Lund, Sweden April 22, 2021 Hansa Biopharma, the leader in immunomodulatory enzyme technology for rare IgG mediated diseases, today announced its business update and interim report for January – March, 2021.

Highlights for the first quarter 2021

• First commercial sales of  Idefirix^® recorded in Q1 2021 following treatment of the first patients. Commercial launch activities in early launch countries continue to be carried out as planned. National level reimbursement application processes underway and decisions by authorities in the first markets expected from mid-year and onwards.
• First Healthcare Technology Assessment report published in Sweden. The Swedish “TLV” assessment is favorable to the use of Idefirix^® in highly sensitized patients incompatible with a deceased donor.
• Hansa Biopharma enters into preclinical research collaboration agreement with argenx BV to evaluate the therapeutic potential of combining the two companies’ IgG-modulating technologies for potential use in both the acute and chronic setting of autoimmune diseases and transplantation.
• Encouraging three-year follow-up outcome and safety data in imlifidase treated transplant patents in line with expectations compared to outcomes in patients undergoing HLA-incompatible transplantation. Data expected to be presented later in the year in a peer-reviewed journal.
• Magnus Korsgren, M.D., Ph.D. appointed new Head of R&D. Dr Korsgren will lead research and development activities based on Hansa’s proprietary enzyme technology platform as the Company expands into new therapeutic areas.
• Patient recruitment in the phase 2 studies in AMR and GBS ongoing under a risk-based, site-by-site approach due to the COVID-19 pandemic. In the AMR trial, 9 out of a target of 30 patients have been enrolled, and in the GBS trial 8 out of 30 have been enrolled.
• US trial: Hansa continues to be in productive dialogue with the FDA and expects to reach an agreement near-term with the Agency on the protocol for a randomized controlled study in the US. Preparatory work to initiate the trial is ongoing. Hansa expects to initiate the trial over summer and to recruit the first patient in the second half of 2021.
• COVID-19 pandemic: The global COVID-19 pandemic may still adversely impact Hansa Biopharma’s operational business and trial activities.

Events after the end of the reporting period

• Hilary Malone, PhD. in Molecular Neuropharmacology (born 1965, U.S. and UK citizen) proposed as new member of the Board of Directors at the next AGM. Dr. Malone is currently COO and EVP at Valo Health, Inc. (U.S.) and has held global executive positions at Sanofi, Reata Pharmaceuticals, Pfizer, Wyeth and AstraZeneca, among others. Birgit Stattin Norinder has decided not to stand for re-election to the Board of Directors at the next AGM.

Financial summary

• Solid cash position of SEK 1,255m at the end of March 2021.
• Investments in SG&A and R&D in the first quarter amounting to SEK 60m (Q1’20: SEK 39m) and SEK 47m (Q1’20: SEK 53m), respectively, in line with plans.
• Cash flow from operating activities for the first quarter ended at SEK -121m (Q1’20: SEK -121m).

Søren Tulstrup, President and CEO of Hansa Biopharma, comments

“Hansa Biopharma’s evolution into a fully integrated, commercial-stage biopharmaceutical company is now a reality following the Company’s first commercial sales of Idefirix^® and treatments of the first patients.

Our long-term objective is to build Hansa into a recognized global leader in rare diseases across multiple broad therapeutic areas through the development of new transformative medicines for patients suffering from rare immunologic diseases. In order to do so, we need to successfully execute on our strategic priorities. This early in 2021, we have already demonstrated clear progress across our business and organization and that we are on track to deliver on our targets for the year.

In Europe, our commercial launch activities continue to be rolled out and implemented in early launch countries as planned. As part of this effort, we continue to have close interactions with national reimbursement authorities and leading transplant clinics. Decisions by authorities in the first of the early launch countries can be expected from mid-year and onwards following publication of Healthcare Technology Assessments to evaluate the health-economic impact from using Idefirix^®. A first such assessment was recently published in Sweden, which was favorable to the use of Idefirix^® in scenarios representing both high and low mortality assumptions for dialysis patients.

On March 29, Hansa entered into a preclinical research collaboration agreement with argenx BV to explore the potential of combining imlifidase, Hansa’s IgG antibody-cleaving enzyme, and efgartigimod, argenx’s FcRn antagonist. We are pleased to collaborate with argenx, a leader in the field of FcRn-inhibition, as they share our commitment to bringing innovative new medicines to patients suffering from autoimmune diseases. A combination of imlifidase and efgartigimod could potentially be used in both the acute and chronic setting of autoimmune diseases and transplantation and may potentially unlock additional therapeutic value.

In the US, Hansa is in productive dialogue with the FDA and we expect to finalize near-term an agreement with the Agency on a protocol for a randomized controlled study in the US. Preparatory work to initiate the trial is already ongoing and we are encouraged by the strong interest shown by leading US transplant centers to participate in the trial. Subject to the expected agreement with FDA on the study protocol in the coming months, we expect study initiation over the summer and the first patient to be enrolled in the second half of 2021.

In our ongoing phase 2 programs, GBS and AMR, we see patient enrollment progressing again following a temporary halt in the recruitment process during large parts of 2020 due to the COVID-19 pandemic. In December 2020, patient enrollment was reinitiated in both studies under a risk-based, site-by-site approach. As of April 21, 2021, 9 out of a target of 30 patients have now been enrolled in the AMR study, while 8 out of 30 have been enrolled in the GBS study.  Depending on the impact of the COVID-19 pandemic, enrollment is expected to be completed towards the end of 2021, as previously guided.

Furthermore, I am pleased to announce that our long-term follow-up study in highly sensitized kidney patients continues to show encouraging outcomes after imlifidase treatment and transplantation. We now have three-year data available, demonstrating follow-up outcomes in line with expectations compared to outcomes in patients undergoing HLA-incompatible transplantation. Data is expected to be published later this year following submission of a manuscript to a peer-reviewed journal.

I am also happy to see that we continue to attract the talent and competences needed to build a high-performance organization. In March, we announced the recruitment of Magnus Korsgren, M.D., Ph.D as our new Head of R&D. Dr. Korsgren’s extensive international experience in translational medicine and drug development will be very helpful for our continued efforts to build a highly valuable pipeline of drug candidates within transplantation, autoimmune diseases and beyond.

Speaking about attracting highly qualified, international competences, I am also very pleased to see Hilary Malone, Ph.D in Molecular Neuropharmacology, being proposed at the next AGM as a new member of the Board of Directors at Hansa Biopharma. Ms. Malone currently holds the position of Executive Vice President and Chief Operating Officer at Valo Health, Inc. in the US and has previously held global executive positions at Sanofi, Reata Pharmaceuticals, Pfizer, Wyeth and AstraZeneca, among others.

Hansa is off to a good start in 2021 and 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 generating value to shareholders and society at large.”

Upcoming milestones and news flow

H1 2021           NiceR: initiate IND-enabling tox studies

Q2/Q3 2021     First national reimbursement agreement

H2 2021           Kidney transplantation US: First patient dosed

H2 2021           AMR Phase 2 study: Complete enrollment 

H2 2021           GBS Phase 2 study: Complete enrollment

H2 2022           Kidney transplantation US: Complete enrollment

H2 2022           AMR Phase 2 study: Data read out

H2 2022           GBS Phase 2 study: Data read out

H2 2023           Kidney transplantation US: 12 months follow-up completed

H1 2024           Kidney transplantation US: BLA submission

Conference call details

Hansa Biopharma will host a telephone conference today Thursday April 22 14:00 CET / 8:00am EST.

The presentation will be held in English and be hosted by Hansa Biopharma’s CEO, Søren Tulstrup, and CFO, Donato Spota. Slides used in the presentation will be live on the company website during the call under ”Events & Presentation” and will also be made available online after the call.

To participate in the telephone conference, please use the dial-in details provided below:

Sweden: +46 8 50 55 83 75

United Kingdom: +44 333 300 90 35

United States: +1 833 526 83 82

The webcast will be available on https://streams.eventcdn.net/hansa/2021q1/

The interim report and latest investor presentation can be downloaded from our web

Interim report January – March 2021

https://investors.hansabiopharma.com/English/financial-data/quarterly-report/default.aspx

Investor road show presentation Q1, 2021

https://investors.hansabiopharma.com/English/events-and-presentations/presentations/default.aspx

This is information that Hansa Biopharma AB is obliged to make public pursuant to the Securities Markets Act.