Equity research Immunovia: Eventful Q2 and rights issue to support PancreaSure launch

The second quarter of 2025 was an eventful one for Immunovia, with many milestones and events that set the stage for the commercial launch of PancreaSure, slated for 2 September. A big headline that arrived just before the publication of the Q2 report is the intent to conduct a rights issue of SEK 100 million. The raise’s timing and size align with our previous expectations; however, the subscription price is yet to be determined.

During the second quarter, cash burn was lower than expected, with Immunovia decreasing the burn to SEK 6 million per month. This compares to Q1, when the burn was just under SEK 9 million per month. However, as is highlighted in the report, the burn rate will likely go back up to SEK 8-10 million for Q3, coinciding with the launch of the PancreaSure test. Royalties received during the quarter amounted to SEK 90 thousand, while R&D costs amounted to SEK 6.9 million. Cash flow from operations improved to negative SEK 18 million, as compared to Q2 last year, with a cash flow of negative SEK 26.7 million. Cash reserves were boosted by the exercise of series TO3 warrants in April, raising approximately SEK 10.6 million before costs. With the SEK 100 million rights issue around the corner, this leaves Immunovia with a cash position of SEK 29 million, for the time being. However, one should note that, in conjunction with the announcement of the rights issue, bridge loans were set up for SEK 20 million. These loans should cover the interim period and allow for the launch of the PancreaSure test.

Some of the highlights during the quarter include the initiation of a study with Leiden University, a ruling concerning LDTs, and, although announced on July 1, the assignment of a CPT code for PancreaSure. The new study is a case-controlled study designed to evaluate the accuracy of PancreaSure in the detection of early-stage pancreatic cancer. In total, 150 patients with CDKN2A mutations will be recruited at the Leiden University Medical Center, with the results of the study being pertinent for reimbursement purposes. A timeline for the study has not been communicated. Further, the American Medical Association (AMA) assigned a proprietary laboratory analysis code (PLA) to the PancreaSure test. Although not indicative of the reimbursement coverage or payment rate, this is a necessary first step in a three-step process to acquire reimbursement, with the aim of achieving a price of around USD 897 through a taxonomy crosswalk.

Looking ahead, the launch of the test next week and the incoming rights issue are big inflection points. As stated in the report, the launch of the test will include pancreatic cancer centers that implement high-risk surveillance programs, such as the University of Pennsylvania, Honor Health, Hackensack Meridian, University of Colorado and Northwestern University, among others. As mentioned in the conference call, there are 7 centers lined up for the launch, with around the same number of centers intended for just after launch. Although it is not publicly stated how many patients are part of the surveillance programs, it has been mentioned before that some centers have had more patients interested in screening than the capacity of the centers has allowed. The report mentions a three-phased launch strategy, with the first phase focusing on leveraging existing relationships to promote the test and sell at a low cost. The aim is to promote the test to more KOLs and centers. The CLARITI study was awarded a Distinguished Abstract Award by the Academy of Diagnostics & Laboratory, an award reserved for the top 2% of submitted abstracts. The award should aid in spreading recognition of the test and pave the way for penetration among new centers. As for the rights issue, board and management will take approximately 1% of the issue, with guarantee commitments covering ~79%, meaning that 80% in total is secured. The announcement came just before the quarterly report, but the determination of the subscription price will be according to a VWAP during the period 12 – 25 September. The subscription period, pending approval from the EGM, will run from 7 – 21 October.

Taken together, we see the second quarter of 2025 as an eventful one for Immunovia. However, the bigger inflection points are around the corner. We see it as beneficial that short-to-mid-term financing was solved before the launch of PancreaSure and we believe this may aid in potential discussions with partners for distribution. Furthermore, given the continued progress towards launch and the subsequent strong share performance in recent months, we see now as an appropriate timing for a capital raise. As for the launch of the test, we believe news on the Medicare decision regarding pricing of the test, expected some time in the coming 2 to 3 months, is another near-term milestone.

In summary, we are encouraged by the recent progress and the confirmation of the launch timeline. The size of the rights issue is in line with our previous assumptions and the rapid share gain during the summer is timely. Consequently, we do not necessarily foresee negative adjustments to our base case valuation (SEK per share) based on the share issue as such. However, we intend to return with a full update once the subscription price is determined.

Read our latest update here.

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