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Hansa Biopharma advances to commercial stage following conditional EU approval of Idefirix; Positive high-level data from investigator-initiated phase 2 trial with imlifidase in anti-GBM
Lund October 22, 2020. Hansa Biopharma, the leader in immunomodulatory enzyme technology for rare IgG mediated diseases, today announced its business update and interim report for January - September, 2020.Highlights for the third quarter 2020
- The EU Commission granted conditional approval for Idefirix® (imlifidase) in highly sensitized kidney transplant patients in the European Union. Idefirix is the Company's first approved drug and will transform Hansa Biopharma into a commercial stage biopharmaceutical company.
- Entered exclusive agreement with Sarepta Therapeutics to develop and promote imlifidase as pre-treatment ahead of gene therapy in select indications. The agreement with Sarepta includes an upfront payment and will potentially generate milestone payments to Hansa totaling up to USD 397.5m plus royalties on imlifidase enabled gene therapy sales. All imlifidase sales will be booked by Hansa.
- Anti-GBM: Reported positive high-level data from investigator-initiated phase 2 trial with imlifidase to treat anti-GBM disease with two-thirds of patients achieving dialysis independence six months after treatment. The positive data marks an important milestone for the Company's expansion of imlifidase outside transplantation.
- US trial in kidney transplantation: Recruitment of first patient expected in H1 2021, given the continued impact of the COVID-19 pandemic in the US and the timeline to finalize the study protocol. Potential BLA submission is expected by 2023 under the accelerated approval path.
- Pipeline: Enrollment in both phase 2 studies in GBS and AMR have been temporarily halted for the past months due to the COVID-19 pandemic. Reinitiation of enrollment expected in Q4 2020 under a risk-based site-by-site approach. Completion of enrollment in both studies is expected in the second half of 2021.
- Hansa Biopharma AB certified as a Great Place to Work® following the results of a company-wide employee survey and a review of policies.
- SEK 1.1bn (USD 121m) raised in a directed share issue of 4.4 million ordinary shares. The share issue was multiple times oversubscribed due to high demand from US, European and Swedish institutional investors. The capital raised will help finance the Company's R&D pipeline as well as fund the launch and commercialization of imlifidase in kidney transplantation.
- Max Sakajja, VP Corporate Development, appointed to a new role as VP International Markets to prepare Hansa Biopharma's expansion strategy outside the EU. The role reports into the CCO and is part of Hansa's broader leadership team.
- Investments in R&D and SG&A increased in the third quarter to SEK 71m (Q3'19: SEK 47m) and SEK 52m (Q3'19: SEK 46m), respectively. Cash position was SEK 1,476m at the end of September 2020. Cash flow from operating activities for the third quarter ended at SEK 5m (Q3'19: SEK -80m).
Søren Tulstrup, President and CEO of Hansa Biopharma, comments
"Hansa Biopharma's evolution into a fully integrated biopharmaceutical company took a major step forward in the third quarter following the conditional approval of Idefirix (imlifidase) by the European Commission for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor.
The European approval serves as a validation of the potential of our proprietary drug development platform and will transistion Hansa Biopharma into the next phase as a commercial stage biopharmaceutical company.
We are also excited about the progress of our efforts beyond transplantation. In July we announced the achievement of another 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. The agreement with Sarepta is exclusive for the use in Duchenne and and Limb-Girdle indications and serves as a validation of our enzyme technology as we expand beyond transplantation.
Late Septermber we also announced positive high-level data from the investigator-initiated phase 2 trial with imlifidase to treat anti-GBM disease. Data from the trial shows that imlifidase leads to rapid clearance of anti-GBM antibodies, with two-thirds of patients achieving dialysis independence six months after treatment. We are very encouraged by the positive outcome as anti-GBM is the first IgG-mediated disease outside transplantation, where imlifidase has been shown to stop an immunologic attack.
Our strong progress across our platform of immunomodulatory enzymes has also been recognized by our investors, as our investor base has continued to expand in Sweden and internationally. End of September, the number of shareholders has increased to more than 18,000 investors, with 45% of the shares now owned by international investors and institutions. We see this as a testimony to our recent progress and a strong and growing international interest in Hansa Biopharma.
While an exciting and transformative year has impacted us in a postive way, we are still seeing negative effects due to the widespread impact from the COVID-19 pandemic. Enrollment in the phase 2 studies in GBS and AMR has been temporarily halted for the past months, and we expect to reinitiate enrollment of these studies in the fourth quarter 2020 under a risk-based, site-by-site approach.
In the US, the proposed study protocol for a randomised controlled trial (RCT) targeting highly-sensitized kidney patients was submitted to the FDA in June, 2020. Discussions are currently ongoing with the FDA and, once the final protocol has been agreed upon, we will proceed to set up centers in the US and start to enroll patients. Given the continued impact of the COVID-19 pandemic and the timeline for finalization of the study protocol, we expect recruitment of the first patient to be in the first half of 2021 with a potential BLA submission in 2023.
Lastly, I also want to highlight that Hansa Biopharma AB recently got certified as a Great Place to Work®. This certification reflects our efforts to build a strong organization through attracting, developing and retaining the very best talent in the industry as we continue our growth trajectory and development into a fully integrated biopharmaceutical company.
I look forward to keeping you updated on the progress of our journey."
Upcoming milestones and news flow
Q4 2020 Kidney transplantation EU: Commercial launch
H1 2021 Kidney transplantation US: First patient dosed / RCT
H1 2021 NiceR: Completion of GMP process; initiate IND-enabling tox studies
H2 2021 AMR Phase 2 study: Complete enrollment
H2 2021 GBS Phase 2 study: Complete enrollment
2022 Kidney transplantation US: Complete enrollment / RCT
H2 2022 AMR Phase 2 study: Data read out
H2 2022 GBS Phase 2 study: Data read out
2023 Kidney transplantation US: 12 months follow-up on eGFR completed / RCT
2023 Kidney transplantation US: BLA submission
Capital Markets Day
Hansa Biopharma to host Capital Markets Day on Thursday October 29, 2020 in Copenhagen
The CMD event will be focused around Hansa Biopharma's transformation into a fully integrated and commercial stage biopharmaceutical company and will highlight the potential of the Company's unique antibody-cleaving enzyme platform beyond transplantation in areas such as autoimmunity and gene therapy.
The event will feature both senior management and external guest speakers. The event will be livestreamed and available for all viewers on our web at http://www.hansabiopharma.com.
If you wish to participate in the CMD virtually, kindly sign up using the following link https://hansa.eventcdn.net/2020cmd/
No conference call scheduled on Oct 22, 2020
Since Hansa Biopharma will host its Capital Markets Day a week later than the Q3'2020 report it has been decided to incoporate relevant elements and updates from the third quarter into the CMD program and presentations rather than hosting a seperate Q3 conference call. There will be opportunites to ask questions during the Capital Markets Day.
The interim report and latest investor presentation can be downloaded from our web
Interim report January - September 2020
Investor road show presentation Q3, 2020