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CEO presents Immunovia

Immunovia is approaching commercial breakthrough: A sales start is planned for the first quar­ter of 2021. We look forward to helping patients through early detection of pancreatic cancer.

All Immunovia employees are incredibly proud of the progress we have made in 2020, espe­cially with regard to the October 2020 milestone when we were able to document 94 percent accuracy for IMMray™ PanCan-d, the company’s first blood test for the diagnosis of pancreatic cancer in the early stages of the disease when it is still possible to conduct surgery. The result opens the way for significantly improved care and survival of patients suffering from this deadly disease.

The entire business is now focusing wholeheartedly on reaching the introduction of our blood test in the first quarter of 2021.

As 2020 ends, we continue to take major steps forward to launch our first diagnostic test IMMray™ PanCan-d on the U.S. market in the first quarter of 2021. We concluded the year with extraordinari­ly good results from the Verification Study, confirming the unique ability of our product to differen­tiate pancreatic cancer stages I to IV compared to clinically relevant control groups (i.e. patients with non-specific but worrying symptoms, including type II diabetes, as well as healthy individuals). Like the rest of the world, we had several challenges in 2020 due to the COVID-19 pandemic, which led to closing the Immunovia Dx laboratory in the United States for several months during the ”lockdown” period. Additionally, the clinicians involved in our clinical studies have had difficulty collecting relevant samples for long periods of time. However, despite the difficulties, our staff showed strong commitment and perseverance to find solutions for achieving our milestones.

In 2020 a successful share issue was carried out. Currently, Immunovia is in a strong financial position in preparation for a crucial milestone for the business – the launch of the first com­mercial test, IMMray™ PanCan-d for early detection of pancreatic cancer.

Early detection is crucial for improving treatment outcomes in cancer care

Cancer diseases have recently overtaken cardiovascular diseases as the leading cause of death in the industrialized world. With the globally increased burden of cancer, the need and demand to diagnose cancer at an early stage is rapidly growing. Healthcare systems all over the world are being transformed towards applying more proactive methods, including more preventive care, early diagnosis and personalized treatments. Regulatory authorities are implementing processes for priority approvals and new value-based payment models are also being introduced.

Since pancreatic cancer is one of the deadliest forms of cancer and the diagnosis is often made too late, early detection is crucial. Globally, around 350, 000 people are diagnosed each year and the figure is rising rapidly. An early-stage pancreatic cancer detection test, such as IMMray™ PanCan-d, has the potential to dramatically increase the survival rate for patients. Immunovia’s goal is to make early diagnosis a priority for all stake holders.

Intensified preparations for the launch in 2021

With one milestone remaining – a final validation study before the start of sales of IMMray™ PanCan-d in the first quarter of 2021, we are now stepping up the final preparations for launch. We have been successful in establishing a large network of world-renowned Key Opinion Leaders (KOL) and healthcare specialists. They have not only collaborated with us on how to use the test in prac­tical clinical work, but also provided us with the necessary blood tests, collected in a real clinical environment, to test and validate our IMMray™technology. Immunovia’s team in the United States and the laboratory in Marlborough, MA have implemented a logistics and distribution system that provides rapid test results, supporting all our US customers. We have established a scalable sales and marketing organization that caters for our top clinical customers across the United States. Collaborating with different patient organizations has also been a focus area for us, as they play an important role in creating awareness of the disease and supporting patients and their families.

Successful results from the verification study pave the way for sales start during the first quarter 2021

As communicated thorough press releases and webinar during the third and fourth quarters, our verification study was successful. The study was conducted with signature and bioinformatics algo­rithms from the commercial test model study (CTMS). As reported, IMMray™ PanCan-d in combina­tion with tumor marker CA 19-9, showed an accuracy of 94% when it comes to distinguishing stage I/II PDAC patients from healthy controls. We reported a specificity of 99% and a sensitivity of 78%, as well as a high NPV of 99.3% for this patient group.

There is an increasing need for early diagnosis of cancer from the perspective of all stakehol­ders in healthcare. Immunovia’s technology is positioned to address and meet these needs.

Programme with prospective clinical studies continues as planned

To validate the clinical benefit of IMMray™ PanCan-d, especially important for obtaining reimbur­sement from insurance systems, Immunovia’s three major prospective studies covering the three main risk groups for pancreatic cancer continued in 2020:

  • Familial/Hereditary – PanFAM-1 study,
  • New diabetes diagnosis after the age of 50, ”NOD type 2” – PanDIA-1 study,
  • Patients who show symptoms that may indicate pancreatic cancer – PanSYM-1study.

These three clinical studies, among the largest studies in the world for these three risk groups, involve 30 cancer centers in the United States and Europe and over 10,000 individu­als.

All three studies are proceeding according to plan. Interim results will be reported already in the second half of 2021

Early stage development projects

In addition to our main focus on pancreatic cancer, Immunovia conducts early projects in other cancer applications and autoimmune diseases. These are in early stages of development (”Discove­ry Studies”) and we are establishing Key Opinion Leader collaborations to gain access to expertise on clinical needs, as well as high-quality blood tests with clinical information represents these indications. These collaborations mark the most important key activity for succeeding in subse­quent studies, results of which will be crucial for deciding on investing in further development phases (”Development Studies”), leading to product development, a much larger financial commit­ment than ”Discovery studies”. Since these project are part of our discovery program we do not set timelines for them.

New CEO

As the new CEO, I am honoured to start serving Immunovia at this crucial and exciting time in the company’s history. I believe that Immunovia is in a position to advance into a dominant market leader for blood-based diagnosis of pancreatic cancer and I look forward to the exciting further development of the company.

I would like to underline that Immunovia continues to set its goal to reach a long-term market penetration of 30 percent after achieving reimbursement with extensive geographical coverage. The current size of the addressable market for IMMray™ PanCan-d is estimated to exceed USD 4 billion in the EU and the US, from the three risk groups targeted by the company: hereditary/familial, differen­tial diagnosis of early symptoms and recently diagnosed type II diabetes in indivi­duals over 50 years of age. We look forward to continuing to work with healthcare providers around the world.

On behalf of the Board of Directors and the entire Immunovia Team, I thank you for your continued support for Immunovia’s efforts to contribute to a positive impact on the lives of those at risk of pancreatic cancer.

February 2021
Patrik Dahlen CEO, Immunovia AB

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