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Cempra takes $22.9M quarterly loss; president leaving

May, 1 2017, 6:26 AM

​The president of Chapel Hill-based pharmaceutical developer Cempra is leaving the company as it reported a $22.9 million net loss in the first quarter of 2017.

President and Chief Commercial Officer David Moore plans to leave the company, according to a filing with the Securities and Exchange Commission released Friday.

Moore, who has been chief commercial officer since 2014 and president since December 2016, will leave the company Friday. Moore took a management position at another pharmaceutical company, which the company did not disclose.

For the first quarter of 2017, Cempra reported a net loss of $22.9 million, or 44 cents per share. The company reported a loss of $29.4 million in last year’s first quarter.

The earnings outperformed analyst expectations, which predicted a net loss of 53 cents per share.

Cempra’s revenues increased 82 percent for the year, up to $4.9 million from $2.7 million in the same quarter last year.

The company spent significantly less on research and development in the first quarter compared to last year. This year, Cempra spent $15.4 million, compared to $23.5 million last year.

Cempra’s two leading product candidates are currently in development stages.

Last year, the U.S. Food and Drug Administration declined to approve Cempra’s bacterial pneumonia drug Solithromycin, citing possible liver damage associated with the drug.

The FDA also took issue with the number of patients in the clinical trial, saying the 920 patients who took solithromycin did not represent a large enough sample to study its effects on the liver.

In its response letter to Cempra released in December 2016, the FDA told the company to conduct a study of approximately 9,000 patients. Acting CEO David Zaccardelli said expanding clinical trials of solithromycin would not be practical.

“We made it clear to the FDA that submitting data from an additional 9,000 patients treated with (solithromycin) 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.”

Cempra has submitted a new proposal to the FDA, which outlined a clinical trial with fewer than 9,000 patients. If the FDA approves this plan, Cempra will look for ways to finance the trial.





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