Eledon Pharmaceuticals, Inc. Q4 FY2022 earnings call

• Strategic focus: In 2023, prioritized kidney transplantation program, deprioritized IgA nephropathy and islet cell transplant programs.
• Phase Ib kidney trial: Open-label data showed three kidney transplant recipients with eGFR above 70 ml/min/1.73m², no rejection, higher than standard care.
• Phase II ALS trial: Demonstrated dose-dependent target engagement and broad anti-inflammatory effect.
• IgA nephropathy Phase II trial: Safety data on 16 patients up to 42 weeks, no severe adverse events, only two related drug AEs.
• BESTOW trial: Received IND clearance, planned to enroll 120 subjects, initiate mid-2023.
• Xenotransplantation: Collaborated with eGenesis for tegoprubart in preclinical xenotransplantation studies.

No product segments discussed with revenue contribution; overall financials: Net loss for Q4 2022 was $58.4M ($4.09 per share) vs $8.8M ($0.59 per share) in 2021. Full-year 2022 net loss was $88M ($6.16 per share) vs $34.5M ($2.33 per share) in 2021. R&D expenses increased due to clinical development, manufacturing, and personnel costs. G&A expenses decreased slightly.

• 2023 potential: Believes 2023 has potential to be transformative with focus on kidney transplantation.
• BESTOW trial: On track to initiate mid-2023, enrollment expected to take ~1.5 years from first patient, with a year to data.
• Cash position: Ended 2022 with ~$56.4M in cash, less than one year of cash runway under current plan; execution/timing of studies subject to financing.

• Uncertainty in financing: Execution and timing of studies are subject to financing.
• Adverse events: Potential long-term adverse events not fully known though current data shows safety.
• Regulatory challenges: Uncertainties in regulatory approval processes impacting timelines.

Q: What data can we expect from tomorrow's presentation on tegoprubart in kidney transplantation?

A: Focus on eGFR data of first three participants, no acute rejection, good graft function.

Q: Changes in cytokines and tolerogenic environments from blocking CD40 ligand?

A: Preclinical examples show shift from pro-inflammatory to regulatory cells, but not seen in circulation, would need biopsies to observe in transplant context.

Q: Difference in new onset diabetes after transplant between tegoprubart and CNI arms?

A: CNIs have beta cell toxicity, tegoprubart avoids this, BESTOW trial will compare rates.

Q: Context of eGFR rates compared to standard of care?

A: Standard care eGFR averages in 50s, tegoprubart's patients had higher eGFR.

Q: Pace of enrollment in Phase Ib study and BESTOW trial?

A: Phase Ib expects to finish enrollment by end of year; BESTOW enrollment takes ~1.5 years from first patient, with a year to data.

Q: Thoughts on ALS AdComs and biomarkers?

A: AdComs receptive to NFL as biomarker, will incorporate into future studies.

Q: Stability of eGFR post kidney transplantation?

A: eGFR stabilizes by 3 months, similar to 6 months and 12 months.

Q: Learnings from previous trials influencing BESTOW design?

A: Based on belatacept studies, importance of ATG and eGFR as endpoint.