Salute e Benessere
Hansa Biopharma Reports Second Quarter and Interim January-June 2025 Financial Results
In Q2 2025, Hansa completed a successful capital raise with the support of new and existing shareholders. The funding will support two Phase 3 trial readouts in the second half of 2025 including the ConfIdeS US pivotal trial in kidney transplantation and GOOD-IDES-02 trial in anti-GBM.
As part of a directed share issue, Hansa and NovaQuest entered into an amended debt agreement in which the Company offset US $14.9M of outstanding debt through the issue of new shares (equity). The remaining debt will be paid in fixed cash payments in June 2027 , June 2028 and June 2029 . In addition, a true-up payment of approximately US $14.9M is due on January 31, 2026 , which may be settled in cash or equity at the Company's discretion.
IDEFIRIX Q2 product revenues increased by 76% as compared to the same period last year. In Q2 2025, the Company delivered 47.8 MSEK in IDEFIRIX sales reflecting an increase of 76% as compared to previous year (27.2 MSEK) for the same time period. For the 1H 2025, IDEFIRIX sales amounted to 113.5 MSEK representing a 52% increase in product sales over 1H 2024, which represents approximately 80% of full year product sales for 2024.
The Company remains on track to report data from the 20-HMedIdeS-17 study (ConfIdeS). A Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA) is expected in second half 2025, following data readout.
Positive data from the 15-HMedIdeS-09 Phase 2 trial including an indirect treatment comparison to the International Guillain-Barré Syndrome Outcome Study (IGOS) was presented at the Peripheral Nerve Society (PNS) annual meeting in May.
Enrolment is ongoing in GNT-018-IDES, a Phase 2 trial in Crigler Najjar to evaluate the efficacy and safety of Genethon's gene therapy, GNT-0003 following pre-treatment with imlifidase. The Phase 1b trial SRP-9001-104 with Sarepta remains on track for an initial data readout later this year.
Hansa Biopharma will host a telephone conference today Thursday, 17 July 2025 , at 14:00 CEST / 8:00 am EDT .
The event will be hosted by Renée Aguiar-Lucander, CEO, Evan Ballantyne , CFO, Hitto Kaufmann, CSTO, and Maria Törnsén COO and President U.S. The call will include a review of the interim results and a business and pipeline update. It 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:
Participant Dial In (Toll Free): 1-833-821-3542
Participant International Dial In: 1-412-652-1248
*Please ask to be joined into the Hansa Biopharma call
Join the webcast here: https://event.choruscall.com/mediaframe/webcast.html?webcastid=hUSedAeI
Evan Ballantyne, Chief Financial Officer
IR@hansabiopharma.com
Hansa Biopharma AB is a pioneering commercial-stage biopharmaceutical company on a mission to develop and commercialize innovative, lifesaving and life-altering treatments for patients with rare immunological conditions. The company has a rich and expanding research and development program based on its proprietary IgG-cleaving enzyme technology platform, to address serious unmet medical needs in autoimmune diseases, gene therapy and transplantation. The company's portfolio includes imlifidase, a first-in-class immunoglobulin G (IgG) antibody-cleaving enzyme therapy, which has been shown to enable kidney transplantation in highly sensitized patients and HNSA-5487, a next-generation IgG cleaving molecule with redosing potential. Hansa Biopharma is based in Lund, Sweden , and has operations in Europe and the U.S. The company is listed on Nasdaq Stockholm under the ticker HNSA. Find out more at www.hansabiopharma.com and follow us on LinkedIn.
©2025 Hansa Biopharma AB. Hansa Biopharma, the beacon logo, IDEFIRIX, and IDEFIRIX flower logo are trademarks of Hansa Biopharma AB, Lund, Sweden . All rights reserved.
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