Eledon Pharmaceuticals (ELDN) Piper Sandler 37th Annual Healthcare Conference summary

Key clinical results and safety profile

• Phase 2 BESTOW trial showed tegoprubart was not inferior to tacrolimus in efficacy for kidney transplant patients, with a strong safety profile.

• Over 150 patients have used tegoprubart, building a robust efficacy and safety database.

• Tegoprubart demonstrated some of the highest graft function seen in clinical trials, with mean eGFR of 69 vs. 66 for tacrolimus over 52 weeks.

• Adverse events were similar in number and severity, but tegoprubart had fewer serious side effects such as bacteremia, hyperglycemia, new-onset diabetes, hyperkalemia, tremors, and delayed graft function.

• Patients on tacrolimus experienced more post-transplant dialysis days, higher rates of hypertension, heart failure, and other complications.

Strategic development and market focus

• Sufficient funding secured to operate through Q2 2027, following a recent $57.5 million financing.

• Plans to approach the FDA in the first half of next year to discuss phase 3 approval pathway for kidney transplantation.

• Phase 3 trial expected to launch in the second half of the year, with 200-300 patients per arm, focusing on triple endpoints for non-inferiority.

• Tegoprubart development is focused on transplantation, including kidney, islet cell, xenotransplantation, and liver programs.

• Collaborations ongoing in xenotransplantation with United Therapeutics and eGenesis, with upcoming studies in cardiac and kidney xeno.

Market landscape and unmet needs

• Kidney transplantation is the largest segment, with about 27,000 procedures annually in the U.S. and 100,000 patients on the waitlist.

• Current standard of care, tacrolimus, is a $1.5 billion market but is associated with significant toxicity and side effects.

• Improving organ survival and reducing repeat transplants are key goals, as 11% of waitlisted adults need repeat procedures.

• The market is highly concentrated, with 100 centers performing 80% of transplants, making it accessible for targeted commercialization.

• Tegoprubart aims to address both the efficacy and safety limitations of current immunosuppressive therapies.