Immunovia Publishes Full Year Report 2021

LUND, SWEDEN, Feb. 17, 2022 /PRNewswire/ -- Immunovia has today published its full year report 2021. It is available on Immunovia's website.

First product launched in US, well positioned for market penetration

Fourth quarter

• Net sales amounted to kSEK 305 (152) divided between sales of tests kSEK 278 (0) and royalties kSEK 27 (152).
• Net earnings amounted to MSEK -47 (-46) and earnings per share before and after dilution were SEK -2.08 (-2.04).
• Cash flow from operating activities amounted to MSEK -50 (-36).
• Cash and cash equivalents at the end of the period amounted to MSEK 287 (468).
• In December PanDIA-1, the world's most comprehensive prospective study for the early detection of pancreatic cancer in the new onset diabetes type 2 high risk group, achieved the milestone of having collected 6 000 samples, the targeted sample size.
• Immunovia honored World Pancreatic Cancer Day by a grand opening celebration of the US Subsidiary Immunovia, Inc.
• After year-end, on January 20, Philipp Mathieu assumed the role as Acting CEO and President. He replaced Patrik Dahlen who announced his intention to step down in November.

January-December

• Net sales amounted to kSEK 844 (362) divided between sales of tests kSEK 344 (0) and royalties kSEK 500 (362).
• Net earnings amounted to MSEK -156 (-146) and earnings per share before and after dilution were SEK -6.89 (-6.84).
• Cash flow from operating activities amounted to MSEK -153 (-121).
• Cash and cash equivalents at the end of the period amounted to MSEK 287 (468).

CEO's comments

Immunovia's IMMray™ PanCan-d, is the first ever blood test dedicated to early detection of pancreatic cancer with best-in-class performance, as compared to standard of care testing methods. This positions the company at the absolute forefront of new pancreatic cancer surveillance testing.

The commercial launch of IMMray™ PanCan-d in the US in August 2021 was a major milestone in Immunovia's mission to change the testing paradigm and increase the survival rates for pancreatic cancer patients. In targeting pancreatic cancer, which is expected to become the second leading cause of cancer-related deaths by 2040 in the US, Immunovia is the front-runner in addressing a huge and increasing unmet medical need. With a global 5-year survival rate today of only 5–9 percent, pancreatic cancer is today the third deadliest form of cancer, taking more lives than e.g, breast cancer, prostate cancer, and leukemia. Early detection as provided by Immunovia has the potential to increase the five years survival rate up to 50 percent.

I feel honored to lead Immunovia as CEO in this pivotal phase of the company's development as it transitions from a research company to an early-commercial company establishing itself as a leader in the field of early detection of pancreatic cancer.

In my initial weeks with Immunovia, I have witnessed the passion and professional excellence of our employees in Europe and the US. The team has industry-leading competences, is hugely dedicated and energized by its commitment to the mission of improving the survival rates of pancreatic cancer.

In constructive conversations with both the Board and employees I had the opportunity to make an initial assessment of the company's situation and the road which lies ahead. Immunovia's road ahead requires focus and strategic direction, however, I feel very confident that we will succeed.

We are in the middle of refining the strategic roadmap for the company over the next 12-18 months. I nevertheless would like to take the opportunity to already now provide an update on some of the company's most important projects:

• Ensuring reimbursement coverage for IMMray™ PanCan-d in the US will enable an increasing population of patients with a family history of pancreatic cancer in the US to get insurance coverage for testing. During 2021 Immunovia has further refined its reimbursement plan in collaboration with Precision for Medicine Inc, a team of leading experts in the field of diagnostic reimbursement in the US. Through our extensive payer surveys and targeted research publications we feel confident about Immunovia's ability to achieve positive reimbursement coverage decisions.
• The results of the blinded validation study of IMMray™ PanCan-d were announced on the 29th of March 2021. The peer-reviewed study results have already been accepted for publication by the Journal for Clinical and Translational Gastroenterology and the full study will be published in the coming weeks. This is an important step for attaining the PLA-code (Proprietary Laboratory Analysis) and moves us a step closer towards our goal of reimbursement in the US.
• PanFAM-1 is a multicenter prospective study for early detection of pancreatic cancer in individuals presenting with hereditary/familial risk factors. The main goal of the study is to provide actionable information to the clinicians regarding diagnosis of pancreatic cancer. Furthermore, the study will deliver clinical performance data for IMMray™ PanCan-d from a cohort of highrisk asymptomatic individuals compared with currently used surveillance methods i.e. imaging technologies. We have concluded sample collection across the 23 global study sites (starting December 2017 and ending April 2021) with a total of over 3 000 samples from 1 265 subjects. Currently, these samples are being analyzed at our CLIA laboratory in Marlborough and the results will be made public in mid 2022.
• PanDIA-1 started in January 2018 as the world's most comprehensive prospective sample collection for early detection of pancreatic cancer in the new onset diabetes type 2 high risk group. In December 2021, 6 000 samples had been collected from new onset diabetes patients, of which approx. 5 100 are above the age of 50 years. The samples were collected from new onset diabetic patients starting at the time of diabetes diagnosis over a 3-year period, the time span during which patients with new-onset diabetes type 2 have up to 6-8 times higher risk of developing pancreatic cancer than the normal population. In collaboration with ANDIS (All New Diabetics in Skåne) and ANDIU (All New Diabetics in Uppsala) the team is currently obtaining the associated clinical records related to the collected samples. An update will be provided during Q2 this year.
• PanSYM-1 started in November 2018 as a prospective validation study for the early diagnosis of pancreatic cancer in patients with nonspecific but concerning symptoms and other risk factors. The sample collection was conducted at the University College Hospital, London, and The Royal Free Hospital. The study was intended to demonstrate that IMMray™ PanCan-d was equal or better than the standard of care diagnostic pathway. The target sample collection size was 2 000, which was not achieved due to the impact of Covid-19 on patient attendance at the hospitals enrolled in the study. Due to the shortage of samples, the primary endpoints, sensitivity, and specificity of the IMMray™ PanCan-d assay as compared to the standard of care could not be evaluated as intended. Study samples were instead included in the Commercial Test Model and other studies of IMMray™ PanCan-d. In particular more than 200 patient samples from PanSYM-1 were used in the performance study announced on 29th of March 2021 that showed 92 percent specificity and 80 percent sensitivity in discriminating early stage I/II pancreatic cancer from high-risk symptomatic patients. This underscores the promising potential IMMray™ PanCan-d has in this patient group. We are currently investigating our options to fully validate the promising results for IMMray™ PanCan-d in the symptomatic risk group. At the same time, we continue to work with our Key Opinion Leader-network to focus on pancreatic cancer detection in symptomatic patients.
• IMMray™ in other indications continue to be in the discovery phase. We are currently assessing options to maximize the potential of each of our discovery programs in other cancer indications and autoimmune diseases.
• Following the commercial launch in the US, the near-term focus of Immunovia will be the US market, but we also see a strong potential in other markets and we continue to review market access and prioritize according to its potential.

Looking forward into 2022, the initial launch of IMMray™ PanCan-d has been very positively received by early adopters amongst both doctors and patients in the US, who see it as a highly needed addition to the diagnostic tool set for pancreatic cancer as exemplified by the following physician quotes:

Dr. Rajesh Keswani, Gastroenterologist, Northwestern University, remarks "Patients seem to be very pleased with the testing, and all my patients undergoing testing have been appreciative of the opportunity to get this testing and certainly those with normal testing have expressed relief with this further reassurance. As of now, I think the IMMray™ PanCan-d test is another step towards reducing mortality from pancreatic cancer.

Geoffrey M. Burns MD, Family Physician at the Renaissance Family Medicine of Wellesley, remarks: "Given the high specificity of the IMMray™ PanCan-d test, I feel I can offer reassurance and peace of mind to my patients who are concerned about their family history of pancreatic cancer. I appreciate the streamlined process for ordering the test and the ease of receiving the results."

Steven Rubin M.D., Family Physician from Paramus, New Jersey, says: "The test developed by Immunovia, IMMray™ PanCan-d, is an important diagnostic tool to assist in early detection in high-risk patients for Pancreatic carcinoma, along with MRCP/MRI and endoscopic ultrasound with biopsy." He continues, "I personally had the IMMray™ PanCan-d done and probably will have this done alternating with the other above mentioned diagnostic modalities for surveillance of my medical condition. Anything that can be done to find early stage 1 or 2 disease with the potential for cure of pancreatic carcinoma which has a high mortality, is warranted and imperative."

We expect the volumes of tests to significantly increase once insurance coverage is available, with the ambition to have initial coverage in place towards the end of 2022. Until then we see self-pay tests to continue at moderate volumes, which are no indication for the full potential of IMMray™ PanCan-d, as seen with comparable diagnostics tests pre reimbursement in the US.

In short, Immunovia is well positioned as the frontrunner in the early detection of pancreatic cancer, and I very much look forward to working with Immunovia's employees and its Board as well as our community including Key Opinion Leaders to make IMMray™ PanCan-d available to as many patients as possible. The company's mission of increasing the survival rates for this lethal cancer are a hugely motivating and driving force for all of us.

I also want to thank our shareholders for their trust as well as continued support.

February 17, 2022

Philipp Mathieu, Acting CEO and President,

Immunovia AB

For more information, please contact:

Philipp Mathieu

Acting CEO and President

Email: philipp.mathieu@immunovia.com  

Tobias Bülow

Senior Director Investor Relations and Corporate Communications

Email: tobias.bulow@immunovia.com

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 08:30 am CET on February 17, 2022.

Conference call

Immunovia will hold a teleconference at 10:00 am CET on February 17 with President and CEO Philipp Mathieu.

To take part of the presentation, please dial one of the numbers or watch via the web link below.

Sweden: +46 8 50 55 83 53

United Kingdom: +44 33 33 00 92 62

United States: +1 63 19 13 14 22, PIN: 24290298#

Belgium: +32 26 20 05 47

Denmark: +45 78 15 01 08

France: +33 17 07 50 720

Germany: +49 69 22 22 20 377

Norway: +47 23 96 36 88

Switzerland: +41 22 56 75 632

Netherlands: +31 10 71 29 162

Link to the webcast: https://financialhearings.com/event/14003

About Immunovia 

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.

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