EPS · actual vs est
Revenue · actual vs est
Summary
Generated 2024-05-08
Management highlights
• Early January 2024 completed a three-tranche private placement of up to $240 million, well capitalized into Q3 2024. • In February, interim analysis of Phase II CALLIPER trial of vidofludimus calcium at ACTRIMS Forum 2024 showed clear separation from placebo in serum neurofilament light chain levels. • In March, data presented at Society for Virology and Frontiers in Medicinal Chemistry highlighted vidofludimus calcium's activation of Nurr1 and broad-spectrum antiviral activity. • Received Notice of Allowance for a patent on vidofludimus calcium. • Hosted Multiple Sclerosis R&D Day highlighting vidofludimus calcium's potential. • IMU-856 Phase Ib trial in celiac disease showed improvements in key clinical outcomes.
Segment performance
Immunic does not have traditional product segments with revenue breakdowns. The focus is on clinical programs. The lead asset vidofludimus calcium is a key program with ongoing trials, and IMU-856 is another program with Phase Ib data and plans for Phase II testing.
Guidance
• Expect top line data from Phase II CALLIPER trial in progressive MS in April 2025. • Interim futility analysis of Phase III ENSURE program expected later in 2024. • Read-out of first Phase III ENSURE trial in relapsing MS in Q2 2026, second in H2 2026. • Begun preparing Phase II clinical testing of IMU-856.
Risks
• Risks associated with clinical trial outcomes, including uncertainty around trial results and regulatory approvals. • Uncertainties related to the valuation and reclassification of tranche rights in financing.
Q&A highlights
Q: How was the impact on NfL observed in the CALLIPER study interim analysis received at ACTRIMS meeting?
A: Generally appreciated by experts as there are not comparable data with such a strong reduction on NfL reduction.
Q: What are the potential read-outs from the interim futility analysis for the ENSURE program?
A: Just a response to questions from the Safety Monitoring Committee on going ahead as planned or sample size adjustment, no medical results or biomarkers.
Q: Could you comment on visibility on event rates across ENSURE trials and Phase II prep for IMU-856?
A: No current event rates on disability worsening, study on track; working on meeting with U.S. regulators and preparing Phase II studies for IMU-856.
Q: How is neurofilament light chain measured in CALLIPER study and IP for vidofludimus?
A: Using Simoa technology by Quanterix with dual-antibody test system; working on additional IP for vidofludimus calcium and preclinical Nurr1 activator compounds.
Key numbers
Reported versus consensus
Earnings calendar feed
| Metric | Reported | Consensus | Delta | Prior year |
|---|---|---|---|---|
| EPS | — | — | — | — |
| Revenue | — | — | — | — |
Transcript
May 8, 2024Full transcript unavailable for redistribution
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