BioRestorative Provides Update Following Positive Feedback From FDA Regarding Potential Expedited BLA Approval Pathway For Fast-Track-Designated BRTX-100 Program For cLDD Treatment

• 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 Phase 3 study design (i.e., outcome assessments, dosing strategy, and eligibility criteria), sample size, and powering assumptions pending final review of Phase 3 investigational new drug ("IND") application submission
   
• FDA feedback confirms alignment of the Company's ongoing Chemistry Manufacturing and Controls (CMC) activities prior to submission of an IND application for a Phase 3 trial
   
• Based on the positive final official summary of this Type B meeting, BioRestorative has initiated Phase 3 enabling activities, with the goal of submitting the Phase 3 IND application later this year
   

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 provided an update following the positive feedback received from the FDA regarding a potential expedited Biologics License Application ("BLA") approval pathway for the Fast-Track-Designated BRTX-100 program for the treatment of chronic lumbar disc disease ("cLDD"), based on a Type B meeting requested by the Company.