Longeveron Issues Letter to Shareholders Highlighting Corporate Strategy, Clinical Pipeline and 2024 Key Priorities and Goals

MIAMI, April 08, 2024 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage biotechnology company developing regenerative medicines, today announced that the Company’s CEO, Wa’el Hashad, issued the following letter to Longeveron shareholders.

Dear Shareholders,

I am delighted to mark my first anniversary as CEO of Longeveron this month. It has been an extraordinary journey thus far, and I am immensely grateful for the opportunity to lead such a pioneering organization dedicated to transforming healthcare through innovations in regenerative medicine.

Upon joining Longeveron, I set out with a clear objective: to develop a strategic roadmap building on the strength of our science while acknowledging the realities of the capital market environment. Longeveron's foundation in cutting-edge cellular therapy research, coupled with the promise of Lomecel-B^TM, positions us to profoundly impact patients’ lives for the better by addressing numerous unmet medical needs with U.S. market potential opportunities of up to approximately $10-$18 billion.

Today, I am excited to update you on our overall strategy, business objectives, approach to capital allocation, and 2024 key priorities and goals.

Strategic Overview:
Our focus remains steadfast on raising the funds necessary to continue our operations and delivering transformative solutions to patients and creating sustainable value for our shareholders.

Our lead investigational product is Lomecel-B, which is derived from culture-expanded medicinal signaling cells (MSCs) that are sourced from bone marrow of young healthy adult donors. We believe that by using the same cells that promote tissue repair, organ maintenance, and immune system function, we can develop safe and effective therapies for some of the most difficult diseases and conditions.

In 2024, we are focusing our efforts on two of our most promising programs: Hypoplastic Left Heart Syndrome (HLHS); and Alzheimer’s Disease.

HLHS:

HLHS is a rare pediatric disease affecting approximately 1000 live births per year in the US. The results of our successful Phase 1 trial showed 100% transplant free survival of all subjects at up to 5 years of age. Based on historical data, approximately 20% of patients would have been expected to receive a heart transplant or have died by age five. In response to our positive initial data, the US Food and Drug Administration (FDA) awarded our HLHS program with three distinct and important designations: Rare Pediatric Disease designation, Orphan Drug designation, and Fast Track designation, each of which offer benefits to our development and regulatory processes.