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CEO presents Immunovia

The most important event during Q3 was that we announced positive results from the IMM­ray PanCan-d verification study. The analysis from the verification study showed results in line with the previous commercial test model study (CTMS) and was the beginning of the last stage towards CLIA-CAP accreditation in the USA, the final blind validation study.

Q3 started with a virtual presentation by Immunovia’s Thomas King, MD, Ph.D. and Laura Chirica, Ph.D., at the annual meeting of the International Association of Pancreatology (IAP) at the Euro­pean Pancreatic Club (EPC) on July 2, 2020, one of the most important events in the world in the field of pancreatic cancer. Immunovia’s representatives were invited to present an update on the IMMray™ PanCan-d test. This presentation was attended by specialist doctors and was very well received.

In July, we also launched the ”Immunovia Walk Around the World to Raise Awareness for Pancreatic Cancer”, an initiative to raise awareness of pancreatic cancer. Participation in this event has been extremely pleasing and it has been very satisfying to see and hear all the photographs and videos that the participants have shared so far. We will continue to walk around the world until ”World Pancreatic Cancer Day” which this year falls on November 19. By the end of the quarter, we had walked about 25,000 kilometers and over 1,500 people had visited the registration page from over 25 countries worldwide.

In early September, the second webinar in the IMMray™ PanCan-d series was hosted with Linda Mellby, Ph.D, Thomas King, MD, Ph.D. and Laura Chirica, Ph.D., who gave a more detailed presen­tation of the results of the Commercial Test Model Study (CTMS) as well as an update of all our launch activities. A recording of the webinar is available on our website.

During the quarter, we recruited new staff to the Immunovia team in preparation for the start of sales. Our marketing activities have also intensified.

Due to the effect of COVID-19 in the USA, UK, Germany and Spain, patient flow at the sample collection centers fell significantly. The previously agreed sample collection rate and the collection of the additional samples needed to complete the validation stu­dy in accordance with previously communicated timeline for Q4 2020 was affected. Based on the current impact of COVID-19 on sample collection, the company is aiming to start sales at the end of Q1, with subsequent commercial diagnostics during Q2.

We announced the appointment of Patrik Dahlen as our new CEO starting on November 1, 2020, and that Mats Grahn will continue as a board member. This was decided at Immunovia’s Extraordi­nary General Meeting held on September 23, 2020.

As I now begin my new role as a board member of Immunovia, I want to state how incredibly proud I am of what we have achieved, not only during Q3 this year, but from Immunovia’s humble beginnings until the present day.

It feels really good to hand over the baton to Patrik Dahlen, who I have known for a long time and who is one of the most experienced leaders in the international diagnostics industry. Patrik is not only a highly respected business leader with wide-ranging international experience and knowledge of the international diagnostics industry, but he also knows Immunovia well from the ground up, as he was one of our board members during the initial years.

Mats Grahn,
outgoing CEO and current board member of Immunovia AB

 

I am honored to come to Immunovia during this crucial and exciting time in the company’s history. I believe that Immunovia is in a position to develop into a dominant market leader in the blood-ba­sed diagnosis of pancreatic cancer and I look forward to the exciting further development of the company.

I would like to emphasize that Immunovia continues to have the goal of long-term market penetra­tion of 30% after cost reimbursement has been achieved 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 USA, across the three risk groups the company targets: hereditary/familial, diffe­rential diagnosis of early symptoms and newly diagnosed diabetes in individuals over 50. We look forward to continuing to work with caregivers around the world.

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

Patrik Dahlen, CEO at Immunovia AB

November 2020

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