Company delivered significant progress across commercial and R&D priorities

Lund, Sweden, March 21, 2024. Hansa Biopharma AB, "Hansa" or the "Company" (Nasdaq Stockholm: HNSA), today announced the publication of its 2023 Annual and Sustainability Reports. In 2023, the company made solid progress in both Commercial and R&D priorities and continued its journey to become a default sustainable organization.

Peter Nicklin, Chairman of the Board, Hansa Biopharma, said: "2023 was another important year for Hansa Biopharma. With a purpose grounded in scientific innovation, improving patient outcomes, and operating with the highest ethical standards, we look ahead to advancing critical science and delivering new medicines. The Board is confident in the strong and highly experienced team at Hansa and believes in its ability to deliver important drug development and commercial priorities."

Søren Tulstrup, President and CEO, Hansa Biopharma, said: "In 2023, the Company's focus remained firmly on advancing cutting-edge science and delivering new treatments in areas of high unmet need. With a highly experienced, results-driven team we continue to execute against our key strategic priorities, underpinned by our extensive scientific and commercial expertise. As we expand our business, we will also expand our understanding of and commitment to being a sustainable and responsible organization that plays an important role in society and strives to have a positive impact on the communities where we operate. We are poised to deliver on our bold ambition of providing life-altering and life-saving medicines to people with rare immunological diseases and conditions."

2023 highlights

Commercial and access progress were underpinned by expanded access in Europe in a total of 14 markets including the five largest markets. Beyond Europe, Australia became the first country to grant provisional approval for Idefirix® in kidney transplantation from both living and deceased donors. Hansa also established a new commercial partnership with NewBridge Pharmaceuticals covering the Middle East and North Africa regions.

Advancements in clinical development activities were marked by the conclusion of a long-term follow-up study of imlifidase in kidney transplantation (17-HMedIdeS-14) that confirmed sustained benefit up to five years, positive high level data from a  phase 2 trial in Guillain-Barré Syndrome (GBS) (15-HMedIdeS-09), and first patient treated in a pivotal phase 3 trial in anti-glomerular basement membrane disease (anti-GBM) (GOODIDES-02) and in a new investigator-initiated phase 2 study in ANCA-associated vasculitis (ImlifidARDSe.01).

In its commitment to advance the science of immunomodulating therapies, Hansa moved into the clinical setting (NICE-01) with HNSA-5487, the lead candidate from its next generation of IgG-cleaving enzymes program (NiceR), sharing encouraging high-level results on safety and tolerability, pharmacokinetics and pharmacodynamics.

In the gene therapy space, Hansa remains focused on collaborating with leading gene therapy innovators to potentially enable more patients to access life-altering gene therapies. The Company's partnership with Sarepta Therapeutics has now moved to clinical stage with the initiation of the first clinical trial assessing imlifidase as a pre-treatment to SRP-9001 gene therapy in Duchenne Muscular Dystrophy (DMD). In 2023 Hansa also formed a partnership with Généthon, a leading gene therapy non-profit research organization, to evaluate imlifidase as pre-treatment to gene therapy in Crigler-Najjar syndrome.

Hansa's journey towards a more sustainable business 

At Hansa, sustainability is considered an important part of our overall business. Hansa's 2023 Sustainability Report highlights the Company's continued efforts in priority therapeutic areas, to ensure we are operating a transparent, ethical business with appropriate governance, while advancing a culture that is diverse, inclusive, and supportive of all employees.

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 2023, Hansa earned the Great Place to Work® certification for the fourth consecutive year, with a 100% survey participation, which is considered above industry standard for a company of this size. Additionally in 2023, Hansa was selected as one of the best 25 workplaces in Sweden

Read the Annual and Sustainability reports here

This is information that Hansa Biopharma AB is obliged to make public pursuant to the Securities Markets Act. The information was submitted for publication at 7:00am CET on March 21, 2024.

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Contacts for more information:

Klaus SindahlHead of Investor Relations
M: +46 (0) 709 298 269
E: klaus.sindahl@hansabiopharma.com

Stephanie KenneyVP Global Corporate Affairs
M: +1 (484) 319 2802
E: stephanie.kenney@hansabiopharma.com

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. 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 www.hansabiopharma.com and follow us on LinkedIn.

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