• The agreement covers the European Union, United Kingdom, Switzerland, Norway, Liechtenstein, Iceland and the MENA region
• Significantly enhances Hansa's financial position, ensuring a robust U.S. launch and provides path to profitability, subject to US approval
• SERB has a substantial European commercial presence and a successful track record in critical care and rare disease commercialization

LUND, Sweden, May 19, 2026 /PRNewswire/ -- Hansa Biopharma AB ("Hansa" or "the Company") (NASDAQ STOCKHOLM: HNSA) and SERB S.A. ("SERB") today announced an exclusive licensing agreement for development and commercialization of IDEFIRIX (imlifidase) in the European Union (EU), United Kingdom (UK), Switzerland, Norway, Liechtenstein, Iceland and MENA (Middle East and North Africa) regions.

IDEFIRIX is a first-in-class treatment that specifically targets and cleaves all classes of immunoglobulin G (IgG) antibodies within 2 to 6 hours. It is conditionally authorized by the European Commission for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch test against an available deceased donor. IDEFIRIX offers a pioneering breakthrough for patients with a significant unmet medical need.

Renée Aguiar-Lucander, CEO of Hansa Biopharma, said "This agreement is transformative for Hansa Biopharma. It allows patients in the region to benefit from a partner with an established commercial footprint and proven growth track record in Europe. At the same time, it crystallizes the value of the franchise and significantly strengthens our financial position assuring an optimized US launch and a pathway to profitability, subject to a 2026 US approval, as well as the continued pursuit of our R&D pipeline."

Jeremie Urbain, Chairman of SERB, said "SERB is committed to expanding access to transplantation for highly sensitized patients who currently have very limited alternatives. SERB is designed to address rare and urgent conditions, and will leverage its deep expertise, proven commercial execution and established platform across Europe and MENA to expand the reach and clinical impact of IDEFIRIX."

SERB is a, privately owned, global specialty pharmaceutical company with 25+ years of experience in rare diseases, rare medical emergencies and medical countermeasures. With over 70 products across commercial operations in 18 countries, more than 600 employees and a strong M&A track record, SERB is a fully integrated partner with proven, value-driven growth.

Under the agreement, Hansa has granted SERB an exclusive EU, UK, Switzerland, Norway, Liechtenstein, Iceland and MENA license for development and commercialization of IDEFIRIX in transplantation. Hansa will receive an upfront payment of €110 million and a €5 million payment upon acceptance of the filing for full approval of IDEFIRIX by the European Medicines Agency (EMA). Hansa will fully support SERB in the filing and EMA review process following the reporting of the Post-Authorization Efficacy Study (PAES) topline data. SERB will assume responsibility for the long-term PAES follow-up and the ongoing paediatric study upon obtaining Market Authorization Holdership, a process expected to be initiated immediately following the closing of the transaction.

Completion of the transaction is subject to customary conditions, including required foreign direct investment (FDI) regulatory approval, and is expected to be completed within 60 days.

Centerview Partners UK LLP is acting as exclusive financial advisor and Morgan Lewis is acting as legal counsel to Hansa.

Rothschild & Co. is acting as exclusive financial advisor and Freshfields is acting as legal counsel to SERB.

Conference Call Details

Hansa Biopharma will host a telephone conference today Monday, May 19, 2026, at 15:00 CEST / 9:00 am EDT.

The event will be hosted by Renée Aguiar-Lucander, CEO and Evan Ballantyne, CFO. 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 Events and presentations | Hansa Biopharma

To participate in the telephone conference, please use the dial-in details provided below:

Participant Dial In (USA/Canada 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: Webcast | Hansa Biopharma Call

This is information that Hansa Biopharma AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out below, at 07:30 CEST on May 19, 2026.

Contacts for more information:

Kerstin Falck, VP Global Corporate Affairs
media@hansabiopharma.com

IR@hansabiopharma.com

Notes to editors

About imlifidase

Imlifidase is conditionally approved in the European Union, Norway, Liechtenstein, Iceland and the UK under the tradename IDEFIRIX^® for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor. IDEFIRIX^® is also approved in Australia and Switzerland.

Information about the trial is available at ClinicalTrials.gov: NCT04935177

About IDEFIRIX^® (imlifidase)

Imlifidase is an antibody-cleaving enzyme originating from Streptococcus pyogenes that specifically targets and cleaves immunoglobulin G (IgG) antibodies and inhibits IgG-mediated immune response.¹ It has a rapid onset of action, cleaving IgG-antibodies and inhibiting their activity within hours after administration.

Imlifidase has conditional marketing approval in Europe and is marketed under the tradename IDEFIRIX for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor. The use of IDEFIRIX should be reserved for patients who are unlikely to be transplanted under the available kidney allocation system, including prioritization programs for highly sensitized patients.¹ IDEFIRIX was reviewed as part of the European Medicines Agency's (EMA) PRIority Medicines (PRIME) program, which supports medicines that may offer a major therapeutic advantage over existing treatments or benefit patients without treatment options.¹

The efficacy and safety of imlifidase as a pre-transplant treatment to reduce donor-specific IgG antibodies was studied in four Phase 2 single-arm studies in EU and US as well as a randomized, controlled Phase 3 study in US^2,3-5. Hansa is collecting further clinical evidence and will submit additional efficacy and safety data based on one observational follow-up study in addition to the above described post-approval efficacy study.

In the US, the Food and Drug Administration (FDA) accepted the Biologics License Application (BLA) for imlifidase in February of 2026 and assigned a Prescription Drug User Fee Act (PDUFA) action date of December 19, 2026.

Full EU product information can be accessed via the initial Summary of Product Characteristics found here.

About kidney failure

Kidney disease can progress to kidney failure or End-Stage Renal Disease (ESRD), identified when a patient's kidney function is less than 15%.⁶ ESRD poses a significant health burden, affecting nearly 2.5 million patients worldwide.⁶ A kidney transplant is the treatment of choice for suitable patients with ESRD because it offers improved survival and quality of life benefits, and is cost savings compared to long-term dialysis. There are approximately 170,000 kidney patients in the US and Europe waiting for a new kidney.⁷

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 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.

^©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 strategy, commercialization efforts, business plans, regulatory submissions, clinical development plans, revenue and product sales projections or forecasts and focus. 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, including, without limitation, any related to Hansa's business and operations, the presumed mechanism of action of imlifidase, the safety and efficacy of imlifidase in the patient population above or other potential indications, market acceptance of imlifidase, competitive products, anticipated timelines and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. 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.

References

1. European Medicines Agency. Idefirix® summary of product characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/idefirix-epar-product-information_en.pdf.
2. Heidt S, et al. Highly Sensitized Patients are Well Serves by Receiving a Compatible Organ Offer Based on Acceptable Mismatches. Front Immunol. 2021;12:687254. Available at: https://pubmed.ncbi.nlm.nih.gov/34248971/
3. Jordan SC, et al. IgG Endopeptidase in Highly Sensitized Patients Undergoing Transplantation. N Engl J Med. 2017 Aug 3;377(5):442-453. doi: 10.1056/NEJMoa1612567. Erratum in: N Engl J Med. 2017 Oct 26;377(17):1700. doi: 10.1056/NEJMx170015.
4. Winstedt L, et al. Complete Removal of Extracellular IgG Antibodies in a Randomized Dose-Escalation Phase I Study with the Bacterial Enzyme IdeS--A Novel Therapeutic Opportunity. PLoS One. 2015 Jul 15;10(7):e0132011. doi: 10.1371/journal.pone.0132011. PMID: 26177518; PMCID: PMC4503742.
5. Lorant T, et al. Safety, immunogenicity, pharmacokinetics, and efficacy of degradation of anti-HLA antibodies by IdeS (imlifidase) in chronic kidney disease patients. Am J Transplant. 2018 Nov;18(11):2752-2762. doi: 10.1111/ajt.14733.
6. NIH (2018). What is kidney failure? Available at: https://www.niddk.nih.gov/health-information/kidney-disease/kidney-failure/what-is-kidney-failure.
7. Newsletter Transplant 2022. International figures on donation and transplantation. Available at: Newsletter Transplant - latest edition I Freepub (edgm.eu) Accessed: May 2025

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