On December 9, 2024, Immunovia announced positive results and high accuracy in the clinical validation of its next-generation test for pancreatic cancer through the successful completion of the CLARITI study (Clinical Validation of Next-Generation Test for Early-Stage Pancreatic Cancer) aimed at detecting early-stage pancreatic ductal adenocarcinoma (PDAC). Key findings from the study include:
‍The test demonstrated a sensitivity of 78% and a specificity of 94% in detecting PDAC at stages 1 and 2. Among patients aged 65 and older, the sensitivity was 80% and the specificity was 91%.
- Superior Performance Compared to CA19-9: Immunovia’s next-generation test was 14 percentage points more sensitive (p < 0.001) than CA19-9, an FDA-approved biomarker for diagnosing pancreatic cancer, while maintaining comparable specificity.
- Early Detection: Immunovia’s next-generation test was equally accurate in detecting pancreatic cancer at both stage 1 and 2, further demonstrating its strength as an early detection tool.
- Improved Accuracy with Recently Collected Samples: Test performance was higher in blood samples collected within the past five years, showing a sensitivity of 82% and specificity of 95%. (Due to the lack of samples from stage 1 and 2 pancreatic cancer patients, 56% of the pancreatic cancer samples included in the study were older than five years.) In real clinical use, samples will be tested within days of collection, and the test is expected to show even greater accuracy.These results confirm Immunovia's decision to shift focus from IMMray™ PanCan-d to the new test. Immunovia now offers a test that incorporates more accurate biomarkers and eliminates the borderline category of results that sometimes made the IMMray® PanCan-d test difficult for physicians to act upon. The next-generation test is less dependent on CA19-9 (a biomarker frequently used to detect pancreatic cancer), allowing the test to be used on a broader group of patients, including those who do not produce CA19-9. Since the inability to produce CA19-9 is more common among individuals with darker skin and Latin Americans, the next-generation test is expected to be a more inclusive option.According to the company, these features of the next-generation test should expand the market compared to the IMMray PanCan-d test and provide better opportunities to secure reimbursement and drive commercial success. To ensure that the new test is accurate and effective, Immunovia has collaborated with leading researchers and experts in the field. For example, the company relies on advice from its scientific advisory committee in the USA, which includes Professor Randall Brand (University of Pittsburgh Medical Center), Professor Diane Simeone (University of California at San Diego), Professor Aimee Lucas (Mount Sinai), and Professor Bryson Katona (University of Pennsylvania). These and other collaborations have enabled Immunovia to acquire the samples needed to develop and study the next-generation tests. These relationships are also crucial for the cost-effective and rapid study of the next-generation test, as these key opinion leaders can incorporate Immunovia's test into larger clinical trials they are conducting.

During 2024, Immunovia's top priorities were to complete the development of the new test, demonstrate its value in clinical trials, and secure the resources required to bring the test to market in 2025. Based on the test results from the CLARITI study, the company remains on track to introduce its next-generation test to the American market in the second half of 2025.

Immunovia is optimistic and looks forward to facing the challenges ahead with the support of its assets, partnerships, and expertise in the field.

Summary of terms and conditions for warrants series TO 4
Structure: One (1) warrant series TO 4 entitles the holder to subscribe for one (1) new share in the Company
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Exercise period: 18 March 2025 - 1 April 2025
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Subscription price: Seventy (70) percent of the volume-weighted average price of the Company’s share on Nasdaq Stockholm during the period from and including 28 February 2025 up to and including 13 March 2025, however not less than the share’s quota value

Issue volume: 23,555,637 warrants of series TO 4. Upon full exercise, 23,555,637 shares will be issued, and the Company will receive approximately SEK 117.8-188.4 million, based on a subscription price between SEK 5.0 – 8.0 SEK

Share capital and dilution: Upon full exercise of all 23,555,637 warrants series TO 4, the share capital will increase by a maximum of SEK 1,177,781.85 to SEK 6,804,419.35 through the issuance of a maximum of 23,555,637 new shares, resulting in that the total number of outstanding shares in the Company will increase from 112,532,750 to 136,088,387. Upon full exercise of all warrants series TO 4, the dilution amounts to approximately 17.3 percent

Outcome and delivery of new ordinary shares: The outcome of the exercise of warrants will be published via a press release on or around 3 April 2025. Shares that have been subscribed and paid for may be registered on the subscriber's securities depository as interim shares (IA) until registration of the issue has been completed with the Swedish Companies Registration Office, whereupon the interim shares automatically will be converted into shares in Saniona.

Subscription price: Seventy (70) percent of the volume-weighted average price of the Company’s share on Nasdaq Stockholm during the period from and including 28 February 2025 up to and including 13 March 2025, however not less than the share’s quota value

Exercise period: 18 March 2025 - 1 April 2025

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