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  • Immunovia AB
    Medicon Village Scheelevägen 8 SE-223 63 Lund
    +46 46 275 60 00
    http://www.immunovia.com
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    Immunovia Full Year report, January-December 2018

    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™ 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™ Dx Laboratories, at our headquarters in Lund, Sweden. This new state-of-the-art facility,

    McGill, Yale and Universities of Pennsylvania and Massachusetts join PanFAM-1, the largest ever prospective multicenter clinical study for early detection of pancreatic cancer

    New centers give study near complete coverage of North American FPC sites in drive to validate IMMrayTM PanCan-d, the first blood based test for early detection of pancreatic cancerLUND, SWEDEN ― Immunovia AB today announced that four additional North American Familial Pancreatic Cancer (FPC) sites are to participate in PanFAM-1, the largest ever prospective study looking at early diagnosis in high-risk individuals with heredity risk of pancreatic cancer. Designed to validate Immunovia ́s innovative blood test, IMMray™ PanCan-d, PanFAM-1 study will analyze more than two thousand individuals

    Immunovia interim report January-September 2018

    Immunovia’s IMMray™ platform for blood-based biomarker signatures offers exciting new opportunities to develop accurate diagnostic tests that can detect diseases at an early stage. During the period we presented new results and identified no fewer than two new areas for strategic focus in our ongoing development activities – non-small cell lung cancer and Rheumatoid Arthritis (RA). In August we presented the results from our first collaboration trial with a global, top-ten pharmaceutical business. The results showed that Immunovia’s blood-based IMMray™ biomarker array produced very high

    Immunovia sponsors primary care educational symposium at Fenway Park in honor of World Pancreatic Cancer Day

    MARLBOROUGH, MASSACHUSETTS – On November 15, 2018 Immunovia will sponsor a unique educational symposium for primary care clinicians in honor of World Pancreatic Cancer Day. The program will highlight the important role that primary care clinicians can play in detecting pancreatic adenocarcinoma early in patients. This World Pancreatic Cancer Day, Fenway Park will be transformed into a football field in preparation for hosting a historic rivalry game between Harvard University and Yale University. In honor of this, Dr. James Farrell, Director of the Yale Center for Pancreatic Diseases at Yale

    Invitation to presentation of Immunovia´s interim report January-September 2018 on November 7, 2018

    Lund (Sweden) - Immunovia will publish the company’s interim report for the period January-September 2018 on Wednesday, November 7, at 08:30 a.m. CET.Immunovia invites to a teleconference (in English) for investors, analysts and media on November 7, at 4:30 – 5:30 p.m. CET. Mats Grahn, CEO will present Immunovia and comment on the interim report followed by a Q&A-session. Please call in a few minutes in advance. To attend, please dial-in at one of the numbers below from: Telephone:SE: +46856642662CH: +41225675548DE: +4969222229046DK: +4582333178FR: +33170750712UK:

    Immunovia PanFAM-1 clinical trial now available on ClinicalTrials.gov, the largest clinical trials database in the world

    LUND, SWEDEN ― Immunovia has developed a blood based biomarker signature for early detection of pancreatic cancer called IMMray™ PanCan-d. To validate IMMray™ PanCan-d, Immunovia started PanFAM-1 , the largest ever multicenter clinical trial for early detection of pancreatic cancer in familial/hereditary high risk group, in collaboration with major pancreatic cancer centers from Europe and US. To provide patients, their families, health care professionals and the public with the information about this clinical

    Immunovia Interim report, January-June 2018

    “On 3 April, trading in Immunovia’s shares started on NASDAQ Stockholm’s main market, where we are listed in the Mid Cap segment. During the second quarter we also completed a directed share issue worth around SEK 324 million to reputable institutions in Sweden and internationally. Very exciting results have been achieved in two major application areas, lung cancer and rheumatoid arthritis, which show that the general usability of the IMMray™ platform opens up great opportunities for Immunovia. During the spring and summer we completed a lung cancer study with very good results. This

    Invitation to presentation of Immunovia´s interim report January-June 2018 and comments to the previously published autoimmunity study results

    Lund (Sweden) - Immunovia will publish the company’s interim report for the period January-June 2018 on Friday, August 24, at 08:30 a.m. CET.Immunovia invites to a teleconference (in English) for investors, analysts and media on August 24, at 4:00 – 5:00 p.m. CET. Mats Grahn, CEO will present Immunovia and comment on the interim report, as well as comment on the press release of August 22 regarding autoimmunity study results, followed by a Q&A-session. Please call in a few minutes in advance. To attend, please dial-in at one of the numbers below from: Telephone details:SE:

    Breakthrough in autoimmune testing – IMMrayTM based novel biomarker signature identifies patients with anti-CCP negative rheumatoid arthritis

    LUND, Sweden ― Immunovia today announced that a new study confirms that the IMMray™ blood test successfully addresses one of the major challenges in autoimmune testing. The present study, performed in collaboration with Linköping University, showed that IMMray™ technology can identify patients with rheumatoid arthritis (RA), despite testing negative with antibodies against cyclic citrullinated peptides (CCP). Currently, this important group of patients – representing 25-30% of all RA cases – is missed using the present gold standard assay to analyze IgG-class anti-CCP.The present study

    Retrospective study results for IMMray™ PanCan-d conclude Immunovia needs to do further optimizations to meet the expected performance

    Immunovia AB (publ) (“Immunovia”) finalized today a retrospective study performed as part of the preparation for the certification and accreditation of the company’s commercial version of their IMMrayTM PanCan-d assay for early detection of pancreatic cancer. Due to variations in different biobank blood sampling processes, Immunovia needs to do further optimizations to the test algorithms to meet the expected performance for its commercial version of the test. The further optimization work will delay the initiation of the sales of the IMMrayTM PanCan-d until later part of 2019 and in

    Journal of Clinical Oncology publishes that IMMray™ PanCan-d serum biomarker test detects early pancreatic cancer with 96% accuracy

    LUND, SWEDEN ― Immunovia AB announced today that the prestigious Journal of Clinical Oncology (JCO) publishes the results of the major retrospective clinical validation study performed by Scandinavian and US researchers, showing that the IMMray™ PanCan-d serum biomarker microarray detects early pancreatic cancer with 96% accuracy.Pancreatic ductal adenocarcinoma (PDAC) has a poor prognosis, with a 5-year survival of <10% because of diffuse symptoms leading to late-stage diagnosis. It is widely accepted that that survival could increase significantly if localized tumors could be detected

    Invitation to Immunovia’s telephone conference on Thursday, the 9th of August, 2018 at 15:00 (CET)

    Due to today's announcement of the non-small cell lung cancer (NSCLC) collaborative study with a major global pharma company, Immunovia invites to a telephone conference today on August 9, at 15:00 (CET). The presentation will be held in English. After a short presentation by CEO Mats Grahn, you will have an opportunity to ask questions. Please dial in a few minutes before the presentation begins.Date: August 9, 2018Time: 15:00 (CET) Participant dial in numbersSE: +46856642662BE: +3224040635CH: +41225675548DE: +4969222229046DK: +4582333178FR: +33170750712NE: +31207168416

    Immunovia`s blood-based IMMray™ biomarker array provides highly accurate diagnosis of non-small cell lung cancer in a new collaborative study

    LUND, SWEDEN ― Immunovia AB announced today that in a new collaborative study with a major global pharma company, Immunovia ́s innovative blood-based testing platform, IMMray™ could differentiate healthy controls from non-small cell lung cancer (NSCLC) samples with a 95 % accuracy. Accounting for nearly 14% of all new cancers, NSCLC is one of the top three cancer types by incidence and number one by mortality.The study included 100 serum samples - 50 NSCLC and 50 controls - and was performed to assess the technical performance of the IMMray™ platform in lung cancer. As a consequence of the

    Karolinska Institutet participates in Immunovia’s PanFAM-1 prospective  clinical study for early detection of pancreatic cancer using blood-based test

    Prospects rise for world’s first national screening program.LUND and STOCKHOLM, SWEDEN― Immunovia AB today announced that the Karolinska Institutet is to participate in PanFAM-1, the largest ever prospective study looking at early diagnosis in high-risk individuals with Familial Pancreatic Cancer (FPC). Designed to validate Immunovia ́s innovative blood test, IMMray™ PanCan-d, the study will analyze more than thousand individuals over three years across sites in Sweden, the US and Europe already offering FPC screening programs. The aim is to improve the outcome for the cancer patients and

    Change in number of shares and votes in Immunovia AB (publ)

    The number of shares in Immunovia AB (publ) has changed due to the issue of 2,162,794 shares resolved by the Board in June.Following the registration of the new share issue with the Swedish Companies Registration Office and the introduction of the new shares in the share register held by Euroclear Sweden AB, the total number of shares and votes in Immunovia AB (publ) amounts to 19,480,853 shares.  This is information that Immunovia is obliged to make public pursuant to the Swedish Act on Trade in Financial Instruments. The information was submitted for publication, through the agency of

    Immunovia has completed a directed share issue of approximately SEK 324 million

    NOT FOR PUBLICATION, DISTRIBUTION OR RELEASE, DIRECTLY OR INDIRECTLY, IN WHOLE OR IN PART, WITHIN OR INTO AUSTRALIA, HONG KONG, JAPAN, CANADA, NEW ZEELAND, SINGAPORE, SOUTH AFRICA OR THE UNITED STATES OF AMERICA OR ANY OTHER JURISDICTION IN WHICH SUCH RELEASE OR DISTRIBUTION WOULD BE UNLAWFUL. Immunovia AB (publ) (“Immunovia” or the “Company”) today announces that the Company has successfully completed a directed share issue which will provide the Company with a gross proceed of approximately SEK 324 million.The board of directors of Immunovia has, based on the authorization granted by

    Invitation to presentation of Immunovia´s interim report January-March 2018 on April 27, 2018

    Lund (Sweden) - Immunovia will publish the company’s interim report for the period January-March 2018 on Friday, April 27, at 08:00 a.m. CET.Immunovia invites to a teleconference (in English) for investors, analysts and media on April 27, at 3:30 – 4:30 p.m. CET. Mats Grahn, CEO will present Immunovia and comment on the interim report followed by a Q&A-session. Please call in a few minutes in advance. To attend, please dial-in at one of the numbers below from: Telephone: SE: +46856642662BE: +3224040635CH: +41225675548DE: +4969222229046DK: +4582333178FR: +33170750725NE:

    Invitation to presentation of Immunovia´s Full Year Report 2017 on February 15, 2018

    Lund (Sweden) - Immunovia will publish the company’s Full Year Report 2017 for the period January – December 2017 on Thursday, February 15, at 08:00 a.m. CET.Immunovia invites to a teleconference (in English) for investors, analysts and media on February 15, at 4:00 – 5:00 p.m. CET. Mats Grahn, CEO will present Immunovia and comment on the Full Year Report 2017 followed by a Q&A-session. Please call in a few minutes in advance. To attend, please dial-in at one of the numbers below from: Telephone: SE: +46856642662 CH: +41225675548 UK: +442030089803 DK: +4535445579 US:

    Immunovia announces collaboration with Lund University Diabetes Centre for the early detection of pancreatic cancer in diabetes risk group

    LUND, Sweden ― Immunovia AB is delighted to announce a collaboration with the researchers at Lund University Diabetes Centre (LUDC) to validate the company´s biomarker signature in high risk group of newly-onset type 2 diabetics (NoD) patients over the age of 50. The risk of these patients to develop pancreatic cancer is over 8 times greater than that of the general population.The collaboration is designed as a retrospective validation study, in which LUDC, a consortium of research groups at Lund University, will deliver blood samples from NoD patients who subsequently developed pancreatic

    Immunovia chosen as one of the three most innovative small to mid-companies in Europe 2016

    Stars of Innovation nomination recognizes stellar performance since IPO(LUND, Sweden) ― Leading Swedish diagnostics company Immunovia today announced that it has been shortlisted for the Stars of Innovation category in the European Small- and Mid-Cap Awards 2016. The nomination is recognition of the company’s stellar performance since listing in Stockholm in December last year. From an initial 2 EUR, the share price has risen to 9.24 EUR, an increase of 386%, giving the company a valuation of 154 MEUR. During this period, Immunovia has made major progress in developing the first

    Immunovia: Insiders transfer subscription rights free of charge

    LUND, Sweden ― Within the framework of the ongoing rights issue at Immunovia AB (publ) ("the company ") Carl Borrebaeck and Christer Wingren, Chairman of the Board and Chief Technical Officer respectively at the company, have, on request from professional investors and in consultation with the company's financial advisor Vator Securities, transferred all subscription rights received in the rights issue to named investors.The purpose of the transfer is to further strengthen the company's shareholder base with long-term professional investors. The transfers have been made free of charge and

    Immunovia publishes prospectus regarding preferential rights issue

    NOT FOR DISTRIBUTION, DIRECTLY OR INDIRECTLY, WITHIN OR TO THE UNITED STATES, AUSTRALIA, CANADA, NEW ZEALAND, SINGAPORE, SOUTH AFRICA, JAPAN OR HONG KONG OR WITHIN ANY OTHER JURISDICTION IN WHICH THE DISTRIBUTION OF THIS PRESS RELEASE WOULD NOT COMPLY WITH APPLICABLE LAWS AND REGULATIONS. Immunovia publishes prospectus regarding preferential rights issue Immunovia AB (publ) (”Immunovia” or the ”Company”) publishes prospectus in connection with the Company’s preferential rights issue (the “Rights Issue”). Publication of prospectusImmunovia’s prospectus, prepared in connection with

    Immunovia intends to launch a directed and preferential right issue

    NOT FOR DISTRIBUTION, DIRECTLY OR INDIRECTLY, WITHIN OR TO THE UNITED STATES, AUSTRALIA, CANADA, NEW ZEALAND, SINGAPORE, SOUTH AFRICA, JAPAN OR HONG KONG OR WITHIN ANY OTHER JURISDICTION IN WHICH THE DISTRIBUTION OF THIS PRESS RELEASE WOULD NOT COMPLY WITH APPLICABLE LAWS AND REGULATIONS. Immunovia intends to launch a directed and preferential right issue SummaryImmunovia AB (publ) (”Immunovia” or the ”Company”) intends to launch a directed share issue of approximately 2 300 000 of shares. Thereafter, the Company, intends to launch a new share issue amounting to approximately SEK

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