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What changed in BioRestorative Therapies, Inc.'s 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of BioRestorative Therapies, Inc.'s 2024 and 2025 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 2025 report.

+304 added−301 removedSource: 10-K (2026-03-26) vs 10-K (2025-03-28)

Top changes in BioRestorative Therapies, Inc.'s 2025 10-K

304 paragraphs added · 301 removed · 216 edited across 5 sections

Item 1. Business

Business — how the company describes what it does

80 edited+28 added−52 removed185 unchanged
Biggest changePreviously, we were licensed by the NYSDOH to act as a tissue bank for the processing of mesenchymal stem cells derived from autologous donors only. In November 2024, we announced new preliminary 26–52 week blinded data from the first 10 patients with chronic lumbar disc disease, or cLDD, enrolled in our ongoing Phase 2 clinical trial of BRTX-100 .
Biggest changeIn May 2025, we announced that preliminary 26-, 52- and 104- week blinded data from the first 15 patients with cLDD enrolled in our ongoing Phase 2 clinical trial of BRTX-100 was presented by our Vice President of Research and Development at the International Society for Cell and Gene Therapy 2025 Annual meeting.
If the FDA determines that we have failed to comply with applicable regulatory requirements, it can impose a variety of enforcement actions from public warning letters, fines, injunctions, consent decrees and civil penalties to suspension or delayed issuance of approvals, seizure of our products, total or partial shutdown of our production, withdrawal of approvals, and criminal prosecutions.
If 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.
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; 34 ● state statutes and regulations related to the corporate practice of medicine; ● laws and regulations administered by U.S.
Laws In addition to the above-described regulation by United States federal and state government, the following are other federal and state laws and regulations that could directly or indirectly affect our ability to operate the business: ● state and local licensure, registration, and regulation of the development of pharmaceuticals and biologics; ● state and local licensure of medical professionals; ● state statutes and regulations related to the corporate practice of medicine; 34 ● laws and regulations administered by U.S.
If regulated solely under the FDA’s HCT/P statutory and regulatory provisions, once our laboratory in the United States becomes operational, it will need to satisfy the following requirements, among others, to process and store stem cells: ● registration and listing of HCT/Ps with the FDA; ● donor eligibility determinations, including donor screening and donor testing requirements; ● current good tissue practices, specifically including requirements for the facilities, environmental controls, equipment, supplies and reagents, recovery of HCT/Ps from the patient, processing, storage, labeling and document controls, and distribution and shipment of the HCT/Ps to the laboratory, storage, or other facility; 26 ● tracking and traceability of HCT/Ps and equipment, supplies, and reagents used in the manufacture of HCT/Ps; ● adverse event reporting; ● FDA inspection; and ● abiding by any FDA order of retention, recall, destruction, and cessation of manufacturing of HCT/Ps.
If regulated solely under the FDA’s HCT/P statutory and regulatory provisions, once our laboratory in the United States becomes operational, it will need to satisfy the following requirements, among others, to process and store stem cells: ● registration and listing of HCT/Ps with the FDA; ● donor eligibility determinations, including donor screening and donor testing requirements; ● current good tissue practices, specifically including requirements for the facilities, environmental controls, equipment, supplies and reagents, recovery of HCT/Ps from the patient, processing, storage, labeling and document controls, and distribution and shipment of the HCT/Ps to the laboratory, storage, or other facility; ● tracking and traceability of HCT/Ps and equipment, supplies, and reagents used in the manufacture of HCT/Ps; ● adverse event reporting; ● FDA inspection; and ● abiding by any FDA order of retention, recall, destruction, and cessation of manufacturing of HCT/Ps.
The following illustrates the process: 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: 11 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 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) 12 ● 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 up to 16 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 13 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.
Although physicians may, in their independent professional medical judgment, prescribe legally available drugs for off-label uses, manufacturers typically may not market or promote such off-label uses. We have determined that, under the FDA’s current interpretation of the applicable law, our BRTX-100 product candidate will be regulated as a biological product under the PHSA.
Although physicians may, in their independent professional medical judgment, prescribe legally available drugs for off-label uses, manufacturers typically may not market or promote such off-label uses. 29 We have determined that, under the FDA’s current interpretation of the applicable law, our BRTX-100 product candidate will be regulated as a biological product under the PHSA.
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. 7 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.
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. See “ Clinical Trial ” below. 10 Production and Delivery The production of our product candidate, BRTX-100, begins with the physician collecting bone marrow from the patient under local anesthesia.
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. See “ Clinical Trial ” below. Production and Delivery The production of our product candidate, BRTX-100, begins with the physician collecting bone marrow from the patient under local anesthesia.
Competition We will compete with many pharmaceutical, biotechnology and medical device companies, as well as other private and public stem cell companies involved in the development and commercialization of cell-based medical technologies and therapies. Regenerative medicine is rapidly progressing, in large part through the development of cell-based therapies or devices designed to isolate cells from human tissues.
Competition We will compete with many pharmaceutical, biotechnology and medical device companies, as well as other private and public stem cell companies involved in the development and commercialization of cell-based medical technologies and therapies. 22 Regenerative medicine is rapidly progressing, in large part through the development of cell-based therapies or devices designed to isolate cells from human tissues.
It is anticipated that physicians who are trained and skilled in performing spinal injections will be the physicians most likely to treat discs with injections of BRTX-100 upon regulatory approval. These physicians would include interventional physiatrists (physical medicine physicians), pain management anesthesiologists, interventional radiologists and neurosurgeons. 24 Governmental Regulation U.S.
It is anticipated that physicians who are trained and skilled in performing spinal injections will be the physicians most likely to treat discs with injections of BRTX-100 upon regulatory approval. These physicians would include interventional physiatrists (physical medicine physicians), pain management anesthesiologists, interventional radiologists and neurosurgeons. Governmental Regulation U.S.
The patents that are the subject of the Regenerative License Agreement have been assigned to Regenexx, LLC which we have been advised by Regenerative is an affiliate of Regenerative. 11 Animal Study The efficacy and safety of our product candidate, BRTX-100, has been tested in a degenerative intervertebral rabbit disc model.
The patents that are the subject of the Regenerative License Agreement have been assigned to Regenexx, LLC which we have been advised by Regenerative is an affiliate of Regenerative. Animal Study The efficacy and safety of our product candidate, BRTX-100, has been tested in a degenerative intervertebral rabbit disc model.
These government regulations may delay or prevent approval of product candidates for a considerable period of time and impose costly procedures upon our business operations. The FDA may require, or companies may pursue, additional clinical trials, referred to as Phase 4 clinical trials, after a product is approved.
These government regulations may delay or prevent approval of product candidates for a considerable period of time and impose costly procedures upon our business operations. 28 The FDA may require, or companies may pursue, additional clinical trials, referred to as Phase 4 clinical trials, after a product is approved.
The technology is an advanced stem cell culture and injection procedure into the intervertebral disc, or IVD, that may offer relief from lower back pain, buttock and leg pain, and numbness and tingling in the leg and foot. 8 Lower back pain is the most common, most disabling, and most costly musculoskeletal ailment faced worldwide.
The technology is an advanced stem cell culture and injection procedure into the intervertebral disc, or IVD, that may offer relief from lower back pain, buttock and leg pain, and numbness and tingling in the leg and foot. Lower back pain is the most common, most disabling, and most costly musculoskeletal ailment faced worldwide.
If we are unable to obtain adequate funding, we may be required to significantly curtail or discontinue our proposed operations. Disc/Spine Program General Among the initiatives that we are currently pursuing is our Disc/Spine Program , with our initial product candidate being called BRTX-100 .
If we are unable to obtain adequate funding, we may be required to significantly curtail or discontinue our proposed operations. 8 Disc/Spine Program General Among the initiatives that we are currently pursuing is our Disc/Spine Program , with our initial product candidate being called BRTX-100 .
We have labeled this initiative our ThermoStem Program . 15 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.
We have labeled this initiative our ThermoStem Program . 16 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.
In our Disc/Spine Program , thirteen patent applications have been filed with regard to technology that is the subject of the Regenerative License Agreement (see “Disc/Spine Program- Exclusive License ” above). Regenerative has been issued a patent from one of these applications with regard to its curved needle therapeutic delivery device. This patent expires in March 2031.
In our Disc/Spine Program , 14 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 September 2021, we were awarded a National Institutes of Health Small Business Technology Transfer (STTR) Phase 1 grant for $256,000 to evaluate the therapeutic effects on our hypoxic cultured bone marrow derived mesenchymal stem cells ( BRTX-100 ) after encapsulation with a PEG-peptide hydrogel. The work is being done in collaboration with Washington University of St. Louis.
In September 2021, we were awarded a National Institutes of Health Small Business Technology Transfer (STTR) Phase 1 grant for $256,000 to evaluate the therapeutic effects on our hypoxic cultured bone marrow derived mesenchymal stem cells ( BRTX-100 ) after encapsulation with a PEG-peptide hydrogel. The work was done in collaboration with Washington University of St. Louis.
The BRTX-100 production process utilizes proprietary technology and involves collecting a patient’s bone marrow, isolating and culturing stem cells from the bone marrow and cryopreserving the cells. In an outpatient procedure, BRTX-100 is to be injected by a physician into the patient’s damaged disc.
The BRTX-100 production process utilizes proprietary technology and involves collecting a patient’s bone marrow, isolating and culturing stem cells from the bone marrow and cryopreserving the cells. In an outpatient procedure, BRTX-100 is injected by a physician into the patient’s damaged disc.
As discussed in a 2020 article published in the International Journal of Molecular Sciences , recent advancements in unraveling the mechanisms that control the induction, differentiation, proliferation, and thermogenic activity of BAT, along with the application of imaging technologies for human BAT visualization, have generated optimism that these advances may provide novel strategies for targeting BAT activation/thermogenesis, leading to efficacious and safe obesity targeted therapies. 16 We are developing a cell-based product candidate to target obesity and metabolic disorders using BADSCs.
As discussed in a 2020 article published in the International Journal of Molecular Sciences , recent advancements in unraveling the mechanisms that control the induction, differentiation, proliferation, and thermogenic activity of BAT, along with the application of imaging technologies for human BAT visualization, have generated optimism that these advances may provide novel strategies for targeting BAT activation/thermogenesis, leading to efficacious and safe obesity targeted therapies. 17 We are developing cell-based product candidates to target obesity and metabolic disorders using BADSCs.
The patents and patent applications for the Disc/Spine Program , the ThermoStem Program and the curved needle device are listed below under “Technology; Research and Development.” 6 Overview Every human being has stem cells in his or her body. These cells exist from the early stages of human development until the end of a person’s life.
The patents and patent applications for the Disc/Spine Program , the ThermoStem Program and the curved needle device are described below under “Technology; Research and Development.” Overview Every human being has stem cells in his or her body. These cells exist from the early stages of human development until the end of a person’s life.
No serious adverse events were reported in any of the 10 safety run-in subjects. In addition, there was no dose limiting toxicity at 26-52 weeks. In February 2025, we announced new preliminary 26–52 week blinded data from the first 15 patients with cLDD enrolled in our ongoing Phase 2 clinical trial of BRTX-100 .
In February 2025, we announced new preliminary 26- and 52- week blinded data from the first 15 patients with cLDD enrolled in our ongoing Phase 2 clinical trial of BRTX-100 . No serious adverse events were reported in any of the 15 subjects. In addition, there was no dose limiting toxicity at 26-52 weeks.
Under the BPCIA, an application for a biosimilar product cannot be submitted to the FDA until four years following approval of the reference product, and it may not be approved by the FDA until 12 years after the original branded product is approved under a biologics license application, or BLA.
Under the BPCIA, an application for a biosimilar product cannot be submitted to the FDA until four years following approval of the reference product, and it may not be approved by the FDA until 12 years after the original branded product is approved under a BLA.
A great range of cells can serve in cell therapy, including cells found in peripheral and umbilical cord blood, bone marrow and adipose (fat) tissue. Physicians have been using adult stem cells from bone marrow to treat various blood cancers for more than 65 years (the first successful bone marrow transplant was performed in 1956).
A great range of cells can serve in cell therapy, including cells found in peripheral and umbilical cord blood, bone marrow and adipose (fat) tissue. Physicians have been using adult stem cells from bone marrow to treat various blood cancers for 70 years (the first successful bone marrow transplant was performed in 1956).
With regard to the first patent family in the ThermoStem Program, patent applications have been filed in five foreign jurisdictions (of which four applications have been granted as foreign patents and one application has lapsed). The patents expire in June 2032.
Four of the patents expire in June 2032 and three of the patents expire in April 2034. With regard to the first patent family in the ThermoStem Program, patent applications have been filed in five foreign jurisdictions (of which four applications have been granted as foreign patents and one application has lapsed). The patents expire in June 2032.
Supreme Court reverses the Court of Appeals decision in the California Stem Cell case, we could face competition from stem cell clinics that would not be required to undergo the costly and time-consuming FDA approval process. 23 Set forth below is a comparison of BRTX-100 to Mesoblast’s adult stem cell biologic: We believe that BRTX-100 has competitive advantages to Mesoblast’s product for the following reasons: ● The use of autologous cells results in low to no risk of rejection, greater safety profile (introduction of viral/genetic) and a streamlined regulatory path ● Hypoxic culturing creates increased cell proliferation, greater plasticity, increased paracrine effect and increased cell survival after application ● Autologous platelet lysate provides growth factors that interact with the cells, allowing for better cell survival ● Low to no risk of safety concerns related to immunological and zoonotic (animal to human) transmission Customers Upon regulatory approval, our cell product candidates are intended to be marketed to physicians, other health care professionals, hospitals, research institutions, pharmaceutical companies and the military.
Therefore, we could face competition from stem cell clinics that would not be required to undergo the costly and time-consuming FDA approval and compliance process. 23 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 potentially 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 24 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.
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; 27 ● 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.
The process required by the FDA before a drug or biologic may be marketed in the United States generally involves the following: ● completion of non-clinical laboratory tests, animal studies and formulation studies conducted according to Good Laboratory Practice, or GLP, or other applicable regulations; ● submission of an IND, which allows clinical trials to begin unless the FDA objects within 30 days; ● performance of adequate and well-controlled human clinical trials to establish the safety and efficacy of the proposed drug or biologic for its intended use or uses conducted in accordance with FDA regulations and Good Clinical Practices, or GCP, which are international ethical and scientific quality standards meant to ensure that the rights, safety and well-being of trial participants are protected and that the integrity of the data is maintained; ● registration of clinical trials of FDA-regulated products and certain clinical trial information; ● preparation and submission to the FDA of a new drug application, or NDA, in the case of a drug or BLA in the case of a biologic; ● review of the product by an FDA advisory committee, where appropriate or if applicable; ● satisfactory completion of pre-approval inspection of manufacturing facilities and clinical trial sites at which the product, or components thereof, are produced to assess compliance with cGMP requirements and of selected clinical trial sites to assess compliance with GCP requirements; and ● FDA approval of an NDA or BLA which must occur before a drug or biologic can be marketed or sold. 27 Approval of an NDA requires a showing that the drug is safe and effective for its intended use and that the methods, facilities, and controls used for the manufacturing, processing, and packaging of the drug are adequate to preserve its identity, strength, quality, and purity.
Our current commercial product, formulated and manufactured as a third party contract manufacturer using our cGMP ISO-7 certified clean room, is a cell-based secretome containing exosomes, proteins and growth factors. This proprietary biologic serum has been specifically engineered by us to reduce the appearance of fine lines and wrinkles and bring forth other areas of cosmetic effectiveness.
Our current commercial product, formulated and manufactured using our cGMP ISO-7 certified clean room, is a cell-based secretome containing exosomes, proteins and growth factors. This proprietary biologic serum has been specifically engineered by us to reduce the appearance of fine lines and wrinkles and bring forth other areas of cosmetic effectiveness.
The treatment is intended for patients whose pain has not been alleviated by non-surgical procedures and who potentially face the prospect of surgery. We have received authorization from the FDA to commence a Phase 2 clinical trial using BRTX-100 to treat chronic lower back pain arising from degenerative disc disease.
The treatment is intended for patients whose pain has not been alleviated by non-surgical procedures and who potentially face the prospect of surgery. We have commenced a Phase 2 clinical trial using BRTX-100 to treat chronic lower back pain arising from degenerative disc disease.
We are developing a cell-based therapy candidate to target obesity and metabolic disorders using brown adipose (fat) derived stem cells, or BADSC, to generate brown adipose tissue, or BAT. We refer to this as our ThermoStem Program . BAT is intended to mimic naturally occurring brown adipose depots that regulate metabolic homeostasis in humans.
We are developing cell-based therapy candidates to target obesity and metabolic disorders using brown adipose (fat) derived stem cells, or BADSC, to generate brown adipose tissue, or BAT, as well as exosomes secreted by BADSC. We refer to this as our ThermoStem Program . BAT is intended to mimic naturally occurring brown adipose depots that regulate metabolic homeostasis in humans.
Moreover, it is possible that a biosimilar product could be approved as “interchangeable” with our product and therefore substitutable for our product by a healthcare professional under applicable state laws. We may also face increased competition from stem cell therapies performed by treatment centers that do not require FDA premarket approval.
Moreover, it is possible that a biosimilar product could be approved as “interchangeable” with our product and therefore substitutable for our product by a healthcare professional under applicable state laws. We may also face competition from unapproved stem cell therapies performed by treatment centers that do not comply with FDA requirements.
Initial preclinical research indicates that increased amounts of brown fat in animals may be responsible for additional caloric burning as well as reduced glucose and lipid levels. Researchers have found that people with higher levels of brown fat may have a reduced risk for obesity and diabetes.
Initial preclinical research indicates that increased amounts of brown fat in animals may be responsible for additional caloric burning as well as reduced glucose and lipid levels. Researchers have found that people with higher levels of brown fat may have a reduced risk for obesity and diabetes. BADSC secreted exosomes may also impact weight loss.
Our current commercial product, formulated and manufactured as a third party contract manufacturer using our cGMP ISO-7 certified clean room, is a cell-based secretome containing exosomes, proteins and growth factors. This proprietary biologic serum has been specifically engineered by us to reduce the appearance of fine lines and wrinkles and bring forth other areas of cosmetic effectiveness.
Further, we operate a commercial biocosmeceuticals business. Our current commercial product, formulated and manufactured using our cGMP ISO-7 certified clean room, is a cell-based secretome containing exosomes, proteins and growth factors. This proprietary biologic serum has been specifically engineered by us to reduce the appearance of fine lines and wrinkles and bring forth other areas of cosmetic effectiveness.
Moving forward, we also intend to explore the potential of expanding our commercial offering to include a broader family of cell-based biologic aesthetic products and therapeutics via IND-enabling studies, with the aim of pioneering FDA approvals in the emerging biocosmeceuticals space.
Moving forward, we also intend to explore the potential of expanding our commercial offering to include a broader family of cell-based biologic aesthetic products and therapeutics via IND-enabling studies, with the aim of pioneering FDA approvals in the emerging biocosmeceuticals space. 19 We market our biocosmeceutical products to distributors, medical spas and direct to consumers.
Employees We currently have 11 employees, all of whom are full-time employees. We believe that our employee relations are good.
Employees We currently have 14 employees, 13 of whom are full-time employees. We believe that our employee relations are good.
We intend to rely on a combination of patent, trade secret and know-how, copyright and trademark laws, as well as confidentiality agreements, licensing agreements, non-compete agreements and other agreements, to establish and protect our proprietary rights.
Our success will depend in large part on our ability to develop and protect our proprietary technology. We intend to rely on a combination of patent, trade secret and know-how, copyright and trademark laws, as well as confidentiality agreements, licensing agreements, non-compete agreements and other agreements, to establish and protect our proprietary rights.
In February 2024, we also received approximately $8,100,000 in gross proceeds pursuant to the exercise of warrants and in February 2025, we received approximately $1,084,000 of gross proceeds pursuant to what is commonly is referred to as an “at-the-market” program with Rodman & Renshaw, LLC (the “2024 ATM”).
In February 2024, we received approximately $8,100,000 in gross proceeds pursuant to the exercise of warrants. During 2025, we received approximately $2,000,000 of gross proceeds pursuant to what is commonly is referred to as an “at-the-market” program with Rodman & Renshaw, LLC, or the 2024 ATM.
In January 2021, a European patent related to our ThermoStem Program was issued to us. This European patent was validated in France, Germany, Italy, Spain, and the United Kingdom. In March 2021, a United States patent related to our ThermoStem Program was issued to us. In June 2021, a Japanese patent related to our ThermoStem Program was issued to us.
This European patent was validated in France, Germany, Italy, Spain and the United Kingdom. In March 2025, an Israeli patent related to our ThermoStem Program was issued to us . In September 2025, a Japanese patent related to our ThermoStem Program was issued to us.
An NDA or BLA supplement for a new indication typically requires clinical data similar to that in the original application, and the FDA uses the same procedures and actions in reviewing NDA and BLA supplements as it does in reviewing NDAs and BLAs. 29 Drug and biological products must also comply with applicable requirements, including monitoring and recordkeeping activities, manufacturing requirements, reporting to the applicable regulatory authorities of adverse experiences with the product, providing the regulatory authorities with updated safety and efficacy information, product sampling and distribution requirements, and complying with promotion and advertising requirements, which include, among others, standards for direct-to-consumer advertising, restrictions on promoting drugs for uses or in patient populations that are not described in the drug’s approved labeling, or off-label use, limitations on industry-sponsored scientific and educational activities and requirements for promotional activities involving the internet.
Drug and biological products must also comply with applicable requirements, including monitoring and recordkeeping activities, manufacturing requirements, reporting to the applicable regulatory authorities of adverse experiences with the product, providing the regulatory authorities with updated safety and efficacy information, product sampling and distribution requirements, and complying with promotion and advertising requirements, which include, among others, standards for direct-to-consumer advertising, restrictions on promoting drugs for uses or in patient populations that are not described in the drug’s approved labeling, or off-label use, limitations on industry-sponsored scientific and educational activities and requirements for promotional activities involving the internet.
We received gross proceeds of approximately $8,100,000 from the warrant exercise. In April 2024, we announced that the FDA cleared an important amendment to the protocol of our ongoing Phase 2 study investigating the use of BRTX-100 . The protocol amendment removes saline injection in the control arm of the study and replaces it with a sham injection.
In April 2024, we announced that the FDA cleared an important amendment to the protocol of our ongoing Phase 2 study investigating the use of BRTX-100 . The protocol amendment removed saline injection in the control arm of the study and replaced it with a sham injection.
During the years ended December 31, 2024 and 2023, we incurred $5,348,709 and $4,034,591, 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, 2025 and 2024, we incurred $10,094,671 and $6,706,913, 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.
Clinical Trial Pursuant to an IND application we submitted to the FDA, we have obtained authorization to undertake 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.
BRTX-100 showed a significant improvement in the cellularity and matrix of the disc when compared to the control group at day 120. 12 Clinical Trial Pursuant to an IND application we submitted to the FDA, we have obtained authorization to conduct 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 intend to undertake additional preclinical animal studies in order to optimize delivery and explore the feasibility of targeting additional indications. We anticipate that much of our development work in this area will take place at our laboratory facility, outside core facilities at academic, research or medical institutions, or contractors. See “Laboratory” below. BioCosmeceuticals We operate a commercial biocosmeceutical platform.
We anticipate that much of our development work in this area will take place at our laboratory facility, outside core facilities at academic, research or medical institutions, or contractors. See “Laboratory” below. BioCosmeceuticals We operate a commercial biocosmeceutical platform.
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 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.
Upon regulatory approval, we will seek to obtain third party reimbursement for our products and procedures; however; if we are not successful, patients may be required to pay for our products and procedures out of pocket in full and without the ability to be reimbursed by any governmental and other third party payers, which would adversely impact our prospects.
Upon regulatory approval, we will seek to obtain third party reimbursement for our products and procedures; however; if we are not successful, patients may be required to pay for our products and procedures out of pocket in full and without the ability to be reimbursed by any governmental and other third party payers, which would adversely impact our prospects. 7 We have undertaken research and development efforts in connection with the development of investigational therapeutic products and medical therapies using cell and tissue protocols, primarily involving adult stem cells.
These clinical trials are intended to further evaluate dosage, effectiveness and safety, to establish the overall benefit-risk profile of the investigational product and to provide an adequate basis for product labeling and approval by the FDA.
These clinical trials are intended to further evaluate dosage, effectiveness and safety, to establish the overall benefit-risk profile of the investigational product and to provide an adequate basis for product labeling and approval by the FDA. In most cases, the FDA requires two adequate and well-controlled Phase 3 clinical trials to demonstrate the efficacy of an investigational drug or biologic.
In March 2025, an Israeli patent related to our ThermoStem Program was issued. 5 (b) Business General We develop therapeutic products, using cell and tissue protocols, primarily involving adult stem cells. Our two core programs, as described below, relate to the treatment of disc/spine disease and metabolic disorders: ● Disc/Spine Program (brtxDisc).
(b) Business General We develop therapeutic products, using cell and tissue protocols, primarily involving adult stem cells. As described below, our two core programs relate to the treatment of disc/spine disease and metabolic disorders. We also operate a commercial biocosmeceutical platform: ● Disc/Spine Program (brtxDisc).
We may also use this laboratory to develop our pipeline of future products and expand our stem cell-related IP. See “Laboratory” and “Technology; Research and Development” below. In March 2022, a United States patent related to BRTX-100 was issued. We have been granted exclusive license rights with respect to the patent. See “ Exclusive License ” below.
See “Laboratory” and “Technology; Research and Development” below. In March 2022, a United States patent related to BRTX-100 was issued. We have been granted exclusive license rights with respect to the patent. See “ Exclusive License ” below.
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.
This process is intended to result in a large cell count population with enhanced viability and therapeutic potential following injection into the injured disc. 9 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 do not intend to utilize this device in connection with our Phase 2 clinical trial with regard to BRTX-100 . See “Curved Needle Device” below.
We anticipate that FDA approval or clearance will be necessary for this device prior to commercialization. We do not intend to utilize this device in connection with our Phase 2 clinical trial with regard to BRTX-100 . See “Curved Needle Device” below.
Moving forward, we also intend to explore the potential of expanding our commercial offering to include a broader family of cell-based biologic aesthetic products and therapeutics via IND-enabling studies, with the aim of pioneering FDA approvals in the emerging biocosmeceuticals space.
Moving forward, we also intend to explore the potential of expanding our commercial offering to include a broader family of cell-based biologic aesthetic products and therapeutics via IND-enabling studies, with the aim of pioneering FDA approvals in the emerging biocosmeceuticals space. 6 We have also licensed an investigational curved needle device designed to deliver cells and/or other therapeutic products or material to the spine and discs (and other parts of the body).
In addition to developing BRTX-100 , we may also seek to sublicense the technology to a strategic third party, who may assist in gaining FDA approval for a lumbar disc indication, or third parties for use in connection with cellular-based developmental programs with regard to disc and spine related conditions. 9 We have established a laboratory, which includes a clean room facility, to perform the production of cell products (including BRTX-100 ) for use in our clinical trials, for third party cell products or for general research purposes.
In addition to developing BRTX-100 , we may also seek to sublicense the technology to a strategic third party, who may assist in gaining FDA approval for a lumbar disc indication, or third parties for use in connection with cellular-based developmental programs with regard to disc and spine related conditions.
The agreement provides for the supply by us of pre-set minimum quantities of finished vials of a proprietary cell-based biologic serum to Cartessa annually as private label under Cartessa’s Chronos ExoCR mark. 19 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.
In June 2023, we announced that the independent Data Safety Monitoring Board, which is overseeing our Phase 2 clinical trial, unanimously recommended the continuation of our study in accordance with the version of the protocol with no changes. 13 In April 2024, we announced that the FDA cleared an important amendment to the protocol of our ongoing Phase 2 study investigating the use of BRTX-100 .
In June 2023, we announced that the final subject in our BRTX-100 Phase 2 clinical trial safety cohort had been dosed. In June 2023, we announced that the independent Data Safety Monitoring Board, which is overseeing our Phase 2 clinical trial, unanimously recommended the continuation of our study in accordance with the version of the protocol with no changes.
We believe that, based upon our periodic reports to the FDA as to the commencement of the clinical trial, the existing IND remains effective.
We are conducting our Phase 2 clinical trial as described below under “ Clinical Trial .” We believe that, based upon our periodic reports to the FDA as to our clinical trial, the existing IND remains effective.
Food and Drug Administration, or the FDA, to obtain authorization to commence a Phase 2 clinical trial investigating the use of BRTX-100 in the treatment of chronic lower back pain arising from degenerative disc disease. We have received such authorization from the FDA and have commenced such clinical trial.
We are conducting 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 also obtained U.S. Food and Drug Administration, or the FDA, Investigational New Drug, or IND, clearance to evaluate BRTX-100 in the treatment of chronic cervical discogenic pain.
No serious adverse events were reported in any of the 15 subjects. In addition, there was no dose limiting toxicity at 26-52 weeks. Further, we announced certain positive preliminary data analyses.
In February 2025, we announced new preliminary 26–52 week blinded data from the first 15 patients with cLDD enrolled in our ongoing Phase 2 clinical trial of BRTX-100 . No serious adverse events were reported in any of the 15 subjects. In addition, there was no dose limiting toxicity at 26-52 weeks. Further, we announced certain positive preliminary data analyses.
The report indicated that, if BRTX-100 were to be granted FDA approval, the KOLs anticipate that it would be integrated into the standard of care for eligible chronic lumbar disc disease patients. 14 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).
No assurance can be given that any licensing agreement will be entered into, whether upon commercially reasonable terms or otherwise. 15 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).
The recent extensive use of both FDA-approved and compounded versions of glucagon-like peptide-1 (GLP-1) receptor agonist drug products, such as Wegovy and Ozempic (semaglutide) for the treatment of obesity has significantly increased the competition in the obesity market. 22 Many of our competitors and potential competitors have substantially greater financial, technological, research and development, marketing and personnel resources than we do.
The recent extensive use of both FDA-approved and compounded versions of glucagon-like peptide-1 (GLP-1) receptor agonist drug products, such as Wegovy and Ozempic (semaglutide), including the launch of FDA- approved oral Wegovy in January 2026, for the treatment of obesity has significantly increased the competition in the obesity market.
We cannot, with any accuracy, forecast when or if these companies are likely to bring their products and therapies to market in competition with those that we are pursuing.
Many of our competitors and potential competitors have substantially greater financial, technological, research and development, marketing and personnel resources than we do. We cannot, with any accuracy, forecast when or if these companies are likely to bring their products and therapies to market in competition with those that we are pursuing.
Publications and scientific literature have indicated that MSCs preconditioned in hypoxic environment show enhanced skeletal muscle regeneration properties and improved impacts upon circulation and vascular formation compared to MSCs cultured under normoxic (normal oxygen) conditions.
Publications and scientific literature have indicated that MSCs preconditioned in a hypoxic environment show enhanced skeletal muscle regeneration properties and improved impacts upon circulation and vascular formation compared to MSCs cultured under normoxic (normal oxygen) conditions. 10 In August 2018, the Journal of Translational Medicine published the results of our study evaluating the benefits of long-term hypoxic culturing of human bone marrow-derived MSCs.
As a result of these programs, we have seven United States patents, sixteen foreign patents, one United States patent application, and two foreign patent applications related to research regarding our ThermoStem Program.
See “Disc/Spine Program,” “Metabolic Brown Adipose (Fat) Program” and “Curved Needle Device” below. As a result of these programs, we have seven United States patents, 18 foreign patents and one United States patent application related to research regarding our ThermoStem Program.
Patents related to the ThermoStem Program have been issued in the United States and other jurisdictions. See “Metabolic Brown Adipose (Fat) Program” below. ● BioCosmeceuticals : We operate a commercial biocosmeceutical platform.
Patents related to the ThermoStem Program have been issued in the United States and other jurisdictions. See “Metabolic Brown Adipose (Fat) Program” below. ● BioCosmeceuticals : We operate a commercial biocosmeceutical platform. Our current commercial product, formulated and manufactured using our cGMP ISO-7 certified clean room, is a cell-based secretome containing exosomes, proteins and growth factors.
As of that date, manufacturers of products marketed as HCT/Ps that do not comply with the HCT/P Regulations are subject to immediate FDA enforcement action. If we are not regulated solely under the HCT/P Regulations, we would need to expend significant resources to comply with the FDA’s broad regulatory authority under the FDCA.
If we are not regulated solely under the HCT/P Regulations, we would need to expend significant resources to comply with the FDA’s broad regulatory authority under the FDCA. Historically, the U.S. federal courts have upheld the FDA’s authority to regulate stem cell products under the FDCA that do not comply with the FDA’s interpretations of the HCT/P Regulations.
In order to enhance the survivability of our bone marrow-derived MSCs in the avascular environment of the damaged disc, BRTX-100 is designed to expand under hypoxic conditions. This process is intended to result in a large cell count population with enhanced viability and therapeutic potential following injection into the injured disc.
In 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.
If the FDA determines that we have failed to comply with applicable regulatory requirements, it can impose a variety of enforcement actions including public warning letters, fines, consent decrees, orders of retention, recall or destruction of product, orders to cease manufacturing, and criminal prosecution. If any of these events were to occur, it could materially adversely affect us.
In addition, the importer must hold the HCT/P intact and under conditions necessary to prevent transmission of communicable disease until an admissibility decision is made by the FDA. 26 If the FDA determines that we have failed to comply with applicable regulatory requirements, it can impose a variety of enforcement actions including public warning letters, fines, consent decrees, orders of retention, recall or destruction of product, orders to cease manufacturing, and criminal prosecution.
Our allogeneic brown adipose derived stem cell platform potentially provides a therapeutic and commercial model for the cell-based treatment of obesity and related metabolic disorders. In February 2014, our research with regard to the identification of a population of brown adipose derived stem cells was published in Stem Cells , a respected stem cell journal.
Our allogeneic brown adipose derived stem cell platform potentially provides a therapeutic and commercial model for the cell-based treatment of obesity and related metabolic disorders. 18 In July 2024, a Japanese patent related to our ThermoStem program was issued to us. In March 2025, a European patent related to our ThermoStem Program was issued to us .
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, two 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 12 eleven applications that were filed, one application remains pending.
No serious adverse events were reported in any of the 10 safety run-in subjects. In addition, there was no dose limiting toxicity at 26-52 weeks.
No serious adverse events were reported and there was no dose limiting toxicity at 26-104 weeks.
We have secured registrations in the U.S. Patent and Trademark Office for the following trademarks: ● ● BRTX-100 21 ● THERMOSTEM ● BRTX The Dragonfly Logo is also registered with the U.S. Copyright Office.
Patent and Trademark Office for the following trademarks: ● ● BRTX-100 ● THERMOSTEM ● BRTX The Dragonfly Logo is also registered with the U.S. Copyright Office. We also have federal common law rights in the trademark BioRestorative Therapies and other trademarks and trade names used in the conduct of our business that are not registered.
This proprietary biologic serum has been specifically engineered by us to reduce the appearance of fine lines and wrinkles and bring forth other areas of cosmetic effectiveness. We also intend to explore the potential of expanding our commercial offering to include a broader family of cell-based biologic aesthetic products and therapeutics via IND-enabling studies.
This proprietary biologic serum has been specifically engineered by us to reduce the appearance of fine lines and wrinkles and bring forth other areas of cosmetic effectiveness.
With regard to the third patent family in the ThermoStem Program , patent applications have been filed in four foreign jurisdictions (of which three applications have been granted as a foreign patents). Our patent applications and those of Regenexx, LLC are currently in prosecution (i.e., we and Regenexx, LLC are seeking issued patents).
With regard to the third 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 2040. 21 We have secured registrations in the U.S.
We are currently pursuing our Disc/Spine Program with our initial investigational therapeutic product being called BRTX-100 . In March 2022, a United States patent issued in our Disc/Spine Program . We submitted an investigational new drug, or IND, application to the U.S.
We develop therapeutic products using cell and tissue protocols, primarily involving adult stem cells. 3 We are currently pursuing our Disc/Spine Program with our initial investigational therapeutic product being called BRTX-100 . In March 2022, a United States patent issued in our Disc/Spine Program .
Progress reports detailing the results of the clinical trials must be submitted at least annually to the FDA and more frequently if serious adverse events occur. Phase 1, Phase 2 and Phase 3 clinical trials may not be completed successfully within any specified period, or at all.
Phase 1, Phase 2 and Phase 3 clinical trials may not be completed successfully within any specified period, or at all.
The protocol amendment removes saline injection in the control arm of the study and replaces it with a sham injection. In November 2024, we announced new preliminary 26–52 week blinded data from the first 10 patients with cLDD enrolled in our ongoing Phase 2 clinical trial of BRTX-100 .
In November 2024, we announced new preliminary 26–52 week blinded data from the first 10 patients with cLDD enrolled in our ongoing Phase 2 clinical trial of BRTX-100 . No serious adverse events were reported in any of the 10 safety run-in subjects. In addition, there was no dose limiting toxicity at 26-52 weeks.
In our ThermoStem Program , we have one pending United States patent application and seven United States patents within three patent families. Four of the patents expire in June 2032 and three of the patents expire in April 2034.
The patents that are the subject of the Regenerative License Agreement have been assigned to Regenexx, LLC which we have been advised is an affiliate of Regenerative. In our ThermoStem Program , we have one pending United States patent application and seven United States patents within three patent families.
In most cases, the FDA requires two adequate and well-controlled Phase 3 clinical trials to demonstrate the efficacy of an investigational drug or biologic. 28 All clinical trials must be conducted in accordance with FDA regulations, GCP requirements and their protocols in order for the data to be considered reliable for regulatory purposes.
All clinical trials must be conducted in accordance with FDA regulations, GCP requirements and their protocols in order for the data to be considered reliable for regulatory purposes. Progress reports detailing the results of the clinical trials must be submitted at least annually to the FDA and more frequently if serious adverse events occur.
To date, we have sold approximately $1.1 million of our shares pursuant to the Offering Agreement. Material Events During 2025 In February 2025, we announced new preliminary 26–52 week blinded data from the first 15 patients with cLDD enrolled in our ongoing Phase 2 clinical trial of BRTX-100 .
In May 2025, we announced that preliminary 26-, 52- and 104- week blinded data from the first 15 patients with cLDD enrolled in our ongoing Phase 2 clinical trial of BRTX-100 was presented by our Vice President of Research and Development at the International Society for Cell and Gene Therapy 2025 Annual meeting.
In July 2024, a Japanese patent related to our ThermoStem program was issued to us. In February 2025, a European patent related to our ThermoStem Program was issued. In March 2025, an Israeli patent related to our ThermoStem Program was issued. We have completed proof of concept preclinical animal studies using our first generation brown adipose derived stem cells.
We have completed proof of concept preclinical animal studies using our first generation brown adipose derived stem cells. We intend to undertake additional preclinical animal studies in order to optimize delivery and explore the feasibility of targeting additional indications.
No serious adverse events were reported in any of the 15 subjects. In addition, there was no dose limiting toxicity at 26-52 weeks. Further, we announced certain positive preliminary data analyses. In February 2025, a European patent related to our ThermoStem Program was issued.
Further, we announced certain positive preliminary data analyses. In February 2025, we announced that the FDA cleared our IND application for BRTX-100 for the treatment of chronic cervical discogenic pain. In March 2025, a European patent related to our ThermoStem Program was issued. In March 2025, an Israeli patent related to our ThermoStem Program was issued.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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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 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. ● Our activity as a contract manufacturer of biologic-based cosmetics could result in FDA enforcement for reasons outside of our control, which could disrupt the development of our own product candidates or harm our reputation. 37 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.
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; there is substantial doubt about our ability to continue as a going concern within the next twelve months from the date of this filing; the report of our independent registered public accounting firm contains an explanatory paragraph that expresses substantial doubt about our ability to continue as a going concern. ● 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. ● In the event that we are unable to utilize our current premises and need to relocate, we will be required to comply with regulatory requirements as to the operation of our laboratory, which could have had a material adverse effect on the conduct of our clinical trials and on our business. 36 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. 37 ● 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. ● Our activity as a contract manufacturer of biologic-based cosmetics could result in FDA enforcement for reasons outside of our control, which could disrupt the development of our own product candidates or harm our reputation.
To the extent that any disruption, theft of information, or security breach were to result in a loss of or damage to data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur liability and the clinical development and the future development of our product candidates could be delayed.
To 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 future development of our product candidates could be delayed.
If we fail to comply with applicable regulatory requirements for any product candidate following approval, a regulatory authority may: ● issue a warning or untitled letter asserting that we are in violation of the law; ● seek an injunction or impose administrative, civil or criminal penalties or monetary fines; ● suspend or withdraw regulatory approval; ● suspend any ongoing clinical trials; ● refuse to approve a pending BLA or comparable foreign marketing application (or any supplements thereto) submitted by us or our strategic partners; ● restrict the marketing or manufacturing of the product; ● seize or detain the product or otherwise demand or require the withdrawal or recall of the product from the market; ● refuse to permit the import or export of products; ● request and publicize a voluntary recall of the product; or ● refuse to allow us to enter into supply contracts, including government contracts.
If we fail to comply with applicable regulatory requirements for any product candidate following approval, a regulatory authority may: ● issue a warning or untitled letter asserting that we are in violation of the law; ● seek an injunction or impose administrative, civil or criminal penalties or monetary fines; ● suspend or withdraw regulatory approval; 58 ● suspend any ongoing clinical trials; ● refuse to approve a pending BLA or comparable foreign marketing application (or any supplements thereto) submitted by us or our strategic partners; ● restrict the marketing or manufacturing of the product; ● seize or detain the product or otherwise demand or require the withdrawal or recall of the product from the market; ● refuse to permit the import or export of products; ● request and publicize a voluntary recall of the product; or ● refuse to allow us to enter into supply contracts, including government contracts.
Even if we are able to successfully complete our clinical development program for our product candidates, and ultimately receive regulatory approval to market one or more of the products, we may, among other things: ● obtain approval for indications that are not as broad as the indications we sought; ● have the product removed from the market after obtaining marketing approval; ● encounter issues with respect to the manufacturing of commercial supplies; 42 ● be subject to additional post-marketing testing requirements; and/or ● be subject to restrictions on how the product is distributed or used.
Even if we are able to successfully complete our clinical development program for our product candidates, and ultimately receive regulatory approval to market one or more of the products, we may, among other things: ● obtain approval for indications that are not as broad as the indications we sought; ● have the product removed from the market after obtaining marketing approval; ● encounter issues with respect to the manufacturing of commercial supplies; ● be subject to additional post-marketing testing requirements; and/or ● be subject to restrictions on how the product is distributed or used.
There are many factors that will impact our stock price and trading volume, including, but not limited to, the factors listed above under “Risks Related to Our Business Generally,” “Risks Related to Our Cell Therapy Product Development Efforts,” “Risks Related to Our Intellectual Property,” “Risks Related to Government Regulation,” “Risks Related to Our Common Stock” and “Risks Associated with Our Nasdaq Listing.” Stock markets, in general, experience significant price and volume volatility, and the market price of our securities may continue to be subject to such market fluctuations that may be unrelated to our operating performance and prospects.
There are many factors that will impact our stock price and trading volume, including, but not limited to, the factors listed above under “Risks Related to Our Business Generally,” “Risks Related to Our Cell Therapy Product Development Efforts,” “Risks Related to Our Intellectual Property,” “Risks Related to Government Regulation,” “Risks Related to Our Common Stock” and “Risks Associated with Our Nasdaq Listing.” 67 Stock markets, in general, experience significant price and volume volatility, and the market price of our securities may continue to be subject to such market fluctuations that may be unrelated to our operating performance and prospects.
It is possible that competitors may obtain patent protection, approval or clearance from the FDA or achieve commercialization earlier than we can, any of which could have a substantial negative effect on our business. We will compete against cell-based therapies derived from alternate sources, such as bone marrow, adipose tissue, umbilical cord blood and potentially embryos.
It is possible that competitors may obtain patent protection, approval or clearance from the FDA or achieve commercialization earlier than we can, any of which could have a substantial negative effect on our business. 48 We will compete against cell-based therapies derived from alternate sources, such as bone marrow, adipose tissue, umbilical cord blood and potentially embryos.
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. 55 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. In addition, the Supreme Court has recently taken more limiting positions as to what constitutes patentable subject matter.
It is possible that the FDA could determine, based on how the product is marketed (among other considerations), that it is intended for unapproved therapeutic use(s), which could result in the temporary or permanent suspension of manufacturing and/or commercialization of the product and/or a wide range of enforcement actions, such as warning letters, recall, ‘dear doctor’ letters, and others.
It is possible that the FDA could determine, based on how the product was marketed (among other considerations), that it was intended for unapproved therapeutic use(s), which could result in the temporary or permanent suspension of manufacturing and/or commercialization of the product and/or a wide range of enforcement actions, such as warning letters, recall, ‘dear doctor’ letters, and others.
Any delay or failure to complete clinical trials and obtain FDA approval for our product candidates could have a material adverse effect on our cost to develop and commercialize, and our ability to generate revenue from, a particular product candidate. 43 The development of our cell therapy product candidates is subject to uncertainty because autologous cell therapy is inherently variable.
Any delay or failure to complete clinical trials and obtain FDA approval for our product candidates could have a material adverse effect on our cost to develop and commercialize, and our ability to generate revenue from, a particular product candidate. The development of our cell therapy product candidates is subject to uncertainty because autologous cell therapy is inherently variable.
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; 41 ● 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 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.
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 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. 42 Any inability to successfully complete pre-clinical and clinical development could result in additional costs to us or impair our ability to generate revenue.
Such compulsory licenses could be extended to our product candidates, which may limit our potential revenue opportunities, including with respect to any future revenues that may result from our product candidates. Risks Related to Government Regulation Even if we obtain regulatory approval for a product candidate, our products will remain subject to regulatory oversight.
Such compulsory licenses could be extended to our product candidates, which may limit our potential revenue opportunities, including with respect to any future revenues that may result from our product candidates. 57 Risks Related to Government Regulation Even if we obtain regulatory approval for a product candidate, our products will remain subject to regulatory oversight.
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. 44 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. 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.
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. 64 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. We have incurred, and will continue to incur, increased costs as a result of being an SEC reporting company.
This could result in substantial costs, divert our efforts and attention from other aspects of our business, and could have a material adverse effect on our results of operations and financial condition. Changes to United States patent law may have a material adverse effect on our intellectual property rights.
This could result in substantial costs, divert our efforts and attention from other aspects of our business, and could have a material adverse effect on our results of operations and financial condition. 56 Changes to United States patent law may have a material adverse effect on our intellectual property rights.
Implementation of the IRA is expected to be carried out through upcoming actions by regulatory authorities, the outcome of which is uncertain. Healthcare reform measures that may be adopted in the future, may result in more rigorous coverage criteria and decreased reimbursement.
Implementation of the IRA is expected to be carried out through upcoming actions by regulatory authorities, the outcome of which is uncertain. 64 Healthcare reform measures that may be adopted in the future, may result in more rigorous coverage criteria and decreased reimbursement.
Enrollment challenges in clinical trials often result in increased development costs for a product candidate, significant delays and potentially the abandonment of the clinical trial. We may have other delays in completing our clinical trials and we may not complete them at all.
Enrollment challenges in clinical trials often result in increased development costs for a product candidate, significant delays and potentially the abandonment of the clinical trial. 43 We may have other delays in completing our clinical trials and we may not complete them at all.
The occurrence of any of these events would delay, and increase the cost of, our development efforts and may render the commercialization of our proposed products and/or services impractical or impossible. 47 We are vulnerable to competition and technological change, and also to physicians’ inertia.
The occurrence of any of these events would delay, and increase the cost of, our development efforts and may render the commercialization of our proposed products and/or services impractical or impossible. We are vulnerable to competition and technological change, and also to physicians’ inertia.
At any time during our clinical trials or after commercialization, if that occurs, we may not be able to obtain or maintain product liability insurance on acceptable terms with adequate coverage or at all, or if claims against us substantially exceed our coverage, then our financial position could be significantly impaired. 51 Whether or not we are ultimately successful in any product liability litigation that may arise, such litigation could consume substantial amounts of our financial and managerial resources, result in decreased demand for our products and injure our reputation.
At any time during our clinical trials or after commercialization, if that occurs, we may not be able to obtain or maintain product liability insurance on acceptable terms with adequate coverage or at all, or if claims against us substantially exceed our coverage, then our financial position could be significantly impaired. 52 Whether or not we are ultimately successful in any product liability litigation that may arise, such litigation could consume substantial amounts of our financial and managerial resources, result in decreased demand for our products and injure our reputation.
Therefore, we can give no assurance that any dividends of any kind will ever be paid to holders of our common stock. There is no assurance that an active trading market for our common stock will be sustained. Our common stock is listed on Nasdaq.
Therefore, we can give no assurance that any dividends of any kind will ever be paid to holders of our common stock. 65 There is no assurance that an active trading market for our common stock will be sustained. Our common stock is listed on Nasdaq.
To date, such efforts have not been successful. 48 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.
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; 49 ● 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.
Products that appear promising in research and development may be delayed or may fail to reach later stages of clinical development. The successful development of cellular based products is highly uncertain. Product candidates that appear promising in preclinical and early research and development may be delayed or fail to reach later stages of development.
The successful development of cellular based products is highly uncertain. Product candidates that appear promising in preclinical and early research and development may be delayed or fail to reach later stages of development.
Additionally, fluctuations in currency exchange rates may adversely affect demand for our services and products by increasing the price of our products and services in the currency of the countries in which the products and services are offered. 52 There can be no assurance that we will obtain regulatory approvals or clearances in all of the countries where we intend to market our products and services, that we will not incur significant costs in obtaining or maintaining foreign regulatory approvals or clearances, or that we will be able to successfully commercialize our products and services in various foreign markets.
Additionally, fluctuations in currency exchange rates may adversely affect demand for our services and products by increasing the price of our products and services in the currency of the countries in which the products and services are offered. 53 There can be no assurance that we will obtain regulatory approvals or clearances in all of the countries where we intend to market our products and services, that we will not incur significant costs in obtaining or maintaining foreign regulatory approvals or clearances, or that we will be able to successfully commercialize our products and services in various foreign markets.
The sale of a substantial number of shares of our common stock or securities convertible into, or exchangeable or exercisable for, shares of our common stock, whether directly by us in future offerings or by our existing stockholders in the secondary market, the perception that such issuances or resales could occur or the availability for future issuances or resale of shares of our common stock or securities convertible into, or exchangeable or exercisable for, shares of our common stock could materially and adversely affect the market price of our securities and our ability to raise capital through future offerings of equity or equity-related securities on attractive terms or at all.
The sale of a substantial number of shares of our common stock or securities convertible into, or exchangeable or exercisable for, shares of our common stock, whether directly by us in future offerings or by our existing securityholders in the secondary market, the perception that such issuances or resales could occur or the availability for future issuances or resale of shares of our common stock or securities convertible into, or exchangeable or exercisable for, shares of our common stock could materially and adversely affect the market price of our securities and our ability to raise capital through future offerings of equity or equity-related securities on attractive terms or at all.
Our consolidated financial statements as of December 31, 2024 and 2023 and for the years then ended which are included in this Annual Report following Item 16 (“Form 10-K Summary”) have been prepared on the basis that we will continue as a going concern, which contemplates realization of assets and satisfying liabilities in the normal course of business.
Our consolidated financial statements as of December 31, 2025 and 2024 and for the years then ended which are included in this Annual Report following Item 16 (“Form 10-K Summary”) have been prepared on the basis that we will continue as a going concern, which contemplates realization of assets and satisfying liabilities in the normal course of business.
We cannot assure that we will successfully achieve our clinical development goals or fulfill our plans to capture a piece of the cell therapy market. 49 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.
We cannot assure that we will successfully achieve our clinical development goals or fulfill our plans to capture a piece of the cell therapy market. 50 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.
We recognize the critical importance of cybersecurity in safeguarding sensitive information, maintaining operational resilience, and protecting stakeholders’ interests. 68 Information Technology and Cybersecurity Governance Our corporate IT infrastructure, communication networks, and related systems are essential operational components. These systems manage product development, internal and external communications, accounting functions, data storage, and other critical operations.
We recognize the critical importance of cybersecurity in safeguarding sensitive information, maintaining operational resilience, and protecting stakeholders’ interests. 70 Information Technology and Cybersecurity Governance Our corporate IT infrastructure, communication networks, and related systems are essential operational components. These systems manage product development, internal and external communications, accounting functions, data storage, and other critical operations.
The report states that, as of December 31, 2024 there is substantial doubt about our ability to continue as a going concern within one year after the issuance date of such financial statements. Our plans in regard to these matters are described in footnote 1 to such financial statements.
The report states that, as of December 31, 2025 there is substantial doubt about our ability to continue as a going concern within one year after the issuance date of such financial statements. Our plans in regard to these matters are described in footnote 1 to such financial statements.
We anticipate that we will continue to incur net losses and negative cash flows from operations as we execute our development plans for 2025 and beyond, as well as other potential strategic and business development initiatives.
We anticipate that we will continue to incur net losses and negative cash flows from operations as we execute our development plans for 2026 and beyond, as well as other potential strategic and business development initiatives.
Stockholders who hold unregistered shares of our common stock are subject to resale restrictions pursuant to Rule 144 due to our former status as a “shell company.” We previously were a “shell company” pursuant to Rule 144, promulgated under the Securities Act, or Rule 144, and, as such, sales of our securities pursuant to Rule 144 cannot be made unless, among other things, we continue to remain subject to Section 13 or 15(d) of the Exchange Act, and we file all of our required periodic reports with the SEC under the Exchange Act.
See “Risks Associated with Our Nasdaq Listing.” Stockholders who hold unregistered shares of our common stock are subject to resale restrictions pursuant to Rule 144 due to our former status as a “shell company.” We previously were a “shell company” pursuant to Rule 144, promulgated under the Securities Act, or Rule 144, and, as such, sales of our securities pursuant to Rule 144 cannot be made unless, among other things, we continue to remain subject to Section 13 or 15(d) of the Exchange Act, and we file all of our required periodic reports with the SEC under the Exchange Act.
Under the BPCIA, an application for a biosimilar product cannot be approved by the FDA until 12 years after the original branded product is approved under a biologics license application, or BLA. The FDA has developed considerable experience with the biosimilar and interchangeable biosimilar processes since the enactment of the BPCIA in 2009.
Under the BPCIA, an application for a biosimilar product cannot be approved by the FDA until 12 years after the original branded product is approved under a BLA. The FDA has developed considerable experience with the biosimilar and interchangeable biosimilar processes since the enactment of the BPCIA in 2009.
Pursuant to our November 2021 public offering of securities, we issued warrants for the purchase of an aggregate of 2,645,000 shares of common stock (of which warrants for the purchase of an aggregate of 1,675,000 shares of common stock have been exercised) as well as underwriter warrants for the purchase of 235,970 shares of common stock.
Pursuant to our November 2021 public offering of securities, we issued warrants for the purchase of an aggregate of 2,645,000 shares of common stock (of which warrants for the purchase of an aggregate of 1,675,000 shares of common stock have been exercised and warrants for the purchase of 970,000 shares of common stock remain outstanding) as well as underwriter warrants for the purchase of 235,970 shares of common stock.
Although the market price of our common stock satisfied the initial listing minimum bid price requirement for Nasdaq, there can be no assurance that the market price of our common stock will remain at the $1.00 per share level required for continuing compliance with that requirement.
Although the market price of our common stock satisfied the initial listing minimum bid price requirement for Nasdaq, there can be no assurance that the market price of our common stock will increase to, or remain at, the $1.00 per share level required for continuing compliance with that requirement.
If safety concerns develop, we may, or the FDA or an institutional review board may require us to, stop the affected trials before completion. 60 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.
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.
Except for a certain license agreement with Regenerative Sciences, LLC, a product manufacturing agreement with Cartessa Aesthetics, LLC, and agreements relating to the conduct of our Phase 2 clinical trial, we do not have any material agreements or understandings in place with respect to the implementation of our business strategy.
Except for a certain license agreement with Regenerative Sciences, LLC and agreements relating to the conduct of our Phase 2 clinical trial, we do not have any material agreements or understandings in place with respect to the implementation of our business strategy.
The loss of the services of Mr. Alstodt and/or Mr. Silva or the inability to attract and retain additional personnel and develop expertise as needed would have a substantial negative effect on our results of operations and financial condition.
Silva or the inability to attract and retain additional personnel and develop expertise as needed would have a substantial negative effect on our results of operations and financial condition.
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.
Our certificate of incorporation provides that our Board of Directors may issue up to 20,000,000 shares of preferred stock (less the 1,398,158 shares of preferred stock previously issued), in one or more series, without stockholder approval and with such terms, preferences, rights and privileges as the Board of Directors may deem appropriate.
The report of our independent registered public accounting firm with respect to our financial statements as of December 31, 2024 and 2023 and for the years then ended indicates that our financial statements have been prepared assuming that we will continue as a going concern.
The report of our independent registered public accounting firm with respect to our financial statements as of December 31, 2025 and for the year then ended indicates that our financial statements have been prepared assuming that we will continue as a going concern.
Failure to comply with the FCPA will adversely affect our business. 58 In addition to the FCPA, we will also need to comply with the foreign government laws and regulations of each individual country in which any therapy centers that we may establish are located and products are to be distributed and sold.
In addition to the FCPA, we will also need to comply with the foreign government laws and regulations of each individual country in which any therapy centers that we may establish are located and products are to be distributed and sold.
We also have effective registration statements on Form S-8 under the Securities Act registering an aggregate of 6,850,000 shares of our common stock issuable under our 2021 Stock Incentive Plan, or the 2021 Plan (of which 319,797 shares have been issued).
We also have effective registration statements on Form S-8 under the Securities Act registering an aggregate of 9,850,000 shares of our common stock issuable under our 2021 Stock Incentive Plan, or the 2021 Plan (of which 349,046 shares have been issued).
Supreme Court. Should it be reversed by the Supreme Court, we could face competition from stem cell clinics that would not be required to undergo the costly and time-consuming FDA approval process. The FDA’s regulation of regenerative medicine products remains unpredictable and we are not certain what impact this will have on the potential approval of our products.
Therefore, we could face competition from stem cell clinics that would not be required to undergo the costly and time-consuming FDA approval and compliance process. The FDA’s regulation of regenerative medicine products remains unpredictable and we are not certain what impact this will have on the potential approval of our products.
These laws, regulations, and interpretive determinations may result in additional reductions in Medicare and other health care funding, which could impact our business. 62 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.
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 intend to retain earnings, if any, to finance the development and expansion of our business. Our future dividend policy will be subject to the discretion of our Board of Directors and will be contingent upon future earnings, if any, our financial condition, capital requirements, general business conditions, and other factors.
Our future dividend policy will be subject to the discretion of our Board of Directors and will be contingent upon future earnings, if any, our financial condition, capital requirements, general business conditions, and other factors.
Our material weaknesses related to the following control deficiencies: ● Lack of adherence to formal policies and procedures; ● Lack of risk assessment procedures on internal controls to detect financial reporting risks on a timely manner; ● Lack of design and implementation of effective controls to achieve complete and accurate financial reporting and disclosures, including documented controls over the preparation and review of journal entries, account reconciliations and income taxes. ● Lack of design and implementation of effective controls over the accounting for warrants issued in connection with equity financings.
Our material weaknesses related to the following control deficiencies: ● Lack of adherence to formal policies and procedures; 66 ● Lack of risk assessment procedures on internal controls to detect financial reporting risks on a timely manner; ● Lack of design and implementation of effective controls to achieve complete and accurate financial reporting and disclosures, including documented controls over the preparation and review of journal entries, account reconciliations and income taxes.
However, there is a risk that the FDA could approve biosimilar applicants for other reference products that no longer have such exclusivity, thus potentially creating the opportunity for greater competition sooner than anticipated. 50 We may also face increased competition from stem cell therapies performed by treatment centers that do not require FDA premarket approval.
However, there is a risk that the FDA could approve biosimilar applicants for other reference products that no longer have such exclusivity, thus potentially creating the opportunity for greater competition sooner than anticipated. 51 We may also face competition from unapproved stem cell therapies performed by treatment centers that do not comply with FDA requirements.
Ultimately, the degree of market acceptance of our product candidates (or any of our future product candidates) will depend on a number of factors, including: ● the clinical effectiveness, safety and convenience of the product particularly in relation to alternative treatments; ● our ability to distinguish our products (which involve adult cells) from any ethical and political controversies associated with stem cell products derived from human embryonic or fetal tissue; and ● the cost of the product, the reimbursement policies of government and third-party payors and our ability to obtain sufficient third-party coverage or reimbursement.
Ultimately, the degree of market acceptance of our product candidates (or any of our future product candidates) will depend on a number of factors, including: ● the clinical effectiveness, safety and convenience of the product particularly in relation to alternative treatments; ● our ability to distinguish our products (which involve adult cells) from any ethical and political controversies associated with stem cell products derived from human embryonic or fetal tissue; and ● the cost of the product, the reimbursement policies of government and third-party payors and our ability to obtain sufficient third-party coverage or reimbursement. 47 Even if we are successful in achieving sales of our product candidates, it is not clear to what extent, if any, the products will be profitable.
Government agencies have recently increased regulatory scrutiny and enforcement activity with respect to programs supported or sponsored by pharmaceutical companies, including reimbursement and co-pay support, funding of independent charitable foundations and other programs that offer benefits for patients. Several investigations into these programs have resulted in significant civil and criminal settlements.
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.
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. 65 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.
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.
These exemptions could allow our competitors to make sales in the EU without having obtained a marketing authorization and without undergoing the expense of clinical trials, especially if those competitors have cell processing facilities in the relevant EU member state.
These exemptions could allow our competitors to make sales in the EU without having obtained a marketing authorization and without undergoing the expense of clinical trials, especially if those competitors have cell processing facilities in the relevant EU member state. Similarly, certain hospitals may be able to compete with us on the basis of these rules.
Patent and Trademark Office, or the Patent Office, or a foreign patent office to determine priority of invention, which could result in substantial costs and diversion of effort, even if the eventual outcome is favorable to us. Any such litigation or interference proceeding, regardless of outcome, could be expensive and time-consuming.
Patent and Trademark Office, or the Patent Office, or a foreign patent office to determine priority of invention, which could result in substantial costs and diversion of effort, even if the eventual outcome is favorable to us.
For the year ended December 31, 2024, we had a net loss of $9.0 million and a negative cash flows from operations of $8.2 million and as of December 31, 2024, we had working capital of $7.4 million.
For the year ended December 31, 2025, we had a net loss of $14.2 million and a negative cash flows from operations of $10.8 million and as of December 31, 2025, we had a working capital deficit of $0.6 million.
To the extent that any health care reform favors the reimbursement of other therapies over our therapeutic products under development, such reform could affect our ability to sell our services, which may have a material adverse effect on our revenues.
To the extent that any health care reform favors the reimbursement of other therapies over our therapeutic products under development, such reform could affect our ability to sell our services, which may have a material adverse effect on our revenues. 63 The limitation on reimbursement available from private and government payors may reduce the demand for, or the price of, our products and services, which could have a material adverse effect on our revenues.
Because of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available, it is possible that some of our business activities could be subject to challenge under one or more of such laws.
Several investigations into these programs have resulted in significant civil and criminal settlements. 59 Because of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available, it is possible that some of our business activities could be subject to challenge under one or more of such laws.
In addition, we may experience delays or rejections based upon additional government regulation from future legislation or administrative action, or changes in regulatory authority policy during the period of product development, clinical trials and the review process.
Additional delays may result if an FDA Advisory Committee or other regulatory authority recommends non-approval or restrictions or conditions on approval. In addition, we may experience delays or rejections based upon additional government regulation from future legislation or administrative action, or changes in regulatory authority policy during the period of product development, clinical trials and the review process.
Although other available sources for these media, reagents, devices, materials and systems may exist in the marketplace, we have not evaluated their cost, effectiveness, or intellectual property foundation and therefore cannot guarantee the suitability or availability of such other potential sources.
Although other available sources for these media, reagents, devices, materials and systems may exist in the marketplace, we have not evaluated their cost, effectiveness, or intellectual property foundation and therefore cannot guarantee the suitability or availability of such other potential sources. 44 Products that appear promising in research and development may be delayed or may fail to reach later stages of clinical development.
We have a limited operating history. Since our inception, we have incurred net losses. As of December 31, 2024, our accumulated deficit was $155,678,715.
We have a limited operating history. Since our inception, we have incurred net losses. As of December 31, 2025, our accumulated deficit was $169,920,690.
Any of the foregoing scenarios could materially harm the commercial prospects for our product candidates and materially and adversely affect our business, financial condition, results of operations and prospects. 45 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 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.
It would be both time consuming and expensive to replace this capacity with third parties, particularly since any new facility would need to comply with the regulatory requirements. 46 Ultimately, if we are unable to supply our cell therapy product candidates to meet commercial demand (assuming commercial approval is obtained), whether because of processing constraints or other disruptions, delays or difficulties that we experience, our production costs could dramatically increase and sales of the product and its long-term commercial prospects could be significantly damaged.
Ultimately, if we are unable to supply our cell therapy product candidates to meet commercial demand (assuming commercial approval is obtained), whether because of processing constraints or other disruptions, delays or difficulties that we experience, our production costs could dramatically increase and sales of the product and its long-term commercial prospects could be significantly damaged.
Our development costs will increase if there are material delays in our clinical trials, or if we are required to modify, suspend, terminate or repeat a clinical trial. If we are unable to conduct our clinical trials properly, we may never receive regulatory approval to market our product candidates.
Our development costs will increase if there are material delays in our clinical trials, or if we are required to modify, suspend, terminate or repeat a clinical trial.
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.
We are currently conducting a Phase 2 clinical trial using BRTX-100 to treat chronic lower back pain due to degenerative disc disease related to protruding/bulging discs. 41 Clinical testing is expensive, difficult to design and implement, and can take many years to complete.
If we are unable to conduct clinical studies in accordance with regulations and accepted standards, we may be delayed in receiving, or may never receive, regulatory approvals of our product candidates from the FDA and other regulatory authorities.
Similarly, any regulatory approval we ultimately obtain may be limited or subject to restrictions or post-approval commitments that render the approved product not commercially viable. 61 If we are unable to conduct clinical studies in accordance with regulations and accepted standards, we may be delayed in receiving, or may never receive, regulatory approvals of our product candidates from the FDA and other regulatory authorities.
Consequently, the trading liquidity of our common stock may not improve . Although we believe that our Nasdaq listing has helped generate greater and broader investor interest, including institutional investors, there can be no assurances in that regard.
Although we believe that our Nasdaq listing has helped generate greater and broader investor interest, including institutional investors, there can be no assurances in that regard. In addition, there can be no assurance that the market price of our common stock will satisfy the investing requirements of those investors.
Successful challenges to our patents through oppositions, re-examination proceedings or interference proceedings could result in a loss of patent rights in the relevant jurisdiction.
Any such litigation or interference proceeding, regardless of outcome, could be expensive and time-consuming. 55 Successful challenges to our patents through oppositions, re-examination proceedings or interference proceedings could result in a loss of patent rights in the relevant jurisdiction.
We have registered the resale of the shares of common stock underlying such warrants. The issuance of shares of common stock upon exercise of the above warrants would dilute the ownership of our stockholders.
The issuance of shares of common stock upon the exercise of the above warrants and options would dilute the ownership of our stockholders.
Advertising and promotional materials must comply with the Federal Food, Drug and Cosmetic Act, or FDCA, and implementing regulations and are subject to FDA oversight and post-marketing reporting obligations, in addition to other potentially applicable federal and state laws. 56 In addition, product manufacturers and their facilities may be subject to payment of application and program fees and are subject to continual review and periodic inspections by the FDA and other regulatory authorities for compliance with cGMP requirements and adherence to commitments made in the NDA, BLA or foreign marketing application.
In addition, product manufacturers and their facilities may be subject to payment of application and program fees and are subject to continual review and periodic inspections by the FDA and other regulatory authorities for compliance with cGMP requirements and adherence to commitments made in the NDA, BLA or foreign marketing application.
These conditions raise substantial doubt about our ability to continue as a going concern for at least twelve months after the issuance date of the financial statements included herein. Our current funds will not be sufficient to enable us to fully complete our development activities or attain profitable operations.
These conditions raise substantial doubt about our ability to continue as a going concern for at least twelve months after the issuance date of the financial statements included herein.
Availability for such reimbursement may be further limited by reductions in Medicare, Medicaid and other federal healthcare program funding in the United States. To the extent that health care providers cannot obtain coverage or reimbursement for our products and therapies, they may elect not to provide such products and therapies to their patients and, thus, may not need our services.
To the extent that health care providers cannot obtain coverage or reimbursement for our products and therapies, they may elect not to provide such products and therapies to their patients and, thus, may not need our services.
To the extent that the results of the trials are not satisfactory to the FDA for support of a marketing application, we may be required to expend significant resources, which may not be available to us, to conduct additional trials in support of potential approval of our product candidates.
To the extent that the results of the trials are not satisfactory to the FDA for support of a marketing application, we may be required to expend significant resources, which may not be available to us, to conduct additional trials in support of potential approval of our product candidates. 45 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 anticipate that we will not be able to commercialize our BRTX-100 product candidate for at least five years. We may experience delays and other difficulties in enrolling a sufficient number of patients in our clinical trials which could delay or prevent the receipt of necessary regulatory approvals.
We may 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.
While we believe the product we manufacture for Cartessa is intended for cosmetic uses, we (as the contract manufacturer) do not ultimately have control over how the product is marketed.
We manufactured a commercial product as a contract manufacturer for a third-party company. While we believe the product we manufactured for the third party was intended for cosmetic uses, we (as the contract manufacturer) did not ultimately have control over how the product was marketed.
We may also issue other equity and equity-related securities that are senior to our common stock in the future for a number of reasons, including, without limitation, to support operations and growth, and to comply with any future changes in regulatory standards. 67 Anti-takeover provisions and the regulations to which we may be subject may make it more difficult for a third party to acquire control of us, even if the change in control would be beneficial to our securityholders.
We may also issue other equity and equity-related securities that are senior to our common stock in the future for a number of reasons, including, without limitation, to support operations and growth, and to comply with any future changes in regulatory standards.
Such misconduct also could involve the improper use of information obtained in the course of clinical trials or interactions with the FDA or other regulatory authorities, which could result in regulatory sanctions and cause serious harm to our reputation. 59 The precautions we take to detect and prevent employee and third-party misconduct may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from government investigations or other actions or lawsuits stemming from a failure to comply with these laws or regulations.
The precautions we take to detect and prevent employee and third-party misconduct may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from government investigations or other actions or lawsuits stemming from a failure to comply with these laws or regulations.
Our commercial success will depend in large part upon our ability to protect our proprietary rights.
Risks Related to Our Intellectual Property We may not be able to protect our proprietary rights. Our commercial success will depend in large part upon our ability to protect our proprietary rights.
Any inability to successfully complete pre-clinical and clinical development could result in additional costs to us or impair our ability to generate revenue. In addition, if we make manufacturing or formulation changes to our product candidates, we may be required, or we may elect, to conduct additional studies to bridge our modified product candidates to earlier versions.
In addition, if we make manufacturing or formulation changes to our product candidates, we may be required, or we may elect, to conduct additional studies to bridge our modified product candidates to earlier versions.
In addition, some changes in manufacturing processes or procedures generally require FDA or foreign regulatory authority review and approval prior to implementation. We may need to conduct additional pre-clinical studies and clinical trials to support approval of any such changes. Furthermore, this review process could be costly and time-consuming and could delay or prevent the commercialization of product candidates.
The costs of goods associated with production of cell therapy products are significant. In addition, some changes in manufacturing processes or procedures generally require FDA or foreign regulatory authority review and approval prior to implementation. We may need to conduct additional pre-clinical studies and clinical trials to support approval of any such changes.
As a result, significant uncertainty exists as to whether and how much third-party payors will reimburse patients for their use of newly-approved drugs and biologics. If we are unable to obtain adequate levels of reimbursement for our product candidates, our ability to successfully market and sell our product candidates will be harmed.
As a result, significant uncertainty exists as to whether and how much third-party payors will reimburse patients for their use of newly-approved drugs and biologics.
Even if our product candidates meet their safety and efficacy endpoints in clinical trials, the regulatory authorities may not complete their review processes in a timely manner, or we may not be able to obtain regulatory approval. Additional delays may result if an FDA Advisory Committee or other regulatory authority recommends non-approval or restrictions or conditions on approval.
We cannot commercialize a product candidate until the appropriate regulatory authorities have reviewed and approved the product candidate. Even if our product candidates meet their safety and efficacy endpoints in clinical trials, the regulatory authorities may not complete their review processes in a timely manner, or we may not be able to obtain regulatory approval.
If the FDA takes enforcement action against Cartessa or us in connection with this product, it could have an adverse impact on our operations and/or harm our reputation as a biologics company. 53 Risks Related to Our Intellectual Property We may not be able to protect our proprietary rights.
If the FDA takes enforcement action against the third party or us in connection with this product, or against others for whom we may serve in the future as a contract manufacturer, it could have an adverse impact on our operations and/or harm our reputation as a biologics company.
Violations of the FCPA can result in the imposition of civil penalties or criminal prosecution.
Violations of the FCPA can result in the imposition of civil penalties or criminal prosecution. Failure to comply with the FCPA will adversely affect our business.
Failure to comply with such healthcare laws and regulations, as well as the costs associated with such compliance or with enforcement of such healthcare laws and regulations, may have a material adverse effect on our operations or may require restructuring of our operations or impair our ability to operate profitably.
Failure to comply with such healthcare laws and regulations, as well as the costs associated with such compliance or with enforcement of such healthcare laws and regulations, may have a material adverse effect on our operations or may require restructuring of our operations or impair our ability to operate profitably. 60 Our current and future employees, consultants and advisors and our future principal investigators, medical institutions and commercial partners may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements.
We may have difficulties in sourcing brown adipose (fat) tissue. We use brown adipose (fat) tissue to identify and characterize brown adipose derived stem cells for use in our pre-clinical ThermoStem Program.
Furthermore, this review process could be costly and time-consuming and could delay or prevent the commercialization of product candidates. We may have difficulties in sourcing brown adipose (fat) tissue. We use brown adipose (fat) tissue to identify and characterize brown adipose derived stem cells for use in our pre-clinical ThermoStem Program.

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Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

2 edited+3 added−0 removed0 unchanged
Biggest changeRecent Sales of Unregistered Securities None. Issuer Purchases of Equity Securities None. ITEM 6 . [RESERVED]
Biggest changeIssuer Purchases of Equity Securities None. ITEM 6 . [RESERVED] 72
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 20, 2025, there were 530 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 23, 2026, there were 343 record holders of our shares of common stock. Dividends Not applicable.
Added
Recent Sales of Unregistered Securities Warrants Date Issued Common Stock Shares Exercise Price Term (Years) Purchaser(s) Consideration (1) 10/8/25 - 508,592 $ 2.75 5 (2 ) $ 361,409 (3) 10/8/25 - 35,062 $ 2.75 5 (4 ) $ 38,761 (5) (1) The value of the non-cash consideration was estimated to be the fair value of our restricted common stock.
Added
Since our shares are thinly traded in the open market, the fair value of our equity instruments was estimated by management based on observations of the cash sales prices of both restricted shares and freely tradable shares. (2) Accredited investor.
Added
(3) The warrants were issued pursuant to a private placement concurrently with the sale of an aggregate of 678,125 shares of common stock in a registered direct offering for aggregate gross proceeds of approximately $1.1 million. (4) Placement Agent. (5) Issued as compensation to the placement agent in connection with the sale of common stock and warrants.

Item 6. [Reserved]

Selected Financial Data — reserved (removed by SEC in 2021)

3 edited+0 added−0 removed7 unchanged
Biggest changeOther Information. 80 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections. 80 PART III Item 10. Directors, Executive Officers and Corporate Governance. 81 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.
Biggest changeOther Information. 83 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections. 83 PART III 84 Item 10. Directors, Executive Officers and Corporate Governance. 84 Item 11. Executive Compensation. 88 Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters. 92 Item 13. Certain Relationships and Related Transactions, and Director Independence. 94 Item 14.
Principal Accountant Fees and Services. 91 PART IV Item 15. Exhibits and Financial Statement Schedules. 92 Item 16. 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.
Principal Accountant Fees and Services. 95 PART IV 96 Item 15. Exhibits and Financial Statement Schedules. 96 Item 16. Form 10-K Summary. 100 Signatures 101 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.
Item 6. [Reserved]. 70 Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations. 70 Item 7A. Quantitative and Qualitative Disclosures About Market Risk. 78 Item 8. Financial Statements and Supplementary Data. 78 Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure. 78 Item 9A. Controls and Procedures. 78 Item 9B.
Item 6. [Reserved]. 72 Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations. 73 Item 7A. Quantitative and Qualitative Disclosures About Market Risk. 80 Item 8. Financial Statements and Supplementary Data. 80 Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure. 80 Item 9A. Controls and Procedures. 81 Item 9B.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

28 edited+15 added−16 removed20 unchanged
Biggest changeCash Flows During the years ended December 31, 2024 and 2023, our sources and uses of cash were as follows: Year Ended December 31, 2024 2023 Net Cash Used In Operating Activities $ (8,230,346 ) $ (6,430,211 ) Net Cash Provided By Investing Activities $ 514,529 $ 3,252,043 Net Cash Provided By Financing Activities $ 7,379,330 $ 2,348,773 Net Decrease in Cash $ (336,487 ) $ (829,395 ) Net Cash Used in Operating Activities Net cash used in operating activities was $8,230,346 for the year ended December 31, 2024, primarily due to cash used to fund the net loss of $8,979,381 which gives effect to net non-cash expenses of $720,382, partially offset by $28,653 of cash provided by changes in operating assets and liabilities.
Biggest changeNet cash used in operating activities was $8,230,346 for the year ended December 31, 2024, primarily due to cash used to fund the net loss of $8,979,381 partially offset by net non-cash expenses of $720,382 and $28,653 of cash provided by changes in operating assets and liabilities.
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. 70 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. Overview We develop therapeutic products and medical therapies using cell and tissue protocols, primarily involving adult stem cells.
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. 77
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.
The following discussion and analysis of the consolidated results of operations and financial condition of BioRestorative Therapies, Inc. as of December 31, 2024 and 2023 and for the years ended December 31, 2024 and 2023 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, 2025 and 2024 and for the years ended December 31, 2025 and 2024 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”).
Based on these conditions, we believe we may not have sufficient cash for at least twelve months after the issuance date of the financial statements included in this Annual Report which raises substantial doubt about our ability to continue as a going concern.
Based on these conditions, we believe we do not have sufficient cash for at least twelve months after the issuance date of the financial statements included in this Annual Report which raises substantial doubt about our ability to continue as a going concern.
We anticipate that we will continue to incur net losses and negative cash flows from operations as we execute our development plans for 2025 and beyond, as well as other potential strategic and business development initiatives.
We anticipate that we will continue to incur net losses and negative cash flows from operations as we execute our development plans for 2026 and beyond, as well as other potential strategic and business development initiatives.
We anticipate that we will continue to incur net losses and negative cash flows from operations as we execute our development plans for 2025 and beyond, as well as other potential strategic and business development initiatives.
We anticipate that we will continue to incur net losses and negative cash flows from operations as we execute our development plans for 2026 and beyond, as well as other potential strategic and business development initiatives.
In November 2024, we entered into an At The Market Offering Agreement with Rodman, under which we currently have the ability to issue and sell shares of our common stock, from time to time, through Rodman, up to an aggregate offering price of approximately $3,614,000 in an ATM program.
In November 2024, we entered into an At The Market Offering Agreement with Rodman & Renshaw, LLC, or Rodman, under which we had the ability to issue and sell shares of our common stock, from time to time, through Rodman, up to an aggregate offering price of approximately $3,614,000 in an ATM program.
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 June 2023, and July 2024; Israeli patents related to our ThermoStem Program were issued in October 2019, May 2020, March 2022 and March 2025; and European patents related to the ThermoStem Program were issued in April 2020, January 2021, July 2023 and February 2025.
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 June 2023, July 2024 and September 2025; Israeli patents related to our ThermoStem Program were issued in October 2019, May 2020, March 2022 and March 2025; and European patents related to the ThermoStem Program were issued in April 2020, January 2021, July 2023 and March 2025. 73 We operate a commercial biocosmeceutical platform.
As of December 31, 2024, our accumulated deficit was $155,678,715. We have historically only generated a modest amount of revenue, and our losses have principally been operating expenses incurred in research and development, marketing and promotional activities in order to commercialize our products and services, plus costs associated with meeting the requirements of being a public company.
We have historically only generated a modest amount of revenue, and our losses have principally been operating expenses incurred in research and development, marketing and promotional activities in order to commercialize our products and services, plus costs associated with meeting the requirements of being a public company.
For the year ended December 31, 2023, we recognized a gain on the change in fair value of warrant liabilities of $3,997,780 related to the reduction in the fair value of the warrants that are accounted for as warrant liabilities.
For the year ended December 31, 2024, we recognized a gain on the change in fair value of warrant liabilities of $97,188 related to the reduction in the fair value of the warrants that are accounted for as warrant liabilities.
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.
Effects of Inflation We do not believe that inflation had a material impact on our business, revenues or operating results during the periods presented. 79 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.
No assurance can be given that the amount of funding that we anticipate may be required for such purposes is correct or that we will be able to accomplish our goals within the timeframes projected.
No assurance can be given that the amount of funding that we anticipate may be required for such purposes is correct or that we will be able to accomplish our goals within the timeframes projected. In addition, no assurance can be given that we will be able to obtain any required financing on commercially reasonable terms or otherwise.
For the year ended December 31, 2024, we had a net loss of $9.0 million and negative cash flows from operations of $8.2 million and as of December 31, 2024, we had working capital of $7.4 million.
Availability of Additional Funds For the year ended December 31, 2025, we had a net loss of $14.2 million and negative cash flows from operations of $10.8 million and, as of December 31, 2025, we had a working capital deficit of $0.6 million.
Recently Issued Accounting Pronouncements See Note 2 to our consolidated financial statements for the years ended December 31, 2024 and 2023 included elsewhere in this Annual Report following Item 16 (“Form 10-K Summary”).
There are items within our financial statements that require estimation but are not deemed critical, as defined above. Recently Issued Accounting Pronouncements See Note 2 to our consolidated financial statements for the years ended December 31, 2025 and 2024 included elsewhere in this Annual Report following Item 16 (“Form 10-K Summary”).
Gain on Exchange of Warrants For the year ended December 31, 2024, we recognized a gain on exchange of $1,711,698 related to the issuance of warrants and common stock in exchange for the cancellation of existing warrants. 74 Change in fair value of derivative liabilities For the year ended December 31, 2024, we recognized a gain on the change in fair value of warrant liabilities of $97,188 related to the reduction in the fair value of the warrants that are accounted for as warrant liabilities.
Change in fair value of warrant liabilities For the year ended December 31, 2025, we recognized a gain on the change in fair value of warrant liabilities of $1,121,502 related to the reduction in the fair value of the warrants that are accounted for as warrant liabilities.
We do not intend to utilize this device in connection with our Phase 2 clinical trial with regard to BRTX-100 . 71 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.
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, 2025, our accumulated deficit was $169,920,690.
Subsequent to the year ended December 31, 2024, we sold 492,000 shares of our common stock under the ATM program with Rodman at a weighted-average gross price of approximately $2.20 per share and raised approximately $1,084,000 of gross proceeds. The total commissions and related legal fees were approximately $178,000, and we received net proceeds of approximately $906,000.
During the year ended December 31, 2025, we sold 965,424 shares of our common stock under the ATM program with Rodman at a weighted-average gross price of approximately $2.08 per share and raised approximately $2.0 million of gross proceeds. We received net proceeds of approximately $1.8 million.
We are currently pursuing our Disc/Spine Program with our initial investigational therapeutic product being called BRTX-100 . In March 2022, a United States patent issued in our Disc/Spine Program .
We are currently pursuing our Disc/Spine Program with our initial investigational therapeutic product being called BRTX-100 . In March 2022, a United States patent issued in our Disc/Spine Program . We are conducting 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 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, 2024, interest income increased $63,784, or 12%, to $616,077 from $552,293 for the year ended December 31, 2023.
We expect that our general and administrative expenses related to operations will continue to increase as we expand our staff, develop our infrastructure and incur additional costs to support the growth of our business.
This proprietary biologic serum has been specifically engineered by us to reduce the appearance of fine lines and wrinkles and bring forth other areas of cosmetic effectiveness.
Our current commercial product, formulated and manufactured using our cGMP ISO-7 certified clean room, is a cell-based secretome containing exosomes, proteins and growth factors. This proprietary biologic serum has been specifically engineered by us to reduce the appearance of fine lines and wrinkles and bring forth other areas of cosmetic effectiveness.
In addition, no assurance can be given that we will be able to obtain any required financing on commercially reasonable terms or otherwise. 72 Consolidated Results of Operations Year Ended December 31, 2024 Compared with Year Ended December 31, 2023 The following table presents selected items in our consolidated statements of operations for the years ended December 31, 2024 and 2023, respectively: For the Years Ended December 31, 2024 2023 Revenues $ 401,000 $ 145,800 Cost of goods sold 28,072 - Gross profit 372,928 145,800 Operating Expenses: Research and development 5,348,709 4,034,591 General and administrative 6,579,413 11,331,983 Total Operating Expenses 11,928,122 15,366,574 Loss From Operations (11,555,194 ) (15,220,774 ) Other Income: Interest income 616,077 552,293 Grant income - 83,333 Other income 150,850 169,664 Gain on exchange of warrants 1,711,698 - Change in fair value of warrant liabilities 97,188 3,997,780 Total Other Income 2,575,813 4,803,070 Net Loss $ (8,979,381 ) $ (10,417,404 ) Revenues For the years ended December 31, 2024 and 2023, we generated $401,000 and $145,800, respectively, of royalty revenue in connection with our sublicense agreement and sales revenue in connection with our cosmeceuticals business.
Consolidated Results of Operations Year Ended December 31, 2025 Compared with Year Ended December 31, 2024 The following table presents selected items in our consolidated statements of operations for the years ended December 31, 2025 and 2024, respectively: For the Years Ended December 31, 2025 2024 Revenues $ 359,700 $ 401,000 Cost of goods sold 23,844 28,072 Gross profit 335,856 372,928 Operating Expenses: Research and development 10,094,671 6,706,913 General and administrative 5,888,317 5,221,209 Total Operating Expenses 15,982,988 11,928,122 Loss From Operations (15,647,132 ) (11,555,194 ) Other Income (Expense): Interest income, net 266,207 616,077 Other income 17,448 150,850 Gain on exchange of warrants - 1,711,698 Change in fair value of warrant liabilities 1,121,502 97,188 Total Other Income 1,405,157 2,575,813 Net Loss $ (14,241,975 ) $ (8,979,381 ) 75 Revenues For the years ended December 31, 2025 and 2024, we generated $59,700 and $101,000, respectively, of royalty revenue in connection with our sublicense agreement with the stem cell treatment company.
If we are unable to obtain adequate funds on reasonable terms, we may be required to significantly curtail or discontinue operations or obtain funds by entering into financing agreements on unattractive terms. 75 “At-the-Market” Offering In November 2024, we entered into an At The Market Offering Agreement with Rodman, under which we currently have the ability to issue and sell shares of our common stock, from time to time, through Rodman, up to an aggregate offering price of approximately $3,614,000 in an ATM, program.
If we are unable to obtain adequate funds on reasonable terms, we may be required to significantly curtail or discontinue operations or obtain funds by entering into financing agreements on unattractive terms. Public Offerings In October 2025, we sold 678,125 shares of our common stock in a registered direct offering.
For the year ended December 31, 2024, research and development expenses increased by $1,314,118, or 33%, to $5,348,709 compared to $4,034,591 for the year ended December 31, 2023.
For the year ended December 31, 2025, research and development expenses increased by $3,387,758, or 51%, to $10,094,671 compared to $6,706,913 for the year ended December 31, 2024.
The increase was primarily driven by headcount costs of $323,025 and general lab supplies expense of $1,041,952, partially offset by the reversal of a 2023 bonus accrual of $257,873. 73 We expect that our research and development expenses will continue to increase with the continuation of the aforementioned initiatives.
We expect that our research and development expenses will continue to increase with the continuation of the aforementioned initiatives.
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.
We currently may not sell any shares of common stock under the ATM program with Rodman. In October 2025, we sold 678,125 shares of our common stock in a registered direct offering. We received net proceeds of approximately $0.9 million from the offering.
Liquidity and Capital Resources Liquidity We measure our liquidity in a number of ways, including the following: December 31, 2024 2023 Cash and cash equivalents $ 547,890 $ 884,377 Investments held in marketable securities $ 10,184,701 $ 10,181,618 Working capital $ 7,395,815 $ 8,783,181 Availability of Additional Funds For the year ended December 31, 2024, we had a net loss of $9.0 million and negative cash flows from operations of $8.2 million and as of December 31, 2024, we had working capital of $7.4 million.
We received net proceeds of approximately $4.5 million from the offering. 74 For the year ended December 31, 2025, we had a net loss of $14.2 million and negative cash flows from operations of $10.8 million and, as of December 31, 2025, we had a working capital deficit of $0.6 million.
The increase was due to the interest and dividend income of the investments held in marketable securities. Grant income There was no grant income for the year ended December 31, 2024.
The change was primarily due to a decrease in interest income from the investments held in marketable securities due to a lower average balance of the marketable securities during 2025 as compared to 2024. 76 Other income For the year ended December 31, 2025, other income decreased $133,402, or 88%, to $17,448 from $150,850 for the year ended December 31, 2024.
Removed
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.
Added
We do not intend to utilize this device in connection with our Phase 2 clinical trial with regard to BRTX-100 .
Removed
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.
Added
In February 2026, we sold 12,560,715 shares of our common stock, pre-funded warrants to purchase 1,725,000 shares of our common stock (which have been exercised in full) and warrants for the purchase of 14,285,715 shares of our common stock in a public offering.
Removed
We operate a commercial biocosmeceutical platform. Our current commercial product, formulated and manufactured as a third party contract manufacturer using our cGMP ISO-7 certified clean room, is a cell-based secretome containing exosomes, proteins and growth factors.
Added
The decrease was primarily due to a decrease in disc procedures. For each of the years ended December 31, 2025 and 2024, we generated $300,000 of cosmetic product sales revenue in connection with our supply agreement with Cartessa Aesthetics, LLC.
Removed
In April 2023, we entered into a Capital on Demand Sales Agreement with JonesTrading Institutional Services LLC, or JonesTrading, under which we had the ability to issue and sell shares of our common stock, from time to time, through JonesTrading, 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.
Added
The increase was primarily the result of an increase in recruitment and other costs for our Phase 2 clinical trial of $2,682,474, an increase of general lab supplies expense of $485,166, and an increase in stock-based compensation expense of $165,849, partially offset by a decrease in bonus expense of $33,996 and a decrease in headcount costs of $9,851.
Removed
During the year ended December 31, 2023, we sold 132,827 shares of our common stock under the ATM program with JonesTrading 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.
Added
For the year ended December 31, 2025, general and administrative expenses increased by $667,108, or 13%, to $5,888,317 from $5,221,209 for the year ended December 31, 2024.
Removed
No shares were sold during the year ended December 31, 2024 pursuant to the ATM program with JonesTrading. In connection with the ATM program with Rodman & Renshaw, LLC, or Rodman, discussed below, in November 2024, we terminated the Capital on Demand Sales Agreement with JonesTrading.
Added
The increase was primarily driven by an increase in stock-based compensation expense of $347,212, an increase in headcount costs of $212,274, an increase in consulting expense of $130,453, and an increase in professional fees of $31,241.
Removed
As of March 24, 2025, we had remaining capacity to sell up to an additional $2,530,000 of common stock under the ATM program with Rodman.
Added
Interest income, net For the year ended December 31, 2025, interest income, net of interest expense decreased $349,870, or 57%, to $266,207 from $616,077 for the year ended December 31, 2024.
Removed
For the year ended December 31, 2024, general and administrative expenses decreased by $4,752,570, or 42% to $6,579,413 from $11,331,983 for the year ended December 31, 2023. The decrease was primarily driven by a decrease in stock-based compensation expense of $4,970,401 and a decrease in headcount costs of $111,363, offset by an increase in professional fees of $229,273.
Added
The change was primarily due to a one-time payment received in the 2024 period in connection with the development of our biocosmeceuticals product line.
Removed
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. Other income For the year ended December 31, 2024, other income of $150,850 primarily related to investment dividend income and other miscellaneous income.
Added
Gain on Exchange of Warrants For the year ended December 31, 2024, we recognized a gain on exchange of warrants of $1,711,698 related to the issuance of warrants and common stock in exchange for the cancellation of existing warrants. There was no gain on exchange of warrants for the year ended December 31, 2025.
Removed
For the year ended December 31, 2023, other income of $169,664 primarily related to an Employee Retention Tax Credit, gains from settlements of certain accrued expenses and realized and unrealized gain on investments.
Added
Liquidity and Capital Resources Liquidity We measure our liquidity in a number of ways, including the following: December 31, 2025 2024 Cash and cash equivalents $ 1,511,188 $ 547,890 Investments held in marketable securities $ 1,441,734 $ 10,184,701 Working capital (deficit) $ (586,029 ) $ 7,395,815 77 Working capital decreased by $7,981,844 primarily due to $10,788,963 of cash used to fund our operations and a $8,742,967 decrease in marketable securities, offset by $8,897,470 of cash provided by investing activities and $2,854,791 of cash provided by financing activities.
Removed
Subsequent to the year ended December 31, 2024, we sold 492,000 shares of our common stock under the ATM program with Rodman at a weighted-average gross price of approximately $2.20 per share and raised approximately $1,084,000 of gross proceeds. The total commissions and related legal and accounting fees were approximately $178,000 and we received net proceeds of approximately $906,000.
Added
We received net proceeds of approximately $0.9 million from the offering. In February 2026, we sold 12,560,715 shares of our common stock, pre-funded warrants to purchase 1,725,000 shares of our common stock (all of which have been exercised) and warrants for the purchase of 14,285,715 shares of our common stock in a public offering.
Removed
As of March 26, 2025, we had remaining capacity to sell up to an additional $2,530,000 of common stock under the ATM program with Rodman. 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.
Added
We received net proceeds of approximately $4.5 million from the offering. 78 Cash Flows During the years ended December 31, 2025 and 2024, our sources and uses of cash were as follows: Year Ended December 31, 2025 2024 Net Cash Used In Operating Activities $ (10,788,963 ) $ (8,230,346 ) Net Cash Provided By Investing Activities $ 8,897,470 $ 514,529 Net Cash Provided By Financing Activities $ 2,854,791 $ 7,379,330 Net Increase (Decrease) in Cash $ 963,298 $ (336,487 ) Net Cash Used in Operating Activities Net cash used in operating activities was $10,788,963 for the year ended December 31, 2025, primarily due to cash used to fund the net loss of $14,241,975, partially offset by net non-cash expenses of $2,143,536 and $1,309,476 of cash provided by changes in our operating assets and liabilities.
Removed
Net cash used in operating activities was $6,430,211 for the year ended December 31, 2023, primarily due to cash used to fund the net loss of $10,417,704 which gives effect to net non-cash expenses of $3,472,167, partially offset by $515,326 of cash provided by changes in our operating assets and liabilities.
Added
Net Cash Provided by Investing Activities Net cash provided by investing activities was $8,897,470 for the year ended December 31, 2025 primarily due to the sale of marketable securities which provided $11,692,686 of cash, offset by the purchase of marketable securities which used $2,679,147 of cash and purchases of equipment which used $116,069 of cash.
Removed
Net Cash Provided by Investing Activities Net cash provided by investing activities decreased by $2,737,514 for the year ended December 31, 2024 compared to the year ended December 31, 2023, primarily due to the purchase of marketable securities. 76 Net Cash Provided by Financing Activities Net cash provided by financing activities increased by $5,030,557 for the year ended December 31, 2024 compared to the year ended December 31, 2023 due to the gross proceeds from the exchange and issuance of warrants of $8,123,391, less issuance costs of $595,364, all partially offset by $2,348,773 of gross proceeds from the sale of common stock pursuant to an ATM and direct offering undertaken during the year ended December 31, 2023.
Added
Net cash provided by investing activities was $514,529 for the year ended December 31, 2024 primarily due to the sale of marketable securities which provided $21,508,641 of cash, offset by the purchase of marketable securities which used $20,887,923 of cash and purchases of equipment which used $106,189 of cash.
Removed
Effects of Inflation We do not believe that inflation had a material impact on our business, revenues or operating results during the periods presented.
Added
Net Cash Provided by Financing Activities Net cash provided by financing activities was $2,854,791 for the year ended December 31, 2025 due to net proceeds of $2,918,297 received in connection with the issuance of common stock pursuant to the 2024 ATM offering and an October 2025 registered direct offering and $41,165 due to the exercise of stock options, partially offset by the payment of deferred offering costs of $99,973 and repayment of financed insurance premiums of $4,698, compared to $7,379,330 net cash provided by financing activities for the year ended December 31, 2024 due to net proceeds of $7,528,027 received in connection with the exercise and issuance of warrants, partially offset by the payment of deferred offering costs of $148,697.
Removed
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.

Other BRTX 10-K year-over-year comparisons