Immunovia (IMMNOV) Study Update summary

Study design and objectives

• The study was a case-control clinical validation evaluating a next-generation blood test for early pancreatic cancer detection in high-risk populations, using 385 blood samples from six US centers.

• 115 samples were from patients with stage I/II pancreatic ductal adenocarcinoma (PDAC), and 271/270 were high-risk controls, focusing on familial/genetic risk and pancreatic cysts.

• The primary endpoint was sensitivity for detecting stage I/II pancreatic cancer; specificity and comparison to CA 19-9 were secondary endpoints.

• The study design matched the previous CLARITY study to enable robust combined analyses and addressed previous feedback by balancing age, gender, and cyst cases.

• High-risk controls reflected the intended use population and met payer/regulator expectations.

Key results and performance

• The test achieved 77% sensitivity for early-stage pancreatic cancer, meeting the primary endpoint and outperforming MRI/CT imaging and CA 19-9.

• Specificity was 88%, close to the 90% target and comparable to CA 19-9, though slightly lower than in CLARITY due to more challenging cyst cases.

• Combined data from Verify and CLARITY showed 78% sensitivity and 92% specificity overall.

• The test performed well in subgroups: 78% sensitivity/94% specificity in familial/genetic risk, 72%/89% in cysts, and similar results in diabetes.

• High accuracy in early-stage detection was confirmed in a second independent high-risk population.

Implications for commercialization and reimbursement

• Two successful clinical validation studies support reimbursement efforts, regulatory submissions, and commercial partnerships.

• The test is on track for a targeted US launch in Q3 2025, focusing on high-risk surveillance centers.

• Additional clinical utility studies are planned, including NIH-led studies in pancreatic cysts and new-onset diabetes.

• Financial planning incorporates expected proceeds from TO3 warrants, supporting launch and scale-up.

• Results will support regulatory submissions, payer reimbursement, and commercial partnerships.