Background and rationale for the Rights Issue
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:
- High Accuracy: 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 3
One (1) warrant series TO 3 entitles the holder the right to subscribe for one (1) new share in the company to a subscription price corresponding to seventy (70) percent of the volume-weighted average price of the company's share on Nasdaq Stockholm during the period from and including 14 March 2025 up to and including 27 March 2025, however not less than the share's quota value and not higher than 150 percent of the subscription price per share in the rights issue. Subscription of shares by exercise of warrants series TO 3 shall be made during the period from and including 1 April 2025 up to and including 15 April 2025.
Subscription price: 0.24 SEK
Exercise period: 1 April 2025 - 15 April 2025
Warrant series TO2
One (1) warrant series TO 2 entitles the holder the right to subscribe for one (1) new share in the company at a subscription price corresponding to seventy (70) percent of the volume-weighted average price of the company's share on Nasdaq Stockholm during the period from and including 12 December 2024 up to and including 27 December 2024, however not less than the share's quota value and not higher than 125 percent of the subscription price per share in the rights issue. Subscription of shares by exercise of warrants series TO 2 shall be made during the period from and including 2 January 2025 up to and including 16 January 2025.
Read moreWarrant series TO3
One (1) warrant series TO 3 entitles the holder the right to subscribe for one (1) new share in the company to a subscription price corresponding to seventy (70) percent of the volume-weighted average price of the company's share on Nasdaq Stockholm during the period from and including 14 March 2025 up to and including 27 March 2025, however not less than the share's quota value and not higher than 150 percent of the subscription price per share in the rights issue. Subscription of shares by exercise of warrants series TO 3 shall be made during the period from and including 1 April 2025 up to and including 15 April 2025.
Read moreFDI legislation and registration certificate
FDI legislationRegistration certificate
