Cempra reports net loss of $10.3 million in first quarter 2013

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 first quarter ended March 31, 2013. The company will host a conference call and webcast at 4:30 p.m. EDT, today.

"The first quarter of 2013 was an important one for Cempra as we continued our oral solithromycin Phase 3 clinical trial in patients with community-acquired bacterial pneumonia and our Taksta Phase 2 trial in patients with prosthetic joint infections," said Prabhavathi Fernandes , Ph.D., chief executive officer of Cempra.  "Looking ahead, we continue to prepare to initiate the solithromycin intravenous-to-oral Phase 3 trial in community-acquired bacterial pneumonia, or CABP, pending available resources, and to plan meetings with the FDA on the solithromycin IV-to-oral Phase 3 trial in the second quarter and the Taksta prosthetic joint infection program later this year."

Financial Results

Quarter ended March 31, 2013 compared to quarter ended March 31, 2012

For the quarter ended March 31, 2013, Cempra reported a net loss of $10.3 million, or $0.42 per share, compared to a net loss of $3.5 million, or $0.26 per share, for the same period in 2012. 

Research and development expense in the quarter ended March 31, 2013, was $7.4 million, an increase of 293% compared to the same quarter in 2012. The higher R&D expense was primarily due to the initiation of the oral solithromycin Phase 3 clinical trial in patients with community-acquired bacterial pnuemonia and the initiation of the Taksta™ Phase 2 clinical trial in patients with prosthetic joint infections; both of which were initiated during the fourth quarter of 2012.  General and administrative expense was $2.7 million, a 172% increase compared to the quarter ended March 31, 2012, driven primarily by increased stock compensation expense and professional fees.  

First Quarter and early second quarter 2013 Highlights

• Filed an S-3 shelf registration statement with the Securities and Exchange Commission
• Submitted our request for an end-of-phase 2 meeting on solithromycin to the FDA

Clinical program update

The company is primarily focused on the development of its two lead clinical-stage antibiotic candidates, the fluoroketolide, solithromycin, and Taksta™, the oral antibiotic being developed for staphylococcal infections.  The company expects the following events to occur during 2013:

Solithromycin

• 2Q13: End of Phase 2 meeting with the FDA
• 2H13: Initiation of the IV-to-oral Phase 3 clinical trial in CABP, subject to available resources
• 2Q13: Present the ongoing Phase 2 gonococcus clinical study at ECCMID

Taksta

• 4Q13: Top-line results of the Phase 2 trial in PJI patients

Financial Guidance

Cempra expects its research and development expense to increase due to the initiation of clinical trials during the fourth quarter of 2012.  The company's cash and equivalents are expected to be sufficient to fund current operations into 2015.  This projection does not include any funds for the initiation of the solithromycin IV-to-oral Phase 3 clinical trial in CABP.

Conference Call and Webcast

The conference call may be accessed by dialing 877-377-7553 for domestic callers and 253-237-1151 for international callers. Please specify to the operator that you would like to join the "Cempra, Inc., First Quarter 2013 Financial Results Call, conference ID#: 33311244." The conference call will be webcast live under the investor relations section of Cempra's website at www.cempra.com, and will be archived there for 30 days following the call. Please visit Cempra's website several minutes prior to the start of the broadcast to ensure adequate time for any software download that may be necessary.