Bay Area’s Ardelyx Slashes 28% of Workforce in Restructuring
Published: Aug 10, 2017
August 9, 2017
By Mark Terry, BioSpace.com Breaking News Staff
Fremont, Calif. – As part of its strategic review and second-quarter financial reporting, Ardelyx announced it planned to cut 28 percent of its workforce.
The company, which focuses on developing treatments for cardiorenal and gastrointestinal (GI) diseases, reported a cash position of $148.7 million as of June 30, compared to its cash, cash equivalents and short-term investments of $200.8 million on December 31, 2016. Its research and development expenses for the quarter were $20.6 million, and its general and administrative expenses were $5.8 million for the quarter. Net loss for the quarter was $25.7 million.
A comprehensive strategic review assessed core areas, and is focusing its resources on parts of its pipeline. As a result, it is cutting staff by 28 percent to only 76 employees. It expects that this will allow the company to continue operating to the end of 2018, excluding any potential partnership revenue.
The company also updated its clinical activities. In May, the company reported positive, topline results from T3MPO-1, the first of two Phase III trials looking at tenapanor for irritable bowel syndrome with constipation (IBS-C). It showed a statistically significant responder rate for six of 12 weeks over placebo. For its T3MPO-2 trial for IBS-C, enrollment has been completed, and T3MPO-3, its long-term safety extension study of tenapanor in IBS-C also completed enrollment. Results from T3MPO-2 are expected in the fourth quarter of this year, and T3MPO-3 completion is expected by the end of the year.
The company, based on T3MPO-1 and pending T3MPO-2 results, plans to submit its first New Drug Application (NDA) for tenapanor for IBS-C in 2018.
Ardelyx has also completed and hit the primary endpoint of its first Phase III trial of tenapanor for hyperphosphatemia in patients with end-stage renal disease (ESRD) on dialysis. After consultation with the U.S. Food and Drug Administration (FDA), the company plans to start patient enrollment by October 2017 for its second Phase III trial, a 26-week randomized treatment period followed by up to a 12-week, double-blind, placebo-controlled, randomized withdrawal (RW) period with an open-label extension.
And finally, earlier in the year the company initiated an onset-of-action study and a single Phase III trial in support of registration of RDX76775 for hyperkalemia. The company adjusted its timeline for the study because of the various other ongoing studies, but expects to report data on T3MPO-2 in the fourth quarter of this year.
“At Ardelyx, we have advanced a unique, late-stage pipeline of programs, led by our first-in-class drug candidate, tenapanor, in Phase III development for both IBS-C and hyperphosphatemia, and RDX7675, our proprietary binder for the treatment of hyperkalemia, which is also in Phase III development,” said Mike Raab, Ardelyx’s president and chief executive officer in a statement. “Based on the clinical data we’ve generated to date, we are highly confident in both the registration and commercial potential for tenapanor and RDX7675. In order to fully focus on the execution of our late-stage pipeline, we have implemented a plan designed to align our resources to deliver on these programs, while also creating strategic optionality and reinforcing our financial strength.”
Ardelyx is currently trading at $4.35. According to recent filings with the U.S. Securities and Exchange Commission (SEC), the Bank of New York Mellon Corp increased its position in Ardelyx shares in the first quarter by 4.8 percent. Previously the fund owned 145,916 shares, but acquired another 6,647 shares during that period. At its most recent filing, Bank of New York Mellon Corp owned 0.31 percent of Ardelyx worth $1,846,000.