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Hansa Biopharma publishes Annual Report 2022

30 Mar 2023, 08:00
Regulatory information

Lund, Sweden, March 30, 2023 Hansa Biopharma AB “Hansa” (Nasdaq Stockholm: HNSA), a pioneer in enzyme technology for rare immunological conditions, today announced the release of the Annual Report 2022.

Søren Tulstrup, President and CEO of Hansa Biopharma, comments:

“2022 was a successful year at Hansa, with solid performance and strong progress across the organization. While the global geopolitical and financial environment made 2022 a very challenging year for the biotech sector overall, I am very pleased with the solid performance and strong progress across our R&D and commercial operations.

Commercial launch activities and market access efforts for Idefirix® in Europe continued to progress as planned. Importantly, by year-end 2022, commercial access had been obtained in eleven European countries, including four of the five largest markets: Germany, UK, Italy and France. Additional market access procedures are ongoing in nine countries, including Spain.

In August, the first medical guidelines for desensitization treatment of highly sensitized kidney transplant patients were published by the European Society for Organ Transplantation, ESOT. These guidelines are the first to include Idefirix® and represent the first international consensus on a management pathway for kidney transplant patients with high unmet need. The early publication of these guidelines underscores the important role that Idefirix® can play as a new, transformative therapy to enable kidney transplantation, and is an important step in ensuring its use as a potential new “Gold Standard” in desensitization protocols.

On the clinical development side, we continued to make progress across our pipeline. In November, we presented topline data from our phase 2 program in kidney transplant AMR (post transplantation episodes or organ rejection), demonstrating significantly superior capacity of imlifidase to rapidly reduce donor specific antibodies (DSA) levels in comparison to plasma exchange in the five days following the start of the treatment.

During the year, we initiated two new phase 3 studies: - the European Post Approval Efficacy Study in kidney transplantation and the pivotal, global phase 3 study in anti-GBM disease. Both studies will target 50 patients and involve a significant number of clinics as we broaden our experience with imlifidase to become a potential new standard of care in both transplantation and acute autoimmune diseases.

In the U.S., patient enrollment continues in our third ongoing phase 3 study, the pivotal ConfIdeS trial in kidney transplantation. The ConfIdeS study 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. We expect to complete enrollment in the first half of 2023, while completion of randomization is expected in the second half of this year. There has been strong interest from leading transplantation centers to participate in this trial, and we expect to initiate around 20 leading centers across the U.S.

The enrollment in the phase 2 program in Guillain-Barré Syndrome (GBS) was impacted by the COVID-19 pandemic due to staff constraints in trial centers and a shortage of IVIg at a subset of participating hospitals. We have worked to mitigate these hurdles and saw an increase in patient enrollment at the end of 2022. Completion of enrollment in the GBS trial is expected in the first half of 2023, with top line data expected in the second half 2023, as previously guided.

I am pleased with the achievements made in our preclinical development programs, in particular in the Duchenne Muscular Dystrophy (DMD) project with Sarepta Therapeutics in gene therapy and the NiceR program, which is exploring utilization of second-generation enzymes for repeat dosing. In DMD, imlifidase is being investigated as a potential pre-treatment in patients with pre-existing IgG antibodies to Sarepta’s SRP-9001. To date, the data appears promising, and plans have been announced to initiate a clinical study in 2023. In the NiceR program, we completed IND enabling toxicology studies at the end of the year for our lead candidate, HNSA-5487. A CTA approval has since been obtained and we expect to begin a clinical trial in the first half of 2023.

In addition, while the capital markets for biotech companies remained challenging throughout 2022, I am pleased that we were able to successfully secure additional financing through two transactions last year, enabling us to extend our cash runway into 2025. In July, we raised USD 70m through a non-dilutive financing transaction with NovaQuest, and in December we raised USD 40m in a directed share issue targeting U.S. and other international healthcare specialist investors. The funds raised will help finance preparations for a potential U.S. launch of imlifidase in kidney transplantation and further advance our exciting pipeline of drug candidates.

I am particularly grateful to our employees for their commitment, passion, and hard work over the past year. We are dedicated to building and maintaining a high performance team, while also creating a rewarding and stimulating workplace for our employees. A clear reflection of our successful efforts in this regard was the certification as a Great Place to Work® for the third consecutive year.

At Hansa, sustainability is at the core of all we do, and during 2022 we continued to build on the formalized ESG framework which was created in 2021. Embarking on this journey, we have identified key objectives for our environmental, social and governance priorities, which will be addressed separately in our Sustainability Report.

We now have an exciting year ahead with several key milestones across our platform and therapeutic areas as we continue to pursue the development and launch of new, transformative medicines that will enable patients with rare immunologic diseases to lead long and healthy lives.”

Hansa Biopharma’s Sustainability Report 2022 will be available online on the Company’s website

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 8:00am CET on March 30, 2023.

For further information, please contact:

Klaus Sindahl, VP Head of Investor Relations
M: +46 (0) 709–298 269

Stephanie Kenney, VP Global Corporate Affairs
M: +1 (484) 319 2802

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