Boobalan Pachaiyappan's questions to Longeveron (LGVN) leadership • Q2 2025
Question
Boobalan Pachaiyappan asked about the viability of the HLHS BLA filing given the potential sunsetting of the PRV program, the impact of FDA leadership changes, the availability of six-year survival data from the HLHS Phase 1 trial, the rationale for using a CDMO for manufacturing, and the basis for the FDA's confidence in allowing a pivotal Phase 2 trial for pediatric DCM.
Answer
CEO Wa'el Hashad expressed cautious optimism about the PRV program's reauthorization but noted that Fast Track designation also allows for a rolling submission. He affirmed confidence in the FDA's commitment based on multiple recent collaborative meetings. Chief Medical Officer Nataliya Agafonova clarified the Phase 1 study's follow-up was set at five years. CTO Devin Blass detailed that using a CDMO is faster, more cost-effective, and lower risk. Multiple executives, including Dr. Agafonova and CSO Dr. Joshua Hare, attributed the FDA's confidence in the DCM program to the robust trial design, meaningful endpoints, and the therapy's strong existing safety profile.