- Closing of the €115 million licensing transaction with SERB
- Cash and cash equivalents amounted to 1,337.2 MSEK as of 30 September 2026
- The first commercial patient in Australia received a living-donor kidney transplant following treatment with Idefirix (Imlifidase)
LUND, Sweden, Nov. 11, 2026 /PRNewswire/ -- Hansa Biopharma AB, "Hansa" (NASDAQ Stockholm: HNSA), today announced its interim report for the three and nine months ended September 30, 2026.
Renée Aguiar-Lucander, CEO, Hansa Biopharma, said, "This was a quarter of strong execution for Hansa. The closing of the SERB transaction has strengthened our financial position and sharpened our strategic focus as we prepare for the potential US launch of imlifidase, subject to approval, while continuing to advance HNSA-5487 in GBS. We enter the final part of the year with clear priorities, strong momentum and increased flexibility to execute on our next phase of growth."
Business Update
Revenue for the third quarter amounted to 143.0 MSEK compared with 30.8 MSEK in the corresponding period in 2025, primarily driven by revenue recognized under the license agreement with SERB Pharmaceuticals. Revenue for the nine months ended September 30, 2026 was 225.7 MSEK, compared with 146.3 MSEK in the corresponding period last year. Following the licensing of Idefirix® to SERB, SERB will exclusively market Idefirix in Europe and MENA for transplantation. As a result, the revenue composition has changed significantly, and revenue is therefore not directly comparable with the corresponding periods in 2025.
The license agreement with SERB closed on July 1, followed by receipt of a one-time EUR 110 million upfront payment on July 8. After the quarter end, the European Commission granted the transfer of the Marketing Authorization and orphan designation for Idefirix to SERB.
Cash and cash equivalents amounted to 1,337.2 MSEK as of September 30, 2026, compared with 252.1 MSEK on September 30, 2025.
During the quarter, the first commercial patient in Australia received a living-donor kidney transplant following treatment with Idefirix, reflecting the start of commercial activities in Australia.
Changes to the Hansa Board of Directors included the election of Shannon Campbell and Gregory Perry and the resignation of Michael Bologna.
Clinical updates after the quarter
Results from the European post-authorization efficacy and safety study (PAES) of Idefirix in kidney transplantation were shared in an oral presentation at ASN Kidney Week on October 23.
Additionally, an Investigational New Drug Application (IND) was submitted to the FDA for HNSA-5487 in Guillain-Barré syndrome (GBS) to enable initiation of the clinical development program.
Financial Summary
Amounts in MSEK, unless otherwise stated | Q3 2026 | Q3 2025 | 9M 2026 | 9M 2025 |
Revenue | 143.0 | 30.8 | 225.7 | 146.3 |
- product sales | 0.0 | 30.1 | 80.7 | 143.6 |
- license revenue, €110m SERB upfront | 121.6 | - | 121.6 | - |
- supply and service revenue, SERB | 20.8 | - | 20.8 | - |
SG&A expenses | (147.6) | (88.4) | (372.0) | (254.9) |
R&D expenses | (65.4) | (70.2) | (190.6) | (230.3) |
Loss from operations | (138.6) | (147.6) | (455.1) | (395.8) |
Loss for the period | (178.5) | (148.3) | (635.3) | (364.2) |
Net cash from (used in) operations | 964.4 | (106.9) | 715.8 | (327.4) |
Cash and short-term investments | 1,337.2 | 252.1 | 1,337.2 | 252.1 |
EPS before and after dilution (SEK) | (1.75) | (1.75) | (6.24) | (4.90) |
Number of outstanding shares | 101,763,222 | 84,763,222 | 101,763,222 | 84,763,222 |
Weighted average number of shares before and after dilution | 101,763,222 | 84,763,222 | 101,763,222 | 74,270,996 |
Number of employees at period end | 111 | 133 | 111 | 133 |
Conference Call Details
Hansa will host a telephone conference today Wednesday, November 11, 2026, at 14:00 CET / 08:00 ET.
The event will be hosted by Renée Aguiar-Lucander, CEO, Richard Philipson, CMO, Adam Cutler, CFO, and Maria Törnsén, COO and President US. The call will be held in English.
Slides used in the presentation will be live on the webcast during the call and will also be made available online after the call under Financial reports | Hansa Biopharma.
To participate in the conference:
The webcast will be available on: Hansa Biopharma Interim Report for January-September 2026
To participate in the live Q&A session, please register here: Register for Q&A
Contacts for more information:
Adam Cutler, Chief Financial Officer
IR@hansabiopharma.com
Kerstin Falck, VP Global Corporate Affairs
media@hansabiopharma.com
Notes to editors
About Hansa Biopharma
Hansa Biopharma AB is a pioneering commercial-stage biopharmaceutical company developing and commercializing novel immunomodulatory therapies to transform care for patients with acute or complex immune disorders. Hansa's proprietary IgG-cleaving enzyme technology platform addresses serious unmet medical needs in transplantation, gene therapy and autoimmune diseases. 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 that will be developed for Guillain-Barré syndrome (GBS). Hansa Biopharma is based in Lund, Sweden, and has operations in Europe and the US. The company is listed on Nasdaq Stockholm under the ticker HNSA. Find out more at www.hansabiopharma.com and follow us on LinkedIn.
©2026 Hansa Biopharma AB. Hansa Biopharma, the beacon logo, Idefirix, and Idefirix flower logo are trademarks of Hansa Biopharma AB, Lund, Sweden. All rights reserved.
Forward-Looking Statements
This press release contains forward-looking statements relating to the business of Hansa, including, without limitation, statements regarding Hansa's commercial activities in Australia and the potential US launch of imlifidase. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties, and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release. Hansa cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Hansa disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent Hansa's views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.
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The following files are available for download:
HNSA Q3 2026 Quarterly Report ENG FINAL |
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