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 June 30, 2015 and provided an update on recent corporate developments. The company will host a webcast and conference call today at 4:30 p.m. EDT.

Second Quarter 2015 and Recent Corporate Highlights

  • In April 2015, abstracts and select data from clinical and scientific studies of solithromycin were presented by investigators at the European Congress of Clinical Microbiology (ECCMID) in Copenhagen, Denmark. Two additional studies were presented on Cempra’s other principal development compound, Taksta™ (fusidic acid). Cempra also made a presentation on solithromycin at the 2015 Pediatric Academic Societies (PAS) Annual Meeting in San Diego. This pediatric study was funded by the Biomedical Advanced Research Development Authority (BARDA).
  • In May 2015, investigators presented results from the Phase 3 oral solithromycin clinical trial conducted in patients with community acquired bacterial pneumonia (CABP) at the American Thoracic Society meeting in Denver. Oral solithromycin demonstrated statistical non-inferiority to oral moxifloxacin for the treatment of CABP and the solithromycin early clinical response (ECR) and short term follow-up (SFU) rates were numerically higher than moxifloxacin in the elderly, the patients at greatest risk for CABP. Solithromycin was shown to be non-inferior to moxifloxacin on every pre-specified outcome measure in the study and was well tolerated.
  • In July 2015, Cempra reported completion of patient enrollment in its Phase 3 solithromycin IV clinical trial. The study, Solitaire-IV, is a randomized, double-blind, active-controlled, multi-center global study that enrolled 863 patients of which 25% were classified as PORT Class II, 50% PORT Class III and at least 25% PORT Class IV CABP patients. Patients received intravenous (IV) administration of either 400 mg of solithromycin or 400 mg of moxifloxacin. The primary efficacy objective is non-inferiority of early clinical response at 72 hours in the intent-to-treat (ITT) population.

“Cempra’s positive momentum continued in the second quarter and thereafter with the completion of patient enrollment in the Solitaire IV Phase 3 clinical trial in CABP representing a significant milestone for the company,” said Prabhavathi Fernandes, Ph.D., president and chief executive officer ofCempra. “We anticipate announcing top line results from this important study by the end of 2015. In addition, we look forward to initiating our planned Phase 2 studies investigating the potential use of solithromycin in chronic obstructive pulmonary disease (COPD) and in nonalcoholic steatohepatitis (NASH), which we expect to begin soon. Subject to positive results from our Solitaire IV trial, we believe we remain on track for an NDA filing for solithromycin in 2016 and our pre-commercialization readiness activities are continuing.”

Upcoming Expected Clinical Development Milestones

Solithromycin

  • Solitaire-IV: Announcement of top line results during 2H 2015.
  • Solitaire-U: Patient enrollment for Phase 3 expected to complete by the end of 2015.
  • Solithromycin pediatric: Patient enrollment for Phase 1b continues.
  • 2H 2015: Initiate a Phase 2 trial in chronic obstructive pulmonary disease (COPD).
  • 2H 2015: Initiate a Phase 2 trial in nonalcoholic steatohepatitis (NASH).

Taksta

  • 2H 2015: Continue discussion with the U.S. Food and Drug Administration (FDA) to finalize protocols for the Phase 3 development of Taksta in refractory bone and joint infections and in acute bacterial skin and skin structure infections. Cempra expects to initiate a Phase 3 trial by the end of 2015.

Financial Results for the Three and Six Months Ended June 30, 2015

For the quarter ended June 30, 2015, Cempra reported a net loss of $25.0 million, or $0.57 per share, compared to a net loss of $16.4 million, or $0.49per share, for the same period in 2014. Research and development expense in the second quarter was $23.7 million, an increase of 56% compared to the same quarter in 2014. The higher R&D expense was primarily due to greater activity related to the Solitaire-IV trial that exceeded a decrease in activity for the Solitaire-Oral trial which was winding down, and the order of active pharmaceutical ingredient (API) necessary to support the launch of solithromycin as we begin our commercial readiness activities. General and administrative expense was $5.7 million, a 119% increase compared to the quarter ended June 30, 2014, driven primarily by early pre-commercialization costs and increased headcount as the company begins to plan for commercialization.

For the six months ended June 30, 2015, Cempra reported a net loss of $42.4 million, or $0.98 per share, compared to a net loss of $33.4 million, or$1.01 per share, for the six months ended June 30, 2014. Research and development expense was $49.8 million, an increase of 58% compared to the six months ended June 30, 2014. The increase was primarily due to greater activity related to the Solitaire-IV trial that exceeded a decrease in activity for the Solitaire-Oral trial which was winding down, and the order of API necessary to support the launch of solithromycin as we begin our commercial readiness activities. General and administrative expense was $10.4 million, a 79% increase compared to the six months ended June 30, 2014, driven primarily by early pre-commercialization costs and increased headcount as the company begins to plan for commercialization.

As of June 30, 2015, Cempra had cash and equivalents of $202.4 million and 43.8 million shares outstanding. (Original Source)

Shares of Cempra closed today at $44.84, down $0.50 or 1.1%. CEMP has a 1-year high of $46.99 and a 1-year low of $9.12. The stock’s 50-day moving average is $37.21 and its 200-day moving average is $34.05.

On the ratings front, Cempra has been the subject of a number of recent research reports. In a report issued on July 27, Roth Capital analyst Debjit Chattopadhyay maintained a Buy rating on CEMP, with a price target of $56, which implies an upside of 23.0% from current levels. Separately, on June 23, Stifel Nicolaus’ Stephen Willey reiterated a Buy rating on the stock and has a price target of $57.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Debjit Chattopadhyay and Stephen Willey have a total average return of 31.1% and 37.6% respectively. Chattopadhyay has a success rate of 66.7% and is ranked #18 out of 3718 analysts, while Willey has a success rate of 67.0% and is ranked #24.

Cempra Inc is a clinical-stage pharmaceutical company. It develops antibiotics for acute care & community settings to meet critical medical needs in treatment of bacterial infectious diseases, respiratory tract & chronic staphylococcal infections.