Immunic, Inc. Q3 FY2024 earnings call

1. Management team strengthened: Jason Tardio joined as President and COO, Werner Gladdines promoted to Chief Development Officer, Simona Skerjanec added to Board. 2. Hosted MS R&D day in September with key opinion leaders, discussed vidofludimus calcium's dual mode of action. 3. Enrolled first patient in Post COVID Syndrome investigator-sponsored trial. 4. Presented data at ECTRIMS Congress, including interim analysis of CALLIPER trial in progressive MS. 5. Positive interim analysis of Phase 3 ENSURE Trials in relapsing MS. 6. Upcoming topline data from CALLIPER trial in April 2025, Phase 3 ENSURE trials expected to complete in Q2 2026 and H2 2026. 7. IMU-856 Phase 1b data showed significant improvements in celiac disease, preparing for Phase 2 clinical testing.

No specific product segment financial performance data provided in the transcript, including absolute revenue and revenue contribution percentages.

1. Anticipate topline data from Phase 2 CALLIPER trial in progressive MS in April 2025. 2. Expect to complete first Phase 3 ENSURE trial in relapsing MS in Q2 2026 and second in H2 2026. 3. Preparing for Phase 2 clinical testing of IMU-856, exploring various gastrointestinal applications.

No specific detailed risks discussed in the transcript, but notes that forward-looking statements involve risks and uncertainties that could cause actual results to differ from projections.

Q: About CALLIPER study readout in April, details on subpopulations and endpoints A: Daniel Vitt states they plan to have detailed data on general and subforms tested during the study, including clinical endpoints like confirmed disability worsening, biomarker NfL, GFAB, and brain atrophy data Q: Regarding Post COVID investigator-led trial and its relation to ENSURE and CALLIPER A: Daniel Vitt mentions the Post COVID study is investigator-sponsored, can't guide on recruitment speed, but data could be meaningful. No predefined sub-analysis in ENSURE or CALLIPER for Post COVID syndrome patients, but general safety monitoring may extract data later Q: Hazard ratio for disability worsening in CALLIPER and accelerated approval opportunity A: Daniel Vitt says no predefined hazard ratio bar, but a 20% benefit would be a big win. Accelerated approval is an opportunity depending on data and signal strength, worth discussing with FDA Q: Unmet need in PMS and subgroups A: Jason Tardio notes huge unmet need in non-relapsing secondary progressive MS (no approved treatment) and primary progressive MS. Non-relapsing secondary progressive has ~175,000 patients, primary progressive has ~120,000. Vidofludimus calcium's dual mechanism offers neuroprotective play without broad immunosuppression Q: Peak sales calculation regarding market share A: Jason Tardio mentions extensive work on forecast and opportunity, notes large delta between diagnosed relapsing MS patients and those on therapy, and vidofludimus calcium's potential to address unmet needs leading to significant uptake