Akcea Therapeutics, a wholly owned subsidiary of Ionis Pharmaceuticals, today filed for a $100 million initial public offering (IPO), with concurrent plans to sell $50 million of its shares to Novartis in a private placement at the IPO price.
Akcea was established in 2015 to focus on developing antisense drugs for treating cardiometabolic diseases caused by lipid disorders. Novartis’ planned purchase of Akcea stock follows the pharma giant’s $100 million equity investment in Ionis—part of $225 million in near-term payments for the Ionis subsidiary announced in January, which included a $75 million up-front payment toward an up-to-$1 billion-plus collaboration.
In that collaboration, Novartis agreed to develop Akcea’s Phase I/IIa-stage cardiovascular disease candidates AKCEA-APO(a)-LRx and AKCEA-APOCIII-LRx. Both drugs have been developed using Ionis’s antisense technology.
AKCEA-APO(a)-LRx is in development for recurring cardiovascular disease (CVD) with high lipoprotein(a) [Lp(a)], calcific aortic stenosis with high Lp(a), and CVD with high Lp(a). AKCEA-APOCIII is in development for severe high triglycerides and high triglycerides with type 2 diabetes.
Novartis agreed to pay up to $1.655 billion-plus in up-front and milestone payments as well as royalties, in addition to buying $50 million in shares of either Ionis or Akcea.
The price range for Akcea shares, and the number of shares the company plans to offer, have yet to be determined.
Also undetermined is how much of the proceeds to use toward five of six priorities identified in Akcea’s Form S-1 registration statement. The first listed priority is to complete planned Phase III development of Akcea’s lead product candidate volanesorsen in familial chylomicronemia syndrome (FCS) and familial partial lipodystrophy (FPL), including regulatory expenses for global marketing authorizations for FCS, and to support the launch and initial commercialization of volanesorsen for FCS, if approved.
Volanesorsen is designed to reduce production of the liver protein ApoC-III. In December, Akcea and Ionia announced that volanesorsen met its primary endpoint in the Phase III COMPASS study by achieving a statistically significant mean reduction in triglycerides of 71.2% from baseline in 75 patients after 13 weeks of treatment, compared with 0.9% in 38 placebo-treated patients. Volanesorsen also achieved a mean reduction in triglycerides of 73% from baseline in a subset of seven FCS patients after 13 weeks, compared with 70% in two placebo patients.
Other uses of proceeds identified in the IPO include:
- Complete the planned Phase II program for AKCEA-APO(a)-LRx.
- Complete the planned Phase II program for AKCEA-APOCIII-LRx.
- Complete the planned Phase II program for AKCEA-ANGPTL3-LRx, a Phase II candidate in development for mixed dyslipidemias.
- Pay for development personnel expenses, other development activities, working capital, and other general corporate purposes.
Akcea also plans to spend $15 million to satisfy obligations to Ionis under its license agreement after receiving the $75 million up-front payment from Novartis.
Akcea has applied to list its common stock on the NASDAQ Global Market under the symbol AKCA. Joint book running managers for the IPO include Cowen and Co., Stifel, and Wells Fargo Securities.