-
OpEx: Just over SEK30 million, a 20% reduction compared to the same quarter last year.
-
Cash Burn: SEK21 million for the quarter, down 40% relative to last year.
-
Cash Balance: SEK54 million at the end of Q3.
-
Rights Issue: Raised SEK52 million, net of issue costs, with a subscription level of 91%.
-
Test Sensitivity: 85% sensitivity in the model-development study.
-
Test Specificity: 98% specificity in the model-development study.
-
Comparison to CA19-9: 20 percentage points more sensitive than CA19-9.
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) 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.