Immunovia (IMMNOV) Q1 2025 earnings summary

Executive summary

• PancreaSure, a blood test for early pancreatic cancer detection, is set for commercial launch in September 2025, following strong clinical validation and growing physician and patient interest.

• The addressable U.S. market for PancreaSure doubled to 1.2 million high-risk individuals annually, with advocacy groups and key opinion leaders supporting launch and adoption.

• Strategic focus on efficient, low-cost commercialization, targeted outreach to high-risk surveillance centers, and ongoing discussions with potential commercial partners and investors.

• Cost management, automation, and outsourcing have reduced fixed costs, and the company is engaging with potential strategic partners for future growth.

• Clinical studies (VERIFI and CLARITI) demonstrated high sensitivity and specificity for early-stage pancreatic cancer detection, supporting reimbursement efforts and commercial potential.

Financial highlights

• Q1 2025 cash balance was SEK 37.7 million, with a monthly cash burn rate of SEK 8.1 million, at the lower end of guidance.

• Cash expected to fund operations through late Q3 2025, with additional 10 MSEK from TO3 warrants in April.

• Net sales for Q1 2025 were 139 KSEK, consisting solely of royalties.

• Operating loss improved to -18.9 MSEK from -24.2 MSEK year-over-year, reflecting lower R&D and external service costs.

• 74.1% of TO2 and 71.0% of TO3 warrants were exercised, raising a combined 53 MSEK before costs.

Outlook and guidance

• Commercial launch of PancreaSure in the US is planned for September 2025, with focus on high-risk surveillance centers and continued clinical utility studies.

• Additional clinical study results are expected through 2026, with Medicare reimbursement projected in the second half of 2026.

• Working capital is secured through late Q3 2025; the company is evaluating funding options to extend runway into 2026.

• Actively seeking a commercial collaboration partner and planning for future financing needs.