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].

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]

Core Insights - BioRestorative Therapies, Inc. has received a Notice of Allowance for a new patent application from the European Patent Office, which covers key aspects of its ThermoStem® metabolic disease platform, expected to provide protection until April 29, 2040 [1][3] Patent and Technology - The new patent covers a method for creating a non-naturally occurring three-dimensional brown adipose derived stem cell aggregate [2] - The patent allowance validates the advancements made in the metabolic disease program, with a focus on transforming the treatment landscape for obesity and related metabolic diseases [3] Market Opportunities - The company sees a significant market opportunity for ThermoStem®-based BADSCs, particularly in regions dominated by GLP-1 treatments for obesity [3] - BioRestorative is in discussions with a commercial stage regenerative medicine company regarding a potential license of its ThermoStem® metabolic intellectual property [3] Clinical Development Programs - BioRestorative's core clinical development programs include: - **Disc/Spine Program (brtxDISC™)**: Focused on treating painful lumbosacral disc disorders using BRTX-100, which is derived from a patient's own cultured mesenchymal stem cells [4] - **Metabolic Program (ThermoStem®)**: Developing therapies targeting obesity and metabolic disorders using brown adipose derived stem cells to generate brown adipose tissue [5] BioCosmeceuticals - The company operates a commercial BioCosmeceutical platform, offering a cell-based secretome product designed to reduce fine lines and wrinkles, with plans to expand its product offerings [6][7]