Crigler-Najjar Syndrome

Strong product sales and key progress in pipeline catalysts LUND, Sweden, April 24, 2025 /PRNewswire/ -- Hansa Biopharma AB, "Hansa" or the "Company" (Nasdaq Stockholm: HNSA), today announced its interim report for January-March 2025. Peter Nicklin, Chairman of the Board, Hansa Biopharma said, "In Q1, the Company delivered strong growth with total revenue of 66.3 MSEK and products sales of 65.7 MSEK. This represents a 39 percent increase as compared to Q1 2024 (47.4 MSEK). While the organ allocation market remains unpredictable and directly impacts our quarterly sales, we remain confident in our ability to significantly increase revenue year on year. In Q1, we completed enrollment in the Post Authorization Efficacy and Safety (PAES) study, secured access and reimbursement in three additional European markets, and saw growing repeat utilization of IDEFIRIX® (imlifidase) in key centers across Europe. In the second half of 2025, we anticipate several key pipeline catalysts, including data readouts from Hansa's U.S. ConfIdeS Phase 3 pivotal trial in kidney transplantation and the anti-GBM Phase 3 pivotal trial." "Also, of note, following the positive full results from the 15-HMedIdeS-09 single arm Phase 2 study in Guillain Barre Syndrome (GBS) shared in December 2024, the data is set to be presented at an upcoming medical congress. Finally, the development of the Company's next generation molecule for repeat dosing, HNSA-5487, remains on track. We recently had very positive interaction with BfArM confirming the clinical development plan for HNSA-5487 in myasthenia gravis (MG)." The Company also announced Renée Aguiar-Lucander has been appointed Chief Executive Officer effective immediately. Søren Tulstrup has stepped down from his position of CEO by mutual agreement after seven years of dedicated service to the Company. Financial Performance Q1 2025 product sales of IDEFIRIX® totaled 65.7 MSEK representing a 39 percent increase over Q1 2024 (47.4 MSEK). Revenue for the first quarter 2025 totaled 66.3 MSEK. The addition of new sites using IDEFIRIX combined with growing repeat utilization contributed to the performance. Hansa expects to see continued strong year-on-year product sales growth despite continued quarterly product sales fluctuation due to variations in European kidney allocation systems, which impacts the availability of organs for patients. Pipeline Progress During the first quarter of 2025, Hansa completed enrolment of the 20-HMedIdeS-19 Post Authorization Efficacy and Safety (PAES) study. The PAES study is part of the Company's obligation following conditional authorization by the European Commission for IDEFIRIX. The study is expected to read out in the second half of 2026 and is intended to support full marketing authorization in Europe. With completed enrollment, Hansa expects increased commercial utilization of imlifidase at key centers across Europe that participated in the PAES study. Following positive data from the 15-HMedIdeS-09 Phase 2 trial and indirect treatment comparison to the International Guillain-Barré Syndrome Outcome Study (IGOS), the data has been accepted for oral presentation at an upcoming medical conference in 2025. The trial and indirect treatment comparison demonstrated imlifidase's potential to address significant unmet need in GBS. The Phase 2 trial GNT-018-IDES in collaboration with Genethon in patients with Crigler Najjar syndrome with pre-existing antibodies against adeno-associated vectors (AAV) continues to progress with enrolment currently ongoing. The 20-HMedIdeS-17 study (ConfIdeS) remains on track for a data readout in the second half of 2025. This pivotal Phase 3 trial is evaluating imlifidase as a potential desensitization therapy, compared to standard of care, to enable kidney transplantation in highly sensitized patients. Financial Summary Conference Call Details Hansa Biopharma will host a telephone conference today Thursday, 24 April, 2025, at 14:00 CEST / 8:00 am EDT. The event will be hosted by Peter Nicklin, Chairman of the Board, Evan Ballantyne, CFO, and Hitto Kaufmann, CR&DO and Renée Aguiar-Lucander. 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 live on the company website during the call under Events & Presentations and will also be made available online after the call. To participate in the telephone conference, please use the dial-in details provided below: Participant Dial In (Toll Free): 1-833-821-3542 Participant International Dial In: 1-412-652-1248 *Please ask to be joined into the Hansa Biopharma call Join the webcast here: For the full financial calendar and list of events in 2025 please visit Contacts for more information: Evan Ballantyne, Chief Financial Officer [email protected] Stephanie Kenney, VP Global Corporate Affairs [email protected] Notes to editors About Hansa Biopharma Hansa Biopharma AB is a pioneering commercial-stage biopharmaceutical company on a mission to develop and commercialize innovative, lifesaving and life-altering treatments for patients with rare immunological conditions. The company has a rich and expanding research and development program based on its proprietary IgG-cleaving enzyme technology platform, to address serious unmet medical needs in autoimmune diseases, gene therapy and transplantation. The company's portfolio includes imlifidase, a first-in-class immunoglobulin G (IgG) antibody-cleaving enzyme therapy, which has been shown to enable kidney transplantation in highly sensitized patients and HNSA-5487, a next generation IgG cleaving molecule with redosing potential. Hansa Biopharma is based in Lund, Sweden, and has operations in Europe and the U.S. The company is listed on Nasdaq Stockholm under the ticker HNSA. Find out more at and follow us on LinkedIn. ©2025 Hansa Biopharma AB. Hansa Biopharma, the beacon logo, IDEFIRIX, and IDEFIRIX flower logo are trademarks of Hansa Biopharma AB, Lund, Sweden. All rights reserved. This information was brought to you by Cision The following files are available for download: WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

LUND, Sweden, March 21, 2025 /PRNewswire/ -- Hansa Biopharma AB, "Hansa" or the "Company" (NASDAQ Stockholm: HNSA), today published its Annual and Sustainability Reports for 2024. Peter Nicklin, Chair of the Board, Hansa Biopharma, said: "Hansa delivered several important milestones in 2024 and remains on track to advance innovative science and important new medicines. This is in large part due to the dedicated, results-driven employees, and the Company's commitment to delivering on its discovery, development and commercialization goals. In my third year as Chair of the Board of Directors, I remain inspired and excited for what is to come for Hansa." Søren Tulstrup, President and CEO, Hansa Biopharma, said, "2024 was a momentum-building year for Hansa. With year-on-year IDEFIRIX® sales growth of 83%, a successful financing round, and several critical pipeline catalysts for imlifidase and HNSA-5487, 2024 has positioned us well to advance our efforts in Autoimmune, Gene Therapy and Transplantation. 2025 promises to be an exciting and important year, marked by several data readouts and a planned BLA submission to the U.S. FDA in kidney transplantation under the accelerated approval pathway. Hansa's science-led, patients-first business model remains at the core of what we do, executed by a team of highly experienced and dedicated individuals. We remain focused on our mission to advance critical science that can address the unmet medical needs of people living with rare, immune-mediated diseases." 2024 highlights In 2024, Hansa advanced the commercialization of IDEFIRIX® (imlifidase) in Europe as a desensitization treatment for kidney transplant patients, achieving record quarterly and full year sales. The ongoing commercialization of IDEFIRIX in Europe is being driven by continued strong market access in a total of 18 markets, including the five key markets of France, Germany, Italy, Spain and the UK. A growing body of data, real-world evidence and clinical guidelines on the utilization of imlifidase as a desensitization strategy for highly sensitized kidney transplant patients has been published. The most recent guidance published in Transplant International provides specific guidelines on appropriate use of imlifidase in clinical practice to enable kidney transplants in highly sensitized patients. Preparation for commercialization in the US is progressing, with complete randomization of the pivotal Phase 3 trial - ConfIdeS - announced in May 2024. Data readout for the trial and submission of a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) are planned in 2H 2025. In October 2024, Hansa announced full results of the NICE-01 first in human trial and 12-month follow up analysis of HNSA-5487, demonstrating that it can robustly and rapidly reduce IgG levels, has redosing potential, and a favorable safety and tolerability profile. Initial clinical development will be focused on neuro-autoimmune disease with a well characterized role of specific autoantibodies in disease pathology and recurring acute phases - specifically, myasthenia gravis (MG). The company plans to align with regulatory authorities in the first half of 2025 on a clinical development path for HNSA-5487 in MG. In Autoimmune, enrolment was completed for the GOOD-IDES-02 Phase 3 trial in anti-glomerular basement membrane (anti-GBM) disease in December, with data readout expected in the second half of 2025. In Guillain-Barré Syndrome (GBS), Hansa announced positive full results from the 15-HMedIdeS-09 single arm Phase 2 study and an indirect treatment comparison to the International Guillain-Barré Syndrome Outcome Study (IGOS) in December 2024. In Gene Therapy, Hansa and Genethon announced initiation of GNT-018-IDES, a Phase 2 trial sponsored by Genethon evaluating the efficacy and safety of a single intravenous administration of Genethon's gene therapy GNT-0003 following pre-treatment with imlifidase in patients with severe Crigler-Najjar syndrome and pre-formed antibodies to AAV8. Enrolment continues in the SRP-9001-104 Phase 1b trial evaluating the use of imlifidase as a pre-treatment to Sarepta Therapeutics Inc.'s (Sarepta) ELEVIDYS (delandistrogene moxeparvovec) gene therapy in Duchenne Muscular Dystrophy (DMD). Hansa's journey towards a more sustainable business continues Over the last three years, Hansa has continuously evolved its approach to Sustainability aligning to the changes happening within the Company and the external environment. This year's Sustainability Report outlines the continued efforts the Company has advanced and our focus for 2025. The report highlights our work to address high unmet medical need in our three core therapy areas - Autoimmune, Gene Therapy and Transplantation, as well as our continued focus on ensuring that we are operating as a transparent, ethical business. Finally, we continue to believe that a diverse, inclusive, and supportive culture is integral to the Company's success. 2024 also marked the first year Hansa conducted a Double Materiality Assessment, an opportunity to better understand the Company's impact on stakeholders and the environment as well as what opportunities influence its business. The output - a list of prioritized material topics - provided insight and perspective on the Company's sustainability strategy and areas of focus for effective risk management. Hansa uses an annual company-wide survey by Great Place to Work®, a global authority on workplace culture, to seek employee feedback with the purpose of constantly developing and refining a healthy work environment with highly engaged and motivated colleagues. In 2024, Hansa was certified as a Great Place to Work® for the fifth consecutive year, with a 95% survey participation, Read the Annual and Sustainability Reports here. This is information that Hansa Biopharma AB (publ) is obliged to make public pursuant to the Securities Markets Act. The information was submitted for publication at 15:00 CET on 21 March 2025. Contacts for more information: Evan Ballantyne, Chief Financial Officer [email protected] Stephanie Kenney, VP Global Corporate Affairs [email protected] About Hansa Biopharma Hansa Biopharma AB is a pioneering commercial-stage biopharmaceutical company on a mission to develop and commercialize innovative, lifesaving and life-altering treatments for patients with rare immunological conditions. The company has a rich and expanding research and development program based on its proprietary IgG-cleaving enzyme technology platform, to address serious unmet medical needs in autoimmune diseases, gene therapy and transplantation. The company's portfolio includes imlifidase, a first-in-class immunoglobulin G (IgG) antibody-cleaving enzyme therapy, which has been shown to enable kidney transplantation in highly sensitized patients and HNSA-5487, a next-generation IgG cleaving molecule with redosing potential. Hansa Biopharma is based in Lund, Sweden, and has operations in Europe and the U.S. The company is listed on Nasdaq Stockholm under the ticker HNSA. Find out more at and follow us on LinkedIn. ©2025 Hansa Biopharma AB. Hansa Biopharma, the beacon logo, IDEFIRIX, and IDEFIRIX flower logo are trademarks of Hansa Biopharma AB, Lund, Sweden. All rights reserved. This information was brought to you by Cision The following files are available for download: SOURCE Hansa Biopharma AB WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

IDEFIRIX Product Sales Increased 83% Compared to the Prior Year LUND, Sweden, Feb. 6, 2025 /PRNewswire/ -- Hansa Biopharma AB, Hansa or the Company (Nasdaq Stockholm: HNSA) today announced its full year and Q4 2024 financial results. Søren Tulstrup, President and CEO, Hansa Biopharma said, "2024 proved to be a transformative year for Hansa, marked by ongoing commercial success of IDEFIRIX® across Europe and the achievement of key pipeline milestones in our priority therapy areas – Autoimmune, Gene Therapy, and Transplantation. Importantly, 2024 IDEFIRIX product sales, excluding the impact of a 49.6 MSEK provision to account for retroactive price adjustments linked to successful special early access programs following IDEFIRIX's launch in 2020, totaled 189.7 MSEK which represents an 83% increase over the prior year (103.7 MSEK). Including the impact of the provision, 2024 IDEFIRIX product sales totaled 140.1 MSEK which represents a 35% increase over prior year (103.7 MSEK) while total 2024 sales (171.3 MSEK) increased by 28% compared to the prior year (134.1 MSEK). The year-on-year IDEFIRIX growth reflects the continued successful launch execution in Europe and the ongoing momentum we are creating in the clinical community to help drive greater utilization of IDEFIRIX. Q4 2024 IDEFIRIX product sales were 25.6 MSEK and despite strong full year sales, quarterly product sales continue to fluctuate given the unpredictable nature of the European kidney allocation systems and availability of organs." Tulstrup continued, "Our efforts to advance our exciting pipeline of drug candidates resulted in the achievement of several key milestones, including positive results from a Phase 2 study and indirect treatment comparison of imlifidase in Guillain-Barré Syndrome (GBS), a favorable 12-month analysis from the NICE-01 study of HNSA-5487, completion of enrolment in our GOOD-IDES-02 Phase 3 study of imlifidase in anti-GBM, and the initiation of a Phase 2 trial of imlifidase in Crigler-Najjar for patients with anti-AAV antibodies in collaboration with our gene therapy partner, Genethon." Financial Performance Revenue for the full year 2024 totaled 220.9 MSEK excluding the impact of a 49.6 MSEK provision. The provision reflects price adjustments linked to successful early access programs following IDEFIRIX's launch in 2020. Excluding the provision, full year 2024 revenue totaled 171.3 MSEK representing a 28% increase over the prior year (134.1 MSEK). In 2024 IDEFIRIX product sales, excluding the provision, totaled 189.7 MSEK which represents an 83% increase over the prior year (103.7 MSEK). Including the provision, 2024 IDEFIRIX product sales totaled 140.1 MSEK which represents a 35% increase over prior year (103.7 MSEK). In Q4 2024, Hansa reported total revenue of 32.3 MSEK and IDEFIRIX product sales of 25.6 MSEK. Despite the strong performance of IDEFIRIX in 2024, Hansa product sales continue to fluctuate due to variations in European kidney allocation systems impacting availability of organs to specific patients. Pipeline Progress Progress across the company's pipeline continues with a positive read out from the Phase 2 15-HMedIdeS study in Guillain-Barré Syndrome (GBS) and an indirect treatment comparison of imlifidase to the International Guillain-Barré Syndrome Outcome Study (IGOS). In the Phase 2 study, patients treated with imlifidase plus IVIg had rapid overall improvement in functional status - specifically 37% of patients in the study returned to walking independently at one week. In the indirect treatment comparison to the IGOS-IVIg group, patients experienced significantly faster improvement across clinically relevant measures including median time to return to walking independently six weeks sooner than the IVIg-comparator group. The Company also shared positive results from a 12-month follow-up analysis from the NICE-01 trial of HNSA-5487, assessing IgG recovery, immunogenicity and redosing potential. In the analysis, HNSA-5487 reduced IgG levels by more than 95% in a few hours and achieved lower peak anti-drug antibody (ADA) responses confirming its redosing potential. In the first half of 2025, the Company plans to meet with regulatory agencies to establish a clinical pathway focused on neuro-autoimmune disease. The Company's Phase 3 GOOD-IDES-02 study in anti-GBM completed enrolment and data read out is expected in the second half of 2025. The Post Authorization Efficacy and Safety (PAES) study in kidney transplantation continued to enroll patients (96%) and is expected to be completed in mid-2025. A Phase 2 trial, GNT-018-IDES, in patients with Crigler Najjar syndrome with pre-existing antibodies against adeno-associated (AAV) vectors was initiated in collaboration with Genethon. Finally, the ConfideS Phase 3 US pivotal trial in kidney transplantation completed enrolment in 2024 and a data read out is expected in the second half of 2025. This will provide the basis for the Company's Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) in the second half of 2025. Financial Summary Conference Call Details Hansa Biopharma will host a telephone conference today Thursday, February 6, 2025, at 14:00 CET / 8:00 am ET. 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 live on the company website during the call under Events & Presentations and will also be made available online after the call. To participate in the telephone conference, please use the dial-in details provided below: Participant Dial In (Toll Free): 1-833-821-3542 Participant International Dial In: 1-412-652-1248 *Please ask to be joined into the Hansa Biopharma call Join the webcast here: For the full financial calendar and list of events in 2025 please visit This is information that Hansa Biopharma AB is obliged to make public pursuant to the Securities Markets Act. The information was submitted for publication at 7:00 CET on 2025-02-06. For more information, please contact: Evan Ballantyne, Chief Financial Officer [email protected] Stephanie Kenney, VP Global Corporate Affairs [email protected] Notes to editors About Hansa Biopharma Hansa Biopharma is a pioneering commercial-stage biopharmaceutical company on a mission to develop and commercialize innovative, lifesaving and life-altering treatments for patients with rare immunological conditions. The company has a rich and expanding research and development program based on its proprietary IgG-cleaving enzyme technology platform, to address serious unmet medical needs in autoimmune diseases, gene therapy and transplantation. The company's portfolio includes imlifidase, a first-in-class immunoglobulin G (IgG) antibody-cleaving enzyme therapy, which has been shown to enable kidney transplantation in highly sensitized patients and HNSA-5487, a second-generation IgG cleaving molecule with redosing potential. Hansa Biopharma is based in Lund, Sweden, and has operations in Europe and the U.S. The company is listed on Nasdaq Stockholm under the ticker HNSA. Find out more at and follow us on LinkedIn. ©2025 Hansa Biopharma AB. Hansa Biopharma, the beacon logo, IDEFIRIX, and IDEFIRIX flower logo are trademarks of Hansa Biopharma AB, Lund, Sweden. All rights reserved. This information was brought to you by Cision The following files are available for download: WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED