End of the Year 2024 Letter from Immunovia CEO Jeff Borcherding

Rhea-AI Summary

Immunovia reported significant achievements in 2024 and outlined plans for 2025. The company successfully developed and validated its next-generation pancreatic cancer detection test, achieving 94% specificity and 78% sensitivity in a large clinical validation study of 1,066 blood samples. The test outperformed CA19-9 biomarker by 14 percentage points and showed even better results (83% sensitivity, 96% specificity) in more recent samples.

For 2025, Immunovia plans to launch the test in the US during the second half of the year, targeting medical centers with high-risk pancreatic cancer surveillance programs. The company is seeking strategic partnerships with large diagnostics companies to accelerate commercialization and will conduct additional clinical studies to secure reimbursement.

Positive

• Successful development of next-generation test with 94% specificity and 78% sensitivity
• Test outperformed CA19-9 biomarker by 14 percentage points
• Higher accuracy in recent samples (83% sensitivity, 96% specificity)
• Raised 52.4 MSEK through rights issue with 91% subscription rate
• More cost-effective and convenient than current imaging approaches

Negative

• Additional clinical studies needed for reimbursement approval
• Strategic partnership still pending
• Commercial launch not planned until H2 2025

Insights

Medical Research Analyst

The clinical validation results for Immunovia's next-generation pancreatic cancer test are genuinely groundbreaking. The 94% specificity and 78% sensitivity in detecting Stage I and II pancreatic cancer represent a significant advancement over current diagnostic methods. Most notably, the test outperforms CA19-9 by 14 percentage points in sensitivity, identifying 28 additional cancer cases that would have been missed.

The performance metrics are even more impressive in recent samples, showing 83% sensitivity and 96% specificity within the last 2.5 years. This blood-based test offers substantial advantages over current imaging-based surveillance methods like endoscopic ultrasound, MRI and CT, while being less invasive and more cost-effective. For early-stage pancreatic cancer detection, these results could revolutionize screening protocols for high-risk populations.

Financial Analyst

The successful rights issue raising 52.4 MSEK strengthens Immunovia's financial position as they transition from R&D to commercialization. The company's strategic focus on securing a diagnostic company partnership is particularly shrewd - it would significantly reduce commercialization costs and capital requirements while leveraging established sales networks.

The planned U.S. market entry in H2 2025 targets an addressable market of 1.8 million high-risk individuals. The company's approach to additional clinical studies is financially prudent, utilizing existing biobank samples and seeking external funding through grants and institutions rather than self-funding large prospective studies. This capital-efficient strategy, combined with the test's superior performance metrics, positions Immunovia favorably for potential strategic partnerships and market penetration.

Market Research Analyst

The market opportunity for Immunovia's test is compelling given the critical unmet need in pancreatic cancer early detection. The focused commercialization strategy targeting major medical centers with established high-risk surveillance programs demonstrates smart market entry planning. The test's superior accuracy combined with its convenience and cost advantages over imaging methods creates a strong value proposition for both healthcare providers and payers.

The active pursuit of partnerships with major diagnostic companies is well-timed following the strong CLARITI study results. Initial positive responses from potential partners suggest strong commercial interest. The planned additional clinical studies focusing on expanded use cases and clinical utility will be important for securing reimbursement coverage, which will be essential for widespread adoption and market penetration.

LUND, Sweden, Dec. 19, 2024 /PRNewswire/ -- As we near the holidays and year end, I am energized by what Immunovia has accomplished in 2024 and the opportunities that lie ahead in 2025.

In 2024 we rapidly delivered multiple key milestones to put Immunovia on a path to success

As 2024 began, we had recently completed a significant transformation of the company. We were a much smaller, more agile team focused on the development of our next-generation test. This focus—and the talents of the Immunovia team—drove excellent progress in 2024. Key highlights:

• We developed accurate and reliable lab tests to measure the most promising protein biomarkers identified in the discovery study.
• We selected the final biomarkers and defined the algorithm for our next-generation test, creating a high-accuracy test to detect pancreatic cancer at Stage I and II.
•  We demonstrated high sensitivity and specificity in detecting early-stage pancreatic cancers in the model-development study.
• We opened and staffed a smaller and more efficient lab in North Carolina under the direction of our new Clinical Lab Director, Lisa Ford.
• We conducted a rights issue that was subscribed at 91% to raise 52.4 MSEK net of issuance costs.
• We validated the analytical precision of the next generation test, showing precision, stability and reliability.
• We completed the largest clinical validation of a pancreatic cancer test in a high-risk population, achieving 94% specificity and 78% sensitivity in a study of 1,066 blood samples from Stage I and II pancreatic cancer patients and high-risk individuals.

Strong results in the CLARITI study validated the excellent accuracy of the next generation test

The clinical validation study proved our next-generation test has the sensitivity and specificity to meet the market's demand for a convenient, accurate blood test to detect Stage I and II pancreatic cancer. The test exceeded the performance targets for the study, reaching sensitivity of 78% and specificity of 94%. The Immunovia test was 14 percentage points more sensitive than CA19-9, a biomarker commonly used to monitor for pancreatic cancer. This increased sensitivity enabled us to correctly identify 28 cases of pancreatic cancer that were missed by CA19-9 in the study.

The following chart shows that the accuracy of the Immunovia test compares very favorably to the current standard-of-care for pancreatic cancer surveillance. Currently, surveillance is based on imaging, including endoscopic ultrasound, MRI, and CT. The specificity of our next-generation test—94%—is superior to all these imaging approaches, which means fewer false positives (i.e., a positive result when no cancer is present). Our 78% sensitivity exceeds both MRI and CT imaging, which would enable us to detect more Stage I and II pancreatic cancer cases:

The Immunovia next-generation blood test is also much more convenient and less costly than the imaging approaches.

The accuracy of the Immunovia test in the CLARITI study was even more impressive in blood samples collected more recently. Among samples collected with the last 2.5 years, sensitivity of the test was 83% and specificity was 96%, as shown in the chart below:

Experts in pancreatic cancer early detection have been very enthusiastic about the clinical validation results and we are actively discussing next steps with many key opinion leaders.

In 2025 we will transition from product development to commercialization and market introduction

Looking forward to 2025, our plan is clear and focused. We have the following goals:

1. Execute on a targeted launch of the next-generation test in the US during the second half of the year.
2. Secure a strategic partner at the appropriate time to expand commercial reach and accelerate market penetration.
3. Complete additional clinical studies to secure reimbursement for the test.

We expect to launch the next-generation test in the USA in the second half of 2025. Our objective will be to demonstrate the strong physician and consumer demand for an early-detection pancreatic cancer test. The initial launch will be highly targeted, focusing on large medical centers with high-risk pancreatic cancer surveillance programs. We will leverage our strong relationships with top pancreatic cancer specialists to drive trial and adoption of the new test.

We are actively pursuing a strategic collaboration with a large diagnostics company to accelerate commercialization of our test. A partner with a large, established sales team will allow us to drive more volume, faster. Partnering will also allow us to lower our commercialization costs, reducing our need for capital. Finally, a partner will augment our in-house expertise in several areas, most importantly regulatory affairs and reimbursement.

We have active business development conversations underway with several potential strategic partners. Following the completion of the CLARITI study, we have begun sharing the clinical validation data results with these prospective partners. Initial response has been very positive, and we will have many more business development conversations in the first quarter of 2025.

Next year, our R&D spending will shift from developing the next-generation test to conducting clinical studies to further prove the accuracy and value of our test. We will complete clinical validity studies in additional groups of high-risk individuals, expanding the potential uses of our test. We will also initiate clinical utility studies to demonstrate that our test will impact physician decisions and improve patient outcomes. These study results will be crucial for securing reimbursement for our test. They will also increase physician confidence in the test. Finally, the additional studies will support efforts to secure regulatory approval in the USA and in other countries.

Fortunately, we will be able to conduct most of these studies quickly and at a reasonable cost. For some studies, our biobank includes most or all of the blood samples we need. For the prospective studies, our strong relationships with pancreatic cancer researchers, together with our strong clinical validation results, will provide opportunities to include our test in large studies funded primarily by government grants or the institutions themselves. We are not planning any large or prospective studies that Immunovia would need to fund fully.

The future is bright in 2025 and beyond

We accomplished a lot in 2024 and will achieve even more in 2025. We now have a proven test for early detection of pancreatic cancer. In the year ahead we will launch the test to meet the market demand for an accurate, convenient, and affordable blood test. We will drive commercial success with a targeted launch and additional clinical studies. Assuming we can secure favorable terms, we will partner with a large diagnostics company to accelerate adoption of our next-generation test.

As we close out 2024, I want to express my sincere thanks for your support of Immunovia. Best wishes to you and your family for a healthy and prosperous new year!

All the best,

Jeff Borcherding
Chief Executive Officer, Immunovia

For more information, please contact:
Jeff Borcherding
CEO and President
jeff.borcherding@immunovia.com  

Immunovia in brief 

Immunovia AB (IMMNOV: Nasdaq Stockholm), is a diagnostic company whose mission is to increase survival rates for patients with pancreatic cancer through early detection. Immunovia is focused on the development and commercialization of simple blood-based testing to detect proteins and antibodies that indicate a high-risk individual has developed pancreatic cancer. 

Immunovia collaborates and engages with healthcare providers, leading experts and patient advocacy groups to make its test available to individuals at increased risk for pancreatic cancer. 

USA is the world's largest market for detection of pancreatic cancer. The company estimates that in the USA, 1.8 million individuals are at high-risk for pancreatic cancer and could benefit from annual surveillance testing. 

Immunovia's shares (IMMNOV) are listed on Nasdaq Stockholm. For more information, please visit www.immunovia.com 

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SOURCE Immunovia AB

FAQ

What are the accuracy rates of Immunovia's (IMMVF) new pancreatic cancer test?

The test achieved 94% specificity and 78% sensitivity in a clinical validation study of 1,066 blood samples, with even better results in recent samples showing 83% sensitivity and 96% specificity.

When will Immunovia (IMMVF) launch its next-generation pancreatic cancer test?

Immunovia plans to launch its next-generation pancreatic cancer test in the United States during the second half of 2025.

How much funding did Immunovia (IMMVF) raise in its 2024 rights issue?

Immunovia raised 52.4 MSEK net of issuance costs through a rights issue that was subscribed at 91%.

How does Immunovia's (IMMVF) test compare to CA19-9 biomarker?

Immunovia's test demonstrated 14 percentage points higher sensitivity than CA19-9, identifying 28 pancreatic cancer cases that CA19-9 missed in the study.

What is Immunovia's (IMMVF) commercialization strategy for 2025?

The company plans a targeted launch in US medical centers with high-risk pancreatic cancer surveillance programs and seeks strategic partnerships with large diagnostics companies to accelerate market penetration.