Hansa Biopharma enters into €115 million licensing agreement with SERB Pharmaceuticals for IDEFIRIX in Europe and MENA

Rhea-AI Summary

Hansa Biopharma (NASDAQ Stockholm: HNSA) signed an exclusive licensing deal with SERB Pharmaceuticals for IDEFIRIX (imlifidase) in the EU, UK, Switzerland, Norway, Liechtenstein, Iceland and MENA.

Hansa will receive €110 million upfront plus €5 million on EMA filing acceptance. Completion is expected within 60 days, subject to FDI approval.

Positive

• Exclusive EU, UK, Switzerland, EEA countries and MENA license granted to SERB for IDEFIRIX
• Upfront cash payment of €110 million to Hansa Biopharma
• Additional €5 million payment tied to EMA filing acceptance for full approval
• SERB assumes responsibility for long-term PAES follow-up and ongoing paediatric study after MAH transfer
• Hansa expects stronger financial position to support optimized potential US launch and path to profitability

Negative

• Transaction closing subject to customary conditions including foreign direct investment regulatory approval
• Additional €5 million payment depends on EMA accepting filing for full IDEFIRIX approval
• IDEFIRIX currently only conditionally authorized in Europe, pending PAES topline data and EMA review

Market Context

This announcement details a €115 million licensing agreement under which Hansa receives €110 million...

Analysis

This announcement details a €115 million licensing agreement under which Hansa receives €110 million upfront and a €5 million EMA filing milestone, while SERB assumes European and MENA commercialization of IDEFIRIX. The deal shifts long-term responsibilities such as PAES follow-up and paediatric studies to SERB, while supporting Hansa’s planned U.S. launch. Investors may focus on PAES topline data, EMA full approval, and completion of closing conditions within 60 days.

Key Figures

Licensing deal value: €115 million Upfront payment: €110 million Regulatory milestone: €5 million +5 more

8 metrics

Licensing deal value €115 million Total licensing agreement for IDEFIRIX in Europe and MENA

Upfront payment €110 million Upfront payment to Hansa under the SERB agreement

Regulatory milestone €5 million Payment upon EMA filing acceptance for full approval

IgG clearance time 2 to 6 hours Time for IDEFIRIX to cleave all classes of IgG antibodies

Company experience 25+ years SERB experience in rare diseases and emergencies

Product portfolio over 70 products SERB commercial product portfolio

Country footprint 18 countries SERB commercial operations coverage

Employees more than 600 employees SERB workforce size

Key Terms

immunoglobulin g, igg, desensitization, post-authorization efficacy study, +4 more

8 terms

immunoglobulin g medical

"targets and cleaves all classes of immunoglobulin G (IgG) antibodies within 2 to 6 hours"

Immunoglobulin G (IgG) is the most common type of antibody in blood that identifies and helps neutralize viruses, bacteria and other foreign substances, acting like a set of trained security guards that recognize specific intruders. For investors, IgG matters because it is the basis for many diagnostic tests, vaccines and antibody therapies; changes in demand, regulatory approvals or safety data for IgG-based products can directly affect company revenues and valuation.

igg medical

"targets and cleaves all classes of immunoglobulin G (IgG) antibodies within 2 to 6 hours"

IgG is a common type of antibody — a protein the immune system makes to recognize and neutralize viruses, bacteria and other foreign substances. For investors, IgG matters because measuring these antibodies underlies many diagnostic tests, vaccine responses and antibody therapies; like a security badge that shows who has been exposed or is protected, IgG results can drive demand for medical products and influence clinical and commercial decisions.

desensitization medical

"for the desensitization treatment of highly sensitized adult kidney transplant patients"

Desensitization is a medical process that reduces the body’s immune or allergic reaction to a specific drug, protein, or allergen by exposing the immune system to small, controlled amounts over time. For investors, it matters because successful desensitization can make therapies safer, lower side-effect risks, improve dosing schedules, and increase the chances of regulatory approval and market adoption—think of it as training a guard dog to stop overreacting to harmless visitors.

post-authorization efficacy study medical

"following the reporting of the Post-Authorization Efficacy Study (PAES) topline data"

A post-authorization efficacy study is a formal investigation conducted after a medical product has received regulatory approval to confirm how well it works in real-world use or broader populations than those in initial trials. Investors care because the results can affect sales, market access and regulatory obligations—think of it like road testing a car after it’s already on sale: unexpected problems or stronger performance can change customer demand and a company’s financial outlook.

paes medical

"following the reporting of the Post-Authorization Efficacy Study (PAES) topline data"

Patent Assertion Entities (PAEs) are firms that hold patents not to make products but to seek licensing fees or sue companies for alleged infringement. For investors, PAEs matter because their lawsuits or licensing demands can lead to unexpected legal costs, settlements, or injunctions that affect a company’s profits and share price—think of them as toll collectors who can suddenly demand payment for using a road a company built into its business.

market authorization holdership regulatory

"upon obtaining Market Authorization Holdership, a process expected to be initiated"

The market authorization holdership is the legal entitlement granted by a regulator to a company that allows it to sell a medical product, such as a drug or device, in a particular country or region. Think of it like a license to operate a product: the holder is responsible for complying with safety and reporting rules and is the only party normally able to market that product there. Investors care because holdership determines who can generate sales, bears regulatory risk and liability, and influences a company’s revenue potential and competitive position.

foreign direct investment financial

"subject to customary conditions, including required foreign direct investment (FDI) regulatory approval"

Foreign direct investment is when an individual or company in one country puts money into and takes lasting control of a business or asset in another country — for example by buying a factory, opening an office, or acquiring a significant ownership stake. It matters to investors because it changes where profits are earned and how companies grow, can alter a country’s economic outlook and currency, and creates long-term opportunities and risks—like planting a permanent branch in a new market rather than making a one-time trade.

eu market abuse regulation regulatory

"is obliged to make public pursuant to the EU Market Abuse Regulation"

A set of EU-wide rules that prevent cheating in financial markets by banning insider trading, market manipulation, and misleading disclosure; it also requires timely public release of key company information so everyone can play on a level field. For investors, it reduces the risk that prices are driven by secret deals or false signals, making markets fairer and more reliable for deciding when to buy or sell — like referees enforcing fair play in a game.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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• 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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2026-05-19 Licensing Agreement PR ENG FINAL

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SOURCE Hansa Biopharma AB

FAQ

What licensing agreement did Hansa Biopharma (HNSA) announce with SERB for IDEFIRIX on May 19, 2026?

Hansa Biopharma announced an exclusive licensing agreement granting SERB rights to develop and commercialize IDEFIRIX in Europe and MENA. According to Hansa Biopharma, the deal covers the EU, UK, Switzerland, Norway, Liechtenstein, Iceland and the MENA region for transplantation use.

How much is the Hansa Biopharma (HNSA) licensing deal with SERB for IDEFIRIX worth?

The IDEFIRIX licensing deal is valued at up to €115 million in near-term payments. According to Hansa Biopharma, it includes a €110 million upfront payment plus €5 million payable upon acceptance of the full-approval filing by the European Medicines Agency.

How does the SERB IDEFIRIX deal affect Hansa Biopharma’s (HNSA) financial position and US launch plans?

Hansa Biopharma expects the SERB agreement to strengthen its financial position and support an optimized US launch. According to Hansa Biopharma, the deal helps provide a pathway to profitability, subject to a potential 2026 US approval for IDEFIRIX.

What responsibilities will SERB take over for IDEFIRIX after the Hansa Biopharma (HNSA) transaction closes?

After obtaining Market Authorization Holdership, SERB will assume responsibility for long-term PAES follow-up and the ongoing paediatric study. According to Hansa Biopharma, Hansa will initially support SERB during the EMA filing and review process following PAES topline data.

When is the Hansa Biopharma (HNSA) and SERB IDEFIRIX licensing transaction expected to close?

The IDEFIRIX licensing transaction is expected to close within 60 days of announcement. According to Hansa Biopharma, completion is subject to customary conditions, including required foreign direct investment regulatory approval, before SERB assumes the regional rights and post-authorization obligations.

In which regions will SERB commercialize IDEFIRIX under the Hansa Biopharma (HNSA) agreement?

SERB will commercialize IDEFIRIX in the EU, UK, Switzerland, Norway, Liechtenstein, Iceland and MENA. According to Hansa Biopharma, SERB will leverage its European commercial platform and experience in rare and urgent conditions to expand IDEFIRIX’s reach in transplantation.