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Beskrivning
| Land | Sverige |
|---|---|
| Lista | Mid Cap Stockholm |
| Sektor | Hälsovård |
| Industri | Bioteknik |
- Strong revenue generation in Q4 2023, including SEK 43m in Idefirix[®] product sales supported by growth in new markets such as U.K., Germany, and Spain
- 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
Lund, January 6, 2024. Hansa Biopharma today announced a business update for the fourth quarter of 2023 and certain preliminary, unaudited key financials for the fourth quarter and full year 2023.
Søren Tulstrup, President and CEO, Hansa Biopharma said: "Hansa enters 2024 in a strong position to successfully execute on our key priorities. I am particularly encouraged by the strong commercial performance of Idefirix[® ]in the fourth quarter of 2023 and the continued progress we have achieved across our pipeline, with positive phase 2 data read-outs in several potential new indications for imlifidase as well as a positive first-in-human trial of HNSA-5487, Hansa's lead candidate in the Novel Immunoglobulin Cleaving Enzymes for Repeat Dosing (NiceR) program. We also continue to expand access to imlifidase for highly sensitized kidney transplant patients through a new commercial partnership with NewBridge in the MENA region. Finally, in December 2023 the first clinical study with imlifidase as a pre-treatment to Sarepta's SRP-9001 gene therapy in Duchenne Muscular Dystrophy (DMD) was initiated."
Management will be available for meetings in San Francisco during the J.P. Morgan Conference week, January 8-11, 2024. Susan Noonan is coordinating the schedule on behalf of Hansa Biopharma and can be reached at susan@sanoonan.com.
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
Hansa expects to report total fourth quarter revenue of SEK 50m consisting of SEK 43m in product sales and SEK 7m in revenue recognition mainly under the agreement with Sarepta Therapeutics. Product sales is driven by growth in new markets such as U.K., Germany, and Spain.
Commercial partnership with NewBridge in the MENA region
Hansa and NewBridge Pharmaceuticals have formed a partnership to enable supply of Hansa's novel treatment Idefirix[®] to kidney transplant patients in the Middle East and North Africa (MENA) trough NewBridge's capabilities. The new collaboration is rooted in the existing European conditional marketing authorization for Idefirix and pending application for marketing authorization in the respective MENA markets for desensitization treatment in kidney transplantation.
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 Dec 31, 2023 732 732
The fourth quarter 2023 interim report including a comprehensive business update and complete condensed financial statements will be published on February 2, 2024.
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 U.S. ConfIdeS (Kidney tx) Phase 3: Complete randomization
2025 U.S. ConfIdeS (Kidney tx) Phase 3: BLA submission
2025 Anti-GBM disease Phase 3: Completion of enrollment (NEW)
Conference call details
Hansa Biopharma will host a telephone conference Friday February 2, 2024, 14:00 CET / 8:00am EST.
The event will be hosted by Hansa Biopharma's CEO, Søren Tulstrup, CCO and U.S. President, Matthew Shaulis and CFO, Donato Spota. The presentation will be held in English.
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:
Sweden: +46 8 12 41 0952
UK: +44 203 769 68 19
USA: +1 646 787 0157
Participant access code: 765135
The webcast will be available on https://hansabiopharma.eventcdn.net/events/fullyear2023
This is information that Hansa Biopharma AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the contact persons set out below, at 14:00 CET on January 6, 2024.