Significant events after the period
Immunovia continues to build on its unique position as the front-runner in innovative early detection of pancreatic cancer. The team at Immunovia, both in Sweden and in the US, has been working relentlessly in the pursuit of Immunovia’s mission to improve pancreatic cancer survival rates by making IMMray™ PanCan-d broadly available.
During the first quarter, which also was the second full quarter of IMMray™ PanCan-d being commercially available in the US, Immunovia delivered several significant milestones focusing on its strategic priorities for 2022. The first important milestone was the publication of the peer-reviewed blinded validation study in Clinical and Translational Gastroenterology providing additional independent clinical validation of IMMray™ PanCan-d’s performance. The shown performance is unmatched and demonstrates that the IMMray™ PanCan-d blood test can detect pancreatic cancer with a 99 percent specificity and a sensitivity of 92 percent for all stages, and a specificity of 99 percent and sensitivity of 89 percent in the early stages.
The CAP accreditation of our laboratory in Marlborough was another step towards making IMMray™ PanCan-d broadly available throughout the US. The College of American Pathologists (CAP) awarded the accreditation to our US subsidiary based on the positive results of a recent onsite inspection as part of its CAP Accreditation Program. The CAP accreditation not only signifies the highest quality standards of our laboratory, it also allows us to seek licensure in the five remaining US states including California and New York.
Our US team was significantly strengthened through the addition of Jeff Borcherding who will lead our US business and the US commercialization of IMMray™ PanCan-d. Previously Chief Marketing Officer at Myriad Genetics, Jeff is qualified through a number of previous commercial leadership roles and comes with extensive commercial experience in growing diagnostic businesses and healthcare brands in the US market.
Attaining reimbursement in the US as quickly as possible remains key in our mission of making IMMray™ PanCan-d broadly available. We continue executing to have initial insurance coverage towards the end of the year. We are collaborating closely with key opinion leaders and have initiated a physician experience program in the US. The physician experience program aims at selected pancreatic cancer high-risk-surveillance centers which will be provided no-charge testing for a limited number of their patients. Physicians will be able to broadly include IMMray™ PanCan-d in their standard testing routines and assess patient benefit first-hand. Self-pay test volumes continue as anticipated at low levels pre-reimbursement, but we expect volumes of tests to significantly increase once broad insurance coverage is available.
Our prospective trials, PanFAM-1 and PanDIA-1 continue, and as previously announced in the year-end report we intend to provide an up-date on PanDIA-1 during the second quarter this year as well as announce results of PanFAM-1 in mid-2022. Regarding PanSYM-1 we are, as also announced in the year-end report, investigating our options to fully validate the promising and previously reported results for IMMray™ PanCan-d in the symptomatic risk group. In the meantime, we continue to work with our Key Opinion Leader network to focus on pancreatic cancer detection in symptomatic patients.
To fully focus on extending Immunovia’s unique position as an innovation leader in the field of pancreatic cancer we have decided to deprioritize our discovery programs in autoimmune diseases and lung cancer. We are evaluating options on how to best leverage the value of those programs but will currently not dedicate additional resources thereto. Resources will be fully focused on pancreatic cancer and Immunovia becoming the undisputed leader in this field.
In summary, Immunovia has made significant progress in the first quarter. The company is fully focused and well positioned for penetrating the US market and generating significant future growth. IMMray™ PanCan-d continues to be the best-in-class performing test and the first of its kind. Immunovia is positioned as the innovation leader in early detection of pancreatic cancer, and we further extend this leadership position. We have a clear path towards insurance coverage and an industry-leading team, highly passionate about the mission to improve pancreatic cancer survival rates. We aim to make a real difference in addressing the huge unmet medical need for early diagnosis of pancreatic cancer.
April 28, 2022
Philipp Mathieu, Acting CEO and President
For more information, please contact:
Acting CEO and President
Karin Almqvist Liwendahl
Chief Financial Officer
Senior Director Investor Relations and Corporate Communications
Tel: +46 736 36 35 74
The information in this report is information that Immunovia AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08:00 am CET on April 28, 2022.
Immunovia will hold a webcast tele conference at 13:00 pm CET on April 28 with Acting President and CEO Philipp Mathieu and CFO Karin Almqwist Liwendahl.
To take part of the presentation, please dial one of the numbers or watch via the web link below.
Sweden: +46 8 5051 0031
United Kingdom: +44 207 107 06 13
United States: +1 631 570 56 13
Link to the webcast: https://creo-live.creomediamanager.com/c062bfe9-6671-4cee-a51a-3ed5d¬85ca715
Immunovia AB is a diagnostic company with the vision to revolutionize blood-based diagnostics and increase survival rates for patients with cancer.
Our first product, IMMray™ PanCan-d is the only blood test currently available specifically for the early detection of pancreatic cancer. The test has unmatched clinical performance. Commercialization of IMMray™ PanCan-d started in August 2021 in the USA and IMMray™ PanCan-d is offered as a laboratory developed test (LDT) exclusively through Immunovia, Inc. For more information see: www.immunoviainc.com.
Immunovia collaborates and engages with healthcare providers, leading experts and patient advocacy groups globally to make this test available to all high-risk pancreatic cancer groups.
The USA, the first market in which IMMray™ PanCan-d is commercially available, is the world’s largest market for the detection of pancreatic cancer with an estimated value of more than USD 4 billion annually.
Immunovia’s shares (IMMNOV) are listed on Nasdaq Stockholm. For more information, please visit www.immunovia.com.
Immunovia Interim Report, January-March 2022