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IMUX

Immunic, Inc.

Immunic, Inc. Q1 FY2024 earnings call

May 8, 2024 · fiscal period ended 2024-03

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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.

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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.

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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.

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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.

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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.

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Key numbers

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Transcript

May 8, 2024

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