BioRestorative Therapies(BRTX)
Search documents
Biorestorative Therapies, Inc. (BRTX) Reports Q4 Loss, Lags Revenue Estimates
ZACKS· 2026-03-26 23:26
Biorestorative Therapies, Inc. (BRTX) came out with a quarterly loss of $0.32 per share versus the Zacks Consensus Estimate of a loss of $0.37. This compares to a loss of $0.2 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of +13.51%. A quarter ago, it was expected that this company would post a loss of $0.38 per share when it actually produced a loss of $0.38, delivering no surprise.Over the last four quarters, the company has ...
BioRestorative Therapies(BRTX) - 2025 Q4 - Annual Report
2026-03-26 20:20
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED DECEMBER 31, 2025 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM__________ TO__________ Commission File Number 001-37603 BIORESTORATIVE THERAPIES, INC. (Exact name of registrant as specified in its charter) Nevada 30-1341024 (State or ot ...
BioRestorative Therapies to Present Positive Phase 2 Blinded Data for BRTX-100 Demonstrating Meaningful Improvements in Pain and Function in Chronic Lumbar Disc Disease
Globenewswire· 2026-03-19 12:00
New blinded data from ~45 patients to date in key pain and function scales and safety and tolerability of the Company’s proprietary hypoxic-cultured mesenchymal stem cells to be unveiled on March 28th at the 2026 Orthopaedic Research Society Annual Meeting MELVILLE, N.Y., March 19, 2026 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (“BioRestorative,” “BRTX,” or the “Company”) (Nasdaq:BRTX), a late-stage clinical regenerative medicine company focused on stem cell-based therapies and products, today anno ...
BioRestorative Therapies, Inc. to Participate in the Be+Well Beauty and Wellness Show in New York City, March 8-10, 2026
Globenewswire· 2026-03-05 13:00
Core Viewpoint - BioRestorative Therapies, Inc. is expanding its BioCosmeceutical commercialization strategy by engaging with industry partners and distribution channels at the Be+Well Beauty and Wellness Show, highlighting its focus on regenerative biologics technology in the aesthetics and longevity markets [1][2][4]. Group 1: Company Engagement and Strategy - The company will participate in the Be+Well Beauty and Wellness Show from March 8-10, 2026, to enhance commercialization awareness and distribution opportunities for its BioCosmeceutical platform [1][2]. - Crystal Romano, Head of Global Commercial Operations, will lead the company's engagement at the conference, focusing on discussions with potential business partners, distributors, and practitioners regarding product adoption and marketing collaborations [3][4]. - The Be+Well show is a significant opportunity for the company to connect with industry stakeholders and promote its unique approach that combines skincare, aesthetics, and regenerative medicine [4][6]. Group 2: Product and Market Positioning - BioRestorative is positioned as a biotechnology company rather than a traditional beauty brand, leveraging its cGMP-compliant, ISO-7 cleanroom cell manufacturing capabilities to ensure quality and reliability in its products [5]. - The company aims to differentiate itself in the market by translating regenerative science into premium biocosmeceutical products, supported by its scientific credibility and regulatory discipline [5][6]. - The BioCosmeceutical platform is designed for scalability and premium monetization, with plans for global distribution partnerships and a direct-to-consumer model to capture recurring revenue [6]. Group 3: Market Trends and Future Outlook - The aesthetics and longevity markets are experiencing a shift towards regenerative technologies, with clinics and medspas increasingly adopting solutions that focus on biological performance rather than just cosmetic improvement [4][5]. - BioRestorative's therapeutic heritage and integrated manufacturing capabilities position it to potentially emerge as a leader in next-generation regenerative skincare [6].
BioRestorative Therapies, Inc. Issues Letter to Shareholders Highlighting Major Milestones, Regulatory Alignment, Clinical Execution and Capital Strategy
Globenewswire· 2026-03-04 13:00
Core Insights - BioRestorative Therapies is positioned for growth following a successful FDA Type B meeting, completion of a Phase 2 trial enrollment, and a recent $5 million public offering, indicating strong momentum in clinical and commercial operations [1][4][9] Clinical Development - The company completed enrollment of 99 patients in a Phase 2 trial for BRTX-100, a stem cell therapy for chronic lumbar disc disease, marking it as one of the largest FDA-authorized trials in this area [3] - The trial's sham-controlled design meets high evidentiary standards, reflecting clinical demand and potential commercial opportunity [3] - Topline results from the trial are expected after database lock and statistical analysis [3] Regulatory Progress - A Type B meeting with the FDA confirmed alignment on the Phase 3 trial design and no safety concerns were raised, reducing uncertainty in the development pathway [4] - The company plans to submit a Phase 3 IND amendment in the second half of 2026, which is crucial for its long-term value-creation strategy [4][10] Commercial Strategy - The BioCosmeceutical platform is a key revenue strategy, with plans to expand product distribution and enhance commercialization efforts [5][11] - The company aims to generate non-dilutive revenue streams while supporting its clinical pipeline [5][7] Financial Position - The recent $5 million public offering has strengthened the company's balance sheet and extended its operational runway [9] - The company emphasizes capital discipline and strategic flexibility in its financial strategy, focusing on advancing BRTX-100 and maintaining operational readiness [9][17] Strategic Priorities - The primary focus for 2026 is advancing BRTX-100 into late-stage clinical development, including refining protocols and confirming manufacturing readiness [10][12] - The company is also developing its BioCosmeceutical platform and exploring strategic partnerships for BRTX-100 commercialization [15][14] Intellectual Property and Market Position - The ThermoStem platform has received patent allowances, enhancing the company's intellectual property portfolio in the metabolic disease sector [8] - BioRestorative aims to lead in the BioCosmeceuticals market by leveraging its biotechnology background and regulatory compliance to differentiate itself from traditional beauty brands [11][22]
BioRestorative Expands Global Protection for ThermoStem®, a Potentially Longer-Lasting and Safer Cell-Based Alternative to GLP-1 Drugs
Globenewswire· 2026-02-24 13:30
Core Viewpoint - BioRestorative Therapies, Inc. has received patent approval in Australia for its innovative ThermoStem technology, which utilizes brown adipose-derived stem cells to address obesity and metabolic disorders, enhancing its competitive position in the regenerative medicine market [1][2][3] Group 1: Patent Approval and Technology - The Australian government has allowed Patent Application No. 2020265664, providing broad protection for BioRestorative's ThermoStem technology [1] - The patent covers a method for creating non-naturally occurring three-dimensional brown adipose-derived stem cell aggregates [1] - This patent strengthens BioRestorative's position in developing alternatives to GLP-1 drugs, which are rapidly growing in the therapeutic market [2][3] Group 2: Company Overview and Programs - BioRestorative focuses on developing therapeutic products using adult stem cells, with two main clinical programs targeting disc/spine disease and metabolic disorders [4] - The Disc/Spine Program includes BRTX-100, a cell therapy candidate for treating chronic lower back pain, currently in Phase 2 clinical trials [4] - The Metabolic Program, ThermoStem, aims to utilize brown adipose-derived stem cells to generate brown adipose tissue, which may enhance metabolic health and aid in weight loss [5] Group 3: BioCosmeceuticals - BioRestorative operates a BioCosmeceutical platform, offering a proprietary biologic serum designed to improve cosmetic appearance by reducing fine lines and wrinkles [6][7] - The company plans to expand its product offerings in the BioCosmeceuticals space through IND-enabling studies, aiming for FDA approvals [7]
BioRestorative Announces Closing of $5.0 Million Public Offering
Globenewswire· 2026-02-14 01:30
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].
BioRestorative Announces Pricing of $5.0 Million Public Offering
Globenewswire· 2026-02-12 03:30
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].
BioRestorative Announces Positive Outcome from Type B Meeting with FDA
Globenewswire· 2026-02-11 12:30
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]
BioRestorative Therapies(BRTX) - Prospectus(update)
2026-02-10 22:20
As filed with the Securities and Exchange Commission on February 10, 2026. Registration No. 333-293322 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 (Amendment No. 1) REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 BIORESTORATIVE THERAPIES, INC. (Exact name of registrant as specified in its charter) incorporation or organization) Classification Code Number) Identification Number) Nevada 8099 30-1341024 (State or other jurisdiction of (Primary Standard Industrial (I ...