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CEMP Third Quarter 2014 Financial Results

Third Quarter 2014 and Operational Highlights

Completed enrollment of the global Solitaire-Oral Phase 3 clinical trial of oral solithromycin in adult patients with moderate to moderately severe community-acquired bacterial pneumonia (CABP)
Received a $10 million milestone payment from Toyama Chemical Co., a subsidiary of FUJIFILM Holdings Corporation, triggered by Toyama's receipt of regulatory clearance to begin a Phase 2 trial of solithromycin in Japan, the world's second largest antibiotic market
Initiated the Solitaire-U study, a Phase 3 clinical study of a single 1000 mg dose of oral solithromycin in patients with uncomplicated gonorrhea and chlamydia infections
Completed a Phase 1a study with solithromycin capsules as add on therapy in adolescents, age 12 to 17 years old, with suspected or confirmed bacterial infections. The study demonstrated safety and a pharmacokinetic profile similar to that seen in adults. Based on these positive results, a Phase 1b study is planned pending funding approval from Biomedical Advanced Research and Development Authority (BARDA)
"I am thrilled by the progress we have made on our broad solithromycin development plan during the quarter, including completion of enrollment for our global Solitaire - oral Phase 3 study, as well as initiation of our Solitaire-U Phase 3 study for oral solithromycin in uncomplicated gonorrhea," stated Prabhavathi Fernandes, Ph.D., president and chief executive officer of Cempra. "We are also very pleased that Toyama, our partner in Japan, where the regulatory criteria are quite stringent, successfully demonstrated safety in a Phase 1 study with solithromycin and has advanced quickly into a Phase 2 trial. We look forward to a strong finish to 2014 and to the release of topline data from Solitaire-oral which is expected during the first quarter of 2015."

Clinical Development Update

Cempra is focused on the development of its two lead clinical-stage candidates: solithromycin, a novel fluoroketolide antibiotic, and Taksta(TM), an oral fusidic acid based therapy in development for staphylococcal infections. Upcoming potential development and regulatory milestones include:

Solithromycin

4Q 2014: Initiate NAIAD-funded urogenital solithromycin PK study
4Q 2014/1Q2015: Regulatory documents have been submitted for investigator-sponsored Phase 2 study in COPD and initiation of dosing is expected late 2014/early 2015
1Q 2015: Report top-line data from Solitaire-Oral Phase 3
Taksta(TM)

4Q 2014: Meet with the FDA to define pivotal study for Taksta(TM)
Financial Results for the Three and Nine Months Ended September 30, 2014

For the quarter ended September 30, 2014, Cempra reported a net loss of $11.4 million, or $0.34 per share, compared to a net loss of $13.6 million, or $0.41 per share, for the same period in 2013. Research and development expense in the quarter ended September 30, 2014, was $15.7 million, an increase of 32% compared to the same quarter in 2013. The higher R&D expense was primarily due to increased clinical trial activities, with three Phase 3 trials running for solithromycin. General and administrative expense was $2.9 million, a 32% increase compared to the quarter ended September 30, 2013, driven primarily by increased employee compensation expense.

For the nine months ended September 30, 2014, Cempra reported a net loss of $44.8 million, or $1.34 per share, compared to a net loss of $28.2 million, or $1.00 per share, for the nine months ended September 30, 2013. Research and development expense was $47.2 million, an increase of 84% compared to the nine months ended September 30, 2013. The increase was primarily due to increased clinical trial activities. General and administrative expense was $8.6 million, a 25% increase compared to the nine months ended September 30, 2013.

As of September 30, 2014, Cempra had cash and equivalents of $74.2 million compared to $96.5 million as of December 31, 2013. During the quarter, Cempra's balance sheet was strengthened by the receipt of a $10 million milestone payment from Toyama and $10.6 million from the sale of newly issued shares through an At The Market (ATM) financing vehicle. In October Cempra received approximately $19.8 million of additional proceeds under its ATM.

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