BioRestorative Therapies, Inc. (BRTX): History, Ownership, Mission, How It Works & Makes Money

BioRestorative Therapies, Inc. (BRTX): History, Ownership, Mission, How It Works & Makes Money

US | Healthcare | Biotechnology | NASDAQ

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How does a regenerative medicine company like BioRestorative Therapies, Inc. (BRTX), with a Q3 2025 net loss of $3.0 million, continue to drive multi-billion dollar market opportunities? This clinical-stage innovator is focused on autologous stem cell therapy (BRTX-100) for chronic lower back pain and an allogeneic platform (ThermoStem) for metabolic disorders, securing a crucial FDA Fast Track designation for BRTX-100 and a new Japanese patent for ThermoStem in 2025. Despite Q3 2025 revenue of approximately $11,800-a sharp decline from the prior year due to order timing in their BioCosmeceutical segment-the company's value defintely hinges on these regulatory and intellectual property milestones, not near-term sales. You need to understand the underlying science and financial structure to accurately map the risk-reward profile here, especially with only $4.5 million in cash and marketable securities at the end of Q3 2025.

BioRestorative Therapies, Inc. (BRTX) History

If you are looking at BioRestorative Therapies, Inc., you are really looking at a company with a long fuse that has only recently begun to spark. It started as a Delaware corporation back in 1997, but its modern identity as a regenerative medicine player didn't solidify until its strategic pivot to stem cell therapies around 2008. That long runway is important context for understanding its current clinical focus and financial profile.

The company is a classic example of a biotech firm burning cash for years in pursuit of a massive, multi-billion dollar market opportunity. For the first three quarters of the 2025 fiscal year alone, the combined net loss was substantial, totaling $11.0 million (Q1: $5.3 million; Q2: $2.7 million; Q3: $3.0 million), which tells you everything about its R&D-heavy model. You're investing in the science, not the current revenue stream.

Given Company's Founding Timeline

Year established

BioRestorative Therapies, Inc. was incorporated in Delaware in 1997.

Original location

While incorporated in Delaware, the company's operational base was established later, and it is currently headquartered in Melville, New York.

Founding team members

The initial efforts were driven by scientists and researchers committed to developing cell-based therapies. The specific individual founder names from that early period are less prominent than the subsequent executive and scientific teams that shaped the current clinical programs.

Initial capital/funding

Operations were initially funded through private capital raises. The company later accessed public markets to fund its clinical development programs, including a recent registered direct offering in October 2025 that raised approximately $1.085 million in gross proceeds.

Given Company's Evolution Milestones

Year Key Event Significance
1997 Incorporated in Delaware. Formal legal establishment, setting the stage for future corporate structure.
~2008 Strategic Shift to Regenerative Medicine. Moved focus entirely to stem cell therapies, defining the core business model today.
2013 Licensed ThermoStem® Program. Acquired the brown fat technology license, expanding the pipeline into metabolic disorders like obesity and diabetes.
2017 Commenced Phase 2 Clinical Trial for BRTX-100. Began the clinical-stage development of the lead autologous cell therapy candidate for chronic lumbar disc disease (cLDD).
2021 Uplisted to the NASDAQ Capital Market (BRTX). Increased visibility, liquidity, and access to a broader pool of institutional capital.
Feb 2025 BRTX-100 Granted FDA Fast Track Designation. A major regulatory win, enabling more collaborative interaction with the FDA and potential for an accelerated Biologics License Application (BLA) pathway.
Jun 2025 Presented Promising BRTX-100 Phase 2 Data. Updated preliminary blinded data showed over 74% of subjects had >50% improvement in function (ODI) and over 72% had >50% reduction in pain (VAS) by 52 weeks.
Oct 2025 Japanese Patent Office Notice of Allowance for ThermoStem®. Expanded intellectual property protection for the metabolic program, targeting a potential cell-based alternative to the multi-billion dollar GLP-1 drug market.

Given Company's Transformative Moments

The company's trajectory has been defined by two major transformative decisions: the early pivot to regenerative medicine and the strategic pursuit of a dual-program pipeline.

The 2008 shift from its initial, less-defined corporate structure to a pure-play regenerative medicine company was the first, most defintely crucial, move. This focus allowed it to attract the specialized talent and capital needed for the high-risk, high-reward world of stem cell therapy.

The second major moment is the concentrated clinical and financial execution seen in 2025. This year has been all about validating the core technology and strengthening the balance sheet to sustain the burn rate. For example, the FDA's Fast Track designation in February 2025 for BRTX-100 is a game-changer; it means the agency sees the potential for this therapy to address a serious unmet medical need.

  • Clinical Validation: The June 2025 Phase 2 data presentation confirmed the BRTX-100 program's potential, showing compelling efficacy signals well above the FDA's minimum required thresholds (30% improvement) for a significant portion of subjects.
  • IP Diversification: The October 2025 Japanese patent allowance for ThermoStem® is key. It positions the metabolic program to potentially compete with GLP-1 drugs, giving the company a valuable, allogeneic (off-the-shelf) asset outside its primary disc/spine program.
  • Financial Fortification: The company ended Q3 2025 with $4.5 million in cash, cash equivalents, and marketable securities, plus the subsequent October financing. This capital is critical, as the total net loss for the first nine months of 2025 was $11.0 million, underscoring the need for continued strategic financing to reach the next clinical inflection point.

To understand the full context of these moves, especially the institutional interest in their financing rounds, you should read Exploring BioRestorative Therapies, Inc. (BRTX) Investor Profile: Who's Buying and Why?

BioRestorative Therapies, Inc. (BRTX) Ownership Structure

BioRestorative Therapies, Inc.'s ownership is currently dominated by retail investors, but insiders hold a significant stake, which aligns their interests directly with the company's long-term clinical success. This structure means that a large portion of the stock is held by the general public, but the management team and affiliated parties retain a powerful block of shares, driving the strategic direction.

BioRestorative Therapies, Inc.'s Current Status

BioRestorative Therapies, Inc. is a publicly traded, clinical-stage biotechnology company. It trades on the NASDAQ Capital Market under the ticker symbol BRTX. As a micro-cap biotech, its financial health is closely tied to clinical milestones, not near-term revenue. For instance, the company reported a Q3 2025 net loss of $3.0 million, or $0.33 per share, with revenues totaling just $11,800 from royalties. This low revenue and high burn rate is typical for a company focused on Phase II clinical trials, like its lead candidate BRTX-100 for chronic lumbar disc disease. If you want to dive deeper into the financials, you can check out Breaking Down BioRestorative Therapies, Inc. (BRTX) Financial Health: Key Insights for Investors.

BioRestorative Therapies, Inc.'s Ownership Breakdown

The company's ownership is heavily weighted toward individual shareholders, which can lead to higher stock volatility, but the substantial insider stake provides a clear signal of management's conviction. As of November 2025, the breakdown is as follows, with the remaining percentage held by the general public.

Shareholder Type Ownership, % Notes
Insiders (Management & Affiliates) 24.02% A strong stake that aligns leadership's financial interests with shareholder returns.
Institutions (Funds, Banks) 8.77% Includes major holders like Vanguard Group and Geode Capital Management, Llc.
Retail/Public Investors 67.21% The largest group, calculated as the remainder of the float.

The institutional holding of 8.77% is relatively low for a NASDAQ-listed company, but it's defintely anchored by a high-conviction group of healthcare specialist investors, which is a positive sign.

BioRestorative Therapies, Inc.'s Leadership

The company is steered by a small, experienced leadership team with an average tenure of five years, which is solid for a clinical-stage biotech. Their compensation structure reflects the high-risk, high-reward nature of the industry.

  • Lance Alstodt: President, Chief Executive Officer, and Chairman of the Board. He has led the company since November 2020, with a 2025 total compensation of $1.31 million.
  • Robert Kristal: Chief Financial Officer. He provides over 25 years of Wall Street and Bay St. experience, with a 2025 compensation of $683.75 thousand.
  • Francisco Silva: Vice President of Research & Development. A key figure in the company's stem cell programs, his 2025 compensation is reported at $1.23 million.
  • Crystal Romano: Global Head of Commercial Operations. Appointed in October 2025 to accelerate the BioCosmeceutical business, she brings two decades of experience in the medical and aesthetics industries.

Here's the quick math on cash: the company ended Q3 2025 with $4.5 million in cash and marketable securities, plus a subsequent October financing that raised gross proceeds of about $1.085 million. This cash position is what the leadership team must manage to fund the ongoing Phase II clinical trial and commercial expansion.

BioRestorative Therapies, Inc. (BRTX) Mission and Values

BioRestorative Therapies, Inc. (BRTX) is fundamentally driven by a commitment to regenerative medicine, aiming to develop cell-based therapies that address significant unmet needs in chronic conditions like degenerative disc disease and metabolic disorders. This focus on pioneering non-surgical, cell-based solutions forms the core of its mission, which is backed by a realist view of its commercial engine and clinical progress.

Given Company's Core Purpose

The company's purpose is rooted in translating complex stem cell science into tangible, therapeutic products. This is not just about R&D; it's about creating a viable, scalable alternative to conventional medicine, which is a major value driver for investors.

  • Develop therapeutic products using cell and tissue protocols, primarily involving adult stem cells.
  • Condition the body's own regenerative potential to treat major diseases more effectively than current interventions.
  • Address unmet medical needs in patients with highly prevalent conditions, such as chronic lumbar disc disease and metabolic disorders.

To be fair, the company is still in the clinical stage for its lead candidates, so this mission is a long-term goal. For instance, the company reported a Q3 2025 net loss of $3.0 million, which is a clear reminder that the financial payoff is still ahead, tied directly to advancing these clinical programs.

Official mission statement

While BioRestorative Therapies does not publish a single, formal mission statement in the traditional sense, its consistent messaging centers on being a 'regenerative medicine innovator focused on stem cell-based therapies and products.' This is the clearest articulation of what they do and why they exist.

  • Pioneer autologous (a person's own) cultured mesenchymal stem cell therapy, like BRTX-100, for non-surgical treatment of painful lumbosacral disc disorders.
  • Advance the ThermoStem platform, a brown adipose-derived stem cell technology, to target the multi-billion dollar obesity and metabolic disorders market.
  • Build a growing commercial engine through the BioCosmeceutical platform, which generated approximately $11,800 in royalty revenue in Q3 2025.

You can learn more about their strategic focus here: Mission Statement, Vision, & Core Values of BioRestorative Therapies, Inc. (BRTX).

Vision statement

The company's vision is clearly focused on becoming a market leader by offering superior, cell-based alternatives to existing treatments, particularly in high-growth areas like the $100 billion global obesity market projected by the end of the decade.

  • Deliver meaningful value creation by accelerating clinical progress and expanding the commercial engine.
  • Offer a regenerative cell-based solution to mitigate tolerability issues associated with chronic treatments like GLP-1 drugs for metabolic disorders.
  • Revolutionize treatment for chronic lower back pain, aiming for an accelerated Biologics License Application (BLA) approval pathway for BRTX-100, which has received FDA Fast Track designation.

It's a bold vision, but still, the path requires careful resource management; the company ended Q3 2025 with $4.5 million in cash and marketable securities, plus a subsequent financing of approximately $1.1 million gross proceeds.

Given Company slogan/tagline

BioRestorative Therapies does not use a fixed, external slogan, but their repeated self-description and core product focus point to a clear, action-oriented tagline that captures their innovative identity.

  • Regenerative Medicine Innovator.
  • Harnessing the Body's Regenerative Potential.
  • Cell-Based Therapies for Unmet Needs.

That last one, 'Cell-Based Therapies for Unmet Needs,' defintely sums up their dual focus on disc disease and metabolic disorders.

BioRestorative Therapies, Inc. (BRTX) How It Works

BioRestorative Therapies, Inc. (BRTX) is a regenerative medicine innovator that creates value by developing and commercializing stem cell-based therapies for chronic, highly prevalent conditions like disc/spine disease and metabolic disorders. Its business model is currently a hybrid, generating minimal revenue from a commercial platform while the main focus is on advancing two multi-billion dollar market opportunity clinical programs through FDA trials.

The company's primary financial focus is on clinical development, which is why the Q3 2025 net loss was $3.0 million, compared to a net loss of $1.0 million in Q3 2024. Still, they ended Q3 2025 with a cash position of $4.5 million, plus an additional approximate $1.1 million gross raised in a subsequent financing.

BioRestorative Therapies, Inc.'s Product/Service Portfolio

Product/Service Target Market Key Features
BRTX-100 (brtxDISC™) Chronic Lumbar Disc Disease (cLDD) and Cervical Discogenic Pain patients who face surgery. Autologous (patient's own) cultured mesenchymal stem cells. Non-surgical, single outpatient injection intended to repair damaged discs. Currently in a Phase 2 clinical trial.
ThermoStem® Program Obesity and related metabolic disorders. Allogeneic (off-the-shelf) brown adipose-derived stem cells (BADSC) and their secreted exosomes. Aims to generate brown adipose tissue (BAT) to regulate metabolic homeostasis.
BioCosmeceutical Platform Aesthetic medicine market (physicians, spas). Cell-based biologic aesthetic products. Generates near-term revenue, which was approximately $303,000 in Q2 2025, primarily through an exclusive supply agreement with Cartessa Aesthetics, LLC.

BioRestorative Therapies, Inc.'s Operational Framework

The company's operational framework centers on a proprietary cell culturing and expansion process, which is the core of their value creation. They are essentially a biotech research and development firm with a small commercial arm.

  • Cell Sourcing and Processing: For BRTX-100, the process begins with collecting the patient's own bone marrow. They isolate and culture the mesenchymal stem cells (MSCs) using proprietary technology to expand the cell population.
  • Cryopreservation and Delivery: The cultured cells are then cryopreserved (frozen) and prepared for injection. The final BRTX-100 product is intended for a physician to inject into the patient's damaged disc in an outpatient procedure.
  • Metabolic Development: The ThermoStem® platform focuses on developing allogeneic (non-patient-specific) brown adipose-derived stem cells (BADSC) and their exosomes, which simplifies logistics by creating an off-the-shelf therapeutic.
  • Commercialization: The BioCosmeceutical platform provides a modest, near-term revenue stream to help offset R&D costs, with sales managed through a partnership, allowing the core team to focus on clinical trials. Q3 2025 revenue was only $11,800, consisting exclusively of royalty revenue.

BioRestorative Therapies, Inc.'s Strategic Advantages

The company's market success hinges on its ability to translate proprietary cell science into FDA-approved treatments, which is a high-risk, high-reward strategy. It's a race to commercialization.

  • Proprietary Autologous Technology: BRTX-100 uses the patient's own cells (autologous), which significantly reduces the risk of rejection and is protected by proprietary culturing technology.
  • FDA Fast Track Designation: BRTX-100 has been granted Fast Track designation by the FDA for chronic lumbar disc disease, which could accelerate the Biologics License Application (BLA) approval pathway. That's a defintely big deal.
  • Intellectual Property Moat: They are methodically building a comprehensive patent portfolio. In October 2025, they announced a Japanese Notice of Allowance for the ThermoStem® platform, providing broad protection for their allogeneic BADSC technology, which is positioned as a potential alternative to the multi-billion dollar GLP-1 drug market.
  • Targeting Unmet Needs: Both BRTX-100 and ThermoStem® address multi-billion dollar markets (disc disease, obesity) where current non-surgical or non-drug treatments are often inadequate or have significant side effects.

If you want a deeper dive into who is betting on these advantages, check out Exploring BioRestorative Therapies, Inc. (BRTX) Investor Profile: Who's Buying and Why?

BioRestorative Therapies, Inc. (BRTX) How It Makes Money

BioRestorative Therapies, Inc. is a clinical-stage biotechnology company, so its primary financial engine is built on capital raises and intellectual property (IP) value rather than commercial product sales of its main therapies.

Still, the company generates near-term, albeit low-volume, revenue through its commercial BioCosmeceutical platform and small royalty payments from its technology, which helps to partially offset the high research and development (R&D) costs inherent in advancing its cell therapy candidates, BRTX-100 and ThermoStem®.

BioRestorative Therapies, Inc.'s Revenue Breakdown

The company's revenue is highly volatile due to the nature of its current commercial platform, which is subject to the timing of large orders. For instance, the third quarter of 2025 saw revenue plummet due to order timing, making the second quarter's breakdown a better reflection of the near-term commercial strategy.

Revenue Stream % of Total (Q2 2025) Growth Trend
BioCosmeceutical Product Sales ~98.9% Increasing (Q2 2025 sales were up 240% year-over-year)
Royalty/Licensing Revenue ~1.1% Fluctuating (Represents 100% of Q3 2025 revenue, but of a small total)

Here's the quick math: In the second quarter of 2025, BioRestorative Therapies, Inc. reported approximately $303,000 in total revenue, with the vast majority coming from BioCosmeceutical product sales under an exclusive supply agreement with Cartessa Aesthetics, LLC. By contrast, in the third quarter of 2025, total revenue dropped to just $11,800, which consisted entirely of royalty revenue, demonstrating the extreme volatility of the developing BioCosmeceutical stream.

Business Economics

The core economic reality for BioRestorative Therapies, Inc. is that it is a high fixed-cost, pre-revenue biotech firm; its valuation rests almost entirely on the success of its two clinical-stage programs, not on its current sales. This is defintely a high-risk, high-reward model.

  • Cost-Plus R&D Model: The company's main expenditure is Research and Development (R&D), which totaled approximately $8.9 million for the nine months ended September 30, 2024, reflecting the intense focus on advancing BRTX-100. This R&D spend is essentially the cost of creating the future product.
  • IP Value Creation: The company's future revenue will come from either a lucrative licensing deal for its intellectual property (IP) or direct commercialization of its cell therapies, like BRTX-100 for chronic lumbar disc disease or ThermoStem® for metabolic disorders. The recent Japanese patent allowance for the ThermoStem® platform, for instance, strengthens its position in the multi-billion-dollar obesity market, creating a significant future licensing opportunity.
  • BioCosmeceutical Margin: The commercial BioCosmeceutical platform, while small, is designed as a near-term revenue source to build a commercial infrastructure and potentially generate higher-margin product sales under its exclusive supply agreement. This is a strategic move to secure a small, immediate revenue stream while the main clinical candidates progress.

You need to read the full story on the investors backing this model. Exploring BioRestorative Therapies, Inc. (BRTX) Investor Profile: Who's Buying and Why?

BioRestorative Therapies, Inc.'s Financial Performance

As of November 2025, the financial performance of BioRestorative Therapies, Inc. is characterized by significant losses that are typical for a company deep in the clinical trial phase, but with a recent strengthening of its balance sheet.

  • Net Loss: The net loss for the third quarter of 2025 was $3.0 million, or $0.33 per share, which is a widening from the $1.0 million net loss reported in the comparable period of 2024.
  • Operating Loss: The loss from operations for Q3 2025 was $3.7 million, compared to $2.3 million for Q3 2024. This increase reflects the continued, and accelerating, investment in clinical development and general corporate activities.
  • Cash Position: The company ended the third quarter of 2025 with cash, cash equivalents, and marketable securities of $4.5 million. Critically, this was bolstered by an additional approximately $1.1 million in gross proceeds from a registered direct offering completed in October 2025, subsequent to the quarter end, with no outstanding debt.
  • Burn Rate: With a loss from operations of $3.7 million for the quarter, the company's cash burn rate is substantial, meaning the recent $5.6 million total cash position (Q3 end cash plus subsequent raise) provides a runway of only a few quarters at the current spend rate.

BioRestorative Therapies, Inc. (BRTX) Market Position & Future Outlook

BioRestorative Therapies, Inc. is positioned as a high-risk, high-reward clinical-stage innovator, with its near-term value tied to the successful advancement of its lead candidate, BRTX-100, and the commercial ramp-up of its BioCosmeceuticals platform. The company's future trajectory hinges on a potential accelerated Biologic License Application (BLA) pathway for BRTX-100, which would unlock a multi-billion-dollar market opportunity in chronic lumbar disc disease (cLDD).

Competitive Landscape

In the regenerative medicine space, BioRestorative Therapies competes with both clinical-stage biotech firms and established commercial clinics, plus large pharmaceutical companies entering the obesity market. Since BRTX-100 is in a Phase II clinical trial, its current market share is nominal, primarily driven by its commercial BioCosmeceuticals platform.

Company Market Share, % Key Advantage
BioRestorative Therapies, Inc. <1% Autologous (patient's own) mesenchymal stem cell therapy (BRTX-100) with FDA Fast Track designation for cLDD.
QC Kinetix ~5% (Regenerative Clinics) Broad national network of non-surgical regenerative medicine clinics offering PRP and stem cell treatments.
Adipo Therapeutics LLC <1% (Preclinical/Obesity) Direct competitor in the brown fat (BAT) therapy space, also developing a novel approach to convert white fat to brown fat for obesity.

Opportunities & Challenges

As a clinical-stage biotech, the company faces a mix of massive market opportunities and significant development hurdles, which is typical for the sector. Honestly, the biggest swing factor is the FDA's decision on the BLA pathway for BRTX-100.

Opportunities Risks
Potential for accelerated BLA approval for BRTX-100 due to Fast Track designation. Uncertainty in the timing and outcome of the anticipated FDA Type B meeting in late 2025/early 2026.
ThermoStem program targeting the obesity/metabolic disorder market, projected to exceed $100 billion annually. Heavy dependence on the success of two key programs (BRTX-100 and ThermoStem); failure of either would be a major setback.
Expansion of the BioCosmeceuticals platform targeting the $63 billion market, providing an immediate, though volatile, revenue stream. High operating losses; Q3 2025 net loss was $3.0 million, up from $1.0 million in Q3 2024.

Industry Position

BioRestorative Therapies, Inc. is a small-cap player in the vast regenerative medicine market, but it has carved out a distinct niche with its proprietary cell-based platforms. The company's focus on autologous (using the patient's own cells) mesenchymal stem cells (MSCs) for cLDD, and allogeneic (off-the-shelf) brown adipose-derived stem cells for metabolic disorders, gives it a unique two-pronged approach.

The company's financial footing is lean but stable for a pre-commercial biotech, ending Q3 2025 with $4.5 million in cash, cash equivalents, and marketable securities, plus a subsequent $1.1 million financing, and importantly, zero outstanding debt. This runway is critical for funding the final push of the BRTX-100 Phase II trial, which is nearing completion.

  • BRTX-100 is an autologous therapy, which generally carries a lower risk of rejection and is a preferred segment in the disc disease stem cell therapy market.
  • The ThermoStem program's allogeneic approach is designed to be an alternative to chronic GLP-1 injections, mitigating tolerability issues like muscle mass loss.
  • Q3 2025 revenue was only $11,800, a sharp decline from Q3 2024's $233,600, due to the timing of BioCosmeceutical orders, so revenue is defintely lumpy.

Analysts project the company could reach breakeven by 2027, with anticipated positive profits of $17 million that year, but this relies on an optimistic annual growth rate of 74%. For a deeper dive into the specifics of their cash burn and balance sheet, you should read Breaking Down BioRestorative Therapies, Inc. (BRTX) Financial Health: Key Insights for Investors.

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