Immunic Reports Q3 2026 Results; ENSURE Phase 3 Data Expected in December

Immunic, Inc. (Nasdaq: IMUX) reported financial results for the third quarter ended September 30, 2026, and provided an update on its clinical development programs. The company highlighted that its Phase 3 ENSURE-1 and ENSURE-2 trials for vidofludimus calcium in relapsing multiple sclerosis remain on track to report top-line data in December 2026.

The ENSURE-1 and ENSURE-2 trials are fully enrolled, having randomized 1,121 and 1,100 patients, respectively, across more than 100 sites in 15 countries. Management stated that if the results are positive, the company plans to submit a New Drug Application (NDA) in the United States in mid-2027, with a targeted potential regulatory approval date in 2028.

In addition to the relapsing MS program, Immunic is advancing its Phase 3 PROTECT-MS trial in progressive MS. Initiation activities are ongoing, with the company expecting the first patient to be enrolled in the first half of 2027.

On the financial front, the company reported total operating expenses of $43.4 million for the quarter ended September 30, 2026, and $111.9 million for the nine months ended the same date. Research and Development (R&D) expenses for the third quarter were $23.9 million, up from $20.0 million in the prior year period. General and Administrative (G&A) expenses for the third quarter were $19.4 million, compared to $6.0 million in the prior year period.

Immunic reported a net loss of approximately $42.3 million for the third quarter of 2026, or $0.99 per basic and diluted share, based on 42,797,370 weighted-average common shares outstanding. For the nine months ended September 30, 2026, the net loss was approximately $109.0 million, or $2.83 per basic and diluted share.

The company also announced appointments to its executive leadership team and board of directors. Jaa Roberson was appointed Chief People Officer effective October 19, 2026. Chitrang Davé was appointed Chief Data and Digital Officer effective September 1, 2026. Additionally, Elena Ridloff, CFA, was appointed to the Board of Directors effective August 6, 2026.