Hansa Biopharma AB: Hansa Biopharma announces closing of €115 million licensing transaction with SERB Pharmaceuticals for Idefirix in Europe and MENA

• SERB assumes responsibility for the commercialization of Idefirix in transplantation in the EU, UK, Switzerland, Norway, Liechtenstein, Iceland and MENA region
• The transaction significantly strengthens Hansa's financial position and enables a robust US launch,subject to US approval of imlifidase

LUND, Sweden, July 1, 2026 /PRNewswire/ -- Hansa Biopharma AB ("Hansa" or "the Company") (NASDAQ Stockholm: HNSA) and SERB S.A. ("SERB") today announced required regulatory approvals have been obtained and that the previously announced exclusive licensing transaction with SERB has closed.

Under the agreement, Hansa has granted SERB an exclusive license for the development and commercialization of Idefirix in solid organ transplantation in the European Union (EU), United Kingdom (UK), Switzerland, Norway, Liechtenstein, Iceland and the MENA (Middle East and North Africa) region. The total transaction value is €115 million, comprising 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.

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: "The closing of this transaction marks an important milestone for Hansa. With SERB as our partner in Europe and MENA, we believe Idefirix will benefit from additional expertise, reach and resources to enable access for appropriate highly sensitized kidney transplant patients, addressing a significant unmet medical need. At the same time, the transaction strengthens Hansa's financial position as we continue to prepare for a potential US launch of imlifidase, subject to US approval, and advance our broader R&D pipeline."

SERB is a privately owned, global speciality 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.

Hansa will apply to the EMA for transfer of the Market Authorization of Idefirix to SERB and continue to fully support SERB in the filing for conversion to full approval and the EMA review process based on the outcome of the Post-Authorization Efficacy Study topline data announced May 27. SERB will assume responsibility for the long-term PAES follow-up and the ongoing paediatric study upon obtaining Market Authorization Holdership.

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

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

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 14:30 CEST on July 1, 2026.

Contacts for more information:
Kerstin Falck, VP Global Corporate Affairs
[e-mail]
[e-mail]

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 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 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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2026-07-01 Closing Licensing Agreement ENG FINAL

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