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September 04, 2015 9:20 PM ET

Pharmaceuticals

Company Overview of Cempra, Inc.

Company Overview

Cempra, Inc., a clinical-stage pharmaceutical company, focuses on developing antibiotics to meet medical needs in the treatment of bacterial infectious diseases in North America. Its lead product candidates include solithromycin (CEM-101), which is in Phase III clinical trials for the treatment of community acquired bacterial pneumonia, as well as for uncomplicated bacterial urethritis; and Taksta (CEM-102), an antibiotic that has completed Phase II clinical trials for refractory bone and joint infections. The company also produces novel macrolides for non-antibiotic uses, such as the treatment of chronic inflammatory diseases, endocrine diseases, and gastric motility disorders. It has colla...

6320 Quadrangle Drive

Suite 360

Chapel Hill, NC 27517

United States

Founded in 2005

55 Employees

Phone:

919-313-6601

Key Executives for Cempra, Inc.

Founder, Chief Executive Officer, President and Director
Age: 66
Total Annual Compensation: $475.0K
Chief Financial Officer and Executive Vice President
Age: 52
Total Annual Compensation: $325.0K
Chief Commercialization Officer and Executive Vice President
Age: 41
Total Annual Compensation: $300.0K
Compensation as of Fiscal Year 2014.

Cempra, Inc. Key Developments

FDA Grants Fast Track Designation to Cempra, Inc. for Solithromycin in the Treatment of Community Acquired Bacterial Pneumonia

Cempra, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for solithromycin intravenous (IV) and capsules for the treatment of community acquired bacterial pneumonia (CABP). Solithromycin is currently in Phase 3 development for the treatment of CABP and submission of a New Drug Application (NDA) is planned for 2016. Additional clinical studies with solithromycin include a Phase 3 trial in uncomplicated gonorrhea that is expected to complete patient enrollment by the end of 2015, a Phase 2 trial in chronic obstructive pulmonary disease (COPD), a Phase 2 trial in nonalcoholic steatohepatitis (NASH), and a Phase 1b trial in pediatric patients. The FDA has previously designated solithromycin IV and capsules for the treatment of CABP and solithromycin capsules for the treatment of gonorrhea as a Qualified Infectious Disease Product (QIDP). The QIDP designation will make solithromycin eligible to benefit from certain incentives as provided under the Generating Antibiotic Incentives Now (GAIN) program. These incentives include FDA priority review, eligibility for fast-track status and, if ultimately approved by the FDA, solithromycin would be eligible for an additional five-year extension of Hatch-Waxman new chemical entity exclusivity.

Cempra, Inc. Reports Unaudited Consolidated Earnings Results for the Second Quarter and Six Months Ended June 30, 2015

Cempra, Inc. reported unaudited consolidated earnings results for the second quarter and six months ended June 30, 2015. For the quarter, the company reported net loss attributable to common shareholders of $25.0 million, or $0.57 per basic and diluted share, compared to a net loss of $16.4 million, or $0.49 per basic and diluted share, for the same period in 2014. Loss from operations was $24.353 million against $15.906 million a year ago. For the six months, the company reported net loss attributable to common shareholders of $42.4 million, or $0.98 per basic and diluted share, compared to a net loss of $33.4 million, or $1.01 per basic and diluted share, for the six months ended June 30, 2014. Loss from operations was $41.158 million against $32.397 million a year ago.

Cempra, Inc. to Report Q2, 2015 Results on Jul 29, 2015

Cempra, Inc. announced that they will report Q2, 2015 results at 5:00 PM, Eastern Standard Time on Jul 29, 2015

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