Immunic, Inc. Reports Third Quarter 2026 Financial Results and Provides Corporate Update

(NASDAQ:IMUX) Immunic, Inc. reported financial results for the third quarter ended September 30, 2026, and provided a corporate update. The company continues to execute its fully enrolled twin Phase 3 ENSURE-1 and ENSURE-2 trials of vidofludimus calcium in relapsing multiple sclerosis (MS), which randomized 1,121 and 1,100 patients, respectively, at more than 100 sites in 15 countries. Top-line data from these trials is expected in December 2026. Immunic is preparing for a potential New Drug Application (NDA) submission in relapsing MS, targeting a potential regulatory approval date in 2028, subject to positive ENSURE results. The initiation of the Phase 3 PROTECT-MS trial in progressive MS is ongoing, with first-patient-enrolled expected in the first half of 2027. The company presented new clinical, biomarker, and preclinical data for vidofludimus calcium at MSToronto2026, including analyses from the Phase 2 CALLIPER trial and preclinical findings on neuronal survival. Only 6.5% of patients discontinued during the open-label extension phase of CALLIPER through the January 27, 2026 data cutoff. Immunic hosted two virtual R&D days focused on progressive and relapsing MS, featuring expert perspectives from Jiwon Oh, M.D., Ph.D., Maria Pia Sormani, Ph.D., Amit Bar-Or, M.D., and Stephen Krieger, M.D. The executive leadership team was expanded with the appointments of Jaa Roberson as Chief People Officer (effective October 19, 2026), Chitrang Davé, M.B.A., as Chief Data and Digital Officer (effective September 1, 2026), and Elena Ridloff, CFA, to the Board of Directors (effective August 6, 2026). Total operating expenses for the three and nine months ended September 30, 2026, were $43.4 million and $111.9 million, respectively, including $13.9 million and $25.2 million of non-cash charges primarily related to stock compensation. Research and development expenses were $23.9 million for the three months ended September 30, 2026, and $75.5 million for the nine months ended September 30, 2026. General and administrative expenses were $19.4 million for the three months ended September 30, 2026, and $36.4 million for the nine months ended September 30, 2026. Interest income was $1.1 million for the three months and $3.1 million for the nine months ended September 30, 2026. Other income (expense) was ($0.03 million) for the three months and ($0.2 million) for the nine months ended September 30, 2026. Net loss for the three months ended September 30, 2026, was approximately $42.3 million, or $0.99 per basic and diluted share, based on 42,797,370 weighted-average common shares outstanding. Net loss for the nine months ended September 30, 2026, was approximately $109.0 million, or $2.83 per basic and diluted share, based on 38,508,964 weighted-average common shares outstanding. Cash and cash equivalents as of September 30, 2026, were $132.0 million. Immunic expects these funds will be sufficient to fund operations into late 2027. The IMU-381 program remains in preclinical testing with lead candidate identification ongoing.

Immunic to Host Virtual Progressive Multiple Sclerosis R&D Day on November 5, 2026

(NASDAQ:IMUX) Immunic, Inc. announced it will host a virtual Research and Development (R&D) Day focused on progressive multiple sclerosis (MS) on Thursday, November 5, 2026, at 12:30 pm ET. The event will feature presentations from Immunic's management team, including Erik Lundgren, M.B.A., Chief Executive Officer; Michael A. Panzara, M.D., M.P.H., Chief Medical Officer; Hella Kohlhof, Ph.D., Chief Scientific Officer; and Jason Tardio, M.B.A., President & Chief Operating Officer. Two external experts, Jiwon Oh, M.D., Ph.D., FRCPC, Division of Neurology, University of Toronto, and Maria Pia Sormani, Ph.D., University of Genoa, Italy, will also present. The group will discuss unmet needs in progressive MS and the need for innovative therapies targeting novel mechanisms of neurodegeneration and MS progression. Immunic management will highlight the potential expansion opportunity for its lead investigational asset, vidofludimus calcium (IMU-838), in progressive MS. The company plans to initiate a Phase 3 progressive MS trial later in 2026. Vidofludimus calcium is described as a nuclear receptor-related 1 (Nurr1) activator with potential neuroprotective effects and is currently being evaluated in Phase 3 clinical trials in relapsing multiple sclerosis. Top-line data from the relapsing MS Phase 3 trials are expected by the end of 2026. Vidofludimus calcium also has anti-inflammatory and anti-viral effects associated with selective inhibition of the enzyme dihydroorotate dehydrogenase (DHODH). Immunic's development pipeline includes earlier-stage programs, IMU-381 and IMU-856, aimed at neurodegenerative and autoimmune diseases. The R&D Day is open for registration.

Immunic Appoints Chitrang Davé as Chief Data and Digital Officer

(NASDAQ:IMUX) Immunic, Inc. announced a new C-Suite role and appointment to underscore its commitment to building a strong, commercial-ready data ecosystem in preparation for potential NDA submission and commercialization.

Immunic Appoints Seasoned Biopharmaceutical Executive Michael W. Bonney as Chair of the Board of Directors

Immunic, Inc. (NASDAQ:IMUX), a late-stage biotechnology company, announced the appointment of Michael "Mike" W. Bonney as Chair of its Board of Directors, effective May 16, 2026. Simona Skerjanec, M.Pharm, MBA, will transition from Interim Chairperson to continue serving as a member of the Board. Mr. Bonney brings over three decades of leadership experience in the biopharmaceutical industry, including roles at Biogen Inc., Cubist Pharmaceuticals, and Zeneca Pharmaceuticals. The company's lead program, vidofludimus calcium (IMU-838), is in phase 3 clinical trials for relapsing multiple sclerosis, with top-line data expected by the end of 2026. Vidofludimus calcium has shown therapeutic activity in phase 2 clinical trials for multiple sclerosis and other diseases. Immunic's pipeline also includes IMU-856 and IMU-381, targeting neurodegenerative, chronic inflammatory, and autoimmune-related diseases. The announcement highlights upcoming milestones, including the readout of the phase 3 ENSURE trials and the planned phase 3 development program in primary progressive MS.