Cempra, Inc. (CEMP)

[Power of Emouna]

CEMP earnings came in lower due to expenses driven primarily by early pre-commercialization costs and increased headcount as the company begins to plan for commercialization.

As of September 30, 2015, Cempra had cash and equivalents of $182.0 million and 44.0 million shares outstanding.

Company will host a webcast &conference call this morning at 8am regarding todays announcement.

Conference Call and Webcast

Cempra management will host a webcast and conference call regarding this announcement at 8:00 a.m. EDT today. The live call may be accessed by dialing [phone] for domestic callers and [phone] for international callers and using conference ID # 58583734. A live webcast of the call will be available from the investor relations section of the company website at www.cempra.com, and will be archived there for 30 days. A telephone replay of the call will be available by dialing [phone] for domestic callers, or [phone] for international callers, and entering the conference ID # 58583734.

Nice accomplishments in this last quarter. Nice upcoming clinical developments milestones.

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), Cempra's 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 FDA's Fast Track program, and a potential five-year extension of exclusivity under the Hatch-Waxman Act.
"Cempra's 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

Solithromycin

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.
Taksta

Cempra expects to initiate a Phase 3 trial in ABSSSI by the end of 2015.
Financial Results for the Three and Nine Months Ended September 30, 2015