Immunovia (IMMNOV) Q4 2024 earnings summary

Executive summary

• Completed clinical and analytical validation of a next-generation pancreatic cancer test, demonstrating superior sensitivity (78%) and specificity (94%) compared to CA19-9 and imaging, and eliminating the borderline result category for clearer outcomes.

• The test uses five protein biomarkers, reducing reliance on CA19-9 and enabling accurate results for all patients, regardless of race or ethnicity.

• Transitioned from R&D to commercialization, with a US launch planned for Q3/Q4 2025 targeting high-risk surveillance centers, and ongoing strategic partnership and reimbursement efforts.

• Engaged in additional clinical studies to support reimbursement, physician adoption, and future FDA approval.

• Ongoing discussions with potential strategic partners to maximize shareholder value and accelerate market penetration.

Financial highlights

• Q4 2024 operating expenses were 30.6 MSEK, up 7 MSEK year-over-year, with declining headcount costs and rising clinical study expenses; average Q4 headcount was 9, down 50% year-over-year.

• Q4 2024 cash burn averaged 9.4 MSEK per month, totaling 28.3 MSEK, in line with guidance.

• Rights issue in autumn 2024 raised 53 MSEK net; TO2 warrants exercised in January 2025 brought in 37 MSEK, with 74.1% participation.

• End-Q4 2024 cash balance was 25.3 MSEK, with further proceeds expected to fund operations into H2 2025.

• Full-year 2024 net loss was -76,541 KSEK, a significant improvement from -309,438 KSEK in 2023.

Outlook and guidance

• Commercial launch of the next-generation test in the US planned for Q3/Q4 2025, initially targeting high-risk surveillance centers.

• Monthly cash burn for 2025 expected at 8–10 MSEK, with OpEx shifting from R&D to clinical studies and commercialization.

• Additional clinical studies planned in 2025 to support reimbursement, regulatory submissions, and physician adoption.

• Working capital needs are secured into H2 2025, with further liquidity options being explored.

• Expansion of the sales team will be limited in 2025, with broader commercialization expected in 2026, potentially supported by a strategic partner.