Release Date: November 27, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Immunovia AB (LTS:0G8X, Financial) achieved significant progress with their next-generation test, showing 85% sensitivity and 98% specificity in detecting pancreatic cancer.
- The company successfully reduced operating expenses by 20% compared to the same quarter last year, primarily due to a 60% reduction in headcount costs.
- Immunovia AB (LTS:0G8X) raised SEK52 million through a rights issue, exceeding expectations with a 91% subscription level.
- The company has acquired over 1,000 blood samples for their clinical validation study, marking it as potentially the largest study of its kind in pancreatic cancer.
- Immunovia AB (LTS:0G8X) plans to launch their test in the US market in the second half of 2025, targeting high-risk pancreatic cancer surveillance centers.
Negative Points
- Cash burn is expected to increase in Q4 due to ongoing R&D activities, projected to be between SEK8 million to SEK10 million.
- Revenue from the test is expected to be limited in 2025, with significant revenue anticipated only after reimbursement approval in 2026.
- The company faces challenges in securing a strategic partner, as potential partners are waiting for clinical validation data before proceeding.
- There is a risk that the clinical validation study may yield different results from the model-development study, which could impact future plans.
- The need for additional clinical studies post-validation could delay broader market adoption and reimbursement processes.
Q & A Highlights
Q: When do you expect a decision on the grant of the patent application that was submitted?
A: The review of the patent application is currently on hold intentionally. We filed a provisional patent application to preserve our standing as the first to invent, allowing us to provide more data to support patentability. We expect action on this later in 2025.
Q: How will the changed political landscape in the US impact Immunovia as a Swedish company?
A: We are preparing for success regardless of the political climate. For example, we are preparing for increased FDA regulatory oversight on lab-developed tests, despite uncertainties due to political changes.
Q: Are there ongoing discussions with potential partners?
A: Yes, we have ongoing dialogues with about a dozen potential partners. We regularly share information with them as we develop it, such as data from our model-development and analytical validation studies.
Q: What would be considered viable results for accuracy in the clinical validation study?
A: We aim for accuracy that meets market needs, ideally above 70% sensitivity and around 94-95% specificity. It's also important to demonstrate statistical superiority to CA19-9.
Q: Do you think the market has correctly assessed the value of Immunovia at the current share price?
A: While it's risky for a CEO to comment on share price, we see significant upside in our market value given the need we address and the value we bring with our next-generation test.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
