Pancreatic Carcinoma, Familial

LUND, Sweden, Aug. 1, 2024 /PRNewswire/ -- Immunovia (Nasdaq Stockholm: IMMNOV), the pancreatic cancer diagnostics company, today announces enhanced performance for its next-generation test for detecting stage 1 and 2 pancreatic ductal adenocarcinomas (PDAC) in high-risk individuals, which are potentially curable with surgery and modern treatments. On 22 April 2024, Immunovia announced positive results from the initial model-development study for its next-generation pancreatic cancer detection test. Subsequent efforts to increase test performance have now enhanced test accuracy, substantially improving the sensitivity of the next-generation test to 85% with a specificity of 98% in detecting stage 1 and 2 PDAC. 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. Specificity of 98% means this new test should return a false positive result just once for every 50 people tested who do not have pancreatic cancer. Test performance was refined by leveraging additional samples with more complete and detailed clinical information and through more sophisticated statistical modeling. Test performance was independently confirmed by ACOMED, a statistical analysis firm with deep expertise in diagnostic studies. In this study, Immunovia's next-generation test outperformed the sensitivity of CA19-9, a commonly used pancreatic cancer biomarker, by 20 percentage points (85% vs 65%, respectively, p<0.001). In 294 patients aged 65 years and older, the next-generation test achieved 91% sensitivity and 98% specificity. Results in this group are particularly important since the average age of PDAC diagnosis is near 70 years. "Results from this study serve as a promising step that a simple blood test may detect pancreatic cancer early in at-risk patients who have limited early detection options," said Randall Brand, MD, gastroenterologist, professor of medicine at the University of Pittsburgh School of Medicine, and director of the UPMC GI Malignancy Early Detection, Diagnosis and Prevention Program. Dr. Brand was an advisor on the study. "We have now completed research and development efforts for our next-generation test and are thrilled with the accuracy of the test," said Jeff Borcherding, CEO of Immunovia. "This is a critical milestone for the company. Our next-generation test shows tremendous promise for improving pancreatic cancer surveillance with a highly accurate, convenient and affordable test. We are very optimistic about the clinical impact of the test when we launch in the U.S. in 2025." The model development study included 624 patient samples from 13 different clinical sites. 129 samples were from patients with stage 1 or 2 PDAC and 495 control samples came predominantly from people at high-risk for hereditary and/or familial pancreatic cancer, and also included people with pancreatic cysts, diabetics, and healthy individuals. The Company will submit these results shortly for peer-reviewed publication as well as for presentation at medical conferences. A large, independent clinical validation study will be conducted in the fourth quarter of 2024 to confirm the accuracy of the Immunovia test in a larger set of patient samples. Immunovia remains on track to launch the new test in the United States in 2025. For more information, please contact: Jeff Borcherding CEO and President [email protected] Karin Almqvist Liwendahl Chief Financial Officer [email protected] +46 709 11 56 08 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  This information was brought to you by Cision The following files are available for download:

LUND, Sweden, April 29, 2024 /PRNewswire/ -- January-March 2024 Net sales, which for the quarter only included royalties, amounted to SEK 156 (520) Net earnings amounted to KSEK -2,946 (-51,658), where exchange rate effects of KSEK 21 358 (435) had a substantial impact. Earnings per share before and after dilution were SEK -0.07 (-2.28). Cash Flow from operating activities amount MSEK -24.4 (39.7). Cash and equivalents at the end of the period amounted to MSEK 51.2 (68.2). On January 31, the Company announced that Norma Alonzo Palma had been appointed Vice President of Clinical and Medical Affairs Significant events after the period On April 9, the Company announced that Immunovia had successfully developed accurate and precise assays to measure targeted proteins for its next-generation test. On April 22, the Company announced positive results from the model-development study for its next-generation pancreatic cancer detection test. CEO's comments I am proud to report that we delivered on our promises in transforming Immunovia to a new and more agile company with a significantly lower cost base, faster pace, greater efficiency, and better results. Our new test demonstrated positive results in the model-development study, validating our decision from last summer to shift resources from IMMray™ PanCan-d to the new product. We are committed to bringing value to shareholders by launching the new test in 2025 to meet the substantial market demand for a simple and affordable blood test for early detection of pancreatic cancer. Our next-generation test met the predefined performance criteria and outperforms IMMray™ Pan-Can-d We were thrilled to announce on April 22 that our next-generation test performed very well in the model-development study, achieving both primary and secondary endpoints. The test demonstrated specificity of 98 percent and sensitivity of 75 percent in detecting early-stage (stage 1 and 2) pancreatic ductal adenocarcinoma (PDAC), which is the most common form of pancreatic cancer. The next-generation test's strong performance in differentiating PDACs from controls was especially impressive since the control samples represented a wide range of subjects, including people at high-risk for hereditary and familial pancreatic cancer, diabetics, patients with benign pancreatic lesions worrisome for PDAC, and healthy individuals. Our next-generation test was also significantly more accurate in the study than CA19-9, the biomarker commonly used to detect pancreatic cancer. Outperforming CA19-9 is crucial to securing reimbursement for the new test. The next-generation test is clearly superior to our first-generation test, IMMray™ PanCan-d. First, the new test accurately distinguished pancreatic cancer from a wider range of control samples. Second, the next-generation test does not have a "borderline" category as the IMMray™ PanCan-d test did. All patients tested with our new test will receive a "positive" or "negative" result. This will provide patients and clinicians with much greater clarity and appropriately guide next steps, eliminating the indecision of a "borderline" result. Finally, the protein biomarkers in the new test are more accurate, reducing reliance on CA19-9. The IMMray™ PanCan-d excluded about 10% of patients because they had a genetic mutation that prevents them from producing CA19-9. This genetic mutation is particularly prevalent in people of African ancestry and Hispanic ethnicity. With our next-generation test we expect to provide a test for the full population of individuals at risk, further expanding the commercial opportunity. These results confirm we made the right decision in shifting our focus from IMMray™ PanCan-d to the new test. We now have a test that includes more accurate biomarkers, outperforms CA19-9, expands the market relative to the IMMray test, and offers a much better chance to secure reimbursement and drive commercial success. We are moving much faster and are completing promised milestones on time In July 2023 we announced a transformation of Immunovia to significantly increase efficiency and speed. The benefits of this transformation have since become clear. We have moved very rapidly through the test development process. We have set aggressive timelines and are hitting our marks. Since July, we have completed the largest-ever study to identify pancreatic cancer protein biomarkers. We developed assays to accurately measure these protein biomarkers and have conducted the model-development study. All these milestones were completed on the promised timing. Our successful collaboration with Proteomedix, an Onconetix company, has provided expertise and capacity, while accelerating our pace. We now have the people, plans, and processes to deliver at a dramatically faster pace than what Immunovia achieved previously. We have transitioned to the lower-cost, more reliable ELISA testing platform In the first quarter, we largely completed the transition from the proprietary IMMray platform to ELISA. The benefits are clear. Lab results prove the ELISA assays are more accurate and more reproducible than IMMray assays. The new ELISA assays will also reduce turnaround time for the commercial test to 1 or 2 days. Finally, the new platform has much lower fixed costs and will reduce our cost per test. Our cash burn is in line with expectations and we have a plan to raise capital First quarter 2024 cash burn averaged 8.7 MSEK per month, in line with our forecast. We have dramatically reduced our staffing costs and operating expenses, as cuts made in 2023 began to deliver the expected savings. In parallel, it is critical that we secure the resources to fuel R&D, clinical studies, and future commercial efforts. The company is currently funded into the fourth quarter of 2024. We are also negotiating to reduce or eliminate long-term financial commitments linked to the now-discontinued IMMray™ Pan-Can-d product. The Immunovia board of directors and management team are actively evaluating multiple financial and strategic options, including exploring strategic transactions such as a merger or sale of the company, raising capital, and selling assets. Our team is performing at a very high level Over the past year we reduced staffing by nearly 80% and had only 11 full-time employees as of the end of the first quarter. The team includes top performers from Immunovia as well as two critical new hires. Our employees are supported by a tremendous set of consultants, contractors, and external partners such as Proteomedix. This collective team has performed tremendously well over the last year. I am incredibly grateful for their agility and focus, their extraordinary level of effort, and their passion for our mission. Our next steps are clear, and we have well-defined plans to bring the next-generation test to market We will now move to a second phase of the model development study, expected to be completed in June. In the second and third quarters, we will perform several analytical validation steps to verify the accuracy and reproducibility of the protein assays. In the fourth quarter, we will initiate a large clinical validation study to confirm the performance of the next-generation test, which we expect to complete in Q1 2025. We also will partner with leading pancreatic cancer researchers on additional clinical studies starting in early 2025 to support a commercial launch in 2025 as well as future reimbursement. The market need for an early detection test remains very strong and we are rapidly making progress to meet this need Market demand for a blood test to detect pancreatic cancer remains very strong. Leading experts in the field confirm the incredible patient desire for a blood test to simplify surveillance. Clinicians who monitor high-risk individuals understand the burdens of annual imaging and are eager to have a blood test to make surveillance faster and more convenient for patients. Meeting this need will enable us to drive volume, revenue, and shareholder value. April 29, 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 April 29, 2024. Conference call Immunovia will hold a webcast tele conference at 15:00 CET on April 29 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: creo-live.creomediamanager.com/b493ca7a-4f83-40f5-85aa-b9e5e7503b63 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  This information was brought to you by Cision The following files are available for download: SOURCE Immunovia AB

LUND, Sweden, April 22, 2024 /PRNewswire/ -- Immunovia (NASDAQ Stockholm: IMMNOV), the diagnostics company with the mission to increase pancreatic cancer survival through early detection, today announces its next-generation pancreatic cancer test achieved both the primary and secondary endpoints in a model-development study. In the study, Immunovia's next-generation test demonstrated specificity of 98 percent and sensitivity of 75 percent in detecting early stage (1 and 2) pancreatic ductal adenocarcinoma (PDAC), a very aggressive and the most common form of pancreatic cancer. The Immunovia test was also significantly more accurate than CA19-9, the biomarker commonly used to detect pancreatic cancer. Importantly, these results confirm the technical advancement of the next-generation test over Immunovia's first-generation test, IMMray PanCan-d. The next-generation test includes high-performing protein biomarkers, making the test less reliant on CA19-9. This is a major achievement as around 10 percent of patients, including many patients of African ancestry, do not produce CA19-9, so the IMMray PanCan-d test could not be used in those patients. The results with the new test were achieved including PDAC patients with low CA19-9 values. Furthermore, the new test does not provide indeterminate or "borderline" results; all patients are classified as positive or negative for pancreatic cancer. With the first-generation Immunovia test, IMMray PanCan-d, about 10 percent of patients received a test result of "borderline", creating indecision for clinicians. The next-generation test is now established on a broadly used ELISA platform, resulting in more precise protein measurement, faster testing, and lower cost of goods sold. "Pancreatic cancer is a brutal and lethal cancer. People at risk for pancreatic cancer need a simple, fast, and easy blood test to detect cancer early. We are very excited about the potential of our test to meet this need and increase survival rates for these patients," says Jeff Borcherding, CEO and President of Immunovia. The model development study was designed to select the highest performing biomarkers to include in the next-generation test, to define the algorithm to produce a diagnostic result, and to provide an initial assessment of the test's clinical performance. The study included 481 blood samples from the U.S. and Europe. Of these, 133 were samples from patients with stage 1 or 2 PDAC. The 348 control samples represented a wide range of subjects, including people at high-risk for hereditary and familial pancreatic cancer, diabetics, patients with benign pancreatic lesions worrisome for PDAC, and healthy individuals. Immunovia will now move to a second phase of the model development study, expected to be completed in 6 - 8 weeks, in which it will conduct additional statistical analyses to refine and assess the robustness of the test model. In addition, test performance will be evaluated in a more selective cohort of patients at high risk for pancreatic cancer. In the second and third quarters of 2024, Immunovia will perform several analytical validation steps to verify the accuracy and reproducibility of the protein biomarker measurements. In the fourth quarter of 2024, the company will conduct a large clinical validation study to confirm the performance of the next-generation test, setting the stage for a U.S. launch in 2025. Immunovia estimates that there are at least 600,000 individuals in the U.S. at high risk of pancreatic cancer due to family history and genetic mutations. Many more are at risk due to other factors. The current standard of care for surveillance is annual imaging using magnetic resonance imaging (MRI) or endoscopic ultrasound (EUS). High-risk individuals and clinicians at leading high-risk pancreatic cancer surveillance centers have expressed a very strong desire for a simple blood test to make surveillance faster, more convenient, and less invasive. For more information, please contact: Jeff Borcherding CEO and President [email protected] Karin Almqvist Liwendahl Chief Financial Officer [email protected] +46 709 11 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 April 22, 2024. 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  This information was brought to you by Cision The following files are available for download: SOURCE Immunovia AB