BioRestorative Therapies, Inc.

BioRestorative Therapies, Inc. (the "Company") is a biotechnology firm focused on developing therapeutic products using cell and tissue protocols, primarily involving adult stem cells. The Company's core business model revolves around its Disc/Spine Program (brtxDisc) and Metabolic Program (ThermoStem), alongside a commercial biocosmeceuticals platform. Revenue is generated from product sales and royalty income, with a mix of transactional and recurring elements. The primary customer segments for its potential therapeutic products include physicians, healthcare professionals, hospitals, research institutions, pharmaceutical companies, and the military, while biocosmeceutical products are marketed to distributors, medical spas, and directly to consumers. The Company operates a cGMP ISO-7 certified clean room for manufacturing its commercial product and clinical-grade product candidates.

The Company's Disc/Spine Program features BRTX-100, an investigational therapeutic product formulated from autologous cultured mesenchymal stem cells (MSCs) derived from a patient's bone marrow. This product is intended for the non-surgical treatment of painful lumbosacral disc disorders or as a complementary therapeutic to surgical procedures. The BRTX-100 production process involves collecting a patient's bone marrow, isolating and culturing stem cells under hypoxic conditions for approximately three weeks, and cryopreserving them for injection into the damaged disc. The Company has obtained an exclusive license for this technology and a U.S. patent was issued in March 2022. The FDA granted Fast Track designation to the BRTX-100 program in February 2025 and cleared an Investigational New Drug (IND) application for its use in chronic cervical discogenic pain in February 2025.

The Metabolic Program, known as ThermoStem, is a pre-clinical initiative utilizing brown adipose (fat) derived stem cells (BADSCs) to generate brown adipose tissue (BAT) and exosomes secreted by BADSCs. This program aims to develop cell-based treatments for type 2 diabetes, obesity, hypertension, other metabolic disorders, and cardiac deficiencies. Patents related to the ThermoStem Program have been issued in the United States, Europe, Israel, and Japan, with an Australian patent application expected to issue soon. The Company has completed proof-of-concept preclinical animal studies for its first-generation BAT and is developing a next-generation product with higher purity BADSCs and functional brown adipocytes, exploring encapsulation technology for delivery.

The BioCosmeceuticals platform offers a commercial product, a cell-based secretome containing exosomes, proteins, and growth factors, engineered to reduce the appearance of fine lines and wrinkles. The Company intends to expand this offering to include a broader family of cell-based biologic aesthetic products and therapeutics via IND-enabling studies, aiming for FDA approvals in this emerging space. Additionally, the Company has licensed an investigational curved needle device (CND) designed for delivering cells and/or other therapeutic products to the spine and discs, or other body areas, which will require FDA approval or clearance prior to commercialization.

For the fiscal year ended December 31, 2025, the Company reported total revenues of $359,700 ⁴, a decrease from $401,000 ⁵ in 2024. This consisted of $59,700 ⁶ in royalty revenue and $300,000 ⁷ in cosmetic product sales revenue. Cost of goods sold was $23,844 ⁸, leading to a gross profit of $335,856 ⁹. Operating expenses totaled $15,982,988 ¹⁰, comprising $10,094,671 ¹¹ in research and development expenses and $5,888,317 ¹² in general and administrative expenses. The Company incurred a loss from operations of $15,647,132 ¹³ and a net loss of $14,241,975 ¹⁴. Diluted EPS was $(1.58) ¹⁵. Cash and cash equivalents stood at $1,511,188 ¹⁶, with investments in marketable securities of $1,441,734 ¹⁷. The Company had a working capital deficit of $586,029 ¹⁸ and an accumulated deficit of $169,920,690 ¹⁹. Net cash used in operating activities was $10,788,963 ²⁰.

Comparing 2025 to 2024, total revenues decreased by $41,300 ²¹, or 10.3%, primarily due to a decrease in royalty revenue from $101,000 ²² to $59,700 ²³, while cosmetic product sales remained flat at $300,000 ²⁴. Research and development expenses increased by $3,387,758 ²⁵, or 50.5%, from $6,706,913 ²⁶ in 2024 to $10,094,671 ²⁷ in 2025, driven by increased recruitment and other costs for the Phase 2 clinical trial ($2,682,474 ²⁸), general lab supplies ($485,166 ²⁹), and stock-based compensation ($165,849 ³⁰). General and administrative expenses rose by $667,108 ³¹, or 12.8%, from $5,221,209 ³² to $5,888,317 ³³. Net interest income decreased by $349,870 ³⁴, or 56.8%, from $616,077 ³⁵ to $266,207 ³⁶. Other income decreased by $133,402 ³⁷, or 88.4%, from $150,850 ³⁸ to $17,448 ³⁹. The Company recognized a gain on exchange of warrants of $1,711,698 ⁴⁰ in 2024, with no such gain in 2025. The gain on change in fair value of warrant liabilities increased from $97,188 ⁴¹ in 2024 to $1,121,502 ⁴² in 2025.

During 2025, the Company received gross proceeds of $1,085,000 ⁴³ from a registered direct public offering of 678,125 ⁴⁴ shares of common stock in October. Concurrently, warrants to purchase up to 508,592 ⁴⁵ shares of common stock were issued to investors and placement agent warrants to purchase 35,062 ⁴⁶ shares were issued. In February 2025, the FDA granted Fast Track designation to the BRTX-100 program for chronic lumbar disc disease (cLDD) and cleared an IND application for BRTX-100 for chronic cervical discogenic pain. Preliminary blinded data from the Phase 2 clinical trial of BRTX-100 for cLDD showed no serious adverse events or dose-limiting toxicity in the first 15 patients at 26-104 weeks, and in 36 patients, over 74% showed greater than 50% improvement in function by 52 weeks and over 72% reported greater than 50% reduction in pain by 52 weeks. The Board of Directors authorized a stock repurchase program of up to $2 million ⁴⁷ of common stock over one year in June 2025, though no shares have been repurchased to date. In November 2025, the Company was granted a Type B meeting with the FDA to discuss a potential accelerated Biologics License Application (BLA) approval pathway for BRTX-100, leading to the initiation of Phase 3 enabling activities with a goal of submitting a Phase 3 IND during 2026. In February 2026, the Company completed enrollment of 99 ⁴⁸ patients in its Phase 2 clinical trial of BRTX-100.

The Company anticipates continuing to incur net losses and negative cash flows from operations as it executes its development plans for 2026 and beyond, including potential strategic and business development initiatives. Current funds are not expected to be sufficient to fund development efforts for at least twelve months after the issuance date of the financial statements, nor to fully complete development activities or attain profitable operations. Significant additional funding will be required to complete clinical trials for BRTX-100 and implement the ThermoStem Program and general operations. The Company intends to seek capital through its 2024 ATM program, warrant exercises, investment bankers, biotech funds, strategic partners, and other financial institutions.

A major growth area for the Company is the advancement of its Disc/Spine Program with BRTX-100. Following positive preliminary data from the Phase 2 clinical trial for chronic lumbar disc disease (cLDD), which showed over 74% of 36 subjects with greater than 50% improvement in function by 52 weeks and over 72% with greater than 50% reduction in pain by 52 weeks, the Company has initiated Phase 3 enabling activities. The goal is to submit a Phase 3 IND during 2026, leveraging the Fast Track designation granted by the FDA in February 2025. The FDA also cleared an IND application for BRTX-100 for chronic cervical discogenic pain in February 2025, indicating a potential expansion of the therapeutic's addressable market. The Company believes that the cost of a single BRTX-100 treatment will compare favorably to conservative treatments and be less expensive than common surgical procedures for back pain.

Another significant growth vector is the Metabolic Program (ThermoStem), which is in pre-clinical development. This program aims to develop cell-based therapies for obesity, type 2 diabetes, hypertension, other metabolic disorders, and cardiac deficiencies using brown adipose (fat) derived stem cells (BADSCs). The Company has completed proof-of-concept preclinical animal studies with its first-generation BAT and is developing a next-generation BAT construct with higher purity BADSCs and functional brown adipocytes, exploring encapsulation technology for improved delivery. Patents related to this program have been issued in multiple jurisdictions, including a European patent in March 2025, an Israeli patent in March 2025, and a Japanese patent in September 2025, with an Australian patent expected soon. The Company anticipates much of this development work will occur at its Melville, New York laboratory facility.

Operationally, the Company expects research and development expenses to continue to increase with the continuation of its Disc/Spine and ThermoStem initiatives. General and administrative expenses are also projected to increase as the Company expands its staff, develops its infrastructure, and incurs additional costs to support business growth. The Company's Melville, New York laboratory facility, which includes a cGMP ISO-7 certified clean room, has expanded capabilities for clinical production of cell-based product candidates and commercial products. The Company received a license from the New York State Department of Health (NYSDOH) in May 2023 to act as a tissue bank for processing autologous mesenchymal stem cells and a provisional license in November 2024 for processing allogeneic donor tissue material for medical research.

Planned capital allocation includes continued significant investment in research and development, as evidenced by the expected increase in R&D expenses. The Board of Directors authorized a common stock repurchase program of up to $2,000,000 ⁴⁹ of its outstanding common stock over a one-year period, though no repurchases have been made as of December 31, 2025. The Company recently raised gross proceeds of $5,000,000 ⁵⁰ from a public offering in February 2026, which included the issuance of 12,560,715 ⁵¹ shares of common stock, pre-funded warrants to purchase up to 1,725,000 ⁵² shares, and warrants to purchase up to 14,285,715 ⁵³ shares.

The Company faces structural headwinds and execution risks, including the substantial doubt about its ability to continue as a going concern for at least twelve months after the issuance date of the financial statements due to significant losses and negative cash flows from operations. The Company's current funds are insufficient to complete its clinical trials and implement its business plan, necessitating significant additional financing. There is no assurance that required financing will be obtained on commercially reasonable terms or at all, which could force the Company to curtail or discontinue operations. The FDA approval process is lengthy, expensive, and uncertain, with no guarantee of product approval. The Company may also experience delays in patient enrollment for clinical trials due to the novelty of cell-based therapies, patient population size, eligibility criteria, and patient concerns. Competition from other pharmaceutical, biotechnology, and medical device companies, many with substantially greater resources, is a significant risk, particularly with the extensive use of GLP-1 receptor agonist drugs in the obesity market. The evolving and unpredictable nature of FDA regulation for regenerative medicine products, including the potential for biosimilar competition after 12 years of exclusivity, also poses a risk.

The Company faces substantial doubt about its ability to continue as a going concern for at least twelve months after the issuance date of the financial statements, having incurred a net loss of $14.2 million ⁵⁴ and negative cash flows from operations of $10.8 million ⁵⁵ for the year ended December 31, 2025, and a working capital deficit of $0.6 million ⁵⁶ as of December 31, 2025. The future success is significantly dependent on the timely and successful development and commercialization of BRTX-100, which is subject to lengthy, expensive, and uncertain clinical trials, with no guarantee of regulatory approval. Delays in patient enrollment, the inherent variability of autologous cell therapy, and potential disruptions to the supply of media and reagents could adversely affect clinical trials. The Company lacks manufacturing capabilities to produce product candidates at commercial scale quantities and does not have an alternate manufacturing supply, which could negatively impact future demand. Competition is intense from numerous pharmaceutical, biotechnology, and medical device companies, many with substantially greater financial, technological, R&D, marketing, and personnel resources, including the increased competition in the obesity market from GLP-1 receptor agonist drugs. The evolving and unpredictable nature of FDA regulation for regenerative medicine products, including the potential for biosimilar competition after a 12-year exclusivity period, and competition from unapproved stem cell therapies, pose significant risks. The Company is also exposed to significant product liability claims and litigation, and its insurance may be inadequate. Cybersecurity risks, including potential system failures or security breaches, could disrupt development programs. The inability to obtain reimbursement for products and services from private and governmental insurers could negatively impact demand. Changes to United States patent law, such as the Leahy-Smith America Invents Act, and recent Supreme Court decisions, create uncertainty regarding the ability to obtain and maintain patents, and the risk of compulsory licenses in certain countries could detrimentally affect future revenues. The Company is also subject to ongoing regulatory oversight, federal and state healthcare fraud and abuse laws, false claims laws, and health information privacy and security laws, with potential for substantial penalties for non-compliance.

Management's overall tone emphasizes the Company's commitment to developing therapeutic products using cell and tissue protocols, primarily adult stem cells, and advancing its core programs. They highlight the progress in the Disc/Spine Program with BRTX-100, noting the FDA's Fast Track designation and IND clearance for chronic cervical discogenic pain, as well as positive preliminary Phase 2 clinical trial data showing over 74% ⁵⁷ of subjects with greater than 50% ⁵⁸ improvement in function and over 72% ⁵⁹ with greater than 50% ⁶⁰ reduction in pain by 52 weeks. A key strategic priority is the initiation of Phase 3 enabling activities for BRTX-100 with the goal of submitting a Phase 3 IND during 2026. Management also underscores the ongoing pre-clinical development of the ThermoStem Program for metabolic disorders and the commercial operations of the biocosmeceuticals platform, with intentions to expand its offerings. Despite these advancements, management explicitly states that the Company anticipates continuing to incur net losses and negative cash flows from operations and that current funds may not be sufficient to fund development efforts for at least twelve months after the issuance date of the financial statements, raising substantial doubt about its ability to continue as a going concern. They plan to seek significant additional funding through various channels to complete clinical trials and implement business plans.