Executive set to leave Chapel Hill pharmaceutical company Cempra

The president and chief commercial officer of the Chapel Hill pharmaceutical company Cempra Inc. is set to leave the company next month, a filing with the Securities and Exchange Commission revealed on Friday.

David Moore, who has been chief commercial officer of Cempra since 2014, will resign on Friday, May 5 to take a management job at another pharmaceutical company, the company said. Moore had also been in the position of president since December 2016.

Moore, who was previously the chief business officer of Ocera Therapeutics, was elevated to president after former CEO Prabha Fernandes retired last year and David Zaccardelli was named her replacement.

A spokesperson for the company said Cempra had no additional comment on the news of Moore’s departure.

The announcement of the departure comes as Cempra struggles to push its flagship pneumonia drug Solithera through the U.S. Food and Drug Administration’s approval process. Cempra, which was founded in 2006, currently has no drugs on the market and has spent more than $300 million developing Solithera to address growing antibiotic resistance.

Last year, the FDA declined to approve the drug after reviewing phase III trials and asked the company to expand its clinical trials to 9,000 patients. The FDA held reservations on the drug due to risk of liver damage to patients.

Since then, the company, which has $203 million in cash reserves, has reduced its workforce by 67 percent, from 136 to 45 employees, and withdrawn the drug’s application from a European regulator. Cempra is also working with the bank Morgan Stanley to evaluate “external clinical and commercial asset and other potential strategic business opportunities.”

Acting CEO Zaccardelli told analysts on Friday that expanding clinical trials to 9,000 patients would not be practical for Cempra, which is enacting cost-saving measures at the company while it negotiates with the FDA.

“We made it clear to the FDA that submitting data from an additional 9,000 patients treated with (Solithera) on a pre-approval basis was not practical for Cempra,” he said during a conference call. “And based on our productive discussion during the meeting, the FDA encouraged us to submit a protocol that we would find acceptable so that they could evaluate it.”

He added that the company had submitted a new proposal with fewer than 9,000 patients, and that it is waiting to discuss the new proposal with the regulator. If the company reaches an agreement with the FDA, Cempra will seek additional financing for any additional clinical study, he said.

Zaccardelli’s comments came after the company reported its first quarter earnings for 2017.

For the quarter ended in March 31, Cempra reported a net loss of $22.9 million, or 44 cents per share. A year prior, the company had reported a loss of $29.4 million.

The company also reduced its research and development expenses significantly as it attempts to sustain cash, decreasing R&D by 34.5 percent during the quarter to $15.4 million from $23.5 million in the same quarter last year.

Revenues at the company were up 82 percent, however, rising to $4.9 million from $2.7 million in the same quarter last year.

Shares of Cempra closed trading at $4.30 per share on Friday, up 45 cents, or 11.7 percent.

Zachery Eanes: 919-419-6684, @zeanes