Longeveron® to Attend BIO International Convention 2025

In This Article:

Longeveron
Longeveron
  • Focus on potential partnership and strategic opportunities for the Company’s stem cell therapy program for Alzheimer’s disease

  • Recent Type B meeting with FDA provided alignment on a planned single, pivotal Phase 2/3 clinical trial, which if positive, would be acceptable for Biological License Application (BLA) submission for Alzheimer’s disease

  • Initiation of planned single, pivotal Phase 2/3 clinical trial in mild Alzheimer’s disease anticipated in 2H 2026, contingent upon obtaining non-dilutive funding and/or partnering support

  • Results from the Phase 2a clinical trial (CLEAR MIND) evaluating laromestrocel as a potential treatment for Alzheimer’s disease were published in the peer reviewed journal Nature Medicine

  • Laromestrocel is, to Company’s knowledge, the first cellular therapeutic candidate to receive FDA Regenerative Medicine Advanced Therapy (RMAT) designation for Alzheimer’s disease

MIAMI, May 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 that the Company will participate in the BIO International Convention taking place June 16-19, 2025 at the Boston Convention & Exhibition Center.

At the conference, members of the Longeveron management team will host meetings with global pharmaceutical company executives to explore potential partnership and strategic opportunities for the Company’s Alzheimer’s disease program, which has generated positive data in successful Phase 1 and Phase 2 clinical trials.   Results from the Phase 2a clinical trial (CLEAR MIND), which support the therapeutic potential of laromestrocel in the treatment of mild Alzheimer’s disease, were published in the peer reviewed journal Nature Medicine in March 2025.

Longeveron’s lead investigational therapeutic candidate is laromestrocel, a proprietary, scalable, allogenic cellular therapy. In the completed Phase 2a clinical trial (CLEAR MIND), laromestrocel treated patients showed an overall slowing/prevention of disease worsening compared to placebo. The trial achieved the primary safety and secondary efficacy endpoints and showed statistically significant improvements in pre-specified clinical and biomarker endpoints in specific laromestrocel groups compared to placebo.
  
Longeveron previously announced top-line results for the CLEAR MIND Phase 2a clinical trial on October 5, 2023, and reported additional clinical data and imaging biomarker results from CLEAR MIND on December 20, 2023. Full results from the CLEAR MIND study were presented in a featured research oral presentation at the 2024 Alzheimer's Association International Conference (AAIC).