Announcement • Jul 22
Hansa Biopharma AB (publ) to Report Fiscal Year 2026 Results on Feb 11, 2027 Hansa Biopharma AB (publ) announced that they will report fiscal year 2026 results on Feb 11, 2027 Announcement • May 27
Hansa Biopharma Announces Late-Breaking Abstract from Confides Phase 3 Trial Selected for Oral Presentation At ATC 2026 Hansa Biopharma AB (publ) Announces Late-Breaking Abstract from ConfIdeS Phase 3 Trial Selected for Oral Presentation at ATC 2026. 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.4,5 Across the U.S. and Europe, highly sensitized patients comprise around 10%-15% of the total of patients on transplant waiting lists.6,7AboutimlifidaseImlifidase is conditionally approved in the European Union, Norway, Liechtenstein, Iceland and the UK under the tradename IDEFIRIX® for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor. IDEFIRIX® is also approved in Australia, Israel and Switzerland. Information about the trial is available at ClinicalTrials.gov:NCT04935177About 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.8 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.8 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.8The efficacy and safety of imlifidase as a pre-transplant treatment to reduce donor-specific IgG antibodies was studied in four phase 2 single-arm, studies in EU and US as well as a randomized, controlled Phase 3 study in US.5,7,10-11 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. In the US, the Food and Drug Administration (FDA) accepted the Biologics License Application (BLA) for imlifidase in February of 2026 and assigned a Prescription Drug User Fee Act (PDUFA) action date of December 19, 2026.Full EU product information can be accessed via the initial Summary of Product Characteristics foundhere. 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 in the U.S. and Europe waiting for a new kidney. Announcement • Apr 28
Hansa Biopharma AB (publ), Annual General Meeting, Jun 01, 2026 Hansa Biopharma AB (publ), Annual General Meeting, Jun 01, 2026, at 14:30 W. Europe Standard Time. Location: elite hotel ideon, scheelevagen 27, se-223 63, lund Sweden Announcement • Mar 21
Hansa Biopharma AB (publ) announced that it expects to receive $30 million in funding from Athyrium Capital Management, LP Hansa Biopharma AB announced a private placement to issue and entered into a U.S. convertible note purchase agreement with certain funds managed by Athyrium Capital Management (“Athyrium”) to issue 3% Unsecured Convertible Notes due March 17, 2031 for gross proceeds of $30,000,000 on March 20, 2026. The Financing extends the Company’s runway into mid 2027 and ensures a robust launch of imlifidase in the US, subject to approval. The Notes carry a fixed interest rate of 3% per year and interest is payable in cash semi-annually, starting September 15, 2026. The conversion premium corresponds to 25% on the 30-day volume-weighted average price per ordinary share ending on March 18, 2026. Announcement • Mar 06
Food and Drug Administration Notifies Hansa Biopharma AB for Imlifidase Hansa Biopharma AB announced that the Food and Drug Administration (FDA) has notified the company that the previously accepted Biologics License Application (BLA) for imlifidase has been assigned a Prescription Drug User Fee Act (PDUFA) action date of December 19, 2026. Announcement • Feb 20
Hansa Biopharma Ab's Biologics License Application (Bla) for Imlifidase Accepted by the Fda Hansa Biopharma AB announced that its Biologics License Application (BLA) for imlifidase has been accepted by the U.S. Food and Drug Administration (FDA). FDA's filing review was completed on day 60 which is meant to verify that the submission is substantially complete and meets the requirements for a full evaluation. Imlifidase is a unique IgG-cleaving enzyme that rapidly inactivates > 95% of donor-specific antibodies within 2-6 hours of administration, providing a crucial window to enable HLA-incompatible kidney transplantation. The BLA submission for imlifidase is supported by the previously communicated highly statistically significant outcome of the pivotal U.S. Phase 3 ConfIdeS trial, which evaluated 12-month kidney function in highly sensitized adult kidney transplant patients (cPRA 99.9%) with a positive crossmatch against a deceased donor, compared to a control arm. The trial successfully met its primary endpoint, demonstrating significantly improved kidney function in the imlifidase arm at 12 months as measured by mean estimated glomerular filtration rate (eGFR) (p < 0.0001). A key secondary endpoint--dialysis independence at 12 months-- was also statistically significant in favor of imlifidase (p = 0.0007). Imlifidase was generally well tolerated, with a safety profile consistent with previous clinical trial experience. ConfIdeS is a pivotal Phase 3 open label, randomized, controlled trial of imlifidase in kidney transplantation. A total of 25 U.S. sites participated in the trial, and the primary endpoint was kidney graft function at 12 months, measured by mean eGFR (estimated glomerular filtration rates). The total trial duration is five years, which includes a long-term follow-up agreed with the FDA as part of the accelerated approval pathway. Imlifidase is conditionally approved in the European Union, Norway, Lichtenstein, Iceland and the UK under the tradename IDEFIRIX®? for the desensitization treatment of highly sensitized adult kidney transplant patient with a positive crossmatch against an available deceased donor. IDEFIRIX®? is also approved in Australia and Switzerland. Imlifidase has conditional marketing approval in Europe and is marketed under the tradename IDEFirIX for the desensitizationtreatment of highly sensitized adult kidney transpl 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. 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. 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.2,3-5 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. Announcement • Dec 20
Hansa Biopharma Submits BLA to FDA for Imlifidase in Desensitization for Kidney Transplantation Hansa Biopharma AB announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for imlifidase. The Company is requesting priority review of the BLA for the use of imlifidase in the desensitization of highly sensitized adult patients undergoing deceased donor kidney transplantation. The trial successfully met its primary endpoint, demonstrating significantly improved kidney function in the desensitization arm at 12 months as measured by mean estimated glomerular filtration rate (eGFR) (p < 0.0001). A key secondary endpoint--dialysis independence at 12 months--was also statistically significant in favor of imlifidase (p = 0.0007). Imlifidase was generally well tolerated, with a safety profile consistent with previous clinical trial experience. Upon determination of acceptance of the application for review, FDA will communicate a target action date under the Prescription Drug User Fee Act (PDUFA). Hansa has requested priority review for the BLA, which if granted would establish a six-month review cycle with a potential for an approval as early as Third Quarter 2026. A total of 25 US sites participated in the trial, and the primary endpoint was kidney graft function at 12 months, measured by mean eGFR (estimated glomerular filtration rates). The total trial duration is five years, which includes a long-term follow-up agreed with the FDA as part of the accelerated approval pathway. Imlifidase is conditionally approved in the European Union, Norway, Lichtenstein, Iceland and the UK under the tradename IDEFIRIX®? for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor. Imlifidase has conditional marketing approval in Europe and is marketed under the tradename IDEFirIX for the desensitizationtreatment of highly sensitized adult kidney transpl patients with a positive crossmatchagainst 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. 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. 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.2,3-5 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 EU product information can be accessed via the initial Summary of Product Characteristics found here. All rights reserved. Announcement • Dec 16
Hansa Biopharma AB Announces Reorganization of its European and International Commercial and Medical Affairs Operations, Effective December 11, 2025 Hansa Biopharma AB on December 15, 2025 announced a reorganization of its European and International Commercial and Medical Affairs operations, effective December 11, 2025. This action follows a comprehensive review of the European commercial operations over the past months, as referenced in the CEO letter of the Third Quarter Jan-Sept interim report. The review identified key areas for improvement and investment aimed at addressing recent challenges and enhancing performance and predictability in 2026. Hansa is implementing operational adjustments designed to improve overall performance, strengthen accountability, enhance collaboration, and simplify decision-making. Announcement • Oct 10
Genethon and Hansa Biopharma Announces Data from Gnt-018-Ides Trial Supports Feasibility of Imlifidase as Pret Treatment for Patients with Crigler-Najjar Syndrome Who Are Immune to Aav Genethon and Hansa Biopharma announced that a patient with a rare liver disease and immunity to the AAV vector has been successfully treated with Genethon's AAV-based GNT0003 gene therapy for Crigler-Najjar syndrome, following prior administration of imlifidase, an enzyme capable of temporarily inhibiting the immune response. This encouraging result, achieved in a clinical trial, is a significant advance in the treatment of patients with immunity to AAVs who were previously ineligible for clinical trials and existing gene therapy treatments. Gene therapy involves injecting a gene drug into an organism using a vector, a "means of transport" usually derived from viruses, such as AAVs (adeno-associated viruses), which are commonly used for gene therapy in for example neuromuscular, liver, and eye diseases. It is estimated that one in three people is naturally immune to AAVs, thereby excluding a large number of patients from the possibility of benefiting from gene therapy using an AAV vector. To evaluate potential options for treating patients with natural immunity to AAVs, researchers at Genethon tested imlifidase, an enzymes developed by Hansa Biopharma, as a pre-treatment. This enzyme is capable of cleaving IgG, thereby rapidly and significantly reducing the level of anti-AAV antibodies and allowing the administration of a gene therapy drug candidate. Dr. Jeremy Do Cao (Beclere Hospital, AP-HP, France) presented at the 2025 congress of theEuropean Society of Gene & Cell Therapy (ESGCT), the results of using imlifidase as a pre-treatment for GNT0003 gene therapy in a patient with a severe form of Crigler-Najj syndrome who is naturally immune to the AAV8 vector, as part of the clinical trial (GNT-018-IDES) conducted by Genethon in collaboration with Hansa Biopharma. In this first patient treated, the study demonstrated: the feasibility and safety of this approach: imlifidase administered prior to GNT0003 gene therapy successfully cleaved and inactivated the patient's antibodies and enabled treatment with GNT0003. No severe side effects related to GNT0003 or imlifidase were reported. initial efficacy data: GNT0003, Genethon's gene therapy drug candidate significantly lowered the patient's birubin levels, enabling her to stop hours of daily phototherapy, which had been essential to her survival until then. The phototherapy has been interrupted sixteen weeks after the injection, as planned in the protocol. Additional data will be needed to confirm this efficacy in the longer term. This is the first time that gene therapy has been successfully administered to a patient with Crigler-Najajjar syndrome who has antibodies against AAV8. If the results are confirmed in the next stages of the trial, this approach could become a promising option for patients with antibodies to AAVs, who are currently ineligible for clinical trials and existing Gene therapy treatments. A first gene therapy drug, to which Genethon contributed, has been approved for marketing for spinal muscular atrophy. With more than 240 scientists and experts, Genethon's goal is to develop innovative therapies that change the lives of patients suffering from rare genetic diseases. Thirteen gene therapy products developed by Genethon or to which Genethon has contributed are currently undergoing clinical trials for diseases of the liver, blood, immune system, muscles, and eyes. Seven other products are in preparation for clinical trials over the next five years. Announcement • Oct 04
Hansa Biopharma AB (publ) has completed a Follow-on Equity Offering in the amount of SEK 671.5 million. Hansa Biopharma AB (publ) has completed a Follow-on Equity Offering in the amount of SEK 671.5 million.
Security Name: Shares
Security Type: Common Stock
Securities Offered: 17,000,000
Price\Range: SEK 39.5
Transaction Features: Subsequent Direct Listing Announcement • Sep 26
Hansa Biopharma AB Announces Positive Topline Results from the US Phase 3 ConfIdeS Trial of imlifidase Hansa Biopharma AB announced positive topline results from the US Phase 3 ConfIdeS trial of imlifidase, evaluating 12-month kidney function in highly sensitized (cPRA 99.9%) adult kidney transplant patients with positive crossmatch against a deceased donor, versus the control arm. The trial was well conducted, with patient retention in excess of 90%, and met the primary endpoint of kidney function at 12 months as measured by mean estimated Glomerular Filtration Rate (eGFR) with a p-value of <0.0001. The Company plans to submit a BLA under the accelerated approval pathway to the US Food and Drug Administration (FDA) by the end of 2025. In the trial, the control arm allowed for a range of treatment options, including remaining on dialysis awaiting a more compatible organ offer, transplantation using off-label desensitization approaches, or transplantation with a compatible organ. A key secondary outcome relating to dialysis independence at 12 months was also statistically significant in favor of imlifidase (p=0.0007). Imlifidase was generally well tolerated with a safety profile consistent with previous clinical trial experience. Full results from the Phase 3 ConfIdeS trial will be submitted to a medical congress in 2026. ConfIdeS is a pivotal Phase 3 open label, randomized, controlled trial of imlifidase in kidney transplantation. A total of 25 US sites participated in the trial and its primary endpoint is kidney graft function at 12 months, measured by mean eGFR (estimated glomerular filtration rate). The total trial duration is five years which includes a long-term follow-up as agreed to with the FDA as part of the accelerated approval pathway. 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. 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. 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.2,3-5 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. Announcement • Sep 03
Hansa Biopharma AB (publ) Announces Board Appointments Hansa Biopharma AB (publ) announced that the Extraordinary General Meeting held on September 2, 2025 resolved on new election of Elisabeth Björk, Natalie Berner and Michael Bologna as members of the Board, all for the time until the end of the next Annual General Meeting. The current members of the Board Eva Nilsagård, Hilary Malone, Mats Blom, Peter Nicklin and Jonas Wikström remain as members of the Board and Anders Gersel Pedersen and Florian Reinaud resigned as members of the Board in connection with the Extraordinary General Meeting. Announcement • Aug 07
Hansa Biopharma AB (Publ) Announces Board Resignations Hansa Biopharma AB (publ) announced at extraordinary general meeting to be held on September 2, 2025, Anders Gersel Pedersen and Florian Reinaud have informed the Nomination Committee that they will resign as members of the Board in connection with the Extraordinary General Meeting. Announcement • Aug 02
Hansa Biopharma AB Announces Positive Data from Treatment with Imlifidase Prior to the Administration of Gene Therapy for Duchenne Muscular Dystrophy Hansa Biopharma AB announced topline results from three patients with Duchenne muscular dystrophy (DMD) treated with Hansa's imlifidase prior to receiving Sarepta's ELEVIDYS (delandistrogene moxeparvovec-rokl) in the SRP-9001-104 trial. After one dose of imlifidase, three patients experienced a rapid reduction of IgG antibodies, to levels 95% less than baseline. In addition, in these three patients pre-existing anti-AAV antibodies were reduced below a kilometre of 1:400, which enabled treatment with ELEVIDYS. The safety profile of imlifidase was in keeping with prior experience and the trial did not generate any new safety signals. Twelve weeks after administration of the gene therapy, patients in the trial demonstrated evidence of AAV-mediated transduction and expression of micro-dystrophin, however with levels lower than seen in other trials with ELEVIDYS. Based on these outcomes, Hansa and Sarepta will discuss appropriate next steps for the program. Announcement • Jul 30
Hansa Biopharma AB (publ) Announces Executive Changes Hansa Biopharma AB announced three leadership appointments. Brian Gorman joins Hansa as Chief Legal Officer and Corporate Secretary, effective August 4; Sandra Frithiof has been appointed Chief Human Resources Officer (CHRO), effective August 4. Brian Gorman is an accomplished legal and business executive with more than 20 years of global experience in advising corporate boards and management teams. Brian joins Hansa from Sinclair Pharma Ltd., a global medical aesthetics company, where he was Chief Legal Officer supporting the company's global expansion efforts. Prior to Sinclair, Brian was Group General Counsel at Calliditas Therapeutics, where he guided the company through its acquisition by Asahi Kasei Corporation of Japan. Previously, Brian was Executive Vice President, Corporate Development and General Counsel at Opiant Pharmaceuticals, where he played a key role in its acquisition by Indivior PLC. Earlier in his career, Brian held senior leadership roles at Endo Pharmaceuticals and AstraZeneca. Brian began his career at international law firm Cleary Gottlieb Steen & Hamilton, and he is a graduate of Gettysburg College and the Villanova University School of Law. Sandra Frithiof brings over 25 years of experience in human resources in different industries, to Hansa. Most recently, Sandra was HR Director at Ayvens Sweden AB, a global leader in the mobility sector. Prior to Ayvens, Sandra was VP Human Resources at Calliditas Therapeutics, where she built the Global HR organization to support the company's entry into the US market. Previously, Sandra was Head of HR and COO at Ramberg Advokater, a Swedish law firm and earlier in her career, Sandra held HR positions at Karolinska University Hospital, UTC, CGI and Manpower Group. Sandra has a bachelor's degree in human resource management from Örebro University, Sweden. Ms Frithiof will replace Anne Säfström Lanner, CHRO, who will leave the organization. Brian Gorman and Sandra Frithiof will report to CEO Renée Aguiar-Lucander and be members of the Executive Committee. Announcement • Jul 18
Hansa Biopharma AB (publ) to Report Fiscal Year 2025 Results on Feb 05, 2026 Hansa Biopharma AB (publ) announced that they will report fiscal year 2025 results on Feb 05, 2026 Announcement • Jul 08
Hansa Biopharma Appoints Richard Philipson as Chief Medical Officer, Effective 14 July, 2025 Hansa Biopharma AB announced that Dr. Richard Philipson has been appointed Chief Medical Officer (CMO) effective 14 July. Dr. Philipson will report to CEO Renée Aguiar-Lucander and be a member of the Executive Committee. Dr. Philipson has over 25 years of industry experience and a successful track record in drug development, providing clinical leadership resulting in four product approvals, including in rare disease and gene therapy, and comes with expertise and success in building high-functioning teams, building pipelines and executing clinical development programs across all phases of development. He also brings in-depth knowledge of regulatory strategy in drug development. Dr. Philipson most recently was CMO of Calliditas Therapeutics and previously spent 16 years at GlaxoSmithKline (GSK), including four years as Therapeutic Area Head in the Rare Diseases Unit. He also has experience from Takeda, and a 4-year period as CMO at Trizell. Announcement • Jun 30
Hansa Biopharma Presents Positive Outcomes of Five-Year Follow-Up Study of Imlifidase in Kidney Transplantation at ESOT Congress 2025 in London Hansa Biopharma AB announced the presentation of its five year extended pooled analysis including data from the 17-HMedIdeS-14 study, an international long-term follow-up study of patients who have received a kidney transplant following desensitization with imlifidase, at the 2025 International Transplant Congress of the European Society for Organ Transplantation (ESOT), taking place in London, June 29 - July 2. Massimo Mangiola, PhD, NYU Langone Transplant Institute, will present the outcomes of the extended pooled analysis including data from The 17-HMedIdeS -14 study, presented at the American Transplant Congress (ATC) 2024, and published as a letter to the editor in the American Journal of Transplantation. The extended pooled analysis, including data from the 17-HMedIdeS-14 study, showed sustained positive outcomes out to five years of highly sensitized patients who received an imlifidase-enabled kidney transplant. After five years, the patient survival rate was 90% (reflecting three deaths occurring between six months and one year) and graft survival (death censored) was 82%, in line with outcomes seen at three-years. At five years, mean estimated glomerular filtration rate (eGFR) or kidney function was 50 mL/min/m in the imlifidase treated patients. eGFR is a measure of how well the kidneys are working in the body - higher eGFR indicates better kidney function. For many kidney transplant recipients three years post-transplant the mean eGFR is anywhere between 40-60 ml/min per 1.73 m with continued decline of eGFR function at five years post-transplant. 17-HMedIdeS-14 is part of the HMedIdeS clinical program for imlifidase. The program includes four global phase 2 trials (13-HMedIdeS-02, 13-HMedIdeS-03, 14-HMedIdeS-04 and 15-HMedIdeS-06), one US open-label phase 3 trial (ConfIdeS), a long-term follow up study (17-HMedIdeS-14) and a post-authorization efficacy and safety study in Europe (PAES). The 17-HMedIdeS-14 study included patients who consented to long-term follow-up and had previously received an imlifidase-enabled transplant in Hansa's phase 2 studies. The 5-year extended pooled analysis is a continuation of the analysis at 3-years of crossmatch positive only patients published in the American Journal of Transplantation. Announcement • May 14
Hansa Biopharma AB to Present Data from its 15-HMedIdeS-09 Phase 2 Single Arm Study of Imlifidase Hansa Biopharma AB, will present data from its 15-HMedIdeS-09 Phase 2 single arm study of imlifidase, a first in class IgG cleaving enzyme, in Guillain-Barre Syndrome (GBS) at the Peripheral Nerve Society (PNS) Annual Meeting, taking place 17-20 May in Edinburgh, Scotland. Hansa communicated the results from the 15-HMedIdeS -09 study in December 2024. Professor Shahram Attarian, Head of Department of Neuromuscular Diseases and ALS, Hopitaux Universitaires de Marseille (APHM) and International Coordinating Principal Investigator will present data from 15-HMedIde S-09 Phase 2 study at the 2025 PNS Annual Meeting. Hansa's Phase 2 15-HMedIdes-09 open-label, single arm study was performed across multi-centers in the UK, France, and the Netherlands evaluating the safety, tolerability, and efficacy of a single dose of imlifidase (0.25 mg/kg) in 30 adult GBS patients in combination with standard of care (SoC) intravenous immunoglobulin (IVIg). The administration of imlifidase prior to SoC in patients with GBS was considered to be safe and well tolerated. Imlifidase is a unique antibody-cleaving enzyme originating from Streptococcus pyogenes that specifically targets IgG and inhibits IgG-mediated immune response. 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. Announcement • Apr 26
Hansa Biopharma AB (publ) Announces Chief Executive Officer Changes Hansa Biopharma AB (publ) announced Renee Aguiar-Lucander has been appointed chief executive officer effective immediately. Soren Tulstrup has stepped down from his position of CEO by mutual agreement after seven years of dedicated service to the company. Announcement • Mar 11
Hansa Biopharma AB Completes Enrolment in European Phase 3 20-HMedIdeS-19 Post Authorization Efficacy and Safety Study in Highly Sensitized Kidney Transplant Patients Hansa Biopharma AB announced that it has completed enrolment of its 20-HMedIdeS-19 Post Authorization Efficacy and Safety (PAES) study, an open-label Phase 3 confirmatory study in Europe investigating the one-year patient and graft survival in highly sensitized patients who have undergone HLA-incompatible kidney transplantation following desensitization treatment with imlifidase. Imlifidase is the Company's first generation, first-in-class, one-time treatment, conditionally approved in Europe as desensitization treatment in kidney transplantation with the brand name IDEFIRIX®?. Imlifidase is also being evaluated in late-stage trials in autoimmune diseases where immunoglobulin G (IgG) antibodies are a driver of disease, and as a pre-treatment to gene therapy in patients with anti-AAV antibodies. Creating an IgG-free window by inactivating the donor-specific antibodies, it makes desensitization-enabled HLA-in compatible kidney transplantation a viable option for those considered highly sensitized and who were previously left on transplant waiting list for extended, often indefinite time. Announcement • Dec 19
Hansa Biopharma Announces Positive Full Results from 15-HMedIdeS-09 Phase 2 Study and comparative Analysis of Imlifidase in Patients with Guillain-Barre Syndrome Hansa Biopharma announced positive full results from 15-HMedIdeS-09 Phase 2 study and comparative analysis of imlifidase in patients with Guillain-Barre Syndrome. The 15-HMed IdeS-09 study included 30 adult patients who were treated with imlifidase plus IVIg. During the study, three patients were re-diagnosed, and the remaining 27 patients received a confirmatory diagnosis of severe GBS and were included in the efficacy analysis. Six months after imlifidase treatment, 63% of patients were able to run or had no functional disability (GBS DS 1). Administration of imlifidase was well tolerated in the study. When compared to the IGOS real-world comparator group (severe GBS patients treated with IVIg, n=754), patients in the 15-HMedIdeS -09 study (severe GBS patients treated With imlifidase in combination with IVIg, n<0.002) and returned to independently walking (GBS DS2) 6 weeks sooner versus patients in the IGOS real- world comparator group treated with IVIg (p=0.03). HNSA-5487 is a second-generation molecule with redosing potential with a clinical development path focused on acute exacerbations in neuro-autoimmune disease including myasthenia gravis (MG). The company plans to publish data from the study and indirect comparison. More information about the study is available at ClinicalTrials.gov under NCT03943589. Hansa Biopharma will host a telephone conference on 18 December at 14:00 CET /8:00 AM ET. Imlifidase is currently being studied in the following autoimmune diseases: anti-glomerular basement membrane (anti-GBM) disease and Guillain-Barre syndrome (GBS). HNSA-5487 are moving quickly into the clinical phase focusing on the GBS DS (GBS). NSA-5487 is moving quickly into the clinical phase focused on the IGOS real-world comparison group including 6.4 times more likely at week 1, and 4.2 times more likely at week 4 to walk independently. Announcement • Dec 06
Hansa Biopharma Completes Enrolment in Global Pivotal Phase 3 Trial of Imlifidase in Anti-Glomerular Basement Membrane Disease Hansa Biopharma AB (publ) 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 planned for 2025. Anti-GBM is Hansa Biopharma's most advanced program in the autoimmune space. GOOD-IDES-02 is an open label, multi-center Phase 3 trial involving over 40 centers across the US, UK, and EU. A total of 50 patients have been enrolled in the trial. In the trial, 25 patients were randomized to receive imlifidase in combination with standard of care (SoC), consisting of a combination of immunosuppressives, glucocorticoids, and plasma exchange, and 25 patients received only SoC. The primary objective of the study is to assess the superior effect on kidney function of imlifidase in combination with SoC versus SoC alone in the treatment of patients affected by severe anti-GBM disease. The performance of the treatment is assessed at 6 months through the evaluation of renal function as measured by estimated glomerular filtration rate (eGFR) and need of dialysis. In addition, the safety profile and efficacy on pulmonary symptoms and health related quality of life aspects are evaluated. Announcement • Dec 03
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 Hansa Biopharma, "Hansa" and Genethon 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 gene therapy GNT-0003 following pre-treatment with imlifidase, Hansa's first-in-class immunoglobulin G (IgG) antibody cleaving enzyme therapy, in patients with severe Crigler-Najjar syndrome and pre-formed antibodies to AAV serotype 8 (AAV8). Antibodies against AAV vectors remain a major challenge, as their presence in patients excludes them from entering clinical studies with potentially curative gene therapy treatments and from access to currently marketed and future gene therapies. GNT-018-IDES, sponsored by Genethon, is a single arm Phase 2 trial with a total of three patients aged =18 years with Crigler-Najjar syndrome and pre-formed anti-AVV8 antibodies and requiring phototherapy. Once screened, patients will undergo a three-month observational period before being dosed with imlifidase followed by GNT-0003. Genethon and Hansa expect to communicate data from the trial in 2025. GNT-0003 is currently being evaluated in a pivotal clinical trial following the positive results of the phase 1-2 dose escalation study showing safety and efficacy of GNT-0003, and was granted PRIME priority drug status from the EMA. If successful, GNT-0003 would be the first gene therapy treatment for Crigler-Najjar syndrome. Announcement • Nov 20
Hansa Biopharma AB (publ) to Report Fiscal Year 2024 Final Results on Mar 21, 2025 Hansa Biopharma AB (publ) announced that they will report fiscal year 2024 final results at 9:00 AM, Central European Standard Time on Mar 21, 2025 Announcement • Oct 07
Hansa Biopharma's Hnsa-5487 Achieves Rapid and Highly Robust Igg Reduction by More Than 95% and Clear Redosing Potential in First-In-Human Trial Hansa Biopharma AB, 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% within a few hours post treatment. In a 12-month followup analysis IgG levels returned to normal range six months after initial dosing. This confirms that HNSA-5487 mirrors the extremely high efficacy of imlifidase, the Company's first-generation IgG-cleaving enzyme, in reducing total IgG levels. It is in preclinical development and is designed to enable expansion into a large spectrum of potential indications, including relapsing autoimmune diseases and gene therapy, as well as oncology indications. The lead molecule in the NiceR program is HNSA-5487. Imlifidase is an antibody-cleaving enzyme originating from Streptococcus pyogenes that specifically targets and cleaving IgG (IgG) antibodies and inhibits IgG-mediated immune response. 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. 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. 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. 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. MOGAD is an inflammatory disorder of the central nervous system characterized by attacks of immune-mediated antibody predominantly targeting the optic nerves, brain, and spinal cord. It is associated with the presence of antibodies directed against myelin oligodendrocyte glycoprotein (MOG). MOG is found in the myelin that insulates the nerves of the central nervous system, which consists of the brain, spinal cord and optic nerves. The antibody attack on MOG disrupts the transmission of nerve signals in the body and causes a variety of symptoms including changes in vision, weakness and numbness of the limbs, andalysis. MOGAD affects 2 - 3.4 in every 100,000 people worldwide and approximately 30% of all cases are in children. Announcement • Aug 23
Matthew Shaulis, Chief Commercial Officer and US President Decides to Leave Hansa Biopharma AB in Late September Hansa Biopharma AB 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. Announcement • Jun 28
Hansa Biopharma AB (publ) Announces Board Appointments Hansa Biopharma AB (publ) at its Annual General Meeting held on June 27, 2024, resolved election of Florian Reinaud and Jonas Wikström, as members of the Board of Directors for the period until the end of the next Annual General Meeting. Announcement • May 31
Hansa Biopharma Completes Randomization in Pivotal Phase 3 Us Confides Trial Hansa Biopharma AB (publ) 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. 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. Announcement • Apr 12
Hansa Biopharma AB (publ) has completed a Follow-on Equity Offering in the amount of SEK 372.1536 million. Hansa Biopharma AB (publ) has completed a Follow-on Equity Offering in the amount of SEK 372.1536 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 10,474,740
Price\Range: SEK 29.12
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 2,305,260
Price\Range: SEK 29.12
Transaction Features: Subsequent Direct Listing Announcement • Feb 22
Hansa Biopharma AB (Publ) Announces CFO Changes Hansa Biopharma, "Hansa" announced the appointment of Evan Ballantyne as Chief Financial Officer (CFO), effective 1 March 2024. He succeeds Donato Spota, who, as previously announced, will leave the Company on 28 February 2024. As CFO, Mr. Ballantyne will be responsible for developing and implementing the Company's corporate financial strategy and activities including financial reporting and investor relations (IR). He will report to President & Chief Executive Officer Søren Tulstrup and serve as a member of Hansa's Executive Committee. Most recently, Mr. Ballantyne was Senior Vice President, Chief Financial Officer at Gain Therapeutics Inc. (Gain), a US based biotech company. He brings more than 30 years international experience as a senior financial executive in both public and private life science companies. Evan joins Hansa from Gain Therapeutics Inc., a clinical stage biotechnology company based in Bethesda, MD in the US. He served as SVP, Chief Financial Officer. He has over 30 years of financial and operational experience developing and implementing successful shareholder value strategies. Over the course of his career, Evan has held roles of increasing responsibility at biotech, medical technology and information services companies throughout Europe and the US, helping these companies navigate complex financial markets and secure funding and capital to support their growth. Additionally, he has experience in all facets of financial reporting, investor and analyst relationship management, corporate restructuring, and acquisitions and partnerships. Evan has a degree in Honors Business Administration from the University of Windsor, Ontario Canada as well as a BA in American History & Political Science from the University of Western Ontario, Canada. He is an independent board member of Preveceutical Medical Inc. in Vancouver, British Columbia, Canada. Announcement • Jan 30
Hansa Biopharma AB (publ) to Report Q2, 2024 Results on Jul 18, 2024 Hansa Biopharma AB (publ) announced that they will report Q2, 2024 results on Jul 18, 2024 Announcement • Jan 19
Hansa Biopharma AB (publ), Annual General Meeting, Jun 27, 2024 Hansa Biopharma AB (publ), Annual General Meeting, Jun 27, 2024. Announcement • Jan 06
Hansa Biopharma AB (Publ) Provides Earnings Guidance for the Fourth Quarter and Full Year 2023 Hansa Biopharma AB (publ) provided earnings guidance for the fourth quarter and full year 2023. Hansa expects to report total fourth quarter revenue of SEK 50 million consisting of SEK 43 million in product sales and SEK 7 million in revenue recognition mainly under the agreement with Sarepta Therapeutics. Product sales is driven by growth in new markets such as U.K., Germany, and Spain. Operating loss to be SEK 177 million.For the year, the company expects total revenue of SEK 134 million and operating loss to be SEK 790 million. Announcement • Dec 15
Hansa Biopharma Announces Full Results from 16-HMedIdeS-12 Phase 2 Trial in Patients with Antibody Mediated Rejection Episodes Following Kidney Transplantation Hansa Biopharma announced full results from the 16-HMedIdeS-12 phase 2 trial in patients with antibody mediated rejection (AMR) episodes following a kidney transplant demonstrating that imlifidase significantly reduced donor-specific antibodies (DSAs) within the first five days of treatment. In the trial, the primary endpoint was the maximum reduction in DSA level at any time point during the 5 days following the start of treatment. Patients treated with imlifidase demonstrated a statistically significant reduction of DSAs by 94.4% compared to a 35.6% (p-value: <0.001) reduction in patients who received standard of care (plasma exchange, or PE). DSA levels subsequently returned to approximately 70% of the initial level in both treatment arms. The secondary endpoint investigated overall kidney function following treatment. The imlifidase arm demonstrated a 74% six-month graft survival and eGFR of 30mL/min/1.73m2. A 100% six-month graft survival and eGFR of 33mL/min/1.73m2 was observed in the PE arm. Given the heterogeneity of the patient population, the trial was not designed nor sufficiently powered to be able show a statistically significant difference in the secondary outcome measures. Imlifidase demonstrated a safety profile consistent with previous clinical trials. The AMR patient population is heterogeneous, consisting of both chronic patients - those who experience slow rejection after a transplant, and which often results in irreversible damage to the organ - and acute patients who experience AMR early post-transplant. Additionally, AMR can be driven by a combination of antibodies and T-cells-mediated action (CMR - cell mediated rejection), creating additional complexity when it comes to treatment strategy. Treatment guidelines indicate reduction of DSA levels as one of the main goals of any AMR treatment. To date, there are no approved therapies for the treatment of AMR, and all current treatments including standard of care are used off-label. Announcement • Dec 14
Hansa Biopharma Nomination Committee Formed Hansa Biopharma AB (publ) announced that the Nomination Committee has been formed in accordance with the principles adopted by the Annual General Meeting (AGM) on June 29, 2023 and has the following composition: Florian Reinaoud representing Redmile Group Jonas Wikström representing Theodor Jeansson Sven Sandberg representing Thomas Olausson As the conveyer of the Nomination Committee, Peter Nicklin, Chairman of the Board of Directors at Hansa Biopharma will be asked to summon the first meeting in the Nomination Committee. The function of the Nomination Committee is to prepare and submit proposals for the AGM regarding the number of board members to be elected by the general meeting, election of chairman and other board members, board fees and any remuneration for committee work, election of the chairman of the AGM, election of auditors (if applicable) and fee for the auditors, and proposals for rules for appointing the Nomination Committee. Announcement • Dec 07
Hansa Biopharma Announces Positive High-Level Data from the 15-HMedIdeS-09 Phase 2 Trial Hansa Biopharma, "Hansa" announced positive high-level data from the 15-HMedIdeS-09 phase 2 trial that demonstrated 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 in 2024. 15-HMedIdeS -09 is an open-label, single arm, trial evaluating the safety, tolerability and efficacy of imlifidase in GBS patients in combination with standard of care (SoC) intravenous immunoglobulin (IVIg). GBS is a rare, acute, paralyzing, inflammatory disease of the peripheral nervous system caused by the immune system damaging nerve cells and structures. It affects 1-2 in 100,000 people annually. In GBS, rapid onset and progression of muscle weakness occurs and can lead to severe paralysis of the arms and legs. Approximately 25% of patients require mechanical ventilation for days to months and 20% are unable to walk after six months. Even with current standard of care - either plasma exchange or immunoglobin therapy - GBS is fatal in 3-7% of cases. Imlifidase was safe and Well tolerated, and when compared to previously published data, a rapid improvement across several efficacy outcome measures was observed in patients treated with imlifidase in combination with standard of care. All subjects received a full dose of imlifidase, and no serious adverse events caused by imlifidase infusion related reactions were recorded. Autoimmune diseases form a group of serious diseases caused by the immune system attacking the body. In many autoimmune diseases the immune system mistakenly recognizes the body's own proteins as foreign and mounts an immune response, creating antibodies to attack the body's own cells and tissues. Pathogenic IgG can contribute to a broad spectrum of autoimmune diseases. Hansa is exploring how imlifidase may be able to prevent or slow the progression of these diseases and their debilitating, life-threatening symptoms. Imlifidase is currently being studied in the following autoimmune diseases: anti-glomerular basement membrane (anti-GBM) disease, Guillain-Barre Syndrome, and ANCA-associated vasculitis. In 2018, the U.S. Food and Drug Administration granted Orphan Drug Designation to imlifidase for the treatment of GBS. Despite treatment with current standard of care, GBS has a serious long-term impact on the patients' work and private life, even 3-6 years after the onset of illness. Recovery can be slow and take years. Persistent disability is seen in 20%-30% of adult patients and severe fatigue is a sequel of GBS in two thirds of adult patients. Announcement • Nov 29
Hahansa Biopharma AB (Publ) Announces Resignation of Donato Spota as Chief Financial Officer, Effective 28 February 2024 Hansa Biopharma announced that Donato Spota, Chief Financial Officer (CFO) has decided to leave the company for private reasons. His last day will be 28 February 2024. A search is underway for a new Chief Financial Officer (CFO). Announcement • Oct 17
Hansa Biopharma Announces Results from an Extended Pooled Analysis Using Data from the 17-Hmedides-14 Study, an International Long-Term Follow-Up Study of Patients Who Have Received A Kidney Transplant Following Desensitization with Imlifidase, Showing Sustained Positive Outcomes Out to 5 Years in the Majority of Highly Sensitized Patients Who Received an Imlifidase-Enabled Kidney Transplant Hansa Biopharma announced results from an extended pooled analysis using data from the 17-HMedIdeS-14 study, an international long-term follow-up study of patients who have received a kidney transplant following desensitization with imlifidase, showing sustained positive outcomes out to 5 years in the majority of highly sensitized patients who received an imlifidase-enabled kidney transplant. After 5 years, the patient survival rate was 90% (three deaths occurring between six months and one year, and no deaths occurring between one and five years) and graft survival (death censored) was 82%, in line with outcomes seen at 3-years post-transplant. At five years, mean estimated glomerular filtration rate (eGFR) was 50 mL/min/m2. eGFR is a measure of how well the kidneys are working in the body. The 17-HMedIdeS-14 study included patients who consented to long-term follow-up and had previously received an imlifidase-enabled transplant in Hansa's phase 2 studies. The 5-year extended pooled analysis is a continuation of the analysis at 3-years of crossmatch positive only patients published in the American Journal of Transplantation. Hansa is continuing to analyze the data from 17-HMedIdeS-14 along with the extended pooled analysis and plans to share further data in 2024. Imlifidase is a promising new strategy for desensitization of transplant patients with donor-specific anti-HLA (Human Leukocyte Antigens) antibodies (DSAs). Highly sensitized patients have high levels of preformed antibodies that can damage the transplant. Once they 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. Announcement • Oct 10
Hansa Biopharma Announces Encouraging High-Level Results for First-In-Human Trial of HNSA-5487 Hansa Biopharma announced high-level results from NICE-01, the first-in-human trial for HNSA-5487. Results showed the molecule was safe and well tolerated. Fast and complete depletion of immunoglobulin G (IgG) antibodies was observed at increasing doses in all subjects. Pharmacokinetics (PK) was in line with expectations and pharmacodynamics (PD) (efficacy on IgG cleavage) showed a fast and complete cleavage of IgG to F(ab')2- and Fc-fragments with increasing doses. NICE-01 is a double blind, randomized, placebo-controlled trial evaluating safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single ascending doses of HNSA-5487 administered as a single intravenous (IV) infusion. The trial included a total of 36 healthy male and female adult participants. HNSA-5487 is the company's lead candidate in the Novel Immunoglobulin Cleaving Enzymes for repeat Dosing (NiceR) program. The NiceR program aims to develop next-generation enzymes with lower immunogenicity that would potentially allow for repeat dosing in a range of indications including IgG-driven autoimmune diseases where patients experience flares, transplantation where repeat dosing would be beneficial, gene therapy and oncology. Analysis of additional exploratory endpoints on IgG recovery and immunogenicity is now being conducted, with follow up on all subjects for 12 months. This analysis will serve as key input in determining the further clinical development program, including selection of indications. Announcement • Sep 03
Hitto Kaufmann Appointed Chief Scientific Officer of Hansa Biopharma, Effective 1 December 2023 Hansa Biopharma announced that Dr. Hitto Kaufmann has been appointed as Hansa's Chief Scientific Officer (CSO) effective 1 December 2023. As CSO, Dr. Kaufmann will be responsible for all research, early development, translational and manufacturing activities. He will report to President & Chief Executive Officer Søren Tulstrup and serve as a member of Hansa's Executive Committee. Dr. Kaufmann joins Hansa from Pieris Pharmaceuticals where he has served as Chief Scientific Officer since 2019. He led the company's R&D platform developing innovative next generation protein therapeutics leading to regulatory submissions across several indications. He played an integral role in transforming the company's operational excellence including accelerated development paths, machine-learning driven R&D and reliable high-performance manufacturing as well as delivery. Dr. Hitto Kaufmann has served as Chief Scientific Officer at Pieris Pharmaceuticals since 2019. He is a biopharma leader with over 20 years of experience in research, development, and manufacturing. His track record includes the development of approximately 100 biological therapeutic entities and many projects advanced by him actively steering strategic partnerships. At Pieris, he was responsible for leading research, technical development, data sciences as well as drug supply while overseeing early-stage projects and alliance management. Additionally, Dr. Kaufmann played an integral role in transforming the company's approach to development and advancement of new drug candidates. He currently serves as a member of the Scientific Advisory Board of Instituto de Biologia Experimental e Tecnologica (iBET), a private, non-profit organization in Portugal specializing in biology research and drug discovery/bioprocess development services. Prior to joining Pieris, Dr. Kaufmann spent five years at Sanofi, where he held several executive positions in Industrial Affairs and R&D. During this time, he led efforts to build a strong cross-divisional end-to-end technology platform for Sanofi Biologics that included several strategic deals. He also led the Global Biopharmaceutics Development, managing over 700 employees across three sites tasked with drug substance and drug product technical development, analytics, clinical supply and release. Before his tenure at Sanofi, Dr. Kaufmann spent more than a decade at Boehringer Ingelheim, and prior to his departure was the Vice President of Process Sciences in the Biopharmaceuticals division. He began his career as a Research Scientist at the Walter and Eliza Hall Institute in Melbourne. Dr. Kaufmann received his Ph.D. in Natural Science, focusing on cell culture technology, at the Swiss Federal Institute of Technology in Zurich. He earned his Master of Science degree in biotechnology from the Technical University of Braunschweig and the Scripps Research Institute. Announcement • Jul 21
Hansa Biopharma Announces First Patient Treated with Imlifidase in an Investigator-Initiated Phase 2 Study in Anca-Associated Vasculitis Hansa Biopharma announced first patient treated with imlifidase in an investigator-initiated phase 2 study in anti-neutrophil cytoplasmic antibody ("ANCA")-associated vasculitis. This is the first study evaluating imlifidase, Hansa's first-generation IgG-cleaving enzyme, in this patient population. The study is a single center, single arm, phase 2 trial led by Dr. Adrian Schreiber and Dr. Philipp Enghard, at Charite Universitatsmedizin, Berlin, Germany. The primary objective of the study is to assess efficacy and safety of imlifidase together with standard of care in the treatment of patients with pulmonary hemorrhage due to severe ANCA-associated vasculitis. A total of 10 patients with severe ANCA- associated vasculitis and Acute Respiratory Distress Syndrome ("ARDS") due to pulmonary hemorrhage will be treated with imlifidase on top of standard of care (consisting of standard immunosuppression as per center protocol and intensive support care). Efficacy and safety of imlifidases will be assessed by evaluating ANCA antibody seroconversion and titers, adverse events, mortality, as well as amelioration of lung and renal function over a 6-month observation period. ANCA-associated vascul inflammation is a group of conditions that affect approximately 30 people in a million annually in the EU and US. It is characterized by the presence of IgG anti-neutrophil Cytoplasmatic antibodies directed against antigens expressed by the neutrophils, a type of white blood cell part of the body's immune system response. The consequent activation of neutrophils by the ANCA antibodies causes blood vessel damage that can affect multiple organs, most frequently lungs and kidneys, where it leads to rapidly deteriorating organ function. The progress of the disease results in end stage kidney disease in 25% of patients. The most severe cases involving lungs lead to pulmonary hemorrhage with consequent respiratory failure. Announcement • Jul 12
Hansa Biopharma Receives Provisionally Approval in Australia as Desensitization Treatment in Highly Sensitized Patients Prior to Kidney Transplantation Hansa Biopharma announced that the Australian Therapeutic Goods Administration has provisionally approved Idefirix (imlifidase) as desensitization treatment for highly sensitized patients prior to kidney transplantation from both living and deceased donors. The provisional approval has a duration of two years and was based on data from Hansa's phase 2 studies that included highly sensitized patients who received a kidney from either a living (17%) or deceased donor (83%) following desensitization treatment with imlifidase. 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. 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. In July 2023 the Australian Therapeutic goods Administration ("TGA") included Idefirix (im lifidase) on the Australian Register of therapeutic Goods as desensitization treatment For highly sensitized adult kidney transplant candidates prior to kidney transplantation from a donor against whom there is a positive cross-match. This indication allows transplants from either living or deceased donor kidneys. Imlifidase is a promising new strategy for desensitization of transplant patients with donor-specific anti-HLA (Human Leukocyte Antigens) antibodies (DSAs). Highly sensitized patients have high levels of these preformed antibodies that can bind to the donor organ and damage the transplant. 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. 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. Announcement • May 30
Hansa Biopharma Announces First Patient Dosed with Imlifidase in a Global Pivotal Phase 3 Trial in Anti-Inaugular Basement Membrane (anti-GBM) Disease Hansa Biopharma announced the first patient has been dosed with imlifidase in the GOOD-IDES-02 trial, a global pivotal phase 3 trial in anti-glomerular basement membrane (anti-GBM) disease. GOOD-IDES-02 is an open label, multi-center, phase 3 trial of 50 patients. A total of 30-40 centers are expected to be included in the study across the US, UK, and EU. The primary objective of the study is to assess the superior effect of imlifidase in combination with standard of care (SoC) versus SoC alone (consisting of a combination of immunosuppressives, glucocorticoids, and plasma exchange) in the treatment of patients affected by severe anti-GBM disease. The performance of the treatment is assessed through the evaluation of renal function at 6 months as measured by filtration rate and need of dialysis. In addition, the safety profile and efficacy on pulmonary symptoms and health related quality of life aspects will be explored. The study follows a completed investigator-initiated phase 2 trial, which concluded that imlifidase therapy leads to rapid clearance of anti-GBM antibodies, with two-thirds of patients achieving dialysis independence six months after treatment compared to 18% in a historical control cohort. Anti-glomerular basement membrane (anti-GBM) disease, also known as Good pasture disease, is a rare, severe autoimmune condition affecting around 1.6 people per million annually with majority of patients losing their kidney function. In anti-GBM disease, the immune system mistakenly develops antibodies against an antigen intrinsic to the glomerular basement membrane, resulting in an acute immune attack of the kidneys and, in around half of the patients, also the lungs. Approximately two thirds of anti-GBM patients will experience kidney failure and require long-term dialysis while awaiting potential kidney transplantation. Some patients may also experience bleeding from the lungs. In one out of six patients, anti-GBM disease can become fatal during the acute phase. Imlifidase has been granted orphan drug designation for the treatment of anti-GBM disease by both the U.S. FDA and the European Medicinal Agency (EMA). Announcement • Jan 31
Hansa Biopharma Announces Planned Departure of Chief Scientific Officer Christian Kjellman Hansa Biopharma announced that Christian Kjellman, Chief Scientific Officer and Chief Operating Officer, has decided to leave the company in 2024. Effective immediately. Christian has been an important part of Hansa Biopharma since 2008 helping advance the Company's research and development projects through several critical milestones including regulatory approval of first drug candidate. Additionally, in 2020 Christian assumed a dual leadership role ensuring tight integration and connectivity between the R&D and Commercial Operations functions during the early launch phase of the Company's first commercial product. Announcement • Jan 03
Hansa Biopharma Announces Positive Reimbursement Decision for Idefirix[®] (Imlifidase) in the Czech Republic Hansa Biopharma announced that it has attained reimbursement in the Czech Republic for its first-in-class treatment, Idefirix®, for the desensitization treatment of highly sensitized adult patients prior to kidney transplant from a deceased donor. Between January and October 2022, a total of 386 kidney transplants from deceased donors were performed in the Czech Republic, while approximately 400 patients remained on the kidney transplant waiting list. Highly sensitized patients have antibodies with a broad reactivity against a wide pool of potential donors, so finding a matched organ for these patients is particularly challenging. As a result, highly sensitized patients end up spending a longer than average time on transplant waiting lists with an increased risk of dying while waiting for a compatible donor. The decision to implement Idefirix® marks an important milestone for highly sensitized patients in the Czech Republic as they may now be desensitized using Idefirix® to enable kidney transplantation. Announcement • Feb 27
Hansa Biopharma AB Announces Grant of Early Access Post Marketing Authorization for its First-In-Class Treatment Idefirix® (imlifidase) Hansa Biopharma AB (‘Hansa’) announced that its first-in-class treatment Idefirix® (imlifidase) has been granted early access post marketing authorization (Autorisation d'accès précoce) in France by French HAS (Haute Autorité de Santé) for use in the desensitization of highly sensitized adult patients prior to kidney transplant, in accordance with the patient population specified in the Marketing Authorization received from the European Medicines Agency (EMA). The aim of early access programs in France is to accelerate access to innovative medicines before (AP1) or after (AP2) marketing authorization (and before completion of the full P&R process), as in the case of Idefirix® when all the following conditions stipulated in article L.5121-12 of the French Public Health Code (CSP) are met: There is no appropriate treatment available on the market; The initiation of the treatment cannot be deferred; The efficacy and safety of the medicinal product are strongly presumed based on the results of clinical trials; and The medicinal product is presumed to be innovative, notably compared with a clinically relevant comparator. The approval of this early access program for Idefirix® is valid for a year from the date of decision, funded through the National Security System, and is effective across kidney transplant centers in France. The authorization has been granted based on Hansa's dossier submitted in December 2021, which rendered a positive opinion of the Transparency Commission. Full details of the early access program can be found at the HAS website. Approximately 3,600 kidney transplantations are carried out annually in France, with more than 80% transplanted from deceased donors. According to the Agence de Biomédecine, in 2020 hyperimmune patients represented 11.1% of kidney transplant recipients, while the proportion of hyperimmune patients on the active renal transplant waiting list was 23.7%. Long-term dialysis can place a significant burden on patients and on healthcare systems and is associated with a reduction in health-related quality of life and increased risk of mortality and hospitalization. Commercial launch and market access efforts for Idefirix® in Europe continue to progress. Pricing and reimbursement processes have been completed in Sweden and the Netherlands, as well as on an individual hospital basis in Finland and Greece. Market access procedures are ongoing in 14 countries including Germany, France, Italy and the United Kingdom (U.K.). A Health Technology Assessment (HTA) dossier for Spain was submitted in January 2022, which completed HTA filings in all of the five larger markets in Europe. Announcement • Feb 26
Hansa Biopharma AB Announces Positive Early Access Decision by French Haute Autorité De Santé to Use Idefirix® (Imlifidase) as Desensitization Treatment for Highly Sensitized Kidney Transplant Patients Hansa Biopharma AB announced that its first-in-class treatment Idefirix® (imlifidase) has been granted early access post marketing authorization (Autorisation d'accès précoce) in France by French HAS (Haute Autorité de Santé) for use in the desensitization of highly sensitized adult patients prior to kidney transplant, in accordance with the patient population specified in the Marketing Authorization received from the European Medicines Agency (EMA). The aim of early access programs in France is to accelerate access to innovative medicines before (AP1) or after (AP2) marketing authorization (and before completion of the full P&R process), as in the case of Idefirix® when all the following conditions stipulated in article L.5121-12 of the French Public Health Code (CSP) are met: There is no appropriate treatment available on the market; The initiation of the treatment cannot be deferred; The efficacy and safety of the medicinal product are strongly presumed based on the results of clinical trials; and The medicinal product is presumed to be innovative, notably compared with a clinically relevant comparator. The approval of this early access program for Idefirix® is valid for a year from the date of decision, funded through the National Security System, and is effective across kidney transplant centers in France. The authorization has been granted based on Hansa's dossier submitted in December 2021, which rendered a positive opinion of the Transparency Commission. Full details of the early access program can be found at the HAS website. Approximately 3,600 kidney transplantations are carried out annually in France, with more than 80% transplanted from deceased donors. According to the Agence de Biomédecine, in 2020 hyperimmune patients represented 11.1% of kidney transplant recipients, while the proportion of hyperimmune patients on the active renal transplant waiting list was 23.7%. Long-term dialysis can place a significant burden on patients and on healthcare systems and is associated with a reduction in health-related quality of life and increased risk of mortality and hospitalization. Commercial launch and market access efforts for Idefirix® in Europe continue to progress. Pricing and reimbursement processes have been completed in Sweden and the Netherlands, as well as on an individual hospital basis in Finland and Greece. Market access procedures are ongoing in 14 countries including Germany, France, Italy and the United Kingdom (U.K.). A Health Technology Assessment (HTA) dossier for Spain was submitted in January 2022, which completed HTA filings in all of the five large markets in Europe. Announcement • Dec 29
Hansa Biopharma Enrolls First Patient in U.S. Randomized, Controlled Pivotal Trial of imlifidase in Highly Sensitized Kidney Transplant Patients Hansa Biopharma AB (publ) announces that the first patient in its U.S. open-label, randomized, controlled pivotal trial ("ConfIdeS") has been enrolled at the Columbia University Medical Center, New York. The ConfIdeS trial is evaluating imlifidase as a potential desensitization therapy to enable kidney transplants in highly sensitized patients waiting for a deceased donor kidney through the U.S. kidney allocation system. The trial is expected to randomize 64 highly sensitized kidney transplant patients with a cPRA of =99.9%, representing a subset of very highly sensitized patients that continue to be disadvantaged despite prioritization under the U.S. kidney allocation system. When a donor organ becomes available and a positive crossmatch with the intended recipient indicates that the organ is not compatible, the patient will be randomized to either imlifidase desensitization treatment or to a control arm that will receive standard of care (i.e. waiting for a more compatible kidney offer or receiving an experimental desensitization treatment). The study's primary endpoint for imlifidase to evaluate benefit in transplanting highly sensitized patients is kidney graft function at 12 months, measured by eGFR (estimated Glomerular Filtration Rate).