Eledon Pharmaceuticals (NasdaqCM:ELDN) FY Conference Transcript

Eledon Pharmaceuticals FY Conference Summary Company Overview - Company: Eledon Pharmaceuticals (NasdaqCM:ELDN) - Focus: Development of tegoprubart (Tego) for kidney transplantation and other transplant-related therapies Key Points Industry Context - Transplantation Market: Approximately 48,000 transplants are performed annually in the U.S., with 60% being kidney transplants [4][5] - Kidney Transplant Statistics: About 25,000 to 27,000 kidney transplants occur each year, while around 100,000 Americans are on the waiting list for transplants [5][6] Product Development and Clinical Trials - Phase 2 BESTOW Data: Recent results show that Tego's efficacy is not inferior to tacrolimus, the current standard of care, with a strong safety profile [1][2] - Patient Involvement: Over 150 patients have used Tego, with more than 100 post-transplant patients included in the study [2] - Future Milestones: Plans to approach the FDA regarding the path to market for kidney transplantation and other transplant types, including islet cell and xenotransplantation [3] Financial Position - Cash Reserves: Eledon finished the last quarter with over $93 million in cash and completed a $57.5 million financing round, providing sufficient funds until the second quarter of 2027 [2] Comparative Analysis with Tacrolimus - Market Size: Tacrolimus represents a $1.5 billion market, despite being over 30 years old [8] - Safety Concerns: Tacrolimus is nephrotoxic and associated with diabetes and hypertension, which are leading causes of kidney issues [9] - Efficacy Metrics: Mean eGFR (estimated Glomerular Filtration Rate) at 52 weeks was 69 for Tego compared to 66 for tacrolimus, indicating superior kidney function [12] Adverse Events (AEs) Comparison - Tego vs. Tacrolimus: Tego showed lower rates of proteinuria, bacteremia, hyperglycemia, and new-onset diabetes compared to tacrolimus [13][14][15][16] - Psychological Impact: Patients on tacrolimus may experience longer post-transplant dialysis, which can be psychologically challenging [17] Regulatory and Future Plans - Phase 3 Trial: Eledon plans to initiate a Phase 3 trial in the second half of the year, pending FDA discussions [18] - Patient Enrollment: Expected enrollment of 200-300 patients per arm for the Phase 3 trial, focusing on achieving non-inferiority in safety and efficacy [19] Market Opportunity - Concentration of Transplant Centers: There are about 250 transplant centers in the U.S., with 40 centers performing half of the transplants, indicating a concentrated market [6] Conclusion Eledon Pharmaceuticals is positioned to make significant advancements in the transplantation market with its product Tego, which has demonstrated promising efficacy and safety compared to the current standard of care, tacrolimus. The company is well-funded and has a clear path forward for regulatory approval and further clinical development.