Financial Results - BioRestorative Therapies, Inc. announced its financial results for Q1 2025, ending March 31, 2025[3] - The company issued a press release on May 14, 2025, detailing its financial performance and business updates[3] Company Operations - The press release is available as Exhibit 99.1, which includes further insights into the company's operations[7]

Core Viewpoint - BioRestorative Therapies, Inc. reported its first quarter 2025 financial results and highlighted significant advancements in its clinical programs, particularly in stem cell-based therapies for disc/spine and metabolic disorders [1][2]. Corporate Highlights - The company has successfully achieved key clinical program milestones since the beginning of 2025 and is focused on executing its growth strategy while managing resources effectively [2]. - BioRestorative confirmed no material exposure to newly imposed U.S. tariffs, attributing this to its 'made-in-America' production strategy [5]. - The CEO participated in an interview at the Benzinga All-Access Show, discussing the company's progress [5]. - The company presented positive preliminary data from its ongoing Phase 2 clinical trial of BRTX-100 for chronic lumbar disc disease (cLDD) at the Orthopaedic Research Society Annual Meeting [5]. - The FDA granted Fast Track designation to the BRTX-100 program for cLDD, which may lead to Priority Review and Accelerated Biologics License Application approval [5]. - The FDA also cleared the Investigational New Drug application for BRTX-100 for chronic cervical discogenic pain, expanding the clinical pipeline [5]. Clinical Programs - The BRTX-100 program aims to treat chronic lower back pain from degenerative disc disease and has shown promising preliminary efficacy trends [5][11]. - The company is developing the ThermoStem metabolic disease platform, targeting obesity and metabolic disorders using brown adipose-derived stem cells [12]. - BioRestorative operates a commercial BioCosmeceutical platform, focusing on cell-based secretome products for cosmetic applications [13]. Financial Results - First quarter 2025 revenues were $25,000, down from $35,000 in the same period last year [7]. - The company reported a loss from operations of $4.8 million for the first quarter of 2025, compared to a loss of $4.1 million in the same period of 2024 [7]. - The net loss for the first quarter of 2025 was $5.3 million, or $0.64 per share, compared to a net loss of $2.2 million, or $0.33 per share, in the first quarter of 2024 [8]. - Cash used in operating activities was $2.8 million in Q1 2025, compared to $2.3 million in Q1 2024 [8]. - The company ended the first quarter of 2025 with $9.1 million in cash and cash equivalents, with no outstanding debt [9].

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 Viewpoint - BioRestorative Therapies, Inc. is set to release its first quarter 2025 financial results on May 14, 2025, followed by a conference call for a business update [1][2]. Company Overview - BioRestorative Therapies, Inc. focuses on developing stem cell-based therapies and products, primarily targeting disc/spine diseases and metabolic disorders [3]. - The company operates a commercial BioCosmeceutical platform, offering products that utilize cell and tissue protocols, particularly adult stem cells [3]. Clinical Development Programs - **Disc/Spine Program (brtxDISC™)**: The lead candidate, BRTX-100, is derived from a patient's own mesenchymal stem cells and is intended for non-surgical treatment of lumbosacral disc disorders. A Phase 2 clinical trial is underway for chronic lower back pain due to degenerative disc disease, with FDA IND clearance obtained for chronic cervical discogenic pain [3]. - **Metabolic Program (ThermoStem®)**: This program aims to develop therapies targeting obesity and metabolic disorders using brown adipose-derived stem cells (BADSC) to generate brown adipose tissue (BAT). Initial research suggests that increased brown fat may enhance caloric burning and lower glucose and lipid levels, potentially reducing obesity and diabetes risk [4]. BioCosmeceuticals - The company has a commercial BioCosmeceutical platform that includes a cell-based secretome product designed to reduce fine lines and wrinkles. Future plans involve expanding the product line to include more cell-based aesthetic products and therapeutics, with the goal of obtaining FDA approvals [5].

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]

MELVILLE, N.Y., April 15, 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 announce that its Chief Executive Officer, Lance Alstodt, will be interviewed during the Benzinga All-Access Show today, Tuesday, April 15, 2025, at 10:50 a.m. Eastern time. Benzinga All-Access Show Date: Tuesday, April 15, 2025Time: 10:50 a.m. Eastern Time ...

MELVILLE, N.Y., April 15, 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 announce that its Chief Executive Officer, Lance Alstodt, will be interviewed during the Benzinga All-Access Show today, Tuesday, April 15, 2025, at 10:50 a.m. Eastern time. Benzinga All-Access Show Date: Tuesday, April 15, 2025Time: 10:50 a.m. Eastern Time ...

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 ...

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 ...

Financial Data and Key Metrics Changes - For the 12-month period ending December 31, 2024, the company's revenue grew 175% year-over-year to $401,000 [10] - The 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 cash, cash equivalents, and marketable securities totaling $10.7 million and no outstanding debt at year-end [10] Business Line Data and Key Metrics Changes - The lead clinical stage candidate, BRTX-100, is being evaluated in a Phase 2 trial for chronic lumbar disc disease, with positive preliminary data showing no serious adverse events and promising trends in patient outcomes [12][14] - The company is also advancing its ThermoStem program, targeting obesity and metabolic disorders, with preclinical data indicating significant weight loss and blood glucose level improvements in animal models [19][20] Market Data and Key Metrics Changes - The FDA granted Fast Track designation for BRTX-100, facilitating development and review processes for serious conditions with unmet medical needs [16] - BRTX-100 is now the first and only stem cell product candidate cleared by the FDA for evaluation in cervical degenerative disc disease, allowing the company to bypass preclinical animal studies and Phase 1 trials [18] Company Strategy and Development Direction - The company aims to leverage its data from the lumbar trial to expedite the regulatory pathway for cervical applications, indicating a broader strategy to expand BRTX-100 into other musculoskeletal indications [36][41] - The management is focused on building a comprehensive portfolio of patents to protect its intellectual property related to the ThermoStem program, ensuring long-term market exclusivity [21] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the financial performance and projected growth plans, indicating a pathway to reduced dependence on capital markets [27] - The company is committed to managing resources efficiently while advancing its clinical development programs [23] Other Important Information - The company is exploring regulatory opportunities to potentially shorten the trial duration and limit patient enrollment for BRTX-100 [50] - Discussions with a commercial stage regenerative medicine company regarding potential licensing agreements for ThermoStem are ongoing, although no updates can be provided at this time [22] Q&A Session Summary Question: Regarding the resolution of annular tears and decreased protrusion size - Management confirmed that spontaneous improvement is unlikely in cases of degenerative disc disease, making the observed resolutions encouraging [33][34] Question: Expansion strategy for BRTX-100 into cervical indications - The company views the cervical program as a strategic expansion, leveraging lumbar data to facilitate regulatory approval [36][39] Question: Enrollment update for the lumbar trial and cash burn estimation for 2025 - Enrollment is progressing well, with cash burn expected to be similar to 2024, potentially decreasing in 2026 as enrollment for lumbar trials concludes [48][49] Question: Future revenue expectations from Cartessa - Management anticipates more consistent revenue from Cartessa as the commercial relationship develops, while also exploring additional commercial opportunities [58][61]