Immunovia (IMMNOV) Q4 2025 earnings summary

Executive summary

• Achieved commercial launch of PancreaSure in September 2025 after over two years of development and clinical research, with strong adoption in high-risk surveillance centers and positive reception from the medical community.

• Published five clinical studies, including pivotal CLARITI and VERIFI validation studies, and received recognition at major scientific conferences.

• Built strong advocacy among key opinion leaders and high-risk surveillance centers, with early adoption by 12 centers by year-end 2025.

• Secured $897 Medicare reimbursement rate and raised over 140 million SEK to support launch and clinical studies.

• Added three strategic account managers to accelerate adoption and integration at key centers.

Financial highlights

• Q4 2025 net sales were SEK 354,000, mainly from royalty and PancreaSure test revenues, down from SEK 455,000 in Q4 2024.

• Operating loss for Q4 2025 was SEK 16.4 million, improved from SEK 30.1 million in Q4 2024.

• Cash burn in Q4 was SEK 6.6 million per month, below guidance, with a year-end cash position of SEK 77.5 million.

• Rights issue in Q4 2025 raised 100 million SEK (net SEK 69.8 million), extending cash runway through Q3 2026.

• Cash flow from operating activities improved to -19.8 MSEK in Q4 2025 from -28.3 MSEK in Q4 2024.

Outlook and guidance

• Expect meaningful revenue from PancreaSure after 2026, with significant ramp-up in 2027.

• Cash runway secured through Q3 2026 based on current cash balance and cost management.

• Plan to submit for Medicare coverage in mid-2026, with some Medicare Advantage reimbursement expected in 2026.

• Initial clinical utility data anticipated in Q2 2026.

• Additional capital will be needed to fund operations beyond Q3 2026; exploring grants, partnerships, and equity options.