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 Therapies, Inc. (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ:BRTX), a late stage clinical regenerative medicine innovator focused ...

Core Viewpoint - BioRestorative Therapies, Inc. has successfully closed a public offering of 14,285,715 shares of common stock and warrants, raising approximately $5.0 million to fund clinical trials and development initiatives [1][3]. Group 1: Offering Details - The public offering price was set at $0.35 per share, with warrants having the same exercise price and an expiration of five years from issuance [1]. - Rodman & Renshaw LLC served as the exclusive placement agent for the offering [2]. - The offering was registered with the SEC, and a final prospectus has been filed [4]. Group 2: Use of Proceeds - The net proceeds from the offering will be allocated to clinical trials for BRTX-100, pre-clinical research for the ThermoStem Program, development of a commercial biocosmeceuticals platform, and general corporate purposes [3]. Group 3: Company Overview - BioRestorative focuses on regenerative medicine, particularly stem cell-based therapies, with key programs targeting disc/spine diseases and metabolic disorders [6]. - The lead therapy candidate, BRTX-100, is designed for non-surgical treatment of lumbosacral disc disorders and is currently in Phase 2 clinical trials [6]. - The ThermoStem Program aims to develop therapies for obesity and metabolic disorders using brown adipose-derived stem cells [7]. - The company also operates a BioCosmeceutical platform, offering products aimed at cosmetic improvements [8][9].

Core Viewpoint - BioRestorative Therapies, Inc. has announced a public offering of 14,285,715 shares of common stock at a price of $0.35 per share, aiming to raise approximately $5.0 million for clinical trials and development projects [1][3]. Group 1: Offering Details - The public offering includes 14,285,715 shares of common stock and warrants to purchase an equal number of shares, priced at $0.35 each [1]. - The warrants will have an exercise price of $0.35 per share, are immediately exercisable, and will expire five years from issuance [1]. - The closing of the offering is expected around February 13, 2026, pending customary closing conditions [1]. Group 2: Use of Proceeds - The net proceeds from the offering will be allocated to clinical trials for BRTX-100, pre-clinical research for the ThermoStem Program, development of a commercial biocosmeceuticals platform, and general corporate purposes [3]. Group 3: Company Overview - BioRestorative focuses on regenerative medicine, particularly stem cell-based therapies, with two main clinical development programs: the Disc/Spine Program and the Metabolic Program [6][7]. - The Disc/Spine Program features BRTX-100, a cell therapy for treating lumbosacral disc disorders, currently in Phase 2 clinical trials [6]. - The Metabolic Program aims to develop therapies targeting obesity and metabolic disorders using brown adipose-derived stem cells [7]. - The company also operates a BioCosmeceutical platform, offering products designed to improve cosmetic appearance through cell-based secretome technology [8].

Core Viewpoint - BioRestorative Therapies, Inc. has received positive feedback from the FDA regarding an expedited Biologics License Application (BLA) approval pathway for its BRTX-100 program aimed at treating chronic lumbar disc disease (cLDD) [1][6] Group 1: FDA Interaction and Approval Pathway - The Type B meeting with the FDA provided clarity for an expedited BLA approval pathway for the BRTX-100 program in cLDD [2][6] - The FDA endorsed the proposed Phase 3 study design, including outcome assessments, dosing strategy, and eligibility criteria [6] - The company plans to submit the Phase 3 IND application in the second half of 2026 [2] Group 2: Clinical Trial and Product Details - BRTX-100 is a novel cell-based therapeutic targeting areas with low blood flow, currently evaluated in a Phase 2 clinical trial involving 99 subjects across 15 clinical sites in the U.S. [5][7] - The trial has a randomized 2:1 design for BRTX-100 versus placebo, with ongoing positive safety and efficacy results [5][6] - The standard treatment for cLDD currently lacks therapies that reverse disc degeneration or address intervertebral disc cell homeostasis [4] Group 3: Company Overview and Other Programs - BioRestorative develops therapeutic products using adult stem cells, focusing on disc/spine disease and metabolic disorders [7] - The company is also developing a metabolic program targeting obesity using brown adipose-derived stem cells [8] - BioRestorative operates a BioCosmeceutical platform, offering a cell-based secretome product aimed at cosmetic effectiveness [9]

Core Viewpoint - BioRestorative Therapies, Inc. reported strong execution in its business and key clinical milestones in 2025, with a focus on growth strategy and resource management [2] Corporate Developments - The company is in discussions with a commercial stage regenerative medicine company regarding a potential license for its ThermoStem metabolic intellectual property [4] - BioRestorative's Board of Directors authorized a stock repurchase program for up to $2 million of its common stock through June 16, 2026 [6] - Sandy Lipkins joined the company to lead strategic alliances and licensing agreements [6] Clinical Programs - The ongoing Phase 2 clinical trial of BRTX-100 for chronic lumbar disc disease (cLDD) showed promising preliminary data, with over 50% improvement in both the Oswestry Disability Index (ODI) and Visual Analog Scale (VAS) [6] - The FDA requires a greater than 30% improvement in ODI and a greater than 30% reduction in VAS for trial progression and Biologics License Application (BLA) approval [6] Financial Results - For Q2 2025, the company reported revenues of approximately $303,000, a 240% increase compared to Q2 2024 [7] - The net loss for Q2 2025 was $2.7 million, or $0.30 per share, compared to a net loss of $4.0 million, or $0.50 per share, in Q2 2024 [8] - The company ended Q2 2025 with $7.4 million in cash and no outstanding debt [8]

Core Insights - BioRestorative Therapies, Inc. has presented preliminary data from its Phase 2 clinical trial of BRTX-100 for chronic lumbar disc disease, showing promising safety and efficacy results [1][3] Group 1: Clinical Trial Data - The ongoing Phase 2 trial of BRTX-100 has shown no serious adverse events and no dose-limiting toxicity at 26-104 weeks [2] - The trial data indicates trends of over 30% improvement in both the Oswestry Disability Index (ODI) and Visual Analog Scale (VAS), with significant improvements observed at various weeks [3] - The percentage of subjects showing greater than 50% improvement in both ODI and VAS is as follows: - Week 2: 0.0% - Week 12: 13.33% - Week 26: 46.15% - Week 52: 70.0% - Week 104: 66.66% [3] Group 2: Product and Company Overview - BRTX-100 is a novel cell-based therapeutic designed to treat areas with low blood flow, specifically targeting chronic lumbar disc disease [5] - The company is conducting a randomized, double-blinded, and controlled study with up to 99 eligible subjects across 16 clinical sites in the U.S. [5] - BioRestorative develops therapeutic products using adult stem cells, focusing on disc/spine disease and metabolic disorders, along with a commercial BioCosmeceutical platform [6][7][8]

Core Insights - BioRestorative Therapies, Inc. is advancing its Phase 2 clinical trial of BRTX-100 for chronic lumbar disc disease, with an update to be presented at the ISCT 2025 Annual Meeting [1][2] Company Overview - BioRestorative is focused on regenerative medicine, particularly stem cell-based therapies and products [1][5] - The company has two main clinical development programs: the Disc/Spine Program and the Metabolic Program [5][6] BRTX-100 Details - BRTX-100 is a cell-based therapeutic targeting areas with low blood flow, currently in a Phase 2 clinical trial for chronic lumbar disc disease [4] - The FDA has granted Fast Track designation to BRTX-100, indicating positive preliminary safety and efficacy data [4] - The FDA also cleared the IND application for BRTX-100 to treat chronic cervical discogenic pain, expanding its clinical pipeline [4] Presentation Information - The clinical update on BRTX-100 will be presented by Francisco Silva at the ISCT 2025 Annual Meeting on May 8, 2025 [3] Additional Programs - The Metabolic Program focuses on therapies targeting obesity and metabolic disorders using brown adipose-derived stem cells [6] - BioRestorative also operates a BioCosmeceutical platform, developing products aimed at cosmetic applications [7]