Immunovia Publishes Interim Report for January-June 2024

USA - English

• USA - English

LUND, Sweden, Aug. 5, 2024 /PRNewswire/ --

April-June 2024

• 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 on April 29.
• Appointment of Dr. Lisa Ford as Clinical Laboratory Director was announced on April 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 approximately SEK 70 million and to raise bridge loans.
• On May 20, the Company gave notice to the AGM to be held June 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 the US National Institutes of Health, was announced August 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 Immunovia and increase shareholder value by bringing our next-generation test to market.

We have finalized development of our test for early detection of pancreatic cancer, substantially increasing accuracy

During the second quarter, Immunovia announced positive results from the Model Development Study of our next-generation text. The initial next-generation test showed sensitivity of 75% and specificity of 98%. The next-generation test also significantly outperformed CA19-9, a biomarker commonly used to detect pancreatic cancer. After the close of the quarter, we announced on August 1, 2024, even better test performance. By leveraging additional patient samples with more detailed clinical information and through more sophisticated statistical modeling, we increased test performance to 85% sensitivity and 98% specificity in detecting stage 1 and 2 pancreatic ductal adenocarcinoma (PDAC), the most common form of pancreatic cancer.

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 Immunovia test as compared to the conventional CA19-9 test will support future efforts to secure reimbursement for the test.

We rapidly established a lean, efficient new lab in Research Triangle Park, North Carolina

We hired a talented, experienced lab director, Dr. Lisa Ford, in April. On May 21 we moved into the new lab space and within six weeks the lab was fully operational. Lisa hired and trained new employees. She and her team implemented and documented processes and standard operating procedures. All equipment is now operational and has been qualified for accuracy and reproducibility. After conducting much of the research and development lab work at the Proteomedix lab in Switzerland, we successfully transferred all assays to our new lab.

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 May 20, 2024, will provide funding as we continue to constrain spending and limit cash burn

The annual general meeting on June 19, 2024, resolved on a rights issue of units – shares and two series of warrants. The share issue, to be executed in the third quarter 2024, is secured to approximately 50%. The secured proceeds of approximately 35 MSEK before issue cost, together with the cash balance of 37 MSEK at the end of the second quarter, should fund the company through 2024. The exercise of the two series of warrants in January and April is expected to provide funding into 2025.

Immunovia continues to aggressively manage costs to limit cash burn. We currently have only 10 employees (versus 45 a year ago) and cut personnel expenses in Q2 2024 to SEK 7.6 million, down 74 percent compared to Q2 2023. We utilize contractors and consultants when needed to provide capabilities or additional capacity. We continue to limit overall operating expenses to preserve cash. Cash flow from operating activities was SEK -26.7 million, down 38% compared to Q2 2023.

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

Immunovia has been transformed into a lean, agile company with a significantly lower cost base and we are aggressively managing costs to extend our runway. We have developed a high-performance next-generation test with excellent accuracy. Our high-performance next-generation test, developed with excellent accuracy, is in the final stages of performance confirmation as we prepare for its commercial launch in the US in 2025.

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.

August 5, 2024
Jeff Borcherding, CEO and President
Immunovia AB

For more information, please contact:

Jeff Borcherding
CEO and President
[email protected] 

Karin Almqvist Liwendahl
Chief Financial Officer
[email protected]
+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 August 5, 2024.

Conference call

Immunovia will hold a webcast tele conference at 15:00 CET on August 5 with CEO and President 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/9b8512c0-acbd-4f80-bb26-08165af4fa28?ref=https%3A%2F%2Fcreo-live.creomediamanager.com%2F9b8512c0-acbd-4f80-bb26-08165af4fa28

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