In fact, as I'm writing this, LGVN stock has already more than doubled on the day. Indeed, as is the case with most such moves in the biotech sector, investors would be right to assume some sort of key headline around one of the company's prospective drugs is driving the tape. LGVN Stock Rockets Higher on Positive Update HLHS is often fatal and is the result of an undeveloped or absent left ventricle at birth. Reconstructive surgeries are needed to allow the right ventricle to do all the work, but given the ...

Longeveron's lead investigational therapeutic candidate is Lomecel-B™, a proprietary, scalable, allogeneic, adult human bone marrow-derived medicinal signaling cell therapy. ELPIS II is enrolling 38 pediatric patients, with enrollment completion anticipated by year end 2024. The clinical trial is being conducted in collaboration with the National Heart, Lung, and Blood Institute (NHLBI) through grants from the National Institutes of Health (NIH). ELPIS II builds on the positive clinical results of ELPIS I. ...

MIAMI, June 10, 2024 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ:LGVN), a clinical stage biotechnology company developing regenerative medicines, today announced that it will participate in the Emerging Growth Virtual Conference taking place June 12-13, 2024. Date: Wednesday, June 12, 2024 Time: 1:45 p.m. ET Questions may be submitted in advance to Questions@EmergingGrowth.com or asked during the event. Longeveron is a clinical stage biotechnology company developing regenerative medicines to address unmet m ...

Contract manufacturing services as a new business line has the potential to generate approximately $4-5 million in annual revenues First manufacturing services contract signed with Secretome Therapeutics MIAMI, June 03, 2024 (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 launch of its contract development and manufacturing business at ...

Contract manufacturing services as a new business line has the potential to generate approximately $4-5 million in annual revenues First manufacturing services contract signed with Secretome Therapeutics MIAMI, June 03, 2024 (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 launch of its contract development and manufacturing business at ...

MIAMI, May 28, 2024 (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 will participate in the BIO International Convention taking place June 3-6, 2024 at the San Diego Convention Center. At the conference, members of the Longeveron management team will host meetings with global pharmaceutical company executives to explore pot ...

MIAMI, May 28, 2024 (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 will participate in the BIO International Convention taking place June 3-6, 2024 at the San Diego Convention Center. At the conference, members of the Longeveron management team will host meetings with global pharmaceutical company executives to explore pot ...

Financial Data and Key Metrics - Revenue for Q1 2024 was $0.5 million, up 96% YoY, driven by increased demand for the Frailty and Cognitive Impairment registry trial in the Bahamas [38] - Contract manufacturing revenue was less than $0.1 million for Q1 2024, with potential to expand to $4-5 million annually once fully operational [10][39] - Total operating expenses decreased by 8% YoY, with G&A expenses increasing to $2.2 million and R&D expenses decreasing to $2.2 million due to reduced Alzheimer's trial costs and discontinuation of the Frailty trial in Japan [40] - Net loss decreased to $4.1 million in Q1 2024 from $4.6 million in Q1 2023 [54] - Cash and cash equivalents were $2.3 million as of March 31, 2024, with $11.4 million raised in April 2024 to fund operations into Q4 2024 [54] Business Line Data and Key Metrics - Lomecel-B, the lead cellular therapy candidate, is being evaluated in three treatment areas: HLHS, Alzheimer's disease, and aging-related Frailty, with a U.S. market potential of $10-18 billion [3][4] - HLHS program is the top priority, with ELPIS II Phase 2b trial on track to complete enrollment by end of 2024 [21][30] - Alzheimer's disease program showed positive results in the CLEAR MIND Phase 2a trial, with plans to meet FDA for future clinical and regulatory strategy [22][24] - Aging-related Frailty trial in Japan was discontinued to prioritize HLHS development, with cost savings redirected to HLHS [25] Market Data and Key Metrics - HLHS program has received Orphan Drug, Fast Track, and Rare Pediatric Disease designations, potentially leading to priority review vouchers worth over $100 million [16] - The company is expanding contract manufacturing operations, leveraging its GMP facility in Miami, which includes 3,000 square feet of clean room space [18][33] Company Strategy and Industry Competition - The company is focused on optimizing resources, reducing expenses, and prioritizing HLHS and Alzheimer's disease programs [25][34] - Longeveron is leveraging its manufacturing expertise to generate additional revenue through contract manufacturing, which could offset clinical development costs [10][33] - The company is exploring partnerships and non-dilutive funding to support further development of Lomecel-B in Alzheimer's disease [24] Management Commentary on Operating Environment and Future Outlook - Management expressed confidence in the potential of Lomecel-B, citing positive data from ELPIS I and CLEAR MIND trials [29][35] - The company believes 2024 could be a transformational year, with multiple catalysts including the completion of ELPIS II enrollment and regulatory discussions for Alzheimer's disease [29][34] - Management highlighted the importance of real-world evidence from the Bahamas registry trial to guide future clinical development [17][31] Other Important Information - The company has initiated a board refreshment process, appointing new members with extensive industry experience, including Richard Kender and Dr. Roger Hajjar [26][27][42] - Longeveron plans to launch an investigational osteoarthritis registry trial in the Bahamas in Q4 2024 [9] Q&A Session Summary Question: Regulatory receptivity to Lomecel-B in HLHS and potential for accelerated approval - Management aims for full approval of Lomecel-B in HLHS, with accelerated approval as a backup plan [45] - The Phase 2 trial (ELPIS II) is a head-to-head study with 19 patients in each arm, designed to show improved right ventricular function and long-term outcomes [46][47] - The company is exploring statistical methodologies to increase the probability of success and will discuss endpoints with the FDA [48][49] Question: Regulatory guidance for Lomecel-B in Alzheimer's disease and implications for future development - Management is optimistic about the potential for Lomecel-B in Alzheimer's disease, despite existing guidelines [66] - The company plans to incorporate imaging biomarkers and clinical scales in future trials, with a focus on early Alzheimer's disease and mild dementia [67][68] - Preliminary data from the CLEAR MIND trial showed slowing of brain volume decrease and cognitive stabilization, supporting future trial designs [73][74]

OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 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, 2024 For the transition period from to . Commission File Number: 001-40060 Longeveron Inc. (Exact name of registrant as specified in its charter) Delaware 47-2174146 (State or Other Jurisdiction of Incorpo ...

Richard Kender, retired SVP of Business Development and Corporate Licensing for Merck & Co., Inc., has been appointed to the Longeveron BoardDr. Roger Hajjar, former head of R&D at Ring Therapeutics, has been nominated as a candidate for the Board, subject to election at the Company's Annual Meeting of StockholdersNeha Motwani, former managing director and senior healthcare investment banker at William Blair, Truist, and Oppenheimer and Company, also has been nominated as a candidate for the Board, subject ...