Immunic advances MS drug toward key Phase 3 data, expects results by year-end

Immunic advances MS drug toward key Phase 3 data, expects results by year-end

Tue, August 11, 2026 at 3:36 PM GMT+3 3 min read

• IMUX -1.40%
• 10VA

Immunic Inc (NASDAQ:IMUX, FRA:10VA) is preparing for a series of clinical and corporate milestones as it advances its lead drug candidate vidofludimus calcium through late-stage development in multiple sclerosis, while expanding its leadership team ahead of potential regulatory filings and commercialization.

The biotechnology company reported second-quarter results on Tuesday and said its Phase 3 ENSURE-1 and ENSURE-2 trials evaluating vidofludimus calcium in relapsing multiple sclerosis remain on track to deliver top-line data by the end of 2026.

If the results are positive, Immunic plans to submit a New Drug Application in the US in mid-2027, with a potential regulatory decision targeted for 2028.

The company is also preparing to begin a Phase 3 program evaluating vidofludimus calcium in progressive multiple sclerosis later this year. The planned study follows data from the Phase 2 CALLIPER trial, including analyses presented at the 2026 Consortium of Multiple Sclerosis Centers annual meeting that covered disability progression, patient-reported outcomes, safety and tolerability.

Immunic has also made several changes to its management and board as it moves toward potential commercialization. Erik Lundgren was appointed chief executive officer in May and joined the board in July, while Michael A. Panzara became chief medical officer in April. Michael W. Bonney was appointed chair of the board in May, and Elena Ridloff joined the board in August.

For the second quarter, Immunic reported total operating expenses of $35.3 million, up from $27.0 million a year earlier.

Research and development expenses rose to $25.9 million from $21.3 million, with the increase primarily reflecting higher personnel expenses and drug-drug interaction studies supporting a potential regulatory filing.

General and administrative expenses increased to $9.4 million from $5.7 million, driven by higher personnel, legal and consulting costs and pre-commercial marketing expenses.

The company reported a second quarter net loss of approximately $34.1 million, or $0.80 per basic and diluted share, compared with a net loss of $26.8 million, or $2.03 per share, in the year-earlier period. The lower per-share loss reflected a higher weighted-average share count.

Immunic ended the quarter with $155.1 million in cash and cash equivalents and said it expects those funds to support operations into late 2027.

Immunic CEO Erik Lundgren said the company had continued to execute on its late-stage development priorities and had strengthened its board and management team with multiple sclerosis development, medical, regulatory and commercialization expertise.

"Following the successful closing of our oversubscribed private placement financing earlier this year, we are well capitalized to execute on our key strategic priorities," Lundgren said.

"We believe the milestones ahead position Immunic for a significant near-term value inflection for vidofludimus calcium in relapsing MS, while continuing to unlock the substantial long-term opportunity across the broader progressive MS patient population."

Michael Panzara, Immunic chief medical officer, highlighted that the ENSURE trials remain on track for year-end data and said the company is preparing for a potential regulatory submission if the trials produce positive results.

"With regulatory alignment and precedent surrounding the time to first relapse primary endpoint, the path to regulatory submission upon positive trial results is clear," Panzara said.

"In parallel, we are preparing to initiate our Phase 3 progressive MS trial later this year, reinforcing our commitment to evaluating the potential of vidofludimus calcium for anyone living with MS."