Uptake of PancreaSure by high-risk surveillance centers accelerated in the second quarter of 2026, with six new centers initiating testing. Ten of the top twenty U.S. cancer hospitals have now ordered PancreaSure tests in the ten months since launch. Our focus in the second half of the year will be to further build testing volume at these centers.
We plan to submit for Medicare coverage in Q3 and the application will be supplemented with additional data from ongoing clinical trials showing the accuracy and benefits of PancreaSure testing. This evidence will fuel clinician use of PancreaSure and support efforts to obtain reimbursement.
Our commercial progress and expanding clinical evidence have resulted in an increasing number of partnership discussions in both the United States and internationally.
PancreaSure trial accelerated in Q2
When we launched the PancreaSure test in September 2025, we noted that our focus through Q2 2026 would be developing advocacy among top experts at pancreatic cancer surveillance programs. I am encouraged to share that 27 high-risk surveillance centers have used the PancreaSure test through the end of the second quarter. Specialists at Memorial Sloan Kettering, Endeavor Health, Providence Health, and Henry Ford Cancer Institute are among those who initiated PancreaSure testing in Q2. They joined top centers like Northwestern University, Stanford Health, Beth Israel Deaconess, and UCLA that have increased their use of PancreaSure.
PancreaSure’s market-leading performance in detecting Stage I and II pancreatic cancers has been a key driver of PancreaSure’s initial commercial success. Multi-cancer early detection tests have raised awareness about the importance of early cancer detection, but those tests cannot match PancreaSure’s sensitivity in early-stage cancers. The specialists who lead pancreatic high-risk surveillance programs demand high sensitivity in Stage I and II pancreatic cancers and PancreaSure uniquely meets this need.
Catalysts for growth in the second half
As outlined in our 2025 launch strategy, in the second half of 2026 we will focus on test adoption and increasing usage among the centers that have begun PancreaSure testing. The most important catalyst for building volume is our Strategic Account Managers, who are growing their expertise, expanding their customer relationships and increasing their impact.
A second catalyst will be the ASSURE registry, a real-world study of the PancreaSure test’s use and impact. The study has generated significant interest among pancreatic cancer experts, who see the study as a way to contribute to important research while providing better surveillance for their patients. We expect ASSURE to drive use of PancreaSure in new high-risk surveillance centers and increase testing volume among current customers.
A further catalyst for growth is the extensive amount of new clinical data we expect to release in the second half of 2026. Compelling new data fosters regular, productive conversations with clinicians, which can drive test growth.
We plan to submit for Medicare coverage in Q3
Medicare reimbursement remains a key strategic priority and represents a major value inflection point for Immunovia. On June 15 we announced new PancreaSure performance data to support our Medicare submission. Because Medicare generally requires the presence of signs or symptoms to pay for diagnostic tests, we analyzed combined data from prior studies in genetic or familial high-risk individuals who also had signs or symptoms of pancreatic cancer. In this group, PancreaSure detected 83.3% of Stage I and II pancreatic cancer cases, while demonstrating specificity of 91.6%.
We remain on track to submit the Medicare coverage request in Q3.
We continue to build clinical evidence for PancreaSure
To secure coverage of the PancreaSure test, we are conducting additional studies to show that PancreaSure is accurate, can impact clinician decisions, and improves patient outcomes. In June we announced the publication of the AFFIRM study, which further confirmed the accuracy of the PancreaSure test.
In late Q2 we completed data collection for ADHERE, a survey of over 400 high-risk individuals designed to show patient acceptance of an early-detection blood test. We will share these results shortly.
The ASSURE registry study, which will illustrate the clinical utility of the PancreaSure test in the real world, has received ethics board approval. We are now contracting with multiple sites to participate.
Business development progresses as market activity accelerates
We continue to engage multiple strategic diagnostic companies regarding potential commercial and strategic partnerships. While discussions remain preliminary, growing commercial adoption and continued progress toward reimbursement are increasing external interest among prospective partners in the U.S.A., Japan and China.
As we pursue partnerships, I am encouraged by the accelerating pace of licensing and acquisition activity across the diagnostics industry, especially for cancer tests.
Financing our growth
The Board continues to evaluate financing alternatives in advance of our projected cash needs. We are prioritizing options that extend our runway while maximizing shareholder value and preserving flexibility to execute our commercial strategy.
Delivering on our commitments
Our strategy follows a deliberate progression. Initial trial usage at leading surveillance centers generates physician advocacy. Increased test utilization produces real-world evidence, strengthening reimbursement efforts and increasing physician confidence. Successful reimbursement, in turn, should support broader adoption, increasing test volume, and revenue growth. We are now transitioning from the first phase of this cycle into the next stage of commercial expansion. We are just beginning to realize our potential.
August 6, 2026
Jeff Borcherding
President & CEO, Immunovia AB
