On October 27, 2016 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, reported financial results for the quarter ended September 30, 2016 and provided an update on recent corporate developments (Press release, Cempra, OCT 27, 2016, View Source [SID1234516066]). The company will host a webcast and conference call today at 5:00 p.m. EDT.

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Third Quarter 2016 and Recent Corporate Highlights

On October 25, Cempra completed enrollment in its ongoing Phase 3 study of fusidic acid as an oral treatment for acute bacterial skin and skin structure infections. The company expects to have topline data to report in the first quarter of 2017.

On October 4, Cempra presented an analysis of patient data at the Academy of Managed Care Pharmacy meeting. The presentation included three abstracts based upon analyzing treatment failures with existing antibiotics from more than 400,000 records of patients diagnosed with community-acquired bacterial pneumonia (CABP) in a large U.S. insurance claims database. This analysis showed that more than one out of five adult CABP patients failed initial antibiotic monotherapy, with the failure rate exceeding one out of four for an elderly population with certain comorbidities.

On September 29, Cempra announced interim results showing anti-NASH effects in the first six nonalcoholic steatohepatitis (NASH) patients dosed with solithromycin in a Phase 2 study. After 90 days of solithromycin treatment, all six NASH patients had a reduction in their nonalcoholic fatty liver disease activity score (NAS), as well as alanine aminotransferase (ALT) reduction. Based on the safety profile and activity seen in the first six patients, Cempra plans to continue the Phase 2 study to obtain data from up to 15 NASH patients. Enrollment is expected to complete in the first quarter of 2017.
On August 30, Cempra announced that the U.S. Food and Drug Administration (FDA) scheduled a meeting of the Antimicrobial Drugs Advisory Committee on November 4, 2016 in Silver Spring, Maryland, to discuss the safety and efficacy of solithromycin in the treatment of CABP. The FDA is currently reviewing New Drug Applications (NDAs) for IV and oral solithromycin for CABP, with PDUFA dates in late December.

On August 25, Cempra announced the publication in Clinical Infectious Diseases of its pivotal Phase 3 study, SOLITAIRE-IV, comparing the efficacy and safety of intravenous-to-oral solithromycin to intravenous-to-oral moxifloxacin for the treatment of CABP. Both of Cempra’s pivotal Phase 3 studies have been published in leading infectious disease journals.

On August 23, Cempra announced that the European Medicines Agency (EMA) had validated the company’s marketing authorization application (MAA) seeking approval of oral capsule and intravenous formulations of solithromycin for the treatment of CABP. The EMA’s Committee for Medicinal Products for Human Use (CHMP) has begun its assessment of solithromycin through the centralized review procedure. If the CHMP review results in a positive opinion, the next step would be for the European Commission to grant marketing clearance for solithromycin, which would apply to all EU member states.

On August 11, Cempra appointed David Zaccardelli, Pharm.D. to serve on the company’s board of directors.

On July 5, Cempra announced that the FDA had accepted for filing Cempra’s two NDAs for intravenous and oral capsule formulations of solithromycin in CABP. Having been granted qualified infectious diseases product (QIDP) designation in 2013, solithromycin’s NDAs have qualified for an eight month priority review, with 2016 PDUFA dates of December 27 for the oral formulation and December 28 for intravenous.
"Cempra continued an exceptional 2016 with further progress in the third quarter, including FDA acceptance of our NDAs for intravenous and oral capsule formulations of solithromycin, the submission of our solithromycin MAA in Europe, publication of our IV to oral Phase 3 solithromycin study in a prestigious journal, and the announcement of exciting interim results from our Phase 2 NASH study," said Prabhavathi Fernandes, Ph.D., president and chief executive officer of Cempra.

"The company is preparing for the potential approval and 2017 launch of solithromycin and we look forward to discussing the safety and efficacy profile of solithromycin, along with the urgent and growing unmet medical need for a new macrolide antibiotic, at our advisory committee meeting next week," Fernandes added.

Upcoming Clinical Development Milestones

Solithromycin

Solithromycin pediatric
Patient enrollment for Phase 1b trial continues.
Phase 2/3 pivotal trial with solithromycin for bacterial infections in pediatric patients has been initiated. Global sites have been added.
Phase 3 trial for solithromycin in urogenital gonorrhea is ongoing.
Enrollment of the Phase 2 NASH trial is ongoing.
FDA Antimicrobial Drugs Advisory Committee to discuss solithromycin November 4, 2016.
Fusidic acid

Data from Phase 3 study in ABSSSI expected in first quarter of 2017.
An exploratory trial for Taksta in patients with refractory bone or joint infections is ongoing.
Financial Results for the Three Months Ended September 30, 2016

For the quarter ended September 30, 2016, Cempra reported a net loss of $32.3 million, or $0.62 per share, compared to a net loss of $27.6 million, or $0.63 per share for the third quarter in 2015. Research and development expense in the third quarter of 2016 was $21.1million, a decrease of 10.2% compared to $23.5 million in the third quarter of 2015. The lower R&D expense was primarily due to a decrease of clinical trial expenses for solithromycin and reduced fusidic acid clinical trial supply purchases. General and administrative expense was $15.0 million compared to $5.8 million in the third quarter of 2015, driven primarily by commercial readiness activities and increased headcount as the company continues to plan for commercialization of solithromycin in 2017.

As of September 30, 2016, Cempra had cash and equivalents of $248.9 million and 52.4 million shares outstanding. In the third quarter, the company utilized its ATM financing facility with the sale of approximately 1.6 million shares resulting in net proceeds of approximately $29.2 million.