BioRestorative Awarded Notice of Allowance for Japanese Patent – Expands Protection for Potential Cell-Based Alternative to Multi-Billion Dollar GLP-1 Drug Market

MELVILLE, N.Y., Oct. 27, 2025 (GLOBE NEWSWIRE) — BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ:BRTX), a regenerative medicine innovator focused on stem cell-based therapies and products, today announced a major intellectual property milestone: the Japanese Patent Office has issued a Notice of Allowance for the Company’s ThermoStem^® platform.

The newly allowed patent provides broad protection for BioRestorative’s allogeneic, off-the-shelf brown adipose-derived stem cell (BADSC) technology, designed to treat obesity and metabolic disorders. These claims are materially stronger than previously granted patents, covering not only the therapeutic cells themselves, but also multiple methods of encapsulation and delivery — including alginate microcapsules, cellulose hydrogels, polymer membranes, and advanced scaffolding systems.

With this allowance, BRTX is further protected in its development of potential next-generation, cell-based alternatives to GLP-1 drugs, one of the fastest-growing therapeutic categories in the world.

“This patent allowance validates the significant progress we have made with ThermoStem^®,” said Lance Alstodt, BioRestorative’s Chief Executive Officer. “GLP-1 drugs have captured global attention, but they come with limitations — tolerability issues, muscle mass loss, and potential cardiovascular risks. We believe our cell-based therapeutic candidates may offer the potential for longer-lasting efficacy with improved safety and dosing advantages. This latest patent not only strengthens our IP portfolio but also advances BioRestorative into a highly attractive commercial position as we continue discussions with potential strategic partners.”

The global obesity market is projected to exceed $100 billion annually by the end of the decade, driven by unprecedented demand for GLP-1 therapies. BioRestorative’s ThermoStem^® platform is uniquely designed to address this demand by:

• Providing an alternative to chronic GLP-1 injections through a regenerative, cell-based solution.
• Mitigating muscle loss and cardiovascular risk, two of the most pressing concerns associated with GLP-1 therapies.
• Creating licensing and partnership opportunities, as evidenced by ongoing discussions with a commercial-stage regenerative medicine company regarding the Company’s metabolic IP. No assurances can be given that a license or partnership agreement will be entered into with such company whether on commercially reasonable terms or otherwise.

About BioRestorative Therapies, Inc.

BioRestorative (www.biorestorative.com) develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells. As described below, our two core clinical development programs relate to the treatment of disc/spine disease and metabolic disorders, and we also operate a commercial BioCosmeceutical platform:

• Disc/Spine Program (brtxDISC^™): Our lead cell therapy candidate, BRTX-100, is a product formulated from autologous (or a person’s own) cultured mesenchymal stem cells collected from the patient’s bone marrow. We intend that the product will be used for the non-surgical treatment of painful lumbosacral disc disorders or as a complementary therapeutic to a surgical procedure. The BRTX-100 production process utilizes proprietary technology and involves collecting a patient’s bone marrow, isolating and culturing stem cells from the bone marrow and cryopreserving the cells. In an outpatient procedure, BRTX-100 is to be injected by a physician into the patient’s damaged disc. The treatment is intended for patients whose pain has not been alleviated by non-invasive procedures and who potentially face the prospect of surgery. We have commenced a Phase 2 clinical trial using BRTX-100 to treat chronic lower back pain arising from degenerative disc disease. We have also obtained U.S. Food and Drug Administration (“FDA”) Investigational New Drug (“IND”) clearance to evaluate BRTX-100 in the treatment of chronic cervical discogenic pain.

• Metabolic Program (ThermoStem^®): We are developing cell-based therapy candidates to target obesity and metabolic disorders using brown adipose (fat) derived stem cells (“BADSC”) to generate brown adipose tissue (“BAT”), as well as exosomes secreted by BADSC. BAT is intended to mimic naturally occurring brown adipose depots that regulate metabolic homeostasis in humans. Initial preclinical research indicates that increased amounts of brown fat in animals may be responsible for additional caloric burning as well as reduced glucose and lipid levels. Researchers have found that people with higher levels of brown fat may have a reduced risk for obesity and diabetes. BADSC secreted exosomes may also impact weight loss.

• BioCosmeceuticals: We operate a commercial BioCosmeceutical platform. Our current commercial product, formulated and manufactured using our cGMP ISO-7 certified clean room, is a cell-based secretome containing exosomes, proteins and growth factors. This proprietary biologic serum has been specifically engineered by us to reduce the appearance of fine lines and wrinkles and bring forth other areas of cosmetic effectiveness. Moving forward, we also intend to explore the potential of expanding our commercial offering to include a broader family of cell-based biologic aesthetic products and therapeutics via IND-enabling studies, with the aim of pioneering FDA approvals in the emerging BioCosmeceuticals space.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events or results to differ materially from those projected in the forward-looking statements as a result of various factors and other risks, including, without limitation, those set forth in the Company’s latest Form 10-K, as amended, filed with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and the Company undertakes no obligation to update such statements.

CONTACT:

Stephen Kilmer
Investor Relations
Direct: (646) 274-3580
Email: skilmer@biorestorative.com