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Here are 1-3 brief analogies for BioRestorative Therapies (BRTX):

• It's like a biotech company similar to Moderna, but focusing on regenerative stem cell therapies for conditions like chronic back pain and obesity instead of mRNA-based treatments.
• Think of it as an early-stage Vertex Pharmaceuticals, but applying adult stem cells to treat disc degeneration and metabolic diseases, rather than developing drugs for genetic disorders.

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• BRTX-100: An autologous cell therapy candidate using cultured mesenchymal stem cells for the non-surgical treatment of painful lumbosacral disc disorders.
• ThermoStem: A preclinical cell-based therapy candidate using brown adipose derived stem cells to generate brown adipose tissue for obesity and metabolic disorders.
• Investigational Curved Needle Device: A device designed to deliver cells or other therapeutic materials to the spine and discs.

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BioRestorative Therapies (BRTX) is a pre-commercial life sciences company primarily focused on the research and development of regenerative medicine products and therapies. Its lead cell therapy candidate, BRTX-100, has completed Phase 1 clinical trials, and another candidate, ThermoStem, is in preclinical development. As such, the company does not currently have commercialized products or therapies available for sale.

Therefore, BioRestorative Therapies does not have major customers in the traditional sense of entities purchasing its products or services. Its relationships with other companies such as Rohto Pharmaceutical Co., Ltd., Pfizer, Inc. (PFE), and the University of Pennsylvania are described as research and development agreements or collaborations, rather than direct commercial sales relationships.

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Lance Alstodt, President, Chief Executive Officer and Chairman of the Board

Mr. Alstodt was appointed President, Chief Executive Officer, and Chairman of the Board of BioRestorative Therapies on November 16, 2020. He previously served as EVP & Chief Strategy Officer from October 2018 to February 2020. With over 25 years of experience, Mr. Alstodt has led medical technology and life sciences companies in areas such as operations, capital raising, strategy, and mergers and acquisitions. Prior to joining BioRestorative Therapies, he founded and served as CEO of MedVest Consulting Corporation, an advisory and capital firm focused exclusively on the healthcare sector. Before MedVest, he had a distinguished career as an investment banker specializing in healthcare, including mergers and acquisitions, at firms like Leerink Partners, Oppenheimer & Co., Bank of America Merrill Lynch, and J.P. Morgan Chase, where he worked on acquisitions, leveraged buyouts, financings, and exclusive sales.

Robert Kristal, Chief Financial Officer and Principal Accounting Officer

Mr. Kristal was appointed Chief Financial Officer in November 2021. He brings over 25 years of strategic and financial markets experience, having advised global public life sciences companies on corporate finance, operations management systems, and strategic collaborations. An experienced Wall Street and Bay Street professional, he has built teams in institutional sales and equity research at firms with a notable presence in healthcare research and capital market activities. Most recently, he served as the Head of Research for H.C. Wainwright. His prior roles include Managing Director at T.R Winston and Rodman & Renshaw, and SVP at Merriman Curhan Ford & Co.

Francisco Silva, Chief Scientist & Vice President, Research and Development, Secretary and Director

Mr. Silva joined BioRestorative Therapies in April 2011 and serves as Vice President of Research and Development, as well as Chief Scientist, Secretary, and Director. He is responsible for all laboratory operations and is actively involved in the development and expansion of the company's stem cell programs. Previously, Mr. Silva held the position of Chief Executive Officer for two companies focused on the commercialization of human-based biologics for both research and therapeutic applications. From 2003 to 2007, he was the Vice President of Research and Development for PrimeGen Biotech LLC. He holds multiple patents related to stem cells, is the inventor of the brown fat technology utilized by BRTX, and has published numerous articles on stem cell research.

Crystal Romano, Global Head of Commercial Operations

Ms. Romano joined BioRestorative Therapies' management team in October 2025. In her role, she is responsible for leading the company's global commercial operations and innovation initiatives. She brings over 19 years of progressive leadership experience across the medical, aesthetics, and regenerative industries, with expertise in product development, innovation, commercialization, sales, account management, clinical and product training, and navigating patent and FDA regulations. Ms. Romano has held pivotal roles at leading organizations such as Cartessa and Lumenis, where she spearheaded medical aesthetics product innovation, development, and commercialization. Most recently, as Head of Innovation and Emerging Technologies at Cartessa, she successfully conceptualized, developed, and commercialized over 11 new products and a biologics line in under two years. She started her career at Integra LifeSciences and MiMedx, where she contributed to their placental and amniotic biologics product lines.

Sandy Lipkins, Technology Commercialization and Business Development

Mr. Lipkins joined BioRestorative Therapies in June 2025, focusing on technology commercialization and business development. He is responsible for sourcing, structuring, negotiating, and executing strategic alliances and licensing/co-development agreements both domestically and internationally, as well as providing expertise in new products and sales. With over 30 years of experience in venture capital, finance, and sales within the healthcare industry, he possesses deep expertise in the anti-aging and wellness sectors. Mr. Lipkins has a proven track record of business development success and has been instrumental in taking companies from incubation to revenue generation and growth, and preparing them for sale or other liquidity events. His extensive experience and network in stem cells, regenerative medicine, and tissue banking have contributed to the development of numerous cutting-edge therapies.

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1. Clinical Development and Regulatory Approval Risk

   BioRestorative Therapies' primary product candidate, BRTX-100, which aims to treat chronic lumbar disc disease, has completed Phase 2 enrollment and is planning for Phase 3 activities in 2026, with top-line results from Phase 2 expected in early 2027. Its other program, ThermoStem, is in the preclinical stage. [BACKGROUND] Companies in the biotechnology sector, especially those with products in early to mid-stage clinical trials, face inherent and significant risks related to regulatory approvals and clinical trial outcomes. A substantial majority of regenerative medicine therapies do not advance past early trials due to issues with efficacy or safety. Even if clinical trials demonstrate success, securing regulatory approval from agencies such as the FDA is a lengthy, complex, and uncertain process with no guarantee of approval. Although BRTX-100 has shown preliminary safety in earlier studies, the broader regenerative medicine field carries risks such as potential tumor formation, immune reactions, and infections.

2. Significant Capital Requirements and Funding Uncertainty

   As an early-stage clinical company, BioRestorative Therapies has reported significant profitability challenges, as evidenced by its operating margin of -3789.03% and net margin of -3308.09%. The company's financial health grades, including its Altman Z-Score and Piotroski F-Score, highlight financial distress and operational challenges. Developing and bringing cell-based therapies to market is a highly capital-intensive endeavor. BioRestorative Therapies recently raised $5 million through a public offering to fund its clinical trials and development initiatives, indicating an ongoing need for substantial additional capital to progress its product candidates through later-stage clinical trials, manufacturing scale-up, and potential commercialization. Failure to secure sufficient funding on favorable terms could severely impede or halt the development of its therapeutic programs.

3. Competition and Market Acceptance Challenges

   BioRestorative Therapies operates within the competitive biotechnology sector, focusing on regenerative medicine for disc/spine disease and metabolic disorders. [BACKGROUND, 4] This field includes both existing conventional treatments and emerging regenerative therapies. The company faces competition from larger pharmaceutical and biotech companies that possess vast resources and established distribution networks. Even if BRTX's product candidates achieve regulatory approval, there is a risk that the market may not widely adopt their cell-based therapies. Factors such as treatment cost, complex administration, and the need to convince insurance providers for coverage can hinder market penetration and acceptance, despite the potential to address unmet medical needs.

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• Highly effective and scalable allogeneic (off-the-shelf) cell therapies for disc/spine disorders: BioRestorative Therapies' lead candidate, BRTX-100, is an autologous (patient's own cells) therapy, requiring individual cell collection and processing. If competing companies successfully develop allogeneic cell therapies for painful lumbosacral disc disorders that demonstrate comparable or superior efficacy and safety, along with the advantages of mass production, easier distribution, and potentially lower costs, they could significantly disrupt the market for BRTX-100.
• Next-generation pharmaceutical interventions for obesity and metabolic disorders: BioRestorative Therapies' Metabolic Program (ThermoStem) is in the preclinical stage, targeting obesity and metabolic disorders with a cell-based therapy. The rapid advancement and market penetration of highly effective pharmacological treatments, such as advanced GLP-1 receptor agonists and other novel drug classes, are increasingly offering simpler, more convenient, and potentially more cost-effective solutions for these conditions. This ongoing pharmaceutical innovation could diminish the future market opportunity for a complex, cell-based therapy like ThermoStem, particularly as it progresses through development.

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BioRestorative Therapies (BRTX) Addressable Markets

BRTX-100 for Disc/Spine Disease

ThermoStem for Obesity and Metabolic Disorders

Investigational Curved Needle Device for Spinal Delivery

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1. Advancement and Potential Accelerated Approval of BRTX-100: BioRestorative Therapies completed enrollment for its Phase 2 clinical trial of BRTX-100 for chronic lumbar disc disease (cLDD) in February 2026. The company has also achieved a positive outcome from its Type B meeting with the FDA, providing clarity for an expedited Biologics License Application (BLA) approval pathway. The initiation of Phase 3 enabling activities and submission of the Phase 3 IND amendment are targeted for the second half of 2026, with topline Phase 2 results expected in early 2027. Furthermore, the company plans to seek strategic partnerships in states like Utah, Wyoming, Texas, and Florida, which allow providers to offer therapies such as BRTX-100 even before full BLA approval, potentially enabling earlier commercialization and revenue generation.
2. Licensing of ThermoStem Metabolic Intellectual Property: BioRestorative Therapies is actively engaged in substantive discussions for a potential licensing agreement concerning its allogeneic, off-the-shelf ThermoStem metabolic intellectual property (IP) with an undisclosed commercial-stage regenerative medicine company. This program, which targets obesity and metabolic disorders, has recently seen expanded global patent protection, including allowances in Japan (October 2025) and Australia (February 2026), strengthening its commercial potential. A successful licensing deal could provide significant upfront payments and future milestone revenues.
3. Expansion and Growth of the BioCosmeceutical Platform: The company is accelerating its commercial BioCosmeceutical strategy, with expectations for it to contribute meaningfully to revenue in 2026. This involves expanding distribution of its secretome-based biologics across global partners, clinics, and direct-to-consumer (DTC) channels, as well as optimizing manufacturing throughput. BioRestorative Therapies also intends to explore expanding its commercial offerings to include a broader range of cell-based biologic aesthetic products and therapeutics.

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Share Repurchases

• BioRestorative Therapies authorized a stock repurchase program on June 17, 2025, allowing for the repurchase of up to $2 million of its outstanding common stock.
• This repurchase program is authorized to continue through June 16, 2026.

Share Issuance

• In February 2026, BioRestorative Therapies closed a public offering, raising approximately $5.0 million in gross proceeds.
• The offering involved the sale of 14,285,715 common shares (or pre-funded warrants) and warrants to purchase an equal number of shares at a combined public offering price of $0.35 per share.
• The warrants issued are immediately exercisable at $0.35 per share and will expire five years from their issuance date.

Inbound Investments

• The company strengthened its capital position with a $5.0 million public offering in February 2026.

Capital Expenditures

• For the trailing twelve months ending September 30, 2025, the capital expenditure (CapEx) year-over-year growth rate was -70.18%.
• In 2024, capital expenditures amounted to $106,000.
• Proceeds from the February 2026 public offering are intended to fund clinical trials for the BRTX-100 disc/spine program, preclinical research for the ThermoStem metabolic program, development of the commercial biocosmeceuticals platform, and general corporate purposes.