Hansa Biopharma Interim Report January–March 2019

MAA filing of IDEFIRIX (imlifidase) in Europe marks a milestone in Hansa’s evolution into a commercial stage biopharmaceutical company

January – March 2019 Highlights

• The European Medicines Agency (EMA) accepted Hansa’s Marketing Authorization Application (MAA) for review of IDEFIRIX (imlifidase). This acceptance marks the beginning of the regulatory review process for IDEFIRIX in the European Union (EU). IDEFIRIX has both EU Orphan Drug Designation and PRIority MEdicine (PRIME) designation. An opinion of the EMA Committee for Medicinal Products for Human Use (CHMP) is expected within 210 days plus potential clock stops for applicant responses.

• In Hansa’s most recent meeting with the U.S. Food and Drug Administration (FDA) in December 2018, the agency provided overall positive feedback on the data generated on imlifidase to date and acknowledged the high unmet medical need of highly sensitized patients who currently can’t access kidney transplantation. Hansa has now decided to do complementary analyses with respect to transplantability for highly sensitized patients, based on data from the successfully completed Phase 2 studies of imlifidase and matched controls from the U.S. transplant registry (SRTR/OPTN). We believe these analyses will help further illustrate the value of imlifidase in the U.S. healthcare system. As soon as the analyses are concluded, Hansa will schedule a subsequent meeting with the FDA, expected to take place in the second half of 2019. In this meeting, the dialogue with the FDA will be continued to determine the path forward for regulatory filing and approval in the U.S. for imlifidase in kidney transplantation of highly sensitized patients.

• The Company has selected a lead candidate from its NiceR program (Novel IgG Cleaving Enzymes for Repeat dosing). The new drug candidate may have broader value as a potential treatment for unmet needs that would benefit from repeat dosing, including relapsing autoimmune diseases, chronic transplant rejection, oncology and gene therapy. This is the first IgG eliminating enzyme from the NiceR program that Hansa intends to advance into clinical development.

• The Company’s Phase 2 study of imlifidase in acute Antibody-Mediated Rejection (AMR) in Kidney Transplantation has received Clinical Trial Application and Ethics Committee approvals. The study will enroll approximately 30 patients at eight clinical trial centers in France, Sweden, Austria, Australia and the United States.

• The Company has continued to expand its leadership team as Hansa transforms into commercial-stage biopharmaceutical company. Donato Spota has been appointed the Company’s new Chief Financial Officer, effective May 15, 2019 and Anne Säfström Lanner has been appointed Vice President, Global Human Resources. Mr. Spota is a senior executive with more than 20 years of strategic and operational experience in the global pharmaceutical industry, including investor relations and international capital markets transactions. Mrs. Lanner has over 15 years of broad human resources experience in international growth companies.

Significant events after the end of the reporting period

• Hansa Biopharma received Clinical Trial Application and Ethics Committee approvals in Europe for its Phase 2 study of imlifidase in Guillain Barré Syndrome (GBS). The study will enroll up to 30 patients at approximately ten clinical trial centers in France, U.K and the Netherlands over the next 18 months.

• Hansa Biopharma divested its entire equity holding in Genovis AB (NASDAQ Stockholm: GENO). The transaction generated gross proceeds of SEK 89 million ($9.6 million). The proceeds will be used as working capital not only to expedite further the clinical development program of imlifidase in transplant rejection (AMR) and autoimmune diseases, but also to ramp up preparations for clinical studies with the recently selected lead in the NiceR-program, Hansa’s program for the development of novel IgG-cleaving enzymes for repeat dosing.

Financial summary for the first quarter

CEO statement
It is now twelve months since I joined Hansa, and I’m extremely proud of all we accomplished this past year to demonstrate the potential of our immunomodulatory enzyme technology and imlifidase. Our main priority is getting our lead compound imlifidase to market to enable lifesaving kidney transplants for highly sensitized patients, who currently cannot receive this standard of care treatment. At the same time, we continue developing our proprietary enzymology platform in other rare, life-threatening diseases.

In February, EMA accepted our MAA for review of IDEFIRIX (imlifidase). This acceptance marks the beginning of the regulatory review process for IDEFIRIX in the EU. In our most recent meeting the FDA in December 2018, the agency provided overall positive feedback on the data generated on imlifidase to date and acknowledged the high unmet medical need of highly sensitized patients who currently can’t access kidney transplantation. Hansa has now decided to do complementary analyses with respect to transplantability for highly sensitized patients, based on data from the successfully completed Phase 2 studies of imlifidase and matched controls from the U.S. transplant registry (SRTR/OPTN). We believe these analyses will help further illustrate the value of imlifidase in the U.S. healthcare system. As soon as the analyses are concluded, Hansa will schedule a subsequent meeting with the FDA, expected to take place in the second half of 2019. In this meeting, the dialogue with the FDA will be continued to determine the path forward for regulatory filing and approval in the U.S. for imlifidase in kidney transplantation of highly sensitized patients.

Imlifidase may have potential applications in transplantation of other organs and tissue as well as an array of acute autoimmune indications, including Acute Kidney Antibody Mediated Rejection (AMR) post transplantation. In March, we received Clinical Trial Application and Ethics Committee approvals for our Phase 2 study of imlifidase in acute AMR in kidney transplantation. Acute AMR is one of the most challenging adverse events after kidney transplantation, occurring in 10-15% of patients, and is the main cause for graft dysfunction. In April we got a similar approval for the initiation of a Phase 2 Study of imlifidase in Guillain Barré Syndrome (GBS). GBS is a rare, acute inflammatory disease of the peripheral nervous system that affects 1-2 in 100,000 people annually.

Our program of next generation IgG-cleaving enzymes, NiceR, also advanced recently with the selection of a lead candidate for clinical development. The new drug candidate may have broader value as a potential treatment for unmet needs that may benefit from repeat dosing, including relapsing autoimmune diseases, chronic transplant rejection, oncology and gene therapy.

Mid-April we divested our shareholding in Genovis to a group of Swedish institutional investors. The transaction provides a profitable exit for Hansa Biopharma, and the funds generated will be used as working capital to further expedite our promising clinical pipeline of potential treatments for rare IgG-mediated diseases.

As part of the ongoing expansion of our organization, we appointed Mr. Donato Spota as new Chief Financial Officer, effective May 15, 2019, and Ms. Anne Säfström Lanner as Vice President, Global Human Resources. We are delighted to welcome Donato and Anne as we grow Hansa Biopharma into a global commercial-stage biopharma company. They will be very valuable additions to our team as we continue the transformation of Hansa and grow our operations and organization.

Based on the progress so far this year, I believe we are poised for continued success in 2019, with a growing body of clinical evidence supporting the efficacy of imlifidase, multiple opportunities in additional indications, and a potential pipeline of next-generation drug candidates. I look forward to updating you on our continued progress.

Søren Tulstrup
President and CEO of Hansa Biopharma

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 April 29, 2019.

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.

For further information, please contact:

Company:
Emanuel Björne, VP Business Development and Investor Relations
Hansa Biopharma AB (Publ)
Mobile: +46 70 717 5477
E-mail: emanuel.bjorne@hansabiopharma.com

Swedish Investor and Media Relations:
Cord Communications Mikael Widell
+46 70-311 99 60

U.K. Investor and Media Relations:
FTI Consulting
Simon Conway / Natalie Garland-Collins
+44 (0)20 3727 1000

U.S. Investor and Media Relations:
Argot Partners
Stephanie Marks / David Rosen (media)
+1 212 600 1902