Eledon Pharmaceuticals, Inc. Q1 FY2023 earnings call

• Focused on kidney transplantation program, with Tegoprubart as an anti-CD40 ligand antibody targeting unmet needs in kidney transplants.
• Presented open label data from Phase 1b trial at World Congress of Nephrology showing no acute rejection and strong graft function in initial participants.
• Strengthened balance sheet via $185 million private placement financing, co-led by BVF Partners, Armistice Capital, and including Sanofi.
• Plan to initiate Phase 2 BESTOW trial midyear to assess Tegoprubart vs tacrolimus in kidney transplantation.
• De-prioritized IgAN program but continue collecting safety data from enrolled patients, with Tegoprubart showing safe and well-tolerated profile.

For the three months ended March 31, 2023, Eledon reported a net loss of $10.8 million or $0.75 per share, compared to a net loss of $9.9 million or $0.69 per share in the same period of 2022. Research and development expenses were $8.1 million in Q1 2023, an increase of $1.5 million from Q1 2022, primarily due to higher clinical development expenses. General and administrative expenses were $3 million in Q1 2023, a decrease of $200,000 from Q1 2022, mainly related to lower stock-based compensation costs. Eledon ended the first quarter with approximately $46.5 million in cash and cash equivalents.

• Expect to initiate Phase 2 BESTOW trial midyear.
• Continue enrolling in Phase 1b kidney transplant trial.
• Anticipate reporting updated data from Phase 1b study later in the year.
• Well-capitalized to execute Phase 2 BESTOW trial and advance kidney transplantation program.

• Actual outcomes and results could differ materially from forecasts due to factors beyond Eledon's control, as stated in SEC reports.
• Risks associated with clinical trial outcomes, including variability in patient responses and potential side effects of investigational drugs.

Q: Can you provide color on Sanofi's investment in Tegoprubart and what drew them to invest?

A: Sanofi is a new investor, saw a good investment opportunity, and received no different rights than other investors in the financing.

Q: How common is BK viremia in kidney transplant and how is it handled in BESTOW study?

A: BK viremia is common (10-20% in studies), managed by PI discretion to wean off immunosuppressants depending on viral load, with flexibility on Tegoprubart dosing while monitoring anti-drug antibody responses.

Q: Talk about clinical benefit of steroid tapering in BESTOW study and how it's captured?

A: Steroid tapering is beneficial to reduce side effects of steroids; in BESTOW, participants will be weaned off steroids by six months, with benefits compared to historical data and captured as part of safety profile.

Q: Are you using the iBox scoring system in the BESTOW study?

A: iBox is being evaluated as an exploratory endpoint, part of collaboration with CareDx.

Q: Potential routes to advance Tegoprubart in ALS?

A: Focused on transplantation, but will continue to look for ways to finance Tegoprubart in ALS with well-designed trials to truly assess efficacy.