- Strong revenue generation in Q4 2023, including
SEK 43m in Idefirix® product sales supported by growth in new markets such asU.K. ,Germany , andSpain - Encouraging first results from first-in-human trial of HNSA-5487,
Hansa's lead candidate from the NiceR program for repeat dosing - Initiation of phase 1b trial of imlifidase as pre-treatment to Sarepta's SRP-9001 in DMD
Søren Tulstrup, President and CEO,
Management will be available for meetings in
The latest investor presentation can be downloaded through following link
https://www.hansabiopharma.com/investors/presentations/
Business Update
Strong commercial performance in the fourth quarter of 2023
Commercial partnership with NewBridge in the MENA region
Clinical pipeline update
- US ConfIdeS phase 3 trial (kidney transplantion): 101 patients have been enrolled with close to 2/3 of 64 targeted patients randomized in the pivotal
U.S. open label, randomized, controlled trial of imlifidase in kidney transplantion. - GOOD-IDES-02 phase 3 (anti-GBM disease): 16 of 50 targeted patients enrolled in this global pivotal phase 3 trial in anti-glomerular basement membrane (anti-GBM) disease. Completion of enrollment is expected in 2025.
- Investigator-initiated phase 2 trial (ANCA-associated vasculitis): 3 of 10 targeted patients enrolled.
- NICE-01 phase 1 (HNSA-5487): Following positive results from the first-in-human trial of HNSA-5487, the lead candidate from the NiceR program for repeat dosing, analysis of additional exploratory endpoints on IgG recovery and immunogenicity is being conducted. The analysis is expected to be complete in 2024 and will help determine further clinical development, including selection of indications.
- SRP-9001-104 phase 1b trial (Duchenne Muscular Dystrophy, DMD): The first clinical study with imlifidase as a pre-treatment to Sarepta's SRP-9001 gene therapy in DMD was initiated
mid-December 2023 . First patient is expected to be dosed in due course.
Key Financials (preliminary, unaudited)
SEK million | Q4 2023 | FY 2023 |
Total Revenue | 50 | 134 |
Product sales | 43 | 103 |
SG&A expenses | -107 | -452 |
R&D expenses | -108 | -411 |
Operating profit/loss | -177 | -790 |
Cash and short-term investments | 732 | 732 |
The fourth quarter 2023 interim report including a comprehensive business update and complete condensed financial statements will be published on
Upcoming milestones and news flow
2024 First high level data read-out from phase 1b study in DMD with Sarepta (NEW)
2024 GBS Phase 2: Outcome of the comparative efficacy analysis to IGOS data
2024 Genethon Crigler-Najjar Phase 1/2: Initiate clinical study with imlifidase prior to GNT-0003
2024 HNSA-5487: Further analysis around endpoints in FIH trial
2024
2025
2025 Anti-GBM disease Phase 3: Completion of enrollment (NEW)
Conference call details
The event will be hosted by
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:
Participant access code: 765135
The webcast will be available on https://hansabiopharma.eventcdn.net/events/fullyear2023
This is information that
For further information, please contact:
M: +46 (0) 709-298 269
E: klaus.sindahl@hansabiopharma.com
M: +1 (484) 319 2802
E: stephanie.kenney@hansabiopharma.com
About
https://news.cision.com/hansa-biopharma-ab/r/hansa-biopharma-provides-update-on-business-and-key-financials-ahead-of-the-jp-morgan-healthcare-con,c3904989
https://mb.cision.com/Main/1219/3904989/2524835.pdf
(c) 2024 Cision. All rights reserved., source