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Immunovia AB (IMMNOV: Nasdaq Stockholm) has announced the publication of its Annual Report for 2024. The company specializes in diagnostic solutions focused on increasing pancreatic cancer survival rates through early detection using blood-based testing technology.
Immunovia's primary market is the United States, where an estimated 1.8 million individuals are considered high-risk for pancreatic cancer and could benefit from annual surveillance testing. The company develops tests to detect specific proteins and antibodies that indicate pancreatic cancer development in high-risk individuals, working closely with healthcare providers, experts, and patient advocacy groups.
Immunovia has announced additional positive results from its VERIFI study for its next-generation pancreatic cancer blood test. The test demonstrated 77% sensitivity in detecting stage I and II pancreatic cancer, exceeding the target of 65% and outperforming the CA19-9 biomarker's 69% sensitivity.
The test showed 88% specificity, slightly below the 90% target but comparable to CA19-9's 89%. Combined data from VERIFI and CLARITI validation studies demonstrated consistent accuracy across various high-risk groups, including individuals with family history, genetic mutations, diabetes, and pancreatic cysts.
The company plans to launch the test commercially in Q3 2025, with additional clinical studies planned throughout the year to support regulatory submissions and payer reimbursement efforts. Immunovia is also seeking commercial partners to accelerate market adoption.
Immunovia (IMMNOV: Nasdaq Stockholm), a pancreatic cancer diagnostics company, has announced a webcast scheduled for March 24, 2025, at 3 pm CET to present additional results from their successful VERIFI clinical validation study. The study results, initially published on March 19, 2025, were positive for their next-generation pancreatic cancer test.
CEO Jeff Borcherding and VP Clinical and Medical Affairs Dr. Norma Alonzo Palma will lead the English-language presentation, which will include a Q&A session. The company focuses on developing blood-based testing to detect proteins and antibodies indicating high-risk pancreatic cancer cases.
Immunovia estimates that 1.8 million individuals in the USA, their largest target market, are at high-risk for pancreatic cancer and could benefit from annual surveillance testing.
Immunovia (IMMNOV: Nasdaq Stockholm) has announced positive results from the VERIFI study, their second clinical validation study of their next-generation pancreatic cancer test. The test successfully achieved its primary endpoint by detecting 77% of stage I and II pancreatic cancer cases.
Dr. Patricio Polanco from the Harold C. Simmons Comprehensive Cancer Center highlighted the test's high accuracy in detecting early-stage PDAC in high-risk patients. CEO Jeff Borcherding emphasized that this second successful validation will support insurance reimbursement efforts.
The company plans to launch the next-generation test in Q3 2025. Additional clinical studies are planned throughout the year to evaluate clinical impact and accuracy in other high-risk populations, supporting regulatory submissions and payer reimbursement. Immunovia is also seeking commercial partners to accelerate market adoption.
Immunovia (IMMNOV: Nasdaq Stockholm) announces that its CLARITI study results have been selected for a distinguished plenary presentation at the Digestive Disease Week® (DDW) 2025 conference on May 5, 2025. The study was chosen as one of only six abstracts for the AGA Institute Council's Pancreatic Disorders Section Distinguished Abstract Plenary.
Dr. Aimee Lee Lucas, Chief of Gastroenterology at Mount Sinai West and Mount Sinai Morningside Hospitals, will present findings on the clinical validation of Immunovia's novel blood-based multi-biomarker test for early pancreatic ductal adenocarcinoma (PDAC) detection in high-risk populations. As a member of Immunovia's Scientific Advisory Board, Dr. Lucas contributed to the study's design and sample collection.
Immunovia (IMMNOV: Nasdaq Stockholm), a pancreatic cancer diagnostics company, announced it is searching for a new Chief Financial Officer as it prepares to commercialize its test in the USA in the second half of 2025. The company seeks a CFO with diagnostics or med tech operating experience, US industry contacts, and expertise in communicating with global capital markets.
Current CFO Karin Almqvist Liwendahl will step down at the end of Q1 2025, after contributing to streamlining the organization, lowering operating costs, and reducing cash burn over the past three years. In the interim, CEO Jeff Borcherding and the finance team will assume financial leadership responsibilities.
Immunovia focuses on developing blood-based testing for early pancreatic cancer detection. The company estimates that 1.8 million high-risk individuals in the USA could benefit from annual surveillance testing, making it the world's largest market for pancreatic cancer detection.
Immunovia AB (IMMNOV: Nasdaq Stockholm) has announced its Nomination Committee appointments ahead of the 2025 Annual General Meeting. The committee comprises four members representing 5.65% of shares and votes: Christer Køhler (representing Jens Henrik Jensen), Mats Leifland (representing Vincent Saldell), Sara Ek (representing Carl Borrebaeck), and Peter Høngaard Andersen as Board Chair.
CEO Jeff Borcherding declined to appoint a representative to ensure committee independence. The committee will prepare proposals for the AGM scheduled for May 14, 2025, including board nominations and compensation recommendations. The focus is on ensuring board competencies align with the company's transition from R&D to US commercialization.
Immunovia focuses on developing blood-based testing for early pancreatic cancer detection, targeting the US market where an estimated 1.8 million high-risk individuals could benefit from annual surveillance testing.
Immunovia (IMMNOV) announced the publication of its discovery study in the Journal of Proteome Research, marking it as the largest pancreatic cancer proteomics study to date. The study identified 41 protein biomarkers that strongly correlate with pancreatic ductal adenocarcinoma (PDAC). The research evaluated approximately 3,000 proteins in 329 blood samples from Stage I and II PDAC and non-PDAC matched control patients.
Five of these biomarkers were selected for Immunovia's next-generation test, which demonstrated excellent sensitivity and specificity in detecting early-stage pancreatic cancer. The company plans to launch this test for high-risk individuals in the second half of 2025.
Immunovia reported significant achievements in 2024 and outlined plans for 2025. The company successfully developed and validated its next-generation pancreatic cancer detection test, achieving 94% specificity and 78% sensitivity in a large clinical validation study of 1,066 blood samples. The test outperformed CA19-9 biomarker by 14 percentage points and showed even better results (83% sensitivity, 96% specificity) in more recent samples.
For 2025, Immunovia plans to launch the test in the US during the second half of the year, targeting medical centers with high-risk pancreatic cancer surveillance programs. The company is seeking strategic partnerships with large diagnostics companies to accelerate commercialization and will conduct additional clinical studies to secure reimbursement.
Immunovia (IMMNOV) announced that CEO Jeff Borcherding and board members will fully exercise their TO2 warrants from the May 2024 rights issue. In total, holders of 1,651,608 warrants have confirmed their intention to exercise during the upcoming period. Each TO2 warrant allows subscription for one new share at 70% of the volume-weighted average price during December 12-27, 2024, with a cap at 125% of the rights issue price (SEK 0.63). The subscription period runs from January 2-16, 2025.
The CEO expressed confidence in the company's mission and recent CLARITI study results validating their next-generation pancreatic cancer detection test. Immunovia focuses on early detection of pancreatic cancer through blood-based testing, targeting the US market where an estimated 1.8 million high-risk individuals could benefit from annual surveillance.
