Immunic (IMUX) Q4 2025 earnings summary

Executive summary

• Top-line data from phase 3 ENSURE trials of vidofludimus calcium in relapsing multiple sclerosis (RMS) expected by year-end 2026, with NDA submission planned for mid-2027 and potential approval in 2028.

• Raised $200 million in a private placement, with potential for an additional $200 million, to fund clinical trials and transition to a commercial-stage organization.

• Initiation of a phase 3 trial in primary progressive multiple sclerosis (PPMS) planned for later in 2026.

• Board and executive leadership changes underway to support commercialization, including search for a new CEO with MS commercial expertise.

Financial highlights

• Research and development expenses were $82.0 million for 2025, up from $80.0 million in 2024, mainly due to increased costs for the vidofludimus calcium program and personnel.

• General and administrative expenses rose to $21.2 million in 2025 from $18.0 million in 2024, driven by higher personnel, legal, and consultancy costs.

• Interest income decreased to $1.0 million in 2025 from $3.4 million in 2024 due to a lower average cash balance.

• Other income (expense) was $5.0 million in 2025, up from ($1.0) million in 2024, primarily due to $4.8 million in grant income from the German Federal Ministry of Finance.

• Net loss for 2025 was $97.2 million ($0.62 per share), compared to $100.5 million ($1.00 per share) in 2024.

Outlook and guidance

• Cash and equivalents of $15.5 million at year-end 2025, plus $187 million net proceeds from the February 2026 private placement, expected to fund operations into late 2027.

• Top-line data from phase 3 ENSURE trials in RMS expected by end of 2026; NDA submission targeted for mid-2027 and regulatory approval in 2028.

• Phase 3 program in PPMS to begin in 2026, estimated to take 3.5 to 4 years to complete.