11:00am Chair Introduction

John Rasko, Professor, University of Sydney

11:05am Presentation: Lomecel-B, a Potential Therapy for Hypoplastic Left Heart Syndrome

• Hypoplastic Left Heart Syndrome (HLHS) is a rare pediatric condition that is fatal without surgical intervention. Despite a series of 3 surgeries, approximately 50-60% survive to adolescence with current standard of care
• Lomecel-B, a proprietary, scalable, off-the-shelf cellular therapy product from Longeveron, has shown potential for benefits to patients with HLHS based on a Phase 1b study that also led to FDA granting Rare Disease, Orphan Drug and Fast Track designations
• Longeveron is currently engaged in a Phase 2 randomized controlled study to determine the efficacy of Lomecel-B in HLHS

Chris Min, Chief Executive Officer, Longeveron

11:20am Presentation: Learnings from the First Completed Human Clinical Trial of IPSC-Derived Cells

• Allogeneic iPSC-derived MSCs were manufactured using the Cymerus platform for the treatment of steroid-resistant acute GvHD
• No treatment-related serious adverse events or safety concerns were identified
• US FDA has approved the IND for A CYP-001 Multicenter, Randomized, Double-blind, Placebo-Controlled Phase II Study (NCT05643638)

John Rasko, Professor, University of Sydney

11:35am Presentation: Tissue Therapeutics: Extending the Power of DNA and Cell-Based Approaches to Engineer Whole Tissues as Novel Therapeutics 

• Built on 20+ years of research, this new class of regenerative medicine turns virtually any cell type into implantable bioengineered tissue
• Tissue Therapeutics provides the adaptive and comprehensive cellular response needed to restore, repair or replace critical organ function impacted by progressive failures across multiple systems
• Satellite Bio’s platform is positioned to address a broad range of complex diseases, replicating the high efficacy but reducing many of the complicating issues of the cell and gene approaches that have come before

Dave Lennon, Chief Executive Officer, Satellite Bio

11:50am Presentation: CLZ2002: A Novel Therapy for Peripheral Nerve Damage

• This Presentation will emphasize the importance of CMC which can make sure of reproducible production and efficacious effect
• Cellatoz have learnt the critical characteristics of cells related to the potency. These cells could remyelinate the damaged nerve to recover sensory function and muscle strength

Jaeseung Lim, Chief Executive Officer and Chief Scientific Officer, Cellatoz Therapeutics

12:05pm Closing Panel with Q&A

With all session participants