Immunovia Ab Stock Price, News & Analysis

Immunovia AB (IMMVF) is a diagnostic company focused on the early detection of pancreatic cancer through blood-based testing. According to the company, its mission is to increase survival rates for patients with pancreatic cancer by identifying the disease at an early, more treatable stage. Immunovia’s shares trade on Nasdaq Stockholm under the symbol IMMNOV, and the company describes the United States as the world’s largest market for pancreatic cancer detection.

Immunovia develops and commercializes blood-based tests that detect proteins and antibodies associated with pancreatic cancer in individuals at increased risk. The company states that its next-generation pancreatic cancer test is designed as a simple blood test to classify cancerous and non-cancerous samples, with a particular focus on detecting stage I and II pancreatic ductal adenocarcinoma in high-risk populations. Immunovia reports that its test has shown high sensitivity and specificity in clinical validation and verification studies, including the CLARITI and VERIFI studies, and that it has outperformed CA19-9, a commonly used biomarker for pancreatic cancer, in these settings.

Business focus and diagnostic platform

Immunovia describes itself as a diagnostic company developing highly accurate blood tests for early cancer detection based on its proprietary IMMray™ test platform. This platform uses antibody biomarker microarray analysis together with machine-learning and bioinformatics to identify sets of biomarkers that form a disease-specific signature. The company’s first product, the IMMray™ PanCan-d test, has been developed for the early detection of pancreatic cancer in high-risk individuals and has been evaluated in large clinical studies such as PanFAM-1, PanSYM-1 and PanDIA-1.

The company reports that IMMray™ PanCan-d has been offered as a laboratory developed test (LDT) through Immunovia’s laboratory operations, with commercialization in the United States having begun earlier. Immunovia has also communicated that it has developed a next-generation pancreatic cancer blood test that builds on its biomarker and algorithm work and that this test is being prepared for commercial launch.

Clinical studies and evidence generation

Immunovia emphasizes clinical evidence as a core part of its business model. The company has conducted and participated in several major studies aimed at validating its pancreatic cancer tests in high-risk populations:

• PanFAM-1: A large, multicenter prospective study in individuals with familial or hereditary risk of pancreatic cancer. Immunovia reports that PanFAM-1 collected more than 3,000 blood samples from 1,265 subjects across numerous surveillance programs in the United States, Canada and Europe, with the goal of diagnosing pancreatic cancer early and comparing IMMray™ PanCan-d performance with imaging-based surveillance.
• PanSYM-1 and PanDIA-1: Clinical studies mentioned by Immunovia as part of the evaluation of IMMray™ PanCan-d in different high-risk or symptomatic groups.
• CLARITI study: A clinical validation study in a high-risk population in which Immunovia states that its next-generation test achieved high sensitivity and specificity for stage I and II pancreatic cancer and exceeded pre-defined performance targets. The company highlights that the test showed higher sensitivity than CA19-9 and that the specificity compared favorably with commonly used imaging approaches.
• VERIFI study: A study of the next-generation test using blood samples from multiple leading pancreatic cancer centers in the U.S. Immunovia reports that the test detected significantly more cancers than CA19-9, with specificity in line with CA19-9, and that the study met its primary endpoint for detecting early-stage pancreatic cancer. Combined data from CLARITI and VERIFI are described as demonstrating strong and consistent test performance across several high-risk groups.

Across these studies, Immunovia highlights performance metrics such as sensitivity and specificity for early-stage pancreatic cancer detection and emphasizes the potential of its blood test as a complement to imaging-based surveillance.

Target patient groups and market focus

Immunovia focuses on individuals at increased risk for pancreatic cancer. The company notes several high-risk categories evaluated in its studies, including people with a family history of pancreatic cancer, carriers of certain genetic mutations, individuals with pancreatic cysts, and patients with diabetes. In its communications, Immunovia states that it aims to make its test available to these high-risk groups through collaborations with healthcare providers and high-risk surveillance programs.

The company repeatedly identifies the United States as its primary commercial focus and as the largest market for pancreatic cancer detection. Immunovia estimates that about 1.8 million individuals in the U.S. are at high risk for pancreatic cancer and could benefit from annual surveillance testing. The company has described efforts to obtain clinical laboratory permits in multiple U.S. states, to work with high-risk surveillance centers, and to engage with payers and regulators to support reimbursement and broader adoption of its tests.

Commercialization and capital raising

Immunovia’s disclosures describe a progression from research and development to commercialization. The company has reported commercialization of IMMray™ PanCan-d as an LDT in the U.S., initial adoption by clinicians and surveillance centers, and a transition toward a next-generation pancreatic cancer test. Immunovia has also outlined plans to launch the next-generation blood test in the U.S. market and to conduct additional clinical studies to support reimbursement and regulatory submissions.

To fund its operations and clinical programs, Immunovia has carried out several capital-raising activities, including rights issues and warrant programs. The company has described rights issues of units that included shares and warrants (series TO 2 and TO 3), as well as subscription and guarantee commitments from investors. These financings are presented by the company as supporting preparation for U.S. commercialization of its next-generation test, further clinical studies, and general operations.

Collaborations and ecosystem

Immunovia states that it collaborates and engages with healthcare providers, leading experts and patient advocacy groups to expand access to its tests. The company has highlighted relationships with high-risk pancreatic cancer surveillance programs, academic medical centers and research consortia in the U.S. and Europe. In earlier communications, Immunovia has also referred to strategic R&D collaborations with diagnostics partners and to participation in large, multi-center clinical studies funded by external organizations.

Through these collaborations, Immunovia positions its blood-based tests as part of broader efforts to improve early detection of pancreatic cancer, complementing existing imaging-based surveillance methods and contributing data to clinical research.

Company background

Immunovia reports that it was founded based on cancer research conducted at Lund University and the CREATE Health Cancer Center in Sweden. The company’s work centers on antibody biomarker microarrays and advanced data analysis to identify disease-specific biomarker signatures in blood. Over time, this research has been translated into the IMMray™ platform and the IMMray™ PanCan-d test for pancreatic cancer, and more recently into a next-generation pancreatic cancer blood test evaluated in CLARITI and VERIFI.

Immunovia’s shares are listed on Nasdaq Stockholm under the symbol IMMNOV, and the over-the-counter symbol IMMVF is used in other markets. The company operates in the diagnostic segment of the healthcare industry and is classified in manufacturing-related categories due to its development and provision of medical testing technologies.

Key points for investors and observers

• Immunovia is a diagnostic company focused on early detection of pancreatic cancer using blood-based tests.
• The company’s IMMray™ platform uses antibody biomarker microarrays and data analysis to identify disease biomarker signatures.
• Its first product, IMMray™ PanCan-d, and a next-generation pancreatic cancer test have been evaluated in large clinical studies, including PanFAM-1, CLARITI and VERIFI.
• Immunovia targets high-risk individuals, such as those with familial or hereditary risk, genetic mutations, pancreatic cysts or diabetes.
• The United States is described as the largest market for pancreatic cancer detection, with an estimated 1.8 million high-risk individuals, and is a primary focus of Immunovia’s commercialization and reimbursement efforts.
• The company has raised capital through rights issues and warrant programs to support development, clinical validation and commercialization of its tests.

Frequently Asked Questions (FAQ)

What does Immunovia AB do?
Immunovia AB is a diagnostic company that develops and commercializes blood-based tests for the early detection of cancer, with a primary focus on pancreatic cancer. Its tests are designed to detect proteins and antibodies in blood that indicate pancreatic cancer in high-risk individuals.

What is IMMray™ PanCan-d?
IMMray™ PanCan-d is Immunovia’s first blood test for early detection of pancreatic cancer. It is based on the company’s IMMray™ platform, which uses antibody biomarker microarrays and data analysis to identify a biomarker signature associated with pancreatic cancer.

What is Immunovia’s next-generation pancreatic cancer test?
Immunovia describes a next-generation pancreatic cancer blood test that has been evaluated in the CLARITI and VERIFI studies. According to the company, this test has demonstrated high sensitivity and specificity for detecting stage I and II pancreatic cancer in high-risk individuals and has outperformed CA19-9 in these studies.

Which patients are targeted by Immunovia’s tests?
Immunovia focuses on individuals at increased risk of pancreatic cancer. The company’s materials highlight groups such as people with a family history of pancreatic cancer, individuals with certain genetic mutations, patients with pancreatic cysts and patients with diabetes, as well as high-risk symptomatic patients.

How does Immunovia’s test compare to CA19-9?
In company-reported data from studies such as CLARITI and VERIFI, Immunovia states that its next-generation test detected significantly more cancers than CA19-9, with similar specificity. The company also notes that in these studies the sensitivity of its test for early-stage pancreatic cancer exceeded that of CA19-9.

How does Immunovia’s test relate to imaging-based surveillance?
Immunovia describes its blood tests as complementary to imaging methods such as endoscopic ultrasound, MRI and CT. The company has stated that its tests aim to provide a convenient blood-based option for early detection in high-risk individuals alongside existing surveillance programs.

What is the PanFAM-1 study?
PanFAM-1 is a large, multicenter prospective study in individuals with familial or hereditary risk of pancreatic cancer. Immunovia reports that PanFAM-1 collected more than 3,000 blood samples from 1,265 subjects and is intended to provide clinical performance data for IMMray™ PanCan-d compared with imaging-based surveillance.

Where are Immunovia’s shares listed?
Immunovia’s shares are listed on Nasdaq Stockholm under the symbol IMMNOV. The symbol IMMVF is used for trading in other markets.

What market does Immunovia consider most important?
Immunovia identifies the United States as the world’s largest market for pancreatic cancer detection and estimates that 1.8 million individuals there are at high risk and could benefit from annual surveillance testing. The company has focused significant commercialization and reimbursement efforts on the U.S. market.

How does Immunovia generate funding for its activities?
Immunovia has raised capital through rights issues of units that include shares and warrants, as well as through warrant programs with subscription and guarantee commitments from investors. The company states that these financings support development, clinical studies and preparation for commercialization of its pancreatic cancer tests.