Hansa Biopharma Enters $70 Million Non-dilutive Product Finance Agreement with NovaQuest

Hansa Biopharma, a pioneer in enzyme technology for rare immunological conditions, said the company has entered into an agreement with U.S.-based NovaQuest Capital Management, securing $70 million in non-dilutive financing.

Photo: Donato Spota, chief financial officer of Hansa Biopharma

“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.

The financing will be used to 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 submission to the U.S. Food and Drug Administration 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.

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. 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 focuses on the development of innovative treatments for patients with rare immunological conditions, which builds on 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.

Author: Rare Daily Staff