Eledon Pharmaceuticals, Inc. Q1 FY2022 earnings call

• David-Alexandre Gros highlighted important progress in Q1 2022, including completing dosing and visits in Phase 2a ALS study, beginning dosing in Phase 2a IgAN study, active sites in Canada and UK for kidney transplant trial, and an open site in Canada with U.S. site to open mid-year.
• Steve Perrin detailed the ALS Phase 2 trial nearing database lock for top-line data, transplantation trials focusing on replacing calcineurin inhibitors, and IgAN program with proteinuria as primary endpoint.
• A meta-analysis showed benefits of anti-CD40 ligand in kidney transplant non-human primate models.

Paul Little reported that Eledon had a net loss of $9.9 million, or $0.69 per share, for the three months ended March 31, 2022, compared to a net loss of $8.5 million, or $0.57 per share in the same period in 2021. Research and development expenses were $6.6 million, an increase of $1 million from the prior year, primarily due to clinical development and trial material costs. General and administrative expenses were $3.2 million, a decrease of $100,000 from the prior year. As of March 31, 2022, Eledon had $76.7 million in cash and cash equivalents, sufficient to fund clinical trials into 2024.

• Eledon remains focused on executing clinical trials, generating ALS data, opening more sites for quicker patient recruitment, and aiming for meaningful initial data in trials during the year.
• The goal is to develop a best-in-class therapeutic targeting the CD40 Ligand pathway for ALS, IgAN, and transplantation.

Statements made during the call include forward-looking statements, and actual outcomes could differ materially due to factors beyond Eledon's control. Participants are directed to risk factors in SEC filings.

Q: Pete Stavropoulos from Cantor Fitzgerald asked about next steps in kidney transplant, interaction with FDA, and sharing ALS safety data.

A: David-Alexandre Gros responded on enrolling patients in Canada and UK trials, planning to reapproach FDA with ALS safety data and non-human primate results.

Q: Nat Charoensook from SVB asked about ALS target engagement and potential interaction with other indications.

A: Steve Perrin discussed target engagement in ALS trial and potential biomarker relevance to other indications.

Q: Unidentified Analyst asked about ALS biomarker decrease and RA data.

A: David-Alexandre Gros and Steve Perrin addressed biomarker analysis in ALS and potential future use of tegoprubart in RA.

Q: Matt Kaplan from Ladenburg Thalmann asked about ALS results relevance to other indications and IgAN study impact on EGFR.

A: David-Alexandre Gros and Jeff Bornstein discussed biomarker relevance across indications and EGFR relationship to proteinuria in IgAN