Equity research Immunovia: All eyes on securing the launch of PancreaSure

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The first quarter of 2025 was calm regarding operations, with royalties of SEK 139 thousand and a cash flow from operations of minus SEK 24.4 million. Rather, the main events of the quarter were financing-related and the publication of the results of the VERIFI study. With sufficient funding until late Q3, and the launch of PancreaSure scheduled for September, the road for Immunovia in the coming quarters is clear.

Lower costs than expected combined with slightly softer funding

Regarding financials, the first quarter showcased flat development of royalties while the operating loss decreased to SEK 18.9 million (-24). We expected an EBITDA of minus SEK 25 million, highlighting slightly better cost control than expected. EPS was more negative than our estimate, landing on minus SEK 0.24 after dilution, as compared to our estimate of minus SEK 0.12, mainly burdened by adverse FX effects from internal transactions. Notably, Immunovia announced that 74.1% of warrants of series TO2 were exercised in January, raising SEK 42.4 million before costs. Just after the quarter, in April, the company raised a further SEK 10.6 million before costs through TO3, extending the cash runway until late Q3.

VERIFI results combined with CLARITI set the stage for PancreaSure

Immunovia is targeting a subset of pancreatic cancer patients, specifically, high-risk patients. These are characterized by a family history of pancreatic cancer, presence of pancreatic cysts, diabetes, or a genetic predisposition for pancreatic cancer. In the VERIFI study, the PancreaSure test demonstrated a sensitivity of 77% and a specificity of 88%, in line with results from CLARITI, which showed 78% and 94%, respectively. The main differentiator was the inclusion of patients with pancreatic cysts, a significant addition, as these patients often are incorrectly diagnosed using other methods, such as tests based solely on CA19-9 or endoscopic ultrasound. Combining both studies, 1,452 blood samples were analyzed, with 1,134 being controls. Overall, PancreaSure achieved a sensitivity of 78% and a specificity of 92%.

Valuation evolving amid funding deliberations and partnering discussions

Although an essential quarter in terms of clinical validation, a pillar for securing reimbursement once the test is launched, the coming quarters are relatively more pivotal. As discussed in our Mrkt BUZZ in April, regulatory tailwinds might aid in partner discussions, which Immunovia is currently holding. Later, in September, the launch of PancreaSure will mark a new chapter for Immunovia. Following the Q1 2025 report, and recent news flow, we adjust our risk-adjusted base case valuation to SEK 0.56 per share (0.65) primarily to reflect the USD depreciation and lower proceeds from the exercise of TO3 warrants than we had anticipated (in a challenging market environment). In our view, clinical development and preparations for the US launch are encouraging ahead of discussions with potential partners and continuing efforts to secure long-term financing.

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