Immunic, Inc. — Third Quarter 2026 Earnings Summary

Financial Performance:

• Total operating expenses for the three months ended September 30, 2026, were $43.4 million, compared to $26.0 million in the same period in 2025.
• Total operating expenses for the nine months ended September 30, 2026, were $111.9 million, compared to $79.9 million in the same period in 2025.
• Research and development (R&D) expenses were $23.9 million for the three months ended September 30, 2026, an increase from $20.0 million in the prior year period.
• R&D expenses were $75.5 million for the nine months ended September 30, 2026, an increase from $62.9 million in the prior year period.
• General and administrative (G&A) expenses were $19.4 million for the three months ended September 30, 2026, compared to $6.0 million in the prior year period.
• G&A expenses were $36.4 million for the nine months ended September 30, 2026, compared to $17.0 million in the prior year period.
• Net loss for the three months ended September 30, 2026, was approximately $42.3 million ($0.99 per share), compared to $25.6 million ($1.32 per share) in the prior year period.
• Net loss for the nine months ended September 30, 2026, was approximately $109.0 million ($2.83 per share), compared to $77.9 million ($5.45 per share) in the prior year period.
• Interest income was $1.1 million for the three months ended September 30, 2026, compared to $0.4 million in the prior year period.
• Interest income was $3.1 million for the nine months ended September 30, 2026, compared to $0.8 million in the prior year period.
• Cash and cash equivalents as of September 30, 2026, were $132.0 million, compared to $15.5 million as of December 31, 2025.
• Total stockholders' equity as of September 30, 2026, was $104.5 million, compared to a deficit of $6.7 million as of December 31, 2025.
• Weighted-average common shares outstanding were 42.8 million for the three months ended September 30, 2026, compared to 19.4 million in the prior year period.

Guidance and Future Outlook:

• Top-line data from the Phase 3 ENSURE-1 and ENSURE-2 trials in relapsing multiple sclerosis (MS) is expected in December 2026.
• If ENSURE results are positive, Immunic plans to submit a New Drug Application (NDA) in the United States in mid-2027.
• A targeted potential regulatory approval date for relapsing MS is 2028.
• Initiation of the Phase 3 PROTECT-MS trial in progressive MS is ongoing, with first-patient enrollment expected in the first half of 2027.
• Immunic expects its current cash balance of $132.0 million to fund operations into late 2027.

Business Segments and Product Lines:

• The Phase 3 ENSURE program in relapsing MS consists of twin trials (ENSURE-1 and ENSURE-2) with 1,121 and 1,100 patients randomized, respectively, across more than 100 sites in 15 countries.
• The Phase 3 PROTECT-MS trial in progressive MS is being initiated based on data from the Phase 2 CALLIPER trial.
• The IMU-381 program, leveraging the Nurr1 platform for neurologic and autoimmune diseases, remains in preclinical testing with lead candidate identification ongoing.
• Vidofludimus calcium (IMU-838) is being evaluated for its potential to address neurodegenerative and inflammatory drivers of MS.

Market and Competitive Landscape:

• New data presented at MSToronto2026 included analyses showing favorable trends on disability outcomes in the CALLIPER trial open-label extension phase, though results should be interpreted with caution due to the lack of placebo control.
• Preclinical findings suggest vidofludimus calcium promotes neuronal survival under apoptotic stress via Nurr1, an effect not observed with teriflunomide.
• Exploratory CALLIPER analysis indicated vidofludimus calcium reduced Epstein-Barr virus (EBV)-specific T-cell receptor sequence matches versus placebo, with reductions associated with improved Symbol Digit Modalities Test (SDMT) scores.
• Post-hoc analyses using novel statistical methods suggested progressive MS patients treated with vidofludimus calcium were more likely to have positive disability outcomes compared to placebo, though these methods are not yet validated by regulatory authorities.

Risks and Challenges:

• Forward-looking statements regarding clinical trial results, NDA submission timing, and regulatory approval are subject to risks, including the possibility that ENSURE top-line results may be delayed, negative, or fail to meet endpoints.
• There is a risk that earlier, post-hoc, exploratory, open-label, or preclinical analyses may not be predictive of or confirmed in subsequent controlled clinical trials.
• Risks include the potential for insufficient cash to fund operations, the need to raise additional capital, and impacts from macroeconomic trends, inflation, and geopolitical conflicts on clinical trials.
• The investigational nature of vidofludimus calcium means its safety and efficacy have not been established.

Management Commentary and Tone:

• CEO Erik Lundgren stated the company is evolving from a science-driven biotechnology company into a fully integrated commercial organization, describing the upcoming period as one of the most important in the company's history.
• CMO Michael A. Panzara, M.D., M.P.H., highlighted that the ENSURE trials remain on track and that teams are focused on the December readout and readiness for a potential NDA submission.
• Management emphasized the potential for vidofludimus calcium to address unmet needs in MS through mechanisms targeting both neurodegeneration and inflammation.

Other Key Points:

• The executive leadership team was strengthened with the appointment of Jaa Roberson as Chief People Officer (effective October 19, 2026) and Chitrang Davé, M.B.A., as Chief Data and Digital Officer (effective September 1, 2026).
• Elena Ridloff, CFA, was appointed to the Board of Directors effective August 6, 2026.
• The company hosted virtual R&D days in September and November 2026 focused on relapsing and progressive MS, respectively.
• G&A expense increases were largely driven by personnel expenses, including $9.7 million in non-cash stock compensation related to a separation agreement for the three-month period and $13.2 million for the nine-month period.
• R&D expense increases were driven by personnel, drug supply, and NDA readiness activities, partially offset by decreases in costs for the ENSURE and CALLIPER clinical trials.
• Interest income increases were attributed to higher average cash balances resulting from a February 2026 Private Placement.
• Other income decreased by $1.4 million for the nine-month period, primarily due to $1.0 million of grant income recognized in Q1 2025 that was not repeated in 2026.