Immunovia Publishes Interim Report for January-June 2024
April-
- Net sales, consisting of royalties, amounted to 85 KSEK (412)
- Net earnings amounted to -25.6 MSEK (-185.1), where one-off costs second quarter 2023 of 141 MSEK impact comparability between the years.
- Earnings per share before and after dilution were -
0.57 SEK (-4.00). - Cash Flow from operating activities amounted to -28.2 MSEK (-43.3).
- Cash and equivalents at the end of the period amounted to 36.8 MSEK (143.9).
- The successful development of accurate and precise assays to measure targeted proteins for the next-generation test was announced on
April 9 . - Positive results from the model-development study for the next-generation pancreatic cancer detection test was announced on
April 22 . - The move to
Research Triangle Park, North Carolina to streamline lab operations was published onApril 29 . - Appointment of Dr.
Lisa Ford asClinical Laboratory Director was announced onApril 29 . - On
May 20 , the Company informed on the board resolution, subject to approval by the AGM, to carry out a rights issue of units of approximatelySEK 70 million and to raise bridge loans. - On
May 20 , the Company gave notice to the AGM to be heldJune 19, 2024 .
Significant events after the period
- New lab staffed and fully operational after rapid implementation was announced on
July 2 . - Detailed discovery study results for the company's next-generation early detection test for pancreatic cancer was 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 large study of pancreatic cysts funded by theUS National Institutes of Health , was announcedAugust 5 .
CEO's comments
The second quarter of 2024 was highly productive, as we moved quickly to deliver key results, which include:
1. Finalized development of our high-performance test to detect early-stage pancreatic cancer
2. Established our new lab, which is now fully operational, in record time
3. Secured shareholder approval for a rights issue to fund the company through completion of the upcoming analytical and clinical validation studies in the second half of 2024.
We are diligently executing to finalize the transformation of
We have finalized development of our test for early detection of pancreatic cancer, substantially increasing accuracy
During the second quarter,
With sensitivity of 85% and specificity of 98%, our test performance will drive future physician adoption and support the pursuit of reimbursement
A sensitivity of 85% means the new test is capable of detecting pancreatic cancer in approximately 6 out of every 7 people with early-stage disease. A specificity of 98% means this new test should only return a false positive result once for every 50 people tested who do not have pancreatic cancer. Importantly, this improved test performance was independently confirmed by ACOMED, a statistical analysis firm with deep expertise in diagnostic studies.
These results are critically important in multiple ways. First, completion of the model development study means that the research and product development phases are now complete for the next-generation test. We have selected the final set of biomarkers and defined the algorithm we will use to generate test results. Second, the level of accuracy shown in detecting stage 1 and 2 pancreatic cancers should meet and exceed the expectations of the physicians who will use the test when it's launched in 2025. Third, the significantly better performance of the
We rapidly established a lean, efficient new lab in
We hired a talented, experienced lab director, Dr.
The new lab and transition to the ELISA testing platform dramatically lowers our cost structure
The new lab is lean, cost-effective, and efficient. The lab itself is dramatically smaller than our prior lab in Marlborough, reflecting the need for fewer processing steps and less equipment to run the assays for our next-generation test. The transition to ELISA assays means we can generally process a patient sample the same day we receive it; the IMMray™ PanCan-d test required 2-3 days of processing. This will reduce labor costs. With the ELISA assays, we will purchase all reagents and other supplies from external suppliers, enabling us to avoid the substantial fixed costs we previously incurred to produce supplies ourselves for the proprietary IMMray platform. In summary, the new lab is performing at a high level and at substantially lower cost.
The shareholder rights issue announced on
The annual general meeting on
We have a clear plan to prepare the next-generation test for market and will execute rapidly
In Q3 we will complete the analytical validation of each of the elements of the next-generation test. These experiments will confirm critical aspects of assay performance, including accuracy, stability, and reproducibility.
In Q4 we will conduct a large clinical validation of the next-generation test. This study will compare blood samples from patients with pancreatic cancer to blood samples from high-risk individuals who do not have cancer. This study will be similar to the model development study but will be conducted on a larger set of samples. In addition, the biomarkers and the algorithm driving test results are now locked, so this study is intended to confirm the performance shown in the model-development study.
The analytical and clinical validation studies will enable a US commercial launch in 2025. These studies will also enable us to conduct additional clinical studies in 2025 to build the portfolio of clinical evidence needed to secure payer reimbursement of the test.
We have turned the corner as a company and are driving toward the launch of our high performance next-generation test
I'm optimistic that our product and clinical success will create significant shareholder value. I humbly ask for your support of the rights issue. With your investment, we can complete the validation studies, fund studies to support reimbursement, and prepare for commercial launch.
Thank you for your support.
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
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