Announcement • Jun 16
Immunovia Announces New Performance Data for PancreaSure Ahead of Upcoming Application for Medicare Coverage Immunovia AB announced new performance data for PancreaSure in support of its upcoming Medicare coverage application. The data represent the first evaluation of PancreaSure in symptomatic individuals at elevated risk of pancreatic cancer. A pooled analysis across two validation studies shows that PancreaSure detected Stage I and II pancreatic ductal adenocarcinoma in genetically or familial individuals with symptoms of pancreatic cancer high-risk with % sensitivity and % specificity. Performance was consistent across 83.391.6 clinically important supporting the usability in its sub-groups, test's intended-use population. The results are based on pooled data from previously reported CLARITI and Immunovia’s VERIFI validation studies, which included individuals at high risk of pancreatic ductal adenocarcinoma (PDAC) due to a genetic mutation (PGV) and/or a family history of pancreatic cancer. The current analysis was restricted to symptomatic individuals, including those with pancreatic cysts, diabetes, pancreatic abnormalities, pancreatitis, unexplained weight loss and other signs of pancreatic cancer. PancreaSure detected Stage I and II PDAC with % sensitivity and % specificity in the 83.391.6 symptomatic study population, consistent with the performance in high-risk test’s high-risk asymptomatic individuals in previous validations. Performance was consistent across symptomatic and in individuals over 65 years of age – the population covered sub-groups by Medicare insurance. Because Medicare generally requires the presence of signs and/or symptoms to cover diagnostic testing, the symptomatic cohort represents the high-risk intended-use population for planned submission to Medicare for a Local Coverage Immunovia’s Determination (LCD) for PancreaSure. Announcement • Jun 11
Immunovia Publishes Final Affirm Study Results in Journal of Clinical Oncology Confirming Strong Diagnostic Performance of Pancreasure Immunovia AB announced that the final results from the AFFIRM clinical study have been published in the Journal of Clinical Oncology: Oncology Advances. The results show 88% sensitivity and 98% specificity for PancreaSure in late-stage pancreatic cancer patients and healthy, average-risk individuals, respectively, consistent with previously reported interim data. The AFFIRM study demonstrated that PancreaSure achieved 88% sensitivity in detecting Stage III and Stage IV pancreatic cancers and 98% specificity in correctly classifying control samples as non-cancerous. The study included blood samples from 619 individuals: 105 Stage III and 119 Stage IV pancreatic cancer samples from the Immunovia biobank, originally acquired from five European pancreatic cancer programs, along with 395 healthy control samples. These results expand and reinforce the previously reported CLARITI and VERIFI data by adding evidence of strong performance in advanced-stage disease. Importantly, the inclusion of a healthy control population for the specificity analysis aligns with methodology commonly used in the broader cancer detection field, enabling more direct benchmarking of PancreaSure against other tests. The AFFIRM study was designed to complement Immunovia's prior clinical validation studies, CLARITI and VERIFI, which focused on Stage I and Stage II pancreatic cancer and evaluated specificity in high-risk individuals – including those with family history, genetic mutations, or pancreatic cysts. AFFIRM addressed two additional objectives: measuring PancreaSure's sensitivity in detecting advanced-stage (Stage III and Stage IV) pancreatic cancer, and assessing specificity in healthy, average-risk individuals. Together, the three studies provide a comprehensive clinical evidence base spanning all major disease stages and both high-risk and average-risk populations. Announcement • Jan 19
Immunovia AB Receives State Regulatory Approval for Pancreasure in California and Initiates Commercial Rollout Immunovia AB announced that it has received regulatory approval for its PancreaSure test in California, US, enabling commercial sales in the state. The approval represents an important milestone in Immunovia’s three-phase commercial launch strategy, under which the company will initially focus on leading medical centers operating surveillance programs for patients at elevated risk of developing pancreatic cancer. In October 2025, Immunovia applied for regulatory approval to offer the test for commercial use in California. By meeting the requirements of both federal CLIA (Clinical Laboratory Improvement Amendments) standards and California’s additional state-specific laboratory regulations, including stricter requirements for laboratory operations and oversight, PancreaSure was approved. The approval allows Immunovia to legally accept, analyze, and report diagnostic test results from California-based healthcare providers. California is a large and strategically important regional market for the PancreaSure test in the US, as numerous leading academic medical centers and high-risk surveillance programs are active in the state. The recent approval allows Immunovia to offer PancreaSure directly to clinics, creating new opportunities to scale up the use of the test. PancreaSure is a blood-based test for the early detection of pancreatic cancer in high-risk individuals. The test is clinically validated and designed to support surveillance programs by identifying disease at earlier, more treatable stages. Announcement • Jan 15
Immunovia AB (publ), Annual General Meeting, May 15, 2026 Immunovia AB (publ), Annual General Meeting, May 15, 2026. Announcement • Aug 28
Immunovia AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 100 million. Immunovia AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 100 million.
Security Name: Shares
Security Type: Common Stock
Transaction Features: Rights Offering Announcement • May 15
Immunovia AB (publ) Approves Board Changes Immunovia AB (publ) announced that at the annual general meeting held on 14 May 2025, approved to elect Bryan Riggsbee as a new member of the board. Former board member Michael Löfman was not available for re-election. Announcement • Mar 27
Immunovia Provides Further Positive Data from the Verifi Study of Its Next-Generation Pancreatic Cancer Test Immunovia AB announced additional results from the successful VERIFI study of its next-generation pancreatic cancer test, strengthening the company's position as it prepares to launch the pancreatic cancer blood test commercially. Immunovia's next-generation test detected significantly more cancers than CA19-9, a common biomarker for pancreatic cancer, in the study. The company also announced that the specificity of its test in the VERIFI study was equivalent to CA19-9 and just below the target specificity for the trial. VERIFI met the primary study endpoint. On March 19, 2025, Immunovia announced the VERIFI study met its primary endpoint, with the test successfully detecting 77% of stage I and II pancreatic cancer cases, far exceeding the target of 65%. Specificity in the VERIFI study were in line with target performance and CA19-9. The specificity of the Immunovia test was 88%, compared to the target specificity of 90%. Like the previous CLARITI study, the specificity of the ImmunovIA test was essentially equal to the specificity of CA19-9 (88% vs. 89%). In the VERIFI study, specificity was a secondary endpoint, not a co-primary endpoint, because the low number of control samples in the study (271) made the quantification of specificity less precise. VERIFI results strengthen and support Immunovia's commercial plans. Immunovia is actively preparing to launch its next-generation test in the third quarter of 2025. The company will conduct additional clinical studies throughout the year to assess the test's clinical impact and further evaluate its accuracy in other high-risk populations. These studies will support regulatory submissions and payer reimbursement efforts. Immunovia is also engaging potential commercial partners to accelerate market adoption. The VERIFI study was conducted using 385 blood samples from six leading pancreatic cancer centers in the U.S. Researchers analyzed 115 samples from patients with Stage I and II pancreatic ductal adenocarcinoma (PDAC), the most common form of pancreatic cancer. These were compared to 270 control samples from people without pancreatic cancer classified as high risk. These high-risk individuals had a family history of pancreatic cancer, concerning genetic mutations, pancreatic cysts (fluid-filled sacs in the pancreas that sometimes develop into pancreatic cancer), or a combination of these risk factors. Early detection is critical for improving patient outcomes, particularly for individuals at high risk of pancreatic cancer. Individuals with certain genetic mutations or family history of PDAC face higher risk. Certain pancreatic cysts, such as intraductal papillary mucinous neoplasms (IPMNs), also pose a significant cancer risk, with up to 15% progressing to pancreatic cancer within 15 years. Announcement • Mar 20
Immunovia Announces Another Successful Clinical Validation of Its Next-Generation Pancreatic Cancer Test Immunovia announced positive results from the VERIFI study, the second clinical validation study of its next-generation pancreatic cancer test. The study met its primary endpoint, with the test successfully detecting 77% of stage I and II cases of pancreatic cancer. Immunovia is actively preparing to launch its next-generation test in the third quarter of 2025. The company will conduct additional clinical studies throughout the year to assess the test's clinical impact and evaluate its accuracy in other high-risk populations. These studies will support regulatory submissions and payer reimbursement efforts. Immunovia is also engaging potential commercial partners to accelerate market adoption. Announcement • Feb 22
Immunovia AB (Publ) Announces Karin Almqvist Liwendahl Step Down as CFO Immunovia announced that it will be hiring a new Chief Financial Officer (CFO) as its focus turns to the US market. As Immunovia transitions to commercializing its test in the second half of 2025, the company's financial leadership needs are changing. The launch of Immunovia's pancreatic cancer test in the USA creates a need for deeper expertise and relationships in the US diagnostics market as well as global capital markets. The company is conducting a search for a CFO with diagnostics or med tech operating experience, a network of US industry contacts, and a track record of successfully communicating with capital markets across different geographies. With this move, Karin Almqvist Liwendahl, will be stepping down as CFO of Immunovia. Karin will continue to fulfill her responsibilities as CFO until the end of the first quarter of 2025. Immunovia has initiated the recruitment process for a successor. In the interim period, financial leadership responsibilities will be assumed by Jeff Borcherding and Immunovia finance team members. Announcement • Jan 09
Immunovia AB (Publ) Appoints Nomination Committee Immunovia announced the appointment of the Company's Nomination Committee. According to the instructions for the Nomination Committee of Immunovia AB (Publ), the Nomination Committee shall consist of four members, of which three should be appointed by the Company's three large shareholders in terms of votes, and the fourth shall be the Chair of the Board of Directors. The Nomination Committee will consist of the following persons who together represent 5.65% of the number of shares and votes in the Company as of September 30, 2024: Christer Køhler, representing Jens Henrik Jensen, Mats Leifland, representing Vincent Saldell, Sara Ek, representing Carl Borrebaeck and Peter Høngaard Andersen in his capacity as Chair of the Board of Directors. Jeff Borcherding, the CEO of Immunovia AB, in his capacity as one of the company's large shareholders, declined the opportunity to appoint a representative to the Nomination Committee in order to ensure the independence of the committee. The Nomination Committee will prepare proposals for shareholder approval at the 2025 Annual General Meeting (AGM). In particular, the Nomination Committee will nominate candidates for the Immunovia Board of Directors, ensuring the board has the appropriate skills and experience to support the company's success in 2025. The Nomination Committee will also recommend appropriate compensation to be offered to the Board of Directors based on proper benchmarks. Further, the Committee will recommend the election and compensation of the company's auditors. Announcement • Dec 12
Immunovia AB (publ), Annual General Meeting, May 14, 2025 Immunovia AB (publ), Annual General Meeting, May 14, 2025, at 11:00 W. Europe Standard Time. Announcement • Dec 09
Immunovia AB (publ) Announces Positive Outcome and Strong Accuracy in the Clinical Validation of Its Next-Generation Test for Pancreatic Cancer Immunovia announced the successful completion of the CLARITI study, (Clinical Validation of Next-Generation Test for Early-Stage Pancreatic Cancer) to detect early-stage pancreatic ductal adenocarcinoma (PDAC). In the study of over 1,000 patient samples, the test achieved the primary endpoint, exceeding the predefined accuracy criteria and marking a critical milestone in Immunovia's mission to increase patient survival through early detection of pancreatic cancer. Key findings from the study include: High accuracy: The test demonstrated sensitivity of 78% and specificity of 94% in detecting stage 1 and 2 PDAC. In patients aged 65 and older, sensitivity was 80% and specificity was 91%. Superior performance 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 monitoring pancreatic cancer, while maintaining equivalent specificity. Early detection: Immunovia's next -generation test was equally accurate in detecting both stage 1 and stage 2 pancreatic cancers, reinforcing its strength as an early detection test. Improved accuracy with recently collected samples: Test performance was higher in blood samples collected within the last five years, with sensitivity of 82% and specificity of 95%. (Due to the rarity of stage 1 and 2 pancreatic cancer samples, 56% of the pancreatic cancer samples included in the study were older than 5 years.) In real-world clinical use, samples will be tested within days of collection and the test would be expected to show even greater accuracy. The CLARITI study utilized blood samples from 18 of the world's leading pancreatic cancer centers, representing the largest reported clinical validation study for a pancreatic cancer blood test in a high-risk patient population. All CLARITI study samples were obtained from patients other than those used in prior development studies. Based on the results announced, Immunovia remains on track to introduce its next-generation test to the U.S. market in the second half of 2025. In parallel, Immunovia will also conduct additional clinical studies to assess the test's accuracy, clinical impact and economic value across different high-risk patient groups. The studies will continue throughout 2025 and will support regulatory submissions and efforts to secure test reimbursement. Announcement • Nov 15
Immunovia Presents Model-Development Study Results At Meeting of the Collaborative Group of the Americas-Inherited Gastrointestinal Cancers Immunovia will present results from the recently completed model-development study of the company's next-generation test at the 2024 annual meeting of the Collaborative Group of Americas--Inherited Gastrointestinal Cancers (CGA-IGC). The Scientific Committee of the CGA-IGC evaluated and accepted Immunovia's abstract, which reports outcomes from the company's model-development study, for presentation at the meeting. Immunovia's submission was also recognized for inclusion in the Henry Lynch Lecture during the conference. The Collaborative Group of the Americas - Inherited Gastrointestinal Cancers (CGA-IGC) was established in 1995 to improve understanding of the basic science and clinical management of inherited gastrointestinal cancers. Its mission is to advance science and clinical care of inherited gastrointestinal cancers through research and education as the leading authority in the Americas. Its annual meeting is attended by gastroenterologists, oncologists, genetic counselors, and other clinicians focused on inherited gastrointestinal cancers, including pancreatic cancer. Immunovia will share results from the model-development study of its next-generation test to detect stage 1 and 2 pancreatic cancer. In addition, the company provided a grant to fund an educational symposium at the meeting titled "Increasing Access to Pancreatic Cancer Screening: Lessons Learned from a Community-Based High-Risk Screening Program." The symposium, led by Ora Gordon, MD, and Miles Picus, LCGC, will discuss the implementation of a high-risk pancreatic cancer surveillance program and early detection tests. Immunovia is currently conducting a clinical validation study of its next-generation test, which is expects to complete in December 2024. The company plans to launch the test later in 2025. Announcement • Oct 07
Immunovia AB (Publ) Acquires All Blood Samples Required to Clinically Validate Its Next-Generation Test for Pancreatic Cancer Immunovia announced that the company has acquired all blood samples required to clinically validate its next-generation test for pancreatic cancer. Con Including the sample collection effort marks a key milestone toward successfully completing the clinical validation study. The study seeks to confirm the sensitivity and specificity reported previously in the company's model-development study of its new test. The trial will be a case-control study evaluating the accuracy of the next-generation test in differentiating blood samples from people with early-stage pancreatic cancer from individuals without it. Immunovia has secured over 1,000 blood samples, including over 200 from patients with stage 1 and 2 pancreatic cancer and more than 800 blood samples from high-risk individuals without cancer. The study will be one of the largest clinical validation studies of a pancreatic cancer biomarker test conducted to date. Immunovia leveraged long-standing relationships with researchers at pancreatic cancer centers in Europe and North America to acquire the blood samples. Key collaborators who contributed an especially large number of samples included Dr. Randall Brand, University of Pittsburgh Department of Medicine; Dr. Rosie Sears, Oregon Health and Science University; and Dr. Salvatore Paiella, University of Verona. This study marks Immunovia's first research collaboration with the Pancreatic Cancer Early Detection (PRECEDE) Consortium. The PRECEDE Consortium, led by Dr. Diane Simeone, is an international, multi-institutional collaborative group of experts working to improve early detection of pancreatic cancer through a novel model of collaboration and data sharing. The PRECEDE Consortium provided nearly 500 samples from its ongoing study of people at high-risk for hereditary cancer.? As communicated previously, Immunovia expects to complete the clinical validation study in December 2024 in preparation for launching its next-generation test for early detection of pancreatic cancer later in 2025. Announcement • Oct 02
Immunovia Completes Analytical Validation of Its Next-Generation Pancreatic Cancer Test Immunovia announced that the company has completed the analytical validation of its next-generation test designed to detect early-stage pancreatic cancer. The validation demonstrated excellent results across a comprehensive set of parameters, reinforcing the reliability and robustness of the test. The biomarkers that make up Immunovia's next-generation test demonstrated excellent performance in a series of experiments. These experiments evaluated over 23 key performance attributes of the next-generation test according to guidelines set by the Clinical and Laboratory Standards Institute (CLSI) under the guidance of Immunovia's lab director, Lisa Ford, Ph.D. The experiments were designed to meet the stringent requirements of the Clinical Laboratory Improvement Amendments (CLIA) and the College of American Pathologists (CAP) accreditation standards, ensuring that the test meets the high industry benchmarks. Key highlights of the analytical validation include: Precision: The test demonstrated high precision and reproducibility across multiple testing runs, ensuring reliable results; Linearity: The test provided accurate readings at varying biomarker concentrations; Sensitivity: The assay exhibited high sensitivity, enabling detection of the target biomarkers even at low levels; Stability: The biomarkers remained stable under various conditions (e.g., different temperatures), maintaining their integrity and ensuring accurate measurement; and Robustness: The test showed consistent performance across different batches of testing supplies and laboratory settings, confirming its robustness. The analytical validation was conducted using an automated ELISA analyzer, which significantly enhances both performance and throughput compared to Immunovia's prior IMMray platform as well as standard manual ELISA tests. Announcement • Aug 05
Immunovia AB (publ) Announces the Next-Generation Test to Be Included in Large Study of Pancreatic Cysts funded by the U.S. National Institutes of Health Immunovia announced that the company's next-generation test to detect pancreatic cancer has been selected for inclusion in a US-government-funded study to evaluate biomarker tests for monitoring cystic tumors of the pancreas. The study's lead author is Diane M. Simeone, an internationally recognized expert in pancreatic neoplasms and the Director of Moores Cancer Center at University of California San Diego Health. The study will assess the use of biomarker tests to detect pancreatic cystic neoplasms (PCNs, or pancreatic cysts) that develop into pancreatic cancer. The overall clinical program will consist of three complementary studies: Study 1 will define the performance and accuracy of blood-based biomarkers through a retrospective study of 200 blood samples that includes early-stage pancreatic cancer cases and controls. Study 2 will evaluate the ability of the biomarker tests to detect early-stage pancreatic cancer in patients undergoing surgery to remove pancreatic cysts suspected to be cancerous. Study 3 will examine biomarker performance for detection of early-stage cancer in a group of individuals undergoing annual surveillance of cystic tumors. The first study should be completed in 2025; the other two will last approximately five years. The study is being funded by a $4.5 million grant from the US National Institutes of Health (NIH). Immunovia's financial commitment will be limited to the company's costs to test the samples received from participating institutions. The study will be conducted through four institutions in the PRECEDE Consortium, an international, multi-institutional collaborative group of experts seeking to increase survival for pancreatic cancer patients by improving early detection, screening, risk modeling and prevention for those at risk. Pancreatic cystic neoplasm (PCNs) are tumors of the pancreas that are relatively common and have a low, but measurable risk of degeneration into pancreatic cancer. Branch-duct intraductal papillary mucinous neoplasms (IPMN), the most common incidentally discovered PCNs, have a risk of malignancy approaching 15% within 15 years of diagnosis. PCNs can be benign, precancerous or cancerous. Accurate identification of PCNs and determining their risk for progression to invasive pancreatic cancer is important to prevent both overtreatment with unnecessary procedures and missed opportunities for early cancer diagnosis. As previously announced, Immunovia will conduct a large, independent clinical validation study in the fourth quarter 2024 to confirm the accuracy of the Immunovia test in detecting pancreatic cancer in a high-risk population. The company is on track to launch the new test in the United States in 2025. Announcement • Aug 02
Immunovia Files US Patent Application to Protect Its Next-Generation Test Immunovia announced the company has filed a US provisional patent application to protect the intellectual property embodied in its next-generation test to detect stage 1 and 2 pancreatic cancer. The patent application claims methods of diagnosing pancreatic ductal adenocarcinoma (PDAC), the most common form of pancreatic cancer. The company is seeking patent protection for the unique combination of five specific biomarkers used in its test, as well as the method for combining these biomarkers to generate a positive or negative test result. Immunovia filed the provisional patent application with the Patent and Trademark Office in the United States of America, the first market for commercializing the company's new test. In coming months, the company expects to submit additional clinical data to the USPTO bolster the patent application. Immunovia also plans to file a single PCT application within the next year, enabling the company to seek patent protection for its invention across dozens of countries at one time. Immunovia will later pursue patents in specific high-value commercial markets outside the US. Immunovia has completed development of its next-generation test to detect stage 1 and 2 pancreatic cancer. Immunovia will conduct a large, independent clinical validation study in fourth quarter 2024 to confirm the accuracy of the Immunovia test. The company is on track to launch the new test in the US in 2025. Announcement • Aug 01
Immunovia Completes Development of Its Pancreatic Cancer Detection Test After Substantially Increasing Test Accuracy Immunovia announced enhanced performance for its next-generation test for detecting stage 1 and 2 pancreatic ductal adenocarcinomas 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. 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. Announcement • Jul 26
Immunovia AB Presents Detailed Discovery Study Results for its Next-Generation Early Detection Test for Pancreatic Cancer at PancreasFest 2024 Annual Meeting Immunovia AB presented detailed discovery study results for the company's next-generation early detection test for pancreatic cancer at the PancreasFest 2024 Annual Meeting. PancreasFest is an annual conference of physicians and translational researchers with special interest in the pancreas who convene to find new ways to improve the care of patients with pancreatic disease, including pancreatic cancer. It is organized by the Collaborative Alliance for Pancreatic Education and Research. Abstracts submitted to this medical conference undergo a rigorous peer-review and selection process in which only a subset of studies are chosen for presentation at the meeting. Results presented at PancreasFest reflect a detailed scientific presentation of the initial positive data the company shared in a 7 November 2023 press release. The discovery study, the most comprehensive pancreatic cancer proteomics study done to date, identified 15 promising protein biomarkers that were shown to strongly correlate with the presence of pancreatic ductal adenocarcinoma (PDAC). These protein biomarkers demonstrated the ability to differentiate PDAC cases from non-PDAC controls. Over 3,000 proteins were evaluated in 329 blood samples from Stage 1 and II PDAC and non-PDAC matched control patients using Olink multiplex technology and conventional immunoassays. Announcement • Jun 20
Immunovia AB (publ) to Report Fiscal Year 2024 Results on Feb 25, 2025 Immunovia AB (publ) announced that they will report fiscal year 2024 results on Feb 25, 2025 Announcement • Apr 23
Immunovia AB Announces Positive Results from the Model-Development Study for Its Next-Generation Pancreatic Cancer Detection Test Immunovia AB announced its next-generation pancreatic cancer test achieved both the primary and secondary endpoints in a model-development study. In the study, the company's next-generation test demonstrated specificity of 98% and sensitivity of 75% 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% 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 Pan can-d, about 10% 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. The model development study was designed to select the high 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, the company 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. Announcement • Apr 09
Immunovia Successfully Develops Assays to Measure Targeted Proteomedix for Its Next-Generation Pancreatic Cancer Test - Moving Forward Towards Model-Development Study Immunovia announced that the company has successfully developed accurate and precise assays to measure targeted proteins for its next-generation test. As announced in November 2023, Immunovia successfully finalized a discovery study that evaluated nearly 3,000 proteins to identify 15 promising protein biomarkers for its next-generation test to detect early-stage pancreatic cancer. As the next milestone in developing its next-generation test Immunovia, in collaboration with the company's research and development partner Proteomedix (an Onconetix company), has developed accurate and reliable assays to measure the most promising proteins identified in the discovery study to move forward to a model-development study. The newly developed assays leverage commercial reagents and an automated, high-throughput ELISA testing platform. By moving from the proprietary IMMray platform used for Immunovia's prior test, IMMray PanCan-d, to the widely used commercial ELISA platform, Immunovia expects to substantially reduce lead-time in production as well as cost of goods sold for its next generation test. Immunovia is currently conducting a model-development study for the next-generation test in which it will select the highest performing biomarkers to include in the test, define the algorithm to produce a diagnostic result, and provide an initial assessment of the test's clinical performance (i.e., sensitivity and specificity). As previously communicated, the company expects to release the results of the model development study early in Second Quarter 2024. Announcement • Nov 22
Immunovia AB (Publ) Elects Melissa Farina and Valerie Bogdan-Powers as New Board Members Immunovia AB announced that at the extraordinary general meeting held on November 21, 2023, approved to elect Melissa Farina and Valerie Bogdan-Powers as new board members. For the time up until the next annual general meeting, the board will consist of Peter Høngaard Andersen (chair), Hans Johansson, Michael Löfman, Martin Møller, Melissa Farina and Valerie Bogdan-Powers. Announcement • Nov 08
Immunovia Successfully Completes Discovery Phase of Next-Generation Test Development Immunovia announced the successful completion of the discovery phase for the Company's next -generation test. The discovery study, which marks a key milestone in the development of Immunovia's next-generation test to detect early-stage pancreatic cancer, successfully found more than a dozen proteins circulating in the blood that identified pancreatic ductal adenocarcinoma (PDAC) stage I and stage II patients. The study is the most comprehensive pancreatic proteomics study done to date and utilized the Olink platform to explore nearly 3,000 protein biomarkers. The new test is designed to work across all racial and ethnic groups without compromising accuracy, overcoming a key limitation of Immunovia's first-generation test, IMMray PanCan-d. Announcement • Jul 12
Immunovia to Significantly Restructure to Focus Resources on its Next-Generation Blood Test for Pancreatic Cancer Detection Immunovia announced plans to restructure its operations. The company will cease commercialization of its IMMray PanCan-d test in the United States to focus its resources on the further development and clinical testing of the company’s promising next generation pancreatic cancer detection test. The next generation assay currently in development is intended to work equally well across multiple patient risk groups. The new test is expected to provide accurate results in patients who do not produce CA19-9, and to reduce reliance on CA19-9, which have been limitations of IMMray PanCan-d. The next generation test will be performed on a widely used commercial platform, enabling the company to better scale production. Immunovia expects to release further details about the next-generation test later this year, with an anticipated launch date in 2024. Immunovia’s strategic decision to focus on its next generation assay will result in significant layoffs in both Sweden and the United States in multiple functions. Importantly, the staffing reductions and the elimination of other operating expenses will lower the company’s cash burn rate and extend the Company’s cash reserves well into 2024. Announcement • May 27
Immunovia AB (publ) Announces Board Changes Immunovia AB (publ) at it's AGM approved to elect Michael Löfman as a new board member and to elect Peter Høngaard Andersen as chairman of the board. Announcement • May 23
Immunovia AB (Publ) Announces Board Changes Immunovia AB (publ) at the Annual General Meeting 2023 on 25 April 2023 together with the Nomination Committee's motivated statement which included the Nomination Committee's proposals for board members. The Nomination Committee has now been informed that Helge Lubenow, Sven Andréasson and Vanessa Rollings will not stand for election as board members in Immunovia. In addition, Philipp von Hugohas previously resigned from the Board of Directors and is thus not available for re-election as a board member. Announcement • May 07
Philipp Von Hugo Resigns from Immunovia's Board at His Own Request Philipp von Hugo, member of the board of directors of Immunovia AB (publ has notified his resignation from the Board of Directors of the Company at his own request and therefore declines re-election at an annual general meeting on 26 May 2023. Philipp von Hugo, who has served as a board member of Immunovia since the annual general meeting in 2022, has on 5 May 2023 at his own request with immediate effect, notified his resignation from his position as board member of Immunovia and consequently declines re-election, at the annual general meeting on 26 May 2023. Announcement • Jan 19
Immunovia Realigning Swedish Operations with Strategic Priorities and its Focus on the US Commercialization of the Immray Pancan-D Test Immunovia AB (publ) announced it is realigning its Swedish operations with its strategic priorities to drive R&D productivity and focus on the US commercialization of the IMMray(TM) PanCan-d test. Immunovia has initiated a consultation process with relevant Swedish unions to create the best possible transition for the affected employees. The Company will provide an update once the consultation process is concluded. Announcement • Jan 17
Immunovia AB (Publ) Appoints Lara E. Sucheston-Campbell as the Head of Clinical and Medical Affairs, Effective February 1, 2023 Immunovia AB (publ) announced that it has appointed Lara E. Sucheston-Campbell as the head of clinical and medical affairs, effective February 1, 2023. Lara joins the company from Roche Molecular Systems, where she served as Global Director of Clinical Development in Oncology and Genetics. Prior to joining Roche, she spent over 13 years in academia, most recently as a tenured Associate Professor at The Ohio State University. Her lab focused on the contribution of genomics to cancer susceptibility and survival following diagnosis. Lara brings expertise in designing, implementing, analyzing, and leading large-scale international clinical, biomarker, genomic and epidemiologic studies resulting in national and international scientific presentations and over 130 peer-reviewed publications. Her academic research was funded by the National Institutes of Health and Department of Defense. She has extensive experience in leading clinical science teams and collaborating with key opinion leaders. Lara holds a PhD in Genetic and Molecular Epidemiology from Case Western Reserve University, an MS in Genetic Counseling from The Ohio State University as well as degrees in engineering and economics.