- Total Revenue of
SEK 67m in the third quarter 2022 - Positive reimbursement decisions received in
Poland andScotland $70 million raised in non-dilutive financing- Imlifidase included in ESOT guidelines published in
Transplant International
Highlights for the third quarter 2022
- Total Q3 revenue of
SEK 67m includingSEK 23m in product sales andSEK 44m under our agreements with Sarepta and AskBio -
Positive reimbursement decisions received in
Poland andScotland for Idefirix® in highly sensitized kidney transplant patients. Market access has now been secured in nine European countries and procedures are ongoing in eight countries, includingSpain ,Italy andBelgium . -
First patient treated in the post-authorization efficacy study (PAES) of imlifidase in highly sensitized kidney transplant patients, at the Vall d'Hebron University Hospital in
Barcelona . $70 million non-dilutive financing executed with NovaQuest to support continued development of the company's antibody-cleaving enzyme technology platform. The transaction extendsHansa's cash runway through 2024.The European Society for Organ Transplantation's (ESOT) guidelines for desensitization treatment of highly sensitized kidney transplant patients published inTransplant International inAugust 2022 . Guidelines include imlifidase and provide a new clinical practice tool for healthcare professionals and represents the first international consensus on a management pathway for highly sensitized patients.Hansa receivedGreat Place to Work ® certification for the third consecutive year. The 2022 certification is based on a company-wide survey completed by 99% ofHansa employees.
Clinical pipeline update
U.S. ConfIdeS: 39 out of the targeted 64 patients have been enrolled for randomization in the pivotalU.S. open label, randomized, controlled trial of imlifidase in kidney transplant with the aim of completing enrollment by the end of this year, as previously guided. The aim is to complete randomization in the first half 2023, while a BLA submission is expected in 2024 under the accelerated approval path.- AMR: After completing enrollment in Q2-22, the first data read out is expected toward end of 2022 as previously guided. The AMR study is a randomized, open-label, multicenter, active control study designed to evaluate efficacy of imlifidase in eliminating donor specific antibodies (DSA) in the treatment of active episodes of acute and chronic acute AMR in kidney transplant patients, in comparison to plasma exchange.
- GBS: In the Guillain Barré Syndrome (GBS) phase2 trial, 20 out of a target of 30 patients have been enrolled. Several initiatives have been implemented to support enrollment including simplifying the protocol and increasing capacity at the center level. New centers were also added before and over the summer with further measures being taken to accelerate recruitment in the coming months. The aim is to complete enrollment of GBS patients H2 2022/H1 2023.
- Anti-GBM: Preparations to commence a phase 3 study later this year, as previously guided, are on track with a protocol in place and approved by FDA. Selection of investigators and site set up activities are now ongoing.
Financial summary
SEKm, unless otherwise stated - unaudited | Q3 2022 | Q3 2021 | 9M 2022 | 9M 2021 |
Revenue | 67.1 | 4.9 | 123.8 | 18.5 |
SG&A expenses | (83.5) | (82.8) | (254.2) | (224.1) |
R&D expenses | (90.4) | (60.6) | (254.0) | (162.5) |
Loss from operation | (139.5) | (148.2) | (442.3) | (384.2) |
Loss for the period | (154.0) | (148.4) | (462.5) | (384.9) |
Net cash used in operations | (128.7) | (131.5) | (392.6) | (364.9) |
Cash and short-term investments | 1,215.3 | 1,006.7 | 1,215.3 | 1,006.7 |
Shareholders' equity | 344.8 | 899.6 | 344.8 | 899.6 |
EPS before and after dilution (SEK) | (3.45) | (3.34) | (10.39) | (8.65) |
Number of outstanding shares | 44,588,118 | 44,473,452 | 44,588,118 | 44,473,452 |
Weighted avg. number of shares before and after dilution | 44,588,118 | 44,473,452 | 44,517,974 | 44,473,452 |
Number of employees at the end of the period | 145 | 127 | 145 | 127 |
Søren Tulstrup, President and CEO of
"In July, we executed a
So, I am pleased to see continued good execution of our market access and commercial launch activities across
We also welcome the publication in
In the
As for our AMR clinical development program, we look forward to the first data read-out from our phase 2 study later this year, following the completion of enrolment in
With respect to our GBS phase 2 program, we have implemented several significant initiatives to increase the enrolment rate and are taking further measures to increase the enrolment rate as the trial has been impacted by the pandemic in various ways, including shortage of IVIg as well as reduced availability of staff across a number of trial centers. We believe we will see an acceleration in recruitment due to these initiatives as well as higher infection rates as we approach the winter season. Completion of enrollment in the GBS trial is anticipated H2 2022/H1 2023.
In anti-GBM, we plan to commence a pivotal phase 3 study of imlifidase following
Lastly, I also want to highlight that
I look forward to keeping you updated on our continued progress, with several upcoming important milestones to be achieved across our platform and franchises as we continue the development of new, transformative medicines for patients suffering from serious, rare immunologic diseases."
Upcoming milestones and news flow
2022 Anti-GBM: Initiation of phase 3 study
2022 NiceR: Completion of GLP tox studies
H2 2022 AMR Phase 2 study: First data read out
H2 2022
H2 2022/H1 2023 GBS Phase 2 study: Complete enrollment
H1 2023
H2 2023 GBS Phase 2 study: First data read out
2023 Long-term follow-up data 5-years out in kidney transplantation
2024 Kidney transplantation US: BLA submission
Updated financial calendar 2022/2023
Conference call details
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The interim report and latest investor presentation can be downloaded from our web
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This is information that
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E-mail: klaus.sindahl@hansabiopharma.com
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