Press release

May 02, 2019

Hansa Biopharma Announces Upcoming Presentations at the 2019 American Transplant Congress

Lund, Sweden, May 2, 2019 - Hansa Biopharma AB (NASDAQ Stockholm: HNSA), the leader in immunomodulatory enzyme technology for rare IgG-mediated diseases, announced today that IDEFIRIX (imlifidase), the Company’s novel IgG-degrading enzyme, will be highlighted in three presentations at the upcoming 2019 American Transplant Congress (ATC), which will be held from June 1 – 5, 2019 in Boston, Massachusetts, USA.

In a plenary session on June 5, 2019 at 8:30AM ET, Stanley C. Jordan, M.D., Director of Kidney Transplantation and Transplant Immunology at the Kidney and Pancreas Transplant Center at Cedars-Sinai Medical Center in Los Angeles, will present “Three-year Outcomes of Highly-sensitized Kidney Transplant Recipients Desensitized with IgG Endopeptidase.”

The presentation will report follow up data from the U.S. investigator-initiated Phase 2 study of imlifidase for kidney transplantation in 16 highly sensitized patients. Results show excellent graft survival out to three years. Over the observed 31.9 person years, there were two graft losses, unrelated to imlifidase treatment, at 2.6 years and 3.2 years, conferring an incidence rate of 6.3 graft losses per 100 patient years. The graft survival for these patients undergoing desensitization was within the same range as for non-sensitized patients being transplanted with a kidney from a deceased donor1. One death, unrelated to imlifidase treatment and the kidney transplant, occurred 10 months after transplant. No patients had Donor Specific Antibodies (DSAs) post imlifidase treatment and DSA rebound out to 30 months was generally mild.

In an oral presentation on June 2, 2019 at 3:06pm ET, Robert A. Montgomery, M.D., Director, NYU Langone Transplant Institute, New York City, will present “Safety and Efficacy of Imlifidase in Highly-Sensitized Kidney Transplant Patients: Results from a Phase 2 Study.” The presentation will report complete Phase 2 results from Hansa’s Phase 2 Highdes study of imlifidase for kidney transplantation in highly sensitized patients. As previously reported, results show that imlifidase was well tolerated and enabled all patients to undergo transplantation resulting in good kidney function and graft survival. There were two graft losses due to graft failure unrelated to imlifidase treatment. In both cases the kidneys failed to recover after transplantation due to transplant recipient co-morbidities. The majority of the patients in this study represent the most highly sensitized patients on the organ donor waiting list by any standard.

In a poster session on June 2, 2019 at 6:00pm ET, Matthew J. Everly, Director of the Terasaki Research Institute in Los Angeles, will present “A Prognostic Drug Development Tool to Assess the Transplantability at the Time of Listing for Kidney Transplant Candidates.” The study reports on results of a machine learning based prognostic tool enabling a way to assess risk of death or long wait time at the time of listing. Simulations in highly sensitized patients demonstrate that transplant rates could be increased by 25% if there were a therapy to address the HLA antibody barrier.

The three abstracts are available on the ATC website: https://atcmeeting.org

References
1. https://optn.transplant.hrsa.gov

This is information that Hansa Medical AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out below at 08:00am CET on May 2, 2019.

About IDEFIRIX (imlifidase)

IDEFIRIX (imlifidase) is an enzyme that specifically cleaves immunoglobulin G (IgG) antibodies, thereby inhibiting the IgG-mediated immune response. Hansa is developing IDEFIRIX as a proprietary treatment to enable kidney transplantation in sensitized patients, previously unable to undergo transplant surgery due to the presence of Donor Specific Antibodies (DSAs). Efficacy data reported from four Phase 2 studies have demonstrated that IDEFIRIX rapidly and significantly reduced all DSAs, enabling transplantation. In addition to transplantation, IDEFIRIX is being evaluated in a Phase 2 clinical study in anti-GBM antibody disease, a rare autoimmune disorder, and IDEFIRIX has potential applications in a variety of additional autoimmune diseases. IDEFIRIX is protected by a strong patent portfolio and results of studies with IDEFIRIX have been published in multiple peer reviewed scientific journals.

About Highly Sensitized Patients

Many patients on the waiting list for organ transplantation carry antibodies to human leukocyte antigen (HLA), which is known as being ‘sensitized.’ Antibodies targeted towards HLA of a potential donor, called Donor Specific Antibodies (DSAs), can significantly compromise the transplanted organ. Patients who are highly sensitized, with high levels of DSAs, will have a very low likelihood of finding a donor towards which they will not have DSA. Therefore, they may not be able to receive a transplant at all and remain on dialysis in a debilitating disease state indefinitely. Current desensitization methods are not feasible for most highly sensitized patients. IDEFIRIX’s rapid cleavage of all IgG antibodies, eliminates DSAs, enabling deceased donor kidney transplantation. Two thirds of kidney transplantations in the U.S. and Europe are from deceased donors.

About Hansa Biopharma

Hansa Biopharma AB (NASDAQ Stockholm: HNSA) is harnessing its proprietary immunomodulatory enzyme technology platform to develop treatments for rare immunoglobulin G (IgG)-mediated autoimmune conditions, transplant rejection and cancer. The Company’s lead product, IDEFIRIX (imlifidase), is a unique antibody-degrading enzyme in late-stage clinical development to enable kidney transplantation in highly sensitized patients, with additional clinical studies in acute autoimmune indications. Hansa’s research and development program is advancing the next generation of the Company’s technology to develop novel IgG-cleaving enzymes with lower immunogenicity, suitable for repeat dosing in relapsing autoimmune diseases and oncology. Hansa Biopharma is based in Lund, Sweden.