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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 ...
BioRestorative Therapies(BRTX) - 2024 Q4 - Earnings Call Transcript
2025-03-28 00:10
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]
BioRestorative Therapies(BRTX) - 2024 Q4 - Annual Results
2025-03-27 20:11
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 ...
BioRestorative Therapies Reports 2024 Financial Results and Provides Business Update
Globenewswire· 2025-03-27 20:05
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 ...