Immunic Inc (NASDAQ:IMUX) highlighted positive clinical results for its lead drug candidate, vidofludimus calcium, showing statistically significant improvement in progressive multiple sclerosis (MS), as the company reported its third quarter 2025 financial results and provided a corporate update.
At the 41st Congress of ECTRIMS in September, Immunic presented data from the Phase 2 CALLIPER trial, which showed a greater than two-fold probability of 24-week confirmed disability improvement versus placebo in patients with progressive multiple sclerosis (PMS). The findings were consistent across subgroups and endpoints, supporting the drug’s neuroprotective potential and its proposed Nurr1 activation mechanism.
The company also recently reported long-term data from the Phase 2 EMPhASIS open-label extension in relapsing-remitting multiple sclerosis (RRMS), which demonstrated that vidofludimus calcium was well tolerated for up to 5.5 years, with most adverse events rated as mild and no new safety signals observed.
In addition, Immunic received a Notice of Allowance from the US Patent and Trademark Office for a patent covering dose strengths and formulations of vidofludimus calcium for PMS, with protection expected into 2041.
"The third quarter was marked by our strong presence at the 41st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), during which we had the opportunity to highlight the clinical momentum of our lead asset, vidofludimus calcium (IMU-838), an orally available nuclear receptor-related 1 (Nurr1) activator, and its potential to transform the oral multiple sclerosis (MS) therapy landscape," Immunic CEO Dr Daniel Vitt said in a statement.
He added that the CALLIPER data support advancing vidofludimus calcium into phase 3 development in progressive forms of MS.
“With only one approved therapy currently available for PPMS, there is a significant opportunity in this underserved, multi-billion-dollar market,” Dr Vitt said. “By slowing disease progression, vidofludimus calcium could help patients maintain independence, manage symptoms more effectively, and achieve improved long-term outcomes.”
Top-line results from the twin Phase 3 ENSURE-1 and ENSURE-2 trials in relapsing multiple sclerosis are expected by year-end 2026.
The company is also preparing for further clinical testing of IMU-856, an oral Sirtuin 6 (SIRT6) modulator, contingent on financing or partnerships.
For Q3, Immunic reported research and development expenses of $20 million, compared with $21.4 million in the same period of 2024, reflecting lower external development costs offset by higher personnel expenses.
General and administrative expenses rose to $6 million from $4.4 million in the prior-year quarter, mainly due to higher personnel and share-based compensation costs.
Net loss for the third quarter of 2025 was $25.6 million, or $0.13 per share, versus $24.4 million, or $0.24 per share, in the prior year.
As of September 30, 2025, Immunic reported $35.1 million in cash and cash equivalents and said it will need to raise additional capital to fund operations beyond the next 12 months.