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Hansa Biopharma publishes Annual Report 2021

Regulatory information

Lund, Sweden April 7, 2022 Hansa Biopharma AB “Hansa” (Nasdaq Stockholm: HNSA), a pioneer in enzyme technology for rare immunological conditions, today announced the release of the Annual Report 2021

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

2021 was, overall, a transformative and successful year for Hansa as we advanced into a fully integrated, commercial-stage biopharmaceutical company following the commercial launch in Europe of Idefirix® (imlifidase), for desensitization of highly sensitized kidney transplant patients incompatible to a deceased donor.

Despite a challenging operating environment, we were able to solidly execute on our key priorities for the year, which were to:

  1. Ensure a successful launch of Idefirix® in leading transplantation centres in select European markets;
  2. Initiate a pivotal study in the U.S. to support a future BLA for imlifidase in highly sensitized patients waiting for a kidney transplant; and
  3. Continue to build on the strong momentum behind our efforts to advance our pipeline of drug candidates within autoimmune diseases and gene therapy.

As far as the European launch of Idefirix® is concerned, we saw solid execution in expanding our market access footprint. During 2021, pricing and reimbursement were secured in Sweden and the Netherlands as well as on an individual hospital basis in Finland and Greece, while Germany and France (early access program) were added to the list of countries with commercial access on negotiated terms during the first quarter of 2022. Notably, a health-economic assessment conducted by the Swedish Dental and Pharmaceutical Benefits Agency (TLV) concluded that Idefirix® treatment in appropriate highly sensitized patients on dialysis waiting for a kidney transplant would be cost effective and potentially even lead to cost savings, which is rarely seen for orphan drugs.

Market access procedures are now ongoing in 10 countries incl. HTA dossiers submitted in the UK, Italy and Spain. This is a great achievement by our experienced market access team and an important milestone as we build the foundation for Idefirix® as a potentially transformative therapy that is bringing hope to the thousands of highly sensitized patients across the continent who are currently waiting for a compatible kidney transplant.

Looking beyond the early launch hospitals and countries, I am also pleased with our new multiregional commercialization partnership with Medison Pharma for Idefirix® in Central Eastern Europe and Israel. Medison is a recognized international pharmaceutical company focused on providing access to highly innovative therapies to patients in international markets. This commercial partnership represents an important milestone for Hansa as we expand access to Idefirix® beyond initial markets for highly sensitized patients awaiting kidney transplants.

In the U.S., we initiated our 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 enroll1 patients at 12-15 leading transplantation centers across the U.S. and aim to complete enrollment by the end of this year. In addition to generating important new data, the ConfIdeS trial will also enable the participating key transplant centers to gain important experience with the use of imlifidase as a desensitization treatment ahead of a potential commercial launch in the U.S.

On the research side, Hansa has entered into two new collaborations during the last 12 months. The first, announced at the end of March 2021, is a pre-clinical research collaboration with argenx BV, a leader in the field of FcRn inhibition, to evaluate the therapeutic potential of combining Hansa’s IgG antibody-cleaving enzyme, and efgartigimod, argenx’s FcRn antagonist. A combination of imlifidase and efgartigimod could potentially be used in both the acute and chronic setting of autoimmune diseases and transplantation.

In the area of gene therapy, we were also excited to announce an agreement in early 2022 with AskBio, a subsidiary of Bayer AG, to evaluate imlifidase in a pre-clinical and clinical feasibility program as pre-treatment ahead of gene therapy in Pompe disease in patients with pre-existing neutralizing antibodies (NAbs). NAbs against adeno-associated virus used in gene therapies remain a major challenge and we see significant potential for our antibody-cleaving enzyme technology to enable gene therapy also in NAbs positive patients. The new collaboration with AskBio marks another key step in the implementation of our partnership strategy in the gene therapy space.

In anti-GBM disease, following a successful pre-IND meeting with the U.S. FDA, we recently announced plans to initiate a phase 3 study of imlifidase. This pivotal study, our first phase 3 study in the area of autoimmune diseases, marks an important milestone for Hansa Biopharma’s expansion beyond transplantation. The study aims at enrolling approximately 50 patients with anti-GBM disease across the U.S. and Europe, with the first patient expected to be enrolled in 2022.

As part of Hansa’s platform strategy and objective to broaden the use of imlifidase as a potential therapy to change the course of IgG-mediated immunological diseases and conditions, the Company is exploring new indications with a high unmet need. One such indication is allogeneic hematopoietic stem cell transplantation (HSCT), also known as “bone-marrow” transplantation is a challenge and there are currently no approved drugs available to facilitate transplantation in these patients. We believe that imlifidase may have the potential to transform this field by enabling clinicians to inactivate DSAs prior to transplantation, thereby creating the basis for enabling engraftment.

Hansa’s mission is to leverage our unique IgG-cleaving enzyme technology platform to develop innovative, lifesaving and life-altering immunomodulating therapies, bring these to the patients with rare diseases and conditions who need them, and generate value to society at large. To help deliver on this mission, we are building a high-performance team by attracting and integrating the most talented and experienced candidates while creating a rewarding, productive and stimulating workplace for our employees. The progress we are making in this effort was illustrated again in 2021 as we received certification as a “Great Place to Work” for the second consecutive year by the GPTW Institute.

At Hansa, sustainability is at the core of all we do, and we have during 2021 formalized our ESG approach. Embarking on this journey, we have identified key environmental, social and governance priorities, which need to be addressed and used to develop the Company’s first sustainability strategy.

We have another exciting year ahead of us with several important milestones to be achieved across our platform and franchises. Our key priorities for the year are to:

  1. Continue the successful execution of our commercial launch strategy for Idefirix® through obtaining pricing and reimbursement agreements in new key markets in Europe, making additional prioritized transplant centers clinically ready for initiation, and generating growing commercial sales.
  2. Complete enrollment in the U.S. ConfIdeS trial.
  3. Further advance our pipeline of drug candidates for autoimmune diseases and post transplant management by initiating a pivotal trial of imlifidase in anti-GBM disease and advancing our ongoing phase 2 trials in Antibody Mediated Rejection (AMR) and Guillian-Barré syndrome (GBS) toward first data read-outs.

I am profoundly grateful to our employees for their commitment, passion and hard work in the past year and I look forward to making further progress in the year ahead towards the vision that we are pursuing with single-minded focus: A world where patients with rare immunologic diseases can lead long and healthy lives.

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 April 7 2022.