#USA #New York #Multiple Sclerosis #Immunic #Vidofludimus Calcium

Immunic, Inc. Reports Second Quarter 2025 Financial Results

On August 7, 2025, Immunic, Inc. (Nasdaq: IMUX) announced its financial results for the second quarter ended June 30, 2025, alongside an update on its corporate developments. The biotechnology firm is committed to addressing chronic inflammatory and autoimmune diseases through its innovative therapies, particularly the promising lead asset, vidofludimus calcium (IMU-838).

Key Highlights

During the call, CEO Dr. Daniel Vitt highlighted notable achievements in advancing vidofludimus calcium, which is a first-in-class nuclear receptor-related 1 (Nurr1) activator. The highlights from the second quarter include the significant reduction in confirmed disability worsening for patients enrolled in the Phase 2 CALLIPER trial in progressive multiple sclerosis (PMS), showcasing a 23.8% reduction overall compared to placebo.

Dr. Vitt emphasized the unique neuroprotective properties of vidofludimus calcium, which are crucial for slowing the progression of multiple sclerosis (MS). This was particularly reinforced by a remarkable 31.3% reduction observed in the subgroup of patients with primary progressive MS (PPMS) and a 19.2% reduction in patients with non-active secondary progressive MS (naSPMS). The data underpins the importance of timings for assessing the drug's efficacy in RAPMS reduce disability worsening.

In addition to successful trial outcomes, Immunic has strengthened its balance sheet with two financings totaling $70.1 million in gross proceeds, which positions the company to continue its research and development initiatives aggressively.

Phase 3 ENSURE Trials

Immunic successfully completed enrollment for its twin Phase 3 ENSURE trials, evaluating vidofludimus calcium in patients with relapsing multiple sclerosis (RMS). The company expects top-line data by the end of 2026, marking another critical milestone in its clinical development journey. Conducted across more than 100 sites in 15 countries, these trials aim to verify the efficacy of their key therapeutic candidates.

Long-Term Efficacy Data

The latest data from the open-label extension phase of the Phase 2 EMPhASIS trial further illustrated the drug's long-term efficacy, showing that at week 144, an impressive 92.3% of patients remained free from 12-week confirmed disability worsening. The continuous monitoring across multiple patient cohorts confirms the favorable safety and tolerability profile of vidofludimus calcium.

Dr. Vitt pointed to these findings as significant achievements for a compound still under clinical development, noting their relevance ahead of the upcoming 41st Congress of ECTRIMS in September, at which five abstracts showcasing promising data from these trials will be presented.

Future Outlook

Beyond vidofludimus calcium, Immunic is also making strides with its secondary candidate, IMU-856, targeting sirtuin 6 (SIRT6), which demonstrates potential for gastrointestinal disorders including celiac disease. The ongoing clinical evaluation is promising, especially given the orally active nature of IMU-856, which could provide feasible treatment alternatives for patients. The organization is on the lookout for additional funding opportunities to facilitate further trials.

The second quarter concluded with a net loss of approximately $27 million, a slight rise from $21.4 million reported the previous year during the same period. As of June 30, 2025, the company held approximately $55.3 million in cash, a figure that underscores the need for continued capital raising efforts to ensure liquidity for ongoing operations.

In summary, Immunic, Inc. has significantly progressed its clinical research and development efforts while bolstering its financial framework. The promising results from trials not only foster optimism for future drug approvals but may also serve to revolutionize treatment options for chronic inflammatory diseases.