Eledon Pharmaceuticals, Inc.
Eledon Pharmaceuticals, Inc. Q2 FY2022 earnings call
August 11, 2022 · fiscal period ended 2022-06
EPS · actual vs est
Revenue · actual vs est
Summary
Generated 2022-08-11
Management highlights
• Second quarter marked start of exciting period with positive phase 2a results in ALS from tegoprubart pipeline. • Focus on execution across four clinical trials: kidney transplantation, ALS, IGA nephropathy, islet cell transplantation. • Renal transplantation: first patient dose in phase 1b open label study in Canada, UK, Australia; FDA cleared IND for phase 2a study in US for prevention of organ rejection. • ALS: phase 2a results showed safety, tolerability, dose-dependent target engagement, biomarker reductions, trend in slowing disease progression as measured by ALS-FRS. • IgAN: phase 2a study enrolling, expanding to US and China, expect fully enrolled high dose cohort in H1 2023, initial six months open label data in Q1 2023. • Islet cell transplantation: granted orphan drug designation; closing Alberta site, opening Chicago site; aim to report initial three month open label data in Q1 2023.
Segment performance
No detailed financial breakdown by product segments provided in the transcript.
Guidance
• Expect initial three and six months open label data from transplant participants in Q1 2023. • Anticipate fully enrolling high dose cohort in IgAN study in H1 2023, initial six months open label data in Q1 2023. • Aim to report initial three month open label data from islet cell transplantation study in Q1 2023. • Cash runway sufficient to fund clinical trials into 2024, but additional financing needed for future ALS trials.
Risks
• Actual outcomes could differ materially from forward-looking statements due to factors beyond Eledon's control. • Geopolitical and regulatory changes may impact clinical trial enrollments and progress. • Uncertainties in clinical trial outcomes and regulatory approvals.
Q&A highlights
Q: Thoughts on patient numbers in initial datasets in Q1 2023?
A: We expect to get the same number of patients as discussed, with a slight delay into Q1, targeting to have a few patients in transplant indications and a handful of patients with six months of data in IgAN.
Q: Team at University of Chicago for islet cell transplant?
A: The University of Chicago is active, has been involved in islet cell transplant for many years, is confident in enrolling our study, and the same PI as at the R&D day is involved.
Q: Renal transplant program, FDA engagement, phase 1b and 2a parallel?
A: Phase 1b is ex-U.S., phase 2a in US with IND cleared, superiority study design, and we plan to run both phase 1b and phase 2 studies in parallel to continue learning and reporting data.
Q: EGFR as endpoint in phase 3?
A: Precedents in the space are non-inferiority focusing on graft rejection and patient graft survival, but EGFR data will inform future pathways and we'll keep engaging with the agency.
Q: Lessons from Canadian islet cell site?
A: Multiple factors like COVID and geopolitical landscape contributed to the Canadian site's outcome, but we're confident in the University of Chicago site as islet cell transplants are experimental in the U.S., allowing a different approach.
Key numbers
Reported versus consensus
Earnings calendar feed
| Metric | Reported | Consensus | Delta | Prior year |
|---|---|---|---|---|
| EPS | $-0.65 | $-0.72 | +9.7% | $-0.50 |
| Revenue | — | — | — | — |
Transcript
August 11, 2022Full transcript unavailable for redistribution
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