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Hansa Biopharma provides updated guidance on its clinical programs

Regulatory information

· Idefirix recently granted formal approval by the EU Commission; First treatments expected in select countries in Q4 2020 in the EU 
· Updating clinical timelines for ongoing and planned imlifidase trials due to continued impact from the COVID-19 pandemic 
· High-level data read-out from the investigator initiated phase 2 study in anti-GBM expected in Q3, 2020, as previously guided

Lund, Sweden September 1, 2020. Hansa Biopharma (“Hansa”), the leader in immunomodulatory enzyme technology for rare IgG mediated diseases, today announced updated guidance regarding its ongong and planned clinical trial program ahead of Management’s participation at upcoming investor conferences in September.

Following the conditional approval recently granted by the EU Commission for Idefirix™ (imlifidase) in highly sensitized kidney transplant patients in the European Union, Hansa Biopharma expects the first treatments with Idefirix to be available to patients in select European countries during the fourth quarter 2020, as communicated earlier. 

As part of the conditional approval, a post-approval study will be initiated following the market authorization. The post-approval study is expected to commence in the second half of 2021 following ongoing site selection and alignment on country specific requirements. The transplantation centers participating in the study will embark on a mutual learning experience, and the post-approval study will run in parallel with the Company’s commercial roll-out activities. 

The proposed study protocol for a randomised controlled trial (RCT) targeting highly-sensitized kidney patients in the US was submitted to the US Food and Drug Administration (FDA) in June, 2020. Discussions are currently ongoing with the FDA and, once the final protocol has been agreed upon, Hansa Biopharma will proceed to set up centers in the US and start to enroll patients.

Given the continued impact of the COVID-19 pandemic in the US affecting patient enrollment, and the timeline for finalization of the study protocol, Hansa Biopharma now expects recruitment of the first patient to be in the first half of 2021 (previously Q4 2020). Completion of enrollment is still expected to be in 2022 with a potential Biologics License Application (BLA) submission by 2023 under the accelerated approval path.

In the investigator initiated Phase 2 trial in anti-glomerular basement membrane (anti-GBM) disease, the last patient last visit took place in July and the Company expects to report high level data from this study during the third quarter of 2020, as previously guided. Anti-GBM is the first IgG mediated disease outside transplantation, where imlifidase is being investigated to potentially stop an immunologic attack.

Due to the widespread impact from the COVID-19 pandemic, the enrollment in the phase 2 programs in Guillain Barré Syndrom (GBS) and Antibody-mediated kidney transplant rejection (AMR) were temporarily halted for the past months. Hansa Biopharma expects to reinitiate enrollment of these studies in Q4 2020 under a risk-based, site-by-site approach. As a consequence, enrollment in the AMR study is now expected to be completed in the second half of 2021 (previously H1 2021). Enrollment in the GBS study is still expected to be completed in the second half of 2021, as previously guided. High-level data readout for both studies are now expected in the second half of 2022. 

Upcoming milestones and news flow
Q3 2020     Anti-GBM Phase 2 study: High-level data read out 
Q4 2020     Kidney transplantation EU: Commercial launch 
H1 2021     Kidney transplantation US: First patient dosed 
H1 2021     NiceR candidate: Completion of GMP process and IND-enabling tox studies
H2 2021     AMR Phase 2 study: Complete enrollment 
H2 2021     GBS Phase 2 study: Complete enrollment 
H2 2022     AMR Phase 2 study: Data read out 
H2 2022     GBS Phase 2 study: Data read out
2022           Kidney transplantation US: Complete enrollment
2023           Kidney transplantation US: 12 months follow-up completed 
2023           Kidney transplantation US: BLA submission

Disclaimer regarding the ongoing COVID-19 pandemic: Clinical trials are being impacted by the COVID-19 Pandemic. Challenges may arise, for example, from self-isolation, site closures, travel limitations, interruptions to the supply chain for the investigational product, or other considerations if site personnel or trial subjects become infected with COVID-19. These challenges may lead to difficulties in meeting recruitment as well as protocol-specified procedures, including administration or use of the investigational product or adhering to protocol-mandated visits and laboratory/diagnostic testing.

This is information that Hansa Biopharma AB is obliged to make public pursuant to the EU Market Abuse Regulation (MAR).