Publication date: 22/01/2020
Sequana Medical NV (Euronext Brussels: SEQUA) (the "Company" or "Sequana Medical"), an innovator in the management of fluid overload in liver disease, malignant ascites and heart failure, announces today that it successfully raised an amount of EUR 19.0 million in gross proceeds by means of a private placement via an accelerated bookbuild offering of 3,166,666 new shares (being approximately 25.11% of the Company's outstanding shares) at an issue price of EUR 6.00 per share (the "Offering").
Ian Crosbie, Chief Executive Officer of Sequana Medical, commented: "Today’s private placement demonstrates the strength of Sequana Medical and the appeal of our investment case, bringing our alfapump® platform to address clear unmet medical needs of liver disease and heart failure patients. The continued support of our existing investors, as well as new experienced life sciences investors and industry experts, is an endorsement of the strong progress we have made over the last year. The proceeds of the transaction will enable us to continue to progress towards launching alfapump® for the treatment of recurrent or refractory liver ascites in the U.S., which we expect in H1 2022, as well as driving forward the clinical development of alfapump® DSR as a potential chronic therapy for heart failure patients who are not well controlled on diuretics."
Sequana Medical currently envisages using the net proceeds to continue to advance its North American pivotal study (POSEIDON) of the alfapump® for the treatment of recurrent and refractory ascites due to liver cirrhosis (interim results are expected in H2 2020, and the primary endpoint results are expected in mid-2021) and its first-in-human repeated dose study of alfapump® DSR (Direct Sodium Removal) for the treatment of diuretic-resistant heart failure patients (RED DESERT) (results are expected in Q2 and Q3 2020), as well as for working capital and other general corporate purposes. The net proceeds from the Offering are expected to extend the current cash runway of the Company from Q2 2020 into H1 2021.
The payment and delivery of the new shares is expected to take place on 27 January 2020, and an application will be made to admit the new shares to trading on the regulated market of Euronext Brussels.
In relation to the number of new shares that is greater than 20% of the currently outstanding shares of the Company already admitted to trading on Euronext Brussels, the Company and Underwriters will have the ability to allocate to certain investors new shares that shall not be immediately admitted to listing upon their issuance. The Company will use reasonable best efforts to obtain the listing of those unlisted new shares within ninety (90) days following their issuance.
The new shares to be issued will have the same rights and benefits as, and rank pari passu in all respects with, the existing and outstanding shares of Sequana Medical at the moment of their issuance and will be entitled to distributions in respect of which the relevant record date or due date falls on or after the date of issue of the new shares.
As a result of the issuance of new shares, the Company's share capital will increase from EUR 1,306,939.52 to EUR 1,635,006.12 and its issued and outstanding shares will increase from 12,611,900 to 15,778,566 shares, representing an increase of the share capital and number of shares of 25.11%.
In relation to the Offering, the Company and the members of the executive management have agreed with the Underwriters to a market customary 180-days standstill period on future share issuances, waivable by the Joint Global Coordinators on behalf of the Underwriters and subject to customary exceptions.
KBC Securities NV ("KBC Securities") and Van Lanschot Kempen Wealth Management N.V. ("Kempen & Co") are acting as Joint Global Coordinators and Joint Bookrunners of the Offering, with Belfius Bank NV/SA, together with its subcontractor Kepler Cheuvreux S.A. ("Belfius"), acting as Joint Bookrunner of the Offering (jointly, the "Underwriters").
Sequana Medical is a commercial stage medical device company developing the alfapump® platform for the management of fluid overload in liver disease, malignant ascites and heart failure. Fluid overload is a fastgrowing complication of advanced liver disease driven by NASH (non-alcoholic steatohepatitis) related cirrhosis and a common complication in heart failure. The U.S. market for the alfapump® resulting from NASH-related cirrhosis is forecast to exceed €3 billion within the next 10-20 years. The heart failure market for the alfapump® DSR (Direct Sodium Removal) is estimated to be over €5 billion in the U.S. and EU5 by 2026. Both indications leverage Sequana Medical's alfapump®, a unique, fully implanted wireless device that automatically pumps fluid from the abdomen into the bladder, where it is naturally eliminated through urination.
In the U.S., the company's key growth market, the alfapump® has been granted breakthrough device designation by the FDA. The North American pivotal study (POSEIDON) in recurrent and refractory ascites due to liver cirrhosis is underway, with interim results expected in H2 2020, and a commercial launch in the U.S. is planned for H1 2022. In Europe, the alfapump® is CE-marked for the management of refractory ascites due to liver cirrhosis and malignant ascites and is included in key clinical practice guidelines. Over 750 alfapump® systems have been implanted to date. Building on its proven alfapump® platform, Sequana Medical is developing alfapump® DSR, a breakthrough, proprietary approach to fluid overload due to heart failure. Clinical proof-of-concept was achieved in a first-in-human single dose DSR study and a repeated dose alfapump® DSR study in heart failure patients is underway with results expected in Q2 and Q3 2020. Sequana Medical is headquartered in Ghent, Belgium. For further information, please visit www.sequanamedical.com.