BioRestorative Therapies, Inc.

Company focus

BioRestorative Therapies develops therapeutic products using cell and tissue protocols centered on adult stem cells. The company pursues two core clinical programs (Disc/Spine and Metabolic) and operates a commercial bio-cosmeceutical platform. It holds an exclusive license for investigational adult stem cell technology for disc and spine conditions (BRTX-100) and is developing a brown adipose tissue (BAT)–based metabolic program (ThermoStem). The company also markets a cell-based secretome cosmetic product and has licensed an investigational curved needle device for spine/disc delivery.

Core programs and products

• Disc/Spine Program (BRTX-100)

  • Lead product: autologous, hypoxic-cultured mesenchymal stem cells derived from a patient’s bone marrow, delivered into an injured intervertebral disc using a proprietary carrier (platelet lysate).
  • Clinical status: Phase 2 trial for chronic lower back pain due to degenerative disc disease; IND clearance for chronic cervical discogenic pain. The disc/spine technology and a curved needle delivery device are licensed exclusively from Regenerative Sciences/Reg Regen.
  • Trial design: Phase 2 prospective, double-blind, placebo-controlled, randomized trial; approximately 99 patients enrolled; 40 million cells per dose; up to 16 sites (10–20 planned); primary efficacy endpoint at 12 months; follow-up to 24 months.
  • Regulatory path: FDA Fast Track designation granted in 2025 for chronic lumbar degenerative disc disease (cLDD). The company intends to pursue Phase 3–enabling activities with a target to file a Phase 3 IND in 2026.

• ThermoStem Program (Metabolic Brown Adipose Program)

  • Objective: cell-based therapy using brown adipose–derived stem cells (BADSCs) to generate brown adipose tissue constructs and secreted exosomes to address obesity, type 2 diabetes, hypertension, and other metabolic conditions.
  • Status: Preclinical; work ongoing on BAT constructs on scaffolds, encapsulation approaches, and delivery methods. Multiple U.S. and foreign patents and applications are associated with ThermoStem.

• BioCosmeceuticals

  • Commercial product: a cell-based secretome containing exosomes, proteins and growth factors intended to reduce the appearance of fine lines and wrinkles.
  • Manufacturing: produced in a cGMP ISO-7 clean room in Melville, NY.
  • Growth plans: expand into a broader family of cell-based biologic aesthetic products through IND-enabling studies.

• Curved Needle Device (CND)

  • Investigational curved needle designed to deposit cells or other substances into the disc/spine and other sites with access challenges.
  • Status: licensed from Regenerative; FDA approval or clearance is anticipated prior to commercialization. The device is not planned for use in the BRTX-100 Phase 2 trial.

Laboratory and manufacturing

• Facilities: laboratory and clean room for clinical and research production in Melville, NY; facility expanded to support clinical manufacturing.
• Capacity: currently producing BRTX-100 for the Phase 2 disc trial. The company does not have commercial-scale manufacturing in place and may use third-party manufacturers in the future.

Intellectual property

• Patents and licenses cover the Disc/Spine Program (exclusive Regenerative license) and the ThermoStem Program, with several U.S. and foreign patents and pending applications related to cell culture, delivery, and brown adipose constructs.
• Trademarks include BRTX-100, THERMOSTEM, and BRTX; the Dragonfly logo is registered with the U.S. Copyright Office.
• Strategy: protect proprietary technology through patents, trade secrets, licenses, and potential future licensing arrangements.

Regulatory and market landscape

• Regulatory pathways under consideration include HCT/P, biologics (BLA), and potential device routes. The company expects cGMP manufacturing requirements and post-approval obligations if products are approved.
• The company is pursuing expedited pathways where appropriate, such as Fast Track, and recognizes the long timelines and uncertainty inherent in regulatory approval.
• Reimbursement and market access: payer coverage and reimbursement for novel cell therapies remain uncertain. Broader healthcare policy changes could affect pricing and access.

Financial overview (2025 year-end / early-2026 disclosures)

• Revenues: no significant revenues to date.
• 2025 net loss: approximately $14.2 million.
• 2025 cash flow from operations: negative approximately $10.8 million.
• Accumulated deficit: approximately $169.9 million as of December 31, 2025.
• Working capital: deficit of about $0.6 million as of December 31, 2025.
• Cash runway and financing needs: management indicates current funds may be insufficient to complete the Phase 2 trial and continue ThermoStem preclinical activities; additional financing will be required for R&D, Phase 3 activities, and operations. Planned financing sources include at-the-market programs, direct public offerings, and other financings.

Recent financing highlights

• February 2024: warrant exercises generated approximately $8.1 million gross.
• 2025: ATM program generated about $2.0 million gross.
• October 2025: registered direct public offering raised about $1.1 million gross; concurrent private placement included issued warrants.
• February 2026: public offering raised about $5.0 million gross; pre-funded and traditional warrants issued with additional placement agent warrants.

Equity and capitalization (as of March 23, 2026)

• Outstanding common shares: 25,478,170.

• Authorized common shares: up to 75,000,000.

• Warrants outstanding: approximately 19,780,753 with varying exercise prices.

• Options outstanding: 5,229,325.

• Pre-funded warrants issued with nominal exercise prices.

• Preferred stock: up to 18,456,842 shares authorized; none issued as of March 23, 2026.

• Employee count: 14 employees (13 full-time).

• Going concern: the independent auditor’s report includes substantial doubt about the company’s ability to continue as a going concern within 12 months after the filing date; management has identified the need for additional financing to sustain operations.

Employees and facilities

• Employees: 14 total (13 full-time).
• Principal office and lab: 40 Marcus Drive, Suite One, Melville, NY. Lease expired December 2024; currently on a month-to-month basis (approximately $14,422/month) while negotiating an extension.

Summary status

BioRestorative Therapies is developing BRTX-100 for disc and spine disease, with Phase 2 enrollment completed (99 patients enrolled as of February 2026) and preparations for Phase 3 activities underway. The company continues preclinical work on ThermoStem and is expanding its bio-cosmeceutical product line. It has completed multiple financing rounds but continues to incur operating losses and requires additional funding to advance clinical development and commercialization.