Immunovia

Striving to increase pancreatic cancer survival rates through early detection

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Advancing early detection of pancreatic cancer

Pancreatic cancer is a lethal cancer with a horribly low survival rate - just 13% at five years. That’s because that pancreatic cancer is usually detected at a late stage when the cancer has spread beyond the pancreas, and surgery is no longer an option.

Immunovia’s mission is to increase survival rates for patients with pancreatic cancer by detecting the cancer at stage 1 or 2.

There’s a significant unmet need in early detection of pancreatic cancer - and a strong desire for a simple, accurate blood test.

Early detection survival rate
44 %
Late detection survival rate
3%

About Immunovia

Leading in early detection of pancreatic cancer

Immunovia's mission is to increase survival rates for patients with pancreatic cancer through early detection

Immunovia is rapidly developing a precise blood test to detect pancreatic cancer at stage 1 or 2.

This next-generation test will give individuals at high risk for pancreatic cancer a simple, convenient and affordable way to check for early signs of cancer.

The test has shown strong results in detecting stage 1 and 2 pancreatic cancer, with specificity of 98% and sensitivity of 75%.

The Company plans to launch the new test in the US market in 2025.

Immunovia today

An efficient and productive organization

Immunovia is now a much leaner and more agile company following its significant transformation in 2023. The Company substantially reduced staffing and operating costs while increasing the pace of its development efforts.

Strong relationships with key experts

Immunovia has close, productive relationships with key professors and pancreatic cancer centers throughout Europe and the US.

Extensive biobank to drive development

Immunovia has accumulated a biobank of thousands of blood samples, including hundreds of samples from pancreatic cancer patients and samples from high-risk individuals who do not have cancer. This biobank has enabled rapid development of the company’s next-generation test.

About the test

Superior test accuracy
High specificity and sensitivity for early detection of pancreatic cancer

In the model-development study, Immunovia's next-generation test achieved specificity of 98% and sensitivity of 75% in detecting early (stage 1 and 2) pancreatic ductal adenocarcinoma (PDAC), the most common form of pancreatic cancer. The test significantly outperformed CA19-9, a biomarker commonly used to detect pancreatic cancer.

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Cost-effective and convenient
Simple and affordable blood test solution for early detection

Immunovia's next-generation test offers early detection with high accuracy through a simple and affordable blood test. Currently, individuals at high-risk for pancreatic cancer are screened annually with inconvenient and expensive imaging such as MRI and endoscopic ultrasound. Immunovia’s convenient and affordable blood test will make pancreatic cancer surveillance available to a wider population, increasing the commercial potential of the test.

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Broad applicability to diverse patient groups
Reliable performance across populations
Like Immunovia’s previous IMMray PanCan-d test, the next-generation test includes the biomarker CA19-9. However, the new test includes multiple other accurate biomarkers, so it is less reliant on CA19-9. This will enable the test to be used in a broader population of patients, including those who do not produce CA19-9. Since the inability to produce CA19-9 is more common in individuals who are Black and Hispanic, the next-generation test will be a more inclusive test that can serve patients regardless of race or ethnicity.

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Strategic shift and commercial success
Improved biomarkers and market potential
The results confirm that Immunovia made the right decision in shifting focus from IMMray™ PanCan-d to the new test. The company now has a test that includes more accurate biomarkers, surpasses CA19-9, expands the market compared to the IMMray test, and offers a much better chance of securing reimbursement and driving commercial success.

Unlike the IMMray test, the new test eliminates the "borderline" category, meaning all tested patients now receive a clear "positive" or "negative" result. This reduces uncertainty and provides both patients and clinicians with clearer guidance on the next steps in treatment.

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Video // 1:56
VD:n kommenterar

Interview highlights

" There's a tremendous clinical need in pancreatic cancer surveillance; the alternatives are not good. 

The market wants and needs a blood-based biomarker test to detect pancreatic cancer. 

We're in a great position to deliver against that need, because of our history, our biobank and our relationships. We are rapidly advancing to address this critical demand.
" The capital we are seeking will fund the analytical and clinical  validation studies needed to commercialize our next-generation test in 2025. 

We've already shown good results, but there will be a larger study to confirm that the accuracy we have shown earlier really holds true and will  be something physicians can count on. 

We are eager to move quickly to bring the test to market to satisfy the tremendous market demand for a simple blood test to detect pancreatic cancer.

Important Recent Events

Q3 2021

Launch of IMMray PanCan-d

In Q3 2021, Immunovia launched IMMray PanCan-d, the first blood test dedicated to the early detection of pancreatic cancer. The IMMray PanCan-d test was used and adopted throughout the United States at many high-risk surveillance centers. The IMMray® PanCan-d test has since been discontinued, but the test paved the way for the next-generation test the Company is now developing.
Q3 2022

Began development of the next-generation test

In Q3 2022, Immunovia initiated development of its next-generation test for early detection of pancreatic cancer. The Company sought to identify new, more accurate biomarkers to increase test performance. In November 2022, Immunovia entered into an agreement with the Swiss company Proteomedix AG to access their extensive experience in developing protein-based assays to detect cancer.
Q2 2023

Jeff Borcherding promoted to CEO

To streamline operations and increase focus on the American market, Immunovia’s board of directors appointed Jeff Borcherding as CEO in April 2023. Jeff had previously led the Company’s US operations since joining Immunovia a year earlier. He immediately began a strategic review to identify changes needed to ensure the success of the Company.
Q3 2023

Initiated a transformation of Immunovia

The company began a broad and sweeping transformation in July 2023. The transformation was intended to significantly lower costs, increase productivity, and drive speed. Immunovia discontinued the IMMray PanCan-d test to focus resources on its next-generation test. The Company also transitioned to the commercially available ELISA platform to enable faster and less expensive testing compared to the previous proprietary IMMray® platform. Finally, staffing and operating expenses were substantially reduced.
Q4 2023

Successfully completed the discovery phase of the next-generation test

The discovery study marked a critical milestone in the development of Immunovia's next-generation test for early detection of pancreatic cancer. Over a dozen proteins were identified that can be used to detect stage I and II pancreatic ductal adenocarcinoma (PDAC) in the blood. This was the most comprehensive pancreatic cancer proteomics study to date and used the Olink platform to explore nearly 3,000 protein biomarkers. The promising biomarkers identified in the discovery study were then transitioned to the ELISA platform for further testing.
Q2 2024

Positive results from the model development study

The next-generation test for pancreatic cancer achieved both the primary and secondary endpoints in a model development study. In the study, Immunovia's next-generation test demonstrated a specificity of 98% and a sensitivity of 75% for detecting early stages (1 and 2) of PDAC (pancreatic ductal adenocarcinoma), a highly aggressive and the most common form of pancreatic cancer. Immunovia's test was also significantly more accurate than CA19-9, the biomarker typically used for detecting pancreatic cancer.
Q2 2024

Moved the laboratory to Research Triangle Park, North Carolina

To further streamline operations and reduce costs, Immunovia moved its lab and US headquarters to Research Triangle Park, North Carolina in May 2024. The new lab in RTP is smaller and more cost-effective than the prior lab in Marlborough, Massachusetts. The RTP market also offered a rich and cost-effective labor market, enabling Immunovia to staff the lab with talented employees at a lower cost.
2024-2025

Analytical and clinical validity studies

During 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 US launch in 2025.
Q3 2021
Launch of IMMray PanCan-d
Q3 2022
Began development of the next-generation test
Q2 2023
Jeff Borcherding promoted to CEO
Q3 2023
Initiated a transformation of Immunovia
Q4 2023
Successfully completed the discovery phase of the next-generation test
Q2 2024
Positive results from the model development study
Q2 2024
Moved the laboratory to Research Triangle Park, North Carolina
2024-2025
Analytical and clinical validity studies

Market potential

1.8 million

peopleare at high risk for pancreatic cancer in the USA
Immunovia will initially commercialize the test in the USA,  focusing on high-risk patients who should be screened once or twice annually
A similar number of individuals in Europe are at high risk as well.
Current approaches to pancreatic cancer surveillance are not attractive because individuals under surveillance must undergo imaging diagnostics using MRI or endoscopic ultrasound. Both methods are cumbersome and expensive.

The offer

Subscription period
16 - 30 August
Subscrition price
SEK 1.02 per unit,
corresponding to SEK 0.51 per share
Issue volume
cirka 69,3 MSEK
1 share
gives the right to subscribe to
3 Unit rights
2 unit rights
gives the right to subscribe to
1 unit
1 unit
consists of
2 shares
2 TO2
1 TO3
Subscription warrant series TO 2, subscription period 12 December 2024 - 27 December 2024
Subscription warrant series TO 3, subscription period 14 March 2025 - 27 March 2025

Management

Jeff Borcherding
CEO AND PRESIDENT
Jeff became CEO in 2023 after joining Immunovia a year earlier to lead the US organization. Jeff came from Myriad Genetics, where he served as Chief Marketing Officer and General Manager of the Mental Health Diagnostics business. Earlier, he managed healthcare brands at Procter & Gamble. Jeff holds an MBA from the Kellogg School of Management at Northwestern University.
Karin Almqvist Liwendahl
CFO
Karin, an experienced CFO and Investor Relations professional, has served as CFO at Dignitana and Sprint Bioscience, and has held senior roles at Telia and Ericsson. She holds a bachelor's degree from Lund University.
Norma Palma, PhD
VP, Clinical & MedicalAffairs
Norma has extensive knowledge in oncology, diagnostics, and reimbursement issues, and most recently comes from Aadi Bioscience where she developed a medical strategic plan. Norma holds a PhD in pharmacology and physiology from Georgetown University and has completed postdoctoral studies in molecular virology at the National Cancer Institute, Cancer Research Center, Vaccine Branch in Bethesda.
Lisa Ford, PhD, HCLD
Clinical Lab Director
Lisa has many years of experience leading laboratory project teams through research, development, validation (clinical and analytical), and implementation of diagnostic tests. Lisa holds a PhD in bioorganic chemistry from Duke University and a bachelor's degree in chemistry from the University of California, as well as certification as a highly qualified clinical laboratory director from the American Board of Bioanalysis.
Tom King, MD
Medical Director
Tom joined Immunovia in 2017 and served as Clinical Lab Director for the Company’s Marlborough, Massachusetts lab, where he oversaw the IMMray PanCan-d test. A board-certified pathologist, Tom now acts as the Company’s Medical Director. Tom holds an MD and PhD from Washington University in St. Louis and managed several labs before joining Immunovia.

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