Immunic Widens Third-Quarter Loss as ENSURE Data Nears

The Tip Desk · November 13, 2026 · 3 min read

The late-stage biotech posted a $42.3 million net loss, or $0.99 a share, and said cash of $132.0 million should fund operations into late 2027.

Immunic, Inc. (IMUX), a late-stage biotechnology company developing oral therapies for neurologic diseases, reported a net loss of approximately $42.3 million, or $0.99 a share, for the three months ended September 30, 2026, compared with a net loss of approximately $25.6 million, or $1.32 a share, a year earlier. Weighted-average shares outstanding were 42.8 million, versus 19.4 million a year earlier.

The company said total operating expenses for the quarter were $43.4 million, including $13.9 million of non-cash charges, primarily stock compensation. Research and development expenses were $23.9 million, up $3.9 million from $20.0 million a year earlier. Immunic attributed the increase to NDA readiness, vidofludimus calcium drug supply and personnel, partly offset by lower ENSURE and CALLIPER trial costs.

General and administrative expenses were $19.4 million, up $13.4 million from $6.0 million a year earlier. The company said the increase was due primarily to an $11.0 million rise in personnel expenses, of which $9.7 million was non-cash stock compensation related to a separation agreement. Interest income was $1.1 million, up $0.7 million from $0.4 million a year earlier, which Immunic said reflected a higher average cash balance after the February 2026 private placement.

Cash and cash equivalents were $132.0 million as of September 30, 2026, versus $15.5 million at December 31, 2025. Based on its current operating plan, Immunic said those funds are expected to be sufficient to fund operations into late 2027.

The pivotal clinical calendar remained the company’s near-term focus. Top-line data from the twin Phase 3 ENSURE-1 and ENSURE-2 trials of vidofludimus calcium in relapsing multiple sclerosis remained on track and were expected in December 2026. The trials randomized 1,121 and 1,100 patients, respectively, at more than 100 sites in 15 countries. If results are positive, Immunic said it plans to submit a U.S. New Drug Application in mid-2027, with a targeted potential regulatory approval date in 2028.

Chief Executive Officer Erik Lundgren said the company is entering one of the most important periods in its history as it approaches the ENSURE readout. He said Immunic is evolving from a science-driven biotechnology company into a fully integrated commercial organization and that, subject to positive ENSURE results, it is preparing for a potential NDA submission in relapsing MS while continuing to advance its Phase 3 program in progressive MS.

Initiation of the Phase 3 PROTECT-MS trial in progressive multiple sclerosis was ongoing, with first-patient-enrolled expected in the first half of 2027. The company said the trial is informed by Phase 2 CALLIPER data. At MSToronto2026 in late October, Immunic presented four posters of clinical, biomarker and preclinical data for vidofludimus calcium. New CALLIPER analyses showed favorable disability trends during the double-blind period appeared maintained in the open-label extension among participants who continued treatment; the company said the extension is not placebo-controlled and results should be interpreted with caution. Only 6.5% of patients discontinued through a January 27, 2026 data cutoff.

The company also hosted virtual R&D days on relapsing MS in September and progressive MS on November 5, 2026.

Leadership additions in the quarter were aimed at regulatory and commercial readiness. Immunic appointed Chitrang Davé as Chief Data and Digital Officer, effective September 1, 2026, and Jaa Roberson as Chief People Officer, effective October 19, 2026, both newly created roles. Elena Ridloff joined the board in August.

The IMU-381 program, selected to leverage the Nurr1 platform for neurologic and autoimmune diseases, continued in preclinical testing with lead candidate identification ongoing.