MELVILLE, N.Y., April 10, 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, is pleased to confirm that it currently faces no material exposure to newly imposed U.S. tariffs. BRTX-100, a novel cell-based therapeutic engineered to target areas of the body that have little blood flow, is BioRestorative's lead clinical candidate. The safety and effi ...

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, 2024 ☐ 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 | | --- ...

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 ...

Financial Data and Key Metrics Changes - For the 12-month period ending December 31, 2024, BioRestorative's revenue grew 175% year-over-year to $401,000 [10] - The company's loss from operations was $11.6 million, a 24% improvement from the $15.2 million loss for 2023 [10] - The net loss for 2024 was $9 million, or $1.16 per share, a 14% improvement from a net loss of $10.4 million, or $2.47 per share, for 2023 [10] - Cash used in operating activities in 2024 was $8.2 million, with the company ending the year with cash, cash equivalents, and marketable securities of $10.7 million and no outstanding debt [10] Business Line Data and Key Metrics Changes - The lead clinical stage candidate, BRTX-100, is being evaluated in a Phase 2 study for chronic lumbar disc disease, with positive preliminary data showing no serious adverse events and promising trends in patient outcomes [12][14][15] - The FDA granted Fast Track designation for BRTX-100, facilitating development and review processes [16] - The company is also advancing its ThermoStem program, targeting obesity and metabolic disorders, with promising preclinical data indicating significant weight loss and blood glucose level reductions [19][20] Market Data and Key Metrics Changes - The company is leveraging its data from the lumbar trial to expedite the regulatory pathway for cervical disc disease, potentially saving time and costs associated with preclinical studies [18][39] - The ThermoStem program is expanding its intellectual property portfolio to ensure long-term market exclusivity [21] Company Strategy and Development Direction - The company is focused on advancing its two clinical development programs, BRTX-100 and ThermoStem, while managing resources efficiently [23] - There is a strategic intent to expand BRTX-100 beyond lumbar and cervical applications to other musculoskeletal indications [37][41] - The company aims to build a comprehensive patent portfolio to protect its innovations and attract potential licensing partners [21] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the company's financial performance and projected growth plans, indicating a pathway to reduced dependence on capital markets [26] - The management team highlighted the importance of FDA interactions and the potential for accelerated regulatory approvals [25][43] Other Important Information - The company is in discussions with a commercial-stage regenerative medicine company regarding potential licensing agreements for its ThermoStem programs [22] - The company is exploring regulatory opportunities to potentially shorten the trial duration for BRTX-100 [51] Q&A Session Questions and Answers Question: Regarding the resolution of annular tears and decreased protrusion size - Management indicated that such improvements are not expected to happen spontaneously, especially in cases of degenerative disease [33][34] Question: Expansion of BRTX-100 to cervical indications - Management confirmed that the cervical space was strategically chosen, and they aim to leverage lumbar data to facilitate regulatory processes [36][39] Question: Enrollment update in the lumbar trial and cash burn estimation for 2025 - Management stated that enrollment is progressing well and cash burn in 2025 is expected to be similar to 2024, with potential reductions in future years [48][49] Question: Future revenues from Cartessa - Management expects revenues to become more consistent as the commercial relationship develops, while also exploring additional commercial opportunities [58][62]

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].