- Solid sales growth in Q1 2022
- Market access secured in
Germany and inFrance - Marketing authorization granted in
Israel - Results from Phase 2 program in anti-GBM published in
Journal of American Society of Nephrology (JASN)
Highlights for the first quarter 2022
- Solid sales growth in the first quarter with
SEK 24.2m in product sales; total revenue amounted toSEK 30.3m . -
Commercial launch activities and market access efforts for Idefirix® in
Europe continued to progress as planned during Q1 2022 with market access secured inFrance through a reimbursed Early Access Program and inGermany through commercial access on negotiated terms. Additional market access procedures are ongoing in 11 countries, includingSpain ,Italy and theU.K. Hansa and Medison Pharma announced that a marketing authorization inIsrael for Idefirix® has been granted for desensitization treatment of highly sensitized kidney transplant patients.-
Key data from a Phase 2 program of imlifidase in anti-Glomerular Basement Membrane (anti-GBM) disease patients were published in the
Journal of 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. -
In January,
Hansa and AskBio entered into an agreement to evaluate the potential use of imlifidase as a pre-treatment prior to the administration of AskBio's investigational gene therapy in Pompe disease in a preclinical and clinical feasibility program for patients with pre-existing neutralizing antibodies (NAbs). As part of the agreement,Hansa received aUSD 5 million upfront payment, while AskBio has received an exclusive option to negotiate a full development and commercialization agreement. - The partnership with Sarepta investigating imlifidase in gene therapy and the preclinical collaboration with argenx exploring the potential for combination therapy with imlifidase moved forward according to plan.
Clinical pipeline update
U.S. ConfIdeS: 16 patients have been enrolled for randomization in our pivotalU.S. open-label, randomized, controlled trial "ConfIdeS" with the aim of completing enrollment by the end of this year, as previously guided.- AMR: In the Antibody Mediated Rejection (AMR) Phase 2 trial, 28 out of a target of 30 patients have been enrolled, and completion of enrollment is expected in the first half of 2022, as previously guided.
- GBS: In the Guillain Barré Syndrome (GBS) Phase 2 trial, 16 patients out of a target of 30 patients have been enrolled. The COVID-19 pandemic has significantly impacted the enrollment rate in our GBS trial at the participating hospitals. To accelerate enrollment rate, we have implemented a number of initiatives to address the current situation and we expect these intiatives to support the completion of enrollment of GBS patients in H2 2022.
Events after the reporting period
- Anti-GBM: On
April 19, 2022 ,Hansa announced that theUS FDA has acceptedHansa's Investigational New Drug (IND) application to proceed with a Phase 3 study of imlifidase in 50 patients acrossEU and theU.S. The first patient is expected to be enrolled in 2022, as previously guided.
Financial summary
SEKm, unless otherwise stated - unaudited | Q1 2022 | Q1 2021 | 12M 2021 | ||
Revenue | 30.3 | 9.0 | 33.9 | ||
SG&A expenses | (80.4) | (60.1) | (327.3) | ||
R&D expenses | (70.9) | (47.4) | (230.8) | ||
Loss from operation | (135.0) | (103.7) | (547.0) | ||
Loss for the period | (138.4) | (103.9) | (548.3) | ||
Net cash used in operation | (130.4) | (120.9) | (481.2) | ||
Cash and short-term investments | 753.7 | 1,254.7 | 889.0 | ||
Shareholders' equity | 636.0 | 1,149.8 | 757.6 | ||
EPS before and after dilution (SEK) | (3.11) | (2.34) | (12.33) | ||
Number of outstanding shares | 44,473,452 | 44,473,452 | 44,473,452 | ||
Weighted avg. number of shares before and after dilution | 44,473,452 | 44,473,452 | 44,473,452 | ||
Number of employees at the end of the period | 141 | 101 | 133 | ||
Søren Tulstrup, President and CEO of
"
We are very pleased to have reached these important agreements with both the German payer association,
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
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
Speaking about anti-GBM, we are also pleased to share the positive news that the
In the
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
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
The presentation will be held in English and be hosted by
To participate in the telephone conference, please use the dial-in details provided below:
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
https://investors.hansabiopharma.com/English/financial-data/quarterly-report/default.aspx
Investor road show presentation Q1, 2022
https://investors.hansabiopharma.com/English/events-and-presentations/presentations/default.aspx
This is information that
For further information, please contact:
Mobile: +46 (0) 709-298 269
E-mail: klaus.sindahl@hansabiopharma.com
Head of Corporate Communications
Mobile: +46 (0) 768-198 326
E-mail: katja.margell@hansabiopharma.com
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