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Hansa Biopharma reaches two landmark milestones: Idefirix (imlifidase) receives positive CHMP opinion in EU; Gene therapy partnership with Sarepta Therapeutics in select indications.
Lund July 16, 2020. Hansa Biopharma, the leader in immunomodulatory enzyme technology for rare IgG mediated diseases, today announced its business update and interim report for January - June, 2020.Highlights for the second quarter 2020
- CHMP/EMA has adopted a positive opinion, recommending conditional approval of Idefirix (imlifidase) for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor. An approval by the European Commission is expected in Q3 2020.
- In the US, Hansa Biopharma submitted the proposed study protocol for the randomized controlled study with imlifidase in kidney transplant to the FDA on June 17, 2020. The trial is planned to be initiated in Q4 this year.
- Pipeline: The first data read-out from the phase 2 study in anti-GBM is expected in Q3 2020 as previously guided. In the AMR and GBS phase 2 studies, 4 of the targeted 30 patients have been enrolled in each of the respective studies. Enrollment in the AMR and GBS studies is expected to be completed in H1 2021 and H2 2021, respectively.
- On June 1, 2020 Achim Kaufhold, M.D. was announced as new Chief Medical Officer and member of the Executive Committee of Hansa Biopharma. Dr. Kaufhold is a highly experienced senior leader in immunology, infectious diseases and oncology and will support the Company's expansion outside transplantation.
- Hansa hosted its 2020 Annual General Meeting on June 23, 2020. All resolutions except articles 18b and 19b were approved, and the entire board of directors was re-elected for the period until the end of the next AGM.
- Investments in R&D and SG&A increased in the second quarter to SEK 53m (Q2'19: SEK 46m) and SEK 49m (SEK 39m), respectively. Cash position was SEK 400m at the end of June 2020. Cash flow from operating activities for the second quarter ended at SEK -77m (SEK -78m).
- On July 2, 2020 Hansa announced an exclusive agreement with Sarepta Therapeutics to develop and promote imlifidase as pre-treatment ahead of gene therapy in select indications. The agreement with Sarepta triggers a USD 10 million upfront payment and will potentially generate milestone payments to Hansa totaling up to USD 397.5m plus royalties on the sales of Sarepta gene therapy products enabled by imlifidase. All imlifidase sales will be booked by Hansa.
- On July 8, 2020 Hansa Biopharma raised SEK 1.1bn (USD 121m) 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 including Redmile, Consonance, HBM and Fonden TIN Ny Teknik. The capital raised will help finance the development and expansion of the Company's R&D pipeline as well as to fund the potential launch and commercialization of imlifidase in kidney transplantation.
Søren Tulstrup, President and CEO of Hansa Biopharma, comments
"Hansa Biopharma's evolution into a fully integrated commercial stage biopharmaceutical company has taken a major step forward with the recent achievement of two landmark milestones.
On June 25, 2020 Hansa Biopharma received a positive opinion from the CHMP of the European Medicines Agency (EMA), recommending conditional approval of Idefirix (imlifidase) for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor.
We are very excited about this recognition from the CHMP/EMA. The recommendation by the CHMP and the expected launch of imlifidase towards the end of this year brings hope to the thousands of highly sensitized patients across Europe waiting for a life-saving kidney transplant and takes Hansa Biopharma a major step forward to becoming a commercial stage biopharmaceutical company.
A week later, on July 2, 2020, Hansa Biopharma 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 in Duchenne muscular dystrophy and Limb-girdle muscular dystrophy in patients with neutralizing antibodies (NAbs) to adeno-associated virus (AAV).
We are very excited to partner with Sarepta, a leading player in the field, to use the unique features of imlifidase to potentially enable gene therapy treatment in patients who today aren't eligible for these breakthrough therapies due to pre-existing neutralizing antibodies in two indications with a very high unmet medical need. The agreement with Sarepta also serves as a validation of our enzyme technology as we expand beyond transplantation and acute autoimmune diseases.
I look forward to keeping you updated on the progress of Hansa Biopharma's journey as we take the next steps towards commercialization of imlifidase in Europe and the transformation of Hansa Biopharma into a global biopharmaceutical company".
Upcoming milestones and news flow
Q3 2020 Kidney transplantation EU: Adoption of Conditional Approval
Q3 2020 Anti-GBM Phase 2 study: Data read out
Q4 2020 Kidney transplantation EU: Commercial launch
Q4 2020 Kidney transplantation US: First patient dosed / RCT
H1 2021 AMR Phase 2 study: Complete enrollment
H1 2021 NiceR candidate: Completion of GMP process and IND-enabling tox studies
H2 2021 GBS Phase 2 study: Complete enrollment
H1 2022 AMR Phase 2 study: Data read out
2022 Kidney transplantation US: Complete enrollment / RCT
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
Conference call details
Hansa Biopharma will host a telephone conference today Thursday July 16 at 2:00 p.m. CET.
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 & Presentations" and will also be made available online after the call.
To participate in the telephone conference, please use the dial-in details provided below:
SE: +46 8 56 64 27 07
UK: +44 333 300 92 65
US: +1 833 249 84 07
The webcast will be available on https://hansa.eventcdn.net/20200716/
The interim report and latest investor presentation can be downloaded from the Hansa Biopharma web
Interim report January - June 2020
Hansa web - Interim Report (https://investors.hansabiopharma.com/English/financial-data/quarterly-report/default.aspx)
Investor road show presentation Q2, 2020
Hansa web - Presentations (https://investors.hansabiopharma.com/English/events-and-presentations/presentations/default.aspx)
Hansa Biopharma expects to organize a Capital Markets Day on Oct 29, 2020. Further details to follow shortly
This is information that Hansa Biopharma AB is obliged to make public pursuant to the EU Market Abuse Regulation.