Anti-Glomerular Basement Membrane Disease

LUND, Sweden, July 18, 2024 /PRNewswire/ -- 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 look forward to communicating data in the second half of 2025 with an expected Biologics License Application (BLA) submission to the US Food and Drug Administration (FDA). Also, our Phase 3 trial in anti-glomerular basement membrane (anti-GBM) disease and the European Post Authorization Efficacy Study (PAES) in kidney transplant have both increased enrollment and remain on track. Looking ahead, the Company has several important milestones in the second half, including further analysis of data from the Phase 1 study of HNSA-5487, the Company's second-generation IgG cleaving enzyme designed to be re-dosed." Financial Performance The Company delivered strong financial performance for the third consecutive quarter with total revenue of 54.2 MSEK. Of this, 47.1 MSEK is attributed to IDEFIRIX sales. This excludes the impact of an approximate 20 MSEK provision related to potential price adjustments from cumulative sales since the launch of IDEFIRIX in Europe in 2020. After accounting for this provision, total IDEFIRIX product sales were 27.2 MSEK. Sales performance was primarily driven by continued expansion of IDEFIRIX in key European markets. To date, the Company has secured reimbursement in 14 European markets. In Q2 2024, the Company completed a directed share issue, raising gross proceeds of 372 MSEK (US $34.6M) primarily from high-quality international healthcare specialist investors. Pipeline Progress Progress across the pipeline included the completed randomization in the ConfIdeS pivotal Phase 3 US trial in kidney transplantation, further enrollment in the European Post Approval Efficacy Study in kidney transplantation (70 percent) with expected completion by 2025, and continued enrollment (70 percent) in the GOOD-IDES-12 Phase 3 trial in anti-GBM disease with data readout in 2025. Financial Summary Conference Call Details Hansa Biopharma will host a telephone conference today Thursday, July 18, 2024, at 14:00 CET / 8:00 am EST. The event will be hosted by Søren Tulstrup, President and CEO, Matthew Shaulis, Chief Commercial Officer and US President, Evan Ballantyne, Chief Financial Officer, and Hitto Kaufmann, Chief R&D Officer. The presentation 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. Link to presentation To participate in the telephone conference, please use the dial-in details provided below: Sweden: +46 812 410 952 United Kingdom: +44 203 769 6819 United States: +1 646 787 0157 Participant access code: 765135 The webcast will be available on For the full financial calendar and list of events in 2024 please visit This is information that Hansa Biopharma AB is obliged to make public pursuant to the Securities Markets Act. For more information: Evan Ballantyne, CFO E: [email protected] Stephanie Kenney, VP Global Corporate Affairs E: [email protected] 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. Hansa has developed a first-in-class immunoglobulin G (IgG) antibody cleaving enzyme therapy, which has been shown to enable kidney transplantation in highly sensitized patients. Hansa has a rich and expanding research and development program, based on the Company's proprietary IgG-cleaving enzyme technology platform, to address serious unmet medical needs in transplantation, autoimmune diseases, gene therapy and cancer. 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 hansabiopharma.com. This information was brought to you by Cision The following files are available for download:

LUND, Sweden, May 31, 2024 /PRNewswire/ -- 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 the ConfIdeS trial is an important step in bringing imlifidase to the US to help address the significant unmet need faced by highly sensitized kidney transplant patients. Our hope is that the ConfIdeS trial will help further validate the role imlifidase may play as a desensitization treatment that enables HLA-incompatible kidney transplantation. We look forward to sharing the data from the ConfIdeS trial in due course." The ConfIdeS trial is evaluating kidney function in 64 highly sensitized (cPRA ≥99.9%) kidney transplant patients with positive crossmatch against a deceased donor, comparing desensitization using imlifidase with standard of care. A total of 24 US sites are participating in the trial and its primary endpoint is kidney graft function at 12 months, measured by eGFR (estimated Glomerular Filtration Rate). Imlifidase has been granted conditional marketing approval in Europe under the trade name IDEFIRIX® for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor. Imlifidase is also being studied in autoimmune conditions including anti-glomerular basement membrane (anti-GBM) disease and Guillain-Barré syndrome (GBS) and as a pre-treatment to gene therapy in rare disease patients with pre-existing antibodies. This is information that Hansa Biopharma AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the contact person set out below, at 13:30 CEST on 31 May 2024. Contacts for more information: Evan Ballantyne, Chief Financial Officer [email protected] Stephanie Kenney, VP Global Corporate Affairs [email protected] Notes to editors About highly sensitized patients Highly sensitized patients have pre-formed antibodies called donor specific antibodies (DSAs) with a broad reactivity against human leukocyte antigens (HLAs), which can cause tissue damage and potentially transplant rejection.1 The presence of DSAs means that highly sensitized patients tend to have limited or no access to transplant, as finding a compatible donor organ can be particularly challenging.2,3 The complexity of their immunological profile means that highly sensitized patients spend longer time than average on transplant waiting lists, with evidence showing that this longer time waiting for a suitable donor relates to an increased mortality risk.2,3 Across the U.S. and Europe, highly sensitized patients comprise around 10-15% of the total of patients on transplant waiting lists.4,5 About IDEFIRIX® (imlifidase) Imlifidase is an antibody-cleaving enzyme originating from Streptococcus pyogenes that specifically targets and cleaves immunoglobulin G (IgG) antibodies and inhibits IgG-mediated immune response.6 It has a rapid onset of action, cleaving IgG-antibodies and inhibiting their activity within hours after administration. Imlifidase has conditional marketing approval in Europe and is marketed under the trade name IDEFIRIX for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor. The use of IDEFIRIX should be reserved for patients who are unlikely to be transplanted under the available kidney allocation system, including prioritization programs for highly sensitized patients.6 IDEFIRIX was reviewed as part of the European Medicines Agency's (EMA) Priority Medicines (PRIME) program, which supports medicines that may offer a major therapeutic advantage over existing treatments or benefit patients without treatment options.6 Imlifidase is an effective strategy for desensitization of transplant patients with donor-specific anti-HLA (Human Leukocyte Antigens) antibodies (DSAs).7 Highly sensitized patients have high levels of these preformed antibodies that can bind to the donor organ and damage the transplant.8 Once they are inactivated with imlifidase, there is a window of opportunity for the transplant to take place. By the time the body starts to synthesize new IgG, the patient will be receiving post-transplant immunosuppressive therapy to reduce the risk of organ rejection. The efficacy and safety of imlifidase as a pre-transplant treatment to reduce donor-specific IgG was studied in four phase 2 open-label, single-arm, six-month clinical trials.7,9-11 Hansa is collecting further clinical evidence and will submit additional efficacy and safety data based on one observational follow-up study and one post-approval efficacy study. Full product information can be accessed via the initial Summary of Product Characteristics found here. About kidney failure Kidney disease can progress to kidney failure or End-Stage Renal Disease (ESRD), identified when a patient's kidney function is less than 15%.12 ESRD poses a significant health burden, affecting nearly 2.5 million patients worldwide.12 A kidney transplant is the treatment of choice for suitable patients with ESRD because it offers improved survival and quality of life benefits, and is cost savings compared to long-term dialysis. There are approximately 170,000 kidney patients on transplant waiting lists across the U.S., European Union and United Kingdom.13 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. Hansa Biopharma has developed a first-in-class immunoglobulin G (IgG) antibody-cleaving enzyme therapy, which has been shown to enable kidney transplantation in highly sensitized patients. Hansa Biopharma has a rich and expanding research and development program based on the Company's proprietary IgG-cleaving enzyme technology platform, to address serious unmet medical needs in transplantation, autoimmune diseases, gene therapy and cancer. 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. ©2024 Hansa Biopharma. Hansa Biopharma, the beacon logo, and IDEFIRIX are trademarks of Hansa Biopharma AB, Lund, Sweden. All rights reserved. References Eurostam Report (A Europe-wide strategy to enhance transplantation of highly sensitized patients on the basis of acceptable HLA mismatches.) Available at . Redfield RR, et al. The mode of sensitization and its influence on allograft outcomes in highly sensitized kidney transplant recipients. Nephrol Dial Transplant. 2016 Oct;31(10):1746-53. doi: 10.1093/ndt/gfw099. Lonze BE, et al. IdeS (Imlifidase): A Novel Agent That Cleaves Human IgG and Permits Successful Kidney Transplantation Across High-strength Donor-specific Antibody. Ann Surg. 2018 Sep;268(3):488-496. doi: 10.1097/ OPTN/SRTR 2022 Annual Data Report. HHS/HRSA; 2024. Accessed [May 2024]. SRTR Database and individual assessments of allocation systems European Medicines Agency. Idefirix® summary of product characteristics. Available at: . Jordan SC, et al. IgG Endopeptidase in Highly Sensitized Patients Undergoing Transplantation. N Engl J Med 2017;377:442-453. DOI: 10.1056/NEJMoa16125 Manook M, et al. Post-listing survival for highly sensitised patients on the UK kidney transplant waiting list: a matched cohort analysis. Lancet. 2017 Feb 18;389(10070):727-734. doi: 10.1016/S0140-6736(16)31595-1. Winstedt L, et al. Complete Removal of Extracellular IgG Antibodies in a Randomized Dose-Escalation Phase I Study with the Bacterial Enzyme IdeS--A Novel Therapeutic Opportunity. PLoS One. 2015 Jul 15;10(7):e0132011. doi: 10.1371/journal.pone.0132011. PMID: 26177518; PMCID: PMC4503742. Lorant T, et al. Safety, immunogenicity, pharmacokinetics, and efficacy of degradation of anti-HLA antibodies by IdeS (imlifidase) in chronic kidney disease patients. Am J Transplant. 2018 Nov;18(11):2752-2762. doi: 10.1111/ajt.14733. Jordan SC, et al. Imlifidase Desensitization in Crossmatch-positive, Highly Sensitized Kidney Transplant Recipients: Results of an International Phase 2 Trial (Highdes). Transplantation. 2021 Aug 1;105(8):1808-1817. doi: 10.1097/TP.0000000000003496 NIH (2018). What is kidney failure? Available at: . Newsletter Transplant 2022. International figures on donation and transplantation. Available at: Newsletter Transplant – latest edition | Freepub (edqm.eu) [Accessed May 2024]. This information was brought to you by Cision The following files are available for download: SOURCE Hansa Biopharma AB

Strong revenue generation in Q4 2023 including SEK 43m in Idefirix® product sales supported by growth in new markets such as U.K., Germany, and Spain Encouraging results from first-in-human trial of HNSA-5487 Initiation of phase 1b trial of imlifidase as pre-treatment to Sarepta's SRP-9001 in DMD LUND, Sweden, Feb. 2, 2024 /PRNewswire/ -- 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 December 2023 . Highlights for the fourth quarter of 2023 Strong commercial performance. Total Q4 revenue of SEK 50m including SEK 43m in product sales and SEK 7m under our agreement mainly with Sarepta. Idefirix® sales were driven by growth in new markets such as U.K., Germany, and Spain. Medical guidelines and recommendations including use of Idefirix® implemented on a national level in Italy and Germany. NICE-01 phase 1 (HNSA-5487): Following positive results from the first-in-human trial of HNSA-5487, the lead candidate from the NiceR program for repeat dosing, an analysis of additional exploratory endpoints on IgG recovery and immunogenicity is being conducted for completion in 2024. AMR (antibody-mediated transplant rejection) phase 2: Full data published in December 2023. Imlifidase met the primary endpoint; explorative secondary outcome measures were not designed nor sufficiently powered to show statistical significance versus the control arm. GBS (Guillain-Barré Syndrome) phase 2: Positive high-level data announced in December 2023 as imlifidase demonstrated positive safety, tolerability, and early efficacy outcomes. Further analysis will contextualize the efficacy data. SRP-9001-104 phase 1b trial (Duchenne Muscular Dystrophy, DMD): The first clinical study with imlifidase as a pre-treatment to Sarepta's SRP-9001 gene therapy in DMD was initiated mid-December 2023. First patient is expected to be dosed in early 2024. On October 17, 2023, Hansa announced 5-year data from the long-term follow-up study of imlifidase, demonstrating 90% patient survival and 82% graft survival in extended pooled analysis with data from the 17-HMedIdeS-14 study. On December 5, 2023, Hansa announced plans to restructure the organization to better align and focus on key clinical development and commercial priorities. The planned restructuring should result in an approximately 20-25% reduction in the current workforce and will provide approximately SEK 75-85 million in annual savings, when fully implemented. Clinical pipeline update US ConfIdeS phase 3 trial (kidney transplantation): 104 patients have been enrolled with 40 of 64 targeted patients randomized in this pivotal U.S. open label, randomized, controlled trial of imlifidase in kidney transplantation. GOOD-IDES-02 phase 3 (anti-GBM disease): 18 of 50 targeted patients enrolled in this global pivotal phase 3 trial in anti-glomerular basement membrane (anti-GBM) disease. Completion of enrollment is expected in 2025. Investigator-initiated phase 2 trial (ANCA-associated vasculitis): 3 of 10 targeted patients enrolled. Events after closing period On January 6, 2024, Hansa and NewBridge Pharmaceuticals announced their partnership to enable supply of Idefirix® to kidney transplant patients in the Middle East and North Africa (MENA). On February 1, 2024, Hansa Biopharma and Medison Pharma announced positive reimbursement decision in Slovenia for Idefirix® in highly sensitized kidney transplant patients. With this, commercial access to Idefirix® has now been obtained in 14 European countries. First patient treated in the new Eurotransplant Desensitization Program, under the Acceptable Mismatch Program, which is intended to transform desensitization across eight European member countries including Germany, the Benelux and select Eastern European countries. Financial summary Søren Tulstrup, President and CEO of Hansa Biopharma, comments "Hansa enters 2024 in a strong position to successfully execute on our key priorities. I am encouraged by the performance of Idefirix® against key launch metrics and the continued progress we have achieved across our pipeline development activities. I am particularly excited about the encouraging first results from the first-in-human trial of HNSA-5487, Hansa's lead candidate in the NiceR program. It is our aim with this new enzyme to enable repeated infusions and thereby target diseases and conditions where either a prolonged IgG-free window or intermittent therapy is desirable. If successful, this new approach could enable innovative treatment approaches in a broad range of indications, including chronic auto-immune diseases. In kidney transplantation, we continue to see good commercial progress in Europe, including the implementation of treatment guidelines in both Italy and Germany and continued growth in the number of hospitals with desensitization protocols in place, while sales were supported by growth in key new markets such as U.K., Germany, and Spain. During the fourth quarter, we also saw increased patient identification through organ allocation systems such as Eurotransplant where both a first and second wave patient assessment took place with the new Desensitization Program. This new pilot program, under the Acceptable Mismatch Program, is intended to transform desensitization across eight European member countries including Germany, the Benelux and select Eastern European countries. In the U.S., we continue enrollment in the phase 3 ConfIdeS trial in kidney transplantation to accelerate randomization of patients. As previously guided, completion of randomization is expected by mid-2024, with a BLA submission expected in 2025 following a 12-month follow-up on kidney function, measured through the mean estimated glomerular filtration rate (eGFR). Beyond our core markets, we continue to expand access to imlifidase for highly sensitized kidney transplant patients through a new commercial partnership with NewBridge Pharmaceuticals in the MENA region. The new collaboration is rooted in the existing European conditional marketing authorization for Idefirix® and pending applications for marketing authorization in the respective MENA markets. Further, I am also pleased to see positive data from our long-term follow-up study further supporting the clinical benefit of imlifidase in kidney transplantation out to year five. The five-year data demonstrate graft survival in line with outcomes seen at 3-years post-transplant. Beyond kidney transplantation, we shared data read-outs from two phase 2 programs in AMR and GBS. In the AMR phase 2 trial (16-HMedIdes-12), imlifidase met the primary endpoint demonstrating statistically significant reduction in donor-specific antibodies (DSAs) observed among imlifidase patients within five days of treatment as compared to plasma exchange which is a common part of a standard of care treatment. While we are encouraged to have met the primary endpoint, it is important to note that the secondary endpoints were not met as the trial was not designed nor sufficiently powered to show a statistically significant difference between the two arms given the heterogeneity of patients, involving many patients with an additional cellular component of the immune rejection, and the small number of patients enrolled. Patients with an acute AMR may be best placed to benefit from a rapid and significant reduction in DSA levels. In the GBS phase 2 study (15-HMedIdeS-09), high level data was announced in December 2024 demonstrating that imlifidase was safe and well tolerated when administered prior to standard of care, including rapid improvement in disease-related efficacy measures. Further analysis of efficacy data will be conducted this year. In our pivotal phase 3 program in anti-glomerular basement membrane (anti-GBM) disease (GOOD-IDES-02), we continue to see good progress, with 18 of 50 targeted patients enrolled as of February 2, 2024. Completion of enrollment is expected in 2025. Further, I am happy to report that the first clinical study with imlifidase in gene therapy was recently commenced by our partners from Sarepta Therapeutics. In the phase 1b study, imlifidase is being investigated as a pre-treatment to Sarepta's FDA approved SRP-9001 (Elevidys) gene therapy in Duchenne Muscular Dystrophy (DMD). First patient is expected to be dosed in due course. Lastly, we recently announced plans to restructure the organisation to better align and focus on key clinical development and commercial priorities. This is expected to result in an approximate 20-25% reduction in the current workforce and will yield approximately 75-85 million SEK in annual savings when fully implemented. While we firmly believe this initiative is a necessary action to help us deliver on our important mission, it was obviously a difficult decision to take as it impacts our most valuable asset – our people. We are grateful for the commitment and relentless efforts of our colleagues who have worked tirelessly to advance potentially lifesaving medicines for people suffering from serious immunological diseases and conditions and we remain committed to supporting those colleagues impacted by the restructure. I look forward to keeping you updated on our continued progress, with several upcoming important milestones to be achieved across our platform and franchises in 2024." Upcoming milestones and news flow 2024 First high level data read-out from phase 1b study in DMD with Sarepta (NEW) 2024 GBS Phase 2: Outcome of the comparative efficacy analysis 2024 Genethon Crigler-Najjar Phase 1/2: Initiate clinical study with imlifidase prior to GNT-0003 2024 HNSA-5487: Further analysis around endpoints in FIH trial 2024 U.S. ConfIdeS (Kidney tx) Phase 3: Complete randomization 2025 U.S. ConfIdeS (Kidney tx) Phase 3: BLA submission 2025 Anti-GBM disease Phase 3: Completion of enrollment (NEW) Updated financial calendar 2024 Mar 20, 2024 Annual Report 2023 Apr 18, 2024 Interim Report for January - March 2024 June 27, 2024 2024 Annual General Meeting in Lund, Sweden July 18, 2024 Half-year Report January - June 2024 Oct 24, 2024 Interim Report for January - September 2024 Conference call details Hansa Biopharma will host a telephone conference Friday February 2, 2024, 14:00 CET / 8:00am EST. The event will be hosted by Hansa Biopharma's CEO, Søren Tulstrup, CCO, U.S. President, Matthew Shaulis, CSO Hitto Kaufmann and CFO, Donato Spota. The presentation 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: Sweden: +46 8 12 41 0952 UK: +44 203 769 68 19 USA: +1 646 787 0157 Participant access code: 765135 The webcast will be available on The year-end report and latest investor presentation can be downloaded from our web: Interim report January to December 2023 Investor road show presentation Q4, 2023 This is information that Hansa Biopharma AB is obliged to make public pursuant to the Securities Markets Act. For more information: Klaus Sindahl, VP Head of Investor Relations M: +46 (0) 709 298 269 E: [email protected] Stephanie Kenney, VP Global Corporate Affairs M: +1 (484) 319 2802 E: [email protected] 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. Hansa has developed a first-in-class immunoglobulin G (IgG) antibody cleaving enzyme therapy, which has been shown to enable kidney transplantation in highly sensitized patients. Hansa has a rich and expanding research and development program, based on the Company's proprietary IgG-cleaving enzyme technology platform, to address serious unmet medical needs in transplantation, autoimmune diseases, gene therapy and cancer. 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 hansabiopharma.com. The following files are available for download: SOURCE Hansa Biopharma AB