LUND, Sweden, Feb. 2, 2023 /PRNewswire/ -- Hansa Biopharma, the pioneer in immunomodulatory enzyme technology for rare IgG mediated diseases, today announced its business update and Year-end report for January to December 2022.
Highlights for the fourth quarter 2022
Clinical pipeline update
Events after the closing period
SEKm, unless otherwise stated - unaudited
Loss from operation
Loss for the period
Net cash used in operations
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
2022 was a successful year at Hansa with solid performance and strong progress across the organization. I'm pleased with the forward momentum we continue to make across R&D, Commercial and Operations. In Europe, we are very pleased to have secured Market Access in 11 countries including four of the five largest markets.
In August, the first medical guidelines for desensitization treatment of highly sensitized kidney transplant patients were published. These guidelines are the first to include Idefirix® and represent the first international consensus on a management pathway for kidney transplant patients with high unmet need. This underscores the important role that Idefirix® can play as a new, transformative therapy to enable kidney transplantation and is an important step in ensuring its use as a potential new Gold Standard in desensitization protocols.
On the development side, we continued to drive progress across our pipeline. In November, we presented topline data from our Phase 2 program in AMR, post transplantation, demonstrating significantly superior capacity of imlifidase to rapidly reduce DSA levels in comparison to plasma exchange in the five days following the start of the treatment.
In 2022 we initiated two new Phase 3 studies, namely the European Post Approval Efficacy Study in kidney transplantation and the pivotal, global Phase 3 study in anti-GBM disease. Both studies will target 50 patients and involve a significant number of clinics as we broaden our experience with imlifidase to become a potential new standard of care in both transplantation and acute autoimmune diseases.
Patient enrolment continues to progress in the ConfIdeS trial - our pivotal, phase 3 trial in kidney transplantation in the US - with 51 out of a target of 64 patients enrolled. In the GBS Phase 2 program, 25 out of a target of 30 patients have been enrolled. We aim to add more clinics to increase capacity and accelerate enrollment in both trials. Enrollment completion for both trials is expected in the first half 2023, while completion of randomization in the US ConfIdeS trial is expected in the second half 2023. We are targeting submission of a Biologics License Application (BLA), under the accelerated approval pathway, in 2024, as previously guided.
I am also very pleased with the achievements made in the preclinical development programs, specifically, in the DMD program with Sarepta in gene therapy and in the NiceR program, which is exploring utilization of second-generation enzymes for repeat dosing. In DMD, imlifidase is being investigated as a potential pre-treatment in patients with pre-existing IgG antibodies to Sarepta's SRP-9001. To date, the data looks promising, and plans have been announced to initiate a clinical study in 2023. We completed IND enabling toxicology studies at the end of last year in the NiceR program for the lead candidate HNSA 5487. A CTA approval has since been obtained and we expect to start a clinical trial in the first half 2023.
An important pillar in our overall strategy is to progress select collaborations. I'm pleased to share that we announced our second collaboration in gene therapy with AskBio, in Pompe disease. Meanwhile, we continue to receive a steady flow of interest from other gene therapy companies, looking to collaborate with us, using our antibody cleaving enzyme technology platform.
We are pleased to have secured financing - giving us runway into 2025 -- through two financing events in 2022. In July, we raised USD 70m through a non-dilutive financing transaction with NovaQuest and in December, raised USD 40m in a directed share issue targeting U.S. and other international healthcare specialist investors. Together these transactions will help finance preparations for a potential U.S. launch of imlifidase in kidney transplantation, strengthen ongoing product development activities and expand the Company's R&D pipeline.
We anticipate an exciting year ahead, with several key milestones across our platform and therapy areas, as we continue the development of new, transformative medicines for patients suffering from serious, rare immunologic diseases."
Upcoming milestones and news flow
H1 2023 GBS Phase 2: Complete enrollment
H1 2023 Anti-GBM Phase 3: First patient enrolled
H1 2023 U.S. Kidney transplantation (ConfIdeS): Complete enrollment
H1 2023 HNSA 5487 (Lead NiceR candidate): Initiate Phase 1 study
2023 Sarepta DMD pre-treatment: Commence clinical study
H2 2023 Long-term follow-up study in kidney transplantation: 5-year data readout
H2 2023 AMR Phase 2: Full data readout
H2 2023 GBS Phase 2: First data readout
H2 2023 U.S. Kidney transplantation (ConfIdeS): Complete randomization
2024 U.S. Kidney transplantation (ConfIdeS): BLA submission
Updated financial calendar 2023
March 30, 2023 2022 Annual Report
April 20, 2023 Interim Report for January-March 2023
June 14, 2023 2023 Annual General Meeting
July 20, 2023 Half-year Report for January-June 2023
October 18, 2023 Interim Report for January-September 2023
Conference call details
Hansa Biopharma will host a telephone conference today Thursday February 2 2023, 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: +44 020 3936 2999
United States: +1 646 664 1960
Participant access code: 031372
The webcast will be available on https://events.q4inc.com/attendee/195504216
The Year-end report and latest investor presentation can be downloaded from our web
Year-end report January to December 2022 https://www.hansabiopharma.com/investors/financial-reports/
Investor road show presentation Q4, 2022 https://www.hansabiopharma.com/investors/presentations/
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, VP Head of Investor Relations
M: +46 (0) 709?298 269
E: [email protected]
Stephanie Kenney, VP Global Corporate Affairs
M: +1 (484) 319 2802
E: [email protected]
The following files are available for download:
20230202 HNSA - Q4 2022 Quarterly Report ENG BoD FINAL
SOURCE Hansa Biopharma AB
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