MIAMI, June 09, 2025 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions, today announced that Wa’el Hashad, CEO, will present at the H.C. Wainwright 6th Annual Neuro Perspectives Hybrid Conference, taking place June 16-17, 2025. Details for the Company’s corporate presentation: Pre-recorded presentation available on-demand Monday, June 16, at 7:00 a.m. ETLonge ...

Core Viewpoint - Longeveron Inc. is actively pursuing partnerships for its Alzheimer's disease program, which has shown promising results in clinical trials, particularly with its lead candidate, laromestrocel [2][5]. Company Overview - Longeveron Inc. is a clinical stage biotechnology company focused on developing regenerative medicines to address unmet medical needs, with laromestrocel as its lead investigational product [7]. - Laromestrocel is an allogeneic mesenchymal stem cell therapy derived from the bone marrow of young, healthy adult donors, with potential applications across various disease areas [7]. Clinical Trial Results - The Phase 2a clinical trial (CLEAR MIND) demonstrated that laromestrocel treated patients experienced an overall slowing or prevention of disease worsening compared to placebo, achieving primary safety and secondary efficacy endpoints [3][4]. - Statistically significant improvements were observed in pre-specified clinical and biomarker endpoints for specific laromestrocel groups compared to placebo [3]. Regulatory Designations - The FDA has granted laromestrocel both Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation for the treatment of mild Alzheimer's disease, facilitating greater access to FDA interactions during its development [5]. - Laromestrocel is noted as the first cellular therapeutic candidate to receive FDA RMAT designation for Alzheimer's disease [5]. Upcoming Events - Longeveron will participate in the BIO International Convention from June 16-19, 2025, to explore potential partnerships and strategic opportunities for its Alzheimer's disease program [1][2].

Company Overview - Longeveron Inc. is a clinical stage biotechnology company focused on developing cellular therapies for life-threatening and chronic aging-related conditions [6] - The company's lead investigational product is laromestrocel (Lomecel-B™), an allogeneic mesenchymal stem cell therapy derived from the bone marrow of young, healthy adult donors [6] - Laromestrocel has potential applications across various disease areas, including hypoplastic left heart syndrome (HLHS), Alzheimer's disease, and aging-related frailty [6] Recent Developments - Longeveron has been selected as a Semi-Finalist Team in the XPRIZE Healthspan competition, receiving a $250,000 Milestone 1 Award [1][2] - The XPRIZE Healthspan competition is a 7-year, $101 million global initiative aimed at revolutionizing the approach to human aging [4] - The competition evaluates teams based on their scientific merit and the feasibility of their therapeutic approaches to restore or preserve functions lost to age-related degradation [2][4] Clinical Trials and FDA Designations - Laromestrocel has shown positive initial results in five clinical trials across three indications: Alzheimer's Disease, aging-related frailty, and HLHS [2] - The development programs for laromestrocel have received five significant U.S. FDA designations, including Orphan Drug, Fast Track, and Rare Pediatric Disease designations for HLHS, and Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations for Alzheimer's Disease [2][6] Competition Goals - The XPRIZE Healthspan competition aims to develop therapeutics that can restore muscle, cognitive, and immune function by at least 10 years, with an ambitious goal of extending healthy life by 20 years [2][4] - The competition's top 100 teams were selected from over 600 applicants across 58 countries, with the potential for a grand prize of between $61 million and $81 million for the winning team [2][4]

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 ...

Investor Presentation Nasdaq (LGVN) │ May 2025 Forward Looking Statements Certain statements in this press release that are not historical facts are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, which reflect management's current expectations, assumptions, and estimates of future operations, performance and economic conditions, and involve known and unknown risks, uncertainties, and other important factors that could cause act ...

Exhibit 99.1 Longeveron® Announces First Quarter 2025 Financial Results and Provides Business Update MIAMI, May 8, 2025 -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions, today reported financial results for the quarter ended March 31, 2025 and provided a business update. "In the first quarter, we made notable progress advancing the development of our stem cell therapy, larom ...

Wa'el Hashad Wa'el Hashad, CEO, Longeveron Pivotal Phase 2b clinical trial (ELPIS II) evaluating laromestrocel in HLHS, a rare pediatric disease and orphan-designated indication, has reached approximately 95% enrollment and is expected to complete enrollment in the second quarter of 2025Laromestrocel Biological License Application (BLA) submission for full traditional approval for HLHS anticipated in 2026, if ELPIS II is successfulResults from the Phase 2a clinical trial (CLEAR MIND) evaluating laromest ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 Longeveron Inc. (Exact name of registrant as specified in its charter) | Delaware | 47-2174146 | | --- | --- | | (State or Other Jurisdiction | (IRS Employer | | of Incorporation) | Identification No.) | | th 1951 NW 7 Avenue, Suite 520, Miami, Florida | 33136 | | (Address of principal executi ...

MIAMI, May 02, 2025 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions, today announced that it will report first quarter 2025 financial results and provide a business update on Thursday, May 8, 2025 after the U.S. financial markets close. The Company will host a conference call and webcast the same day at 4:30 p.m. ET. Conference Call and Webcast Details: ...