Release Date: February 25, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Immunovia AB (LTS:0G8X, Financial) successfully completed the clinical validation of their next-generation test, showing high sensitivity and specificity.
- The new test reduces reliance on the CA 199 biomarker, allowing results for all patients, including those who previously could not be tested.
- The next-generation test can be used across all races and ethnicities, addressing previous limitations with the IMRA test.
- The company has reduced costs by transitioning to a widely used industry-standard ELISA platform, lowering both fixed and variable costs.
- Immunovia AB (LTS:0G8X) raised significant funds through a rights issue and warrants, demonstrating strong investor interest and securing financial stability into the second half of 2025.
Negative Points
- The company faces challenges in commercializing the test, requiring strategic partnerships to expand market reach effectively.
- There is uncertainty regarding the impact of US healthcare policies under the Trump administration, which could affect funding and regulatory processes.
- The share price has not reflected the positive results of the next-generation test, possibly due to market conditions and recent financial activities.
- The company anticipates some volatility in cash burn due to the timing of clinical studies and commercialization efforts.
- Immunovia AB (LTS:0G8X) needs to secure FDA approval in the coming years, which may be delayed due to reduced staffing at the FDA.
Q & A Highlights
Q: Can you elaborate on the second clinical validation study mentioned in the report?
A: Yes, we are conducting a second clinical validation study focusing on high-risk individuals with a family history or genetic risk of pancreatic cancer. This study will also include individuals with pancreatic cysts. We expect to announce the results by the end of the first quarter. This study will apply insights from the clarity study, such as limiting the age of samples to those collected within the last five years, to provide a clearer read on test performance. Having two clinical validation studies is crucial for securing reimbursement in the US. - Jeff Borshedding, CEO
Q: Does the guidance for cash burn include expanding the sales team and initial sales from the launch?
A: Yes, the guidance includes these factors. However, the expansion of our commercial team will be limited in 2025 as we aim for a targeted launch focusing on high-risk surveillance centers. Our investment in the sales team will be modest in 2025, with expectations to increase in 2026, supported by a partner. These costs are included in the guidance, reflecting a shift from R&D to commercialization and clinical studies. - Jeff Borshedding, CEO
Q: Can you confirm if the next generation test reduces dependency on CA 199 and lowers the rate of non-performance tests?
A: Yes, we can detect pancreatic cancer even if the patient does not secrete CA 199, which was not possible with the previous test. While the test is more sensitive for patients who produce CA 199, we can still identify cancers in those who do not. - Jeff Borshedding, CEO
Q: How feasible is it for other blood tests to use CA 199 to boost accuracy, given the challenges you faced with the previous test?
A: Other tests in the market, which often look for circulating tumor DNA, face challenges in detecting early-stage pancreatic cancer due to the low shedding of cancer cells into the bloodstream. Some companies incorporate CA 199 to improve accuracy, but our test's focus on proteins allows us to detect cancer earlier, even without CA 199. - Jeff Borshedding, CEO
Q: Can you explain why Immunovia was profitable in the fourth quarter?
A: The profitability relates to accounting practices involving an inter-company transaction between our Swedish parent company and our US subsidiary. Due to currency fluctuations between the US dollar and Swedish kroner, we recognized an unrealized exchange effect in the income statement. This is not a real profit but an accounting requirement. - Karn Alquist, CFO
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
