Søren Tulstrup, President and CEO of Hansa Biopharma, comments:
"2020 was a highly successful and transformative year for Hansa Biopharm - a year where we saw significant progress across all areas important to building a leading biopharmaceutical company: Pipeline development, medical and commercial operations and organizational development. 

Most notably, we received conditional approval of Idefirix[®] by the European Commission for desensitization treatment of highly sensitized kidney transplant patients - our first market approval. We are also very excited about our continued progress in advancing Hansa's valuable pipeline of drug candidates in therapeutic areas beyond transplantation.

In July, we achieved a landmark milestone with the exclusive agreement with Sarepta Therapeutics to develop and promote imlifidase as a potential pre-treatment prior to the administration of gene therapy for Duchenne muscular dystrophy and Limb-girdle muscular dystrophy in patients with neutralizing antibodies (NAbs) to adeno-associated virus (AAV). The partnership is progressing as planned, and in the second half of 2020 Sarepta initiated ongoing pre-clinical investigations with imlifidase in the gene therapy setting. 

There is ongoing strong interest from companies active in the gene therapy space in using our IgG-cleaving enzymes as a potential preconditioning therapy to enable gene therapy in patients that are not eligible today due to NAbs against AAV vectors. Our enzymes, used as a pre-treatment before the introduction of gene therapy, could potentially improve both the efficacy and safety of gene therapy and enable a larger group of patients to benefit from the very promising gene therapies now being investigated and becoming available. We see the gene therapy setting as an important value driver for Hansa and we will continue to build our footprint in this space, including through potential additional partnerships.

In 2020, we also announced positive high-level data from an investigator-initiated phase 2 trial with imlifidase in anti-GBM antibody disease, a serious, ultra-rare disease with no approved therapies on the market. We are very encouraged by the positive outcome, which demonstrated that two-thirds of the anti-GBM patients in the trial achieved dialysis independence six months after treatment. These positive results mark another important milestone for Hansa and serve as validation of the potential of our technology platform to develop valuable drug candidates for indications beyond transplantation.

The COVID-19 global pandemic materially impacted our pipeline activities during 2020, as patient recruitment in the GBS and AMR Phase 2 programs was temporarily halted for a large part of the year Enrollment was reinitiated in December 2020 under a risk-based, site-by-site approach and, depending on the development and impact of the COVID-19 pandemic, we expect to finalize recruitment in both studies towards the end of 2021.

In the U.S., we are in ongoing discussions with the U.S. Food and Drug Administration (FDA) around a proposed study protocol for a randomized, controlled study of imlifidase for the desensitization treatment of highly sensitized adult kidney transplant patients. Assuming a near term approval of the final study protocol and depending on the development of the COVID-19 pandemic in the U.S. and its impact on patient enrollment, the Company expects to complete patient recruitment for this study in 2022, enabling us to potentially submit a Biologics License Application (BLA) by 2023 under the accelerated approval pathway.

In addition to the multiple opportunities to develop imlifidase as a drug candidate for a variety of indications, we see significant potential for our next generation enzymes from the NiceR program that we are developing for repeat dosing. Drug candidates from this program have the potential to address high unmet medical needs within chronic autoimmune diseases, transplantation, repeat dosing gene therapy and oncology. Throughout the past year we have worked on completing a GMP process for our lead candidate and expect to commence IND-enabling toxicology studies during the first half of 2021. Once the toxicology studies are completed, we anticipate to move forward into human trials with this very promising program.

Again in 2020, we were able to productively expand the organization by attracting highly talented and experienced life science professionals across a range of functional areas. We are building a purpose driven, agile high-performance team, and we are very pleased to see our strong culture and work ethics reflected in the certification in 2020 of Hansa Biopharma as a "Great Place to Work" by the Great Place to Work Institute based on employee feedback.

We are also taking steps to sharpen our focus and commitment in advancing Hansa's platform beyond transplantation as we transition into the next phase of our development as a platform Company with the establishment of four distinct franchises in transplantation, autoimmune diseases, gene therapy and oncology/new therapies.

We will build on the strong foundation laid through our accomplishments in 2020 and are well positioned to execute successfully on our key priorities and objectives for 2021, which are to:

1. Ensure the successful launch of Idefirix[®] (imlifidase) in leading transplantation centres in select European markets
2. Initiate a randomized, controlled clinical study in the U.S. to support a future filing of a Biologics License Application (BLA) for imlifidase in highly sensitized patients waiting for a kidney transplant in the U.S.
3. Continue to build on the strong momentum behind our efforts to advance our pipeline of drug candidates within autoimmune diseases and gene therapy

Hansa Biopharma's evolution into a fully integrated, commercial-stage biopharmaceutical Company is becoming a reality. An exciting year lies ahead for Hansa as we launch the commercial roll-out of the Company's first approved drug, Idefirix[®], to help highly sensitized patients get off dialysis by enabling a potentially lifesaving transplantation.

I look forward to updating you on our progress as we deliver on our mission to bring lifesaving and life altering therapies to patients with rare diseases who need them, while generate value to society at large."

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 8 2021.