Immunic (IMUX -4.59%), a late-stage biotechnology company focused on autoimmune and inflammatory diseases, released its second quarter 2025 results on August 7, 2025. The quarter was marked by meaningful clinical progress for its lead product candidate but also persistent financial challenges. There was no revenue reported, consistent with its pre-commercial status. Overall, the period reflected operational headway in drug development but a continued need for capital to fund ongoing trials.
| Metric | Q2 2025 | Q2 2025 Estimate | Q2 2024 | Y/Y Change |
|---|---|---|---|---|
| EPS (GAAP) | $(0.20) | $(0.16) | $(0.21) | 4.8% decrease |
| Revenue (GAAP) | $0.0 | $0.0 | $0.0 | — |
| Research & Development Expenses | $21.4 million | $18.3 million | 16.7% | |
| General & Administrative Expenses | $5.7 million | $4.5 million | 26.7% | |
| Net Loss | $26.8 million | $21.4 million | 25.2% |
Source: Analyst estimates for the quarter provided by FactSet.
Overview of Immunic’s Business and Strategy
Immunic is a clinical-stage biotechnology company. It is primarily developing therapies for chronic inflammatory and autoimmune diseases. Its most advanced program is focused on multiple sclerosis, a disabling neurological condition that affects millions worldwide.
The company’s recent focus is on advancing vidofludimus calcium, an oral small molecule drug, through late-stage clinical trials targeting multiple forms of multiple sclerosis, including both relapsing and progressive populations. Success depends on positive trial results, regulatory clearance, and securing enough capital to reach commercialization. Key drivers for the business include clinical trial progress, investor or partner funding, and differentiation from current and competing treatments in neurological disorders.
Quarter in Review: Clinical Progress, Financial Results, and Operations
The quarter’s headline was positive top-line data from the Phase 2 CALLIPER trial of vidofludimus calcium in progressive multiple sclerosis (PMS). The drug candidate demonstrated a 23.8% reduction in time to 24-week confirmed disability worsening (24wCDW) compared to placebo. In the subgroup with primary progressive MS, the reduction was 31.3% in the Phase 2 CALLIPER trial. In non-active secondary progressive MS, the reduction was 19.2% in the Phase 2 CALLIPER trial of vidofludimus calcium, with higher reductions observed in patients without gadolinium-enhancing lesions at baseline (e.g, 29.8% in non-active SPMS), as reported in April 2025. According to industry experts referenced by management, a 20% reduction is viewed as a meaningful clinical effect, giving this data particular weight.
In the relapsing multiple sclerosis (RMS) group, the company reported on-time completion of enrollment in its parallel Phase 3 ENSURE-1 (1,121 patients) and ENSURE-2 (1,100 patients) studies as of June 2025, with a total of 2,221 randomized patients. No new safety concerns were identified in these programs. Long-term extension data in relapsing-remitting MS (RRMS) at 144 weeks showed that 92.3% of patients remained free of 12-week confirmed disability worsening and 92.7% remained free of 24-week confirmed disability worsening. reinforcing the neuroprotective effect observed in earlier phases and supporting a favorable risk-benefit profile.
Operating expenses (GAAP) increased in Q2 2025, with research and development costs rising due to higher external development expenses related to the vidofludimus calcium programs. Research and development expense (GAAP) rose 16.7% year-over-year in Q2 2025, largely due to external expenses for the vidofludimus calcium program and increased staffing. General and administrative expenses increased 26.7% in Q2 2025, driven by higher personnel and legal costs. The company recorded a net loss (GAAP) of $27.0 million for Q2 2025, 26.2% higher than a year earlier. No revenue was generated during the quarter, reflecting Immunic's ongoing pre-commercial phase.
The company’s cash position strengthened modestly due to new financings, ending the quarter with $55.3 million in cash and cash equivalents. However, management reported that available funds are insufficient to cover twelve months of operations from quarter-end, highlighting the need for timely new funding. Two equity financings raised $70.1 million gross during the quarter, partially offsetting high cash burn from development programs. Additional potential is present from up to $130 million in warrants if exercised for cash.
Pipeline and Product Candidates: Mechanisms and Milestones
Vidofludimus calcium is an oral small molecule drug targeting both inflammatory and neurodegenerative aspects of multiple sclerosis by acting as a nuclear receptor Nurr1 activator (providing neuroprotection) and a DHODH inhibitor (providing anti-inflammatory effects). As of this quarter, it has completed enrollment in two major Phase 3 trials for relapsing MS, with data expected by the end of 2026. The candidate could become the first oral treatment for non-active secondary progressive MS, where no approved therapies currently exist, and offer another option for primary progressive MS, which has limited approved therapies and high unmet need.
The company's broader pipeline includes IMU-856, a small molecule sirtuin 6 modulator, in early clinical development for gastrointestinal disorders such as celiac disease. Recent data showed an increase in GLP-1 hormone levels, suggesting IMU-856 could have value in weight management if future trials confirm these results. Progression of IMU-856 relies on further funding, either from partners or new financing. Immunic is actively exploring collaborations or out-licensing to accelerate this and other pipeline programs.
Looking Forward: Financial Outlook and Upcoming Milestones
Immunic’s management did not provide specific guidance figures for revenue or earnings, and the company does not expect commercial revenue until after potential approval and launch of vidofludimus calcium, which could be several years away. The company reported that its cash position is not adequate for at least twelve months of continued operations, making new financing or partnership deals essential to maintain its clinical programs and business continuity.
Key developments on the horizon include a top-line readout from the Phase 2 CALLIPER trial in progressive MS, expected in April 2025, and Phase 3 ENSURE trial results in relapsing MS by late 2026. Additional financing needs will likely lead to further share issuances or partnership agreements. Investors tracking Immunic should watch for progress on long-term funding, key clinical trial readouts, and updates on strategic collaborations. IMUX does not currently pay a dividend.
Revenue and net income presented using U.S. generally accepted accounting principles (GAAP) unless otherwise noted.
