Eledon Pharmaceuticals, Inc.
Eledon Pharmaceuticals, Inc. Q3 FY2021 earnings call
November 11, 2021 · fiscal period ended 2021-09
EPS · actual vs est
Revenue · actual vs est
Summary
Generated 2021-11-11
Management highlights
- Formed Eledon one year ago by acquiring Anelixis and securing financing. - Nearing completion of enrollment in Phase 2 trial of AT-1501 in ALS, with 16 of 18 subjects in the final cohort. - Received no-objection letter from Health Canada to initiate open-label trial for kidney transplantation and in process of opening first site in Canada. - Gained IND clearance from FDA for AT-1501 in islet cell transplantation. - Initiated non-human primate study for kidney transplantation as requested by FDA. - Announced research collaboration with CareDx. - IgAN announced as next indication for AT-1501, on track to begin Phase II sites by end of 2021. - Presented data at transplant conference on AT-1501 in nonhuman primate islet transplantation.
Segment performance
No detailed product segment financial performance with revenue contribution % provided in the transcript.
Guidance
- Expecting a busy 2022 with sequential clinical data readouts including Phase 2 ALS study, interim data from Islet Cell Transplantation, Kidney Transplantation, and IgAN trials. - Financial resources sufficient to fund operations as planned well into 2023, allowing generation of data across planned trials and having a year of cash on hand.
Risks
No specific risks discussed in detail beyond general disclaimers about forward-looking statements and potential differences from forecasts due to factors beyond control.
Q&A highlights
Q: How thinking about dosing of AT-1501 in IgA nephropathy trial compared to other studies and potential FDA consideration of AlloSure and iBox as approvable endpoints in renal transplant studies?
A: Dosing in IgA nephropathy will be in similar range as ALS, slightly higher than transplant. Currently, FDA guidance is to look at biopsy-proven rejection as primary endpoint, but novel biomarkers and algorithms can be used exploratorily.
Key numbers
Reported versus consensus
Earnings calendar feed
| Metric | Reported | Consensus | Delta | Prior year |
|---|---|---|---|---|
| EPS | $-0.66 | $-0.67 | +1.5% | — |
| Revenue | — | — | — | — |
Transcript
November 11, 2021Full transcript unavailable for redistribution
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