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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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    Hansa Biopharma announces positive full results from 15-HMedIdeS-09 Phase 2 study and comparative analysis of imlifidase in patients with Guillain-Barré Syndrome

    Lund, Sweden, 17 December 2024. Hansa Biopharma, “Hansa” (Nasdaq Stockholm: HNSA), today announced positive full results from the 15-HMedIdeS-09 single arm Phase 2 study of imlifidase, a first in class IgG cleaving enzyme, in Guillain-Barré Syndrome (GBS) and an indirect treatment comparison of the 15-HMedIdeS-09 study data to the International Guillain-Barré Syndrome Outcome Study (IGOS), a worldwide prospective study by the Inflammatory Neuropathy Consortium on prognosis and biomarkers of GBS. Data from the 15-HMedIdeS-09 study demonstrated that severe GBS patients treated with a

    Hansa Biopharma Completes Enrolment in Global Pivotal Phase 3 Trial of imlifidase in Anti-Glomerular Basement Membrane Disease

    Data from the trial is expected to be shared in 2025Lund, Sweden, 5 December 2024. Hansa Biopharma, “Hansa” (Nasdaq Stockholm: HNSA) today announced it has completed the enrolment of patients in the GOOD-IDES-02 trial, a global pivotal Phase 3 trial in anti-glomerular basement membrane (anti-GBM) disease. Anti-GBM is a rare, severe autoimmune condition affecting around 1.6 people per million annually.[1] Imlifidase has been granted orphan drug designation for the treatment of anti-GBM disease by both the U.S. FDA and the European Medicines Agency (EMA). Enrolment completion was originally

    Genethon and Hansa Biopharma announce initiation of a Phase 2 trial of imlifidase as a pre-treatment to GNT-0003 in severe Crigler-Najjar syndrome

    The trial will be conducted in patients with pre-existing anti-AAV antibodies which limit use of gene therapy treatmentLund, Sweden and Evry, France 3 December 2024. Hansa Biopharma, “Hansa” (Nasdaq Stockholm: HNSA) and Genethon, a pioneer and a leader in gene therapy research and development for rare genetic diseases, today announced initiation of GNT-018-IDES, a Phase 2 trial in patients with Crigler-Najjar syndrome with pre-existing antibodies against adeno-associated virus (AAV) vectors. The trial will evaluate the efficacy and safety of a single intravenous administration of Genethon’s

    Hansa Biopharma to Attend Jefferies London Healthcare Conference

    Lund, Sweden, 13 November, 2024. Hansa Biopharma, “Hansa” (Nasdaq Stockholm: HNSA) today announced it will attend Jefferies London Healthcare Conference 19-21 November. Hansa management will be available for meetings at the conference. If you are interested in meeting with the management team, please contact Hansa Biopharma at  ir@hansabiopharma.com. To learn more about Hansa Biopharma see the latest Corporate Presentation here.  The latest investor presentation can be viewed here (

    Hansa Biopharma to Attend Truist Securities BioPharma Symposium

    Lund, Sweden, 30 October, 2024. Hansa Biopharma, “Hansa” (Nasdaq Stockholm: HNSA) today announced it will attend Truist Securities BioPharma Symposium on November 7 in New York, NY. Hitto Kaufmann, Chief R&D Officer at the Company will participate in a panel discussion entitled, ‘Inflammatory Insights:  Advancing Novel Therapeutics Across Autoimmune and Inflammatory Indications’ on Thursday November 7th from 10:30 to 11:20 AM EST. Recently Hansa conducted a 12-month follow up analysis of data from the NICE-01 trial of HNSA-5487, the company’s next generation molecule. The analysis

    Hansa Biopharma Reports Third Quarter and Interim January - September 2024 Financial Results

    Q3 2024 marks highest ever in-market quarterly sales performance and fourth consecutive quarter of strong sales performanceLund, Sweden, October 17, 2024, Hansa Biopharma today announced its interim report for January-September and third quarter 2024 financial results. Søren Tulstrup, President and CEO, Hansa Biopharma said, “The third quarter of 2024 marks the highest ever IDEFIRIX[®] sales performance to date, resulting in four consecutive quarters of strong sales performance. The launch of IDEFIRIX in Europe continues to advance with adoption in international organ allocation systems

    Hansa Biopharma’s HNSA-5487 Achieved Rapid and Highly Robust IgG Reduction by More Than 95% and Clear Redosing Potential in First-in-Human Trial

    Lund, Sweden, 7 October 2024. Hansa Biopharma AB, (“Hansa” or the “Company”) (Nasdaq Stockholm: HNSA), today announced positive results from a 12-month follow up analysis from the NICE-01 trial of HNSA-5487, the Company’s next generation immunoglobulin G (IgG)-cleaving molecule, assessing IgG recovery, immunogenicity and redosing potential. In the NICE-01 trial, HNSA-5487 demonstrated rapid and highly robust reduction of IgG levels by more than 95 percent within a few hours post treatment. In a 12-month follow up analysis IgG levels returned to normal range six months after initial

    Hansa Biopharma to host Q3 2024 interim results conference call

    Lund, Sweden, October 3, 2024. Hansa Biopharma, “Hansa” (Nasdaq Stockholm: HNSA), will publish its interim report for January-September 2024 on October 17, 2024. Interested parties may join the Company’s quarterly conference call on the same date at 14:00 CEST/8:00 AM EST. The event will be hosted by Søren Tulstrup, President and CEO, Evan Ballantyne, CFO, and Hitto Kaufmann, CR&DO. The call will include a review of the interim results and a business and pipeline update. It will be held in English.  Slides used in the presentation will be made available on the company website at the

    Hansa Biopharma to Participate in H.C. Wainwright 26th Annual Global Investment Conference

    Lund, September 5, 2024. Hansa Biopharma today announced that Søren Tulstrup will participate in a Fireside chat hosted by Douglas Tsao, Managing Director and Senior Financial Analyst at H.C. Wainwright on Wednesday, September 11 at 8:00 AM EST. Mr. Tsao’s research focuses on biopharmaceuticals and specialty pharmaceuticals. The company will cover Hansa’s clinical stage programs, recent performance and upcoming milestones.   Hansa management will be available for meetings at the conference. If you are interested in meeting with the management team, please contact Hansa Biopharma at  ir@

    Hansa Biopharma Announces Departure of Chief Commercial Officer, Matthew Shaulis

    Lund, Sweden, 23 August 2024. Hansa Biopharma AB, (“Hansa” or the “Company”) (Nasdaq Stockholm: HNSA), today announced that Matthew Shaulis, Chief Commercial Officer and US President has decided to leave the company in late September. Effective immediately, the Commercial Leadership team will report to Søren Tulstrup, President and CEO. A search is underway for a new CCO and US President. Matthew Shaulis, CCO and US President, Hansa Biopharma said, “Joining Hansa was a key moment for my career and while the decision to leave was hard, especially given the company’s solid progress, I know

    Hansa Biopharma Reports Second Quarter 2024 Financial Results and Business Update

    Lund, Sweden, July 18, 2024, Hansa Biopharma today announced its first half and second quarter 2024 financial results and business update. Søren Tulstrup, President and CEO, Hansa Biopharma said: “For the third consecutive quarter, Hansa Biopharma delivered solid IDEFIRIX[®] sales performance driven by continued utilization of IDEFIRIX in key transplant centers across all major European markets. Additionally, we continued to progress key trials across the pipeline. Notably, we completed randomization of all patients in ConfIdeS, our pivotal Phase 3 US trial in kidney transplantation, and

    Hansa Biopharma to host Q2 2024 interim results conference call

    Lund, Sweden, July 3, 2024. Hansa Biopharma, “Hansa” (Nasdaq Stockholm: HNSA), will publish its interim report for January-June 2024 on July 18, 2024. Interested parties may join the Company’s quarterly conference call on the same date at 14:00 CEST/8:00 AM EST. The event will be hosted by Søren Tulstrup, President and CEO, Matthew Shaulis, CCO and US President, Evan Ballantyne, CFO, and Hitto Kaufmann, CR&DO. The call will include a review of the interim results and a business and pipeline update. It will be held in English. Slides used in the presentation will be made available on the

    Hansa Biopharma: increase in number of shares and votes

    Lund, Sweden June 28, 2024. Hansa Biopharma AB, (“Hansa Biopharma” or the “Company”) (Nasdaq Stockholm: HNSA) today announced that Hansa’s registered share capital and number of shares and votes have increased through (i) the issue of 2,305,260 new ordinary shares resolved on 12 April 2024 and registered with the Swedish Companies Registration Office during June 2024, whereby the number of votes increased with 2,305,260 and the share capital increased with SEK 2,305,260, and (ii) conversion of all 2,362,445 issued class C shares in Hansa to a total of 2,362,445 ordinary shares, in order to

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

    Lund, Sweden, June 27, 2024. Hansa Biopharma AB (publ), “Hansa” (Nasdaq Stockholm: HNSA), has today on June 27, 2024 held its Annual General Meeting. The Annual General Meeting was held by physical presence of shareholders and with the option for shareholders to exercise their voting rights by advance voting (postal voting). The Annual General Meeting of Hansa passed the following resolutions. 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

    Hansa Biopharma publishes prospectus for admission to trading of shares on Nasdaq Stockholm

    Lund, Sweden June 7, 2024. Hansa Biopharma AB, (“Hansa” or the “Company”) (Nasdaq Stockholm: HNSA) on April 12, 2024, announced that the board of directors had resolved on a directed share issue of 12,780,000 ordinary shares, divided into two tranches whereby the first tranche consisted of 10,474,740 ordinary shares (the “First Tranche”) and the second tranche consisted of 2,305,260 ordinary shares (the “Second Tranche”), to a number of Swedish and international institutional investors (the First Tranche and the Second Tranche are jointly referred to as the “Directed Share Issue”). A

    Hansa Biopharma Completes Randomization in Pivotal Phase 3 US ConfIdeS Trial

    Lund, Sweden, 31 May, 2024. Hansa Biopharma AB, (“Hansa” or the “Company”) (Nasdaq Stockholm: HNSA), today announced recruitment and randomization in its US ConfIdeS trial is complete. ConfIdeS is a pivotal Phase 3 open label, randomized, controlled trial of imlifidase in kidney transplantation. Data from the trial is expected to support a Biologic License Application (BLA) submission under the accelerated approval pathway to the US Food and Drug Administration (FDA) in the second half of 2025. Søren Tulstrup, President and CEO, Hansa Biopharma said, “The randomization of 64 patients in

    Notice to Annual General Meeting in Hansa Biopharma AB (publ)

    Lund, Sweden May 27, 2024, Hansa Biopharma AB (publ), Reg. No. 556734-5359 (“Hansa Biopharma”), with registered office in Lund, gives notice to Annual General Meeting to be held on Thursday June 27, 2024 at 13:00 CEST, Elite Hotel Ideon, Scheelevägen 27, SE-223 63 Lund. Registration starts at 12:30 CEST. Right to participate in the Annual General Meeting and notice of participation Participation in the Annual General Meeting at the venue A shareholder who wishes to participate in the Annual General Meeting at the venue in person or represented by a proxy must (i) be recorded as a

    Hansa Biopharma to present data at 2024 American Transplant Congress annual meeting

    Lund, Sweden, 21 May, 2024. Hansa Biopharma, “Hansa” (Nasdaq Stockholm: HNSA), today announced data featuring imlifidase will be presented at the American Transplant Congress (ATC), the joint annual meeting of the American Society of Transplant Surgeons (ASTS) and the American Society of Transplantation (ATS). Imlifidase is Hansa’s unique antibody-cleaving enzyme that specifically targets IgG and inhibits IgG-mediated immune response.[1] Søren Tulstrup, CEO and President, Hansa Biopharma, said: “ATC is a valuable opportunity for Hansa to share the latest science and data around

    Correction: Hansa Biopharma: increase in number of shares and votes

    The correction only concerns the removal of the reference to the EU Market Abuse Regulation that was incorrectly included in the original press release, distributed at 8:00am CEST on May 03, 2024, and inclusion of reference to the Swedish Financial Instruments Trading Act (1991:980). Lund, Sweden May 3, 2024. Hansa Biopharma AB (publ), (“Hansa” or the “Company”) (Nasdaq Stockholm: HNSA) today announced that the company’s registered share capital and number of shares and votes have increased through the issue of 10,474,740 new ordinary shares on 12 April 2024, whereby the number of votes

    Hansa Biopharma: increase in number of shares and votes

    Lund, Sweden May 3, 2024. Hansa Biopharma AB (publ), (“Hansa” or the “Company”) (Nasdaq Stockholm: HNSA) today announced that the company’s registered share capital and number of shares and votes have increased through the issue of 10,474,740 new ordinary shares on 12 April 2024, whereby the number of votes increased with 10,474,740 and the share capital increased with SEK 10,474,740. As of today, the total number of registered shares of the company amounts to 65,508,981, whereof 63,146,536 are ordinary shares and 2,362,445 are class C shares. As of today, the number of votes in the

    Hansa Biopharma interim report January-March 2024

    •    Strong sales performance and solid momentum with the Phase 3 trial in anti-GBM disease •    Cash runway extended into 2026•    Evan Ballantyne joins Hansa Biopharma as Chief Financial OfficerLund, Sweden, April 18, 2024, Hansa Biopharma, the pioneer in immunomodulatory enzyme technology for rare IgG mediated diseases, today announced its business update and year-end report for January to March 2024. Highlights for the first quarter of 2024 · Strong commercial performance. Total Q1 revenue of SEK 56m including product sales of SEK 47m – sales growth during Q1 2024 was driven

    Hansa Biopharma Expects Strong First Quarter 2024 Sales Performance

    Company expects revenue of SEK 54m including product sales of SEK 48m - an increase of 10% versus the prior quarter and a 234% increase versus Q1 2023 Q1 2024 is the first time Hansa has delivered two consecutive quarters of strong revenue and growthLund, Sweden, April 2, 2024, Hansa Biopharma AB (Nasdaq Stockholm: HNSA) expects to report revenue of approximately SEK 54m for Q1 ending March 31, 2024 (preliminary and unaudited), consisting of SEK 48m in product sales and SEK 6m in revenue recognition primarily related to its agreement with Sarepta Therapeutics, Inc. Revenue growth during

    Hansa Biopharma publishes 2023 Annual and Sustainability Reports

    Company delivered significant progress across commercial and R&D prioritiesLund, Sweden, March 21, 2024. Hansa Biopharma AB, “Hansa” or the “Company” (Nasdaq Stockholm: HNSA), today announced the publication of its 2023 Annual and Sustainability Reports. In 2023, the company made solid progress in both Commercial and R&D priorities and continued its journey to become a default sustainable organization. Peter Nicklin, Chairman of the Board, Hansa Biopharma, said: “2023 was another important year for Hansa Biopharma. With a purpose grounded in scientific innovation, improving patient

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