BioRestorative Therapies(BRTX)
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BioRestorative Therapies Reports First Quarter 2025 Financial Results and Provides Business Update
Globenewswire· 2025-05-14 20:05
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].
Phase 2 Trial of BRTX-100 in cLDD Continues to Generate Positive Preliminary Blinded Data
Globenewswire· 2025-05-13 13:15
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]
BioRestorative Therapies to Report First Quarter 2025 Financial Results and Host Conference Call on May 14, 2025
GlobeNewswire News Room· 2025-05-08 20:30
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].
BioRestorative to Present a BRTX-100 Clinical Update at ISCT 2025
Globenewswire· 2025-05-07 13:15
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]
BioRestorative to Participate in Benzinga All-Access Show Today to Discuss Recent Achievements of Key Clinical & Regulatory Milestones, and Highlight Commercial Opportunities
Globenewswire· 2025-04-15 12:30
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 ...
BioRestorative to Participate in Benzinga All-Access Show Today to Discuss Recent Achievements of Key Clinical & Regulatory Milestones, and Highlight Commercial Opportunities
Newsfilter· 2025-04-15 12:30
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 ...
BioRestorative Confirms No Material Impact from Reciprocal Tariffs; All BRTX-100 Production & Manufacturing Performed in the United States
Globenewswire· 2025-04-10 13:15
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 ...
BioRestorative Confirms No Material Impact from Reciprocal Tariffs; All BRTX-100 Production & Manufacturing Performed in the United States
Newsfilter· 2025-04-10 13:15
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 ...
BioRestorative Therapies(BRTX) - 2024 Q4 - Annual Report
2025-03-28 01:06
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) - 2024 Q4 - Earnings Call Transcript
2025-03-28 02:29
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 ...