BioRestorative Therapies (BRTX) Q4 2024 Earnings Call March 27, 2025 10:29 PM ET Company Participants Stephen Kilmer - Investor RelationsLance Alstodt - Chairman of the Board, President & CEORobert Kristal - CFOFrancisco Silva - Chief Scientist, VP of Research & Development, Secretary and Director Conference Call Participants Michael Okunewitch - Senior Biotechnology AnalystElemer Piros - Senior Biotechnology Analyst Operator Good afternoon, everyone, and welcome to the BioRestorative Therapies twenty twent ...

BioRestorative Therapies, Inc. (NASDAQ:BRTX) Q4 2024 Earnings Conference Call March 27, 2025 4:30 PM ET Company Participants Stephen Kilmer ??? Investor Relations Lance Alstodt ??? Chairman and Chief Executive Officer Rob Kristal ??? Chief Financial Officer Francisco Silva ??? Vice President-Research and Development Conference Call Participants Michael Okunewitch ??? Maxim Group Elemer Piros ??? Rodman & Renshaw Operator Good afternoon, everyone, and welcome to the BioRestorative Therapies 2024 Results Conf ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Date of Report (Date of earliest event reported): March 27, 2025 BioRestorative Therapies, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation) (Commission File Number) Nevada 001-37603 30-1341024 (IRS Employer Identification No.) 40 Marcus Drive Melville, New York 11747 (Address of princip ...

MELVILLE, N.Y., March 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 reported financial results for the year ended December 31, 2024 and provided an update on its business. “2024 was a transformative year for BioRestorative, highlighted by significantly improved financial performance and meaningful clinical program advancement,” said Lance Alstodt ...

MELVILLE, N.Y., March 20, 2025 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. ("BioRestorative", "BRTX" or the "Company") (NASDAQ:BRTX), a clinical stage regenerative medicine innovator focused on stem cell-based therapies and products, today announced that it will release its 2024 financial results after market close on Thursday, March 27, 2025. Following the announcement, BioRestorative management will host a conference call to review the financial results and provide a business update. 2024 Results C ...

– BRTX-100 is the first and only stem cell product candidate cleared to be evaluated in the cervical degenerative disc disease setting – – IND clearance expands Company’s advanced clinical pipeline for BRTX-100 treatment of both chronic lower back and neck pain – – Company to host webcasted conference call today at 10:30am EST – MELVILLE, N.Y., Feb. 27, 2025 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ:BRTX), a clinical stage regenerative medicine in ...

Core Viewpoint - BioRestorative Therapies, Inc. has announced a change in the timing of its upcoming webcasted conference call to discuss its pipeline update, now scheduled for 10:30am EST on February 27, 2025 [1] Company Overview - BioRestorative Therapies, Inc. is focused on developing therapeutic products using cell and tissue protocols, primarily involving adult stem cells [3] - The company has two core clinical development programs targeting disc/spine disease and metabolic disorders, along with a commercial BioCosmeceutical platform [3] Clinical Development Programs - **Disc/Spine Program (brtxDISC)**: The lead cell therapy candidate, BRTX-100, is formulated from autologous cultured mesenchymal stem cells from the patient's bone marrow, intended for non-surgical treatment of painful lumbosacral disc disorders. A Phase 2 clinical trial has commenced to treat chronic lower back pain from degenerative disc disease [3][4] - **Metabolic Program (ThermoStem)**: This program focuses on developing cell-based therapies targeting obesity and metabolic disorders using brown adipose derived stem cells (BADSC) to generate brown adipose tissue (BAT). Initial preclinical research suggests that increased brown fat may enhance caloric burning and reduce glucose and lipid levels [4] BioCosmeceuticals - BioRestorative operates a commercial BioCosmeceutical platform, with a current product that is a cell-based secretome designed to reduce fine lines and wrinkles. The company plans to expand its offerings to include a broader range of cell-based biologic aesthetic products and therapeutics, aiming for FDA approvals [5]

Core Viewpoint - BioRestorative Therapies, Inc. is set to provide a positive clinical pipeline update on February 27, 2025, highlighting significant developments in its regenerative medicine initiatives [1][2]. Clinical Pipeline - The company is focused on two main clinical development programs: the Disc/Spine Program and the Metabolic Program [4][5]. - BRTX-100, the lead candidate in the Disc/Spine Program, is designed for non-surgical treatment of lumbosacral disc disorders and is currently in a Phase 2 clinical trial targeting chronic lower back pain due to degenerative disc disease [4]. - The Metabolic Program, known as ThermoStem, aims to develop therapies targeting obesity and metabolic disorders using brown adipose-derived stem cells, which may enhance caloric burning and reduce glucose and lipid levels [5]. BioCosmeceuticals - BioRestorative operates a commercial BioCosmeceutical platform, offering a cell-based secretome product aimed at reducing fine lines and wrinkles [6]. - The company plans to expand its offerings in the BioCosmeceuticals space, pursuing FDA approvals for additional cell-based aesthetic products and therapeutics [6]. Conference Call Details - A conference call will be held on February 27, 2025, at 8:00 am EST, allowing investors to participate via telephone or through a live webcast [3].

Core Insights - The FDA has granted Fast Track designation to BioRestorative's BRTX-100 program for treating chronic lumbar disc disease (cLDD), highlighting the significant unmet medical need for effective alternatives to opioids and surgical interventions [1][2] - Preliminary Phase 2 clinical data for BRTX-100 has been reported positively, which may facilitate Priority Review and Accelerated Biologics License Application (BLA) approval [1][2] Company Overview - BioRestorative Therapies, Inc. is focused on developing stem cell-based therapies and products, with its lead candidate BRTX-100 targeting chronic lumbar disc disease [1][6] - The company also has a metabolic program targeting obesity and metabolic disorders, and a BioCosmeceutical platform for aesthetic products [8][9] Industry Context - Chronic lumbar disc disease is a prevalent issue, with at least 80% of adults in the U.S. experiencing lower back pain at some point in their lives, making it a leading cause of disability and economic burden [4] - Current treatment options primarily involve conservative non-surgical approaches or surgical interventions, with no existing therapies aimed at reversing disc degeneration [4]

Core Insights - BioRestorative Therapies, Inc. presented promising preliminary data for its lead product BRTX-100 at the ORS annual meeting, indicating significant improvements in pain and function for patients with chronic lumbar disc disease [1][5][7] Company Overview - BioRestorative is a clinical stage regenerative medicine company focused on stem cell-based therapies, particularly for musculoskeletal disorders and metabolic diseases [8] - The company is developing BRTX-100, a cell-based therapy targeting areas with low blood flow, currently in a Phase 2 clinical trial for chronic lumbar disc disease [3][8] Clinical Trial Details - The ongoing Phase 2 trial of BRTX-100 involves up to 99 subjects across 16 clinical sites in the U.S., with a randomized 2:1 allocation to treatment or placebo [3] - Preliminary data from the first 15 patients showed no serious adverse events and no dose-limiting toxicity at the 26-52 week mark [4] Efficacy Results - At 26 weeks, the average improvement in the Visual Analog Scale (VAS) for pain was 71.20%, and at 52 weeks, it was 73.58% [5] - The Oswestry Disability Index (ODI) showed an average improvement of 69.04% at 26 weeks and 65.16% at 52 weeks, both significantly exceeding the FDA's minimum threshold of 30% improvement [5] Imaging Analysis - MRI comparisons at 52 weeks indicated potential disc microenvironment remodeling, including increased hydration and reduced protrusion size, suggesting positive morphological changes due to BRTX-100 treatment [6] Future Outlook - The CEO expressed optimism regarding the trial's ability to meet primary and secondary endpoints, which could lead to FDA approval [7]