IMMUNIC, INC. Q3 FY2022 earnings call

• Jan Van den Bossche stepped down from the Board, and Maria Tornsen was appointed. • Received Notice of Allowance for a key patent on IMU-856. • Positive unblinded results from Phase 1 trial of IMU-856 in healthy subjects showing favorable safety, tolerability, and pharmacokinetic profile. • Interim analysis of Phase 1b trial of IMU-935 in psoriasis showed no benefit vs placebo, but trial is ongoing. • Closed $60M private financing in October 2022, extending runway into Q4 2024. • Upcoming milestones include data readouts for vidofludimus calcium trials, interim readout of CALLIPER trial in Q2 2023, top line data from ENSURE trial end 2024, and interim readout of EMPhASIS trial open-label extension soon.

No specific product segments with revenue contribution percentages provided. Financials discussed include R&D expenses ($16.5M Q3 2022 vs $15.5M Q3 2021; $50.5M YTD 2022 vs $42.7M YTD 2021), G&A expenses ($3.6M Q3 2022 vs $2.9M Q3 2021; $11.6M YTD 2022 vs $10M YTD 2021), other expense ($1.1M Q3 2022 vs $0.9M Q3 2021; $1.8M YTD 2022 vs $1.8M YTD 2021), and net loss ($21.2M Q3 2022 vs $19.3M Q3 2021; $64M YTD 2022 vs $71.8M YTD 2021).

• Goal to report interim analysis of Phase 2 CALLIPER trial in progressive MS in second half of 2023 and top line data from Phase 3 ENSURE trial end 2025. • Plan to perform interim readout of open-label extension of Phase 2 EMPhASIS trial soon. • Initial data readout from IMU-856 Phase 1 trial expected in 2023.

• Uncertainty around clinical trial outcomes, such as the lack of benefit observed in the IMU-935 Phase 1b trial vs placebo. • Regulatory uncertainties that could impact the development and approval of pipeline candidates. • Currency exchange rate fluctuations affecting intercompany loan losses.

Q: What's the latest on IMU-935 and mCRPC?

A: Andreas Muehler said the trial is in dose escalation phase, with several dose cohorts completed, and they've completed the 600-milligram dose escalation, with the next level being 900 milligram.

Q: Regarding AbbVie's discontinuation of ABBV-157 due to preclinical chronic tox study, any relevance to IMU-935 and differentiations?

A: Daniel Vitt reiterated that they don't know the specifics of AbbVie's findings but emphasized IMU-935's selectivity is different, and they can't speculate further without more information.