
(AGENPARL) – Fri 21 March 2025 3.00 PM CET / 21-Mar-2025 / Hansa Biopharma AB (STO:HNSA)
Lund, Sweden, 21 March 2025. Hansa Biopharma AB, “Hansa” or the “Company”
(Nasdaq Stockholm: HNSA), today published its Annual and Sustainability Reports
for 2024.
Peter Nicklin, Chair of the Board, Hansa Biopharma, said: “Hansa delivered
several important milestones in 2024 and remains on track to advance innovative
science and important new medicines. This is in large part due to the dedicated,
results-driven employees, and the Company’s commitment to delivering on its
discovery, development and commercialization goals. In my third year as Chair of
the Board of Directors, I remain inspired and excited for what is to come for
Hansa.”
Søren Tulstrup, President and CEO, Hansa Biopharma, said, “2024 was a momentum
-building year for Hansa. With year-on-year IDEFIRIX[®] sales growth of 83%, a
successful financing round, and several critical pipeline catalysts for
imlifidase and HNSA-5487, 2024 has positioned us well to advance our efforts in
Autoimmune, Gene Therapy and Transplantation. 2025 promises to be an exciting
and important year, marked by several data readouts and a planned BLA submission
to the U.S. FDA in kidney transplantation under the accelerated approval
pathway. Hansa’s science-led, patients-first business model remains at the core
of what we do, executed by a team of highly experienced and dedicated
individuals. We remain focused on our mission to advance critical science that
can address the unmet medical needs of people living with rare, immune-mediated
diseases.”
2024 highlights
In 2024, Hansa advanced the commercialization of IDEFIRIX[®] (imlifidase) in
Europe as a desensitization treatment for kidney transplant patients, achieving
record quarterly and full year sales. The ongoing commercialization of IDEFIRIX
in Europe is being driven by continued strong market access in a total of 18
markets, including the five key markets of France, Germany, Italy, Spain and the
A growing body of data, real-world evidence and clinical guidelines on the
utilization of imlifidase as a desensitization strategy for highly sensitized
kidney transplant patients has been published. The most recent guidance
published in Transplant International provides specific guidelines on
appropriate use of imlifidase in clinical practice to enable kidney transplants
in highly sensitized patients.
Preparation for commercialization in the US is progressing, with complete
randomization of the pivotal Phase 3 trial – ConfIdeS – announced in May 2024.
Data readout for the trial and submission of a Biologics License Application
(BLA) to the US Food and Drug Administration (FDA) are planned in 2H 2025.
In October 2024, Hansa announced full results of the NICE-01 first in human
trial and 12-month follow up analysis of HNSA-5487, demonstrating that it can
robustly and rapidly reduce IgG levels, has redosing potential, and a favorable
safety and tolerability profile. Initial clinical development will be focused on
neuro-autoimmune disease with a well characterized role of specific
autoantibodies in disease pathology and recurring acute phases – specifically,
myasthenia gravis (MG). The company plans to align with regulatory authorities
in the first half of 2025 on a clinical development path for HNSA-5487 in MG.
In Autoimmune, enrolment was completed for the GOOD-IDES-02 Phase 3 trial in
anti-glomerular basement membrane (anti-GBM) disease in December, with data
readout expected in the second half of 2025. In Guillain-Barré Syndrome (GBS),
Hansa announced positive full results from the 15-HMedIdeS-09 single arm Phase 2
study and an indirect treatment comparison to the International Guillain-Barré
Syndrome Outcome Study (IGOS) in December 2024.
In Gene Therapy, Hansa and Genethon announced initiation of GNT-018-IDES, a
Phase 2 trial sponsored by Genethon evaluating the efficacy and safety of a
single intravenous administration of Genethon’s gene therapy GNT-0003 following
pre-treatment with imlifidase in patients with severe Crigler-Najjar syndrome
and pre-formed antibodies to AAV8. Enrolment continues in the SRP-9001-104 Phase
1b trial evaluating the use of imlifidase as a pre-treatment to Sarepta
Therapeutics Inc.’s (Sarepta) ELEVIDYS (delandistrogene moxeparvovec) gene
therapy in Duchenne Muscular Dystrophy (DMD).
Hansa’s journey towards a more sustainable business continues
Over the last three years, Hansa has continuously evolved its approach to
Sustainability aligning to the changes happening within the Company and the
external environment. This year’s Sustainability Report outlines the continued
efforts the Company has advanced and our focus for 2025. The report highlights
our work to address high unmet medical need in our three core therapy areas –
Autoimmune, Gene Therapy and Transplantation, as well as our continued focus on
ensuring that we are operating as a transparent, ethical business. Finally, we
continue to believe that a diverse, inclusive, and supportive culture is
integral to the Company’s success.
2024 also marked the first year Hansa conducted a Double Materiality Assessment,
an opportunity to better understand the Company’s impact on stakeholders and the
environment as well as what opportunities influence its business. The output – a
list of prioritized material topics – provided insight and perspective on the
Company’s sustainability strategy and areas of focus for effective risk
management.
Hansa uses an annual company-wide survey by Great Place to Work[®], a global
authority on workplace culture, to seek employee feedback with the purpose of
constantly developing and refining a healthy work environment with highly
engaged and motivated colleagues. In 2024, Hansa was certified as a Great Place
to Work[®] for the fifth consecutive year, with a 95% survey participation,
Read the Annual and Sustainability Reports
here (https://www.hansabiopharma.com/investors/annual-sustainability-report/).
This is information that Hansa Biopharma AB (publ) is obliged to make public
pursuant to the Securities Markets Act. The information was submitted for
publication at 15:00 CET on 21 March 2025.
— ENDS —
Contacts for more information:
Evan Ballantyne, Chief Financial Officer
Stephanie Kenney, VP Global Corporate Affairs
Notes to editors
About Hansa Biopharma
Hansa Biopharma AB is a pioneering commercial-stage biopharmaceutical company on
a mission to develop and commercialize innovative, lifesaving and life-altering
treatments for patients with rare immunological conditions. The company has a
rich and expanding research and development program based on its proprietary IgG
-cleaving enzyme technology platform, to address serious unmet medical needs in
autoimmune diseases, gene therapy and transplantation. The company’s portfolio
includes imlifidase, a first-in-class immunoglobulin G (IgG) antibody-cleaving
enzyme therapy, which has been shown to enable kidney transplantation in highly
sensitized patients and HNSA-5487, a next-generation IgG cleaving molecule with
redosing potential. Hansa Biopharma is based in Lund, Sweden, and has operations
in Europe and the U.S. The company is listed on Nasdaq Stockholm under the
ticker HNSA. Find out more at http://www.hansabiopharma.com and follow us on
LinkedIn (https://www.linkedin.com/company/hansa-medical-ab/).
©2025 Hansa Biopharma AB. Hansa Biopharma, the beacon logo, IDEFIRIX, and
IDEFIRIX flower logo are trademarks of Hansa Biopharma AB, Lund, Sweden. All
rights reserved.
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Hansa Biopharma AB, Scheelevägen 22, Lund, 22362 Sweden
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