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ELDN

Eledon Pharmaceuticals, Inc.

Eledon Pharmaceuticals, Inc. Q2 FY2021 earnings call

August 12, 2021 · fiscal period ended 2021-06

EPS · actual vs est

$-0.50 / $-0.58Beat +13.8%

Revenue · actual vs est

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Summary

Generated 2021-08-12

Management highlights

• Advancing lead molecule AT-1501 in up to four clinical trials: ALS, prevention of kidney allograft transplant rejection, autoimmune nephritis (IgA nephropathy), and prevention of islet cell allograft transplant rejection for Type 1 diabetes. • In ALS Phase 2 biomarker study, enrolling third cohort, top-line data expected H1 2022. • Received no objection letter from Health Canada for renal transplant study, expect to initiate by end 2021. • FDA requested non-human primate renal transplant study, to start Q4 2021 with completion mid-2022. • Plan to launch Phase 2 study for IgA nephropathy by end 2021. • In islet cell transplantation, facing COVID delays in Canada, working to enroll first patient soon. • Financials: Net loss $7.4M Q2 2021 vs $2.6M Q2 2020; R&D expenses $4.2M Q2 2021 vs $0.8M Q2 2020; G&A expenses $3.7M Q2 2021 vs $1.3M Q2 2020. Cash and cash equivalents $101.1M as of June 30, 2021.

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Segment performance

No detailed product segment financial performance with revenue contribution % provided in the transcript.

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Guidance

• Expect to present AT-1501 non-human primate data at International Pancreas and Islet Cell Transplantation World Congress Annual Meeting in October. • Plan to initiate clinical trials for prevention of kidney transplant rejection, IgA nephropathy, and non-human primate kidney transplant study by end 2021. • Anticipate data readouts from trials starting H1 2022 including ALS and islet cell transplantation for Type 1 diabetes, and non-human primate kidney transplant study.

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Risks

• Impact of COVID-19 on trial enrollments and operations, particularly in Canada affecting islet cell transplantation. • General risks associated with forward-looking statements and potential differences between actual outcomes and forecasts due to factors beyond control.

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Q&A highlights

Q: For the islet cell transplantation program, when might the first patient be enrolled, location, and recruitment timeline?

A: Looking to enroll first patient as soon as possible, focused in Canada initially, may expand to other countries as COVID progresses. Can get data quickly as patients often need second transplants within 90 days. Plan to report data on enrolled patients in H1 2022.

Q: On the renal transplant program, when might U.S.-focused study start?

A: Dependent on data from Canada study. Need to wait for Canadian study data, then reinitiate discussions with FDA, likely H2 2022.

Q: Color on Phase 2 study for IgA nephropathy and read through to other autoimmune nephritises?

A: Will provide more color as trial initiates and enrolls patients. Read through possible as data from one indication may inform other autoimmune nephritises due to common themes like kidney dysfunction and proteinuria.

Q: Differentiation of AT-1501 from B cell modulating therapies for IgA nephropathy?

A: AT-1501 targets upstream processes of antibody formation and production, and modulates immune cell infiltrate into the kidney post-immune complex deposition, which may differentiate it from some B cell modulating therapies.

Q: Expectations at October conference and relation to IgA nephropathy research?

A: Presentation primarily on islet cell transplants, but non-human primate renal transplant study may provide mechanistic insights relevant to autoimmune nephritis.

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Key numbers

Reported versus consensus

Earnings calendar feed

MetricReportedConsensusDeltaPrior year
EPS$-0.50$-0.58+13.8%
Revenue

Transcript

August 12, 2021

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