Equity research Immunovia: PancreaSure launch in the US is underway

In early September, Immunovia launched PancreaSure as an LDT-type test in targeted pancreatic surveillance program centres in the US, in line with previously communicated plans. The company is raising SEK 100m in a fully secured rights issue to support the initial commercialisation phase. We are encouraged by the launch progress and the successful capital raise and bump up our base case valuation.

Focused US launch an early commercial proving ground

Immunovia’s PancreaSure test has launched in the U.S. and is already available at eight leading surveillance centres, with further expansion underway. Patients are accessing the test out-of-pocket, building advocacy ahead of insurance reimbursement targeted for 2026. Encouragingly, CMS has issued a payment determination of $897 per test, which is expected to take effect in January 2026, a vital step in a reimbursement pathway. The company is also re-engaging with key centres previously utilising its earlier test. Further, the company plans to initiate clinical trials to demonstrate clinical utility, which will be key to securing insurance coverage from 2026.

Fully secured SEK 100m rights issue to support commercialisation

Immunovia has announced a rights issue to finance the initial phase of the US launch. It amounts to SEK 100m and is fully secured through subscription intentions and guarantee commitments. We believe the size and timing were appropriate and expected, as the launch is already well underway, removing possible uncertainty regarding execution of the timeline. The subscription price has been determined at 0.30 SEK per share. The subscription period, pending approval from the EGM, will run from 7 to 21 October. To ensure short-term liquidity until the issue is completed, Immunovia has taken up a SEK 20m bridge loan.

Project progress and secured financing prop up our valuation

The launch of the PancreaSure test, a promising pace in the rollout to US surveillance centres, and progress towards securing insurance coverage are encouraging signs in the company’s commercialisation efforts. Immunovia has also licensed some rights related to the test manufacturing, a move expected to improve the gross margin. Overall, we see somewhat lower risk to our previous forecasts and raise the risk-adjusted base case valuation. We see the opportunity for further rerating depending on clinical and commercial development, e.g.,  if and when Immunovia secures reimbursement through Medicare for PancreaSure.

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