What changed in BioRestorative Therapies, Inc.'s 2023 10-K compared to 2022?

Across the narrative sections we track, BioRestorative Therapies, Inc. (BRTX) added 276 paragraphs, removed 280, and edited 211 between the 2022 and 2023 10-K filings. The biggest movers are Item 1. Business (+225/−230), Item 5. Market for Registrant's Common Equity (+46/−45), Item 2. Properties (+2/−2).

Where does this BRTX 10-K diff come from?

The source filings are BioRestorative Therapies, Inc.'s official 2022 and 2023 Form 10-K annual reports from SEC EDGAR. 10q10k.net parses each filing, aligns paragraphs by section (Item 1, 1A, 1C, 2, 3, 7, 7A), and highlights every added, removed and edited sentence side-by-side.

What changed in BioRestorative Therapies, Inc.'s 10-K — 2022 vs 2023

Paragraph-level year-over-year comparison of BioRestorative Therapies, Inc.'s 2022 and 2023 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2023 report.

+276 added−280 removedSource: 10-K (2024-04-01) vs 10-K (2023-03-27)

Top changes in BioRestorative Therapies, Inc.'s 2023 10-K

276 paragraphs added · 280 removed · 211 edited across 4 sections

Item 1. Business+225 / −230 · 181 edited
Item 5. Market for Registrant's Common Equity+46 / −45 · 26 edited
Item 2. Properties+2 / −2 · 1 edited
Item 7A. Quantitative and Qualitative Disclosures About Market Risk+3 / −3 · 3 edited

Item 1. Business

Business — how the company describes what it does

181 edited+44 added−49 removed394 unchanged

2022 filing

2023 filing

Biggest changeRisks 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 in connection with our Phase 3 clinical trial and at commercial scale quantities and do not have an alternate manufacturing supply, which could negatively impact our ability to meet any future demand for the products. 27 ● 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.

Biggest changeRisks 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. 35 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. 36 Risks Related to Our Intellectual Property ● We may not be able to protect our proprietary rights. ● Changes 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.

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 general research purposes.

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. Wayne Olan, Dr. Joy Cavagnaro, Dr. Jason Lipetz, Dr. Harvinder Sandhu and Dr. Christopher Plastaras. The Disc Advisory Committee members are Dr. Lipetz (Chairman), Dr. Olan, Dr.

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.

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 FDA’s interpretations of the HCT/P Regulations. However, in August 2022, a federal District Court in the case of United States v.

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 FDA alleged were biological products were instead within the HCT/P definition and therefore did not require FDA approval.

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.

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.

These regulations vary in complexity and can be as stringent, and on occasion even more stringent, than FDA regulations in the United States.

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

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.

Such 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.

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.

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; 20 ● 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.

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; 26 ● 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.

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).

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: 14 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).

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. 6 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.

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.

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. 46 Furthermore, there has been a trend in recent years towards reductions in overall funding for Medicare, Medicaid and other federal health care programs.

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 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.

The diseases, disorders and syndromes that may be targeted by our ThermoStem Program are as follows: 15 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.

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. 30 Clinical testing is expensive, difficult to design and implement, and can take many years to complete.

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. Clinical testing is expensive, difficult to design and implement, and can take many years to complete.

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.

We have established a research laboratory facility with Good Manufacturing Practice, or cGMP, capabilities to produce clinical grade products and 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.

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.

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 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. 30 Medical Device Regulation The FDA also has broad authority over the regulation of medical devices marketed for sale in the United States.

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. 25 Other Applicable U.S.

If any of these events were to occur, it could materially adversely affect us. Current 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.

If any of these events were to occur, it could materially adversely affect us. 31 Current 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.

If any of these events were to occur, it could materially adversely affect us. 24 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.

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.

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 .

No assurance can be given that any licensing agreement will be entered into, whether upon commercially reasonable terms or otherwise. 13 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 .

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.

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

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.

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. 43 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.

We may include a resale prospectus in our 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.

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.

Similarly, certain hospitals may be able to compete with us on the basis of these rules. 47 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.

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.

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.

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

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.

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. 32 The CLIA program is designed to establish quality laboratory testing by ensuring the accuracy, reliability, and timeliness of patient test results.

Increased market volatility and fluctuations could result in a substantial decline in the market price of our securities. 49 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 .

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 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; ● delays 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; ● delays 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; ● delays 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; ● delays in our clinical trials caused by the COVID-19 pandemic or other health emergencies; ● delays 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 may not accept 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. 31 Any inability to successfully complete pre-clinical and clinical development could result in additional costs to us or impair our ability to generate revenue.

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

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 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. 44 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.

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. 58 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.

Further, collaborations involving our product candidates, such as our collaborations with third-party research institutions, are subject to numerous risks, which may include the following: ● collaborators have significant discretion in determining the efforts and resources that they will apply to a collaboration; 36 ● collaborators 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; ● collaborators 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; ● collaborators 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; ● collaborators 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 ● collaborators 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.

To date, such efforts have not been successful. 47 Further, collaborations involving our product candidates, such as our collaborations with third-party research institutions, are subject to numerous risks, which may include the following: ● collaborators have significant discretion in determining the efforts and resources that they will apply to a collaboration; ● collaborators 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; ● collaborators 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; ● collaborators 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; ● collaborators 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 ● collaborators 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.

The following illustrates the process: 8 Exclusive License Pursuant 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 following illustrates the process: 10 Exclusive License Pursuant 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.

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.

No toxicity or adverse finding was evident in the systemic tissues or the discs of animals receiving BRTX-100 . 11 ● There was no detectable presence of human cells ( BRTX-100 ) observed at the day 56 interim time point.

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, FDA stated it will exercise enforcement discretion until May 31, 2021 for products that do not comply with the HCT/P Regulations.

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.

If any of these events were to occur, it could materially adversely affect us. 22 FDA Expedited Review Programs The FDA is authorized to expedite the review of NDAs and BLAs in several ways.

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.

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.

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. 38 We will need to maintain insurance coverage adequate to cover our clinical trials and increase that coverage before commercializing product candidates, if ever.

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. 50 We will need to maintain insurance coverage adequate to cover our clinical trials and increase that coverage before commercializing product candidates, if ever.

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. 41 In addition, the Supreme Court has recently taken more limiting positions as to what constitutes patentable subject matter.

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. 54 In addition, the Supreme Court has recently taken more limiting positions as to what constitutes patentable subject matter.

Since June 2022, we have entered into clinical trial agreements with 11 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.

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.

In our Disc/Spine Program , twelve 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 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.

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, 1,518,158 shares of Series B preferred stock are issued and outstanding.

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.

Most recently, on August 16, 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.

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.

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). 12 In order to deliver these differentiated cells into target locations in vivo , we seeded BADSCs onto 3-dimensional biological scaffolds.

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). 16 In order to deliver these differentiated cells into target locations in vivo , we seeded BADSCs onto 3-dimensional biological scaffolds.

The inability to procure brown fat tissue would have a material adverse effect upon our ability to advance our ThermoStem Program. 35 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 inability to procure brown fat tissue would have a material adverse effect upon our ability to advance our ThermoStem Program. 46 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.

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 applicable.

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

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

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, concerns over COVID-19, 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; ● delays 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; 32 ● 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.

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; ● delays or failure to obtain clinical supply for our products necessary to conduct clinical trials from contract manufacturers; 42 ● 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.

Interchangeability requires that a product is biosimilar to the reference product, and the product must demonstrate that it can be expected to produce the same clinical results as the reference product 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.

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.

The Patient Protection and Affordable Care Act, or PPACA, as well as the Inflation Reduction Act, passed on August 16, 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.

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.

See “Laboratory” below. 14 Curved Needle Device Pursuant 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.

Curved Needle Device Pursuant 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.

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. and its subsidiaries. We were incorporated in Nevada on June 13, 1997.

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.

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.

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

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 in connection with a Phase 3 clinical trial and 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.

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.

We submitted an IND application to the FDA to obtain 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 received such authorization from the FDA in February 2017.

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 agreements with 11 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. 9 The following describes the Phase 2 clinical trial authorized by the FDA: A Phase 2 Prospective, Double-Blinded, Placebo Controlled, Randomized Study ● General ● 99 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) ● Additional or Secondary Endpoints ● Clinical response at 12 months ● Changes from baseline in pain as assessed with the VAS score and ODI at weeks 2, 12, 26, 52 and 104 ● Changes from baseline in function as assessed with the ODI at weeks 2, 12, 26, 52 and 104 ● Changes from baseline in function as assessed by Roland Morris Disability Questionnaire (RMDQ) at weeks 26, 52 and 104 ● Changes from baseline function as assessed by Functional Rating Index (FRI) at weeks 12, 52 and 104 ● Changes 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.

The following describes the Phase 2 clinical trial authorized by the FDA: A Phase 2 Prospective, Double-Blinded, Placebo Controlled, Randomized Study ● General ● 99 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 12 ● 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) ● Additional or Secondary Endpoints ● Clinical response at 12 months ● Changes from baseline in pain as assessed with the VAS score and ODI at weeks 2, 12, 26, 52 and 104 ● Changes from baseline in function as assessed with the ODI at weeks 2, 12, 26, 52 and 104 ● Changes from baseline in function as assessed by Roland Morris Disability Questionnaire (RMDQ) at weeks 26, 52 and 104 ● Changes from baseline function as assessed by Functional Rating Index (FRI) at weeks 12, 52 and 104 ● Changes 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 addition, in March 2022, a United States patent related to BRTX- 100 was issued. This patent expires in December 2029. The other ten 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 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.

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 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.

Clinical Trial We submitted an IND application to the FDA to obtain 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 received such authorization from the FDA.

Clinical Trial Pursuant 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.

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.

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, Olan, Cavagnaro, Lipetz, Sandhu and Plastaras.

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.

During the years ended December 31, 2022 and 2021, we incurred $3,513,352 and $729,058, 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.

During 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.

Federal Regulation of Clinical Laboratories Congress passed the Clinical Laboratory Improvement Amendments, or CLIA, in 1988, which provided 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.

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 Food and Drug Administration Safety and Innovation Act, or FDASIA, amended the FDCA to require that 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, 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.

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.

As of December 31, 2022, our accumulated deficit was $152,640,897. 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.

As of December 31, 2023, our accumulated deficit was $167,056,381. 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.

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.

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.

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, including the Final Omnibus Rule published on January 25, 2013, imposes specified requirements relating to the privacy, security and transmission of individually identifiable health information on certain types of individuals and organizations.

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.

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.

We have labeled this initiative our ThermoStem Program . 11 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.

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.

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.

We intend to market our products and services both domestically and in foreign markets. A number of risks are inherent in international transactions.

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. 17 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 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.

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 23 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.

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, and potential subjects’ concern over the COVID-19 pandemic.

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.

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.

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.

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.

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. 64 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.

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.

It is anticipated that the delivery of the product candidate will be a 30 minute procedure. 9 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.

… 194 more changes not shown on this page.

Item 2. Properties

Properties — owned and leased real estate

1 edited+1 added−1 removed0 unchanged

2022 filing

2023 filing

Biggest changeITEM 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.

Removed

The lease provides for an annual base rental during the five year period ending in December 2024 ranging between $153,748 and $173,060. Our premises are suitable and adequate for our current operations.

Added

Our premises are suitable and adequate for our current operations.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

26 edited+20 added−19 removed18 unchanged

2022 filing

2023 filing

Biggest changeThe decrease is primarily due to a decrease of $10.4 million in stock-based compensation during the year ended December 31, 2022 compared to the year ended December 31, 2021. 55 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.

Biggest changeWe 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 income 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.

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

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

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) for general corporate and working capital purposes.

ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA . The financial statements required by this Item 8 of this Annual Report are included in this Annual Report following Item 16 (“Form 10-K Summary”). As a smaller reporting company, we are not required to provide supplementary financial information.

Not applicable. ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA . The financial statements required by this Item 8 of this Annual Report are included in this Annual Report following Item 16 (“Form 10-K Summary”). As a smaller reporting company, we are not required to provide supplementary financial information.

General and administrative General and administrative expenses consist primarily of salaries, bonuses, payroll taxes, severance costs 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.

General 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.

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 applicable.

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. 76 ITEM 7A . QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK .

The following discussion and analysis of the consolidated results of operations and financial condition of BioRestorative Therapies, Inc. and its subsidiary as of December 31, 2022 and 2021 and for the years ended December 31, 2022 and 2021 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”).

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”).

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 22, 2023, there were 352 record holders of our shares of common stock. Dividends Not applicable.

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 applicable.

We have received such authorization from the FDA and 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 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.

The net proceeds received from our November 2021 public 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).

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).

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, 2022, our accumulated deficit was $152,640,897.

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. 70 As of December 31, 2023, our accumulated deficit was $167,056,381.

United States patents related to the ThermoStem Program were issued in September 2015, January 2019, March 2020, March 2021, and July 2021; a notice of allowance for a United States patent application related to our ThermoStem Program was issued in February 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 and February 2022; Israeli patents related to our ThermoStem Program were issued in October 2019, May 2020 and March 2022; European patents related to the ThermoStem Program were issued in April 2020 and January 2021; and a notice of allowance for a European patent application related to our ThermoStem Program was issued in February 2023.

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 submitted an IND application to 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 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 not identified any impairment losses. 57 Recently Issued Accounting Pronouncements See Note 2 to our consolidated financial statements for the years ended December 31, 2022 and 2021 included elsewhere in this Annual Report following Item 16 (“Form 10-K Summary”).

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”).

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.

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 addition, no assurance can be given that we will be able to obtain any required financing on commercially reasonable terms or otherwise. 54 Consolidated Results of Operations Year Ended December 31, 2022 Compared with Year Ended December 31, 2021 The following table presents selected items in our consolidated statements of operations for the years ended December 31, 2022 and 2021, respectively: For The Years Ended December 31, 2022 2021 Revenues $ 119,800 $ 46,000 Operating Expenses: Research and development 3,513,352 729,058 General and administrative 15,580,473 25,624,815 Total Operating Expenses 19,093,825 26,353,873 Loss From Operations (18,974,025 ) (26,307,873 ) Other Expense (Income): Interest (income) expense (11,650 ) 1,815,366 Loss on extinguishment of notes payable, net - 16,180,056 Gain on PPP Loan forgiveness (250,000 ) - Grant income (110,518 ) - Other expense (107,088 ) - Total Other Expense (479,256 ) 17,995,422 Net Loss $ (18,494,769 ) $ (44,303,295 ) Revenues For the years ended December 31, 2022 and 2021, we generated $119,800 and $46,000, respectively, of royalty revenue in connection with our sublicense agreement.

In addition, no assurance can be given that we will be able to obtain any required financing on commercially reasonable terms or otherwise. 71 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 December 31, 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 ) Total Other Income (805,290 ) (479,256 ) Net Loss $ (14,415,484 ) $ (18,494,769 ) 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.

There were no gains recorded for PPP loan forgiveness for the year ended December 31, 2021. Grant income Our grant income of $110,518 for the year ended December 31, 2022 consists of funding received under a $256,000 National Institutes of Health Small Business Technology Transfer (“STTR”) Phase 1 grant, which was awarded in September 2021.

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 expense For the year ended December 31, 2022, Other income, net primarily relates to gains from settlements of certain accrued expenses and unrealized gain on investments.

Other income, net For the year ended December 31, 2023, other income, net 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.

ITEM 6 . [RESERVED] ITEM 7 . MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS .

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 .

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.

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.

Liquidity and Capital Resources Liquidity We measure our liquidity in a number of ways, including the following: December 31, 2022 2021 Cash, Cash Equivalents and Investments $ 14,749,408 $ 21,026,727 Working Capital $ 14,688,188 $ 21,104,086 Notes Payable (Gross) $ - $ 250,000 56 Availability of Additional Funds Based upon our accumulated deficit of $152.6 million as of December 31, 2022, along with our forecast for continued operating losses and our need for financing to fund our contemplated clinical trials, as of such date, we required additional equity and/or debt financing to continue our operations.

For the year ended December 31, 2022, Other income, net of $107,088 primarily related to gains from settlements of certain accrued expenses and unrealized gain on investments. 73 Liquidity and Capital Resources Liquidity We measure our liquidity in a number of ways, including the following: December 31, 2023 2022 Cash, Cash Equivalents and Investments $ 11,065,995 $ 14,749,408 Working Capital $ 10,327,134 $ 14,688,188 Availability of Additional Funds Based upon our accumulated deficit of $167,056,381 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.

We do not intend to utilize this device in connection with our Phase 2 clinical trial with regard to BRTX-100 .

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.

For the year ended December 31, 2022, general and administrative expenses decreased by $10.0 million, or 39%, compared to the year ended December 31, 2021.

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 net cash used in operating activities for the year ended December 31, 2022 was primarily due to cash used to fund a net loss of $18.5 million, adjusted for non-cash expenses in the aggregate amount of $12.9 million.

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 $18,494,769 and a non-cash gain of $250,000 on forgiveness of our PPP loan, which was partially offset by non-cash expenses of $12,567,525 related primarily to stock-based compensation and $14,144 of cash provided by changes in operating assets and liabilities.

The net proceeds of the public offering are sufficient for us to complete our Phase 2 clinical trial investigating the use of BRTX-100 . 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.

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.

Removed

Recent Sales of Unregistered Securities During the three months ended December 31, 2022, we issued the following securities in a transaction not involving any public offering. For the following transaction, we relied upon Section 4(a)(2) of the Securities Act of 1933, as amended, as a transaction by an issuer not involving any public offering.

Added

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.

Removed

For such transaction, we did not use general solicitation or advertising to market the securities, the securities were offered to a single entity, the investor had access to information regarding us (including information contained in our Annual Report on Form 10-K for the year ended December 31, 2021, Quarterly Reports on Form 10-Q for the periods ended March 31, 2022, June 30, 2022 and September 30, 2022 and Current Reports on Form 8-K filed with the Securities and Exchange Commission and press releases made by us), and we were available to answer questions by the prospective investor.

Added

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.

Removed

We reasonably believe that the investor is an accredited investor. No proceeds were received from the issuance. Warrants Date Issued Common Stock Shares Exercise Price Term (Years) Purchaser(s) Consideration (1) 11/21/2022 - 51,370 $ 2.92 5 (2 ) $ 117,030 (1) The warrants were issued pursuant to an amendment to a license agreement.

Added

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.

Removed

The value of the warrants was $117,030 as of November 21, 2022, the date of issuance.

Added

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.

Removed

(2) Accredited investor. 52 Issuer Purchases of Equity Securities The following table sets forth certain information with respect to purchases of common stock made by affiliated purchasers during the quarter ended December 31, 2022: Period Total Number of Shares Purchased(1) Average Price Paid per Share Total Number of Shares Purchased as Part of Publicly Announced Plans or Programs Maximum Number of Shares that May Be Purchased Under the Plans or Programs 10/1/22 – 10/31/22 1,531 $ 3.55 - - 11/1/22 – 11/30/22 1,943 $ 2.75 - - 12/1/22 – 12/31/22 2,100 $ 2.99 - - Total 5,574 $ 3.06 - - (1) Purchases were made by affiliated purchasers in open market transactions.

Added

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

Removed

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. 53 We are also developing our ThermoStem Program .

Added

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.

Removed

For the year ended December 31, 2022, research and development expenses increased by $2.8 million, or 382%, compared to the year ended December 31, 2021, as we recommenced research and development activities. We expect that our research and development expenses will continue to increase with the continuation of the aforementioned initiatives.

Added

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.

Removed

Interest expense For the year ended December 31, 2022, interest expense decreased $1.8 million, or 101%, as compared to the year ended December 31, 2021. The decrease was due to the exchange of our outstanding convertible debt for common stock, preferred stock and warrants in connection with our public offering in November 2021.

Added

Grant income 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.

Removed

Loss on extinguishment of notes payable, net For the year ended December 31, 2021, we recorded a loss on extinguishment of notes payable, net of $16.2 million related to the conversion of convertible debt principal pursuant to exchange agreements with noteholders in connection with our public offering.

Added

“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.

Removed

The Company did not convert or extinguish any debt during the year ended December 31, 2022. Gain on PPP loan forgiveness During the year ended December 31, 2022, our outstanding PPP loan balance was forgiven in full, which was recorded as a gain in the consolidated statement of operations.

Added

Removed

On November 9, 2021, we completed a public offering of units, each consisting of one share of common stock and a warrant for the purchase of one share of common stock.

Added

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. 74 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.

Removed

Pursuant to the public offering, we issued and sold 2,300,000 units at a public offering price of $10.00 per unit (resulting in gross proceeds of $23,000,000) and, pursuant to the exercise of an option granted to the underwriters, warrants for the purchase of 345,000 shares of common stock at a public offering price of $0.01 per warrant, less underwriting discounts and commissions.

Added

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.

Removed

During the years ended December 31, 2022 and 2021, our sources and uses of cash were as follows: Net Cash Used in Operating Activities We experienced negative cash flows from operating activities for the years ended December 31, 2022 and 2021 in the amounts of $5.9 million and $3.3 million, respectively.

Added

Cash Flows During the years ended December 31, 2023 and 2022, our sources and uses of cash were as follows: Year Ended December 31, 2023 2022 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 2,351,343 - Net decrease in cash $ (826,825 ) $ (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 $14,415,484, which was partially offset by non-cash expenses of $7,469,947 related primarily to stock-based compensation and $515,326 of cash provided by changes in our operating assets and liabilities.

Removed

The net cash used in operating activities for the year ended December 31, 2021 was primarily due to cash used to fund a net loss of $44.3 million, adjusted for non-cash expenses in the aggregate amount of $40.5 million.

Added

Net Cash Provided by (Used in) Investing Activities Net cash provided by investing activities increased by $16,731,432 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. 75 Net Cash Provided by Financing Activities Net cash provided by financing activities increased by $2,351,343 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.

Removed

Net Cash Used in Investing Activities Net cash used in investing activities for the year ended December 31, 2022 was $13.5 million compared to $31,000 for the year ended December 31, 2021. The net change was primarily the result of investments in marketable securities of $13.0 million in 2022.

Added

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

Removed

Net Cash Provided by Financing Activities There were no financing activities during the year ended December 31, 2022. Net cash provided by financing activities during the year ended December 31, 2021 was $21.3 million, primarily as a result of $21.1 million of net proceeds from an equity financing.

Added

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.

Removed

Critical Accounting Policies and Estimates Impairment of Long-lived Assets We review for the impairment of long-lived assets whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable.

Added

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.

Removed

An impairment loss would be recognized when estimated future cash flows expected to result from the use of the asset and its eventual disposition are less than its carrying amount.

Added

We evaluate these estimates on an ongoing basis.

Removed

While our near-term liquidity is tight, historically we have been successful in raising capital as needed (although there can be no assurance that we will continue to be successful in raising capital as needed). We continue to progress our scientific agenda.

Added

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.

Added

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.

Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

3 edited+0 added−0 removed7 unchanged

2022 filing

2023 filing

Biggest changeItem 7A. Quantitative and Qualitative Disclosures About Market Risk. 58 Item 8. Financial Statements and Supplementary Data. 58 Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure. 58 Item 9A. Controls and Procedures. 58 Item 9B. Other Information. 60 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections. 60 PART III Item 10.

Biggest changeItem 7A. Quantitative and Qualitative Disclosures About Market Risk. 77 Item 8. Financial Statements and Supplementary Data. 77 Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure. 77 Item 9A. Controls and Procedures. 77 Item 9B. Other Information. 79 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections. 79 PART III 80 Item 10.

Form 10-K Summary. 72 Signatures 73 2 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.

Form 10-K Summary. 95 Signatures 96 2 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.

Directors, Executive Officers and Corporate Governance. 61 Item 11. Executive Compensation. 64 Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters. 66 Item 13. Certain Relationships and Related Transactions, and Director Independence. 69 Item 14. Principal Accountant Fees and Services. 69 PART IV Item 15. Exhibits and Financial Statement Schedules. 70 Item 16.

Directors, Executive Officers and Corporate Governance. 80 Item 11. Executive Compensation. 85 Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters. 88 Item 13. Certain Relationships and Related Transactions, and Director Independence. 90 Item 14. Principal Accountant Fees and Services. 91 PART IV 92 Item 15. Exhibits and Financial Statement Schedules. 92 Item 16.

Top changes in BioRestorative Therapies, Inc.'s 2023 10-K

Item 1. Business

Item 2. Properties

Item 5. Market for Registrant's Common Equity

Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Other BRTX 10-K year-over-year comparisons