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 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: ...

Wa'el Hashad Wa'el Hashad, CEO, Longeveron MIAMI, April 22, 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 the Company’s CEO, Wa’el Hashad, issued the following letter to Longeveron shareholders. Dear Fellow Shareholders, Twenty twenty-four was a year of execution for Longeveron. We made significant progress advancing Longeve ...

Core Insights - Longeveron Inc. announced a positive outcome from a Type B meeting with the FDA regarding laromestrocel (Lomecel-B™) as a potential treatment for Alzheimer's disease [1][2] - The FDA and the company aligned on the study design for a pivotal Phase 2/3 clinical trial, which includes patient population, placebo control, dosing, trial duration, and endpoints [2][8] - The FDA granted laromestrocel both RMAT and Fast Track designations, facilitating closer interaction during development [6][8] Company Overview - Longeveron is a clinical stage biotechnology company focused on developing regenerative medicines for unmet medical needs, with laromestrocel as its lead investigational product [12] - The company is pursuing multiple indications, including Alzheimer's disease, hypoplastic left heart syndrome, and aging-related frailty [12] Clinical Trial Details - The planned pivotal Phase 2/3 clinical trial is expected to begin in the second half of 2026, contingent on securing non-dilutive funding or partnerships [5][8] - Previous clinical trials, including a Phase 1 study and a Phase 2a trial (CLEAR-MIND), demonstrated a favorable safety profile and potential clinical efficacy in patients with mild Alzheimer's disease [3][4] Mechanism of Action - Laromestrocel is derived from mesenchymal stem cells (MSCs) and is believed to have multiple mechanisms of action that may address inflammatory responses associated with Alzheimer's disease [7][11] - The therapy aims to tackle the underlying pathology of Alzheimer's without the limitations of existing treatments [5] Alzheimer's Disease Context - Alzheimer's disease is a leading cause of dementia, significantly impacting patients, families, and society, with substantial economic costs [9] - Neuroinflammation is a key feature of Alzheimer's, contributing to the disease's progression and associated cognitive decline [10]

Nataliya Agafonova MIAMI, March 20, 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 the positive outcome of a Type B meeting with the U.S. Food and Drug Administration (FDA), supporting the advancement of laromestrocel (Lomecel-B), a proprietary, scalable, allogeneic, investigational cellular therapy, as a potential treatment for Alzhe ...