Hansa Biopharma Announces $70 Million Non-Dilutive Product Financing Transaction with NovaQuest to Support the Continued Development of the Company’s Antibody Cleaving Enzyme Technology Platform

The profits will mainly be used for:

– Further strengthen the Company’s position in the kidney transplant field through continued support of ongoing European commercial launch activities for Idefirix (imlifidase) and execution of the US ConfIdeS trial of imlifidase, which is expected to support a possible Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA) under the fast-track approval pathway in the first half of 2024. In addition, Hansa will advance the global clinical trial phase 3 of imlifidase in anti-GBM antibody disease and ongoing clinical programs in other indications

LUND, Sweden, July 18, 2022 /PRNewswire/ — Hansa Biopharma AB, (Hansa), (Nasdaq Stockholm: HNSA), a pioneer in enzyme technology for rare immunological diseases, today announces that the company has entered into an agreement with US-based NovaQuest Capital Management , guaranteeing $70 million in non-dilutive financing.

“This transaction, which extends our cash trail through 2024, helps strengthen our ability to invest in the continued development of our unique antibody cleaving enzyme technology platform across multiple therapeutic areas,” said Donato Spotafinancial director of Hansa Biopharma.

Mr. Spota continued, “We now have the resources we need to fully fund our US ConfIdeS trial, which is evaluating imlifidase as a potential desensitization therapy to enable kidney transplants in highly sensitized patients awaiting a kidney. deceased donor through the US Kidney Allocation System. and is expected to support the submission of a BLA to the FDA under the accelerated approval pathway in the first half of 2024, as well as our global Phase 3 development program in GBM antibody disease, which is expected to begin this year. , along with our existing cash, can also be used to complement our existing Phase 2 programs in Antibody-Mediated Kidney Transplant Rejection (AMR) and Guillain-Barré Syndrome (GBS) and to advance our next generation of enzymes (NiceR) in clinical development. “

“Hansa’s team has demonstrated the clinical benefit of imlifidase to enable kidney transplantation in patients who are highly sensitized enough to gain EMA approval and appropriate reimbursement in a growing number of key European countries,” said declared Brett FleshmanManaging Director of NovaQuest Capital Management, “NovaQuest is delighted that Hansa has chosen to fund the ongoing launch in Europeand pivotal trials in the United States for kidney transplantation and anti-GBM antibody disease through this unique product financing transaction,” he continued.

$70 million in financing

Under the terms of the agreement, NovaQuest will provide Hansa $70 million within 15 working days from the signing of the contract. In return, Hansa will pay quarterly single-digit royalties to NovaQuest on future worldwide annual net sales of imlifidase, commencing upon FDA approval of imlifidase in kidney transplantation or anti-GBM. In addition, Hansa will make certain milestone payments to NovaQuest upon FDA approval of imlifidase in kidney transplantation or anti-GBM. Total payments from Hansa to NovaQuest are capped.at $140 million. The agreement also provides for time-based catch-up payments under the payment cap if specified payment amounts have not been received by NovaQuest by the specified dates, with the last potential catch-up payment due on December 31, 2028. In addition, the transaction includes customary due diligence, governance and disclosure obligations as well as non-financial covenants. Hansa and NovaQuest have also entered into a security agreement to provide NovaQuest with customary security and lien over right, title and interest in certain of Hansa’s assets and intellectual property.

Hansa’s mission is to become a world leader in the field of rare diseases through the development of innovative, life-saving and life-changing treatments for patients with rare immunological diseases. The Company’s strategy leverages its proprietary enzyme technology platform, with the goal of developing and commercializing first-in-class or best-in-class immunomodulatory treatments for organ transplants, rare IgG-mediated autoimmune diseases and gene therapy, as well as exploring the potential of the technology in oncology.

Hansa has received conditional approval for Idefirix® in Europe in August 2020. The underwriting and reimbursement processes were completed in England, Wales and North Ireland, Germany, Sweden and the Netherlandsas well as on an individual hospital basis in Finland and Greece. In addition, Hansa was granted access to France thanks to a fully refunded early access program earlier this year, while Swiss and Israelalso earlier this year, respectively granted temporary and full marketing authorization for Idefirix®. Additional market access procedures are currently underway in 11 countries, including Spain and Italy.

This is information that Hansa Biopharma AB is required to make public under the EU Market Abuse Regulation. The information has been submitted for publication, through Hansa Biopharma and the contact persons listed below, to 21:00 CET on July 18 2022.


For more information, please contact:

Hansa Biopharma
Klaus SindahlHead of Investor Relations
Hansa Biopharma
Mobile: +46 (0) 709-298 269
E-mail: [email protected]

Katja Margell
Corporate Communications Manager
Hansa Biopharma
Mobile: +46 (0) 768-198 326
E-mail: [email protected]

NovaQuest Capital Management
Philippe NunesBackBay Communications
M: +1 617-391-0792
E : [email protected]

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SOURCE Hansa Biopharma AB

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