IMMUNIC, INC. Q1 FY2023 earnings call

• In February, hosted a Celiac Disease R&D Webcast with experts discussing celiac disease dynamics, immune stimulation, epithelial barrier, and treatment options. • In March, positive data from the maintenance phase of Phase IIb CALDOSE-1 Trial of vidofludimus calcium in UC was reported, showing statistically significant activity vs placebo with favorable safety. • Welcomed Dr. Richard Rudick to the Board of Directors. • In May, announced highly positive results from the Part C portion of Phase I clinical trial of IMU-856 in celiac disease, demonstrating clinical improvements in multiple dimensions. • Dr. Bob Fox presented data on vidofludimus calcium at ACTRIMS Forum 2023, highlighting its neuroprotective potential. • Research and development expenses for Q1 2023 were $23 million, up from $17.4 million in Q1 2022, driven by external development costs for ongoing trials. • General and administrative expenses were $4.3 million in Q1 2023, slightly up from $4 million in Q1 2022. • Other income was $2 million in Q1 2023, up from $0.6 million in Q1 2022, due to increases in German tax incentives and interest income.

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

• Anticipate interim biomarker analysis of CALLIPER trial in progressive MS in 2H 2023. • Expect top line data from ENSURE trials in relapsing MS at end of 2025. • Preparing for Phase 2b clinical trial of IMU-856 in ongoing active celiac disease patients. • Ongoing studies for vidofludimus calcium in MS include ENSURE trials in relapsing MS and CALLIPER trial in progressive MS.

• Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially. • Refer to Immunic's SEC filings for detailed risk factors affecting results.

Q: Can you provide additional insight into what gives confidence IMU-856 could work in celiac disease and if it could be beneficial in other indications?

A: The Phase 1b data showed protection of villi, increased vitamin B12, and aligned with preclinical findings. Believes IMU-856 could be beneficial in Crohn's Disease and Ulcerative Colitis due to preclinical work in colitis models.

Q: When are you planning to tighten guidance for the interim CALLIPER in 2H 2023 and what is the utility of the key data?

A: Guidance for 2H 2023 remains as is; interim focus is on biomarkers like NfL and GFAP levels to assess benefit in progressive MS patients.

Q: When do you expect to have a meeting with the FDA for Phase 2b design details and when might data from the study be shared?

A: Team is working on including Phase 2 findings in protocol and design, aiming to submit IND filing and discuss with regulators; data from the study could be shared in 2024.

Q: Any update on business development interest for celiac disease data and partnership opportunities?

A: Inbound interest on celiac disease data is uptick; open to partnership opportunities based on data and molecule potential; details on specific partnerships not disclosed publicly.

Q: Tell us about the IMU-381 program for GI diseases?

A: IMU-381 is a new pipeline addition for GI diseases, in preclinical development, complementing the portfolio in the GI space with preclinical work ongoing.