BRTX BIORESTORATIVE THERAPIES INC

BioRestorative to Present Major Update on Promising Preliminary Phase 2 BRTX-100 Data at ISSCR 2025

BioRestorative to Present Major Update on Promising Preliminary Phase 2 BRTX-100 Data at ISSCR 2025

– New blinded safety and efficacy data from 30 patients in ongoing Phase 2 trial to be unveiled June 13, 2025 –

– ISSCR 2025 is the premier global event for stem cell research, drawing nearly 4,000 leaders from academia, biotech, and pharma –

– BioRestorative to release new clinical data to the public prior to market open on June 13th –

MELVILLE, N.Y., June 09, 2025 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (“BioRestorative,” “BRTX” or the “Company”) (NASDAQ: BRTX), a clinical-stage regenerative medicine company developing stem cell-based therapies for serious musculoskeletal conditions, today announced that new preliminary, blinded clinical data from 30 patients enrolled in its ongoing Phase 2 trial of BRTX-100 for the treatment of chronic lumbar disc disease (cLDD) will be presented at the prestigious International Society for Stem Cell Research (ISSCR) 2025 Annual Meeting, held June 11–14, 2025, in Hong Kong.

The highly anticipated presentation will be delivered by Francisco Silva, Vice President of Research and Development at BioRestorative, on Friday, June 13, at 5:00 p.m. HKT, as part of ISSCR 2025’s clinical innovations track. The Company will issue a press release pre-market that day, detailing the newly reported data.

“This represents a milestone moment for BioRestorative,” said Lance Alstodt, Chief Executive Officer. “With preliminary data from twice as many patients as previously shared, we are seeing strong, consistent signals around both safety and functional improvement. We are eager to bring this update to the global scientific community at the world’s most influential stem cell conference.”

BRTX-100 is BioRestorative’s lead clinical candidate — a hypoxic-cultured, autologous mesenchymal stem cell therapy designed to target areas of the body with limited blood flow, such as damaged spinal discs. The ongoing Phase 2 study is a prospective, randomized, double-blinded, placebo-controlled trial evaluating BRTX-100 in patients with cLDD across up to 16 U.S. clinical sites. A total of 99 patients will be enrolled, randomized 2:1 to receive either BRTX-100 or placebo via a single intradiscal injection.

The presentation, titled “Stem Cell Therapy for Chronic Lumbar Disc Disease: Phase 2 Clinical Safety and Feasibility Data of Intradiscal Injections of Hypoxic Cultured Mesenchymal Stem Cells,” will highlight key preliminary outcomes focused on patient-reported pain and function metrics, as well as safety endpoints.

About the ISSCR 2025 Annual Meeting

ISSCR 2025 is the largest and most influential gathering of stem cell scientists and regenerative medicine experts globally, attracting nearly 4,000 participants from over 80 countries. It serves as a key venue for groundbreaking clinical and translational research, offering BioRestorative a high-profile platform to share its latest advancements.

For more information on ISSCR 2025, visit .

About BioRestorative Therapies, Inc.

BioRestorative (NASDAQ: BRTX) is a clinical-stage biotechnology company developing cell-based therapies using adult stem cells to address unmet needs in musculoskeletal and metabolic diseases. The Company’s pipeline includes BRTX-100, a novel therapy targeting chronic lumbar disc disease, and ThermoStem®, a platform focused on brown adipose (fat) biology for the treatment of obesity and metabolic disorders. The Company also operates a commercial BioCosmeceutical platform.

For more information, please visit .

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, 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:



EN
09/06/2025

Underlying

To request access to management, click here to engage with our
partner Phoenix-IR's CorporateAccessNetwork.com

Reports on BIORESTORATIVE THERAPIES INC

 PRESS RELEASE

BioRestorative Expands Global Protection for ThermoStem®, a Potentiall...

BioRestorative Expands Global Protection for ThermoStem®, a Potentially Longer-Lasting and Safer Cell-Based Alternative to GLP-1 Drugs GLP-1 drugs have captured global attention, but they come with limitations — tolerability issues, muscle mass loss, and potential cardiovascular risks. BioRestorative believes its cell-based therapeutic candidates may offer the potential for longer-lasting efficacy with improved safety and dosing advantages. MELVILLE, N.Y., Feb. 24, 2026 (GLOBE NEWSWIRE) -- . (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ:), a late stage clinical regenerative medicin...

 PRESS RELEASE

BioRestorative Announces Closing of $5.0 Million Public Offering

BioRestorative Announces Closing of $5.0 Million Public Offering MELVILLE, N.Y., Feb. 13, 2026 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ:BRTX), a late stage clinical regenerative medicine innovator focused on stem cell-based therapies and products, today announced the closing of its previously announced public offering of 14,285,715 shares of common stock (or pre-funded warrants in lieu thereof) and warrants to purchase up to 14,285,715 shares of common stock, at a combined public offering price of $0.35 per share (or pre-funded...

 PRESS RELEASE

BioRestorative Announces Pricing of $5.0 Million Public Offering

BioRestorative Announces Pricing of $5.0 Million Public Offering MELVILLE, N.Y., Feb. 11, 2026 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ:BRTX), a late stage clinical regenerative medicine innovator focused on stem cell-based therapies and products, today announced the pricing of a public offering of 14,285,715 shares of common stock (or pre-funded warrants in lieu thereof) and warrants to purchase up to 14,285,715 shares of common stock, at a combined public offering price of $0.35 per share (or pre-funded warrant in lieu thereo...

 PRESS RELEASE

BioRestorative Announces Positive Outcome from Type B Meeting with FDA

BioRestorative Announces Positive Outcome from Type B Meeting with FDA BioRestorative completed a Type B meeting with the U.S. Food and Drug Administration (“FDA”) regarding a potential accelerated Biologics License Application (“BLA”) approval pathway for the Fast-Track-Designated BRTX-100 program for the treatment of chronic lumbar disc disease (“cLDD”)Consistent positive clinical safety endpoints from BioRestorative’s ongoing 99 patient Phase 2 clinical trial of BRTX-100 in cLDD were discussed in the meeting and the FDA did not raise any clinical safety concerns FDA endorsed the proposed...

 PRESS RELEASE

BioRestorative Completes Patient Enrollment in Landmark Phase 2 Trial ...

BioRestorative Completes Patient Enrollment in Landmark Phase 2 Trial of BRTX-100 for Chronic Lumbar Disc Disease Largest FDA-authorized Phase 2 cell therapy trial conducted in chronic lumbar disc diseaseThe study has enrolled a total of 99 participants, each of whom was randomized to receive either BRTX-100 or placeboProspective, randomized, double-blind, sham-controlled single-disc study — gold-standard clinical designEnrollment completion strengthens regulatory pathway toward Phase 3 and potential BLA filing MELVILLE, N.Y., Feb. 10, 2026 (GLOBE NEWSWIRE) -- . (“BioRestorative”, “BRTX”...

ResearchPool Subscriptions

Get the most out of your insights

Get in touch