Eledon Pharmaceuticals, Inc. Q3 FY2022 earnings call

• In renal transplantation: Dosed first two subjects in Phase 1b study, on track for initial data in Q1 2023; FDA cleared IND for Phase 2 trial vs standard of care for kidney transplant rejection, Phase 2 to enroll ~120 subjects and start next year.
• In IgA Nephropathy: FDA cleared IND for evaluating tegoprubart in US, trial now has regulatory clearances in 11 countries, enrolling subjects, on track to enroll full cohort by H1 2023, with six-month data expected in Q1 2023.
• In islet cell transplantation: Opened first US clinical site at Univ of Chicago, expect first subject dosed by year-end, plan to enroll up to six Type 1 diabetes patients, with initial three-month data in Q1 2023.
• In ALS: Engaged with ALS community on next steps, evaluating funding for potential future trial, data from Phase 2a showed favorable safety, toxicity profile, and biomarker reductions relevant to other indications.

No specific product segment financial performance is detailed; focus is on clinical trial progress and development programs for tegoprubart across various indications.

• Expect to provide initial data updates for kidney transplant, IgAN, and islet cell transplant in Q1 2023.
• Plan to launch Phase 2 kidney transplant study next year.
• Aim to provide further clarity on next steps for ALS program.

Actual outcomes and results could differ materially from forecasts due to factors beyond Eledon's control; forward-looking statements are subject to risks outlined in company reports with the SEC.

Q: Pete Stavropoulos asks about percent change of IgA in ALS and relevance to IgAN clinical benefit.

A: Steve Perrin says reductions in IgA were fast but how they translate to IgAN is unknown.

Q: Pete Stavropoulos asks about target population for IgAN.

A: Steve Perrin and Jeff Bornstein say earlier intervention is likely better as disease progresses and earlier reduction in proteinuria may lead to better outcomes.

Q: Matt Kaplan asks about read-through of Phase 1b renal transplant data to Phase 2.

A: Jeff Bornstein says Phase 1b is a pilot to show safety, efficacy, graft function, and side effects to inform Phase 2.

Q: Matt Kaplan asks about initial data for islet cell transplant.

A: Jeff Bornstein says initial data will cover adverse events, graft function, rejection, and glucose control.

Q: Thomas Smith asks about CD40 landscape and Sjögren's, and superiority of CD40 ligand in solid organ transplant.

A: Steve Perrin and Jeff Bornstein discuss differences between CD40R and CD40L, and learnings from competitor programs.

Q: Thomas Smith asks about Phase 2 kidney transplant study start.

A: David-Alexandre Gros says working with CROs to execute the study with no major gating factors.

Q: Rami Katkhuda asks about dosing in IgAN Phase 2a study.

A: Steve Perrin explains dosing chosen based on pharmacokinetics from prior studies, and work on subcutaneous formulation.