BioRestorative Therapies, Inc.

What they do

BioRestorative Therapies develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells. Its lead investigational product, BRTX-100, is in a Phase 2 clinical trial for chronic lower back pain from degenerative disc disease, and it has FDA IND clearance for chronic cervical discogenic pain. Its ThermoStem Program, a pre-clinical effort using brown adipose tissue for type 2 diabetes, obesity and other metabolic disorders, has patents issued in the U.S. and other jurisdictions. It also sells a cell-based biologic serum containing exosomes, proteins and growth factors, made in its cGMP ISO-7 clean room, for cosmetic use.

Revenue drivers

• Biocosmeceuticals — The only commercial product line: a cell-based secretome biologic serum sold for cosmetic use and manufactured in the company's cGMP ISO-7 clean room. It produces essentially all reported revenue, but at a very small scale.
• BRTX-100 (Disc/Spine) — Investigational only, in a Phase 2 trial for chronic lower back pain from degenerative disc disease; no product revenue. It is treated as the lead product candidate.
• ThermoStem Program — Pre-clinical only, targeting type 2 diabetes, obesity, hypertension, other metabolic disorders and cardiac deficiencies; no revenue.

Recent performance

Annual revenue was $359,700 in 2025, down from $401,000 in 2024, after rising from $145,800 in 2023 and $119,800 in 2022. Net loss widened to $14.2 million in 2025 from $9.0 million in 2024, and operating cash flow was negative $10.8 million in 2025 versus negative $8.2 million in 2024. Quarterly revenue in 2026 first quarter was $23,170; earlier 2025 quarters were uneven at $303,300 (June 30), $11,800 (September 30) and $19,600 (December 31). At March 31, 2026, total assets were $4.6 million, shareholder equity was $3.0 million and cash and equivalents were $3.1 million.

Strategy

The stated near-term priority is advancing BRTX-100 through its Phase 2 chronic lumbar disc disease trial and the indicated cervical discogenic pain program. In February 2025 the FDA granted Fast Track designation to BRTX-100 for chronic lumbar disc disease, and in February 2025 the FDA cleared the IND for chronic cervical discogenic pain. The company also continues patent work around ThermoStem, with European, Israeli and Japanese patents issued in 2025, and in October 2025 issued 678,125 shares of common stock in a registered direct public offering. In June 2025 the Board authorized a stock repurchase program of up to $2 million over one year; no shares had been repurchased to date.

Risks

• Going concern — The 10-K risk factors state there is substantial doubt about the company's ability to continue as a going concern within the next twelve months, and the auditor's report contains an explanatory paragraph on this.
• Heavy financing need — The company states it will need to obtain a significant amount of financing to complete its clinical trials and implement its business plan.
• Dependence on BRTX-100 — Future success is significantly dependent on timely and successful development and commercialization of BRTX-100 for chronic lumbar disc disease; delays or difficulties would significantly harm business prospects.
• Nasdaq listing — Risk factors cite failure to meet Nasdaq continued listing requirements, which could result in delisting of the common stock.
• Small commercial base — All reported revenue comes from the biocosmeceuticals product, which totaled $359,700 in 2025, leaving the company dependent on external capital.

Outlook

Management does not provide revenue or earnings guidance in the excerpts. Its stated focus is completing clinical development of BRTX-100 in chronic lumbar disc disease and cervical discogenic pain, plus continued preclinical work on ThermoStem. The company continues to require significant financing for clinical trials and its business plan, and the going-concern language indicates it will need capital within the next twelve months.