Immunovia's PancreaSure Gears Up for Medicare and Volume Expansion

From Advocacy to Volume

Immunovia is officially moving from targeted advocacy to the volume building phase of its PancreaSure launch. The company ended Q2 with 27 high-risk surveillance programs using the test, including 10 of the top 20 U.S. cancer centers. Driven by a dedicated team of strategic account managers, the pipeline of engaged centers has expanded from 71 in Q1 to more than 110, with a clear focus on large GI groups that can deploy the test across multi-state networks. As CEO Jeff Borcherding noted, “As of the end of the second quarter, we now have 27 high-risk surveillance programs that have used the PancreaSure test since launch.” — Jeff Borcherding, Chief Executive Officer · 2026-08-06 The transition is deliberate: the company wants to deepen adoption within existing accounts before broadening the sales net.

Clinical Data and Reimbursement Milestones

The most consequential near-term catalyst is the submission for Medicare coverage, planned for Q3. A new pooled analysis of the CLARITI and VERIFI studies, focusing on the high-risk, symptomatic Medicare population, showed sensitivity of 83.3% and specificity just under 92%. Jeff emphasized, “These data give us really good data to submit for coverage as we pursue Medicare coverage and local coverage determination.” — Jeff Borcherding, Chief Executive Officer · 2026-08-06 The company also expects a decision from New York State in Q3, which would unlock one of the largest diagnostic markets in the country. The reimbursement path remains multi-stage, but the company is already billing commercial insurers and seeing early signals of payment, as “we are starting to see some early signs of positive results there.” — Jeff Borcherding, Chief Executive Officer · 2026-08-06 This traction echoes the earlier guidance, when the CEO noted in November, “So Medicare is our clear focus. We are waiting for that last clinical utility evidence that I mentioned, those surveys, we will then be submitting to Medicare in 2026.” — Jeff Borcherding, Executive (likely CEO or similar senior role) · 2025-11-26 The company sees the addressable market expanding well beyond the original 600,000 estimate.

Since we shared that estimate of 600,000, the market has expanded in a pretty meaningful way.

Financial Runway and Strategic Optionality

With only SEK 34.9 million in cash at quarter-end, Immunovia is carefully managing its burn. The average monthly cash burn of SEK 7 million came in below the earlier guidance of 8–10 million, and the company expects its existing cash to fund operations into Q4 2026. Management is actively evaluating equity financing, partnerships, and other sources to extend the runway into end-2027. This disciplined approach is consistent with prior guidance, as the CFO noted in February, “I think that we would expect that our cash flow would return to the levels that we've previously guided to.” — Jeff Borcherding, Chief Executive Officer · 2026-02-24 The real prize, however, lies in business development: the company is pursuing a large U.S. diagnostics partner, collaborations with multi-cancer early detection tests, and pharma partnerships in pancreatic cancer, all of which could provide non-dilutive capital and accelerate adoption. As Jeff outlined, “What we've seen from the results of these multi-cancer tests is that while they are able to detect pancreatic cancer in the later stages of disease, they have very poor detection and sensitivity of early-stage pancreatic cancer, which, as you saw, we have very, very strong results for PancreaSure.” — Jeff Borcherding, Chief Executive Officer · 2026-08-06 This differentiation, combined with the secure payment progress, positions Immunovia as a credible contender in a space where early detection is paramount.