Longeveron Inc Stock Price, News & Analysis

Longeveron Inc. (NASDAQ: LGVN) reported its financial results for Q4 and full year 2022, highlighting a net loss of $4.5 million in Q4, compared to $4.1 million in Q4 2021, and a total loss of $18.8 million for 2022 versus $17.0 million in 2021. Revenue for Q4 2022 was $0.1 million, down from $0.2 million in Q4 2021, largely due to fewer clinical trial participants. On a positive note, the company successfully published ELPIS I trial results in the European Heart Journal Open and initiated Phase 2 studies for Lomecel-BTM targeting aging-related frailty in Japan. They anticipate existing cash will cover expenses into H1 2024.

Longeveron Inc. (NASDAQ: LGVN) is set to release its fourth quarter and full year 2022 financial results on March 10, 2023, before U.S. markets open. A conference call will follow at 8:30 a.m. ET to discuss these results and a corporate update. The company, focused on regenerative medicines, is advancing its investigational product Lomecel-B™ for conditions including hypoplastic left heart syndrome, Alzheimer’s Disease, and Aging-Related Frailty.

For more details, investors can access the audio webcast on the company’s website.

Longeveron Inc. (NASDAQ: LGVN) has announced the appointment of Wa’el Hashad as Chief Executive Officer, effective March 1, 2023. With over 35 years of experience in drug approval, mergers, and business development, Hashad previously held executive positions at Avanir, Amgen, and Eli Lilly. His leadership is expected to drive growth across Longeveron's clinical programs focused on Alzheimer’s Disease, Aging-Related Frailty, and hypoplastic left heart syndrome. The company’s lead product, Lomecel-B™, is advancing through clinical trials, showcasing potential therapeutic benefits in regenerative medicine.

Longeveron Inc. (NASDAQ: LGVN) announced the publication of results from its ELPIS I trial for Lomecel-B^TM targeting hypoplastic left heart syndrome (HLHS) in the European Heart Journal Open. The Phase 1b study included 10 infants who underwent the Glenn Procedure. Key findings revealed:

• No adverse safety events reported over one year.
• All patients were alive and transplant-free, maintaining expected growth.
• Improved cardiac function indicators noted.
• Evidence of Lomecel-B^TM persistence in a subset of patients.

Longeveron is enrolling for the ELPIS II trial, further evaluating Lomecel-B^TM's effectiveness, receiving support from the National Heart, Lung, and Blood Institute.

Longeveron Inc. (NASDAQ: LGVN) announced it plans to enroll the first patient in a Phase 2 clinical trial of Lomecel-B™ for Aging-Related Frailty in Japan in Q1 2023. The company has achieved significant progress in clinical development, with a focus on multiple indications like Hypoplastic Left Heart Syndrome (HLHS) and Alzheimer’s Disease. Additionally, Longeveron extended its cash runway into H2 2024, with approximately $20 million in cash reserves. The ELPIS II trial continues to enroll patients, and topline data from the Phase 2a Alzheimer’s trial is expected in early 2024.

Longeveron Inc. (NASDAQ: LGVN) has provided an update on its strategic priorities and milestones for 2023, including the upcoming enrollment of patients in a Phase 2 clinical trial of Lomecel-B™ for Aging-Related Frailty in Japan, slated for 1Q23. The company has extended its cash runway into the second half of 2024, ensuring sufficient funds for ongoing operations. Key developments include progress in trials for Hypoplastic Left Heart Syndrome (HLHS) and Alzheimer’s Disease, with anticipated data publications and trials advancing in partnership with prominent clinical institutions.

On November 29, 2022, Longeveron Inc. (NASDAQ: LGVN) announced its participation in three upcoming investor conferences. The A.G.P. Virtual Biotech Conference will be held on November 30, 2022, featuring one-on-one meetings. The Benchmark Company 11th Annual Discovery Conference is set for December 1, 2022, in New York, NY, also showcasing one-on-one meetings. Finally, Longeveron will present at the RHK 2022 Disruptive Growth Conference on December 6, 2022, at 10:40 a.m. ET in New York. A live webcast of the presentation will be available for access.

Longeveron Inc. (NASDAQ: LGVN) reported significant progress in its clinical pipeline, achieving key milestones, including the completion of enrollment in its Phase 2a trial for mild Alzheimer's Disease. The FDA granted Fast Track Designation to Lomecel-BTM for infants with Hypoplastic Left Heart Syndrome (HLHS). The company’s Q3 2022 revenue totaled $0.3 million, with a net loss of $5.2 million. R&D expenses rose to $2.9 million, while G&A expenses decreased to $2.1 million. Longeveron expects its cash reserves to last into H1 2024. A conference call discussing these results is scheduled for 8:30 a.m. ET today.

Longeveron Inc. (NASDAQ: LGVN) announced the completion of enrollment in its Phase 2a clinical trial of Lomecel-B™ for mild Alzheimer’s Disease. This trial, known as the CLEAR MIND trial, aims to evaluate the safety of Lomecel-B™ through various endpoints, including serious adverse events and cognitive function measures. The trial follows positive results from a prior Phase 1b study that met its primary safety endpoint. This advancement in clinical trials highlights Longeveron’s commitment to addressing unmet medical needs in Alzheimer’s treatment.