Immunic, Inc. Q4 FY2023 earnings call

• Announced a three-tranche private placement of up to $240 million, with $75 million net proceeds from the first tranche closed on January 8, 2024.
• Positive interim data from Phase II CALLIPER trial of vidofludimus calcium in progressive multiple sclerosis, showing 22.4% improvement in serum NfL at week 24.
• Two patents granted for vidofludimus calcium in the US, protecting into 2041 or beyond.
• Updates on IMU-856, including Phase Ib trial data in celiac disease and preparation for Phase II trial.
• Financial results: R&D expenses $83.2M in 2023 vs $71.2M in 2022; general and administrative expenses $16M in 2023 vs $15.3M in 2022; net loss $93.6M in 2023 vs $120.4M in 2022.

The company has two key clinical programs. Vidofludimus calcium showed overwhelmingly positive interim data from the Phase II CALLIPER trial in progressive multiple sclerosis, with a 22.4% improvement in serum neurofilament light chain (NfL) at week 24. IMU-856 is in preparation for a Phase II clinical trial in ongoing active celiac disease patients and is being considered for additional GI disorders. Revenue contribution details are not applicable as it's not a traditional product segment breakdown.

• Anticipate reporting top line data from Phase II CALLIPER trial of vidofludimus calcium in progressive MS in April 2025.
• Expect interim futility analysis of Phase III ENSURE program late 2024.
• Read out first of the identical twin Phase III ENSURE trials in relapsing MS in Q2 2026.
• IMU-856 preparing for Phase II clinical trial in ongoing active celiac disease patients and considering additional GI disorders.

General risks associated with clinical trial outcomes, including uncertainty around regulatory approvals, potential challenges in meeting trial endpoints, and market conditions affecting partnerships and funding.

Q: Can you discuss what the regulatory path forward looks like in advanced SPMS if CALLIPER data is positive?

A: Daniel Vitt said it may offer an accelerated pathway, requiring discussion with regulators, and a Phase III study may only need one study.

Q: What are the biomarker results expected from the interim analysis for the ENSURE study in late 2024?

A: Daniel Vitt said it will be a futility analysis, not reading out biomarkers or other clinical data at that time.

Q: What are the gating factors to start a Phase II study in ongoing active celiac disease?

A: Daniel Vitt said they are heavily preparing for a Phase II study, ongoing talks with potential partners, and considering other ways to finance, with potential to go beyond celiac disease as an indication.

Q: For the futility analysis later this year for ENSURE, how should we think about its implications upon readout?

A: Daniel Vitt said it's a binary thing, likely getting a proceed as planned answer or sample size adjustment from the Data Safety Monitoring Board.

Q: Are there any plans for the vidofludimus UC program given the stronger maintenance phase data?

A: Daniel Vitt said they would likely separate in a different development track, with molecules from IMU-381 potentially better suited for GI penetration.