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Hansa Biopharma
Hansa Biopharma (HNSA) investor relations material
Hansa Biopharma 44th Annual J.P. Morgan Healthcare Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.44th Annual J.P. Morgan Healthcare Conference summary14 Jan, 2026
Technology and clinical development
Proprietary IgG-cleaving enzyme platform targets acute immune-mediated diseases, with rapid and effective IgG reduction demonstrated in clinical settings.
Differentiated from FcRn inhibitors, the enzyme addresses desensitization in highly sensitized kidney transplant candidates and expands to gene therapy and autoimmune indications.
Late-stage trials in Guillain-Barré syndrome (GBS) are planned, with prior phase II success and conditional approval in Europe for the lead compound.
U.S. phase III trial completed, BLA submitted in December, with priority review requested and potential PDUFA date in February.
Next-generation enzyme (5487) shows lower immunogenicity and similar efficacy, with phase I data supporting further development.
Market opportunity and patient need
U.S. kidney transplant waitlist includes 100,000 patients, with 15,000 highly sensitized and 7,000 at extreme sensitization (CPRA ≥98%).
Median wait time for highly sensitized patients is seven years, with a five-year dialysis survival rate of 40%.
2,500 highly sensitized patients annually die or become ineligible for transplant due to comorbidities.
200 U.S. transplant centers, with 100 handling 80% of volume; commercial launch will target these efficiently.
European market is fragmented, but reimbursement achieved in 20 countries at $300,000–$350,000 per treatment.
Clinical trial results and physician response
U.S. phase III trial (64 patients) showed significant benefit in transplantation rates and dialysis independence for Imlifidase, with strong statistical significance.
Long-term outcomes for cross-matched positive transplants are comparable to natural matches.
European phase III trial (50 patients) fully recruited, with data readout expected mid-2026.
U.S. KOLs express strong enthusiasm, citing lack of effective alternatives and high unmet need.
Safety profile is consistent, with main risk being transient immunosuppression; dosing is a 15-minute infusion, with rare need for redosing.
What drives rapid US adoption for Idefirix?
What is the GBS trial design for 5487?
How will full EMA approval impact EU sales?
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Next Hansa Biopharma earnings date
Q4 202511 Feb, 2026
Hansa Biopharma
Next Hansa Biopharma earnings date
Q4 202511 Feb, 2026
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Frequently asked questions
Hansa Biopharma AB, a biopharmaceutical company, develops immunomodulatory treatments for enabling transplants and rare immunoglobulin G (IgG)-mediated autoimmune conditions, gene therapy, and cancer using its proprietary enzyme technology platform. It develops recombinant IgG endopeptidase/CD26 in Hx-CD26 for IgG-mediated autoimmune indications; and antibody drug conjugates (ADCs) in hu2m14 that targets EGF receptor mutations. The company also develops ADCs against CD56 positive cancers in naxitamab; and multiple bispecific antibodies to meet the needs of the various target populations across hematological cancers under pre-clinical development program. In addition, it involves in developing enzyme platform technology to facilitate the development of antibody therapies by inhibiting unwanted immune reactions; and facilitates bone marrow transplantation between genetically distinct individuals.
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