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Hansa Biopharma announces $70 million non-dilutive product finance transaction with NovaQuest to support continued development of the company’s antibody-cleaving enzyme technology platform

Regulatory information
Proceeds will be mainly utilized to: 

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

Lund, Sweden July 18, 2022. Hansa Biopharma AB, (Hansa), (Nasdaq Stockholm: HNSA), a pioneer in enzyme technology for rare immunological conditions, today announces that the Company has entered into an agreement with U.S.-based NovaQuest Capital Management, securing $70 million in non-dilutive financing.

“This transaction, which extends our cash runway through 2024, helps bolster our ability to invest in the continued development of our unique antibody-cleaving enzyme technology platform across multiple therapeutic areas,” said Donato Spota, Chief Financial Officer of Hansa Biopharma.

Mr. Spota continued, “We now have the resources we need to fully fund our U.S. ConfIdeS trial, which is evaluating imlifidase as a potential desensitization therapy to enable kidney transplants in highly sensitized patients waiting for a deceased donor kidney through the U.S. kidney allocation system and is expected to support 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 anti-GBM antibody disease, which is expected to commence this year. The funds, together with our existing cash, may also be used to complete 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) into clinical development.“

“The team at Hansa has demonstrated the clinical benefit of imlifidase for enabling kidney transplantation in highly sensitized patients sufficiently to gain EMA approval and appropriate reimbursement in an expanding number of key European countries,” said Brett Fleshman, Managing Director at NovaQuest Capital Management, “NovaQuest is delighted that Hansa has chosen to fund the ongoing launch in Europe, and US pivotal trials for kidney transplantation and anti-GBM antibody disease through this unique Product Finance transaction.”, he continued.

$70 million in financing

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

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

Hansa obtained conditional approval for Idefirix® in Europe in August 2020. Pricing and reimbursement processes have been completed in England, Wales and Northern Ireland, Germany, Sweden and the Netherlands, as well as on an individual hospital basis in Finland and Greece. In addition, Hansa was granted access in France through a fully reimbursed early access program earlier this year, while Switzerland and Israel, also earlier this year, granted temporary and full marketing authorization, respectively, for Idefirix®. Additional market access procedures are currently ongoing in 11 countries, including Spain and Italy.

This is information that Hansa Biopharma AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through Hansa Biopharma and the contact persons set out below, at 21:00 CET on July 18 2022.