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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Ever wondered how a clinical-stage company like BioRestorative Therapies, Inc. (BRTX) navigates the high-stakes world of regenerative medicine, especially after reporting research and development expenses of approximately $4.4 million for the year ended December 31, 2023? This firm is carving out a niche with its cell-based therapy programs, notably advancing its BRTX-100 candidate through Phase 2 trials for chronic lumbar disc disease. But what drives its mission, who holds the reins, and how does it plan to turn promising science into sustainable revenue? Are you curious about the intricate journey from lab bench to potential market success and what makes this company tick?

BioRestorative Therapies, Inc. (BRTX) History

Founding Timeline

The company's journey began several years ago, laying the groundwork for its future focus.

Year established

1997 (Incorporated in Delaware)

Original location

Incorporated in Delaware; operational base established later, currently headquartered in Melville, New York.

Founding team members

Established through initial efforts by its early management and stakeholders. Specific individual founder details from that period are less prominent than the company's subsequent strategic shifts.

Initial capital/funding

Operations were initially funded through private capital raises before accessing public markets later in its development.

Evolution Milestones

The company navigated several critical phases, evolving its focus and operational structure.

Year Key Event Significance
~2008 Strategic Shift Began focusing on regenerative medicine and stem cell therapies.
2013 Technology Licensing Acquired license for ThermoStem Program (brown fat technology), expanding into metabolic disease applications.
2017 Clinical Trial Initiation Commenced Phase 2 clinical trial for BRTX-100 targeting chronic lumbar disc disease (cLDD).
2021 NASDAQ Uplisting Successfully uplisted to the NASDAQ Capital Market (BRTX), enhancing visibility and access to capital.
2023 Clinical Progress & Financials Continued patient enrollment in Phase 2 BRTX-100 trial. Reported Research and Development expenses of approximately $3.8 million and a net loss of approximately $9.7 million for the fiscal year ending Dec 31, 2023. Ended the year with cash reserves of around $1.5 million.
2024 Capital Raising Completed registered direct offerings and private placements during the first half of 2024 to raise additional capital for operations and clinical trial advancement.

Transformative Moments

Several key decisions and events significantly shaped the company's path.

Focus on Autologous Cell Therapy

Pivoting to concentrate resources on the BRTX-100 program, utilizing a patient's own stem cells for treating cLDD, became a defining strategic direction.

Diversification via ThermoStem

The licensing of the ThermoStem technology represented a significant move to diversify its pipeline beyond orthopedic applications into the metabolic space, targeting obesity and diabetes.

Achieving NASDAQ Listing

The 2021 uplisting provided crucial access to a broader investor base and potentially more stable funding avenues, essential for a development-stage biotech company. Understanding the types of investors attracted during and after this phase is key. Exploring BioRestorative Therapies, Inc. (BRTX) Investor Profile: Who’s Buying and Why? offers deeper insights into this aspect.

BioRestorative Therapies, Inc. (BRTX) Ownership Structure

BioRestorative Therapies operates as a publicly traded entity, meaning its ownership is distributed among various shareholders, including institutional bodies and individual retail investors. This structure influences its governance and strategic direction, reflecting a broad base of stakeholder interests.

BioRestorative Therapies, Inc. (BRTX) Current Status

As of the end of 2024, BioRestorative Therapies, Inc. is a public company. Its common stock is listed and traded on the NASDAQ Capital Market under the ticker symbol BRTX. Being public subjects the company to regulatory oversight by the Securities and Exchange Commission (SEC), requiring regular financial disclosures and adherence to governance standards.

BioRestorative Therapies, Inc. (BRTX) Ownership Breakdown

Understanding who holds the shares provides insight into the company's stability and potential influences. The ownership distribution as of late 2024 reflects a typical pattern for many development-stage biotechnology firms. For a deeper dive into the company's financial standing, consider Breaking Down BioRestorative Therapies, Inc. (BRTX) Financial Health: Key Insights for Investors.

Shareholder Type Ownership, % Notes
Public & Other ~95% Comprises primarily retail investors and smaller funds not meeting threshold reporting requirements.
Institutional Investors ~4.5% Represents holdings by mutual funds, pension funds, and other large investment entities, based on required filings like Form 13F.
Insiders (Management & Directors) ~0.5% Includes shares held directly by the company's executive team and board members, indicating their vested interest.

BioRestorative Therapies, Inc. (BRTX) Leadership

The company's strategic direction and day-to-day operations are guided by its executive management team and Board of Directors. As of the end of 2024, the key leadership included:

  • Lance Alstodt, Chief Executive Officer
  • Paul Jude Tonna, Chairman of the Board
  • Francisco Silva, Chief Financial Officer

This team brings experience across finance, biotechnology, and corporate governance, steering the company through its clinical development and commercialization efforts.

BioRestorative Therapies, Inc. (BRTX) Mission and Values

BioRestorative Therapies is driven by a commitment to advancing regenerative medicine, focusing on developing treatments for conditions with significant unmet needs. Understanding their guiding principles offers insight into their long-term strategy and dedication beyond pure financial returns.

BioRestorative Therapies' Core Purpose

The company's direction is shaped by its core objectives in the biotechnology space. Examining the Mission Statement, Vision, & Core Values of BioRestorative Therapies, Inc. (BRTX) provides deeper context.

Official mission statement

While a single, formally published mission statement isn't prominently displayed across all corporate materials as of early 2024, BioRestorative Therapies consistently communicates its core objective: To develop and commercialize innovative stem cell therapies targeting degenerative diseases and metabolic disorders, aiming to address significant unmet medical needs and improve patient quality of life.

Vision statement

The company envisions becoming a leader in the field of regenerative medicine. Their aspiration centers on translating scientific discovery into transformative therapies, particularly focusing on their BRTX-100 program for chronic lumbar disc disease and their ThermoStem® program related to metabolic disorders.

Company slogan

BioRestorative Therapies does not appear to utilize a widely publicized official company slogan as of early 2024.

BioRestorative Therapies, Inc. (BRTX) How It Works

BioRestorative Therapies operates as a clinical-stage biotechnology company focused on developing therapeutic products using cell and tissue protocols, primarily involving adult stem cells. Its core activities revolve around research, development, and the progression of its candidates through rigorous clinical trials aimed at addressing unmet medical needs.

BioRestorative Therapies, Inc.'s Product/Service Portfolio

Product/Service Target Market Key Features
BRTX-100 Patients with chronic lower back pain due to degenerative disc disease Autologous (patient's own) cultured mesenchymal stem cells injected into the disc; Investigational, currently in Phase 2 clinical trials.
ThermoStem Program Patients with obesity and metabolic disorders (e.g., type 2 diabetes) Platform utilizing brown adipose (fat) derived stem cells to generate brown adipose tissue; Preclinical stage.

BioRestorative Therapies, Inc.'s Operational Framework

The company's operational framework is heavily centered on research and development (R&D) and clinical progression. Value creation hinges on advancing its therapeutic candidates through the necessary phases of clinical testing required by regulatory bodies like the FDA. This involves significant investment in scientific research, preclinical studies, and human clinical trials. For instance, R&D expenses for the nine months ended September 30, 2024, were reported at approximately $8.9 million, reflecting the intense focus on advancing BRTX-100. General and administrative expenses for the same period were around $5.5 million. As a clinical-stage company without commercialized products as of late 2024, its operations are funded through equity offerings, debt financing, and potentially future partnerships or licensing agreements. Understanding the sources of this funding is crucial. Exploring BioRestorative Therapies, Inc. (BRTX) Investor Profile: Who’s Buying and Why? offers insights into the company's investor base. Manufacturing for clinical trials may involve contract manufacturing organizations (CMOs), and scaling up production will be a key operational step upon potential regulatory approval.

BioRestorative Therapies, Inc.'s Strategic Advantages

Several factors potentially contribute to the company's strategic position in the regenerative medicine field:

  • Targeting significant unmet medical needs with large potential patient populations, particularly in chronic lower back pain and metabolic disorders.
  • Development of proprietary cell therapy platforms, including methods for isolating, culturing, and delivering stem cells.
  • Focus on autologous therapies (BRTX-100), which may reduce risks associated with immune rejection compared to allogeneic (donor-derived) therapies.
  • Progression of its lead candidate, BRTX-100, into Phase 2 clinical trials, representing a significant developmental milestone that differentiates it from earlier-stage companies.
  • Intellectual property portfolio protecting its core technologies and therapeutic candidates.

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

BioRestorative Therapies, as a clinical-stage biotechnology company, currently focuses on research and development rather than commercial sales for revenue generation. Its financial engine is primarily fueled by raising capital through equity offerings and potentially securing grants or collaborative agreements to fund its therapeutic programs targeting disc/spine disease and metabolic disorders.

BioRestorative Therapies, Inc.'s Revenue Breakdown

As of late 2024, the company remains in the pre-commercialization phase, meaning it does not generate significant revenue from product sales. Its income, if any, typically stems from non-operational sources.

Revenue Stream % of Total Revenue (Illustrative) Growth Trend
Product Sales 0% N/A (Pre-Commercial)
Grants/Other Income 100% (if any received) Variable

BioRestorative Therapies, Inc.'s Business Economics

The economic model is characteristic of developmental biotech firms, involving substantial investment in research and development for its cell-based therapies like BRTX-100. Key cost drivers include:

  • Clinical trial expenses for advancing product candidates through regulatory phases.
  • Personnel costs for specialized scientific and administrative staff.
  • Laboratory operations, materials, and manufacturing scale-up activities.
  • General and administrative expenses covering corporate functions and intellectual property protection.
Profitability hinges entirely on the future successful commercialization or lucrative licensing/partnership deals for its pipeline assets, which requires significant upfront capital and navigating lengthy regulatory pathways.

BioRestorative Therapies, Inc.'s Financial Performance

Financial health is assessed by tracking capital reserves, expenditures, and funding activities rather than traditional revenue metrics. For the nine months ending September 30, 2024, the company reported a net loss, reflecting its R&D focus. Research and development expenses constituted a major portion of the operating costs during this period, alongside general and administrative expenses. The company's cash position and burn rate are critical indicators watched closely by investors; securing adequate funding to sustain operations through clinical milestones remains paramount. Understanding who holds stakes is also vital; Exploring BioRestorative Therapies, Inc. (BRTX) Investor Profile: Who’s Buying and Why? provides insights into the investor base. As of September 30, 2024, the company maintained a cash balance intended to fund operations into 2025, dependent on expenditure levels and potential capital infusions.

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

BioRestorative Therapies operates as a clinical-stage biotechnology company focused on regenerative medicine, specifically cell-based therapies for orthopedic and metabolic disorders. Its future hinges entirely on successful clinical trial outcomes and subsequent regulatory approvals, positioning it as a high-risk, potentially high-reward entity within its niche.

Competitive Landscape

The regenerative medicine field, particularly for chronic low back pain (CLBP) and metabolic diseases, features several players, though direct comparison is complex due to differing therapeutic approaches and stages of development. Market share based on 2024 revenues for BRTX is effectively 0% as it remains pre-commercialization.

Company Market Share, % (Estimated 2024 Relevant Niche) Key Advantage
BioRestorative Therapies (BRTX) 0% Proprietary hypoxic culturing process for allogeneic mesenchymal stem cells (BRTX-C01); ThermoStem program targeting metabolic disorders.
Mesoblast Limited (MESO) <1% (in relevant CLBP niche, pre-approval) Advanced clinical development (Phase 3 data) for Rexlemestrocel-L in Chronic Low Back Pain; established platform technology.
Vericel Corporation (VCEL) Small % (Established products, different primary focus) Existing FDA-approved cell therapies (Maci, Epicel) generating revenue; established manufacturing and commercial infrastructure, though primarily in cartilage/burns.

Opportunities & Challenges

Navigating the path from clinical development to market requires careful management of both potential upsides and significant hurdles.

Opportunities Risks
Successful Phase 2/3 trial results for BRTX-C01 in CLBP, potentially validating the platform. Clinical trial failures or delays halting development progress.
Securing FDA approval for lead candidates, unlocking significant market potential in areas with high unmet needs. Regulatory hurdles and stringent requirements from agencies like the FDA.
Strategic partnerships or licensing deals providing non-dilutive funding and development support. Ongoing need for capital; reliance on equity/debt financing impacting shareholder value and overall Breaking Down BioRestorative Therapies, Inc. (BRTX) Financial Health: Key Insights for Investors.
Expansion of the ThermoStem platform into additional metabolic indications. Competition from existing treatments and other regenerative medicine companies.
Positive market reception and adoption by physicians and patients post-approval. Manufacturing scale-up challenges and cost of goods management post-approval.

Industry Position

As of early 2025, BioRestorative Therapies is firmly positioned as a developmental-stage player within the broader biotechnology and regenerative medicine sectors. Key aspects of its industry standing include:

  • Focus Niche: Specializes in allogeneic cell therapies derived from bone marrow, targeting large markets like CLBP (BRTX-C01) and metabolic diseases (ThermoStem).
  • Clinical Stage Dependency: Value is primarily driven by clinical progress. Positive data readouts are critical catalysts; setbacks pose significant risks. Based on 2024 data, the company generated no product revenue.
  • Funding Reliance: Like many clinical-stage biotechs, consistent access to capital is essential for funding operations, research, and clinical trials. Its financial runway and cash burn rate are key metrics monitored by investors.
  • Competitive Dynamics: Competes with companies ranging from small biotechs with similar cell therapy approaches to larger pharmaceutical firms exploring regenerative medicine, albeit often at different stages or with different technologies.

Its success is contingent upon demonstrating clinical efficacy, navigating the regulatory landscape, securing adequate funding, and eventually achieving commercial viability against established and emerging competitors.

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