What changed in BioRestorative Therapies, Inc.'s 10-K — 2023 vs 2024
vs
Paragraph-level year-over-year comparison of BioRestorative Therapies, Inc.'s 2023 and 2024 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 2024 report.
+127 added−500 removedSource: 10-K (2025-03-28) vs 10-K (2024-04-01)
Top changes in BioRestorative Therapies, Inc.'s 2024 10-K
127 paragraphs added · 500 removed · 90 edited across 4 sections
- Item 1. Business+122 / −424 · 87 edited
- Item 5. Market for Registrant's Common Equity+2 / −64 · 2 edited
- Item 7A. Quantitative and Qualitative Disclosures About Market Risk+1 / −10
- Item 2. Properties+2 / −2 · 1 edited
Item 1. Business
Business — how the company describes what it does
87 edited+35 added−337 removed195 unchanged
Item 1. Business
Business — how the company describes what it does
87 edited+35 added−337 removed195 unchanged
2023 filing
2024 filing
Biggest changeSuch aggregate funds are sufficient for us to complete our Phase 2 clinical trial investigating the use of BRTX - 100 in the treatment of chronic lower back pain arising from degenerative disc disease, as further described in this section, as well as to continue our pre-clinical research and development efforts with respect to our ThermoStem Program and to satisfy our current working capital needs; however, the implementation of our business plan, as discussed below, will require the receipt of additional financing to fund our research and development efforts, including our contemplated Phase 3 clinical trial with regard to BRTX-100 and our contemplated clinical trials relating to our ThermoStem Program , and otherwise fund our operations.
Biggest changeHowever, notwithstanding the above, we believe that our current funds may not be sufficient for us to complete our Phase 2 clinical trial investigating the use of BRTX - 100 in the treatment of chronic lower back pain arising from degenerative disc disease, as further described in this section, continue our pre-clinical research and development efforts with respect to our ThermoStem Program and satisfy our current working capital needs through the end of the 12 month period following the date of the financial statements included in this Annual Report.
The following describes the Phase 2 clinical trial authorized by the FDA: A Phase 2 Prospective, Double-Blinded, Placebo Controlled, Randomized Study ● General ● 99 patients; randomized 2:1, BRTX-100 to control, 40 million cells/dose ● 10-20 clinical trial sites (we intend to utilize 15 clinical trial sites) ● Primary efficacy endpoint at 12 months ● Patient safety and efficacy follow up at 24 months ● Included subjects must have only one symptomatic diseased disc ● Included subjects must have current diagnosis of chronic lumbar disc disease typical pain with degeneration of a single disc confirmed by history, exam, radiography, or other acceptable means ● Included subjects must have exhausted previous conservative non-operative therapies 12 ● Primary Efficacy Endpoint ● Responder endpoint - percentage of patients that meet the improvement in function and reduction in pain threshold ● Improvement in function defined as at least a 30% increase in function based on the Oswestry questionnaires (ODI) ● Reduction of pain defined as at least a 30% decrease in pain as measured using the Visual Analogue Scale (VAS) ● Additional or Secondary Endpoints ● Clinical response at 12 months ● Changes from baseline in pain as assessed with the VAS score and ODI at weeks 2, 12, 26, 52 and 104 ● Changes from baseline in function as assessed with the ODI at weeks 2, 12, 26, 52 and 104 ● Changes from baseline in function as assessed by Roland Morris Disability Questionnaire (RMDQ) at weeks 26, 52 and 104 ● Changes from baseline function as assessed by Functional Rating Index (FRI) at weeks 12, 52 and 104 ● Changes from baseline Quality of Life assessment (SF-12 questionnaire) scores at weeks 2, 12, 26, 52 and 104 In December 2021, we entered into a Master Service Agreement with Professional Research Consulting Inc. d/b/a PRC Clinical, a contract research organization, or CRO, specializing in clinical trial management, to conduct our Phase 2 clinical trial.
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 work is to be done in collaboration with Dr. Sheng Wu, Associate Professor, Center for Metabolic Disease Research at Temple University. In June 2023, a Japanese patent related to our ThermoStem Program was issued to us . 18 In June 2023, a United States patent related to our ThermoStem Program was issued to us .
The work is to be done in collaboration with Dr. Sheng Wu, Associate Professor, Center for Metabolic Disease Research at Temple University. 18 In June 2023, a Japanese patent related to our ThermoStem Program was issued to us . In June 2023, a United States patent related to our ThermoStem Program was issued to us .
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.
The process required by the FDA before a drug or biologic may be marketed in the United States generally involves the following: ● completion of non-clinical laboratory tests, animal studies and formulation studies conducted according to Good Laboratory Practice, or GLP, or other applicable regulations; ● submission of an IND, which allows clinical trials to begin unless the FDA objects within 30 days; ● performance of adequate and well-controlled human clinical trials to establish the safety and efficacy of the proposed drug or biologic for its intended use or uses conducted in accordance with FDA regulations and Good Clinical Practices, or GCP, which are international ethical and scientific quality standards meant to ensure that the rights, safety and well-being of trial participants are protected and that the integrity of the data is maintained; 26 ● registration of clinical trials of FDA-regulated products and certain clinical trial information; ● preparation and submission to the FDA of a new drug application, or NDA, in the case of a drug or BLA in the case of a biologic; ● review of the product by an FDA advisory committee, where appropriate or if applicable; ● satisfactory completion of pre-approval inspection of manufacturing facilities and clinical trial sites at which the product, or components thereof, are produced to assess compliance with cGMP requirements and of selected clinical trial sites to assess compliance with GCP requirements; and ● FDA approval of an NDA or BLA which must occur before a drug or biologic can be marketed or sold.
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 following illustrates the process: 10 Exclusive License Pursuant to our license agreement with Regenerative Sciences, LLC, or Regenerative, that became effective in April 2012, or the Regenerative License Agreement, we have obtained, among other things, a worldwide (excluding Asia and Argentina), exclusive, royalty-bearing license from Regenerative to utilize or sublicense a certain method for culturing cells for use in our developmental program involving disc and spine conditions, including protruding or painful discs and the treatment of avascular zones.
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 recent extensive use of both FDA-approved and compounded versions of glucagon-like peptide-1 (GLP-1) receptor agonist drug products, such as Wegovy and Ozempic (semaglutide) for the treatment of obesity has significantly increased the competition in the obesity market. Many of our competitors and potential competitors have substantially greater financial, technological, research and development, marketing and personnel resources than we do.
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 diseases, disorders and syndromes that may be targeted by our ThermoStem Program are as follows: 15 We have had initial success in transplanting the brown adipose tissue construct in animals, and we are currently exploring ways to deliver into humans. Even though present, BAT mass is very low in healthy adults and even lower in obese populations.
The diseases, disorders and syndromes that may be targeted by our ThermoStem Program are as follows: We have had initial success in transplanting the brown adipose tissue construct in animals, and we are currently exploring ways to deliver into humans. Even though present, BAT mass is very low in healthy adults and even lower in obese populations.
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. 28 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. 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. 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. 7 We have not generated any significant revenues to date.
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. 22 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 increased competition from stem cell therapies performed by treatment centers that do not require FDA premarket approval.
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.
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.
No assurance can be given that any licensing agreement will be entered into, whether upon commercially reasonable terms or otherwise. 13 Defined Health Report In March 2018, we engaged Defined Health, a business development and strategy consulting firm, to conduct an independent review of BRTX-100 .
No assurance can be given that any licensing agreement will be entered into, whether upon commercially reasonable terms or otherwise. Defined Health Report In March 2018, we engaged Defined Health, a business development and strategy consulting firm, to conduct an independent review of BRTX-100 .
On August 15, 2011, we changed our name from “Stem Cell Assurance, Inc.” to “BioRestorative Therapies, Inc.” Effective January 1, 2015, we reincorporated in Delaware. Effective December 31, 2022, we reincorporated in Nevada. 3 We develop therapeutic products and medical therapies using cell and tissue protocols, primarily involving adult stem cells.
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.
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.
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 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.
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.
We may also use outside laboratories specializing in cell therapy services and manufacturing of cell products. Technology; Research and Development We intend to utilize our laboratory or a third party laboratory in connection with cellular research activities. We also intend to obtain cellular-based therapeutic technology licenses and increase our IP portfolio.
We may also use outside laboratories specializing in cell therapy services and manufacturing of cell products. 20 Technology; Research and Development We intend to utilize our laboratory or a third party laboratory in connection with cellular research activities. We also intend to obtain cellular-based therapeutic technology licenses and increase our IP portfolio.
If we are unable to obtain adequate funding, we may be required to significantly curtail or discontinue our proposed operations. 7 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. 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 .
In March 2022, a United States patent related to our Disc/Spine Program was issued. We have been granted exclusive license rights with regard to the patent. See “Disc/Spine Program” below. 5 ● Metabolic Program (ThermoStem) .
In March 2022, a United States patent related to our Disc/Spine Program was issued. We have been granted exclusive license rights with regard to the patent. See “Disc/Spine Program” below. ● Metabolic Program (ThermoStem) .
No toxicity or adverse finding was evident in the systemic tissues or the discs of animals receiving BRTX-100 . 11 ● There was no detectable presence of human cells ( BRTX-100 ) observed at the day 56 interim time point.
No toxicity or adverse finding was evident in the systemic tissues or the discs of animals receiving BRTX-100 . ● There was no detectable presence of human cells ( BRTX-100 ) observed at the day 56 interim time point.
If one or more of the above factors has been exceeded, the product would be regulated as a drug, biological product, or medical device rather than an HCT/P. 24 Because we are an enterprise in the early stages of operations and have not generated significant revenues from operations, it is difficult to anticipate the likely regulatory status of the array of products and services that we may offer.
If one or more of the above factors has been exceeded, the product would be regulated as a drug, biological product, or medical device rather than an HCT/P. 25 Because we are an enterprise in the early stages of operations and have not generated significant revenues from operations, it is difficult to anticipate the likely regulatory status of the array of products and services that we may offer.
In addition to other benefits, such as the ability to have greater interactions with the FDA, the FDA may initiate review of sections of a Fast Track NDA or BLA before the application is complete, a process known as rolling review. 29 Any product submitted to the FDA for marketing, including under a Fast Track program, may also be eligible for the following other types of FDA programs intended to expedite development and review: ● Breakthrough therapy designation.
In addition to other benefits, such as the ability to have greater interactions with the FDA, the FDA may initiate review of sections of a Fast Track NDA or BLA before the application is complete, a process known as rolling review. 30 Any product submitted to the FDA for marketing, including under a Fast Track program, may also be eligible for the following other types of FDA programs intended to expedite development and review: ● Breakthrough therapy designation.
With regard to the second patent family in the ThermoStem Program, patent applications have been filed in four foreign jurisdictions (of which four applications have been granted as foreign patents). The patents expire in April 2034. With regard to the third patent family in the ThermoStem Program , patent applications have been filed in four foreign jurisdictions.
With regard to the second patent family in the ThermoStem Program, patent applications have been filed in four foreign jurisdictions (of which four applications have been granted as foreign patents). The patents expire in April 2034.
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; 33 ● 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; 34 ● state statutes and regulations related to the corporate practice of medicine; ● laws and regulations administered by U.S.
In addition, in March 2022, a United States patent related to BRTX- 100 was issued. This patent expires in December 2029. Of the other eleven applications that were filed, four applications remain pending. The patents that are the subject of the Regenerative License Agreement have been assigned to Regenexx, LLC which we have been advised is an affiliate of Regenerative.
In 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.
The benefits of a RMAT designation include early interactions with the FDA to expedite development and review, benefits available to breakthrough therapies, potential eligibility for priority review and accelerated approval based on surrogate or intermediate endpoints. 30 Medical Device Regulation The FDA also has broad authority over the regulation of medical devices marketed for sale in the United States.
The benefits of a RMAT designation include early interactions with the FDA to expedite development and review, benefits available to breakthrough therapies, potential eligibility for priority review and accelerated approval based on surrogate or intermediate endpoints. 31 Medical Device Regulation The FDA also has broad authority over the regulation of medical devices marketed for sale in the United States.
It is possible that we may not be permitted to expand our business into one or more foreign jurisdictions. 34 We do not have any definitive plans or arrangements with respect to the establishment by us of stem cell therapy clinics in any country. We intend to explore any such opportunities as they arise.
It is possible that we may not be permitted to expand our business into one or more foreign jurisdictions. 35 We do not have any definitive plans or arrangements with respect to the establishment by us of stem cell therapy clinics in any country. We intend to explore any such opportunities as they arise.
If any of these events were to occur, it could materially adversely affect us. 31 Current Good Manufacturing Practices and other FDA Regulations of Cellular Therapy Products Products that fall outside of the HCT/P regulations and are regulated as drugs, biological products, or devices must comply with applicable cGMP regulations.
If any of these events were to occur, it could materially adversely affect us. 32 Current Good Manufacturing Practices and other FDA Regulations of Cellular Therapy Products Products that fall outside of the HCT/P regulations and are regulated as drugs, biological products, or devices must comply with applicable cGMP regulations.
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. 27 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.
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.
Clinical Trial Pursuant to an IND application we submitted to the FDA, we have obtained authorization to commence a Phase 2 clinical trial investigating the use of BRTX-100 , our lead cell therapy candidate, in the treatment of chronic lower back pain arising from degenerative disc disease.
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.
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.
No assurance can be given that the amount of funding that we anticipate may be required for the above 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.
The Division of Laboratory Services, within the Survey and Certification Group, under the Center for Medicaid and State Operations, or CMSO, has the responsibility for implementing the CLIA program. 32 The CLIA program is designed to establish quality laboratory testing by ensuring the accuracy, reliability, and timeliness of patient test results.
The Division of Laboratory Services, within the Survey and Certification Group, under the Center for Medicaid and State Operations, or CMSO, has the responsibility for implementing the CLIA program. 33 The CLIA program is designed to establish quality laboratory testing by ensuring the accuracy, reliability, and timeliness of patient test results.
We have also obtained licenses for four United States patent applications related to our Disc/Spine Program, one United States patent related to our Disc/Spine Program, and a license for one United States patent related to a curved needle device.
We have also obtained licenses for two United States patent applications related to our Disc/Spine Program, one United States patent related to our Disc/Spine Program, and a license for one United States patent related to a curved needle device.
We are currently pursuing our Disc/Spine Program with our initial investigational therapeutic product being called BRTX-100 . In March 2022, a United States patent issued in our Disc/Spine Program . We submitted an IND application to the U.S.
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.
The physician will then send the patient’s bone marrow and blood samples to our laboratory (or a contract laboratory) for culturing and formulation. The hypoxic culturing process is intended to result in the selection of a cell population that is suitable for an improved possibility of survival in the internal disc environment.
Peripheral blood is also collected from the patient. The physician will then send the patient’s bone marrow and blood samples to our laboratory (or a contract laboratory) for culturing and formulation. The hypoxic culturing process is intended to result in the selection of a cell population that is suitable for an improved possibility of survival in the internal disc environment.
Metabolic Brown Adipose (Fat) Program Since June 2011, we have been engaging in pre-clinical research efforts with respect to an investigational platform technology utilizing brown adipose (fat) derived stem cells, or BADSCs, for therapeutic purposes. We have labeled this initiative our ThermoStem Program .
Metabolic Brown Adipose (Fat) Program Since June 2011, we have been engaging in pre-clinical research efforts with respect to an investigational platform technology utilizing brown adipose (fat) derived stem cells, or BADSCs, for therapeutic purposes.
Sandhu and Dr. Plastaras. See Item 10 of this Annual Report (“Directors, Executive Officers and Corporate Governance – Scientific Advisory Board”) for a listing of the principal positions for Drs.
Sandhu and Dr. Plastaras. See Item 10 of this Annual Report (“Directors, Executive Officers and Corporate Governance – Scientific Advisory Board”) for a listing of the principal positions for Drs. Marasco, Lipetz, Olan, Cavagnaro, Sandhu and Plastaras.
As a result of these programs, we have seven United States patents, thirteen foreign patents, one United States patent application, and four foreign patent applications related to research regarding our ThermoStem Program.
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.
In connection with the issuance, we issued warrants for the purchase of 2,513,686 shares of our common stock and are obligated to issue an additional 1,351,580 shares of our common stock, which additional shares have been fully paid for but have not yet been issued due to a maximum beneficial ownership limitation for one of the warrantholders.
In connection with the issuance, we issued warrants for the purchase of 2,513,686 shares of our common stock and are obligated to issue an additional 1,138,055 shares of our common stock, which additional shares have been fully paid for but have not yet been issued due to a maximum beneficial ownership limitation for one of the warrant holders.
These are generally referred to as adult (non-embryonic) stem cells. These cells are important for the purpose of medical therapies aiming to replace lost or damaged cells or tissues or to otherwise treat disorders. Regenerative cell therapy relies on replacing diseased, damaged or dysfunctional cells with healthy, functioning ones or repairing damaged or diseased tissue.
These cells are important for the purpose of medical therapies aiming to replace lost or damaged cells or tissues or to otherwise treat disorders. Regenerative cell therapy relies on replacing diseased, damaged or dysfunctional cells with healthy, functioning ones or repairing damaged or diseased tissue.
During the years ended December 31, 2023 and 2022, we incurred $4,034,591 and $3,513,352, respectively, in research and development expenses. Scientific Advisors We have established a Scientific Advisory Board whose purpose is to provide advice and guidance in connection with scientific matters relating to our business.
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.
Since June 2022, we have entered into clinical trial agreements with 16 sites to conduct our Phase 2 clinical trial targeting chronic lumbar disc disease. Production and Delivery The production of our product candidate, BRTX-100, begins with the physician collecting bone marrow from the patient under local anesthesia. Peripheral blood is also collected from the patient.
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.
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 . 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.
Set forth below is a comparison of BRTX-100 to Mesoblast’s adult stem cell biologic: We believe that BRTX-100 has competitive advantages to Mesoblast’s product for the following reasons: ● The use of autologous cells results in low to no risk of rejection, greater safety profile (introduction of viral/genetic) and a streamlined regulatory path ● Hypoxic culturing creates increased cell proliferation, greater plasticity, increased paracrine effect and increased cell survival after application ● Autologous platelet lysate provides growth factors that interact with the cells, allowing for better cell survival ● Low to no risk of safety concerns related to immunological and zoonotic (animal to human) transmission 23 Customers Upon regulatory approval, our cell product candidates are intended to be marketed to physicians, other health care professionals, hospitals, research institutions, pharmaceutical companies and the military.
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.
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.
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.
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. 25 Non-reproductive HCT/Ps and non-peripheral blood stem/progenitor cells that are offered for import into the United States and regulated solely under Section 361 of the PHSA must also satisfy the requirements under 21 C.F.R. § 1271.420.
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.
We believe that there will be readily identifiable groups of patients who will benefit from these procedures. We also believe that these procedures will be significantly less expensive than the most common surgical procedure alternatives and will compare favorably, over the long-term, to conservative treatment costs which may persist for years.
We also believe that these procedures will be significantly less expensive than the most common surgical procedure alternatives and will compare favorably, over the long-term, to conservative treatment costs which may persist for years.
In August 2022, a federal District Court in the case of United States v. California Stem Cell Treatment Center, Inc. held that certain autologous adipose stem cell treatments were not “biological products” and therefore did not require FDA approval.
In August 2022, a federal District Court in the case of United States v. California Stem Cell Treatment Center, Inc. (“ California Stem Cell”) held that certain autologous adipose stem cell treatments were not “biological products” and therefore did not require FDA approval. The FDA appealed the decision and it was reversed by the U.S.
It is anticipated that the delivery of the product candidate will be a 30 minute procedure. 9 Mesenchymal stem cells used in BRTX-100 are similar to other MSCs under development by others; however, in order to enhance the survivability of our bone marrow-derived MSCs in the avascular environment of the damaged disc, BRTX-100 is designed to expand under hypoxic conditions for a period of approximately three weeks.
Mesenchymal stem cells used in BRTX-100 are similar to other MSCs under development by others; however, in order to enhance the survivability of our bone marrow-derived MSCs in the avascular environment of the damaged disc, BRTX-100 is designed to expand under hypoxic conditions for a period of approximately three weeks.
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.
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.
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.
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.
Having completed our proof of concept using our BAT in small animals, we are currently developing our next generation BAT. It is anticipated that this next version will contain a higher purity of BADSC and a greater percent of functional brown adipocytes, which is expected to increase the therapeutic effect compared to our first generation product.
It is anticipated that this next version will contain a higher purity of BADSC and a greater percent of functional brown adipocytes, which is expected to increase the therapeutic effect compared to our first generation product.
Similar Therapies Human data from studies of therapies comparative to BRTX-100 have shown reduced pain, increased function, and an absence of significant safety issues with a durable response, as shown below: 14 Impact on Public Health The United States is the world’s leading consumer of hydrocodone (99%) and oxycodone (83%) and leads the world in per capital consumption of such drugs (twice as much as second ranked Canada).
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).
In November 2021, we completed a $23,000,000 public offering of our securities. In 2023, we raised approximately $2,680,000 in additional gross proceeds through public offerings of our securities. In February 2024, we also received approximately $8,100,000 in gross proceeds pursuant to the exercise of warrants.
In November 2021, we completed a $23,000,000 public offering of our securities. In 2023, we raised approximately $2,680,000 in additional gross proceeds through public offerings of our securities.
California Stem Cell Treatment Center, Inc. held that certain autologous adipose stem cell treatments that the FDA alleged were biological products were instead within the HCT/P definition and therefore did not require FDA approval.
California Stem Cell Treatment Center, Inc. held that certain autologous adipose stem cell treatments that the FDA alleged were biological products were instead within the HCT/P definition and therefore did not require FDA approval. The FDA appealed the decision and it was reversed by the U.S. Court of Appeals for the Ninth Circuit.
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.
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.
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.
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.
Historically, the U.S. federal courts have upheld the FDA’s authority to regulate stem cell products under the FDCA that do not comply with the FDA’s interpretations of the HCT/P Regulations. However, in August 2022, a federal District Court in the case of United States v.
Historically, the U.S. federal courts have upheld the FDA’s authority to regulate stem cell products under the FDCA that do not comply with the FDA’s interpretations of the HCT/P Regulations. However, the U.S. Supreme Court’s 2024 decision in Loper Bright Enterprises v.
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.
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.
Pre-clinical animal models of diet-induced obesity, that were transplanted with differentiated BADSCs supported by a biological scaffold, presented significant reductions in weight and blood glucose levels compared to scaffold only controls. We are identifying technology for in vivo delivery in small animal models.
In order to deliver these differentiated cells into target locations in vivo , we seeded BADSCs onto 3-dimensional biological scaffolds. Pre-clinical animal models of diet-induced obesity, that were transplanted with differentiated BADSCs supported by a biological scaffold, presented significant reductions in weight and blood glucose levels compared to scaffold only controls.
In May 2023, we announced that we had received a license from the New York State Department of Health to act as a tissue bank for the processing of mesenchymal stem cells from autologous donors. In June 2023, we announced that the final subject in our BRTX-100 Phase 2 clinical trial safety cohort had been dosed.
In May 2023, we announced that we had received a license from the New York State Department of Health, or the NYSDOH, to act as a tissue bank for the processing of mesenchymal stem cells from autologous donors.
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.
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.
The clinical rationale of BRTX-100 is to deliver a high concentration of the patient’s own cultured MSCs into the site of pathology to promote healing and relieve pain. 8 We have developed a mesenchymal stem cell product candidate, BRTX-100, derived from autologous (or a person’s own) human bone marrow, cultured and formulated, in a proprietary method, specifically for introduction into a painful lumbar disc.
We have developed a mesenchymal stem cell product candidate, BRTX-100, derived from autologous (or a person’s own) human bone marrow, cultured and formulated, in a proprietary method, specifically for introduction into a painful lumbar disc.
In June 2023, we announced that the final subject in our BRTX-100 Phase 2 clinical trial safety cohort had been dosed. In June 2023, we announced that the independent Data Safety Monitoring Board, which is overseeing our Phase 2 clinical trial, unanimously recommended the continuation of our study in accordance with the version of the protocol with no changes.
In June 2023, 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 December 2023, a United States patent related to our ThermoStem Program was issued to us . Material Events During 2024 In February 2024, we issued 2,000,000 shares of our common stock pursuant to the exercise of warrants.
Material Events During 2024 In February 2024, we issued 2,000,000 shares of our common stock pursuant to the exercise of warrants.
We received gross proceeds of approximately $8,100,000 from the warrant exercise. (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).
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).
Pursuant to the Research and Development Agreement with Rohto, we were engaged to provide research and development services with regard to stem cells. The agreement with Rohto expired upon the completion of the services provided for therein. We have secured registrations in the U.S.
In March 2014, we entered into a Research and Development Agreement with Rohto Pharmaceutical Co., Ltd., a Japanese pharmaceutical company, or Rohto. Pursuant to the Research and Development Agreement with Rohto, we were engaged to provide research and development services with regard to stem cells. The agreement with Rohto expired upon the completion of the services provided for therein.
We are developing a cell-based product candidate to target obesity and metabolic disorders using BADSCs. Our goal is to develop a bioengineered implantable brown adipose tissue construct intended to mimic ones naturally occurring in the human body. We have isolated and characterized a human multipotent stem cell population that resides within BAT depots.
Our goal is to develop a bioengineered implantable brown adipose tissue construct intended to mimic ones naturally occurring in the human body. We have isolated and characterized a human multipotent stem cell population that resides within BAT depots. We have expanded these stem cells to clinically relevant numbers and successfully differentiated them into functional brown adipocytes.
In May 2023, we announced that we had received a license from the New York State Department of Health to act as a tissue bank for the processing of mesenchymal stem cells from autologous donors. 19 As we develop our business and our stem cell product candidates, and we obtain regulatory approval, we will seek to establish ourselves as a key provider of adult stem cells for therapies and expand to provide cells in other market areas for stem cell therapy.
As we develop our business and our stem cell product candidates, and we obtain regulatory approval, we will seek to establish ourselves as a key provider of adult stem cells for therapies and expand to provide cells in other market areas for stem cell therapy.
We 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.
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.
Material Events During 2023 In April 2023, we entered into a Capital On Demand™ Sales Agreement, or the Sales Agreement, with JonesTrading Institutional Services LLC, or the Agent, pursuant to which we may offer and sell, from time to time, through or to the Agent, shares of our common stock having an aggregate offering price of up to $6,109,000.
In November 2024, we entered into an At The Market Offering Agreement, or the Offering Agreement, with Rodman & Renshaw LLC, or Rodman, pursuant to which we may offer and sell, from time to time, through or to Rodman, shares of our common stock having an aggregate offering price of up to approximately $3.6 million.
Companies working in the area of regenerative medicine with regard to the disc and spine include, among others, Mesoblast, SpinalCyte, DiscGenics and Isto Biologics. Companies that are developing products and therapies to combat obesity and diabetes include Novo Nordisk, Sanofi, Merck, Eli Lilly, Roche, Pfizer, Regeneron and Altimmune.
Companies that are developing products and therapies to combat obesity and diabetes include Novo Nordisk, Sanofi, Merck, Eli Lilly, Roche, Pfizer, Regeneron and Altimmune.
Marasco, Lipetz, Olan, Cavagnaro, Sandhu and Plastaras. 21 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.
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.
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.
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.
We intend to develop cell and tissue products and regenerative therapy protocols, primarily involving adult stem cells, to allow patients to undergo cellular-based treatments. 6 We are concentrating initially on therapeutic areas in which risk to the patient is low, recovery is relatively easy, results can be demonstrated through sufficient clinical data, and patients and physicians will be comfortable with the procedure.
We are concentrating initially on therapeutic areas in which risk to the patient is low, recovery is relatively easy, results can be demonstrated through sufficient clinical data, and patients and physicians will be comfortable with the procedure. We believe that there will be readily identifiable groups of patients who will benefit from these procedures.
Overview Every human being has stem cells in his or her body. These cells exist from the early stages of human development until the end of a person’s life. Throughout our lives, our body continues to produce stem cells that regenerate to produce differentiated cells that make up various aspects of the body such as skin, blood, muscle and nerves.
Throughout our lives, our body continues to produce stem cells that regenerate to produce differentiated cells that make up various aspects of the body such as skin, blood, muscle and nerves. These are generally referred to as adult (non-embryonic) stem cells.
We have expanded these stem cells to clinically relevant numbers and successfully differentiated them into functional brown adipocytes. We intend to use adult stem cells that may be differentiated into progenitor or fully differentiated brown adipocytes, or a related cell type, which can be used therapeutically in patients.
We intend to use adult stem cells that may be differentiated into progenitor or fully differentiated brown adipocytes, or a related cell type, which can be used therapeutically in patients. We are focusing on the development of treatment protocols that utilize allogeneic cells (i.e., stem cells from a genetically similar but not identical donor).
Patents related to the ThermoStem Program have been issued in the United States and other jurisdictions. See “Metabolic Brown Adipose (Fat) Program” below. We have also licensed an investigational curved needle device designed to deliver cells and/or other therapeutic products or material to the spine and discs (and other parts of the body).
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.
We intend to seek to raise capital through investment bankers and from biotech funds, strategic partners and other financial institutions. We will require significant additional financing to complete our contemplated Phase 3 clinical trial investigating the use of BRTX-100.
We intend to seek to raise capital through our 2024 ATM and warrant exercises as well as through investment bankers and from biotech funds, strategic partners and other financial institutions.
Regenerative medicine is rapidly progressing, in large part through the development of cell-based therapies or devices designed to isolate cells from human tissues. Most efforts involve cell sources, such as bone marrow, adipose tissue, embryonic and fetal tissue, umbilical cord and peripheral blood and skeletal muscle.
Most efforts involve cell sources, such as bone marrow, adipose tissue, embryonic and fetal tissue, umbilical cord and peripheral blood and skeletal muscle. Companies working in the area of regenerative medicine with regard to the disc and spine include, among others, Mesoblast, Fibrogenesis, DiscGenics and Isto Biologics.
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Item 2. Properties
Properties — owned and leased real estate
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Item 2. Properties
Properties — owned and leased real estate
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2023 filing
2024 filing
Biggest changeITEM 2. PROPERTIES . Our principal executive offices and laboratory are located at 40 Marcus Drive, Suite One, Melville, New York. We occupy 6,800 square feet of space at the premises pursuant to a lease that expires in December 2024. The lease provides for a current annual base rental of $173,060.
Biggest changeITEM 2. PROPERTIES . Our principal executive offices and laboratory are located at 40 Marcus Drive, Suite One, Melville, New York. We occupy 6,800 square feet of space at the premises pursuant to a lease that expired in December 2024. The lease provided for a current annual base rental of $173,060.
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Our premises are suitable and adequate for our current operations.
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We currently occupy the premises on a month-to-month basis at a monthly rental of $14,422 and are negotiating an extension of the term of the lease. Our premises are suitable and adequate for our current operations.
Item 5. Market for Registrant's Common Equity
Market for Common Equity — stock, dividends, buybacks
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Item 5. Market for Registrant's Common Equity
Market for Common Equity — stock, dividends, buybacks
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2023 filing
2024 filing
Biggest changeRecent Sales of Unregistered Securities None. Issuer Purchases of Equity Securities None. ITEM 6 . [RESERVED] ITEM 7 . MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS .
Biggest changeRecent Sales of Unregistered Securities None. Issuer Purchases of Equity Securities None. ITEM 6 . [RESERVED]
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES . Market Information Transactions in our common stock are currently reported under the symbol “BRTX” on the Nasdaq Capital Market. Holders As of March 28, 2024, there were 352 record holders of our shares of common stock. Dividends Not applicable.
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.
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The following discussion and analysis of the consolidated results of operations and financial condition of BioRestorative Therapies, Inc. as of December 31, 2023 and 2022 and for the years ended December 31, 2023 and 2022 should be read in conjunction with our financial statements and the notes to those financial statements that are included elsewhere in this Annual Report following Item 16 (“Form 10-K Summary”).
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References in this “Management’s Discussion and Analysis of Financial Condition and Results of Operations” to “us,” “we,” “our,” and similar terms refer to BioRestorative Therapies, Inc.. This Annual Report contains forward-looking statements as that term is defined in the federal securities laws. The events described in forward-looking statements contained in this Annual Report may not occur.
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Generally, these statements relate to business plans or strategies, projected or anticipated benefits or other consequences of our plans or strategies, projected or anticipated benefits from acquisitions that may be made by us, or projections involving anticipated revenues, earnings or other aspects of our operating results.
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The words “may,” “will,” “expect,” “believe,” “anticipate,” “project,” “plan,” “intend,” “estimate,” and “continue,” and their opposites and similar expressions, are intended to identify forward-looking statements.
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We caution you that these statements are not guarantees of future performance or events and are subject to a number of uncertainties, risks and other influences, many of which are beyond our control, which may influence the accuracy of the statements and the projections upon which the statements are based.
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Reference is made to Item 1A of this Annual Report (“Risk Factors”) for a discussion of some of the uncertainties, risks and assumptions associated with these statements. 69 Overview We develop therapeutic products and medical therapies using cell and tissue protocols, primarily involving adult stem cells.
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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 .
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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.
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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.
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We have obtained an exclusive license to use technology for investigational adult stem cell treatment of disc and spine conditions, including protruding and bulging lumbar discs. The technology is an advanced stem cell injection procedure that may offer relief from lower back pain, buttock and leg pain, and numbness and tingling in the leg and foot.
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We are also developing our ThermoStem Program . This pre-clinical program involves the use of brown adipose (fat) in connection with the cell-based treatment of type 2 diabetes and obesity as well as hypertension, other metabolic disorders and cardiac deficiencies.
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United States patents related to the ThermoStem Program were issued in September 2015, January 2019, March 2020, March 2021, July 2021, June 2023 and December 2023; Australian patents related to the ThermoStem Program were issued in April 2017, October 2019 and August 2021; Japanese patents related to the ThermoStem Program were issued in December 2017, June 2021, February 2022 and June 2023; Israeli patents related to our ThermoStem Program were issued in October 2019, May 2020 and March 2022; and European patents related to the ThermoStem Program were issued in April 2020, January 2021 and July 2023.
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We have licensed a patented curved needle device that is a needle system designed to deliver cells and/or other therapeutic products or materials to the spine and discs or other potential sites. We anticipate that FDA approval or clearance will be necessary for this device prior to commercialization.
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We do not intend to utilize this device in connection with our Phase 2 clinical trial with regard to BRTX-100 . We are seeking to develop a biologics-based cosmetic products business. Pursuant to such business, we would manufacture and sell cosmetics and hair growth products designed for cosmetic and aesthetic uses.
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Our offices are located in Melville, New York where we have established a laboratory facility in order to increase our capabilities for the further development of possible cellular-based treatments, products and protocols, stem cell-related intellectual property and translational research applications. 70 As of December 31, 2023, our accumulated deficit was $167,056,381.
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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.
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We expect to continue to incur substantial costs for these activities over at least the next year. In November 2021, we completed a $23,000,000 underwritten public offering of units of securities pursuant to which an aggregate of 2,300,000 shares of our common stock and warrants for the purchase of an aggregate of 2,645,000 shares of our common stock were issued.
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We are using the net proceeds from the offering as follows: (i) undertaking of clinical trials with respect to BRTX-100 and its related collection and delivery procedure; (ii) pre-clinical research and development with respect to our ThermoStem Program ; and (iii) general corporate and working capital purposes.
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In connection with the public offering, our common stock was listed on the Nasdaq Capital Market.
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In November 2021, concurrently with the consummation of the public offering, we issued an aggregate of 313,789 shares of our common stock, 1,543,158 shares of our Series A preferred stock and warrants for the purchase of an aggregate of 1,856,938 shares of our common stock in exchange for convertible promissory notes in the aggregate principal amount of $10,046,897, together with accrued interest thereon, and warrants for the purchase of an aggregate of 3,677,997 shares of our common stock.
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Such indebtedness and warrants were exchanged at a price of $10.00 per unit of securities, consistent with the public offering price of our units of common stock and warrants. The newly issued warrants are exercisable for a period of five years at an exercise price of $10.00 per share.
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In September 2022, the 1,543,158 shares of Series A preferred stock were exchanged for an equal number of shares of Series B preferred stock. As of March 28, 2024, there were 1,398,158 shares of Series B preferred stock issued and outstanding.
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In April 2023, we entered into a Capital on Demand Sales Agreement with JonesTrading Institutional Services LLC, or the Sales Agent, under which we currently have the ability to issue and sell shares of our common stock, from time to time, through the Sales Agent, up to an aggregate offering price of approximately $6,109,000 in what is commonly referred to as an “at-the-market”, or ATM, program.
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During the year ended December 31, 2023, we sold 132,827 shares of our common stock under the ATM program with the Sales Agent at a weighted-average gross price of approximately $4.68 per share and raised approximately $622,000 of gross proceeds. The total commissions and related legal fees were approximately $127,000, and we received net proceeds of approximately $495,000.
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As of December 31, 2023, we had remaining capacity to sell up to an additional $5,487,000 of common stock under the ATM program. In July 2023, we sold an aggregate of 685,033 shares of our common stock in a registered direct public offering. We received net proceeds of approximately $1,854,000 from the offering.
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The net proceeds received from our November 2021 public offering, the ATM program and the registered direct offering are sufficient for us to complete our Phase 2 clinical trial with regard to BRTX-100; however, we will require significant additional funding to complete our contemplated Phase 3 BRTX-100 clinical trial (assuming the receipt of no revenues).
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We will also require a substantial amount of additional funding to implement our other programs as discussed in this Annual Report under the caption Item 1 (“Business”), including our metabolic ThermoStem Program , and fund general operations.
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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.
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In addition, no assurance can be given that we will be able to obtain any required financing on commercially reasonable terms or otherwise. 71 Consolidated Results of Operations Year Ended December 31, 2023 Compared with Year Ended December 31, 2022 The following table presents selected items in our consolidated statements of operations for the years ended December 31, 2023 and 2022, respectively: For the Years Ended December 31, 2023 2022 Revenues, net $ 145,800 $ 119,800 Operating Expenses: Research and development 4,034,591 3,513,352 General and administrative 11,331,983 15,580,473 Total Operating Expenses 15,366,574 19,093,825 Loss From Operations (15,220,774 ) (18,974,025 ) Other Income: Interest income (552,293 ) (11,650 ) Gain on PPP loan forgiveness - (250,000 ) Grant income (83,333 ) (110,518 ) Other income (169,664 ) (107,088 ) Total Other Income (805,290 ) (479,256 ) Net Loss $ (14,415,484 ) $ (18,494,769 ) Revenues For the years ended December 31, 2023 and 2022, we generated $145,800 and $119,800, respectively, of royalty revenue in connection with our sublicense agreement.
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Research and development Research and development expenses include cash and non-cash compensation of (a) our Vice President of Research and Development; (b) our Scientific Advisory Board members; and (c) laboratory staff and costs related to our brown fat and disc/spine initiatives. Research and development expenses are expensed as they are incurred.
Removed
For the year ended December 31, 2023, research and development expenses increased by $521,239, or 15%, to $4,034,591 compared to $3,513,352 for the year ended December 31, 2022.
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The increase was primarily driven by increased compensation of $857,294 due to salary increases and bonuses, increased lab supplies expenses of $193,298, increased repair and maintenance expenses of $30,521, increased license agreements and fees expenses of $25,155 and increased consulting fees of $112,581, offset by a decrease in lab site fees of $53,029, and a decrease in PRC service expenses of $644,245 as the result of non-recurring start-up and execution expenses incurred during the year ended December 31, 2022. 72 We expect that our research and development expenses will continue to increase with the continuation of the aforementioned initiatives.
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General and administrative General and administrative expenses consist primarily of salaries, bonuses, payroll taxes and stock-based compensation to employees (excluding any cash or non-cash compensation of our Vice President of Research and Development and our laboratory staff), as well as corporate expenses such as legal and professional fees, investor relations and occupancy related expenses.
Removed
For the year ended December 31, 2023, general and administrative expenses decreased by $4,248,490, or 27% to $11,331,983 from $15,580,473 for the year ended December 31, 2022.
Removed
The decrease was primarily driven by a $4,753,377 decrease in stock-based compensation, decreased franchise tax expense of $130,850, decreased amortization expense of $104,630, decreased travel expense of $84,122, and decreased insurance expense of $53,858, all offset by an increase in compensation of $775,678 due to salary increases and bonuses, increased investor relations expense of $80,957, increased professional fees of $44,056 and an increase in office supplies expense of $10,616.
Removed
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, 2023, interest income increased $540,643, or 4641%, to $552,293 from $11,650 for the year ended December 31, 2022.
Removed
The increase was due to the interest and dividend income of the investments held in marketable securities. Gain on PPP loan forgiveness Under the terms of the U.S. Small Business Administration’s Paycheck Protection Program, or PPP, our $250,000 PPP loan was forgiven during the year ended December 31, 2022.
Removed
Grant income Grant income of $83,333 during the year ended December 31, 2023 consisted of funding received under a National Institutes of Health Small Business Technology Transfer (STTR) Phase 1 grant, offset by related expenses.
Removed
Grant income of $110,518 during the year ended December 31, 2022 consisted of funding received under a $256,000 National Institutes of Health Small Business Technology Transfer (STTR) Phase 1 grant, which we were awarded in September 2021.
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Other income, net For the year ended December 31, 2023, other income, net of $169,664 primarily related to an Employee Retention Tax Credit, gains from settlements of certain accrued expenses and realized and unrealized gain on investments.
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For the year ended December 31, 2022, Other income, net of $107,088 primarily related to gains from settlements of certain accrued expenses and unrealized gain on investments. 73 Liquidity and Capital Resources Liquidity We measure our liquidity in a number of ways, including the following: December 31, 2023 2022 Cash, Cash Equivalents and Investments $ 11,065,995 $ 14,749,408 Working Capital $ 10,327,134 $ 14,688,188 Availability of Additional Funds Based upon our accumulated deficit of $167,056,381 as of December 31, 2023, along with our forecast for continued operating losses and our need for financing to fund our contemplated clinical trials, as of such date, we require additional equity and/or debt financing to continue our operations.
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However, based on cash on hand and investments as of December 31, 2023 and the receipt of approximately $8,100,000 in gross proceeds in February 2024 pursuant to the warrant exercises discussed below, management believes that we have sufficient cash to fund operations for the twelve months from the issuance of the financial statements included in this Annual Report.
Removed
Our operating needs include the planned costs to operate our business, including amounts required to fund our clinical trials, working capital and capital expenditures.
Removed
Our future capital requirements and the adequacy of our available funds will depend on many factors, including our ability to successfully commercialize our products and services, competing technological and market developments, and the need to enter into collaborations with other companies or acquire other companies or technologies to enhance or complement our product and service offerings.
Removed
We may be unable to raise sufficient additional capital when we need it or raise capital on favorable terms. Future financing may require us to pledge certain assets and enter into covenants that could restrict certain business activities or our ability to incur further indebtedness and may contain other terms that are not favorable to our stockholders or us.
Removed
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.
Removed
“At-the-Market” Offering In April 2023, we entered into a Capital on Demand Sales Agreement with JonesTrading Institutional Services LLC, or the Sales Agent, under which we currently have the ability to issue and sell shares of our common stock, from time to time, through the Sales Agent, up to an aggregate offering price of approximately $6,109,000 in what is commonly referred to as an “at-the-market”, or ATM, program.
Removed
During the year ended December 31, 2023, we sold 132,827 shares of our common stock under the ATM program with the Sales Agent at a weighted-average gross price of approximately $4.68 per share and raised approximately $622,000 of gross proceeds. The total commissions and related legal fees were approximately $127,000, and we received net proceeds of approximately $495,000.
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As of December 31, 2023, we had remaining capacity to sell up to an additional approximately $5,487,000 of common stock under the ATM program. 74 Registered Direct Offering In July 2023, we sold an aggregate of 685,033 shares of our common stock in a registered direct public offering. We received net proceeds of approximately $1,831,000 from the offering.
Removed
Warrant Exercises In February 2024, we received gross proceeds of approximately $8,100,000 pursuant to the exercise of outstanding warrants. See Item 1 (“Business – Business Development – Material Events During 2024”) for additional information.
Removed
Cash Flows During the years ended December 31, 2023 and 2022, our sources and uses of cash were as follows: Year Ended December 31, 2023 2022 Net cash used in operating activities $ (6,430,211 ) $ (5,913,100 ) Net cash provided by (used in) investing activities 3,252,043 (13,399,855 ) Net cash provided by financing activities 2,351,343 - Net decrease in cash $ (826,825 ) $ (19,312,955 ) Net Cash Used in Operating Activities Net cash used in operating activities was $6,430,211 for the year ended December 31, 2023, primarily due to cash used to fund the net loss of $14,415,484, which was partially offset by non-cash expenses of $7,469,947 related primarily to stock-based compensation and $515,326 of cash provided by changes in our operating assets and liabilities.
Removed
Net cash used in operating activities was $5,913,100 for the year ended December 31, 2022, primarily due to cash used to fund the net loss of $18,494,769 and a non-cash gain of $250,000 on forgiveness of our PPP loan, which was partially offset by non-cash expenses of $12,567,525 related primarily to stock-based compensation and $14,144 of cash provided by changes in operating assets and liabilities.
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Net Cash Provided by (Used in) Investing Activities Net cash provided by investing activities increased by $16,731,432 for the year ended December 31, 2023 compared to the year ended December 31, 2022, primarily due to the initial use of cash in the amount of $16,000,000 for the purchase of investments held in marketable securities made in 2022 for which there was no corresponding activity in 2023. 75 Net Cash Provided by Financing Activities Net cash provided by financing activities increased by $2,351,343 for the year ended December 31, 2023 compared to the year ended December 31, 2022 due to the net proceeds from the ATM and registered direct public offerings of our common stock.
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Effects of Inflation We do not believe that inflation had a material impact on our business, revenues or operating results during the periods presented.
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Critical Accounting Estimates We prepare our consolidated financial statements in accordance with U.S. generally accepted accounting principles, or GAAP, which require our management to make estimates that affect the reported amounts of assets, liabilities and disclosures of contingent assets and liabilities at the balance sheet dates, as well as the reported amounts of revenues and expenses during the reporting periods.
Removed
To the extent that there are material differences between these estimates and actual results, our financial condition or results of operations would be affected. We base our estimates on our own historical experience and other assumptions that we believe are reasonable after taking account of our circumstances and expectations for the future based on available information.
Removed
We evaluate these estimates on an ongoing basis.
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We consider an accounting estimate to be critical if: (i) the accounting estimate requires us to make assumptions about matters that were highly uncertain at the time the accounting estimate was made, and (ii) changes in the estimate that are reasonably likely to occur from period to period or the use of different estimates that we reasonably could have used in the current period would have a material impact on our financial condition or results of operations.
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.
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Recently Issued Accounting Pronouncements See Note 2 to our consolidated financial statements for the years ended December 31, 2023 and 2022 included elsewhere in this Annual Report following Item 16 (“Form 10-K Summary”).
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Off-Balance Sheet Arrangements We have no off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that is material to investors. 76 ITEM 7A . QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK .
Removed
Not applicable. ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA . The financial statements required by this Item 8 of this Annual Report are included in this Annual Report following Item 16 (“Form 10-K Summary”). As a smaller reporting company, we are not required to provide supplementary financial information.
Item 7A. Quantitative and Qualitative Disclosures About Market Risk
Market Risk — interest-rate, FX, commodity exposure
0 edited+1 added−10 removed0 unchanged
Item 7A. Quantitative and Qualitative Disclosures About Market Risk
Market Risk — interest-rate, FX, commodity exposure
0 edited+1 added−10 removed0 unchanged
2023 filing
2024 filing
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Item 7A. Quantitative and Qualitative Disclosures About Market Risk. 77 Item 8. Financial Statements and Supplementary Data. 77 Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure. 77 Item 9A. Controls and Procedures. 77 Item 9B. Other Information. 79 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections. 79 PART III 80 Item 10.
Added
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK . Not applicable. ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA . The financial statements required by this Item 8 of this Annual Report are included in this Annual Report following Item 16 (“Form 10-K Summary”). As a smaller reporting company, we are not required to provide supplementary financial information.
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Directors, Executive Officers and Corporate Governance. 80 Item 11. Executive Compensation. 85 Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters. 88 Item 13. Certain Relationships and Related Transactions, and Director Independence. 90 Item 14. Principal Accountant Fees and Services. 91 PART IV 92 Item 15. Exhibits and Financial Statement Schedules. 92 Item 16.
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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.
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Generally, these statements relate to business plans or strategies, projected or anticipated benefits or other consequences of our plans or strategies, projected or anticipated benefits from acquisitions to be made by us, or projections involving anticipated revenues, earnings or other aspects of our operating results.
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The words “may,” “will,” “expect,” “believe,” “anticipate,” “project,” “plan,” “intend,” “estimate,” and “continue,” and their opposites and similar expressions are intended to identify forward-looking statements.
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We caution you that these statements are not guarantees of future performance or events and are subject to a number of uncertainties, risks and other influences, many of which are beyond our control, that may influence the accuracy of the statements and the projections upon which the statements are based.
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Factors which may affect our results include, but are not limited to, the risks and uncertainties discussed in Item 1A of this Annual Report (“Risk Factors”). Any one or more of these uncertainties, risks and other influences could materially affect our results of operations and whether forward-looking statements made by us ultimately prove to be accurate.
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Our actual results, performance and achievements could differ materially from those expressed or implied in these forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether from new information, future events or otherwise.
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Intellectual Property This Annual Report includes references to our federally registered trademarks, BioRestorative Therapies and Dragonfly design, BRTX-100 , ThermoStem and BRTX . The Dragonfly logo is also registered with the U.S. Copyright Office. This Annual Report also includes references to trademarks, trade names and service marks that are the property of other organizations.
Removed
Solely for convenience, trademarks and trade names referred to in this Annual Report appear without the ®, SM or ™ symbols, and copyrighted content appears without the use of the symbol ©, but the absence of use of these symbols does not reflect upon the validity or enforceability of the intellectual property owned by us or third parties.