Immunovia Full Year Report, January-December 2018

STOCKHOLM, Feb. 14, 2019 /PRNewswire/ --

Throughout 2018, we continued to build on our mission to develop and validate accurate bloodbased diagnostic tests that can make a real and significant impact on healthcare worldwide and to initiate the exciting activities to commercialize those efforts.

As we accelerated the preparations for the commercialization of IMMray(TM) PanCan-d, our lead diagnostic candidate for the early detection of pancreatic cancer, Immunovia completed the expansion of our production and sample testing facilities, IMMray(TM) Dx Laboratories, at our headquarters in Lund, Sweden. This new state-of-the-art facility, working in conjunction with our IMMray(TM) Dx Laboratories at our subsidiary in Marlborough, MA, allows us the capacity and capability to produce slides to not only meet the current foreseen demands for commercial testing but at the same time meet the demands of the large prospective studies to be performed in parallel.

We worked diligently to establish and expand the world's most comprehensive set of prospective clinical trials within the area of detection of pancreatic cancer for IMMray(TM) PanCan -d consisting of three large studies, PanSYM-1, PanFAM-1 and PanDIA-1.

We also identified two additional strategic focus areas adding to our pipeline activities in 2018 -non-small cell lung cancer (NSLC) and Rheumatoid Arthritis (RA). Both indication areas address very large unmet clinical needs, in focus of the global healthcare systems, and thereby represent tremendous commercial opportunities for Immunovia adding to our main focus on earlier detection of pancreatic cancer.

On the corporate side, we rounded out the first quarter of 2018 with the announcement of an important corporate milestone: Immunovia's application to move its shares to the Main Market, Mid Cap segment on Nasdaq Stockholm. Our shares commenced trading on April 3, 2018. This move not only reflects that we have matured as a company, but it also strengthens our brand and furthers awareness of our work as we move closer to commencing commercial activities.

Mats Grahn, CEO of Immunovia AB

Key Indicators


             Key Indicators
              (SEK thousand
              unless
              otherwise
              stated)         
     Oct-Dec 2018          
     Oct-Dec 2017          
     Full year 2018         
     Full year 2017


             Net Sales                             91                      26                      333                       149


             Operating
              earnings                        -25,756                 -15,362                  -87,708                   -45,520


             Earnings before
              tax                             -25,655                 -15,318                  -86,531                   -45,232


             Net earnings                     -25,655                 -15,318                  -86,536                   -45,232


             Earnings per
              share before
              and after
              dilution (SEK/
              share)                            -1.31                   -0.88                    -4.67                     -2.67


    Equity ratio, %                              97                      94                       97                        94


             No. of shares at
              the end of the
              period                       19,531,353              17,318,059               19,531,353                17,318,059

This financial statement has been produced in accordance with IFRS for the Immunovia Group, which comprises Immunovia AB and the wholly-owned subsidiaries, Immunovia Inc and Immunovia GmbH.

Outlook

Immunovia is focused on fundamentally transforming diagnosis of complex forms of cancer and autoimmune diseases. The antibody-based platform, IMMray(TM), is the result of 15 years of research at CREATE Health - the Center for Translational Cancer Research at Lund University, Sweden. IMMray(TM) is a technology platform for the development of diagnostic tests and the company's primary test, IMMray(TM) PanCan-d, is the first test in the world for early diagnosis of pancreatic cancer.

The company's financial targets remain in place from the previous quarter. The company expects to receive the first revenues from self-pay sales in the latter part of 2019. The following financial targets have been established:

    --  Immunovia's target is to achieve turnover of SEK 250-300 million by 2022
        based on self-pay for IMMray(TM) PanCan-d.
    --  Immunovia's target is to achieve total turnover, including payment via
        self-pay and cost remuneration from insurance systems, of SEK 800-1,000
        million by 2024.

About Immunovia

Immunovia AB was founded in 2007 by investigators from the Department of Immunotechnology at Lund University and CREATE Health, the Center for Translational Cancer Research in Lund, Sweden. Immunovia's strategy is to decipher the wealth of information in blood and translate it into clinically useful tools to diagnose complex diseases such as cancer, earlier and more accurately than previously possible. Immunovia´s core technology platform, IMMray(TM), is based on antibody biomarker microarray analysis. The company is now performing clinical validation studies for the commercialization of IMMray(TM) PanCan-d that could be the first blood based test for early diagnosis of pancreatic cancer. In the beginning of 2016, the company started a program focused on autoimmune diseases diagnosis, prognosis and therapy monitoring. (Source: www.immunovia.com)

This information 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.

Immunovia's shares (IMMNOV) are listed on Nasdaq Stockholm. For more information, please visit www.immunovia.com.

CONTACT:

For more information, please contact:

Julie Silber
Director of Investor Relations, Immunovia
Email: julie.silber@immunovia.com
Tel: +46-7-93-486-277

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     https://mb.cision.com/Main/13121/2741755/991565.pdf Immunovia, Q4 2018 ENG

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SOURCE Immunovia AB