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Cempra Reports Third Quarter 2015 Financial Results And Provides Corporate Update

The following excerpt is from the company's SEC filing.

CHAPEL HILL, N.C. October 22, 2015

Cempra, Inc. (Nasdaq: CEMP), a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, today reported financial results for the quarter ended September 30, 2015 and provided an update on recent corporate developments. The company will host a webcast and conference call today at 8:00 a.m. EDT.

Third Quarter 2015 and Recent Corporate Highlights

Last week, Cempra announced positive top line results from a global, pivotal Phase 3 clinical trial of intravenous (IV) to oral solithromycin (Solitaire-IV) in the treatment of patients with community-acquired bacterial pneumonia (CABP). Intravenous solithromycin met the U.S. Food and Drug Administration (FDA) primary objective of statistical non-inferiority in the intent-to-treat (ITT, all randomized patients) population compared to intravenous moxifloxacin at the early clinical response (ECR, 72 [-12/+36] hours after initiation of therapy). Solithromycin was well tolerated relative to the known effects of older macrolide antibiotics. Solithromycin oral and IV products have already been designated a qualified infectious disease product (QIDP) and will receive priority review. A rolling new drug application (NDA) submission to the FDA is expected to begin later in the fourth quarter of 2015 for solithromycin IV and oral capsules in the treatment of CABP with completion during the first half of 2016. The European Medicines Agency (EMA) submission also is expected to be completed in the first half of 2016.

In August, the FDA granted Fast Track designation for solithromycin intravenous and capsules for the treatment of CABP. Drugs with the Fast Track are allowed to submit completed sections of their NDA on a rolling basis to expedite eventual review completion.

In September, the FDA granted QIDP designation to Taksta (CEM-102, sodium fusidate, the sodium salt of fusidic acid), Cempras investigational antibiotic product candidate. The designation is for Taksta oral tablets for the indication of acute bacterial skin and skin structure infections (ABSSSI). The QIDP designation provides certain incentives for the development of new anti-infectives, including eligibility for priority review, the FDAs Fast Track program, and a potential five-year extension of exclusivity under the Hatch-Waxman Act.

Cempras successful achievement of the completion of two solithromycin Phase 3 clinical trials, with intravenous and oral capsule formulations in the treatment of CABP, is a profound accomplishment for our company and we are planning to begin a rolling submission of our NDA to the FDA later this quarter, said Prabhavathi Fernandes, Ph.D., president and chief executive officer of Cempra. Our Phase 3 clinical trial with Taksta in patients with acute bacterial skin and skin structure infections is expected to begin enrolling patients during the first half of 2016.

Upcoming Expected Clinical Development Milestones

Solitaire-U: Patient enrollment for Phase 3 expected to complete by the end of 2015.

Solithromycin pediatric: Patient enrollment for Phase 1b continues.

Enrollment Phase 2/3 pivotal trial in pediatric patients is expected to initiate in Q1 2016.

Phase 2 trial in chronic obstructive pulmonary disease (COPD) is ongoing.

Phase 2 trial in nonalcoholic steatohepatitis (NASH) is ongoing.

Cempra expects to...