NFL super-agent Leigh Steinberg opens up about the brain trauma crisis in football and his mission to protect athletes through advocacy, research, and a groundbreaking collaboration on stem cell therapy. Learn more: https://european-wellness.eu/ The man who inspired the multiple award-winning movie “Jerry Maguire” meets the pioneering stem cell scientist who is transforming regenerative medicine. Together, they may just hold the key to healing the silent epidemic of sports-related brain injuries. A ...

BioRestorative Therapies (BRTX) Update / Briefing June 18, 2025 10:50 AM ET Speaker0 Thank you so much. Hey, Zakers, and welcome back to All Access. I got that wonderful guest for you today, another one, and that's Lance Allstott, the Chairman and CEO of Bio Restorative Therapies. The NASDAQ ticker is BRTX. He's joining us for another exclusive talk today. All Access starts right now. And it is my pleasure to welcome back in the Chairman and CEO of BioRestorative Therapies, Lance Allstad. It's fantastic to ...

Core Insights - BioRestorative Therapies, Inc. presented promising preliminary data for its BRTX-100 therapy at the ISSCR 2025 Annual Meeting, showing over 50% improvement in pain and function for chronic lumbar disc disease (cLDD) patients [1][4][5] - The number of evaluated subjects in the ongoing Phase 2 clinical trial has more than doubled, indicating significant progress towards full enrollment [1][5] Clinical Trial Data - In the Phase 2 trial, 67.57% of subjects showed over 50% improvement in function (ODI) and 73.82% reported over 50% reduction in pain (VAS) at 12 weeks [4] - By 52 weeks, over 74% of subjects demonstrated over 50% improvement in function and over 72% reported significant pain reduction [5] - The trial aims to enroll up to 99 subjects across 16 U.S. sites, with a randomized, double-blinded, placebo-controlled design [6] Safety and Efficacy - No serious adverse events or dose-limiting toxicities were reported between 26 and 104 weeks at the target dose of 40 million cells, indicating an excellent safety profile [5] - Each new data analysis has shown an upward trend in efficacy markers, enhancing confidence in the therapy's potential to meet FDA thresholds for approval [5][4] Company Overview - BioRestorative focuses on developing stem cell-based therapies for serious musculoskeletal conditions, with BRTX-100 as its lead candidate for treating painful lumbosacral disc degeneration [7] - The company also has a metabolic program targeting obesity and metabolic disorders, and a commercial BioCosmeceutical platform aimed at aesthetic applications [8][9]

CAMBRIDGE, Mass., June 10, 2025 (GLOBE NEWSWIRE) -- Ernexa Therapeutics (Nasdaq: ERNA), developing innovative cell therapies for the treatment of advanced cancer and autoimmune disease, today announced a reverse stock split of its issued and outstanding shares of common stock, par value $0.005 per share (the “Common Stock”), at a ratio of 1-for-15, effective June 12, 2025 at 12:01 a.m. Eastern Time. The Company’s Common Stock is expected to begin trading on a split-adjusted basis when the market opens on Ju ...

– New blinded safety and efficacy data from 30 patients in ongoing Phase 2 trial to be unveiled June 13, 2025 – – ISSCR 2025 is the premier global event for stem cell research, drawing nearly 4,000 leaders from academia, biotech, and pharma – – BioRestorative to release new clinical data to the public prior to market open on June 13th – MELVILLE, N.Y., June 09, 2025 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (“BioRestorative,” “BRTX” or the “Company”) (NASDAQ: BRTX), a clinical-stage regenerative me ...

Summary of Biocardia (BCDA) FY Conference Call Company Overview - Biocardia is a late-stage development company focused on autologous stem cell therapy for ischemic heart failure and chronic myocardial ischemia, located in Sunnyvale, California [1][2][5] - The company has four clinical programs at various stages of advancement [5] Core Points and Arguments Heart Failure Program - The lead indication is heart failure, specifically the BCDA DAO one cardiac phase three trial [6] - Heart failure is described as an enormous unmet medical need, with the therapy aiming to treat microvascular dysfunction by delivering high dosages of autologous cells directly into the heart muscle [6][7] - Preclinical models have shown that the therapy can reduce fibrosis and enhance capillary density [7] - The therapy includes a selection diagnostic to screen out patients who are not appropriate for treatment [7][8] Clinical Trial Data - In March, data from the heart failure one trial was presented, showing reduced mortality and improved quality of life, despite not hitting the primary endpoint [10][11] - The trial involved 115 patients and demonstrated statistical significance in secondary endpoints, including survival and reduction in major adverse cardiac events [11][12] - A one-time dosage of cells is administered, with a two-year follow-up showing robust effects [12] Upcoming Trials and Regulatory Submissions - The FDA approved a subsequent trial (Heart Failure II) to address previous enrollment challenges, with modifications to the study design [14][15] - The new trial will focus on patients with elevated markers of heart stress and aims to double the enrollment rate [19] - Biocardia is pursuing expedited approval from Japan's PMDA for cardiac cell therapy, with a submission expected within the year [21][24] - The company is also working on FDA submissions for its delivery system, which has shown excellent safety data [25] Chronic Myocardial Ischemia Program - The CardiAmp CMI program targets chronic myocardial ischemia with refractory angina, a condition poorly met by existing therapies [26][28] - There are at least one million patients in the U.S. with this condition, and Biocardia's approach aims to be the least expensive cardiac cell therapy available [30][31] - The company is working on a manuscript for early data from the low dose cohort of the CMI trial [32] Other Important Information - Biocardia has an allogeneic platform and is exploring partnerships for both cardiac and pulmonary indications [38][40] - The partnership environment is currently challenging due to market stability concerns, but Biocardia's assets are proven and in the clinic [41] - The company is focused on advancing its lead program while also exploring opportunities in other areas [39][41]

BioRestorative Therapies (BRTX) Q1 2025 Earnings Call May 14, 2025 04:30 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 DirectorJason Mccarthy - Senior Managing Director & Head of Biotechnology Research Conference Call Participants Jonathan Aschoff - Managing Director, Senior Research Analyst Operator Please note this conference is being reco ...

Financial Data and Key Metrics Changes - For Q1 2025, revenues were $25,000, a decrease from $35,000 in the same period last year [6] - Deferred revenues for Q1 2025 were $150,000 compared to nil in Q1 2024, indicating a timing difference in revenue recognition [6] - The loss from operations for Q1 2025 was $4,800,000, compared to $4,100,000 for Q1 2024 [7] - The net loss for Q1 2025 was $5,300,000 or $0.64 per share, compared to a net loss of $2,200,000 or $0.33 per share in Q1 2024 [7] - Cash used in operating activities in Q1 2025 was $2,800,000, with cash, cash equivalents, and marketable securities totaling $9,100,000 and no outstanding debt [8][19] Business Line Data and Key Metrics Changes - The lead clinical stage candidate, BRTX-one hundred, is being evaluated in a Phase II trial for chronic lumbar disc disease (CLDD) [10] - Preliminary data from the trial shows positive trends in safety and efficacy, with no serious adverse events reported [11][12] - The FDA granted Fast Track designation for BRTX-one hundred, facilitating its development and review process [13] Market Data and Key Metrics Changes - The company is developing ThermoStem, a cell-based therapy targeting obesity and metabolic disorders, using brown adipose-derived stem cells [14] - The company has built a comprehensive patent portfolio to protect its intellectual property in both US and international markets [15] Company Strategy and Development Direction - The company is focused on advancing its two core clinical development programs: BRTX-one hundred and ThermoStem [16] - There are ongoing discussions regarding a potential licensing agreement for the ThermoStem metabolic disease programs [15][19] - The company aims to leverage positive preliminary data to potentially shorten the regulatory process for BLA approval [45] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing Phase II trial for BRTX-one hundred, expecting data to remain consistent with previous trends [17] - The company is actively managing resources while executing strategic goals, ending the quarter with a strong financial position [19] Other Important Information - The company is preparing for a presentation of data from 45 subjects at an upcoming conference in June [26] - Management emphasized the importance of maintaining a clean and valid data set for the trial [36] Q&A Session Summary Question: Clarification on efficacy endpoint - Management confirmed that the primary endpoint is safety, with a secondary efficacy endpoint of greater than or equal to 30% improvement [22] Question: Interim analysis status - Management stated that an interim analysis is still a potential option but has not been determined yet [23][24] Question: Enrollment pace and characteristics - Management indicated that enrollment is picking up due to new recruitment strategies and that they expect to counteract any summer slowdown [36] Question: FDA emphasis on pain or function - Management noted that both pain reduction and functional improvement are being collected, with ongoing discussions with the FDA [38] Question: Morphological changes observed - Management provided details on encouraging morphological changes observed in patients, including increased hydration and decreased protrusion size [42][44]

Longeveron (LGVN) Q1 2025 Earnings Call May 08, 2025 04:30 PM ET Company Participants Derek Cole - PresidentJoshua Hare - Co-Founder, Chief Science Officer & ChairmanWa'el Hashad - CEO & DirectorNataliya Agafonova - Chief Medical OfficerDevin Blass - SVP & CTOLisa Locklear - CFO & TreasurerRaghuram Selvaraju - Managing Director, Healthcare Equity Research Conference Call Participants Boobalan Pachaiyappan - Managing Director, Senior Research AnalystMichael Okunewitch - Senior Biotechnology Analyst Operator ...

Longeveron (LGVN) Q1 2025 Earnings Call May 08, 2025 04:30 PM ET Speaker0 a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Derek Cole of Investor Relations Advisory Solutions. Thank you. You may begin. Speaker1 Thank you, operator. Good afternoon, everyone, and thank you for joining us today to review Longgevron's twenty twenty five first quarter financial results and business update. After The U. S. Markets closed today, we issued a press release with financial r ...