Immunic advances Phase 3 MS program, eyes topline data by year-end

Immunic Inc (NASDAQ:IMUX, FRA:10VA) said on Wednesday it remains on track to deliver top-line Phase 3 data for its lead multiple sclerosis drug candidate, vidofludimus calcium, by the end of 2026, as the company strengthens its leadership team and bolsters its balance sheet with a recently completed $200 million private financing.

Along with the release of its first quarter financial results, the biotechnology company said it continues to advance its twin Phase 3 ENSURE-1 and ENSURE-2 trials evaluating vidofludimus calcium in relapsing multiple sclerosis (RMS). Immunic plans to submit a New Drug Application in the US in mid-2027, targeting a potential approval in 2028.

During Q1, Immunic appointed neurologist and biopharmaceutical executive Michael Panzara as chief medical officer. The company also added Jon Congleton to its board of directors and elevated Simona Skerjanec to interim chairperson of the board.

Immunic completed an oversubscribed private placement financing in February that could provide up to $400 million in gross proceeds, including $200 million received at closing. The financing was led by existing investor BVF Partners and included participation from several institutional investors.

Daniel Vitt, Immunic CEO, said the financing is expected to fund operations through completion of the phase 3 RMS trials and support preparations for a potential commercial launch.

“This highly successful transaction signals investors' continued confidence in Immunic and has provided the resources we need to advance our programs through key milestones and to continue our transition into a commercial-stage company,” Vitt said.

The company also said it plans to initiate a Phase 3 clinical program later this year evaluating vidofludimus calcium in primary progressive multiple sclerosis (PPMS), a study expected to take between three and four years to complete.

Additional data from Immunic’s Phase 2 CALLIPER trial in progressive multiple sclerosis were presented earlier this year at the ACTRIMS Forum 2026. According to the company, the findings provided further evidence supporting the drug candidate’s effects on biomarkers associated with disease progression.

Immunic said vidofludimus calcium is designed to combine neuroprotective effects through Nurr1 activation with anti-inflammatory activity via selective DHODH inhibition.

“Unlike currently available oral therapies that primarily target inflammatory pathways, vidofludimus calcium is designed to deliver both direct neuroprotective effects through Nurr1 activation and anti-inflammatory activity via selective DHODH inhibition,” Immunic chief operating officer Jason Tardio said.

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“In clinical trials to date, vidofludimus calcium has demonstrated a favorable safety and tolerability profile. Taken together, these attributes may support a compelling benefit-risk profile in the global MS market, which is projected to exceed $30 billion by the early 2030s."

Immunic also noted that it is exploring strategic alternatives for its IMU-856 program, including potential financing, licensing, or partnership opportunities.

For the quarter ended March 31, Immunic reported a net loss of approximately $32.6 million, or $1.08 per share, compared with a net loss of $25.5 million, or $2.51 per share, in the prior-year period.

Research and development expenses rose to $25.6 million from $21.5 million a year earlier, primarily due to higher development costs tied to the vidofludimus calcium program and increased personnel expenses. General and administrative expenses increased to $7.6 million from $5.3 million.

Cash and cash equivalents totaled $186.6 million as of March 31. Immunic said it expects its current cash position to fund operations into late 2027.

Shares of Immunic gained around 5.9% on Wednesday morning.

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