IMMUNIC, INC. Q4 FY2022 earnings call

• In October 2022, closed a $60 million pipe financing, extending runway through several value inflection points into Q4 2024.
• Phase Ib clinical trial of IMU-935 in psoriasis had interim analysis showing no benefit of active doses vs placebo, but administration was well-tolerated; flexibility to explore higher dosing and longer treatment periods in future testing.
• Throughout 2022, continued development of vidofludimus calcium in MS program; November 2022 hosted MS R&D webcast, and Phase II EMPhASIS trial data in relapsing remitting MS showed low rate of confirmed disability worsening.
• February 2023 held celiac disease R&D webcast, discussing IMU-856 and celiac disease dynamics.
• Anticipated upcoming milestones: Phase II CALLIPER trial interim biomarker analysis in H2 2023, ENSURE trial interim analysis end 2024, IMU-856 Part C data mid-2023.

No detailed product segment financial performance with revenue contribution percentages provided in the transcript. Overall financials: Cash ended 2022 at $116.4 million. Research and development expenses in 2022 were $71.3 million vs $61.1 million in 2021. General and administrative expenses $15.3 million vs $13.3 million in 2021. Net loss for 2022 was approximately $120.4 million.

• Expect to report data from interim biomarker analysis of CALLIPER trial in MS in H2 2023 and top line data end 2024; ENSURE trial interim analysis end 2024, top line end 2025.
• Plan to provide update on potential next steps for IMU-935 development in psoriasis towards end of Q1 2023.
• IMU-856 Part C data, assessing safety, tolerability, pharmacokinetics, etc., expected mid-2023.

• Clinical trial results may not meet expectations, e.g., IMU-935 Phase Ib trial in psoriasis showed no benefit vs placebo.
• Uncertainty in regulatory approval processes for MS and celiac disease programs.
• Dependence on successful clinical trial outcomes and continued funding to support operations and development.

Q: Yasmeen Rahimi asked about the time taken to gather data for IMU-935 and the encouraging signals for next steps, and clarification on ENSURE interim analysis timing.

A: Daniel Vitt responded that data analysis for IMU-935 is ongoing, taking time for thorough decision-making on next steps; confident in delivering ENSURE interim analysis end of 2024.

Q: Unidentified Analyst asked about IMU-856 Phase I celiac data expectations and MOA disclosure, and CALLIPER trial biomarker data expectations.

A: Daniel Vitt said IMU-856 data expected to show reduced IL-2 levels after gluten challenge, plan to disclose MOA target during 2023; CALLIPER trial interim focuses on biomarkers, looking for signal in progressive MS.

Q: Matthew Kaplan asked about IMU-935's impact on IL-17 and ENSURE interim analysis type.

A: Daniel Vitt said expectations include looking for group differences to guide next steps; ENSURE interim is a powering/sizing analysis, not futility.

Q: Andreas Argyrides asked about IMU-935 dosing and patient population changes.

A: Daniel Vitt said considering longer treatment periods and higher dosing, evaluating patient characteristics to address placebo activity.

Q: William Wood asked about CALLIPER trial biomarker details, FDA meetings, and enrollment for ENSURE and CALLIPER.

A: Daniel Vitt said CALLIPER trial interim focuses on NFL, GFAP biomarkers, no immediate FDA meetings; enrollment in both trials is proceeding as expected with no major slowdowns.