Release Date: August 05, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Immunovia AB (OSTO:IMMNOV, Financial) has developed a next-generation test for pancreatic cancer with 98% specificity and 85% sensitivity, significantly improving early-stage detection.
- The company successfully transitioned to a new lab in North Carolina, which is fully operational and uses the ELISA platform, allowing for faster and more cost-effective testing.
- The next-generation test is 20 percentage points more sensitive than the commonly used CA19-9 biomarker, enhancing its potential for clinical adoption and reimbursement.
- Immunovia AB (OSTO:IMMNOV) has secured a USD4.5 million NIH-funded study, which will provide robust research opportunities at a low cost, validating the test's effectiveness in detecting pancreatic cancer.
- The company has reduced operational expenses significantly, with a 74% decrease in headcount-related costs, aligning with its leaner, more agile business model.
Negative Points
- Immunovia AB (OSTO:IMMNOV) is dependent on a rights issue to secure funding for critical validation studies, with only 50% of the issue currently secured.
- The company's cash runway is limited, with a monthly cash burn of SEK8-9 million, necessitating successful fundraising to continue operations into 2025.
- There is uncertainty regarding the timing of securing a commercial partner, which is crucial for the test's market launch and revenue generation.
- The company faces risks in the analytical and clinical validation stages, which could impact the test's commercialization timeline if results are not favorable.
- Regulatory approval processes have not yet begun, and the company will initially launch the test as a lab-developed test without FDA approval, which may limit market penetration.
Q & A Highlights
Q: What feedback have you received from physicians on the test performance numbers you announced?
A: The feedback has been very positive. We've received feedback from our scientific advisory board and informally from clinicians who reached out to congratulate us on the test results and express excitement about the outcomes.
Q: What is the definition of a high-risk person for pancreatic cancer?
A: High-risk individuals include those with a family history of pancreatic cancer, genetic mutations increasing risk, pancreatic cysts, and new-onset diabetes after age 50.
Q: When do you expect to sign up with a partner for commercialization?
A: The timing is driven by the partner's interest, which increases as we approach revenue and commercialization. We need to complete clinical validation in Q4 2024 before securing a partner, though exact timing is uncertain.
Q: Have you begun pursuing regulatory approval for the test?
A: Regulatory approval efforts will start after completing clinical validation in Q4 2024.
Q: What is the risk that the analytical or clinical validation studies will fail or return poor results?
A: While there's always some risk in science, we are confident due to robust work and steps taken to ensure replicable results. Analytical validation is low-risk, and we feel good about replicating results in clinical validation.
Q: How will you use the proceeds from the rights issue?
A: The proceeds will primarily fund analytical and clinical validation. Depending on the amount raised, they may also support additional clinical studies for regulatory approval and reimbursement.
Q: Who do you want to partner with to commercialize the test?
A: We are looking for a large diagnostics company with commercial capabilities to reduce our investment in sales and leverage existing market relationships.
Q: Are you confident in your ability to complete the clinical validation study this year?
A: Yes, we are confident, provided we secure the necessary samples from identified pancreatic cancer centers in the US and Europe. We aim to complete the study in Q4 2024.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
