Immunovia's Promising Developments in Pancreatic Cancer Detection

Celebrating Progress at Immunovia in 2024

As we approach the end of another year, I reflect on the remarkable strides Immunovia has made this year. Our achievements in 2024 not only exemplify the hard work of our dedicated team but also set a solid foundation for the exciting prospects that lay ahead in 2025.

An Agile Workforce Driving Innovation

This year, Immunovia has undergone a significant transformation, becoming a nimble and focused organization. With a streamlined team, we've emphasized our commitment to enhancing pancreatic cancer diagnostics. Our efforts have borne fruit, and I am thrilled to highlight some standout accomplishments:

• We developed precise lab tests that focus on the most promising protein biomarkers identified in our in-depth studies.
• Our team selected the final biomarkers and established an algorithm for a groundbreaking next-generation test capable of detecting pancreatic cancer at Stage I and II with high accuracy.
• In our model-development study, the sensitivity and specificity of our tests in early-stage pancreatic cancer detection were proven to be exceptional.
• A new, efficient lab has been established under the leadership of Clinical Lab Director, Lisa Ford, allowing us to enhance our operational capabilities.
• Our successful rights issue, with a 91% subscription rate, raised 52.4 MSEK, providing essential funding for our initiatives.
• The next-generation test demonstrated outstanding analytical precision, establishing its reliability and stability.
• Furthermore, we completed the largest clinical validation study of its kind, achieving an impressive 94% specificity and 78% sensitivity among 1,066 blood samples.

Validation from the CLARITI Study

The results of our clinical validation study were a testament to the accuracy of our next-generation test. It clearly met market demands for a convenient and precise method to detect pancreatic cancer in its earlier stages. Impressively, our test outperformed the commonly used CA19-9 biomarker by identifying 28 cases of pancreatic cancer that had been previously missed. This victory illustrates the potential of our technology to make a real difference in early detection.

The Immunovia test's accuracy in detecting pancreatic cancer is compelling when compared to standard care measures, which heavily rely on imaging technologies like MRI and CT scans. Our test's superior specificity means there will be fewer false positives, a crucial factor for patient peace of mind.

Recent samples have also shown substantial improvements, with sensitivity reaching 83% and specificity an astounding 96% among the last 2.5 years of collected data. Enthusiastic feedback from industry experts reinforces our confidence in our clinical validation results.

A Clear Roadmap for 2025

Looking ahead, my vision for 2025 centers around transitioning from product development to the commercial launch of our groundbreaking test. Our clear objectives include:

1. Initiating a targeted launch of our next-generation test in the US during the latter part of the year.
2. Identifying a strategic partner who can enhance our commercial reach and boost market penetration.
3. Conducting additional clinical studies to ensure reimbursement can be secured for our test.

The anticipated launch in the US is set to meet the strong demand for early pancreatic cancer detection. We plan to target medical centers that focus on high-risk patient surveillance. Tapping into our existing relationships with leading specialists in pancreatic cancer will be instrumental in fostering the adoption of our innovative test.

In this process, we are actively seeking collaboration with a major diagnostics player to expedite our commercialization strategy. Partnering with a well-respected entity in the field will not only increase our sales potential but also optimize our operational costs.

Engaging in dialogue with several potential partners has already yielded positive feedback, and we will continue exploring these opportunities into the new year.

Our R&D direction will pivot from solely developing the test to conducting comprehensive clinical studies. We’ll validate our test’s efficacy in various high-risk populations while ensuring it becomes a key decision-making tool for physicians aiming to improve patient outcomes.

Most importantly, many of these necessary studies will be feasible at a lower cost, as we can leverage our existing biobank for blood samples and utilize our connections within the cancer research community for support in larger studies.

A Bright Future Ahead

In 2024, we have laid a powerful groundwork, and I foresee even greater accomplishments in 2025. Now that we have validated our pancreatic cancer detection test, the coming year presents ample opportunities to introduce our solution to professionals and patients who need it most. Our commercial strategy will be reinforced by additional clinical studies to ensure we meet demand while advocating for the adoption of our invaluable test.

As we conclude this year, I extend my heartfelt gratitude to you—our supporters—who have been fundamental in our journey. I wish you and your loved ones a happy and prosperous new year!

Best regards,

Jeff Borcherding
Chief Executive Officer, Immunovia

Contact Information

For inquiries, please reach out to:

Jeff Borcherding
CEO and President
jeff.borcherding@immunovia.com

About Immunovia

Immunovia AB (IMMVF) is dedicated to boosting survival rates for pancreatic cancer through early detection. The company is focused on developing and commercializing innovative blood-based tests that detect markers signaling high-risk conditions for pancreatic cancer.

Collaborating with healthcare professionals and patient advocacy groups, Immunovia aims to make its tests accessible to those at higher risk. The US market presents vast potential—approximately 1.8 million individuals are estimated to be at high risk of pancreatic cancer, highlighting the need for routine surveillance.

Our shares (IMMVF) are traded on Nasdaq Stockholm, marking our commitment to transparency and performance in the biotech sector.

Frequently Asked Questions

What are the key achievements of Immunovia in 2024?

Immunovia developed precise lab tests for pancreatic cancer detection, validated their next-generation test, and conducted a successful rights issue.

What are the objectives for Immunovia in 2025?

The objectives include launching the next-generation test in the US, securing strategic partnerships, and completing clinical studies for reimbursement.

How does the Immunovia test compare to standard imaging methods?

The Immunovia test offers superior specificity and sensitivity, reducing false positives compared to current imaging technologies.

Who leads the clinical lab at Immunovia?

Lisa Ford is the Clinical Lab Director, overseeing the operations of their newly established lab in the US.

What is Immunovia's mission?

Immunovia aims to increase survival rates for pancreatic cancer patients through early detection using innovative blood tests.

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