Immunic, Inc. Q2 FY2023 earnings call

• In April, positive data from Phase IIb CALDOSE-1 trial of vidofludimus calcium in ulcerative colitis; Dr. Richard Rudick joined the Board. • In May, strong results from Part C of Phase I clinical trial of IMU-856 in celiac disease; publication in Journal of Medicinal Chemistry on vidofludimus calcium's Nurr1 activation. • Upcoming milestones: Interim biomarker analysis from Phase II CALLIPER trial in progressive MS in fall 2023; readout of Phase III ENSURE program late 2024; readout of first Phase III ENSURE trial in relapsing MS in 2025; preparing for Phase II clinical trial of IMU-856 in active celiac disease.

Cash: Ended the quarter with $77.3 million in cash, expected to fund operations into Q4 2024. R&D expenses: $21.2 million for Q2 2023 vs $16.5 million in Q2 2022; $44.1 million for first half of 2023 vs $34 million in first half of 2022. G&A expenses: $3.8 million for Q2 2023 vs $4.1 million in Q2 2022; $8.1 million for first half of 2023 vs $8 million in first half of 2022. Other income: $1 million for Q2 2023 vs negative $1.3 million in Q2 2022; $3 million for first half of 2023 vs negative $0.7 million in first half of 2022. Net loss: $24 million for Q2 2023 vs $21.9 million in Q2 2022; $49.3 million for first half of 2023 vs $42.7 million in first half of 2022.

• Expect interim biomarker analysis from Phase II CALLIPER trial in progressive MS in fall 2023. • Expect readout of Phase II CALLIPER trial in progressive MS at end of 2024. • Expect interim analysis of Phase III ENSURE program late 2024. • Expect readout of first Phase III ENSURE trial in relapsing MS at end of 2025.

Q: Lauren Timmins asked about NFL separation vs placebo, magnitude for strong signal, and correlation to brain volume change; also about end of Phase II meeting for IMU-856.

A: Daniel Vitt said NFL is to look for a signal in specific sub-indications, correlation to brain volume not established; no end of Phase II meeting plan, ongoing IND submission dialogue with FDA.

Q: Jessica Breu asked Andreas Argyrides about ENSURE patient enrollment and UC program status; follow-up on Nurr1 activator in progressive MS.

A: Daniel Vitt said ENSURE enrollment is on track; UC program has ongoing discussions, IMU-381 added to pipeline; Nurr1 activator's potential in progressive MS is based on biology and study objective to prove in CALLIPER study.

Q: Matt Kaplan asked about Phase II design for IMU-856 and development of IMU-856 and IMU-838 in UC.

A: Daniel Vitt said Phase II design is being discussed with experts, aligning with FDA guidance; focus on IMU-856 in GI space due to non-immunosuppressive nature, potential for IBD development; IMU-838 development is concurrent but GI focus is on IMU-856 currently.