Immunovia AB: Immunovia Publishes Interim Report for January-September 2024

July-September 2024

• Net sales, which for the quarter only included royalties, amounted to 235 KSEK (488).
• Net earnings amounted to -51.1 MSEK (-38.6).
• Earnings per share before and after dilution were -0.73 SEK (-0.91).
• Cash flow from operating activities amounted to -21.2 MSEK (-35.6).
• Cash and cash equivalents at end of period amounted to 54.2 MSEK (106.7)
• New lab staffed and fully operational after rapid implementation and validation was announced on July 2.
• Detailed discovery study results for the company's next-generation early detection test for pancreatic cancer were presented at the PancreasFest 2024 Annual Meeting on July 25.
• Completion of the development of the pancreatic cancer detection test after substantially increasing test accuracy was announced on August 1.
• Filing of a US provisional patent application to protect its next-generation test was announced on August 2.
• Immunovia's next generation test to be included in a large study of pancreatic cysts funded by the US National Institutes of Health, was announced August 5.
• On August 6 Immunovia announced final terms of rights issue and on August 12 the prospectus in connection with forthcoming rights issue was published.
• On September 2 the preliminary outcome off the rights issue was published and on September 3 the final outcome in rights issue was announced.
• On September 12 Immunovia carried out a directed issue of units to guarantors in connection with the completed rights issue.
• Data from the model development study was presented at the 2024 AACR Advances in Pancreatic Cancer medical conference, which was announced on September 16.
• On September 30 the company informed on the change in number of shares and votes in Immunovia AB.

Significant events after the period

• October 2 the company informed that the company has completed the analytical validation of its next-generation test designed to detect early-stage pancreatic cancer, which demonstrated excellent results, reinforcing the reliability and robustness of the test.
• The successful acquisition of all blood samples required to clinically validate its next-generation test for pancreatic cancer was announced on October 6.
• On the November 7 Immunovia presented an update from the model development study on its next-generation test at the annual meeting of the PRECEDE Consortium, a collaboration of 51 pancreatic centers worldwide.
• On November 15, the Company presented the model-development study results at a meeting of the Collaborative Group of the Americas-Inherited Gastrointestinal Cancers.
   

 
CEO's comments

ON PLAN FOR A US MARKET INTRODUCTION IN 2025

Q3 marked another quarter of strong performance as we continued to achieve our goals and deliver on milestones. As previously reported, the analytical validation proved our next-generation test to be accurate, stable and precise. The test development will culminate with the clinical validation, which will read out in Q4. Looking ahead to 2025, we will transition from focusing on research and development to commercializing the new test and generating further clinical evidence.

WE ACHIEVED OUR Q3 GOALS AND ARE MAKING EXCELLENT PROGRESS IN Q4

We closed a successful rights issue in which Investors subscribed to over 90% of the units offered, significantly exceeding expectations. This high level of participation enhances our chances for a very successful outcome for our TO2 and TO3 warrants in January and April 2025, respectively. Assuming the same level of participation in the warrants offering as in the rights issue in total would give us more than 12 months of runway and enable us to pursue our 2025 goals, outlined below.

We took important steps to validate the performance of our new test in Q3. Through the analytical validation, we have confirmed the technical performance of our next-generation test in measuring the target proteins. We also obtained blood samples from over 200 pancreatic cancer patients and more than 800 high-risk individuals for the next step: the clinical validation of the test. Securing over a thousand samples on such short timing was possible thanks to our strong relationships with experts at leading pancreatic cancer programs. We were also the first diagnostics company to receive blood samples from the PRECEDE Consortium.

Clinical validation is our key focus in Q4. The study is well underway, with our lab team in Research Triangle Park, North Carolina, analyzing hundreds of samples. We expect to complete the study and announce results in December 2024.

OUR PLAN FOR 2025 IS CLEAR AND FOCUSED

Looking forward to 2025, we will focus on the following goals:

1. Execute on a targeted introduction of the next-generation test in the US.
2. Complete additional clinical studies needed to secure reimbursement.
3. Secure a strategic partner at the appropriate time to expand commercial reach and accelerate market penetration.
4. Ensure sufficient resources for the targeted launch and additional clinical studies.

We will execute a targeted launch of the next-generation test in the second half of 2025. We expect to conduct a targeted launch of the next-generation test in the United States in the second half of 2025. The test will be launched as a lab-developed test (LDT) and all samples will be processed at our lab in Research Triangle Park, USA.

Our objective for the initial launch phase is to demonstrate physician and patient demand. The key measure of success will be test adoption and volume at targeted pancreatic centers. This will support our efforts to secure a strategic partner. It will also bolster our reimbursement efforts as payers want to see evidence that clinicians are using the test.

We expect reimbursement of the test to come in 2026 after payer review of published clinical study results. At launch, we will likely pursue a patient-pay model in which patients will be asked to pay a portion of the normal cost of the test.

Since revenue per test will be very limited in 2025, we will pursue a targeted, limited scale, cost-effective launch. Immunovia will employ a small sales team focused on the top high-risk surveillance programs for pancreatic cancer. Their goal will be to drive trial and adoption of the test at these expert centers, creating advocacy among the key opinion leaders in pancreatic cancer. We expect the broader selling effort to be executed later by a strategic partner, deploying a much larger sales team to expand reach and drive volume among pancreatologists, interventional endoscopists, gastroenterologists and genetic counselors.

We will conduct additional clinical studies required by US payers. We will conduct two additional clinical validity studies in the high-risk hereditary patient population in the first half of 2025. We will then investigate additional high-risk groups, including individuals with new-onset diabetes, chronic pancreatitis, and pancreatic cysts. Fortunately, we expect to conduct this clinical program quickly and at a reasonable cost by utilizing Immunovia biobank samples, plus samples from pancreatic cancer centers where we have strong relationships. Further, as announced in August 2024, Immunovia's next-generation test will be studied as part of a National Institutes of Health (US) clinical program in pancreatic cyst patients.

We will pursue a strategic partner to drive commercialization of the test. Lessons from the IMMray PanCan-d launch made it clear we need a strategic partner to help commercialize our next-generation test. Partnering with a diagnostics company with a large sales force will enable us to drive more test volume, sooner and at a lower cost. Over the last 18 months, we have established relationships with more than a dozen promising prospective partners, holding regular update meetings. After successful completion of the clinical validation study we will share study results with them.

We will be intentional about the timing of any partnership. We will develop the product and clinical portfolio far enough to secure attractive terms. We will diligently pursue a strategic partner in the coming quarters and strike an agreement when timing is optimal.

We are well positioned to fund activities for the next twelve months and will strategically manage capital needs. In 2025 we will shift spending from research and product development to clinical studies and a targeted introduction of the test in the US. We will strategically evaluate the optimal timing and vehicles to fund these operating expenses beyond the next twelve months.

The Immunovia team is committed to rewarding our shareholders. I want to emphasize how committed we are as a team to seeing Immunovia succeed. This is a passionate, dedicated, resilient group of people and I'm incredibly proud to see their hard work paying off. I believe deeply in what we are doing. As evidence of my belief and engagement, I purchased 1,470,588 units in the rights issue, 140 percent of my pro rata share of the issue.

I welcome your input and feedback on how we achieve our goals and deliver value for shareholders. Contact me at info@immunovia.com with questions or suggestions. Also, please follow and connect with us on LinkedIn https://www.linkedin.com/company/immunovia-ab/ . This platform provides an excellent opportunity for me to share information with you beyond our quarterly reports and press releases.

November 27, 2024
Jeff Borcherding, CEO and President
Immunovia AB

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

Karin Almqvist Liwendahl
Chief Financial Officer
karin.almqvist.liwendahl@immunovia.com
+46 70 911 56 08

The information in this report is information that Immunovia AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08:30 am CET on November 27, 2024.
 

Conference call

Immunovia will hold a webcast tele conference at 15:00 pm CET on November 27 with President and CEO Jeff Borcherding and CFO Karin Almqwist Liwendahl.

To take part of the presentation, please dial one of the numbers or watch via the web link below.

Sweden: +46 8 5051 0031

United Kingdom: +44 207 107 06 13

United States: +1 631 570 56 13

Link to the webcast: https://access.creomediamanager.com/registration/0cb413c2-e586-432a-8ccd-449b18e56ee0?ref=https%3A%2F%2Fcreo-live.creomediamanager.com%2F0cb413c2-e586-432a-8ccd-449b18e56ee0

 
Immunovia in brief

Immunovia AB 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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