Immunic, Inc. Q3 FY2023 earnings call

• Vidofludimus calcium development program: Completed enrollment of Phase 2 CALLIPER trial in PMS, with positive interim data showing 22.4% improvement in serum NfL at week 24; in October, reported overwhelmingly positive interim data; received notice of allowance for patent covering treatment of relapsing MS. - IMU-856 program: Hosted Virtual Celiac Disease Expert Roundtable, presented abstracts at UEGW 2023, with positive Phase 1b trial results; beginning preparations for Phase 2 clinical trial in ongoing active celiac disease patients. - Financial results: Cash position at $59.7M at end of Q3 2023; R&D, G&A, other income, and net loss details for Q3 and 9 months 2023 compared to prior year.

No detailed product segment financial performance with revenue contribution percentages provided in the transcript. Financials discussed include R&D expenses ($19.8M for Q3 2023, $63.9M for 9 months 2023), G&A expenses ($3.8M for Q3 2023, $11.9M for 9 months 2023), net loss ($22.8M for Q3 2023, $72M for 9 months 2023), etc.

• Anticipate reporting top line data from Phase 2 CALLIPER trial in progressive MS in April 2025. - Expect interim futility analysis of Phase 3 ENSURE program late next year, with first of twin Phase 3 ENSURE trials in relapsing MS to read out end of 2025. - Preparing for Phase 2 clinical trial in ongoing active celiac disease patients for IMU-856 program.

Q: Can you provide any insight into where you are in terms of preparing for the Phase 2 trial for IMU-856 in celiac disease? What do you anticipate the trial design would look like and the timelines for when you think you would initiate the trial?

A: As stated before, work in progress; likely a 3-month treatment phase in ongoing active celiac disease patients, still in preparation process.

Q: Can you talk about how enrollment is progressing in the ENSURE program and what your target timeline is to complete enrollment?

A: Usually don't give rolling update on recruitment status, but keep guidance of completion of enrollment with first of ENSURE studies reading out end of 2025.

Q: What type of data are you expecting to report in April 2025 from the CALLIPER trial and what's the bar of success expected for the readout?

A: Expect to report NfL as secondary readout, primary endpoint is brain volume change (whole brain atrophy), key secondary endpoint is confirm disability worsening; want to see benefit on all endpoints, with meaningful medical difference in disability prevention being ideal.

Q: Have you spoken with the FDA at all, with Phase 2 design for IMU-856, or is it still just in the preliminary stage?

A: This is an ongoing process, usually submit IND filing and have written communication with regulators on protocol design, etc.

Q: Can you talk a little bit more about business development goals for IMU-856 and vidofludimus calcium?

A: Using good data readouts to intensify discussions with companies, building optionality and access to non-dilutive financing sources to fuel pipeline.

Q: What is the new IP that was allowed and what does that get you in terms of exclusivity period?

A: Patent covers dose strength and treatment of relapsing MS, runs until 2041 (plus potential patent term extension).

Q: What does it mean for vidofludimus calcium to be a Nurr1 activator?

A: Nurr1 activation is a protective signal for neurons independent of focal inflammation, combining with DHODH inhibition for double strike on inflammation and neuroprotection; drug binds to both DHODH and Nurr1.

Q: Any update on early pipeline programs like IMU-381?

A: Program initiated based on CALDOSE trial data, but company prioritizing current clinical programs (vidofludimus calcium and IMU-856) due to time and resource reasons.

Q: Are there any specific gating factors for the IMU-856 celiac study in terms of getting the program off the ground and starting to enroll patients?

A: Preparing trial material, physically preparing trial, considering partnering to broaden development beyond celiac disease, interaction with regulators ongoing.

Q: Thoughts on NfL data from CALLIPER, subpopulations, and path forward?

A: Data for non-active population is key as it's an untreatable area; will look at April 2025 data to see clinical signals, with non-active secondary progressive likely being indication of choice if data supports.