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  • Hansa Biopharma AB
    Scheelevägen 22 22363 Lund, Sweden
    +46 (0) 461 656 70
    http://www.hansabiopharma.com
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    Bulletin from the Annual General Meeting in Hansa Biopharma AB (publ)

    The following resolutions were passed at the Annual General Meeting of Hansa Biopharma AB (publ) (the “Company”) on 22 May 2019. Resolution regarding the adoption of the income statement and the balance sheet as well as consolidated income statement and consolidated balance sheet, appropriation of result and discharge from liability The Annual General Meeting resolved to adopt the income statement and balance sheet, consolidated income statement and balance sheet for 2018. Furthermore, it was resolved that the Company’s results shall be carried forward and thus no dividend will be

    Hansa Biopharma Year-End Report 2018

    With positive clinical results from the Company’s lead clinical program, Hansa readies for transition to commercial-stage companyOctober – December 2018 in brief ›› To better reflect its evolution and long-term aspirations, Hansa Medical AB changed its name to Hansa Biopharma AB. The new name represents the next stage in the Company’s lifecycle and emphasizes Hansa’s focus on the development and commercialization of biopharmaceuticals. This refinement of Hansa’s profile is particularly salient as the Company continues the international expansion of its business and investor base. ›› In

    Increase of number of votes in Hansa Medical AB (publ)

    Lund, Sweden, January 31, 2019 – Hansa Medical AB (publ) (Nasdaq Stockholm: HNSA) (“Hansa Medical” or the “Company”), under name change to Hansa Biopharma AB, a biopharmaceutical company focused on inhibition of immunoglobulin G (IgG)-mediated immunopathologies, today announced that the Company’s number of votes has changed as a result of the conversion of 13,142 C shares into ordinary shares during January under Hansa Medical’s long-term incentive program.As of January 31, 2019, the total number of registered and outstanding shares of Hansa Medical totals 40,681,654 of which 39,973,032 are

    Hansa Medical AB to change name to Hansa Biopharma AB

    Lund, Sweden, December 20, 2018-Hansa Medical AB (publ) (Nasdaq Stockholm:HMED) (“Hansa Medical” or the “Company”), the leading biopharma company focusing on inhibition of immunoglobulin G (IgG)-mediated immunopathologies, today announced that the name change resolutions approved at an Extraordinary General Meeting ("EGM") held on December 4, 2018, have been approved by the ‘Bolagsverket’ in Sweden.The name change will be implemented in the next days and weeks and the Company stock ticker symbol has changed from “HMED” to “HNSA”.  The information was submitted for publication, through

    Presentation at ASN Kidney Week 2018 Highlights Stable Renal Function at up to 24 Months Following Transplantation Enabled by Imlifidase

    Lund, Sweden, October 26, 2018- Hansa Medical AB (NASDAQ Stockholm:HMED), the leading biopharma company focusing on inhibition of immunoglobulin G (IgG)-mediated immunopathologies, today announced that data on imlifidase (previously known as IdeS), the Company’s IgG cleaving enzyme, was highlighted in a presentation at the American Society of Nephrology (ASN) Kidney Week 2018, being held October 23-28, 2018 in San Diego, USA.The presentation, titled IdeS in Highly Sensitized Patients, was presented at ASN Kidney Week 2018 by Stanley C. Jordan, M.D., Director of Kidney Transplantation and

    Hansa Medical's Nomination Committee for the AGM 2019 Appointed and 2019 Financial Calendar Published

    Lund, Sweden, October 25, 2018 - Hansa Medical AB (Nasdaq Stockholm: HMED), the leading biopharma company focusing on inhibition of immunoglobulin G (IgG)-mediated immunopathologies, today announced the appointment of the Nomination Committee for the Annual General Meeting (AGM) 2019 and the publication of the 2019 financial calendar.In accordance with the decision of the AGM on May 29, 2018, a Nomination Committee for the Hansa Medical AGM 2019 has been formed. Based on the list of shareholders as of 31 August 2018, the three largest shareholders have been contacted and invited to each

    Hansa Medical Receives Positive Opinion for Orphan Drug Designation in the EU for Imlifidase for Anti-GBM Disease

    Lund, Sweden, October 24, 2018- Hansa Medical AB (NASDAQ Stockholm:HMED), the leading biopharma company focusing on inhibition of immunoglobulin G (IgG)-mediated immunopathologies, today announced that the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) has issued a positive opinion on Orphan Drug Designation for imlifidase for the treatment of anti-glomerular basement membrane (anti-GBM) antibody disease. A positive opinion by the COMP precedes official designation by the European Commission."This positive opinion on Orphan Drug Designation for

    Hansa Medical Receives FDA Fast Track Designation for Imlifidase for Transplantation

    Lund, Sweden, October 17, 2018- Hansa Medical AB (NASDAQ Stockholm: HMED), the leading biopharma company focusing on inhibition of immunoglobulin G (IgG)-mediated immunopathologies, today announced that the U.S. Food and Drug Administration (FDA) has granted imlifidase Fast Track Designation for the investigation of imlifidase for transplantation.Imlifidase (IdeS) is an enzyme in late-stage clinical development that specifically cleaves IgG antibodies, thereby inhibiting the IgG-mediated immune response. Hansa Medical is initially developing imlifidase as a proprietary treatment to enable

    Notice of Extraordinary General Meeting of Hansa Medical AB (publ)

    The shareholders of Hansa Medical AB (publ) are summoned to attend the Extraordinary General Meeting on 29 October 2018, at 10.00 CET at Hansa Medical’s offices on Scheelevägen 22, Lund, Sweden.  The shareholders of Hansa Medical AB (publ) are hereby summoned to attend the Extraordinary General Meeting (“EGM”) on 29 October 2018, at 10.00 CET at Hansa Medical’s offices on Scheelevägen 22, Lund, Sweden. Registration starts at 09.30 CET and will be possible until the EGM starts.  Right to participateThose who have been recorded as shareholders in the share register kept by Euroclear

    Hansa Medical Reports Positive Final Top Line Results from Two Phase 2 Studies of Imlifidase for Kidney Transplantation

    · Imlifidase meets all primary and secondary endpoints in both studies · Treatment with imlifidase enables highly sensitized patients to receive lifesaving transplants  · Hansa Medical plans to submit BLA and MAA filings in Q4 2018 or Q1 2019 · Company to host conference call today, September 27 2018 at 2pm CEST (5am PDT, 8am EDT, 1pm BST)Lund, Sweden, September 27, 2018- Hansa Medical AB (NASDAQ Stockholm: HMED), the leading biopharma company focusing on inhibition of immunoglobulin G (IgG)-mediated immunopathologies, announced today the successful completion of two Phase 2

    Issue and repurchase of class C shares for incentive program

    By virtue of authorization by the annual general meeting held on 29 May 2018, the board of directors of Hansa Medical AB (publ) has resolved to issue and immediately thereafter repurchase 391,503 class C shares. The shares are issued and repurchased in accordance with the incentive programme LTIP 2018, which was adopted by the annual general meeting held on 29 May 2018.Carnegie Investment Bank AB will subscribe for the entire issue of new class C shares at a subscription price of SEK 1 per share, corresponding to the quota value of the shares. The entire issue of class C shares will

    Hansa Medical Interim report April – June 2018

    April – June 2018 in brief ›› Long-term follow-up data from the 17 patients treated with imlifidase in the investigator-initiated Phase II study in highly sensitized patients was presented at the 2018 American Transplant Congress in early June by Professor Stanley C. Jordan, M.D., Director of Nephrology, Cedars-Sinai Medical Center. ›› Patients show good renal function and minimal evidence of antibody-mediated rejection (AMR) at a mean 19 months post kidney transplantation, with graft and patient survival at 94%. ›› Two-year follow-up data demonstrate good patient and graft

    Hansa Medical lead candidate imlifidase (IdeS) granted orphan drug designation by the FDA for anti-GBM antibody disease

    Hansa Medical today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to imlifidase (IdeS) for the treatment of anti-GBM antibody disease (anti-GBM), also known as Goodpastures disease. More information about the orphan drug designation has been posted on www.fda.govAnti-GBM is a severe kidney disease where the immune system mistakenly develops IgG-antibodies, resulting in an acute immune attack on the kidneys and in some patients also on the lungs. In severe anti-GBM, the disease may progress to renal failure or death. There is no approved

    Increase of number of shares in Hansa Medical AB (publ)

    As previously announced, the general meeting of Hansa Medical AB (publ) resolved to adopt a warrant program 2015-2019 on June 2, 2015. As part of the completion of the program, 205,000 ordinary shares have been issued. The company’s registered share capital and number of outstanding shares and votes have thus increased during the month of June 2018.As of today, the total number of registered and outstanding shares of Hansa Medical amounts to 38,413,386 whereof 38,083,125 are ordinary shares and 330,261 are Class C shares. As of today, the number of votes in Hansa Medical amounts to 38,116,

    Long-term follow up data from investigator-initiated Phase II study with imlifidase (IdeS) to be presented at 2018 American Transplant Congress (ATC)

    Hansa Medical AB (Nasdaq Stockholm: HMED), a biopharmaceutical company developing novel immunomodulatory enzymes, today announced that long-term follow up results from the ongoing investigator-initiated US study with imlifidase (IdeS) in highly sensitized patients will be presented in an oral session at the 2018 American Transplant Congress (ATC) in Seattle, U.S. on June 5.The long-term follow up results from the study, demonstrate that patients desensitized with imlifidase (IdeS) and transplanted with HLA-incompatible kidney show good renal function and minimal evidence of antibody

    Bulletin from the Annual General Meeting in Hansa Medical AB (publ)

    The following resolutions were passed at the Annual General Meeting of Hansa Medical AB (publ) (the “Company”) on May 29, 2018. Resolution regarding the adoption of the income statement and the balance sheet as well as consolidated income statement and consolidated balance sheet, apropriation result and discharge from liability The Annual General Meeting resolved to adopt the income statement and balance sheet, consolidated income statement and balance sheet for 2017. Furthermore, it was resolved that the Company’s results shall be carried forward and thus no dividend will be

    Hansa Medical Interim Report January–March 2018

    IdeS (INN: imlifidase) continues to demonstrate its unprecedented ability to enable transplantation for highly sensitized patientsJanuary-March 2018 in brief · Søren Tulstrup appointed new President and CEO of Hansa Medical, effective March 20, 2018. He has broad and extensive experience as senior executive in the global biopharma industry. Hansa Medical’s acting CEO Ulf Wiinberg reverts to his former role as Chairman of Hansa Medical and Birgit Stattin Norinder reverts to her former role as board member. · Completed enrollment in Hansa Medical’s international multicenter Phase II

    Completed enrollment in Hansa Medical’s international multi-center Phase II study Highdes

    Hansa Medical AB (Nasdaq Stockholm: HMED), a biopharmaceutical company focusing on novel immunomodulatory enzymes, announced today the completion of enrollment for the international multi-center study Highdes.The study aimed to recruit 15-20 patients. A total of 18 patients have been treated with the company’s lead candidate IdeS and subsequently transplanted at five clinics in the US and Europe. All treated and transplanted patients will be followed up for six months. The primary objective of the study - to turn a positive cross-match test into a negative and thereby enable kidney

    Finalized enrollment in US Phase II study with IdeS in highly sensitized patients

    Hansa Medical AB (Nasdaq Stockholm: HMED), a biopharmaceutical company focusing on novel immunomodulatory enzymes, announced today that enrollment has been finalized in the US investigator-initiated Phase II study with lead candidate IdeS in highly sensitized patients.A total of 17 patients have been enrolled in the study (ClinicalTrials.gov Identifier: NCT02426684) at Cedars-Sinai Medical Center with Professor Stanley Jordan as principal investigator. The study aimed at enrolling 10 to 20 patients. Patients had donor specific antibodies (DSAs) and a positive cross-match test prior to IdeS

    Increase of number of shares and votes in Hansa Medical AB (publ)

    As previously announced, the general meeting of Hansa Medical AB (publ) has, on December 22, 2017, resolved on a share issue of 2,752,526 ordinary shares. The company’s registered share capital and number of outstanding shares and votes have thus increased during December.As of December 29, 2017, the total number of registered and outstanding shares of Hansa Medical amounts to 38,208,386 of which 37,807,386 are ordinary shares and 401.000 are C shares. As of December 29, 2017, the number of votes in Hansa Medical amounts to 37,847,486 and the registered share capital amounts to SEK 38,208,

    Hansa Medical Interim report July – September 2017

    July-September in brief ›› Combined data from three independent clinical Phase II studies with Hansa Medical’s lead candidate IdeS was published in The New England Journal of Medicine 2017;377:442-53, August 3, 2017 issue. Data from these studies show that IdeS effectively reduces HLA antibodies and enables patients with very poor prognosis, who are unlikely to find a kidney donor, to be transplanted. Importantly, patients were doing well with good kidney function at last follow up. ›› Patient enrollment on target to have all patients recruited and treated by the end of 2017 in two

    The time point for Hansa Medical’s Third Quarter 2017 Business Update Conference Call has been changed

    As previously announced on 7 November 2017, Hansa Medical will publish its report for the third quarter of 2017 at 08:00AM CET on Tuesday, 14 November 2017. The time for the conference call has been changed from 2:00PM CET to 11:00AM CET on the same day.The presentation will be held in English and will be hosted by Hansa Medical’s Acting CEO Ulf Wiinberg. Slides used in the presentation will be live on the company’s website during the call under Events & Webcast and will also be made available after the call. To participate in the telephone conference, please call: SE: +46 (0) 856 642

    Hansa Medical’s Capital Market Days provide an update on number of patients included in the company’s kidney transplantation and anti-GBM studies

    Hansa Medical AB (Nasdaq Stockholm: HMED), a biopharmaceutical company focusing on novel immunomodulatory enzymes, today announced that on its Capital Markets Days in Stockholm (today, October 3) and London (October 4), the company will present an update on the number of patients included in the company’s clinical studies.The update will present the status of the ongoing clinical Phase II studies with the lead drug candidate IdeS in kidney transplantation, where the number of patients treated with IdeS prior to kidney transplantation now amounts to 42. The ongoing studies are expected to be

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