Hansa Biopharma publishes 2025 Annual and Sustainability Reports

Rhea-AI Summary

Hansa Biopharma (NASDAQ: HNSA) published its 2025 Annual and Sustainability Reports on March 26, 2026, highlighting a pivotal U.S. Phase 3 win for imlifidase (ConfIdeS, p<0.0001) and a December 2025 BLA submission to FDA under the accelerated pathway. Europe IDEFIRIX revenue rose 46% and the company raised ~USD 96 million while completing a debt restructuring to support U.S. launch readiness and pipeline advancement.

Positive

• ConfIdeS Phase 3 met primary endpoint (p<0.0001)
• Submitted BLA to FDA in December 2025 under accelerated pathway
• European IDEFIRIX revenue +46%
• Raised approximately USD 96 million and completed debt restructuring
• Advanced HNSA-5487 toward development for GBS with FDA engagement planned H1 2026

Negative

• U.S. approval pending following BLA submission
• Commercial sales growth cited for Europe; U.S. launch not yet realized

LUND, Sweden, March 26, 2026 /PRNewswire/ -- Hansa Biopharma AB, "Hansa" or the "Company" (NASDAQ STOCKHOLM: HNSA), today published its Annual and Sustainability Reports for 2025.

Peter Nicklin, Chair of the Board, Hansa Biopharma, said: "2025 was a year of transformation for Hansa Biopharma, marked by the appointment of Renée Aguiar-Lucander as our new CEO with a clear mandate to reshape the company for sustainable growth. Under her leadership, we strengthened our foundations by improving our financial resilience and assembling a substantially new leadership team of proven, high-performing leaders. At the same time, we achieved major scientific progress, including highly positive results from the pivotal U.S. Phase 3 imlifidase trial, supporting our preparations for a potential U.S. launch. Complementing this progress, decisive organizational changes have further sharpened our strategic focus and strengthened our capabilities. With strong clinical momentum and a more resilient platform for growth, Hansa is well-positioned to deliver meaningful impact for patients and long-term value for shareholders."

Renée Aguiar-Lucander, CEO, Hansa Biopharma, said, "2025 was a year of meaningful progress for Hansa. We advanced our science, significantly improved our financial robustness, and positioned the company for long-term growth. The highly statistically significant ConfIdeS results and our BLA submission of imlifidase, marked major steps toward addressing the urgent unmet needs of highly sensitized kidney transplant patients in one of the largest global transplant markets. In Europe, access to IDEFIRIX continued to grow, reflected by a 46% increase in product revenue. We also progressed our gene therapy programs, took a strategic decision to advance our next generation enzyme HNSA-5487 in autoimmune diseases, and continued to embed sustainability across our strategy. As we look ahead to a potential U.S. approval and further pipeline developments in 2026, I am proud of the dedication of our employees and partners and confident in our ability to deliver transformative therapies to patients who need them most."

2025 highlights

Pivotal U.S. Phase 3 Success
Hansa reported positive topline results from ConfIdeS, its pivotal U.S. Phase 3 trial of imlifidase. The study met its primary endpoint with strong statistical significance (p<0.0001), demonstrating that imlifidase can enable transplantation for highly sensitized patients who otherwise face years on dialysis with very limited or no access to compatible organs. ConfIdeS is the first large, randomized trial of imlifidase and reinforces the clinical relevance of Hansa's IgG cleaving enzyme platform.

BLA Submission to the FDA
Building on the ConfIdeS results, Hansa submitted a Biologics License Application (BLA) to the FDA in December 2025, seeking approval under the accelerated pathway, a major milestone toward a potential U.S. launch.

European Commercial Momentum
Across Europe, IDEFIRIX product revenue grew by 46%, driven by increased adoption, two new national guidelines (Spain and Belgium), and expanded reimbursement, which now covers 24 countries.

Strengthening Financial Position
Hansa significantly strengthened its financial profile by raising approximately USD 96 million and completing a debt restructuring with NovaQuest. These actions enabled continued investment in regulatory activities, commercial readiness for a potential U.S. launch, and advancement of pipeline programs.

Pipeline Advancement: HNSA-5487
Hansa made the strategic decision to advance its next generation enzyme HNSA-5487 into development for Guillain–Barré syndrome (GBS), with FDA interactions planned for first half of 2026.

Strengthened Leadership to Support Next Phase of Growth
To drive execution of its strategy, Hansa strengthened its executive leadership team with appointments across key roles, including a new CEO, COO & President U.S., Chief Medical Officer, Chief Legal Officer & Corporate Secretary, Chief Human Resources Officer, and SVP Regulatory Affairs. These additions enhance operational depth and support the company's growth ambitions.

This is information that Hansa Biopharma AB (publ) is obliged to make public pursuant to the Securities Markets Act. The information was submitted for publication at 7:00 AM CET on 26 March 2026.

Contacts for more information:

Evan Ballantyne, 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 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. 

This information was brought to you by Cision http://news.cision.com

https://news.cision.com/hansa-biopharma-ab/r/hansa-biopharma-publishes-2025-annual-and-sustainability-reports,c4326814

The following files are available for download:

https://mb.cision.com/Main/1219/4326814/4006377.pdf	Hansa Biopharma Annual Report 2025
https://mb.cision.com/Main/1219/4326814/4006387.zip	549300LLEO25ZJJ3NT91-2025-12-31-1-sv.zip
https://mb.cision.com/Public/1219/4326814/b3952aca5ea18de9.pdf	Hansa Biopharma Sustainability Report 2025

 

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SOURCE Hansa Biopharma AB

FAQ

What were the ConfIdeS Phase 3 results for imlifidase announced by Hansa (HNSA) in 2025?

The ConfIdeS pivotal U.S. Phase 3 met its primary endpoint with strong statistical significance (p<0.0001). According to the company, results show imlifidase can enable transplantation for highly sensitized patients who otherwise face long waits for compatible organs.

When did Hansa (HNSA) submit the BLA for imlifidase to the FDA and under which pathway?

Hansa submitted a Biologics License Application to FDA in December 2025 under the accelerated pathway. According to the company, this BLA follows the positive ConfIdeS results and aims to support a potential U.S. launch.

How much did IDEFIRIX product revenue grow in Europe in 2025 for Hansa (HNSA)?

IDEFIRIX product revenue in Europe increased by 46% year-over-year in 2025. According to the company, growth was driven by increased adoption, two new national guidelines and expanded reimbursement across 24 countries.

How did Hansa (HNSA) strengthen its financial position in 2025?

Hansa raised approximately USD 96 million and completed a debt restructuring with NovaQuest in 2025. According to the company, these measures improved financial resilience and funded regulatory, commercial readiness, and pipeline advancement.

What are Hansa's near-term plans for the next-generation enzyme HNSA-5487 (HNSA)?

Hansa decided to advance HNSA-5487 into development for Guillain–Barré syndrome with planned FDA interactions in the first half of 2026. According to the company, this move progresses their next-generation IgG-cleaving program toward clinical development.

What is the investor implication of Hansa's (HNSA) 2025 reports and next steps for U.S. commercialization?

The reports emphasize clinical momentum, a BLA submission, and strengthened finances as preparation for a potential U.S. launch. According to the company, these steps aim to support commercial readiness while U.S. regulatory approval remains pending.