Cempra Hldgs (CEMP) Reports Q2 Loss of $0.16
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Cempra Hldgs (NASDAQ: CEMP) reported Q2 EPS of ($0.16), versus ($0.45) reported last year. Revenue for the quarter came in at $4.6 million, versus $0 reported last year.
"Cempra achieved several significant milestones during the second quarter of 2013 that, in particular, clarify the path toward approval for solithromycin," said Prabhavathi Fernandes, Ph.D., chief executive officer of Cempra. "Our end-of-Phase 2 meeting with the FDA for solithromycin provided a very satisfactory outcome so that we now understand the expected regulatory path to an NDA submission for CABP. We are planning to initiate the IV-to-oral Phase 3 trial of solithromycin in CABP in the fourth quarter of 2013 based on that meeting. We have raised the necessary capital estimated to fund our solithromycin Phase 3 program in community-acquired bacterial infections, or CABP, through a follow-on equity offering. The Biomedical Advanced Research and Development Authority, or BARDA, is expected to fund the development of solithromycin to treat infections in pediatric populations and infections by bioterror threat pathogens. We are especially proud of our exclusive license and development agreement for solithromycin in the Japanese market with Toyama Chemical Co. Finally, we extended the potential exclusivity period for Taksta to 2029 and we continue to look forward to disclosing interim top-line results of the Taksta Phase 2 prosthetic joint infection, or PJI, study by the end of the year. We look forward to an exciting second half of 2013 as we move closer to bringing our differentiated antibiotics to market."
For earnings history and earnings-related data on Cempra Hldgs (CEMP) click here.
"Cempra achieved several significant milestones during the second quarter of 2013 that, in particular, clarify the path toward approval for solithromycin," said Prabhavathi Fernandes, Ph.D., chief executive officer of Cempra. "Our end-of-Phase 2 meeting with the FDA for solithromycin provided a very satisfactory outcome so that we now understand the expected regulatory path to an NDA submission for CABP. We are planning to initiate the IV-to-oral Phase 3 trial of solithromycin in CABP in the fourth quarter of 2013 based on that meeting. We have raised the necessary capital estimated to fund our solithromycin Phase 3 program in community-acquired bacterial infections, or CABP, through a follow-on equity offering. The Biomedical Advanced Research and Development Authority, or BARDA, is expected to fund the development of solithromycin to treat infections in pediatric populations and infections by bioterror threat pathogens. We are especially proud of our exclusive license and development agreement for solithromycin in the Japanese market with Toyama Chemical Co. Finally, we extended the potential exclusivity period for Taksta to 2029 and we continue to look forward to disclosing interim top-line results of the Taksta Phase 2 prosthetic joint infection, or PJI, study by the end of the year. We look forward to an exciting second half of 2013 as we move closer to bringing our differentiated antibiotics to market."
For earnings history and earnings-related data on Cempra Hldgs (CEMP) click here.
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