Sweden-based Hansa Biopharma AB (Nasdaq Stockholm: HNSA), a commercial-stage immunology company with an EU-approved enzyme therapy and a pending US FDA decision due in December, has submitted a confidential draft Form F-1 registration statement to the SEC for a potential US offering and listing of American Depositary Shares (ADSs) on the Nasdaq Global Market under the ticker HNSA. The company is also considering a concurrent private placement of ordinary shares to qualified investors in Europe.
The proposed transaction would effectively give Hansa a secondary US listing while retaining its existing Nasdaq Stockholm listing. The ADS-to-share ratio, offering size, price range, and use of proceeds have not yet been determined, and completion remains subject to market and other conditions.
In March 2026, Hansa secured USD 30 million in convertible senior notes from funds managed by Athyrium Capital Management, extending its cash runway into mid-2027. A US listing could broaden the company's access to specialist biotech investors as it approaches a major regulatory catalyst for its lead asset.
Hansa's lead product, imlifidase (Idefirix), is a first-in-class IgG-cleaving enzyme conditionally approved in the EU, Australia, and Switzerland for desensitization of highly sensitized kidney transplant patients. The US FDA accepted Hansa's Biologics License Application (BLA) in February 2026 and assigned a December 19, 2026 Prescription Drug User Fee Act (PDUFA) action date. The pivotal Phase III ConfIdeS trial met its primary endpoint with statistical significance (p<0.0001), according to the company.