Company Announcements

LUND, Sweden , Feb. 25, 2025 /PRNewswire/ -- 

October-December 2024

• Net sales, which for the quarter only included royalties, amounted to 455 KSEK (155).
• Net earnings were 3,1 MSEK (-49,0) as a result of unrealized exchange rate effects due to a higher dollar rate on the transactions to finance operations in Immunovia Inc.
• Operating losses were -30,1 MSEK (-23,4).
• Earnings per share before and after dilution were 0.02 SEK (-1,08).
• Cash flow from operating activities amounted to -28,3 MSEK (-28,5).
• Cash and cash equivalents at end of period equaled 25,3 MSEK (76,8).
• On October 2, the company announced successful completion of the analytical validation for its next-generation test for early-stage pancreatic cancer, demonstrating excellent reliability and robustness.
• The successful acquisition of all blood samples required to clinically validate the next-generation test for pancreatic cancer was announced on October 6.
• In November, Immunovia presented updates on the model development study for its next-generation test at two major conferences: on November 7 at the annual meeting of the PRECEDE Consortium, a global collaboration of over 50 pancreatic centers, and on November 15 at a meeting of the Collaborative Group of the Americas—Inherited Gastrointestinal Cancers.
• On December 9, Immunovia announced the positive outcome and strong accuracy in the first clinical validation study of its next-generation test for pancreatic cancer.
• In December, Immunovia announced key developments regarding the TO2 warrants. On December 18, the company reported the CEO and board members' intention to exercise all TO2 warrants received in the rights issue. On December 27, Immunovia confirmed the exercise price of SEK 0.46 per TO2 warrant and announced subscription and guarantee commitments totaling SEK 36.3 million, securing 65% of the program.
• On December 20, Immunovia announced that the discovery study to identify protein biomarkers for its next-generation pancreatic cancer test had been published in the Journal of Proteome Research.

Significant events after the period 

• On January 2, the company gave notice of the start of the exercise period for warrants of series TO 2 and on January 20, the exercise rate of approximately 74.1 percent was announced. Further, on January 31, the company disclosed on the registered number of shares and votes in Immunovia after exercise of TO2, which amounted to 261,908,863.
• On January 8, the company announced that a Nomination Committee had been appointed to consist of the following persons who together represent 5,65 percent of the number of shares and votes in the company; Christer Køhler, Mats Leifland, Sara Ek and Peter Høngaard Andersen in his capacity as Chair of the Board of Directors.
• On February 21, the Company informed that they would initiate a search for a new CFO to support commercialization in the USA.

CEO's comments:

"As we closed Q4, we reached a major milestone—completing development and validating the exceptional accuracy of our next-generation pancreatic cancer test. This breakthrough surpasses current imaging methods in early detection while being more convenient and more cost-effective than what is commercially available.

In 2025, we will launch the test in the USA, and conduct clinical studies to drive reimbursement and regulatory approvals. Our CLARITI study confirmed our test's superior sensitivity and specificity, and we are actively engaging with potential commercialization partners. We are confident our next-generation test will transform early pancreatic cancer detection and improve patient outcomes worldwide.

Immunovia's next-generation test represents a significant leap forward in pancreatic cancer testing

The addition of new, high-performing protein biomarkers, smart design choices, and the transition to the ELISA testing platform has produced a highly accurate next-generation test that can be used in all patients, costs less, and is more precise than our prior IMMray PanCan-d test. Here's a summary of the substantial advantages of the new test:

Strong results in the analytical validation proving precision, stability, and robustness of our biomarker assays

In October we announced excellent results from the analytical validation of the biomarkers in our next generation test. The analytical validation experiments evaluated the performance of the lab tests used to measure the biomarkers in our test. The analytical performance of the biomarkers tests was excellent, exceeding our expectations and demonstrating the rigor of our ELISA testing platform.

Strong results in the CLARITI study validate the excellent clinical performance of the next-generation test

Results of the first clinical validation study, announced in December, 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.

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 is far superior to both MRI and CT imaging in detecting Stage I and II pancreatic cancer:

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

Even better test performance in newer samples

The accuracy of the Immunovia test in the CLARITI study was even more impressive in blood samples collected more recently. Due to the rarity of early-stage pancreatic cancer samples, some blood samples in the CLARITI study were collected many years ago. Among samples collected within the last 2.5 years, sensitivity of the test was 83% and specificity was 96%. Since real-world samples will be tested within days of collection, we expect in-market performance to be even better than the accuracy demonstrated in the CLARITI study.

Experts in pancreatic cancer detection have been very enthusiastic about these results and we are in active discussions about the use of our test in upcoming clinical studies these experts want to conduct.

Our focus in 2025 will be commercialization, market impact and setting the stage for reimbursement

Our plan for 2025 is clear and focused, with three key priorities:

1. Execute on a targeted launch of the next-generation test in the US during the second half of 2025.
2. Secure a strategic partner to expand commercial reach and accelerate market penetration.
3. Complete additional clinical studies to secure reimbursement for the test.

We plan to launch the next-generation test in the third quarter

When we start selling the next-generation test commercially in Q3 2025, our objective will be to demonstrate 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 existing relationships with dozens of top pancreatic cancer specialists to drive use of the new test. Some of these physicians used the IMMray PanCan-d test and are eager to resume testing. Others are relationships we nurtured through the development of our new test. Our targeted approach will allow us to drive trial and adoption while minimizing operating expenses and cash burn.

We continue to pursue a strategic commercialization partner

Through 2024 we engaged dozens of diagnostics companies to explore a commercial collaboration. As we begin 2025, we are narrowing our focus to the most promising prospective strategic partners. Our primary target is large US specialty diagnostics companies. A large specialty diagnostic partner should allow us to drive more volume faster, while lowering our commercialization costs and preserving capital. We are also speaking with diagnostics companies outside the US who could provide resources in the near-term and global distribution of our test in the future.

We can conduct valuable additional clinical studies at a reasonable level of investment

We are well-positioned to conduct clinical studies to further prove the accuracy and clinical value of our test. We plan to complete clinical validity studies in additional groups of high-risk individuals, expanding the potential uses of our test. We also plan to initiate clinical utility studies to show that our test can positively impact physician decisions and patient outcomes. These study results should support submissions seeking reimbursement and regulatory approval.

We can conduct studies efficiently since most of the required blood samples are already available in our biobank. Also, our strong clinical validation results, along with established relationships with pancreatic cancer researchers, will enable us to participate in large studies funded primarily by government grants or partner institutions.

Key milestones for Immunovia in 2025

With technical and clinical risks significantly reduced, we anticipate multiple major milestones in 2025, including:

• Announcement of results from our second clinical validation study in high-risk individuals in Q1, with additional studies planned throughout the year.
• Initiation of commercial testing with multiple pancreatic cancer surveillance centers in Q3 and Q4.
• Significant progress this year toward reimbursement for our next-generation test in 2026.

These milestones position Immunovia for strong momentum and value creation."

February 25, 2025
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 February 25, 2025. 

Conference call

Immunovia will hold a webcast tele conference at 15:00 pm CET on February 25 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/1ddbf2a8-43ad-4411-9608-9eaf9c0559f1?ref=https%3A%2F%2Fcreo

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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SOURCE Immunovia AB