Cambridge, Massachusetts-based Akebia Therapeutics announced plans to offer and sell about $85 million of its common stock in an underwritten public offering.
Founded in 2007, Akebia focuses on discovering and developing therapies that leverage the potential of hypoxia inducible factor (HIF). Its lead compound is vadadustat, which is being evaluated in patients with anemia secondary to chronic kidney disease (CKD).
On February 12, the company updated its clinical programs. Vadadustat is in Phase III developments, both INNO2VATE and PRO2TECT. Both programs are expected to be fully enrolled by the end of the year, with top-line results expected in 2019.
The FO2RWARD Phase II trial’s new study design included a broader dialysis population in addition to hyporesponders, and a larger sample size, and will replace a former FO2RWARD trial. It will include once-daily and three-times-weekly dosing. It is expected to begin in the second quarter of this year with top-line results in late 2018 or early 2019.
The TRILO2GY Phase III trial also has a new study design with once-daily and three-times-weekly dosing, a larger sample size, and will replace a former TRILO2GY study. It is designed to create data regarding switching from Amgen’s Epogen (epoetin alfa), Aranesp (darbespoetin alfa) and Roche’s Mircera (methoxy PEG-epoetin beta). It’s expected to start late this year or early next year, with top-line results in early 2020.
The company’s partner, Mitsubishi Tanabe Pharma Corporation, launched a Phase III trial in Japan to support registration in patient populations with anemia due to non-dialysis-dependent and dialysis-dependent chronic kidney disease. A data read-out is expected in 2019.
At its fourth-quarter financial report on March 12, Akebia reported fourth-quarter net income of $12.3 million compared to a net loss of $37.9 million in the same quarter the previous year. It reported a net loss for the full year 2017 of $76.9 million compared to a net loss of $135.7 million for 2016. Collaboration revenue was $87.3 million for the fourth quarter of 2017 dramatically higher than the $1.5 million figure for the same quarter in 2016, and $178 million for the full-year 2017 compared to $1.5 million for the full years of 2016.
"The past year was highly productive for Akebia as we advanced our global Phase III program for vadadustat and completed significant collaboration and licensing deals to provide us with R&D financing, stronger commercial presence at launch and significant validation of vadadustat," said John Butler, Akebia’s president and chief executive officer, in a statement. "We are now approaching an important inflection point, with top-line Phase III results anticipated next year, subject to the accrual of MACE [major adverse cardiac event] events, and market launch anticipated in 2020, subject to approval."
Morgan Stanley is the sole book-running manager for the latest offering. The company plans to use the proceeds for continued clinical development and optimization of the vadadustat program, including pre-commercial activities. All shares being offered will be sold by Akebia. The company also expects to grant the underwriter a 30-day option to buy up to about $12.75 million in additional shares of its common stock.
Register as Visitor to CPhI China 2018!
(All Rights Reserved)