LUND, Sweden, April 21, 2022 /PRNewswire/ -- Hansa Biopharma, the pioneer in immunomodulatory enzyme technology for rare IgG mediated diseases, today announced its business update and interim report for January to March 2022.
Highlights for the first quarter 2022
Clinical pipeline update
Events after the reporting period
SEKm, unless otherwise stated ? unaudited
Loss from operation
Loss for the period
Net cash used in operation
Cash and short-term investments
EPS before and after dilution (SEK)
Number of outstanding shares
Weighted avg. number of shares before and after dilution
Number of employees at the end of the period
Søren Tulstrup, President and CEO of Hansa Biopharma, comments
"Hansa's commercial launch activities and market access efforts for Idefirix® in Europe continue to progress as planned. During the first quarter of 2022, we have seen additional key transplant centers becoming both clinically and commercially ready to use Idefirix® and solid sales growth. Market access were secured in two of the five major European markets, namely in France on an early access basis and in Germany - two countries with more than 5,600 kidney transplants annually, of which approximately 75% are transplanted from a deceased donor.
We are very pleased to have reached these important agreements with both the German payer association, National Association of Statutory Health Insurance Funds (GKV-SV), and the early access granted by the French Haute Autorité de Santé (HAS). We expect to complete additional agreements in the course of the year as we have market access procedures ongoing in 11 countries, including Spain, Italy and the U.K. During 2021, market access was secured in Sweden and the Netherlands, as well as on an individual hospital basis in Finland and Greece.
Looking beyond our core markets, I am also pleased to see that our new collaboration with Medison Pharma is off to a good start with the recent marketing authorization obtained in Israel for Idefirix® for the treatment of highly sensitized kidney transplant patients. Beyond Israel, our collaboration with Medison also covers Poland, Hungary, Croatia and Slovenia.
In the beginning of March, key data from the investigator-initiated open-label Phase 2 study of imlifidase in patients with anti-glomerular basement membrane (anti-GBM) disease were published in the leading nephrology publication Journal of the American Society of Nephrology (JASN). The publication recognizes the study's significance in autoimmune diseases as it suggests that deactivation of autoantibodies could alter the course of an autoimmune disease, allowing restoration of kidney function. These results highlight the potential of imlifidase as we expand beyond kidney transplantation.
Speaking about anti-GBM, we are also pleased to share the positive news that the U.S. FDA recently accepted Hansa's Investigational New Drug (IND) application to proceed with a pivotal Phase 3 study of imlifidase in approximately 50 patients across EU and the U.S. The first patient is expected to be enrolled later this year, as previously guided.
In the U.S., our pivotal ConfIdeS trial in kidney transplantation is progressing with 16 out of a target of 64 patients enrolled for randomization. The ConfIdeS study is evaluating imlifidase as a potential desensitization therapy to enable kidney transplants in highly sensitized patients waiting for a deceased donor kidney through the U.S. kidney allocation system. We have now initiated enrollment at nine sites and expect participation by up to 15 leading transplantation centers across the U.S., with the aim of completing enrollment by the end of this year.
Turning to our ongoing Phase 2 programs for GBS and AMR, we have enrolled 28 out of a target of 30 patients in the AMR study, while 16 out of a target of 30 patients have been enrolled in the GBS study.
With respect to our GBS program, we have seen how the impact of the COVID-19 pandemic and the emergence of the new variants have negatively affected the enrollment rate across a number of trial centers. To mitigate this situation we have recently implemented several significant initiatives to increase the enrollment rate and we expect these initiatives will support the completion of enrollment of GBS patients in the second half of 2022.
Last, we were pleased to announce at the beginning of January that Hansa and AskBio, a subsidiary of Bayer AG, have entered into a collaboration to evaluate imlifidase in a preclinical and clinical feasibility program as pre-treatment ahead of gene therapy in Pompe disease in patients with pre-existing neutralizing antibodies (NAbs). We see significant potential for our antibody-cleaving enzyme technology to help overcome this barrier in gene therapy as NAbs against adeno-associated virus remain a major challenge.
We have commenced another exciting year with several important milestones to be achieved across our platform and franchises, and I look forward to making further progress in the remainder of the year towards the vision that we are pursuing with single-minded focus: A world where patients with rare immunologic diseases can lead long and healthy lives."
Upcoming milestones and news flow
H1 2022 AMR Phase 2 study: Complete enrollment
2022 NiceR: Completion of GLP tox studies
2022 Anti-GBM: Initiation of phase 3 study
H2 2022 GBS Phase 2 study: Complete enrollment
H2 2022 Kidney transplantation US: Complete enrollment
H2 2022 AMR Phase 2 study: First data read out
H1 2023 GBS Phase 2 study: First data read out
2023 Long-term follow-up data 5-years out in kidney transplantation
H2 2023 Kidney transplantation US: complete 12 months follow-up
H1 2024 Kidney transplantation US: BLA submission
Conference call details
Hansa Biopharma will host a telephone conference today Thursday April 21 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 10 884 80 16
United Kingdom: +44 20 3936 2999
United States: +1 646 664 1960
Participant Access code: 121334
The webcast will be available on https://streams.eventcdn.net/hansa/q1-2022/
The interim report and latest investor presentation can be downloaded from our web
Interim report January to March 2022
Investor road show presentation Q1, 2022
This is information that Hansa Biopharma AB is obliged to make public pursuant to the Securities Markets Act.
For further information, please contact:
Klaus Sindahl, Head of Investor Relations
Mobile: +46 (0) 709-298 269
Head of Corporate Communications
Mobile: +46 (0) 768-198 326
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The following files are available for download:
20220421 HNSA - Q1 2022 Quarterly Report FINAL ENG
SOURCE Hansa Biopharma AB
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