Equity research Immunovia, Q3 2025: US reimbursement in focus

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Following the launch of PancreaSure in the US and the successful rights issue, we expect Immunovia to continue making progress in both clinical development and the reimbursement process in 2026. Expanding availability and potentially securing reimbursement should underpin a gradual increase in sales. A low valuation and weak share price development contrast with the recent rally in share prices of larger cancer diagnostics companies in the US.

Gradually expanding availability of the PancreaSure test to more centres

In Q3 2025, Immunovia launched PancreaSure as an LDT-type test in targeted pancreatic surveillance program centres in the US. Already in September, key opinion leaders at ten high-risk surveillance centres agreed to implement PancreaSure. However, no sales of the test were recorded in the third quarter. As the test is not yet reimbursed,  the initial phase of commercialisation is focused on achieving targeted advocacy in a gradually expanding number of key centres. It is still early days, but Immunovia states that the test is being used both as a complement to existing imaging screening methods and to screen individuals not participating in surveillance programs. If so, we believe that the broad use of PancreaSure is a promising sign.

Successful rights issue supports launch and reimbursement steps in 2026

Following the end of Q3, Immunovia completed the fully guaranteed rights issue of SEK 100m or 333.9m shares at a subscription price of SEK 0.3 per share. It was subscribed to 87.9 per cent. So far in 2025, Immunovia has improved its cost control to prepare for commercialisation, and the cash burn rate in Q3 was somewhat lower than previous guidance. All in all, the company guides that the current cash position provides a runway into Q3 2026, in line with our expectations. It should enable the establishment of a sales team in the US, expansion into additional surveillance centres, and completion of the first clinical utility study to support an application for reimbursement with Medicare. The latter step is crucial to achieving significant volume and revenue growth in the coming years. On 26 November, Immunovia also reported that the CMS has finalised a national payment rate of $897 for the PancreaSure test, effective 1 January 2026, the same as the preliminary payment determination.

Higher peer valuation could underpin the rerating of the Immunovia share

We are encouraged by the activity in recent quarters, culminating in the US launch, which is now underway. At the same time, the management is successfully implementing cost control. With an estimated EV below SEK 100m and the share price trading close to the subscription price in the recent rights issue, we believe the progress is not reflected in the share price. We have become slightly more cautious about sales in the short term, hindered by, for example, potential long lead times between opting for testing with PancreaSure and revenue recognition in the initial phase of commercialisation. We expect some SEK 0.7m (0.9m) in sales for the current quarter (Q4), but have not made any material changes to our medium-term estimates for now. Meanwhile, our reference index of cancer diagnostics peers has rallied, partly fueled by Abbott Labs’ bid for industry leader Exact Sciences. Due to the higher peer valuation, we raise the base case valuation.

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