operations"
to "us," "we," "our," and similar terms refer to BioRestorative Therapies, Inc.. This Annual Report
contains forward-looking statements as that term is defined in the federal securities laws. The events described in forward-looking statements
contained in this Annual Report may not occur. Generally, these statements relate to business plans or strategies, projected or anticipated
benefits or other consequences of our plans or strategies, projected or anticipated benefits from acquisitions that may be made by us,
or projections involving anticipated revenues, earnings or other aspects of our operating results. The words "may," "will,"
"expect," "believe," "anticipate," "project," "plan," "intend,"
"estimate," and "continue," and their opposites and similar expressions, are intended to identify forward-looking
statements. We caution you that these statements are not guarantees of future performance or events and are subject to a number of uncertainties,
risks and other influences, many of which are beyond our control, which may influence the accuracy of the statements and the projections
upon which the statements are based. Reference is made to Item 1A of this Annual Report ("Risk Factors") for a discussion
of some of the uncertainties, risks and assumptions associated with these statements. This "Management's Discussion and Analysis of Financial Condition
and Results of Operations" has been amended and restated to give effect to the restatement of our consolidated financial statements,
as more fully described in Note 2 to our financial statements entitled "Restatement of Previously Issued Consolidated Financial
Statements". For further detail regarding the Restatement, see "Explanatory Note" and "Item 9A. Controls and Procedures."

 Overview

 We
develop therapeutic products and medical therapies using cell and tissue protocols, primarily involving adult stem cells.

 We
are currently pursuing our Disc/Spine Program with our initial investigational therapeutic product being called BRTX-100.
In March 2022, a United States patent issued in our Disc/Spine Program. We have received authorization from the FDA to commence
a Phase 2 clinical trial investigating the use of BRTX-100 in the treatment of chronic lower back pain arising from degenerative
disc disease. We have commenced such clinical trial through the execution of a CRO agreement with PRC Clinical, the execution of clinical
trial site agreements, patient enrollment, the commencement of patient procedures, the purchase of manufacturing equipment and the expansion
of our laboratory to include capabilities for clinical production. We have obtained an exclusive license to use technology for investigational
adult stem cell treatment of disc and spine conditions, including protruding and bulging lumbar discs. The technology is an advanced
stem cell injection procedure that may offer relief from lower back pain, buttock and leg pain, and numbness and tingling in the leg
and foot.

 We
are also developing our ThermoStem Program. This pre-clinical program involves the use of brown adipose (fat) in connection with
the cell-based treatment of type 2 diabetes and obesity as well as hypertension, other metabolic disorders and cardiac deficiencies.
United States patents related to the ThermoStem Program were issued in September 2015, January 2019, March 2020, March 2021, July
2021, June 2023 and December 2023; Australian patents related to the ThermoStem Program were issued in April 2017, October 2019
and August 2021; Japanese patents related to the ThermoStem Program were issued in December 2017, June 2021, February 2022 and
June 2023; Israeli patents related to our ThermoStem Program were issued in October 2019, May 2020 and March 2022; and European
patents related to the ThermoStem Program were issued in April 2020, January 2021 and July 2023.

 We
have licensed a patented curved needle device that is a needle system designed to deliver cells and/or other therapeutic products or
materials to the spine and discs or other potential sites. We anticipate that FDA approval or clearance will be necessary for this device
prior to commercialization. We do not intend to utilize this device in connection with our Phase 2 clinical trial with regard to BRTX-100.

 We
are seeking to develop a biologics-based cosmetic products business. Pursuant to such business, we would manufacture and sell cosmetics
and hair growth products designed for cosmetic and aesthetic uses.

 Our
offices are located in Melville, New York where we have established a laboratory facility in order to increase our capabilities for the
further development of possible cellular-based treatments, products and protocols, stem cell-related intellectual property and translational
research applications.

 As
of December 31, 2023, our accumulated deficit was $146,699,334. We have historically only generated a modest amount of revenue, and our
losses have principally been operating expenses incurred in research and development, marketing and promotional activities in order to
commercialize our products and services, plus costs associated with meeting the requirements of being a public company. We expect to
continue to incur substantial costs for these activities over at least the next year.

 In
November 2021, we completed a $23,000,000 underwritten public offering of units of securities pursuant to which an aggregate of 2,300,000
shares of our common stock and warrants for the purchase of an aggregate of 2,645,000 shares of our common stock were issued. We are
using the net proceeds from the offering as follows: (i) undertaking of clinical trials with respect to BRTX-100 and its related
collection and delivery procedure; (ii) pre-clinical research and development with respect to our ThermoStem Program; and (iii)
general corporate and working capital purposes. In connection with the public offering, our common stock was listed on the Nasdaq Capital
Market.

 In
November 2021, concurrently with the consummation of the public offering, we issued an aggregate of 313,789 shares of our common stock,
1,543,158 shares of our Series A preferred stock and warrants for the purchase of an aggregate of 1,856,938 shares of our common stock
in exchange for convertible promissory notes in the aggregate principal amount of $10,046,897, together with accrued interest thereon,
and warrants for the purchase of an aggregate of 3,677,997 shares of our common stock. Such indebtedness and warrants were exchanged
at a price of $10.00 per unit of securities, consistent with the public offering price of our units of common stock and warrants. The
newly issued warrants are exercisable for a period of five years at an exercise price of $10.00 per share. In September 2022, the 1,543,158
shares of Series A preferred stock were exchanged for an equal number of shares of Series B preferred stock. As of March 28, 2024, there
were 1,398,158 shares of Series B preferred stock issued and outstanding.

 In
April 2023, we entered into a Capital on Demand Sales Agreement with JonesTrading Institutional Services LLC, or the Sales Agent, under
which we currently have the ability to issue and sell shares of our common stock, from time to time, through the Sales Agent, up to an
aggregate offering price of approximately $6,109,000 in what is commonly referred to as an "at-the-market", or ATM, program.
During the year ended December 31, 2023, we sold 132,827 shares of our common stock under the ATM program with the Sales Agent at a weighted-average
gross price of approximately $4.68 per share and raised approximately $622,000 of gross proceeds. The total commissions and related legal
fees were approximately $127,000, and we received net proceeds of approximately $495,000. As of December 31, 2023, we had remaining capacity
to sell up to an additional $5,487,000 of common stock under the ATM program.

 In
July 2023, we sold an aggregate of 685,033 shares of our common stock in a registered direct public offering. We received net proceeds
of approximately $1,854,000 from the offering.

 The
net proceeds received from our November 2021 public offering, the ATM program and the registered direct offering are sufficient for us
to complete our Phase 2 clinical trial with regard to BRTX-100; however, we will require significant additional funding to complete
our contemplated Phase 3 BRTX-100 clinical trial (assuming the receipt of no revenues). We will also require a substantial amount
of additional funding to implement our other programs as discussed in this Annual Report under the caption Item 1 ("Business"),
including our metabolic ThermoStem Program, and fund general operations. No assurance can be given that the amount of funding
that we anticipate may be required for such purposes is correct or that we will be able to accomplish our goals within the timeframes
projected. In addition, no assurance can be given that we will be able to obtain any required financing on commercially reasonable terms
or otherwise.

 Consolidated
Results of Operations

 Year
Ended December 31, 2023 Compared with Year Ended December 31, 2022

 The
following table presents selected items in our consolidated statements of operations for the years ended December 31, 2023 and 2022,
respectively:

 For the Years Ended

 2023

 2022

 Revenues, net

 $
 145,800

 $
 119,800

 Operating Expenses:

 Research and development

 4,034,591

 3,513,352

 General and administrative

 11,331,983

 15,580,473

 Total Operating Expenses

 15,366,574

 19,093,825

 Loss From Operations

 (15,220,774
)

 (18,974,025
)

 Other Income:

 Interest income

 (552,293
)

 (11,650
)

 Gain on PPP loan forgiveness

 -

 (250,000
)

 Grant income

 (83,333
)

 (110,518
)

 Other income

 (169,664
)

 (107,088
)

 (3,997,780
)

 (5,272,473
)

 Total Other Income

 (4,803,070
)

 (5,751,729
)

 Net Loss

 $
 (10,417,704
)

 $
 (13,222,296
)

 Revenues

 For
the years ended December 31, 2023 and 2022, we generated $145,800 and $119,800, respectively, of royalty revenue in connection with our
sublicense agreement.

and development

and development expenses include cash and non-cash compensation of (a) our Vice President of Research and Development; (b) our Scientific
Advisory Board members; and (c) laboratory staff and costs related to our brown fat and disc/spine initiatives. Research and development
expenses are expensed as they are incurred. For the year ended December 31, 2023, research and development expenses increased by $521,239,
or 15%, to $4,034,591 compared to $3,513,352 for the year ended December 31, 2022. The increase was primarily driven by increased compensation
of $857,294 due to salary increases and bonuses, increased lab supplies expenses of $193,298, increased repair and maintenance expenses
of $30,521, increased license agreements and fees expenses of $25,155 and increased consulting fees of $112,581, offset by a decrease
in lab site fees of $53,029, and a decrease in PRC service expenses of $644,245 as the result of non-recurring start-up and execution
expenses incurred during the year ended December 31, 2022.

 We
expect that our research and development expenses will continue to increase with the continuation of the aforementioned initiatives.

and administrative

 General and administrative
expenses consist primarily of salaries, bonuses, payroll taxes and stock-based compensation to employees (excluding any cash or
non-cash compensation of our Vice President of Research and Development and our laboratory staff), as well as corporate expenses
such as legal and professional fees, investor relations and occupancy related expenses. For the year ended December 31, 2023,
general and administrative expenses decreased by $4,248,490, or 27% to $11,331,983 from $15,580,473 for the year ended December 31,
2022. The decrease was primarily driven by a $4,753,377 decrease in stock-based compensation, decreased franchise tax expense of
$130,850, decreased amortization expense of $104,630, decreased travel expense of $84,122, and decreased insurance expense of
$53,858, all offset by an increase in compensation of $775,678 due to salary increases and bonuses, increased investor relations
expense of $80,957, increased professional fees of $44,056, and an increase in office supplies expense of $10,616.

 We
expect that our general and administrative expenses related to operations will increase as we expand our staff, develop our infrastructure
and incur additional costs to support the growth of our business.

 Interest

 For
the year ended December 31, 2023, interest income increased $540,643, or 4641%, to $552,293 from $11,650 for the year ended December
31, 2022. The increase was due to the interest and dividend income of the investments held in marketable securities.

 Gain
on PPP loan forgiveness

 Under
the terms of the U.S. Small Business Administration's Paycheck Protection Program, or PPP, our $250,000 PPP loan was forgiven during
the year ended December 31, 2022.

 Grant

 Grant
income of $83,333 during the year ended December 31, 2023 consisted of funding received under a National Institutes of Health Small Business
Technology Transfer (STTR) Phase 1 grant, offset by related expenses. Grant income of $110,518 during the year ended December 31, 2022
consisted of funding received under a $256,000 National Institutes of Health Small Business Technology Transfer (STTR) Phase 1 grant,
which we were awarded in September 2021.

 Other

 For
the year ended December 31, 2023, other income of $169,664 primarily related to an Employee Retention Tax Credit, gains from settlements
of certain accrued expenses and realized and unrealized gain on investments. For the year ended December 31, 2022, other income
of $107,088 primarily related to gains from settlements of certain accrued expenses and unrealized gain on investments.

 Change
in fair value of derivative liabilities

 For
the years ended December 31, 2023 and 2022, we recognized a gain on the change in fair value of derivative liabilities of $3,997,780
and $5,272,473, respectively, related to the reduction in the fair value of the warrants that are accounted for as derivative liabilities
and, accordingly, are remeasured at each financial reporting date.

 Liquidity
and Capital Resources

 Liquidity

 We
measure our liquidity in a number of ways, including the following:

 2023

 2022

 Cash and cash equivalents

 $
 884,377

 $
 1,713,772

 Investments held in marketable securities

 $
 10,181,618

 $

 Working capital (As Restated)

 $
 8,783,181

 $
 9,146,455

 Availability
of Additional Funds

 Based
upon our accumulated deficit of $146,699,334 as of December 31, 2023, along with our forecast for continued operating losses and our
need for financing to fund our contemplated clinical trials, as of such date, we require additional equity and/or debt financing to continue
our operations. However, based on cash on hand and investments as of December 31, 2023 and the receipt of approximately $8,100,000 in
gross proceeds in February 2024 pursuant to the warrant exercises discussed below, management believes that we have sufficient cash to
fund operations for the twelve months from the issuance of the financial statements included in this Annual Report.

 Our
operating needs include the planned costs to operate our business, including amounts required to fund our clinical trials, working capital
and capital expenditures. Our future capital requirements and the adequacy of our available funds will depend on many factors, including
our ability to successfully commercialize our products and services, competing technological and market developments, and the need to
enter into collaborations with other companies or acquire other companies or technologies to enhance or complement our product and service
offerings.

 We
may be unable to raise sufficient additional capital when we need it or raise capital on favorable terms. Future financing may require
us to pledge certain assets and enter into covenants that could restrict certain business activities or our ability to incur further
indebtedness and may contain other terms that are not favorable to our stockholders or us. If we are unable to obtain adequate funds
on reasonable terms, we may be required to significantly curtail or discontinue operations or obtain funds by entering into financing
agreements on unattractive terms.

 "At-the-Market"
Offering

 In
April 2023, we entered into a Capital on Demand Sales Agreement with JonesTrading Institutional Services LLC, or the Sales Agent, under
which we currently have the ability to issue and sell shares of our common stock, from time to time, through the Sales Agent, up to an
aggregate offering price of approximately $6,109,000 in what is commonly referred to as an "at-the-market", or ATM, program.
During the year ended December 31, 2023, we sold 132,827 shares of our common stock under the ATM program with the Sales Agent at a weighted-average
gross price of approximately $4.68 per share and raised approximately $622,000 of gross proceeds. The total commissions and related legal
fees were approximately $127,000, and we received net proceeds of approximately $495,000. As of December 31, 2023, we had remaining capacity
to sell up to an additional approximately $5,487,000 of common stock under the ATM program.

 Registered
Direct Offering

 In
July 2023, we sold an aggregate of 685,033 shares of our common stock in a registered direct public offering. We received net proceeds
of approximately $1,831,000 from the offering.

 Warrant
Exercises

 In
February 2024, we received gross proceeds of approximately $8,100,000 pursuant to the exercise of outstanding warrants. See Item 1 ("Business
– Business Development – Material Events During 2024") for additional information.

 Cash
Flows

the years ended December 31, 2023 and 2022, our sources and uses of cash were as follows:

 Year Ended December 31,

 2023

 2022

 (As
 Restated)

 (As
 Restated)

 Net cash used in operating activities

 $
 (6,430,211
)

 $
 (5,913,100
)

 Net cash provided by (used in) investing activities

 3,252,043

 (13,399,855
)

 Net cash provided by financing activities

 2,348,773

 -

 Net decrease in cash

 $
 (829,395
)

 $
 (19,312,955
)

 Net
Cash Used in Operating Activities

 Net
cash used in operating activities was $6,430,211 for the year ended December
31, 2023, primarily due to cash used to fund the net loss of $10,417,704 which gives effect to net non-cash expenses of $3,472,167, partially
offset by $515,326 of cash provided by changes in our operating assets and liabilities. Net cash used in operating activities was
$5,913,100 for the year ended December 31, 2022, primarily due to cash used to fund the net loss of $13,222,296 which gives effect
to net non-cash expenses of $7,295,052, partially offset by $14,144 of cash provided by changes in operating assets and liabilities.

 Net
Cash Provided by (Used in) Investing Activities

 Net
cash provided by investing activities increased by $16,651,898 for the year ended December 31, 2023 compared to the year ended December
31, 2022, primarily due to the initial use of cash in the amount of $16,000,000 for the purchase of investments held in marketable securities
made in 2022 for which there was no corresponding activity in 2023.

 Net
Cash Provided by Financing Activities

 Net
cash provided by financing activities increased by $2,348,773 for the year ended December 31, 2023 compared to the year ended December
31, 2022 due to the net proceeds from the ATM and registered direct public offerings of our common stock.

 Effects
of Inflation

 We
do not believe that inflation had a material impact on our business, revenues or operating results during the periods presented.

 Critical
Accounting Estimates

 We
prepare our consolidated financial statements in accordance with U.S. generally accepted accounting principles, or GAAP, which require
our management to make estimates that affect the reported amounts of assets, liabilities and disclosures of contingent assets and liabilities
at the balance sheet dates, as well as the reported amounts of revenues and expenses during the reporting periods. To the extent that
there are material differences between these estimates and actual results, our financial condition or results of operations would be
affected. We base our estimates on our own historical experience and other assumptions that we believe are reasonable after taking account
of our circumstances and expectations for the future based on available information. We evaluate these estimates on an ongoing basis.

 We
consider an accounting estimate to be critical if: (i) the accounting estimate requires us to make assumptions about matters that were
highly uncertain at the time the accounting estimate was made, and (ii) changes in the estimate that are reasonably likely to occur from
period to period or the use of different estimates that we reasonably could have used in the current period would have a material impact
on our financial condition or results of operations. There are items within our financial statements that require estimation but are
not deemed critical, as defined above.

 For
a detailed discussion of our significant accounting policies and related judgments, see Note 2 of the Notes to Consolidated Financial
Statements in "Item 8. Financial Statements and Supplementary Data" of this Annual Report.

 Recently
Issued Accounting Pronouncements

 See
Note 2 to our consolidated financial statements for the years ended December 31, 2023 and 2022 included elsewhere in this Annual Report
following Item 16 ("Form 10-K Summary").

 Off-Balance
Sheet Arrangements

 We
have no off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition,
changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that
is material to investors.

 ITEM
 7A.

 QUANTITATIVE
 AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.

 Not

 ITEM
 8.

 FINANCIAL
 STATEMENTS AND SUPPLEMENTARY DATA.

 The
financial statements required by this Item 8 of this Annual Report are included in this Amendment No. 1 to Annual Report following
Item 16 ("Form 10-K Summary"). As a smaller reporting company, we are not required to provide supplementary financial
information.

 ITEM
 9.

 CHANGES
 IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE.

 None.

 ITEM
 9A.

 CONTROLS
 AND PROCEDURES.

 Evaluation
of Disclosure Controls and Procedures

 We
maintain disclosure controls and procedures (as that term is defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act
of 1934, as amended, or the Exchange Act), that are designed to ensure that information required to be disclosed in our reports under
the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC's rules and forms,
and that such information is accumulated and communicated to our management, including our principal executive officer and principal
financial officer, as appropriate, to allow timely decisions regarding required disclosures. In designing disclosure controls and procedures,
our management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible disclosure controls
and procedures. The design of any disclosure controls and procedures also is based in part upon certain assumptions about the likelihood
of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future
conditions. Any controls and procedures, no matter how well designed and operated, can provide only reasonable, not absolute, assurance
of achieving the desired control objectives.

 Under
the supervision and with the participation of our management, including our principal executive officer and principal financial officer,
we are required to perform an evaluation of our disclosure controls and procedures, as such term is defined in Rule 13a-15(e) under the
Exchange Act, as of December 31, 2023.

has completed such evaluation and has concluded that our disclosure controls and procedures were not effective to provide reasonable
assurance that information required to be disclosed by us in reports we file or submit under the Exchange Act is appropriate to allow
timely decisions regarding required disclosures. As a result of the material weakness in internal controls over financial reporting described
below, we concluded that our disclosure controls and procedures as of December 31, 2023 were not effective.

 Management's
Annual Report on Internal Control Over Financial Reporting

is responsible for establishing and maintaining adequate internal control over financial reporting. Our internal control over financial
reporting is a process designed under the supervision of our principal executive and principal financial officer 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 our consolidated financial statements for external reporting purposes in accordance with GAAP.

 Because
of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. In addition, 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.

Weaknesses in Internal Control over Financial Reporting

assessed the effectiveness of our internal control over financial reporting as of December 31, 2023 based on the framework established
in Internal Control—Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission.
Based on this assessment, management has determined that our internal control over financial reporting as of December 31, 2023 was not
effective.

 A
material weakness, as defined in the standards established by the Sarbanes-Oxley is a deficiency, or a combination of deficiencies, in
internal control over financial reporting such that there is a reasonable possibility that a material misstatement of our annual or interim
consolidated financial statements will not be prevented or detected on a timely basis.

 The
ineffectiveness of our internal control over financial reporting was due to the following material weaknesses:

 Lack
 of adherence to formal policies and procedures;

 Lack
 of risk assessment procedures on internal controls to detect financial reporting risks in a timely manner;

 Lack
 of sufficient formal management testing over documented formal procedures and controls, and time to evaluate continuous effectiveness
 of controls to achieve complete and accurate financial reporting and disclosures, including documented controls over the preparation
 and review of journal entries and account reconciliations; and

 Lack of design and implementation of effective controls over the accounting for warrants issued in connection with
equity financings.

 Management's
Plan to Remediate the Material Weaknesses

has been implementing and continues to implement measures designed to ensure
that control deficiencies contributing to the material weaknesses are remediated, such that these controls are designed, implemented,
and are operating effectively for a sufficient period of time. The remediation actions include:

 personnel, including our Chief Financial Officer, are overseeing the financial reporting process and implementation of enhanced controls
 and governance;

 Engagement
 of external financial consulting firm with expertise in accounting for
significant and complex non-routine transactions to continue to enhance financial reporting, financial operations and internal controls;
and

 Documentation
 of key procedures and controls using a risk-based approach.

is committed to maintaining a strong internal controls environment and implementing measures designed to help ensure that control deficiencies
contributing to the material weakness are remediated as soon as possible. We have documented key procedures and controls using a risk-based
approach and have, therefore, made progress toward remediation. We continue to implement our remediation plan, which includes continued
engagement of an external financial consulting firm to enhance financial reporting and operations as well as design and implementation
of controls. We will consider the material weakness remediated after the applicable controls operate for a sufficient period of time,
and Management has concluded, through testing, that the controls are operating effectively.

 We
will continue to monitor and evaluate the effectiveness of our internal controls and procedures over financial reporting on an ongoing
basis and is committed to taking further action and implementing additional enhancements or improvements, as necessary and as funds allow.

 This
Annual Report does not include an attestation report of our independent registered public accounting firm regarding internal control
over financial reporting. Management's report was not subject to attestation by our independent registered public accounting firm
pursuant to rules of the Securities and Exchange Commission that exempt smaller reporting companies from this requirement.

in Internal Control Over Financial Reporting

 Other
than described above, there have been no changes in our internal control over financial reporting that occurred during our fourth quarter
of 2023 that have materially affected, or that are reasonably likely to materially affect, our internal control over financial reporting.

 ITEM
 9B.

 OTHER
 INFORMATION.

 None.

 ITEM
 9C.

 DISCLOSURE
 REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS.

 Not

 PART
III

 ITEM
 10.

 DIRECTORS,
 EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE.

 Directors
and Executive Officers

 Information
regarding our directors and executive officers is set forth below. Each of our officers devotes his full business time in providing services
on our behalf.

 Name

 Age

 Positions
 Held

 Lance

 Chief
 Executive Officer, President and Chairman of the Board

 Silva

 Vice
 President of Research and Development, Secretary and Director

 E. Kristal

 Chief
 Financial Officer

 Paccasassi

 Vice
 President of Quality Assurance/Regulatory Compliance

 Kukekov, Ph. D.

 Director,
 Compensation Committee Chair

 Director,
 Audit Committee Chair

 David
 Rosa

 Director,
 Nominating Committee Chair

 Lance

 Lance
Alstodt has served as our Chief Executive Officer, President and Chairman of the Board since November 2020. He served as our Executive
Vice President and Chief Strategy Officer from October 2018 to February 2020. Since 2013, Mr. Alstodt has served as Chief Executive Officer
of MedVest Consulting Corporation, an advisory and capital firm that focuses exclusively on the healthcare industry. Prior to MedVest,
he was an investment banker with over 23 years of experience with respect to healthcare investment banking, including mergers and acquisitions.
From 2011 to 2013, Mr. Alstodt was a Managing Director at Leerink Partners where he helped lead its medical technology sector. From 2009
to 2011, he was a Managing Director and Head of Medical Technology at Oppenheimer & Co. From 2000 to 2009, Mr. Alstodt was a Managing
Director in the Healthcare Group and Global Mergers and Acquisitions Group at Bank of America Merrill Lynch. He previously spent seven
years as a Vice President in the Global Mergers and Acquisitions Group at J.P. Morgan Chase, where he worked extensively on acquisitions,
leveraged buyouts, private and public financings, exclusive sales and general advisory assignments. Mr. Alstodt received a degree in
Economics from the State University of New York at Albany, with a secondary concentration in Finance and Marketing. We believe that Mr.
Alstodt's executive-level management experience with us and other healthcare businesses and his extensive experience in the investment
banking field relating to the healthcare sector give him the qualifications to serve as one of our directors.

Silva

Silva has served as our Vice President of Research and Development since March 2013, having also previously served in such position from
April 2011 until March 2012. Mr. Silva was elected our Secretary and a director in November 2020. He served as our Research Scientist
from March 2012 to June 2012 and as our Chief Scientist from June 2012 to March 2013. From 2007 to 2011, Mr. Silva served as Chief Executive
Officer of DV Biologics LLC, and as President of DaVinci Biosciences, LLC, companies engaged in the commercialization of human based
biologics for both research and therapeutic applications. From 2003 to 2007, Mr. Silva served as Vice President of Research and Development
for PrimeGen Biotech LLC, a company engaged in the development of cell based platforms. From 2002 to 2003, he was a Research Scientist
with PrimeGen Biotech and was responsible for the development of experimental designs that focused on germ line reprogramming stem cell
platforms. Mr. Silva has taught courses in biology, anatomy and advanced tissue culture at California State Polytechnic University. He
has obtained a number of patents relating to stem cells and has had numerous articles published with regard to stem cell research. Mr.
Silva graduated from California State Polytechnic University with a degree in Biology. He also obtained a Graduate Presidential Fellowship
and MBRS Fellowship from California State Polytechnic University. We believe that Mr. Silva's executive-level management experience
with us since April 2011 and his extensive knowledge of the science related to our business give him the qualifications to serve as one
of our directors.

E. Kristal

E. Kristal has served as our Chief Financial Officer since November 2021. Mr. Kristal is an experienced Wall Street and Bay Street professional
who has served in various management roles within multiple business lines of investment banks. From 2016 to 2020, he was Head of Equity
Research at H.C. Wainwright. Mr. Kristal provided investment banking and merchant banking services from 2013 to 2016 at H.C. Wainwright
and T.R. Winston. He is a Charted Financial Analyst. Mr. Kristal received a Bachelor of Arts degree in Economics from Wilfrid Laurier
University and a Bachelor of Commerce (Honors) degree in Finance from the University of Windsor.

Paccasassi

Paccasassi has served as our Vice President of Quality Assurance/Regulatory Compliance since December 2021, having previously served
in such position from August 2016 to September 2020, and having previously served as our Director of Quality and Compliance from September
2015 to August 2016. Mr. Paccasassi has over 20 years of experience in highly regulated product operations, with specific expertise in
GMP (large and small molecule) clinical and commercial quality assurance and regulatory compliance leadership roles. He was the Director
of Quality Systems (GMP) at Merck KGaA (Dermstadt, Germany) from 2011 to 2014. In this role, Mr. Paccasassi was responsible for leading
the ongoing development and implementation of the Corporate Quality Unit's global GMP policies, processes and directives. He held
key quality and compliance management roles at EMD Serono, Biogen Idec, Millennium Pharmaceuticals and Regeneron Pharmaceuticals. Mr.
Paccasassi was a Chief Technologist/Site Head overseeing all day to day technical and quality operations of two cGMP biologic production
laboratories for Curative Health Services. He was also a Medical Technologist working in the field of immunohematology at Brigham &
Women's Hospital, Boston, Massachusetts. Mr. Paccasassi received a Masters in Business Administration (MBA) degree from Johnson
& Wales University and a Bachelor of Science degree in Medical Technology/Biology from the University of Rhode Island.

Kukekov, Ph. D.

Kukekov, Ph. D. has served as one of our directors since March 2021 and Chair of our Board's Compensation Committee since November
2021. For more than the past fifteen years, Dr. Kukekov has held a number of healthcare investment banking positions. He has served as
Senior Managing Director of Paulson Investment Company, LLC since 2020. From 2012 to 2020, Dr. Kukekov was a founding partner of Highline
Research Advisors LLC. He served as a Managing Director of Summer Street Research Partners from 2010 to 2012. From 2007 to 2009, Dr.
Kukekov was a Managing Director of Paramount Capital. He served as a Vice President of Rodmen & Renshaw from 2006 to 2007. He serves
as a director of Brain Scientific, Inc. and Omnia Wellness Inc. whose shares are publicly traded. Dr. Kukekov received a Bachelor of
Arts degree in molecular, cellular and developmental biology from the University of Colorado at Boulder and a Ph. D. in neuroscience from
Columbia University College of Physicians and Surgeons. We believe that Dr. Kukekov's extensive experience in the investment banking
field relating to the healthcare sector and his strong background in regenerative medicine give him the qualifications to serve as one
of our directors.

F. Williams has served as one of our directors and Chair of our Board's Audit Committee since November 2021. Mr. Williams has more
than 20 years of experience across medical device, consumer product goods and technology sectors. Appointed as Chief Financial Officer
of STAAR Surgical Company, or STAAR, in July 2020, Mr. Williams is responsible for optimizing the financial performance of STAAR and
ensuring the scalability of various functions to support high growth expansion. From 2016 to 2019, he served as the Chief Financial Officer
of Sientra, Inc. before transitioning to General Manager for its miraDry business unit. From 2012 to 2016, Mr. Williams served as
Chief Financial Officer of ZELTIQ Aesthetics, Inc., a publicly-traded medical device company that was acquired by Allergan. Previously,
he served as Vice President in finance, strategy and investor relations roles from 2007 to 2012 at NuVasive, Inc., a San-Diego based
medical device company servicing the spine sector. He has also held finance roles with Callaway Golf and Kyocera Wireless. Mr. Williams
received an MBA in Finance and Management from San Diego State University and a Bachelor of Arts in Economics from the University of
California, San Diego. We believe that Mr. Williams' executive-level management experience with healthcare-related businesses,
including his financial management expertise, give him the qualifications to serve as one of our directors.

 David
Rosa

 David
Rosa has served as one of our directors and Chair of our Board's Nominating Committee since November 2021. Mr. Rosa has served
as the Chief Executive Officer, President and a director of NeuroOne Medical Technologies Corporation, or NeuroOne (Nasdaq: NMTC), since
July 2017 and served as Chief Executive Officer and a director of NeuroOne, Inc., formerly its wholly-owned subsidiary, from October
2016 until December 2019, when NeuroOne, Inc. merged with and into NeuroOne. NeuroOne is committed to providing minimally invasive and
hi-definition solutions for EEG recording, brain stimulation and ablation solutions for patients suffering from epilepsy, Parkinson's
disease, dystonia, essential tremors, chronic pain due to failed back surgeries and other related neurological disorders that may improve
patient outcomes and reduce procedural costs. From November 2009 to November 2015, Mr. Rosa served as the Chief Executive Officer and
President of Sunshine Heart, Inc., n/k/a CHF Solutions, Inc. (Nasdaq: CHFS), a publicly-held early-stage medical device company. From
2008 to November 2009, he served as Chief Executive Officer of Milksmart, Inc., a company that specializes in medical devices for animals.
From 2004 to 2008, Mr. Rosa served as the Vice President of Global Marketing for Cardiac Surgery and Cardiology at St. Jude Medical,
Inc. He serves as a director on the board of directors of Biotricity Inc. (Nasdaq: BTCY) and Healthcare Triangle, Inc. (Nasdaq: HCTI).
Mr. Rosa is Chairman of Neuro Event Labs, a privately-held company in Finland, and an Advisory Board member of SYNAPS Dx, a privately-held
company in Bethesda, Maryland. We believe that Mr. Rosa's senior leadership experience in the medical device industry and his strong
technical, strategic, and operational expertise give him the qualifications to serve as one of our directors.

 Scientific
Advisory Board

 The
following persons are the members of our Scientific Advisory Board:

 Name

 Principal
 Positions

 Wayne
 Marasco, M.D., Ph. D.

 Chairman

 Professor,
 Department of Cancer Immunology & AIDS, Dana-Farber Cancer Institute;

 Professor
 of Medicine, Harvard Medical School;

 Principal
 Faculty Member, Harvard Stem Cell Institute

 Jason
 Lipetz, M.D.

 Chairman,
 Disc Advisory Committee

 Founder,
 Long Island Spine Rehabilitation Medicine;

 Chief
 of Spine Medicine, Northwell Health Spine Center;

 Assistant Professor, Department of Physical Medicine and Rehabilitation, Zucker School of Medicine at Hofstra/Northwell

 Wayne
 J. Olan, M.D.

 Director,
 Interventional and Endovascular Neurosurgery;

 Associate
 Professor, Neurosurgery and Radiology, George Washington University Medical Center;

 Consulting
 Physician, Department of Radiology, National Institutes of Health

 Joy
 Cavagnaro, Ph. D.,

 DABT,
 RAC

 President
 and Founder, Access BIO, L.C.; Fellow, Academy of Toxicological Sciences and the Regulatory
 Professional Society;

 Formerly
 Senior Pharmacologist and Director of Quality Assurance, Food and Drug Administration's Center for Biologics Evaluation and

 Harvinder
 Sandhu, M.D.

 Orthopedic
 Spine Surgeon, Hospital for Special Surgery;

 Formerly
 Chief of Spinal Surgery Service, UCLA Medical Center

 Christopher
 Plastaras, M.D.

 Director of Musculoskeletal Spine and Sports Rehabilitation Medicine and Physiatrist, MossRehab;

 Formerly
 Director of The Penn Spine and Rehabilitation Center;

 Formerly
 Director of Spine, Sports and Musculoskeletal Medicine Fellowship, University of Pennsylvania

 Family
Relationships

 There
are no family relationships among any of our executive officers, directors and Scientific Advisory Board members.

 Term
of Office

 We
have a classified Board of Directors. The directors will hold office until the respective annual meetings of stockholders indicated below
and until their respective successors are elected and qualified or until their earlier resignation or removal.

 Name

 Class

 Term
 Expires

 Lance

 III

 2026

 Silva

 II

 2025

 Kukekov

 I

 2024

 III

 2026

 David
 Rosa

 II

 2025

 Each
executive officer will hold office until the initial meeting of the Board of Directors following the next annual meeting of stockholders
and until his successor is elected and qualified or until his or her earlier resignation or removal.

 Audit
Committee

 The
Audit Committee of the Board of Directors is responsible for overseeing our accounting and financial reporting processes and the audits
of our financial statements. The members of the Audit Committee are Mr. Williams (Chair), Dr. Kukekov and Mr. Rosa.

 Audit
Committee Financial Expert

 Our
Board has determined that Mr. Williams qualifies as an "audit committee financial expert," as that term is defined in Item
407(d)(5) of Regulation S-K.

 Delinquent
Section 16(a) Beneficial Ownership Reports

 Section
16 of the Exchange Act requires that reports of beneficial ownership of common stock and changes in such ownership be filed with the
Securities and Exchange Commission by Section 16 "reporting persons," including directors, certain officers, holders of more
than 10% of the outstanding common stock and certain trusts of which reporting persons are trustees. We are required to disclose in this
Annual Report each reporting person whom we know to have failed to file any required reports under Section 16 on a timely basis during
the fiscal year ended December 31, 2023. To our knowledge, based solely on a review of copies of Forms 3, 4 and 5 filed with the Securities
and Exchange Commission, during the fiscal year ended December 31, 2023, our officers, directors and 10% stockholders complied with all
Section 16(a) filing requirements applicable to them, except that each of Mr. Alstodt and Mr. Silva filed one Form 4 late (each reporting
one transaction) and Dale Broadrick, a 10% stockholder, filed three Forms 4 late (reporting an aggregate of eight transactions).

 Code
of Ethics for Senior Financial Officers

 Our
Board of Directors has adopted a Code of Ethics for our principal executive officer, principal financial officer, principal accounting
officer or controller, or persons performing similar functions. A copy of the Code of Ethics is posted on our website, www.biorestorative.com.
We intend to satisfy the disclosure requirement under Item 5.05(c) of Form 8-K regarding an amendment to, or a waiver from, our Code
of Ethics by posting such information on our website, www.biorestorative.com.

 ITEM
 11.

 EXECUTIVE
 COMPENSATION.

 Summary
Compensation Table

 The
following Summary Compensation Table sets forth all compensation earned in all capacities during the fiscal years ended December 31,
2023 and 2022 by (i) our principal executive officer, and (ii) our two most highly compensated executive officers, other than our principal
executive officer, who were serving as an executive officer as of December 31, 2023 and whose total compensation for the 2023 fiscal
year, as determined by Regulation S-K, Item 402, exceeded $100,000 (the individuals falling within categories (i) and (ii) are collectively
referred to as the Named Executive Officers):

 Name and Principal Position

 Year

 Salary

 Bonus

 Stock Awards (1)

 Option Awards (1)

 All Other Compensation

 Total

 2023

 $
 479,167

 $
 475,000
 (2)

 $
 -

 $
 300,000

 $
 -

 $
 1,254,167

 Chief Executive Officer

 2022

 $
 400,000

 $
 -
 (2)

 $
 52,364

 $
 -

 $
 -

 $
 452,364

 2023

 $
 454,167

 $
 437,500
 (3)

 $
 -

 $
 300,000

 $
 -

 $
 1,191,667

 VP, Research and Development

 2022

 $
 375,000

 $
 -
 (3)

 $
 52,364

 $
 -

 $
 -

 $
 427,364

 Robert Kristal

 2023

 $
 240,624

 $
 127,500
 (4)

 $
 -

 $
 250,000

 $
 -

 $
 618,124

 Chief Financial Officer

 2022

 $
 175,000

 $
 -
 (4)

 $
 -

 $
 -

 $
 -

 $
 175,000

 (1)

 Amounts
 reflect the aggregate grant date fair value of grants made in the fiscal year computed in accordance with stock-based accounting
 rules (FASB ASC Topic 718-Stock Compensation). Assumptions used in the calculations of these amounts are included in Note 8 to our
 consolidated financial statements included in this Annual Report.

 (2)

 The
 2023 Bonus amount represents (a) a discretionary bonus is the amount of $250,000 in consideration of 2023 services which was paid
 in 2024 and (b) a discretionary bonus in the amount of $225,000 in consideration of 2022 services which was paid in 2023.

 (3)

 The
 2023 Bonus amount represents (a) a discretionary bonus in the amount of $225,000 in consideration of 2023 services which was paid
 in 2024 and (b) a discretionary bonus in the amount of $212,500 in consideration of 2022 services which was paid in 2023.

 (4)

 The
 2023 Bonus amount represents (a) a discretionary bonus in the amount of $75,000 in consideration of 2023 services which was paid
 in 2024 and (b) a discretionary bonus in the amount of $52,500 in consideration of 2022 services which was paid in 2023.

Equity Awards at Fiscal Year-End

 The
following table provides information on outstanding equity awards as of December 31, 2023 to the Named Executive Officers:

 Option Awards

 Stock Awards

 Name

 Number of securities underlying unexercised options exercisable

 Number of securities underlying unexercised options unexercisable

 Equity incentive plan awards: Number of securities underlying unexercised unearned options

 Option exercise price

 Option expiration date

 Number of shares or units of stock that have not vested

 Market value of shares of units that have not vested

 Equity incentive plan awards: Number of unearned shares, units or other rights that have not vested

 Equity incentive plan awards: Market or payout value of unearned shares, units or other rights that have not vested

 293,479

 -

 -

 $
 5.08

 3/18/2031

 -

 $
 -

 -

 $
 -

 34,174

 7,885
 (1)

 -

 $
 5.08

 11/4/2031

 -

 $
 -

 -

 $
 -

 53,381

 53,381
 (2)

 -

 $
 2.91

 2/17/2033

 -

 $
 -

 -

 $
 -

 -

 -

 -

 $
 -

 -

 48,913
 (3)

 $
 85,104

 -

 $
 -

 $
 18,800

 2/18/2024

 -

 $
 -

 -

 $
 -

 $
 18,800

 3/12/2024

 -

 $
 -

 -

 $
 -

 $
 18,800

 10/23/2024

 -

 $
 -

 -

 $
 -

 $
 18,800

 9/4/2025

 -

 $
 -

 -

 $
 -

 $
 14,920

 6/10/2026

 -

 $
 -

 -

 $
 -

 $
 11,200

 7/12/2027

 -

 $
 -

 -

 $
 -

 $
 4,920

 10/29/2028

 -

 $
 -

 -

 $
 -

 293,479

 -

 -

 $
 5.08

 3/18/2031

 -

 $
 -

 -

 $
 -

 34,174

 7,885
 (1)

 -

 $
 5.08

 11/4/2031

 -

 $
 -

 -

 $
 -

 53,381

 53,381
 (2)

 -

 $
 2.91

 2/17/2033

 -

 $
 -

 -

 $
 -

 -

 -

 -

 $
 -

 -

 48,913
 (3)

 $
 85,104

 -

 $
 -

 Robert Kristal

 10,490

 -

 -

 $
 5.08

 11/4/2031

 -

 $
 -

 -

 $
 -

 Robert Kristal

 44,484

 44,484
 (2)

 -

 $
 2.91

 2/17/2033

 -

 $
 -

 -

 $
 -

 (1)

 Option
 becomes exercisable in three nearly equal quarterly installments beginning on February 4, 2024.

 (2)

 Option
 becomes exercisable in eight nearly equal quarterly installments beginning on February 17, 2024.

 (3)

 Restricted
 stock vests on March 18, 2024.

 Employment
Agreements

 Lance

 Effective
November 16, 2020, Mr. Alstodt was elected our Chief Executive Officer, President and Chairman of the Board. On March 18, 2021, we entered
into an employment agreement with Mr. Alstodt which provides for a term ending on March 18, 2026. Pursuant to the employment agreement,
Mr. Alstodt currently is entitled to receive an annual salary of $550,000 (giving effect to a $150,000 performance salary increase received
in November 2021 and $50,000 annual increases in salary pursuant to his employment agreement). Concurrently with the execution of the
employment agreement, we granted to Mr. Alstodt pursuant to the 2021 Plan (i) a ten year option for the purchase of 293,479 shares of
our common stock at an exercise price of $47.60 per share (which exercise price was subsequently reduced to $13.50 per share and further
reduced to $5.08 per share) and (ii) 146,740 restricted stock units, or RSUs. The option vested to the extent of 50% thereof on the date
of grant, 12.5% on November 4, 2021 and the balance in six equal quarterly installments commencing on December 18, 2021. The RSUs vest
in three equal annual installments on the first, second and third anniversaries of the date of grant. In the event that Mr. Alstodt's
employment is terminated by us without "cause", or Mr. Alstodt terminates his employment for "good reason" (each
as defined in the employment agreement), Mr. Alstodt will be entitled to receive severance in an amount up to one time his then annual
base salary. If Mr. Alstodt's employment with us is terminated without cause, the option granted to Mr. Alstodt will remain exercisable
until its expiration date notwithstanding such termination of employment with us. In addition, the RSUs granted to Mr. Alstodt will vest
in the event of the termination of his employment without cause or in the event of a change in control (as defined in the 2021 Plan).
In March 2022, we and Mr. Alstodt agreed that, in lieu of a $50,000 increase in his annual salary (as provided for in his employment
agreement), we issued to Mr. Alstodt 12,438 RSUs (having a value of $50,000), which RSUs vested in twelve equal monthly installments.
Such grant was in consideration of Mr. Alstodt deferring his right to receive the $50,000 increase in his salary for one year.

Silva

 On
March 18, 2021, we and Mr. Silva entered into an employment agreement which provides for a term ending on March 18, 2026. Pursuant to
the employment agreement, Mr. Silva is currently entitled to receive an annual salary of $525,000 (giving effect to a $150,000 performance
salary increase received in November 2021 and $50,000 annual increases in salary pursuant to his employment agreement). Concurrently
with the execution of the employment agreement, we granted to Mr. Silva pursuant to the 2021 Plan (i) a ten year option for the purchase
of 293,479 shares of our common stock at an exercise price of $47.60 per share (which exercise price was subsequently reduced to $13.50
per share and further reduced to $5.08 per share) and (ii) 146,740 RSUs. The option vested to the extent of 50% thereof on the date of
grant, 12.5% on November 4, 2021 and the balance in six equal quarterly installments commencing on December 18, 2021. The RSUs vest in
three equal annual installments on the first, second and third anniversaries of the date of grant. In the event that Mr. Silva's
employment is terminated by us without "cause", or Mr. Silva terminates his employment for "good reason" (each
as defined in the employment agreement), Mr. Silva will be entitled to receive severance in an amount up to one time his then annual
base salary. If Mr. Silva's employment with us is terminated without cause, the option granted to Mr. Silva will remain exercisable
until its expiration date notwithstanding such termination of employment with us. In addition, the RSUs granted to Mr. Silva will vest
in the event of the termination of his employment without cause or in the event of a change in control (as defined in the 2021 Plan).
In March 2022, we and Mr. Silva agreed that, in lieu of a $50,000 increase in his annual salary (as provided for in his employment agreement),
we issued to Mr. Silva 12,438 RSUs (having a value of $50,000), which RSUs vested in twelve equal monthly installments. Such grant was
in consideration of Mr. Silva deferring his right to receive the $50,000 increase in his salary for one year.

Compensation

 The
following table sets forth certain information concerning the compensation of our non-employee directors for the fiscal year ended December
31, 2023:

 Name

 Fees
 Earned or Paid in Cash

 Stock
 Awards

 Option
 Awards

 Non-Equity
 Incentive Plan Compensation

 Nonqualified
 Deferred Compensation Earnings

 All
 Other Compensation

 Total

 Kukekov

 $
 30,000

 $
 -

 $
 90,000
 (1)

 $
 -

 $
 -

 $
 -

 $
 120,000

 $
 30,000

 $
 -

 $
 90,000
 (2)

 $
 -

 $
 -

 $
 -

 $
 120,000

 David
 Rosa

 $
 30,000

 $
 -

 $
 90,000
 (3)

 $
 -

 $
 -

 $
 -

 $
 120,000

 (1)

 As
 of December 31, 2023, Dr. Kukekov held options for the purchase of 57,264 shares of common stock.

 (2)

 As
 of December 31, 2023, Mr. Williams held options for the purchase of 42,518 shares of common stock.

 (3)

 As
 of December 31, 2023, Mr. Rosa held options for the purchase of 42,518 shares of common stock.

 Dr.
Kukekov and Messrs. Williams and Rosa, our non-employee directors, as compensation for their services as a director, are entitled to
receive per annum $30,000 in cash and $90,000 in option grants.

 ITEM
 12.

 SECURITY
 OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS.

 Principal
Stockholders

 The
following table sets forth certain information regarding the beneficial ownership of our common stock, as of March 20, 2024, known by
us, through transfer agent records and reports filed with the SEC, to be held by: (i) each person who beneficially owns 5% or more of
the shares of common stock then outstanding; (ii) each of our directors; (iii) each of our Named Executive Officers (as defined above);
and (iv) all of our directors and executive officers as a group. The following table also sets forth certain information regarding the
beneficial ownership of our Series B preferred stock as of March 20, 2024.

 The
information in this table reflects "beneficial ownership" as defined in Rule 13d-3 of the Exchange Act. To our knowledge,
and unless otherwise indicated, each stockholder has sole voting power and investment power over the shares listed as beneficially owned
by such stockholder, subject to community property laws where applicable. Percentage ownership is based on 6,769,919 shares of common
stock (exclusive of the shares of common stock issuable to Auctus Fund, LLC, or Auctus, as discussed in footnote (10) to the following
table) and 1,398,158 shares of Series B preferred stock outstanding as of March 20, 2024.

 Name and Address of Beneficial
 Owner

 Shares of
 Common Stock
 Beneficially
 Owned

 Approximate
 Percent of
 Class

 Shares of Series
 B Preferred
 Stock
 Beneficially
 Owned

 Approximate
 Percent of Class

 Directors and Executive Officers

 Lance Alstodt (1)

 790,805
 (2)

 10.7
 %

 -

 -

 Francisco Silva (1)

 756,666
 (3)

 10.3
 %

 -

 -

 Robert Kristal (1)

 205,668
 (4)

 3.0
 %

 -

 -

 Nickolay Kukekov

 95,510
 (5)

 1.4
 %

 -

 -

 Patrick F. Williams

 82,341
 (5)

 1.2
 %

 -

 -

 David Rosa

 82,341
 (5)

 1.2
 %

 -

 -

 All directors and executive officers as a group (7 persons)

 2,186,862
 (6)

 25.4
 %

 -

 -

 Certain Beneficial Owners

 Dale Broadrick (7)

 926,126
 (8)

 13.7
 %

 -

 -

 Auctus Fund, LLC (9)
 Auctus Fund Management LLC (9)
 Alfred Sollami (9)
 Louis Posner (9)

 679,753

 (10)

 9.99
 %

 1,398,158
 (11)

 %

 *

 Less
 than 1%

 (1)

 Address
 is c/o BioRestorative Therapies, Inc., 40 Marcus Drive, Suite One, Melville, New York 11747.

 (2)

 618,933 shares of common stock issuable upon the exercise of options that are exercisable currently or within 60 days.

 (3)

 597,079 shares of common stock issuable upon the exercise of options that are exercisable currently or within 60 days and 12,136
 shares of common stock held by Mr. Silva in a retirement account.

 (4)

 197,674 shares of common stock issuable upon the exercise of options that are exercisable currently or within 60 days.

 (5)

 Represents
 shares of common stock issuable upon the exercise of options that are exercisable currently or within 60 days.

 (6)

 1,847,409 shares of common stock issuable upon the exercise of options that are exercisable currently or within 60 days.

 (7)

 Address
 is 3003 Brick Church Pike, Nashville, Tennessee

 (8)

 Based
 upon Amendment No. 9 to Schedule 13D and Forms 4 filed with the SEC. Includes 1,109 shares common stock issuable upon the exercise
 of currently exercisable warrants and 477,972 shares of common stock held by Fleetco Inc. of which Mr. Broadrick is a 93% stockholder.

 (9)

 Address
 is 545 Boylston Street, 2 nd Floor, Boston, Massachusetts 02116.

 (10)

 Based
 upon Amendment No. 2 to Schedule 13G filed with the SEC and other filings made by us with the SEC. Auctus holds a warrant for the
 purchase of up to 1,257,435 shares of our common stock. In addition, Auctus' shares of Series B preferred stock are convertible
 into an aggregate of 1,398,158 shares of our common stock. In connection with the transaction in which the warrants were issued to
 Auctus, we issued to Auctus certain shares of our common stock and have agreed to issue to Auctus, upon receipt of notice from Auctus,
 subject to the limitation discussed below, 1,351,580 shares of our common stock, or the Additional Shares. However, such warrant
 is not exercisable for the purchase of our common stock, such Series B preferred stock is not convertible into shares of our common
 stock and the Additional Shares are not issuable to the extent Auctus would beneficially own, after such exercise, conversion or
 issuance, more than 9.99% of our outstanding shares of common stock. Auctus has advised that, as of March 20, 2024, it owned 645,320
 shares of common stock, which represented 9.5% of the then 6,769,919 outstanding shares of common stock, and that the Additional
 Shares are issuable to it, upon notice from it, to the extent that such issuances would not result in Auctus beneficially owning
 after such issuances more than 9.99% of our outstanding shares of common stock. Based upon the foregoing, as of March 20, 2024, 34,433
 Additional Shares are issuable to Auctus (to comply with the 9.99% beneficial ownership limitation), the remaining Additional Shares
 are not issuable, Auctus' warrant is not currently exercisable for the purchase of shares of common stock and its Series B
 preferred stock is not currently convertible into shares of common stock. The number of shares of common stock beneficially owned
 by Auctus includes the 34,433 Additional Shares currently issuable to it. Without the 9.99% limitation discussed above, Auctus would
 have beneficial ownership of 4,652,493 shares of common stock.

 (11)

 to the Certificate of Designations of Preferred Stock with regard to the Series B preferred stock, Auctus, as the sole holder of the
 1,398,158 outstanding shares of Series B preferred stock, is entitled to vote such shares based on the number of shares of common
 stock into which such shares are convertible (currently 1,398,158); however, pursuant to such Certificate of Designations of
 Preferred Stock, as indicated in footnote (10), such Series B preferred stock is not convertible into shares of common stock to the
 extent Auctus would beneficially own, after such conversion, more than 9.99% of our then outstanding shares of common stock. Since
 Auctus has advised that, as of March 20, 2024, it owned 645,320 shares of common stock, which represented 9.5% of the outstanding
 shares of common stock, and, as indicated in footnote (10) above, 34,433 Additional Shares are issuable to it, Auctus' Series
 B preferred stock is not currently convertible into shares of common stock. Accordingly, as of March 20, 2024, Auctus, as the sole
 holder of the Series B preferred stock, is not entitled to any votes for such shares.

 Securities
Authorized for Issuance Under Equity Compensation Plans

 The
following table sets forth information as of December 31, 2023 with respect to compensation plans (including individual compensation
arrangements) under which our common stock are authorized for issuance, aggregated as follows:

 All
 compensation plans previously approved by security holders; and

 All
 compensation plans not previously approved by security holders.

 EQUITY
COMPENSATION PLAN INFORMATION

securities to be
issued upon
exercise of
outstanding
options (a)

 Weighted-average
exercise price of
outstanding options
(b)

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

 Equity compensation plans approved by security holders

 $
 4.11

 2,063,311
 (1)

 Total

 $
 4.11

 2,063,311

 (1)

 97,824 unvested restricted stock units outstanding at December 31, 2023.

 ITEM
 13.

 CERTAIN
 RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE.

Independence

 Board
of Directors

 Our
Board of Directors is comprised of Lance Alstodt (Chair), Francisco Silva, Nickolay Kukekov, Patrick F. Williams and David Rosa. Each
of Dr. Kukekov, Mr. Williams and Mr. Rosa is an "independent director" based on the definition of independence in Listing
Rule 5605(a)(2) of The Nasdaq Stock Market.

 Audit
Committee

 Mr.
Williams (Chair), Dr. Kukekov and Mr. Rosa are the members of our Board's Audit Committee. Each of Mr. Williams, Dr. Kukekov and
Mr. Rosa is an "independent director" based on the definition of independence in Listing Rule 5605(a)(2) of The Nasdaq Stock
Market and Rule 10A-3(b)(1) under the Exchange Act. Our Board of Directors has determined that Mr. Williams qualifies as an "audit
committee financial expert," as that term is defined in Item 407(d)(5) of Regulation S-K.

 Nominating
Committee

 Mr.
Rosa (Chair), Dr. Kukekov and Mr. Williams are the members of our Board's Nominating Committee. Each of Mr. Rosa, Dr. Kukekov and
Mr. Williams is an "independent director" based on the definition of independence in Listing Rule 5605(a)(2) of The Nasdaq
Stock Market.

 Compensation
Committee

 Dr.
Kukekov (Chair), Mr. Williams and Mr. Rosa are the members of our Board's Compensation Committee. Each of Dr. Kukekov, Mr. Williams
and Mr. Rosa is an "independent director" based on the definition of independence in Listing Rule 5605(a)(2) of The Nasdaq
Stock Market.

 ITEM
 14.

 PRINCIPAL
 ACCOUNTANT FEES AND SERVICES.

 Marcum
LLP served as our independent registered public accountants for the years ended December 31, 2023 and 2022.

 The
following is a summary of the fees billed or expected to be billed to us by Marcum LLP, our independent registered public accountants,
for professional services rendered with respect to the fiscal years ended December 31, 2023 and 2022 and by Friedman LLP, our former
independent registered public accountants, for professional services rendered with respect to the fiscal year ended December 31, 2022:

 2023

 2022

 Marcum LLP

 Marcum LLP

 Friedman LLP

 Audit Fees (1)

 $
 101,500

 $
 65,000

 $
 30,000

 Audit-Related Fees (2)

 37,000

 2,500

 4,000

 Tax Fees (3)

 -

 -

 -

 All Other Fees (4)

 -

 -

 -

 $
 138,500

 $
 67,500

 $
 34,000

 (1)

 Audit
 Fees consist of fees billed and expected to be billed for services rendered for the audit of our consolidated financial statements
 for the fiscal years ended December 31, 2023 and 2022, and the review of our condensed consolidated financial statements included
 in our Quarterly Reports on Form 10-Q.

 (2)

 Audit-Related
 Fees consist of fees billed for assurance and related services that are reasonably related to the performance of the audit of our
 financial statements and in connection with the filing of Forms S-1, S-3 and S-8 registration statements and are not reported under
 "Audit Fees."

 (3)

 Tax
 Fees consist of fees billed for professional services related to preparation of our U.S. federal and state income tax returns and
 tax advice.

 (4)

 All
 Other Fees consist of fees billed for products and services provided by our independent registered public accountants, other than
 those disclosed above.

 The
Audit Committee is responsible for the appointment, compensation and oversight of the work of the independent registered public accountants,
and approves in advance any services to be performed by the independent registered public accountants, whether audit-related or not.
The Audit Committee reviews each proposed engagement to determine whether the provision of services is compatible with maintaining the
independence of the independent registered public accountants. The fees shown above were pre-approved either by our Board or our Audit
Committee.

 PART
IV

 ITEM
 15.

 EXHIBITS
 AND FINANCIAL STATEMENT SCHEDULES.

 Exhibit No.

 3.1

 Amended and Restated Articles of Incorporation, incorporated by reference to the registrant's Current Report on Form 8-K for an event dated December 29, 2022, wherein such document is identified as Exhibit 3.3

 3.2

 Certificate of Designations of Series B Preferred Stock, incorporated by reference to the registrant's Current Report on Form 8-K for an event dated December 29, 2022, wherein such document is identified as Exhibit 3.4

 3.3

 Bylaws, incorporated by reference to the registrant's Current Report on Form 8-K for an event dated December 29, 2022, wherein such document is identified as Exhibit 3.5

 10.1

 License Agreement, dated as of January 27, 2012, between Regenerative Sciences, LLC and BioRestorative Therapies, Inc. ("License Agreement"), incorporated by reference to the registrant's Annual Report on Form 10-K for the year ended December 31, 2011, wherein such document is identified as Exhibit 10.44

 10.2

 Amendment to License Agreement, dated March 21, 2012, incorporated by reference to the registrant's Annual Report on Form 10-K for the year ended December 31, 2011, wherein such document is identified as Exhibit 10.45

 10.3

 Amendment to License Agreement, dated November 30, 2015, incorporated by reference to the registrant's Annual Report on Form 10-K for the year ended December 31, 2015, wherein such document is identified as Exhibit 10.20

 10.4

 Letter agreement, dated November 21, 2022, by and among BioRestorative Therapies, Inc., Regenerative Sciences, LLC and Regenexx, LLC with regard to License Agreement, incorporated by reference to the registrant's Annual Report on Form 10-K for the year ended December 31, 2022, wherein such document is identified as Exhibit 10.4

 10.5

 Lease, dated as of August 25, 2014, between BioRestorative Therapies, Inc. and 50 Republic Road, LLC, incorporated by reference to the registrant's Current Report on Form 8-K for an event dated August 25, 2014, wherein such document is identified as Exhibit 99.1

 10.6

 Lease Amendment, dated as of June 4, 2019, between 50 Republic Road, LLC and BioRestorative Therapies, Inc., incorporated by reference to the registrant's Annual Report on Form 10-K for the year ended December 31, 2019, wherein such document is identified as Exhibit 10.37

 10.7

 BioRestorative Therapies, Inc. 2021 Stock Incentive Plan, as amended*

 10.8

 Executive Employment Agreement, dated as of March 18, 2021, by and between BioRestorative Therapies, Inc. and Lance Alstodt, incorporated by reference to the registrant's Current Report on Form 8-K for an event dated March 18, 2021, wherein such document is identified as Exhibit 99.2

 10.9

 Executive Employment Agreement, dated as of March 18, 2021, by and between BioRestorative Therapies, Inc. and Francisco Silva, incorporated by reference to the registrant's Current Report on Form 8-K for an event dated March 18, 2021, wherein such document is identified as Exhibit 99.3

 10.10

 Non-Qualified Stock Option Award Agreement, dated as of March 18, 2021, between BioRestorative Therapies, Inc. and Lance Alstodt, incorporated by reference to the registrant's Current Report on Form 8-K for an event dated March 18, 2021, wherein such document is identified as Exhibit 99.4

 10.11

 Non-Qualified Stock Option Award Agreement, dated as of March 18, 2021, between BioRestorative Therapies, Inc. and Francisco Silva, incorporated by reference to the registrant's Current Report on Form 8-K for an event dated March 18, 2021, wherein such document is identified as Exhibit 99.5

 10.12

 Executive Employment Agreement, dated as of November 4, 2021, between BioRestorative Therapies, Inc. and Robert Kristal*

 10.13

 Non-Qualified Stock Option Award Agreement, dated as of November 4, 2021, between BioRestorative Therapies, Inc. and Lance Alstodt, incorporated by reference to the registrant's Current Report on Form 8-K for an event dated November 4, 2021, wherein such document is identified as Exhibit 99.2

 10.14

 Non-Qualified Stock Option Award Agreement, dated as of November 4, 2021, between BioRestorative Therapies, Inc. and Francisco Silva, incorporated by reference to the registrant's Current Report on Form 8-K for an event dated November 4, wherein such document is identified as Exhibit 99.3

 10.15

 Non-Qualified Stock Option Award Agreement, dated as of November 4, 2021, between BioRestorative Therapies, Inc. and Nickolay Kukekov, incorporated by reference to the registrant's Annual Report on Form 10-K for the year ended December 31, 2021, wherein such document is identified as Exhibit 10.15

 10.16

 Non-Qualified Stock Option Award Agreement, dated as of November 4, 2021, between BioRestorative Therapies, Inc. and Patrick F. Williams, incorporated by reference to the registrant's Annual Report on Form 10-K for the year ended December 31, 2021, wherein such document is identified as Exhibit 10.16

 10.17

 Non-Qualified Stock Option Award Agreement, dated as of November 4, 2021, between BioRestorative Therapies, Inc. and David Rosa, incorporated by reference to the registrant's Annual Report on Form 10-K for the year ended December 31, 2021, wherein such document is identified as Exhibit 10.17

 10.18

 Amendment No. 1 to Non-Qualified Stock Option Award Agreement, dated as of November 4, 2021, between BioRestorative Therapies, Inc. and Lance Alstodt, incorporated by reference to the registrant's Annual Report on Form 10-K for the year ended December 31, 2021, wherein such document is identified as Exhibit 10.18

 10.19

 Amendment No. 1 to Non-Qualified Stock Option Award Agreement, dated as of November 4, 2021, between BioRestorative Therapies, Inc. and Francisco Silva, incorporated by reference to the registrant's Annual Report on Form 10-K for the year ended December 31, 2021, wherein such document is identified as Exhibit 10.19

 10.20

 Common Stock Purchase Warrant, dated November 9, 2021, issued by BioRestorative Therapies, Inc. pursuant to public offering, incorporated by reference to the registrant's Annual Report on Form 10-K for the year ended December 31, 2021, wherein such document is identified as Exhibit 10.20

 10.21

 Common Stock Purchase Warrant, dated November 9, 2021, issued by BioRestorative Therapies, Inc. to Auctus Fund, LLC, incorporated by reference to the registrant's Annual Report on Form 10-K for the year ended December 31, 2021, wherein such document is identified as Exhibit 10.21

 10.22

 Amendment No. 2 to Non-Qualified Stock Option Award Agreement, dated as of December 10, 2021, between BioRestorative Therapies, Inc. and Lance Alstodt, incorporated by reference to the registrant's Annual Report on Form 10-K for the year ended December 31, 2021, wherein such document is identified as Exhibit 10.22

 10.23

 Amendment No. 2 to Non-Qualified Stock Option Award Agreement, dated as of December 10, 2021, between BioRestorative Therapies, Inc. and Francisco Silva, incorporated by reference to the registrant's Annual Report on Form 10-K for the year ended December 31, 2021, wherein such document is identified as Exhibit 10.23

 10.24

 Amendment No. 1 to Non-Qualified Stock Option Award Agreement, dated as of December 10, 2021, between BioRestorative Therapies, Inc. and Nickolay Kukekov, incorporated by reference to the registrant's Annual Report on Form 10-K for the year ended December 31, 2021, wherein such document is identified as Exhibit 10.24

 10.25

 Amendment No. 1 to Non-Qualified Stock Option Award Agreement, dated as of December 10, 2021, between BioRestorative Therapies, Inc. and Patrick F. Williams, incorporated by reference to the registrant's Annual Report on Form 10-K for the year ended December 31, 2021, wherein such document is identified as Exhibit 10.25

 10.26

 Amendment No. 1 to Non-Qualified Stock Option Award Agreement, dated as of December 10, 2021, between BioRestorative Therapies, Inc. and David Rosa, incorporated by reference to the registrant's Annual Report on Form 10-K for the year ended December 31, 2021, wherein such document is identified as Exhibit 10.26

 10.27

 Executive Employment Agreement, dated as of December 29, 2021, between BioRestorative Therapies, Inc. and Robert Paccasassi*

 10.28

 Incentive Stock Option Award Agreement, dated as of February 17, 2023, between BioRestorative Therapies, Inc. and Lance Alstodt, incorporated by reference to the registrant's Annual Report on Form 10-K for the year ended December 31, 2022, wherein such document is identified as Exhibit 10.28

 10.29

 Incentive Stock Option Award Agreement, dated as of February 17, 2023, between BioRestorative Therapies, Inc. and Francisco Silva, incorporated by reference to the registrant's Annual Report on Form 10-K for the year ended December 31, 2022, wherein such document is identified as Exhibit 10.29

 10.30

 Incentive Stock Option Award Agreement, dated as of February 17, 2023, between BioRestorative Therapies, Inc. and Robert Kristal, incorporated by reference to the registrant's Annual Report on Form 10-K for the year ended December 31, 2022, wherein such document is identified as Exhibit 10.30

 10.31

 Incentive Stock Option Award Agreement, dated as of February 17, 2023, between BioRestorative Therapies, Inc. and Robert Paccasassi, incorporated by reference to the registrant's Annual Report on Form 10-K for the year ended December 31, 2022, wherein such document is identified as Exhibit 10.31

 10.32

 Non-Qualified Stock Option Award Agreement, dated as of February 17, 2023, between BioRestorative Therapies, Inc. and Nickolay Kukekov, incorporated by reference to the registrant's Annual Report on Form 10-K for the year ended December 31, 2022, wherein such document is identified as Exhibit 10.32

 10.33

 Non-Qualified Stock Option Award Agreement, dated as of February 17, 2023, between BioRestorative Therapies, Inc. and Patrick F. Williams, incorporated by reference to the registrant's Annual Report on Form 10-K for the year ended December 31, 2022, wherein such document is identified as Exhibit 10.33

 10.34

 Non-Qualified Stock Option Award Agreement, dated as of February 17, 2023, between BioRestorative Therapies, Inc. and David Rosa, incorporated by reference to the registrant's Annual Report on Form 10-K for the year ended December 31, 2022, wherein such document is identified as Exhibit 10.34

 10.35

 Capital on Demand Sales Agreement, dated as of April 14, 2023, by and between BioRestorative Therapies, Inc. and JonesTrading Institutional Services LLC, incorporated by reference to the registrant's Current Report on Form 8-K for an event dated April 14, 2023, wherein such document is identified as Exhibit 1.1

 10.36

 Incentive Stock Option Award Agreement, dated as of February 13, 2024, between BioRestorative Therapies, Inc. and Lance Alstodt*

 10.37

 Incentive Stock Option Award Agreement, dated as of February 13, 2024, between BioRestorative Therapies, Inc. and Francisco Silva*

 10.38

 Incentive Stock Option Award Agreement, dated as of February 13, 2024, between BioRestorative Therapies, Inc. and Robert Kristal*

 10.39

 Incentive Stock Option Award Agreement, dated as of February 13, 2024, between BioRestorative Therapies, Inc. and Robert Paccasassi*

 10.40

 Non-Qualified Stock Option Award Agreement, dated as of February 13, 2024, between BioRestorative Therapies, Inc. and Nickolay Kukekov*

 10.41

 Non-Qualified Stock Option Award Agreement, dated as of February 13, 2024, between BioRestorative Therapies, Inc. and Patrick F. Williams*

 10.42

 Non-Qualified Stock Option Award Agreement, dated as of February 13, 2024, between BioRestorative Therapies, Inc. and David Rosa*

 Code of Ethics, incorporated by reference to the registrant's Annual Report on Form 10-K for the year ended December 31, 2011, wherein such document is identified as Exhibit 14

 Subsidiaries, incorporated by reference to the registrant's Annual Report on Form 10-K for the year ended December 31, 2018, wherein such document is identified as Exhibit 21

 Independent Registered Public Accounting Firm's Consent*

 31.1

 Principal Executive Officer Certification*

 31.2

 Principal Financial Officer Certification*

 Section 1350 Certification**

 Clawback Policy*

 101.INS

 101.SCH

 101.CAL

 101.DEF

 101.LAB

 101.PRE

 *
Filed herewith

 **
Furnished herewith

 ITEM
 16.

 FORM
 10-K SUMMARY.

 Not
applicable

 SIGNATURES

to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this Amendment No.
1 to the report to be signed on its behalf by the undersigned, thereunto duly authorized.

 Dated:

 By:

 /s/

 Lance

 Chief
 Executive Officer

to the requirements of the Securities Exchange Act of 1934, this Amendment No. 1 to the report has been signed below by the
following persons on behalf of the registrant and in the capacities and on the dates indicated.

 Signature

 Capacity

 Date

 /s/

 Chief
 Executive Officer, President, Chairman of the Board and Director

 Lance

 (Principal
 Executive Officer)

 /s/

 Vice
 President, Research and Development and Director

 Silva

 / s/
 Robert E. Kristal

 Chief
 Financial Officer

 E. Kristal

 (Principal
 Financial Officer and Principal Accounting Officer)

 /s/
 Nickolay Kukekov

 Kukekov

 /s/
 Patrick F. Williams

 /s/
 David Rosa

 David
 Rosa

 ITEM
8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

TO CONSOLIDATED FINANCIAL STATEMENTS

 Page

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

 Consolidated Balance Sheets as of December 31, 2023 and 202 2

 Consolidated Statements of Operations for the Years Ended December 31, 2023 and 202 2

 Consolidated Statements of Stockholders' Equity as of December 31, 2023 and 202 2

 Consolidated Statements of Cash Flows for the Years Ended December 31, 2023 and 202 2

 Notes to Consolidated Financial Statements

 F- 1

 REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

 To
the Stockholders and Board of Directors of

 BioRestorative
Therapies, Inc.

 Opinion
on the Financial Statements

 We
have audited the accompanying consolidated balance sheets of BioRestorative Therapies, Inc. (the "Company") as of December
31, 2023 and 2022, the related consolidated statements of operations, 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.

of 2023 and 2022 Financial Statements

 As
discussed in Note 2 to the financial statements, the accompanying financial statements as of December 31, 2023 and 2022 and for each
of the years then ended, have been restated to correct a misstatement relating to the Company's accounting for warrants.

 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 2020.

 Marlton,
New Jersey

 March
29, 2024, except for Note 2, Note 8, Note 9 and Note 11, as to which the date is June 11, 2024

 F- 2

 CONSOLIDATED
BALANCE SHEETS

 2023

 2022

 31,

 2023

 2022

 Assets

 Assets:

 Cash
 and cash equivalents

 $
 884,377

 $
 1,713,772

 Investments
 held in marketable securities

 10,181,618

 receivable

 19,300

 16,000

 Prepaid
 expenses and other current assets

 305,231

 363,082

 Total
 current assets

 11,390,526

 15,128,490

 and equipment, net

 356,055

 261,003

 Right-of-use
 assets

 151,447

 241,760

 Intangible
 assets, net

 713,692

 803,438

 Total
 Assets

 $
 12,611,720

 $
 16,434,691

 Liabilities
 and Stockholders' Equity

 Liabilities:

 payable

 189,389

 170,902

 Accrued
 expenses and other current liabilities

 711,686

 130,072

 Lease
 liability, current portion

 139,328

 Total
 Current Liabilities

 2,607,345

 5,982,035

 Lease
 liability, net of current portion

 -

 Total
 Liabilities

 2,607,345

 6,144,352

 Commitments
 and contingencies

 -

 -

 Stockholders'
 Equity:

 Preferred
 stock, $ 0.01 par value; 20,000,000 shares authorized;

 B Convertible Preferred Stock; 1,543,158 shares designated, 1,398,158 and 1,518,158 shares issued and outstanding at December 31,
 2023 and 2022, respectively

 13,982

 15,182

 Preferred
 stock, value

 13,982

 15,182

 stock, $ 0.0001 par value; 75,000,000 shares authorized; 4,706,917 and 3,677,775 shares issued and outstanding at December
 31, 2023 and 2022, respectively

 paid-in capital

 deficit

)

)

 Total
 Stockholders' Equity

 Total
 Liabilities and Stockholders' Equity

 $
 12,611,720

 $
 16,434,691

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

 F- 3

 CONSOLIDATED
STATEMENTS OF OPERATIONS

 2023

 2022

 For

 31,

 2023

 2022

 Revenues,
 net

 $
 145,800

 $
 119,800

 Operating
 Expenses:

 and development

 4,034,591

 3,513,352

 and administrative

 11,331,983

 15,580,473

 Total
 Operating Expenses

 15,366,574

 19,093,825

 Loss
 From Operations

 ( 15,220,774
)

 ( 18,974,025
)

 Other
 Income:

 Interest

 ( 552,293
)

 ( 11,650
)

 Gain
 on PPP loan forgiveness

 -

 ( 250,000
)

 Grant

 ( 83,333
)

 ( 110,518
)

 Other

 ( 169,664
)

 ( 107,088
)

)

)

 Total
 Other Income

 ( 4,803,070
)

 ( 5,751,729
)

 Net
 Loss

 $
)

 $
)

 Net
 Loss Per Share - Basic and Diluted

 $
 ( 2.47
)

 $
 ( 3.65
)

 Average Common Shares Outstanding -

 Basic and Diluted

 4,218,347

 3,617,858

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

 F- 4

 CONSOLIDATED
STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY

 FOR
THE YEARS ENDED DECEMBER 31, 2023 AND 2022

 Capital

 Deficit

 Total

 A Convertible

 B Convertible

 Preferred
 Stock

 Preferred
 Stock

 Stock

 Paid-In

 Capital

 Deficit

 Total

 - January 1, 2022 (as previously reported)

 1,543,158

 $
 15,432

 -

 $
 -

 3,520,391

 $

 $
 155,727,292

 $
 ( 134,146,128
)

 $
 21,596,949

 Effect of restatement

 -

 -

 -

 -

 -

 -

)

)

 Balance - January 1, 2022 (as restated)

 1,543,158

 15,432

 -

 -

 3,520,391

 133,826,292

 ( 123,059,334

)

 10,782,743

 Issuance
 of Series B Convertible Preferred Stock in exchange for Series
 A Convertible Preferred Stock

 ( 1,543,158
)

 ( 15,432
)

 1,543,158

 15,432

 -

 -

 -

 -

 -

 issued in connection with license exclusivity agreement

 -

 -

 -

 -

 -

 -

 117,030

 -

 117,030

 Conversion
 of Series B Convertible Preferred Stock into common stock

 -

 -

 ( 25,000
)

 ( 250
)

 25,000

 -

 -

 Stock-based
 compensation:

 Restricted
 share units

 -

 -

 -

 -

 116,486

 4,735,097

 -

 4,735,108

 -

 -

 -

 -

 -

 -

 7,741,864

 -

 7,741,864

 stock

 -

 -

 -

 -

 15,898

 135,888

 -

 135,890

 Net
 loss (as restated)

 -

 -

 -

 -

 -

 -

 -

)

)

 - December 31, 2022 (as restated)

 -

 -

 1,518,158

 15,182

 3,677,775

)

 -

 -

 1,518,158

 15,182

 3,677,775

)

 Stock-based
 compensation:

 Restricted
 share units

 -

 -

 -

 -

 89,840

 4,633,655

 -

 4,633,664

 -

 -

 -

 -

 -

 -

 3,141,803

 -

 3,141,803

 stock

 -

 -

 -

 -

 1,442

 -

 7,500

 -

 7,500

 Conversion
 of Series B Convertible Preferred Stock into common stock

 -

 -

 ( 120,000
)

 ( 1,200
)

 120,000

 1,188

 -

 -

 Issuance
 and sale of common stock, net of issuance costs

 -

 -

 -

 -

 817,860

 2,348,692

 -

 2,348,773

 Net
 loss (as restated)

 -

 -

 -

 -

 -

 -

 -

)

)

 - December 31, 2023 (as restated)

 -

 $
 -

 1,398,158

 $
 13,982

 4,706,917

 $

 $

 $
)

 $

 -

 $
 -

 1,398,158

 $
 13,982

 4,706,917

 $

 $

 $
)

 $

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

 F- 5

 CONSOLIDATED
STATEMENTS OF CASH FLOWS

 2023

 2022

 For

 31,

 2023

 2022

 Cash
 Flows From Operating Activities:

 Net
 loss

 $
)

 $
)

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

 Depreciation
 and amortization

 165,735

 120,545

 Dividend
 and interest income

 ( 569,068
)

 ( 76,004
)

 Stock-based
 compensation

 7,782,967

 12,612,862

 Gain
 on PPP loan forgivesness

 -

 ( 250,000
)

 Non-cash
 lease expense

 90,313

 160,122

)

)

 in operating assets and liabilities:

 receivable

 ( 3,300
)

 ( 11,000
)

 Prepaid
 expenses and other current assets

 57,851

 73,099

 payable

 18,487

 120,075

 Accrued
 expenses and other current liabilities

 581,616

 ( 4,898
)

 Lease
 liability

 ( 139,328
)

 ( 163,132
)

 Net
 Cash Used In Operating Activities

 ( 6,430,211
)

 ( 5,913,100
)

 Cash
 Flows From Investing Activities:

 Sale
 of marketable securities

 20,964,373

 9,492,304

 Purchase
 of marketable securities

 ( 17,541,287
)

 ( 22,451,936
)

 Purchase
 of intangible assets

 -

 ( 175,000
)

 Purchases
 of equipment

 ( 171,043
)

 ( 265,223
)

 Net
 Cash Provided By (Used In) Investing Activities

 3,252,043

 ( 13,399,855
)

 Cash
 Flows From Financing Activities:

 Net
 proceeds from issuance of common stock in ATM transactions

 494,783

 -

 Net
 proceeds from issuance of common stock in registered direct offering

 1,853,990

 -

 Net
 Cash Provided By Financing Activities

 2,348,773

 -

 Net
 Decrease In Cash and Cash Equivalents

 ( 829,395
)

 ( 19,312,955
)

 Cash
 and Cash Equivalents - Beginning of the Year

 1,713,772

 21,026,727

 Cash
 and Cash Equivalents - End of the Year

 $
 884,377

 $
 1,713,772

 Supplemental
 Disclosures of Cash Flow Information:

 Cash
 paid during the year for:

 Interest

 $
 -

 $
 -

 Income
 taxes

 $
 -

 $
 -

 Non-cash
 investing and financing activities:

 issued as consideration for intangible assets

 $
 -

 $
 117,030

 Return and cancellation of shares in lieu of payroll tax withholding

 $
 39,308

 $
 -

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

 F- 6

 NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS

 Note
1 - ORGANIZATION, LIQUIDITY AND BUSINESS OPERATIONS

 Corporate
History

 BioRestorative
Therapies, Inc. has one wholly-owned subsidiary, Stem Pearls, LLC ("Stem Pearls"). BioRestorative Therapies, Inc. and its
subsidiary are referred to collectively as "BRT" or the "Company".

 On
December 23, 2022, the Company reincorporated from Delaware to Nevada by filing Articles of Incorporation with the state of Nevada. The
reincorporation was structured as a statutory merger.

 Liquidity

 The
accompanying consolidated financial statements have been prepared on the basis that the Company will continue as a going concern, which
contemplates realization of assets and satisfying liabilities in the normal course of business. For the year ended December 31, 2023,
the Company had a net loss of $ 10.4 million and negative cash flows from operations of $ 6.4
 million. The Company anticipates that it will
continue to incur net losses and negative cash flows from operations as it executes its development plans for 2024 and beyond, as well
as other potential strategic and business development initiatives. The Company has previously funded, and plans to continue funding,
these losses primarily through current cash on hand, investments in marketable securities and additional infusions of cash from equity
and debt financing. Subsequent to December 31, 2023, the Company raised gross proceeds of approximately $8.1 million in connection with
a warrant exercise program, which is further discussed in Note 12 – Subsequent Events.

 Based
on cash on hand as of the date these financial statements were issued, which includes $ 8.1 million of gross proceeds from the warrant
exercise program, the Company believes it has sufficient cash on hand in order to fund operations for at least the twelve months after
the issuance date of these financial statements.

funds noted above will not be sufficient to enable the Company to fully complete its development activities or attain profitable operations.
If the Company is unable to obtain such needed additional financing on a timely basis, the Company may have to curtail its development,
marketing and promotional activities, which would have a material adverse effect on the Company's business, financial condition
and results of operations, and ultimately the Company could be forced to discontinue its operations and liquidate.

 The
accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the
United States of America ("GAAP"), which contemplate continuation of the Company as a going concern and the realization of
assets and satisfaction of liabilities in the normal course of business. The carrying amounts of assets and liabilities presented in
the consolidated financial statements do not necessarily purport to represent realizable or settlement values. The accompanying consolidated
financial statements do not include any adjustments that might be necessary should the Company be unable to continue as a going concern.

 Business
Operations

 BRT
develops therapeutic products and medical therapies using cell and tissue protocols, primarily involving adult stem cells. BRT's
website is at www.biorestorative.com. The information contained in the website or connected thereto is not intended to be incorporated
by reference into the accompanying financial statements or these footnotes. BRT is currently developing a Disc/Spine Program referred
to as "brtxDISC". Its lead cell therapy candidate, BRTX-100, is a product formulated from autologous (or a person's
own) cultured mesenchymal stem cells collected from the patient's bone marrow. The product is intended to be used for the non-surgical
treatment of painful lumbosacral disc disorders or as a complimentary therapeutic to a surgical procedure. BRT is also engaging in research
efforts with respect to a platform technology utilizing brown adipose (fat) for therapeutic purposes to treat type 2 diabetes, obesity
and other metabolic disorders and has labeled this initiative its ThermoStem Program. Further, BRT has licensed a patented curved needle
device that is a needle system designed to deliver cells and/or other therapeutic products or material to the spine and discs or other
potential sites.

 F- 7

 NOTE
2 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

 Basis
of Presentation

 The
accompanying consolidated financial statements have been prepared in accordance with GAAP. The summary of significant accounting policies
presented below is designed to assist in understanding the Company's consolidated financial statements. Such consolidated financial
statements and accompanying notes are the representations of Company's management, who is responsible for their integrity and objectivity.

 Principles
of Consolidation

 The
consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary, Stem Pearls. All intercompany
accounts and transactions have been eliminated in consolidation.

of Previously Issued Consolidated Financial Statements

 On
May 23, 2024, the Company, in consultation with its Audit Committee, concluded that its previously issued (i) consolidated financial
statements as of and for the two years ended December 31, 2023 included in the Company's Annual Report on Form 10-K for the year
ended December 31, 2023 (the "Annual Periods") and (ii) unaudited interim condensed consolidated financial statements as
of and for the quarters ended March 31, 2022 through September 30, 2023 included in the Company's quarterly reports on Form 10-Q
for the periods ended March 31, 2023, June 30, 2023 and September 30, 2023 (the "Interim Periods", and, together with the
Annual Periods, the "Affected Periods") should be restated because of a misapplication in the guidance around the accounting
for certain warrants, as discussed below, and should no longer be relied upon.

 The
warrants at issue are the following:

 (i)

 the
 warrants to purchase an aggregate of 2,645,000 shares of the Company's common stock, issued in November 2021 pursuant to an
 underwritten public offering, which warrants provide for an exercise price of $ 10.00 per share (the "Public Warrants");

 (ii)

 the
 warrants to purchase an aggregate of 1,856,938 shares of the Company's common stock, issued in November 2021 pursuant to a
 private offering, which warrants provide for an exercise price of $ 10.00 per share (the "Private Warrants"); and

 (iii)

 the
 warrants to purchase an aggregate of 235,970 shares of the Company's common stock, issued in November 2021 to the underwriter
 of the public offering, which warrants provide for an exercise price of $ 12.50 per share (together with the Public Warrants and the
 Private Warrants, the "Warrants").

 Historically,
the Warrants were included as a component of stockholders' equity. It has now been determined, in accordance with Accounting Standards
Codification ("ASC") 815, that the Warrants should be included at fair value as a component of liabilities on the balance
sheets, and the statements of operations should include the subsequent non-cash changes in estimated fair value of the Warrants (the
"Restatement"). See Note 11 – Fair Value Measurement for details of the estimated fair value of the Warrants.

 The
Company evaluated the materiality of these misstatements and determined the effect of correcting these misstatements was material to
the Affected Periods. As a result of the material misstatements, the Company has restated its consolidated financial statements for the
Affected Periods in accordance with ASC 250, Accounting Changes and Error Corrections (the "Restated Financial Statements").

 A
reconciliation from the amounts previously reported for the Affected Periods to the restated amounts in the Restated Financial Statements
is provided for the impacted financial statement line items below for: (i) the consolidated balance sheets as of December 31, 2023 and
2022 (ii) the consolidated statements of operations for the years ended December 31, 2023 and 2022 (iii) the consolidated
statements of changes in stockholders' equity for the years ended December 31, 2023 and 2022 and (iv) the consolidated statements
of cash flows for the years ended December 31, 2023 and 2022. The amounts labeled "Restatement Adjustments" represent the
effects of the Restatement.

 F- 8

 The
following tables present the effects of the Restatement on the Company's consolidated balance sheets as of December 31, 2023 and
2022:

OF RESTATEMENT OF CONSOLIDATED BALANCE SHEETS

 As

 December 31, 2023

 As

 $
 -

 $

 $

 $
 1,063,392

 $

 $
 2,607,345

 $
 1,063,392

 $

 $
 2,607,345

 $
 178,590,256

 $
)

 $

 $
 ( 167,056,381
)

 $
 20,357,047

 $
)

 $
 11,548,328

 $
 ( 1,543,953
)

 $

 $
 12,611,720

 $
 -

 $
 12,611,720

 As

 December 31, 2022

 As

 $
 -

 $

 $

 $
 440,302

 $

 $
 5,982,035

 $
 602,619

 $

 $
 6,144,352

 $
 168,457,418

 $
)

 $

 $
 ( 152,640,897
)

 $

 $
)

 $
 15,832,072

 $
)

 $

 $
 16,434,691

 $
 -

 $
 16,434,691

 The
following tables present the effects of the Restatement on the Company's consolidated statements of operations for the years ended
December 31, 2023 and 2022:

OF RESTATEMENT OF CONSOLIDATED STATEMENTS OF OPERATIONS

 As

 For the Year Ended

 December 31, 2023

 As

 $
 -

 $
)

 $
)

 $
 ( 805,290
)

 $
)

 $
 ( 4,803,070
)

 $
 ( 14,415,484
)

 $
 3,997,780

 $
)

 $
 ( 3.42
)

 $
 0.95

 $
 ( 2.47
)

 As

 For the Year Ended

 December 31, 2022

 As

 $
 -

 $
)

 $
)

 $
 ( 479,256
)

 $
)

 $
 ( 5,751,729
)

 $
 ( 18,494,769
)

 $
 5,272,473

 $
)

 Loss per share:

 $
 ( 5.11
)

 $
 1.46

 $
 ( 3.65
)

 F- 9

 The
following tables present the effects of the Restatement on the Company's consolidated statements of changes in stockholders'
equity for the years ended December 31, 2023 and 2022:

OF RESTATEMENT OF CONSOLIDATED STATEMENTS OF CHANGE IN STOCKHOLDERS' EQUITY

 Balance - December 31, 2023 (as previously reported)

 $
 178,590,256

 $
 ( 167,056,381
)

 $
 11,548,328

)

)

 -

 3,997,780

 3,997,780

 Balance - December 31, 2023 (as restated)

 $

 $
)

 $

 Balance - December 31, 2022 (as previously reported)

 $
 168,457,418

 $
 ( 152,640,897
)

 $
 15,832,072

)

)

 -

 5,272,473

 5,272,473

 Balance - December 31, 2022 (as restated)

 $

 $
)

 $

 The
following tables present the effects of the Restatement on the Company's consolidated statements of cash flows for the years ended
December 31, 2023 and 2022:

OF RESTATEMENT OF CONSOLIDATED STATEMENT OF CASH FLOWS

 As

 December 31, 2023

 As

 $
 ( 14,415,484
)

 $
 3,997,780

 $
)

 Adjustments to reconcile net (loss) income to net cash used in operating activities:

 $
 -

 $
)

 $
)

 $
 ( 6,430,211
)

 $
 -

 $
 ( 6,430,211
)

 As

 December 31, 2022

 As

 $
 ( 18,494,769
)

 $
 5,272,473

 $
)

 Adjustments to reconcile net (loss) income to net cash used in operating activities:

 $
 -

 $
)

 $
)

 $
 ( 5,913,100
)

 $
 -

 $
 ( 5,913,100
)

 The
remainder of the notes to the Company's consolidated financial statements have been updated and restated, as applicable, to reflect
the impact of the Restatement described above.

 See
Note 3 - Restatement of Previously Issued Unaudited Interim Condensed Consolidated Financial Statements for details of the effect of
the Restatement on the Interim Periods.

 Use
of Estimates

 The
preparation of the consolidated financial statements in conformity with GAAP requires management to make estimates, judgments and assumptions
that affect the reported amounts of assets, liabilities, revenues and expenses, together with amounts disclosed in the related notes
to the financial statements. The Company bases its estimates and assumptions on historical experience, known or expected trends and various
other assumptions that it believes to be reasonable. As future events and their effects cannot be determined with precision, actual results
could differ from these estimates which may cause the Company's future results to be affected.

 Reclassifications

 Certain
prior period balance sheet, statement of operations and statement of cash flows amounts have been reclassified to conform to the Company's
fiscal 2023 presentation. These reclassifications have no impact on the Company's previously reported
net loss.

 Concentrations

 Financial
instruments that potentially subject the Company to concentrations of credit risk consist of a cash account in a financial institution.
The Company maintains deposits in its cash account in excess of the Federal Depository Insurance Coverage limit of $ 250,000. As of December
31, 2023, the Company had not experienced losses on this account.

 The
royalties related to the Company's sublicense comprised 100% of the Company's revenue during the years ended December 31,
2023 and 2022. See "Revenue Recognition" below.

 F- 10

 Revenue
Recognition

 The
Company accounts for revenue in accordance with Accounting Standards Codification ("ASC") 606, Revenue from Contracts
with Customers.

 The
Company derives all of its revenue pursuant to a license agreement between the Company and a stem cell treatment company ("SCTC")
entered into in January 2012. In November 2022, the Company's license rights under the agreement became exclusive. Pursuant to
the license agreement, the SCTC granted to the Company a license to use certain intellectual property related to, among other things,
stem cell disc procedures and the Company has granted to the SCTC a sublicense to use, and the right to sublicense to third parties the
right to use, in certain locations in the United States and the Cayman Islands, certain of the licensed intellectual property. In consideration
of the sublicenses, the SCTC has agreed to pay the Company royalties on a per disc procedure basis.

 The
Company's contracted transaction price is allocated to each distinct performance obligation and recognized as revenue when, or
as, the performance obligation is satisfied. The Company's contracts have a single performance obligation which is not separately
identifiable from other promises in the contracts and is, therefore, not distinct. The Company's performance obligation is satisfied
upon the transfer of risk of loss to the customer. The timing of the Company's revenue recognition may differ from the timing of
receiving royalty payments. A receivable is recorded when revenue is recognized prior to receipt of a royalty payment and the Company
has an unconditional right to the royalty payment. Alternatively, when a royalty payment precedes the provision of the related services,
the Company records deferred revenue until the performance obligations are satisfied. During the years ended December 31, 2023 and 2022,
the Company recognized $ 145,800 and $ 119,800, respectively, of revenue related to the Company's sublicenses.

 Practical
Expedients

 As
part of ASC 606, the Company has adopted several practical expedients including:

 Significant
 Financing Component - the Company does not adjust the promised amount of consideration for
 the effects of a significant financing component since the Company expects, at contract inception,
 that the period between when the Company transfers a promised good or service to the customer
 and when the customer pays for that good or service will be one year or less.

 Unsatisfied
 Performance Obligations - all performance obligations related to contracts with a duration
 for less than one year; the Company has elected to apply the optional exemption provided
 in ASC Topic 606 and, therefore, is not required to disclose the aggregate amount of transaction
 price allocated to performance obligations that are unsatisfied or partially satisfied at
 the end of the reporting period.

 Right
 to Invoice - the Company has a right to consideration from a customer in an amount that corresponds
 directly with the value to the customer of the Company's performance completed to date;
 the Company may recognize revenue in the amount to which the entity has a right to invoice.

 F- 11

 Cash
and Cash Equivalents

 The
Company considers all highly liquid investments with maturities of three months or less at the time of purchase to be cash equivalents.
There were no cash equivalents as of December 31, 2023 or 2022.

Receivable

receivable are carried at their contractual amounts, less a provision for current expected credit losses. The reserve represents the
Company's best estimate of expected credit losses it may experience in the Company's receivable portfolio. Management estimates
the allowance for credit losses based on an ongoing review of existing economic conditions, the financial conditions of the customers,
historical trends in credit losses, and the amount and age of past due accounts. The Company writes off accounts receivable against the
provision for current expected credit losses when a balance is determined to be uncollectible. The Company did no t record a provision
for current expected credit losses as of December 31, 2023 or 2022.

and Equipment

and equipment are recorded at cost. Depreciation is computed using straight-line method over the estimated useful lives of the related
assets, generally three to fifteen years. Expenditures that enhance the useful lives of the assets are capitalized and depreciated. Computer
equipment costs are capitalized, as incurred, and depreciated on a straight-line basis over a range of 3 - 5 years.

 Leasehold
improvements are amortized over the lesser of (i) the useful life of the asset, or (ii) the remaining lease term. Maintenance and repairs
are charged to expense as incurred. The Company capitalizes cost attributable to the betterment of property and equipment when such betterment
extends the useful life of the assets. At the time of retirement or other disposition of property and equipment, the cost and accumulated
depreciation will be removed from the accounts and the resulting gain or loss, if any, will be reflected in operations.

 Intangible
Assets

 The
Company records its intangible assets at cost in accordance with ASC 350, Intangibles - Goodwill and Other. Definite lived intangible
assets are amortized over their estimated useful life using the straight-line method, which is determined by identifying the period over
which the cash flows from the asset are expected to be generated.

 Impairment
of Long-Lived Assets

 The
Company reviews long-lived assets, including definite-lived intangible assets and right-of-use assets from operating leases, for impairment
whenever events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable. Recoverability of
these assets is determined by comparing the forecasted undiscounted net cash flows of the operation to which the assets relate to the
carrying amount. If the operation is determined to be unable to recover the carrying amount of its assets, then these assets are written
down first, followed by other long-lived assets of the operation to fair value. Fair value is determined based on discounted cash flows
or appraised values, depending on the nature of the assets. For the years ended December 31, 2023 and 2022, we determined that there
was no impairment charge for our long-lived assets.

 Derivative
Financial Instruments

 The Company evaluates all of its agreements to determine if such instruments have derivatives or contain features that qualify as embedded
derivatives. For derivative financial instruments that are accounted for as liabilities, the derivative instrument is initially recorded
at its fair value and is then re-valued at each reporting date, with changes in the fair value reported in the statements of operations.
For stock-based derivative financial instruments, the Company uses a weighted-average Black-Scholes option pricing model to value the
derivative instruments at inception and on subsequent valuation dates. The classification of derivative instruments, including whether
such instruments should be recorded as liabilities or as equity, is evaluated at the end of each reporting period.

 Fair
Value of Financial Instruments

 Fair
value is defined as the amount that would be received for selling an asset or paid to transfer a liability in an orderly transaction
between market participants at the measurement date and is measured using inputs in one of the following three categories:

 Level
1 measurements are based on unadjusted quoted prices in active markets for identical assets or liabilities that we have the ability to
access. Valuation of these items does not entail a significant amount of judgment.

 Level
2 measurements are based on quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar
assets or liabilities in markets that are not active or market data other than quoted prices that are observable for the assets or liabilities.

 Level
3 measurements are based on unobservable data that are supported by little or no market activity and are significant to the fair value
of the assets or liabilities.

 F- 12

 The
Company considers cash and cash equivalents, investments held in marketable securities, accounts receivable, accounts payable and derivative
liabilities to meet the definition of financial instruments. As of December 31, 2023 and 2022, the carrying amount of cash and cash equivalents,
investments held in marketable securities, accounts receivable, and accounts payable approximate their fair value due to the relatively
short period of time between their origination and their expected realization or payment. The Warrants are measured at fair value (see
Note 11 – Fair Value Measurement for additional details).

the years ended December 31, 2023 and 2022, the Company recognized aggregate dividend and interest income of $ 569,068 and $ 76,004 respectively,
on its marketable securities, which was included within other income on its consolidated statements of operations.

 Net
Loss per Common Share

 Net
loss per share is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the period.
The dilutive effect, if any, of stock options and warrants are calculated using the treasury stock method. All outstanding convertible
preferred stock is considered common stock at the beginning of the period or at the time of issuance, if later, pursuant to the if-converted
method. Since the effect of common stock equivalents is anti-dilutive with respect to losses, options, warrants, and convertible preferred
stock have been excluded from the Company's computation of diluted net loss per common share for the periods presented.

 The
following table summarizes the securities that were excluded from the diluted per share calculation because the effect of including these
potential shares was antidilutive due to the Company's net loss position even though the exercise price could be less than the
average market price of the common shares:

OF WEIGHTED AVERAGE DILUTIVE COMMON SHARES

 For

 31,

 2023

 2022

 Stock options

 864,639

 4,791,082

 Unvested RSUs

 97,827

 201,870

 Convertible Preferred Stock

 1,398,158

 1,518,158

 Total

 7,753,896

 7,375,749

 Stock-Based
Compensation

 The
Company measures the cost of services received in exchange for an award of equity instruments based on the fair value of the award. The
fair value of the award is measured on the grant date and then is recognized over the period during which services are required to be
provided in exchange for the award, usually the vesting period, on a straight-line basis. The Company computes the fair value of equity-classified
warrants and options granted using the Black-Scholes option pricing model. Option forfeitures are recorded as incurred as a reduction
of amounts previously expensed.

 Income
Taxes

tax assets and liabilities are recognized for the future tax consequences attributable to differences between the consolidated financial
statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets, including tax loss
and credit carry forwards, 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.

 F- 13

 The
Company utilizes ASC 740, "Income Taxes," which requires the recognition of deferred tax assets and liabilities for the expected
future tax consequences of events that have been included in the consolidated financial statements or tax returns. The Company accounts
for income taxes using the asset and liability method to compute the differences between the tax basis of assets and liabilities and
the related financial amounts, using currently enacted tax rates. A valuation allowance is recorded when it is "more likely-than-not"
that a deferred tax asset will not be realized.

 For
uncertain tax positions that meet a "more likely than not" threshold, the Company recognizes the benefit of uncertain tax
positions in the consolidated financial statements. The Company's practice is to recognize interest and penalties, if any, related
to uncertain tax positions in income tax expense in the consolidated statements of operations.

 Leases

 The
Company determines whether an arrangement is a lease at inception. Operating leases are included in operating lease right-of-use ("ROU")
assets and operating lease liabilities in our consolidated balance sheets.

 ROU
assets represent the Company's right to use an underlying asset for the lease term and lease liabilities represent its obligation
to make lease payments arising from the lease. ROU assets and liabilities are recognized at commencement date based on the present value
of lease payments over the lease term. As most of the Company's leases do not provide an implicit rate, the Company uses its incremental
borrowing rate based on the estimated rate of interest for collateralized borrowing over a similar term of the lease payments at commencement
date. The operating lease ROU asset also includes any lease payments made and excludes lease incentives. The Company's lease terms
may include options to extend or terminate the lease when it is reasonably certain that it will exercise the option. Lease expense for
lease payments is recognized on a straight-line basis over the lease term.

 Recently
Adopted Accounting Pronouncements

 In
June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses, which requires entities to estimate all
expected credit losses for financial assets measured at amortized cost basis, including trade receivables, held at the reporting date
based on historical experience, current conditions, and reasonable and supportable forecasts. The Company adopted this guidance on January
1, 2023. The adoption of this accounting standard did not have a material impact on the Company's consolidated financial statements.

 NOTE 3 - RESTATEMENT OF PREVIOUSLY ISSUED UNAUDITED
INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

 The following tables present the
effects of the Restatement described in Note 2 - Summary of Significant Accounting Policies – Restatement of Previously Issued Consolidated
Financial Statements on the Company's unaudited interim condensed consolidated financial statements for the periods indicated.

 The
following tables present the effects of the Restatement on the Company's unaudited interim condensed consolidated balance sheets
as of the dates indicated:

 SCHEDULE OF RESTATEMENTS OF THE COMPANY'S UNAUDITED INTERIM CONDENSED CONSOLIDATED STATEMENTS

 As

 March 31, 2022

 As

 $

 -

 $

 14,205,418

 $

 14,205,418

 $

 493,829

 $

 14,205,418

 $

 14,699,247

 $

 762,186

 $

 14,205,418

 $

 14,967,604

 $

 159,103,184

 $

)

 $

 137,202,184

 $

 ( 138,962,278

)

 $

 7,695,582

 $

 ( 131,266,696

)

 $

 20,156,702

 $

 ( 14,205,418

)

 $

 5,951,284

 $

 20,918,888

 $

 -

 $

 20,918,888

 F- 14

 As

 June 30, 2022

 As

 $

 -

 $

 6,430,025

 $

 6,430,025

 $

 621,781

 $

 6,430,025

 $

 7,051,806

 $

 855,841

 $

 6,430,025

 $

 7,285,866

 $

 162,207,334

 $

)

 $

 140,306,334

 $

 ( 143,637,519

)

 $

 15,470,975

 $

 ( 128,166,544

)

 $

 18,585,612

 $

 ( 6,430,025

)

 $

 12,155,587

 $

 19,441,453

 $

 -

 $

 19,441,453

 As

 September 30, 2022

 As

 $

 -

 $

 7,220,748

 $

 7,220,748

 $

 717,179

 $

 7,220,748

 $

 7,937,927

 $

 915,903

 $

 7,220,748

 $

 8,136,651

 $

 165,281,862

 $

)

 $

 143,380,862

 $

 ( 148,293,344

)

 $

 14,680,252

 $

 ( 133,613,092

)

 $

 17,004,315

 $

 ( 7,220,748

)

 $

 9,783,567

 $

 17,920,218

 $

 -

 $

 17,920,218

 As

 March 31, 2023

 As

 $

 -

 $

 7,030,083

 $

 7,030,083

 $

 470,391

 $

 7,030,083

 $

 7,500,474

 $

 593,927

 $

 7,030,083

 $

 7,624,010

 $

 171,796,596

 $

)

 $

 149,895,596

 $

 ( 158,325,119

)

 $

 14,870,917

 $

 ( 143,454,202

)

 $

 13,487,037

 $

 ( 7,030,083

)

 $

 6,456,954

 $

 14,080,964

 $

 -

 $

 14,080,964

 F- 15

 As

 June 30, 2023

 As

 $

 -

 $

 9,758,930

 $

 9,758,930

 $

 812,853

 $

 9,758,930

 $

 10,571,783

 $

 896,433

 $

 9,758,930

 $

 10,655,363

 $

 173,695,154

 $

)

 $

 151,794,154

 $

 ( 161,305,671

)

 $

 12,142,070

 $

 ( 149,163,601

)

 $

 12,403,864

 $

 ( 9,758,930

)

 $

 2,644,934

 $

 13,300,297

 $

 -

 $

 13,300,297

 As

 September 30, 2023

 As

 $

 -

 $

 2,065,177

 $

 2,065,177

 $

 932,619

 $

 2,065,177

 $

 2,997,796

 $

 975,033

 $

 2,065,177

 $

 3,040,210

 $

 177,042,781

 $

)

 $

 155,141,781

 $

 ( 164,231,163

)

 $

 19,835,823

 $

 ( 144,395,340

)

 $

 12,826,068

 $

 ( 2,065,177

)

 $

 10,760,891

 $

 13,801,101

 $

 -

 $

 13,801,101

 The following tables present the
effect of the Restatement on the Company's unaudited interim condensed consolidated statements of operations for the periods indicated:

 As

 March 31, 2022

 As

 $

 -

 $

 $

 Total other (income) expense

 $

 ( 237,643

)

 $

 $

 3,153,569

 Net loss

 $

 ( 4,816,150

)

 $

 ( 3,391,212

)

 $

 ( 8,207,362

)

 $

 ( 1.37

)

 $

 ( 0.96

)

 $

 ( 2.33

)

 As

 As

 For the Six Months Ended

 June 30, 2022

 June 30, 2022

 As

 As

 $

 -

 $

 ( 7,775,393

)

 $

 ( 7,775,393

)

 $

 -

 $

)

 $

)

 Total other (income) expense

 $

 46,613

 $

 ( 7,775,393

)

 $

 ( 7,728,780

)

 $

 ( 191,030

)

 $

)

 $

 ( 4,575,211

)

 $

 ( 4,675,241

)

 $

 7,775,393

 $

 3,100,152

 $

 ( 9,491,391

)

 $

 4,384,181

 $

 ( 5,107,210

)

 Earnings (loss) per share - basic:

 $

 ( 1.28

)

 $

 2.14

 $

 0.85

 $

 ( 2.65

)

 $

 1.22

 $

 ( 1.43

)

 Weighted average common shares oustanding - diluted

 3,638,383

 5,818,645

 9,457,028

 3,581,110

 -

 3,581,110

 Earnings (loss) per share - diluted

 $

 ( 1.28

)

 $

 0.82

 $

 0.33

 $

 ( 2.65

)

 $

 1.22

 $

 ( 1.43

)

 As

 As

 For the Nine Months Ended

 September 30, 2022

 September 30, 2022

 As

 As

 $

 -

 $

 790,723

 $

 790,723

 $

 -

 $

)

 $

)

 Total other expense (income)

 $

 46,125

 $

 790,723

 $

 836,848

 $

 ( 144,905

)

 $

)

 $

 ( 3,738,363

)

 $

 ( 4,655,825

)

 $

 ( 790,723

)

 $

 ( 5,446,548

)

 $

 ( 14,147,216

)

 $

 3,593,458

 $

 ( 10,553,758

)

 $

 ( 1.28

)

 $

 ( 0.22

)

 $

 ( 1.50

)

 $

 ( 3.93

)

 $

 1.00

 $

 ( 2.93

)

 F- 16

 As

 March 31, 2023

 As

 $

 -

 $

 $

 $

 ( 94,876

)

 $

 $

 1,393,474

 $

 ( 5,684,222

)

 $

 ( 1,488,350

)

 $

 ( 7,172,572

)

 $

 ( 1.53

)

 $

 ( 0.40

)

 $

 ( 1.93

)

 As

 As

 For the Six Months Ended

 June 30, 2023

 June 30, 2023

 As

 As

 $

 -

 $

 2,728,847

 $

 2,728,847

 $

 -

 $

 $

 $

 ( 135,999

)

 $

 2,728,847

 $

 2,592,848

 $

 ( 230,875

)

 $

 $

 3,986,322

 $

 ( 2,980,552

)

 $

 ( 2,728,847

)

 $

 ( 5,709,399

)

 $

 ( 8,664,774

)

 $

 ( 4,217,197

)

 $

 ( 12,881,971

)

 $

 ( 0.77

)

 $

 ( 0.70

)

 $

 ( 1.47

)

 $

 ( 2.28

)

 $

 ( 1.11

)

 $

 ( 3.39

)

 As

 As

 For the Nine Months Ended

 September 30, 2023

 September 30, 2023

 As

 As

 $

 -

 $

 ( 7,693,753

)

 $

 ( 7,693,753

)

 $

 -

 $

)

 $

)

 $

 ( 178,951

)

 $

 ( 7,693,753

)

 $

 ( 7,872,704

)

 $

 ( 409,826

)

 $

)

 $

 ( 3,886,382

)

 $

 ( 2,925,492

)

 $

 7,693,753

 $

 4,768,261

 $

 ( 11,590,266

)

 $

 3,476,556

 $

 ( 8,113,710

)

 Earnings (loss) per share - basic:

 $

 ( 0.64

)

 $

 1.68

 $

 1.04

 $

 ( 2.85

)

 $

 0.85

 $

 ( 2.00

)

 Weighted average common shares oustanding - diluted

 4,570,843

 7,753,923

 12,324,766

 4,061,975

 -

 4,061,975

 Earnings (loss) per share - diluted

 $

 ( 0.64

)

 $

 1.03

 $

 0.39

 $

 ( 2.85

)

 $

 0.85

 $

 ( 2.00

)

 The following tables present the
effect of the Restatement on the Company's unaudited interim condensed consolidated statements of changes in stockholders'
equity for the periods indicated:

 Paid-In

 Capital

 Deficit

 Total

 Balance - March 31, 2022 (as previously reported)

 $

 159,103,184

 $

 ( 138,962,278

)

 $

 20,156,702

)

)

 -

 ( 3,391,212

)

 ( 3,391,212

)

 Balance - March 31, 2022 (as restated)

 $

 137,202,184

 $

 ( 131,266,696

)

 $

 5,951,284

 Balance - June 30, 2022 (as previously reported)

 $

 162,207,334

 $

 ( 143,637,519

)

 $

 18,585,612

)

)

 -

 4,384,181

 4,384,181

 Balance - June 30, 2022 (as restated)

 $

 140,306,334

 $

 ( 128,166,544

)

 $

 12,155,587

 Balance - September 30, 2022 (as previously reported)

 $

 165,281,862

 $

 ( 148,293,344

)

 $

 17,004,315

)

)

 -

 3,593,458

 3,593,458

 Balance - September 30, 2022 (as restated)

 $

 143,380,862

 $

 ( 133,613,092

)

 $

 9,783,567

 F- 17

 Paid-In

 Capital

 Deficit

 Total

 Balance - March 31, 2023 (as previously reported)

 $

 171,796,596

 $

 ( 158,325,119

)

 $

 13,487,037

)

 $

)

 -

 ( 1,488,350

)

 ( 1,488,350

)

 Balance - March 31, 2023 (as restated)

 $

 149,895,596

 $

 ( 143,454,202

)

 $

 6,456,954

 Balance - June 30, 2023 (as previously reported)

 $

 173,695,154

 $

 ( 161,305,671

)

 $

 12,403,864

)

 $

)

 -

 ( 4,217,197

)

 ( 4,217,197

)

 Balance - June 30, 2023 (as restated)

 $

 151,794,154

 $

 ( 149,163,601

)

 $

 2,644,934

 Balance - September 30, 2023 (as previously reported)

 $

 177,042,781

 $

 ( 164,231,163

)

 $

 12,826,068

)

 $

)

 -

 3,476,556

 3,476,556

 Balance - September 30, 2023 (as restated)

 $

 155,141,781

 $

 ( 144,395,340

)

 $

 10,760,891

 The following tables present the
effect of the Restatement on the Company's unaudited interim condensed consolidated statements of cash flows for the periods indicated:

 March 31, 2022

 As

 $

 ( 4,816,150

)

 $

 ( 3,391,212

)

 $

 ( 8,207,362

)

 Adjustments to reconcile net loss to net cash provided by operating activities:

 $

 -

 $

 $

 $

 ( 1,594,634

)

 $

 -

 $

 ( 1,594,634

)

 June 30, 2022

 As

 $

 ( 9,491,391

)

 $

 4,384,181

 $

 ( 5,107,210

)

 Adjustments to reconcile net (loss) income to net cash provided by operating activities:

 $

 -

 $

)

 $

)

 $

 ( 2,845,756

)

 $

 -

 $

 ( 2,845,756

)

 F- 18

 September 30, 2022

 As

 $

 ( 14,147,216

)

 $

 3,593,458

 $

 ( 10,553,758

)

 Adjustments to reconcile net (loss) income to net cash provided by operating activities:

 $

 -

 $

)

 $

)

 $

 ( 4,297,412

)

 $

 -

 $

 ( 4,297,412

)

 March 31, 2023

 As

 $

 ( 5,684,222

)

 $

 ( 1,488,350

)

 $

 ( 7,172,572

)

 Adjustments to reconcile net (loss) income to net cash provided by operating activities:

 $

 -

 $

 $

 $

 ( 2,348,740

)

 $

 -

 $

 ( 2,348,740

)

 June 30, 2023

 As

 $

 ( 8,664,774

)

 $

 ( 4,217,197

)

 $

 ( 12,881,971

)

 Adjustments to reconcile net (loss) income to net cash provided by operating activities:

 $

 -

 $

 $

 $

 ( 3,479,065

)

 $

 -

 $

 ( 3,479,065

)

 September 30, 2023

 As

 $

 ( 11,590,266

)

 $

 3,476,556

 $

 ( 8,113,710

)

 Adjustments to reconcile net (loss) income to net cash provided by operating activities:

 $

 -

 $

)

 $

)

 $

 ( 4,656,785

)

 $

 -

 $

 ( 4,656,785

)

 F- 19

 NOTE
4 - PROPERTY AND EQUIPMENT

and equipment consists of the following:

OF PROPERTY PLANT AND EQUIPMENT

 2023

 2022

 Medical equipment

 $
 352,133

 $
 352,133

 Furniture and fixtures

 123,486

 123,486

 Computer software and equipment

 136,205

 117,544

 Office equipment

 18,779

 18,779

 Manufacturing equipment

 395,232

 242,852

 Leasehold improvements

 342,048

 342,048

 1,367,883

 1,196,842

 Less: accumulated depreciation

 ( 1,011,828
)

 ( 935,839
)

 Property and equipment, net

 $
 356,055

 $
 261,003

 Total
depreciation expense for the years ended December 31, 2023 and 2022 was $ 75,989 and $ 42,212, respectively. Depreciation expense is reflected
in general and administrative expenses and research and development expenses in the consolidated statements of operations.

 NOTE
5 - INTANGIBLE ASSETS

 The
Company is a party to a license agreement with the SCTC (as amended) (the "SCTC Agreement"). Pursuant to the SCTC Agreement,
the Company obtained, among other things, a worldwide (excluding Asia and Argentina), exclusive, royalty-bearing license from the SCTC
to utilize or sublicense a certain method for culturing cells and a worldwide, exclusive, royalty-bearing license from the SCTC to utilize
or sublicense a certain medical device patent for the administration of specific cells and/or cell products to the disc and/or spine
(and other parts of the body). Pursuant to the license agreement with the SCTC, certain performance milestones (or payouts in lieu of
performance milestones) had to be satisfied in order for the Company to maintain its exclusive rights with regard to the disc/spine technology.
The Company did not timely satisfy the third of these performance milestones (which needed to be satisfied by February 2022). Accordingly,
such rights became non-exclusive. However, the Company and the SCTC entered into an amended agreement under which the Company paid $ 175,000
and issued 51,370 warrants, with a fair value of $ 117,030, in exchange for renewed exclusivity. The consideration transferred to the
SCTC in exchange for exclusivity was capitalized to intangible assets on the Company's consolidated balance sheet as of December
31, 2022.

 F- 20

 In
February 2017, the Company received authorization from the Food and Drug Administration (the "FDA") to proceed with a Phase
2 clinical trial. In February 2022, the Company announced that the United States Patent and Trademark Office issued a notice of allowance
for a patent application relating to the Company's BRTX-100 clinical program. This patent was issued in March 2022.

 Intangible
assets consist of the following:

 SCHEDULE OF INTANGIBLE ASSETS

 Patents
 and Trademarks

 Licenses

 Total

 Balance as of January 1, 2022

 $
 3,676

 $
 1,301,500

 $
 ( 715,436
)

 $
 589,740

 Considertion transferred for
 license exclusivity

 -

 292,030

 -

 292,030

 expense

 -

 -

 ( 78,332
)

 ( 78,332
)

 Balance as of December 31, 2022

 3,676

 1,593,530

 ( 793,768
)

 803,438

 expense

 -

 -

 ( 89,746
)

 ( 89,746
)

 Balance as of December 31, 2023

 $
 3,676

 $
 1,593,530

 $
 ( 883,514
)

 $
 713,692

 Weighted average remaining amortization period at December
 31, 2023 (in years)

 -

 10.9

of intangible assets consists of the following:

 SCHEDULE OF FINITE LIVED
INTANGIBLE ASSETS AMORTIZATION EXPENSES

 Patents
 and Trademarks

 Licenses

 Balance as of January 1, 2022

 $
 3,676

 $
 711,760

 $
 715,436

 expense

 -

 78,332

 78,332

 Balance as of December 31, 2022

 3,676

 790,092

 793,768

 expense

 -

 Balance as of December 31, 2023

 $
 3,676

 $
 879,838

 $
 883,514

expense for the next five years is as follows:

OF FINITE LIVED INTANGIBLE ASSETS FUTURE AMORTIZATION EXPENSES

 For
 the Years Ending December 31,

 Total

 2024

 $

 2025

 2026

 2027

 2028

 Total

 $
 448,730

 F- 21

 NOTE
6 - ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES

 Accrued
expenses and other current liabilities consist of:

 SCHEDULE OF ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES

 2023

 2022

 31,

 2023

 2022

 Accrued bonuses

 $
 638,000

 $
 26,250

 Accrued
 general and adminstrative expenses

 73,686

 103,822

 Total
 accrued expenses and other current liabilities

 $
 711,686

 $
 130,072

 Note
7 - NOTES PAYABLE

 A
summary of the notes payable activity during the years ended December 31, 2023 and 2022 is presented below:

 SCHEDULE OF NOTES PAYABLE ACTIVITY

 Outstanding, Janaury 1, 2022

 $
 250,000

 Issuance

 -

 Forgiveness

 ( 250,000
)

 Outstanding, December 31, 2022

 -

 Issuance

 -

 Forgiveness

 -

 Outstanding, December
 31, 2023

 $
 -

 Note
8 - STOCKHOLDERS' EQUITY

A Preferred Stock

 On
November 8, 2021, in connection with the Company's public offering, the Company's Board of Directors adopted a resolution
allowing for the designation and issuance of 1,543,158 shares of the Company's Preferred Stock, $.01 par value per share, designated
as Series A Preferred Stock ("Series A"). The Series A had a liquidation preference of $ 0.001 per share. On September 8,
2022, the Company issued 1,543,158 shares of Series B Preferred Stock ("Series B") to Auctus Fund, LLC ("Auctus")
in exchange for an equal number of shares of the Company's outstanding Series A. Simultaneously, the stock certificate representing
the Series A shares was being returned to the Company for cancellation. On such date and upon such exchange, the Company's Board
of Directors cancelled the Series A.

B Preferred Stock

 Effective
September 8, 2022, the Company issued 1,543,158 shares of Series B to Auctus in exchange for an equal number of shares of the Company's
outstanding Series A. The terms of the Series B are substantially identical to those of the Series A, except that, among other things,
the limitation on beneficial ownership of common stock of the Company upon a conversion of the Series B into Common Stock, and the limitation
on the number of votes attributable to the Series B, is 9.99 % of the then outstanding Common Stock of the Company instead of 4.99 % as
provided for the Series A. The Company is required, at all times, to reserve from its authorized and unissued Common Stock a sufficient
number of shares to provide for the issuance of Common Stock upon the full conversion of the Series B. The Series B is not subject to
redemption by the Company or any Series B holder. The exchange of Series A for Series B had no impact on the Company's financial
statements as of December 31, 2022.

 Dividends

B holders shall be entitled to receive, when and as declared by the Board of Directors, dividends on a pari passu basis with the holders
of the shares of Common Stock based upon the number of shares of Common Stock into which the Series B is then convertible.

 F- 22

 Voting
Rights

B holders shall be entitled to vote on all matters presented to the stockholders of the Company for a vote at a meeting of stockholders
of the Company or a written consent in lieu of a meeting of stockholders of the Company, and shall be entitled to such number of votes
for each share of Series B entitled to vote at such meetings or pursuant to such consent, voting together with the holders of shares
of Common Stock and other shares of preferred stock who are entitled to vote, and not as a separate class, except as required by law.
The number of votes to which the Series B holders shall be entitled to vote for each share of Series B shall equal the number of shares
of Common Stock into which such Series B is then convertible; provided, however, that in no event shall a Series B holder be entitled
to vote more than 9.99 % of the then outstanding shares of Common Stock.

 Conversion

 Optional
Conversion - Each share of Series B shall be convertible, at any time and from time to time, at the option of the Series B holder, into
one share of Common Stock; provided, however, that in no event shall a Series B holder be entitled to convert any shares of Series B
to the extent that such conversion would result in beneficial ownership by such Series B holder of more than 9.99 % of the outstanding
shares of common stock.

 Automatic
Conversion - From time to time, in the event that an event occurs which has the effect of reducing a Series B holder's beneficial
ownership of shares of Common Stock to less than 9.5 % of the then publicly disclosed outstanding shares of Common Stock, then, within
five business days, the Series B holder is required to provide notice to the Company to such effect, which notice shall state the number
of shares of Common Stock beneficially owned by the Series B holder and shall provide reasonable detail with regard thereto, including
the number of derivative securities compromising a portion of such beneficial share amount. Such notice shall have the effect of a notice
of conversion with respect to the conversion of such number of shares of Series B as would increase the Series B holder's beneficial
ownership of Common Stock to 9.99 % of the then publicly disclosed outstanding shares of Common Stock.

 On
October 25, 2022, Auctus converted 25,000 shares of Series B into 25,000 shares of Common Stock. The number of shares of Series B remaining
outstanding after this conversion was 1,518,158.

 On
April 4, 2023, Auctus converted 120,000 shares of Series B into 120,000 shares of Common Stock. As of December 31, 2023, the number of
shares of Series B remaining outstanding after giving effect to such conversion was 1,398,158.

 2021
Stock Incentive Plan

 On
March 18, 2021, the Company's Board of Directors adopted the BioRestorative Therapies, Inc. 2021 Stock Incentive Plan (the "2021
Plan"). The 2021 Plan was approved by the Company's stockholders on August 17, 2021. Pursuant to the 2021 Plan, a total of
 1,175,000 shares of common stock were initially authorized to be issued pursuant to the grant of stock options, restricted stock units,
restricted stock, stock appreciation rights and other incentive awards. On December 10, 2021, the Company's Board of Directors
approved an amendment to increase the number of shares of Common Stock authorized to be issued from 1,175,000 to 2,500,000. Such amendment
was approved by the Company's stockholders on November 3, 2022. On July 13, 2023, the Company's Board of Directors approved
an amendment to the 2021 Plan to increase the number of shares of Common Stock authorized to be issued from 2,500,000 to 3,850,000. Such
amendment was approved by the Company's stockholders on September 13, 2023.

 Compensatory
Common Stock Issuance

the year ended December 31, 2022, the Company issued 15,898 shares of immediately vested common stock with an aggregate value of $ 135,888
to third parties for services rendered. During the year ended December 31, 2023, the Company issued 1,442 shares of immediately vested
common stock with a value of $ 7,500 to a consultant for services rendered.

 Sales
of Common Stock

 In
April 2023, the Company entered into a Capital on Demand Sales Agreement with JonesTrading Institutional Services LLC (the "Sales
Agent") under which the Company currently has the ability to issue and sell shares of its Common Stock, from time to time, through
the Sales Agent, up to an aggregate offering price of approximately $ 6,109,000 in what is commonly referred to as an "at-the-market"
("ATM") program. During the year ended December 31, 2023, the Company sold 132,827 shares of its Common Stock at a weighted
average price of $ 4.68 per share and raised $ 494,782 in net proceeds under the ATM program. As of December 31, 2023, the Company had
remaining capacity to sell up to an additional $ 5,487,000 of common stock under the ATM program.

 On
July 13, 2023, the Company sold an aggregate of 685,033 shares of Common Stock to several institutional buyers and accredited investors
in a registered direct offering at an offering price of $ 3.03 per share. The offering closed on July 13, 2023 with net proceeds of $ 1,853,990.
The Company intends to use the net proceeds from the offering in connection with its clinical trials with respect to its lead cell therapy
candidate, BRTX-100, pre-clinical research and development with respect to its metabolic ThermoStem Program and for general corporate
purposes and working capital.

 F- 23

 Warrant
and Option Valuation

 The
Company has computed the fair value of warrants and options granted using the Black-Scholes option pricing model. The expected term used
for warrants and options issued to non-employees is the contractual life and the expected term used for options issued to employees and
directors is the estimated period of time that options granted are expected to be outstanding. The Company utilizes the "simplified"
method to develop an estimate of the expected term of "plain vanilla" employee option grants. The Company is utilizing an
expected volatility figure based on a review of the historical volatilities, over a period of time, equivalent to the expected life of
the instrument being valued, of similarly positioned public companies within its industry. The risk-free interest rate was determined
from the implied yields from U.S. Treasury zero-coupon bonds with a remaining term consistent with the expected term of the instrument
being valued.

 See Note 11 – Fair
Value Measurement – for details regarding the fair value estimates of the Warrants that are classified as derivative liabilities.

 Warrant
Activity Summary

 A
summary of the warrant activity during the year ended December 31, 2023 is presented below:

 SCHEDULE OF WARRANT ACTIVITY

 Remaining

 Exercise

 Life

 Price

 In Years

 Outstanding, January 1, 2023

 4,791,082

 $
 10.71

 Granted

 -

 Exercised

 -

 Expired

 ( 63
)

 10,397

 Outstanding, December 31, 2023

 $
 10.57

 2.9

 Exercisable, December 31, 2023

 $
 10.57

 2.9

 In
applying the Black-Scholes option pricing model to warrants granted during 2022, the Company used the following assumptions:

 SCHEDULE OF WARRANTS GRANTED ASSUMPTIONS

 For the Year Ended

 December 31, 2022

 Risk free interest rate

 4.40
 %

 Expected term (years)

 5.00

 Expected volatility

 313.55
 %

 Expected dividends

 0.00
 %

 The
weighted average estimated fair value of the warrants granted during the year ended December 31, 2022 was $ 2.28 per warrant. The Company
did not issue any warrants during the year ended December 31, 2023.

 F- 24

 The
following table presents information related to stock warrants at December 31, 2023:

OF STOCK WARRANTS

 Exercisable

 Exercisable

 Exercise

 of

 Remaining
 Life

 of

 Price

 In
 Years

 $
 2.92

 51,370

 3.9

 51,370

 $
 10.00

 4,501,938

 2.9

 4,501,938

 $
 12.00

 235,970

 2.9

 235,970

 $
 60.00

 1.0

 $
 800.00

 0.8

 $
 2,240.00

 0.5

 $
 2,800.00

 0.3

 $
 3,400.00

 0.3

 $
 4,000.00

 0.1

 Stock

 A
summary of the option activity during the year ended December 31, 2023 is presented below:

OF STOCK OPTION ACTIVITY

 Remaining

 of

 Exercise

 Life

 Intrinsic

 Price

 In
 Years

 Value

 Outstanding, January 1, 2023

 864,639

 $
 5.08

 Granted

 629,017

 2.91

 Exercised

 -

 Forfeited

 ( 26,764
)

 4.87

 Outstanding, December 31, 2023

 $
 4.11

 7.4

 $
 -

 Exercisable, December 31, 2023

 1,201,526

 $
 4.33

 7.1

 $
 -

 The
weighted average grant date fair value of the stock options granted during the years ended December 31, 2023 and 2022 was approximately
$ 3.00 and $ 4.88, respectively.

 The
following table presents information related to stock options at December 31, 2023:

 SCHEDULE OF INFORMATION RELATED TO STOCK OPTIONS

 Exercisable

 Exercisable

 Exercise

 of

 Remaining
 Life

 of

 Price

 In
 Years

 $
 2.91

 654,017

 7.5

 412,604

 $
 5.08

 812,875

 6.9

 788,922

 1,201,526

 F- 25

 In
applying the Black-Scholes option pricing model to stock options granted, the Company used the following assumptions:

OF STOCK OPTION GRANTED ASSUMPTIONS

 For

 31,

 2023

 2022

 Risk free interest
 rate

 4.22
 %

 2.42
 %

 Expected term (years)

 3.50

 3.50

 Expected volatility

 175.00
 %

 285.91
 %

 Expected dividends

 0.00
 %

 0.00
 %

 Restricted
Share Units

to the 2021 Plan, the Company may grant restricted stock units ("RSUs") to employees, consultants or non-employee directors
("Eligible Recipients"). The number, terms and conditions of the RSUs that are granted to Eligible Recipients are determined
on an individual basis by the 2021 Plan administrator. On the distribution date, the Company shall issue to the Eligible Recipient one
unrestricted, fully transferable share of the Company's common stock (or the fair market value of one such share in cash) for each
vested and nonforfeitable RSU.

 A
summary of the unvested RSUs as of December 31, 2023 is as follows:

OF UNVESTED RESTRICTED STOCK UNITS

 of Shares

 Non-vested at January 1, 2023

 201,870

 Granted

 -

 Vested

 ( 104,043
)

 Forfeited

 -

 Non-vested at December 31, 2023

 97,827

 Stock-Based
Compensation Expense

 The
following table presents information related to stock-based compensation expense:

 SCHEDULE OF STOCK OPTION EXPENSE

 For

 Unrecognized
 at

 Average Remaining

 31,

 31,

 Period

 2023

 2022

 2023

 (Years)

 General and administrative

 $
 7,782,967

 $
 12,612,862

 $
 1,557,071

 0.83

 Total

 $
 7,782,967

 $
 12,612,862

 $
 1,557,071

 0.83

 NOTE
9 - INCOME TAXES

 The
Company identified its federal and New York tax returns as its "major" tax jurisdictions. The Company is no longer
subject to income tax income examinations by these tax authorities for taxable years ended December 31, 2018, and prior. The Company
reviewed the prior New York state income tax filings and concluded that the prior year return will be amended to change the
apportionment from zero to 100 %.
The Company believes its income tax filing positions and deductions will be sustained on audit, and it does not anticipate any
adjustments that would result in a material change to its financial position. Therefore, no liabilities for uncertain tax positions
have been recorded.

 At
December 31, 2023, the Company had approximately $ 63,500,000 and $ 13,600,000, respectively, of federal and state net operating losses
that may be available to offset future taxable income. As a result of the Tax Cuts and Jobs Act of 2017 (the "Tax Act"),
certain future carryforwards do not expire. At December 31, 2023, approximately $ 7,800,000 of federal net operating losses will expire
from 2030 to 2038 and approximately $ 55,700,000 have no expiration but are subject to a utilization limit equal to 80% of current taxable
income.

 In
accordance with Section 382 of the Internal Revenue Code, the usage of the Company's net operating loss carryforwards are subject
to annual limitations due to several greater than 50% ownership changes.

 The
Section 382 limitations resulted in approximately $ 28,200,000 of federal NOLs not being realizable as of December 31, 2023, and 2022
and the cumulative reversal of approximately $ 9,600,000 of net operating loss deferred tax assets.

 F- 26

 The
Company has not performed a formal analysis for the year ended December 31, 2023, but it believes its ability to use such net operating
losses and tax credit carryforwards in the future is subject to annual limitations due to change of control provisions under Sections
382 and 383 of the Internal Revenue Code, which will significantly impact its ability to realize these deferred tax assets.

assesses the available positive and negative evidence to estimate whether sufficient future taxable income will be generated to permit
use of the existing deferred tax assets. A significant piece of objective negative evidence evaluated was the cumulative loss incurred
over the three-year period ended December 31, 2023. For the period ended December 31, 2023, the Company has recorded a full valuation
allowance recorded against the gross deferred tax asset balance as management believes that it is more likely than not that the results
of operations will not generate sufficient taxable income to realize any of the deferred tax assets.

 As
of the date of this filing, the Company has not filed its 2023 federal and state corporate income tax returns. The Company expects to
file these documents as soon as practicable.

 The
Company's net deferred tax assets, liabilities and valuation allowance as of December 31, 2023 and 2022 are summarized as follows:

OF NET DEFERRED TAX ASSETS AND LIABILITIES

 2023

 2022

 31,

 2023

 2022

 Tax Assets:

 Net
 operating loss carryforwards

 $
 14,311,000

 $
 13,200,000

 Stock-based compensation

 15,788,000

 13,810,000

and development costs

 1,676,000

 655,000

and development credits

 330,000

 330,000

 Right-of-use
assets

 25,000

 -

 Other

 4,000

 -

 Total
 Deferred Tax Assets

 32,134,000

 27,995,000

 Tax Liabilities:

 Depreciation

 ( 122,000
)

 ( 106,000
)

 Intangible
 assets

 ( 47,000
)

 ( 113,000
)

 Lease
 liability

 ( 39,000
)

 -

 Other

 ( 86,000
)

 -

 Total
 Deferred Tax Liabilities

 ( 294,000
)

 ( 219,000
)

 Net
 Deferred Tax Asset

 31,840,000

 27,776,000

 Less:
 valuation allowance

 ( 31,840,000
)

 ( 27,776,000
)

 Tax Asset, Net of Valuation Allowance

 $
 -

 $
 -

 Change
 in valuation allowance

 $
 ( 4,064,000
)

 $
 ( 5,822,000
)

 The
income tax provision (benefit) as of December 31, 2023 and 2022 consists of the following:

OF INCOME TAX PROVISION (BENEFIT)

 2023

 2022

 2023

 2022

 Federal:

 $
 -

 $
 -

 ( 3,090,000
)

 ( 4,351,000
)

 State
 & Local:

 -

 -

 ( 974,000
)

 ( 1,471,000
)

 Income
 tax provision (benefit), gross

 ( 4,064,000
)

 ( 5,822,000
)

 Change
in valuation allowance

 4,064,000

 5,822,000

 Income tax provision (benefit)

 $
 -

 $
 -

 F- 27

 A
reconciliation of the statutory federal income tax benefit to actual tax benefit for the years ended December 31, 2023 and 2022 is as
follows:

OF STATUTORY FEDERAL INCOME TAX RATE

 31,

 2023

 2022

 Federal
statutory rate

 21.0
 %

 21.0
 %

 State
 rate, net of federal benefit

 1.7
 %

 7.8
 %

 Permanent
 differences

 7.2
 %

 7.8
 %

 Tax
return to provision adjustment

 - 0.2
 %

 7.3
 %

 Change
in valuation allowance

 - 29.7
 %

 - 44.0
 %

 Effective
 tax rate

 0.0
 %

 0.0
 %

 NOTE
10 – LEASES

 The
Company is a party to a lease for 6,800 square feet of space located in Melville, New York (the "Melville Lease") with respect
to its corporate and laboratory operations. The Melville Lease was scheduled to expire in March 2020 (subject to extension at the option
of the Company for a period of five years) and provided for an annual base rental during the initial term ranging between $ 132,600 and
$ 149,260. In June 2019, the Company exercised its option to extend the Melville Lease and entered into a lease amendment with the lessor
whereby the five-year extension term commenced on January 1, 2020 with annual base rent ranging between $ 153,748 and $ 173,060.

 When
measuring lease liabilities for leases that were classified as operating leases, the Company discounted lease payments using its estimated
incremental borrowing rate at August 1, 2019. The weighted average incremental borrowing rate applied was 12 %.

 The
following table presents net lease cost and other supplemental lease information:

OF NET LEASE COST AND OTHER SUPPLEMENTAL LEASE INFORMATION

 2023

 2022

 For

 31,

 2023

 2022

 Lease Costs

 Operating lease
 cost (cost resulting from lease payments)

 $
 168,028

 $
 163,132

 Net lease costs

 $
 168,028

 $
 163,132

 Operating lease - operating
 cash flows (fixed payments)

 $
 168,028

 $
 163,132

 Operating lease - operating
 cash flows (liability reduction)

 $
 139,328

 $
 119,055

 Non-current leases - right
 of use assets

 $
 151,447

 $
 241,760

 Current liabilities - operating
 lease liabilities

 $

 $
 139,328

 Non-current liabilities -
 operating lease liabilities

 $
 -

 $

 Future
minimum payments under non-cancelable leases for operating leases for the remaining terms of the leases following the year ended December
31, 2023:

OF FUTURE MINIMUM PAYMENTS UNDER NON-CANCELABLE LEASES FOR OPERATING LEASES

 Fiscal
 Year

 Operating
 Leases

 2024

 $
 173,060

 Total future minimum lease
 payments

 173,060

 representing interest

 ( 10,743
)

 Present
 value of net future minimum lease payments

 $

 F- 28

 NOTE
11 – FAIR VALUE MEASUREMENT

 The
Company accounts for the Warrants as liabilities in accordance with the guidance contained in ASC 815-40, Derivatives and Hedging —
Contracts in Entity's Own Equity. In the case of certain of the Warrants, the Company does not control the occurrence of events,
such as a tender offer or exchange, that may trigger cash settlement of the Warrants and not result in a change of control of the Company.
As a result, such Warrants do not meet the criteria for equity treatment and the Warrants must be recorded as a derivative liability.
Additionally, certain other Warrants contain adjustments to the settlement amount based on a variable that is not an input to the fair
value of a "fixed-for-fixed" option as defined under ASC 815-40 and, accordingly, such Warrants are not considered indexed
to the Company's own stock and are not eligible for an exception from derivative accounting.

the years ended December 31, 2023 and 2022, the Company estimated the aggregate fair value of the Warrants to purchase an aggregate of
 4,737,908 shares of common stock classified as derivative liabilities using the Black-Scholes option pricing model (Level 3 inputs) using
the following assumptions:

OF BLACK-SCHOLES OPTION PRICING MODEL (LEVEL 3 INPUTS) USING ASSUMPTIONS

 2023

 2022

 For the Years Ended

 2023

 2022

 Risk free interest rate

 4.04
 %

 4.12
 %

 Expected term (years)

 2.86

 3.86

 Expected volatility

 %

 %

 Expected dividends

 0.00
 %

 0.00
 %

 The
following table sets forth a summary of the changes in the fair value of Level 3 liabilities that are measured at fair value on a recurring
basis during the years ended December 31, 2022 and 2023:

 SCHEDULE OF FAIR VALUE OF LEVEL 3 LIABILITIES MEASURED AT FAIR VALUE ON RECURRING BASIS

 As Restated

 Balance, January 1, 2022

 $
 10,814,206

)

 Outstanding, December 31, 2022

)

 Outstanding, December 31, 2023

 $

 Assets
and liabilities measured at fair value on a recurring basis are as follows:

OF ASSETS AND LIABILITIES MEASURED AT FAIR VALUE ON RECURRING BASIS

 Fair value measurements at reporting date using:

 Quoted prices in active markets for identical liabilities (Level 1)

 Significant other observable inputs (Level 2)

 Significant unobservable inputs (Level 3)

 Total Fair Value

 Assets:

 Marketable securities as of December 31, 2023

 $
 10,181,618

 $
 -

 $
 -

 $
 10,181,618

 Marketable securities as of December 31, 2022

 $

 $
 -

 $
 -

 $

 Marketable securities

 $

 $
 -

 $
 -

 $

 Liabilities:

 Derivative liabilities as of December 31, 2023 (As Restated)

 $
 -

 $
 -

 $

 $

 Derivative liabilities as of December 31, 2022 (As Restated)

 $
 -

 $
 -

 $

 $

 Derivative liabilities (As Restated)

 $
 -

 $
 -

 $

 $

 F- 29

 NOTE
12 - SUBSEQUENT EVENTS

 Warrant
Exercise and Issuance

 On
February 6, 2024, the Company entered into agreements with certain holders of its existing warrants exercisable for an aggregate of 3,351,580
shares of its Common Stock (collectively, the "Existing Warrants"), to exercise their warrants at a reduced exercise price
of $ 2.33 per share, in exchange for new warrants (the "New Warrants") as described below. The aggregate gross proceeds from
the exercise of the Existing Warrants and the payment of the New Warrants, as described below, was approximately $ 8.1 million, before
deducting financial advisory fees. The reduction of the exercise price of the Existing Warrants and the issuance of the New Warrants
was structured as an at-market transaction under Nasdaq rules. Of the 3,351,580 shares of Common Stock issuable upon the exercise of
the Existing Warrants, to date, the Company has issued an aggregate of 2,000,000 shares of Common Stock. The remaining 1,351,580 shares of Common
Stock, which are issuable to Auctus, are being held in abeyance due to Auctus' maximum beneficial ownership limitation. Such shares
have been fully paid for and are issuable upon notice from Auctus to the Company.

 In
consideration for the immediate exercise of the Existing Warrants for cash and the payment of $ 0.125 per share underlying the New Warrants,
the exercising holders received the New Warrants to purchase shares of Common Stock in a private placement pursuant to Section 4(a)(2)
of the Securities Act of 1933, as amended (the "Securities Act"). The New Warrants will be exercisable for a period of five
years into an aggregate of up to 2,513,686 shares of Common Stock at an exercise price of $ 2.43 per share. The securities offered in
the private placement have not been registered under the Securities Act or applicable state securities laws. Accordingly, the securities
may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from
the registration requirements of the Securities Act and such applicable state securities laws. As part of the transaction, the Company
agreed to file a resale registration statement with the SEC to register the resale of the shares of Common Stock underlying the New Warrants
issued in the private placement.

 In
connection with the transaction described above, the Company entered into a financial advisory services agreement, dated February 5,
2024, with Roth Capital Partners, LLC ("Roth"), pursuant to which the Company has paid Roth a cash fee of approximately $ 528,000
for its services, in addition to reimbursement for certain expenses.

 Option
Grants

 S ubsequent
to December 31, 2023, the Company granted options to purchase an aggregate 1,934,716 shares of the Company's common stock at an
exercise price of $ 1.45 per share to employees, the Company's board of directors and a member of the Company's scientific
advisory board. The options had an aggregate grant date fair value of $ 2,140,000 and vest as follows: (i) options to purchase an aggregate
 513,663 shares of common stock vest monthly over one year, and (ii) options to purchase an aggregate of 1,421,053 shares of common stock
vest 50 % immediately with the remainder vesting quarterly over two years commencing one year from the date of grant. The Company will
recognize the grant date fair value of the options proportionate to the vesting period.

 F- 30