Immunic Inc Stock Price, News & Analysis

Immunic (NASDAQ:IMUX) presented key data for vidofludimus calcium in multiple sclerosis at the 41st ECTRIMS Congress. The phase 2 CALLIPER trial demonstrated statistically significant results in progressive multiple sclerosis, showing over two-fold probability of 24-week confirmed disability improvement versus placebo.

The drug reduced the risk of 24-week confirmed disability worsening by 23.8% versus placebo in the overall population and by 33.7% in patients without gadolinium-enhancing lesions. Long-term data from the Phase 2 EMPhASIS trial in relapsing-remitting MS showed 92.3% of patients remained free of 12-week confirmed disability worsening at week 144, with favorable safety profiles.

Immunic (NASDAQ:IMUX) has received a Notice of Allowance from the USPTO for a patent application covering dose strengths of its lead asset vidofludimus calcium (IMU-838) for treating progressive multiple sclerosis (PMS). The patent specifically covers daily doses of 10-45mg for treating PMS, including primary and secondary progressive forms.

The patent provides protection until 2041 and follows positive phase 2 CALLIPER trial results where vidofludimus calcium demonstrated neuroprotective potential by delaying time to 24-week confirmed disability worsening (24wCDW). The drug also showed reductions in thalamic brain volume loss and volume of new/enlarging T2 lesions.

This is the fifth U.S. patent for vidofludimus calcium in multiple sclerosis, part of a multi-layered intellectual property strategy that includes patents for composition-of-matter, treatment methods, and dosing regimens.

Immunic (NASDAQ: IMUX), a biotechnology company focused on inflammatory and autoimmune diseases, has announced its participation in three major conferences in September 2025. The company will present at the H.C. Wainwright Global Investment Conference (Sept 8-10), attend the Leerink Partners Biopharma Summit (Sept 17-19), and participate in the 41st ECTRIMS Congress (Sept 24-26).

At ECTRIMS, the company will showcase significant data on its lead drug candidate vidofludimus calcium (IMU-838), featuring one oral presentation and four poster presentations. The presentations will focus on the drug's efficacy and safety in multiple sclerosis treatment, including results from the Phase 2 CALLIPER trial in progressive MS and long-term safety data from the EMPhASIS trial in relapsing-remitting MS.

Immunic (NASDAQ: IMUX) reported Q2 2025 financial results and significant progress in its clinical pipeline. The company's lead drug vidofludimus calcium showed promising results in multiple sclerosis trials, with a 23.8% reduction in disability worsening in progressive MS patients. Key highlights include completed enrollment for twin Phase 3 ENSURE trials in relapsing MS, with top-line data expected by end of 2026.

The company strengthened its financial position through two financings totaling $70.1 million in gross proceeds. Q2 2025 resulted in a net loss of $27.0 million ($0.20 per share), with cash position of $55.3 million as of June 30, 2025. However, current liquidity is insufficient to fund operations for the next twelve months without additional capital.

Immunic (NASDAQ:IMUX) has reported promising long-term data from the Phase 2 EMPhASIS trial's open-label extension (OLE) studying vidofludimus calcium in relapsing-remitting multiple sclerosis (RRMS) patients. At Week 144, the trial demonstrated remarkable results with 92.3% of patients remaining free of 12-week confirmed disability worsening (CDW) and 92.7% free of 24-week CDW.

The study, representing approximately 952 treatment years, showed that of 29 CDW events confirmed at 12 weeks, 44.8% were associated with relapse-associated worsening, while only 13.8% were linked to progression independent of relapse activity. The drug maintained a favorable safety profile with low discontinuation rates and no new safety signals emerging during treatment durations up to 5.5 years.

Immunic (NASDAQ: IMUX) has achieved two major milestones in its multiple sclerosis (MS) clinical program. First, the company completed enrollment for its Phase 3 ENSURE trials of vidofludimus calcium in relapsing MS, with 1,121 patients in ENSURE-1 and 1,100 in ENSURE-2. Top-line data is expected by end of 2026. Second, additional Phase 2 CALLIPER trial data in progressive MS showed promising results, with vidofludimus calcium demonstrating significant reductions in 24-week confirmed disability worsening (24wCDW): 24% reduction in overall PMS population, 33% in PPMS patients, 19% in naSPMS patients, and 34% in aSPMS patients. The drug showed consistent efficacy in patients with and without inflammatory lesions, supporting its neuroprotective potential through Nurr1 activation mechanism.

Immunic announced the closing of an oversubscribed $65 million public offering consisting of pre-funded warrants, series A warrants, and series B warrants to purchase common stock. The Pre-Funded Warrants are immediately exercisable, Series A Warrants are exercisable until December 31, 2025, and Series B Warrants will be exercisable from October 1, 2025, until June 3, 2030. The company could receive up to an additional $130 million if all warrants are exercised in full. The offering was co-led by BVF Partners and Coastlands Capital, with participation from notable institutional investors including Aberdeen Investments and Janus Henderson. Immunic plans to use the proceeds to fund clinical trials, operations, and general corporate purposes.

Immunic (NASDAQ: IMUX), a biotech company focused on developing oral small molecule therapies for inflammatory and autoimmune diseases, has announced its participation in several key conferences in June 2025. CEO Daniel Vitt will present a company overview at the Jefferies Healthcare Conference and attend multiple other events. The company will showcase data on their lead asset vidofludimus calcium (IMU-838) at scientific conferences, including antiviral applications at the RSC Anglo-Nordic Medicinal Chemistry Symposium and potential neuroprotective effects for multiple sclerosis at the European Academy of Neurology Congress. Management will also participate in partnering activities at the BIO International Convention and attend investor conferences including UBS Life Science Conference and ABI Conference 2025.

Immunic (NASDAQ: IMUX) has announced the pricing of an oversubscribed $65 million underwritten public offering consisting of pre-funded warrants, series A warrants, and series B warrants to purchase common stock. The combined public offering price is set at $0.7499 per unit. The company could receive up to an additional $130 million if all warrants are exercised in full for cash.

The pre-funded warrants will be immediately exercisable, Series A warrants will be exercisable until December 31, 2025, and Series B warrants will be exercisable from October 1, 2025, for five years. The offering is expected to close around June 3, 2025. Leerink Partners is acting as the sole bookrunner, with B. Riley Securities and Brookline Capital Markets as co-managers.