On November 14, 2017 AmpliPhi Biosciences Corporation (NYSE American: APHB), a clinical-stage biotechnology company focused on the development of therapies for antibiotic-resistant infections using bacteriophage technology, reported financial results for the third quarter ended September 30, 2017 (Press release, AmpliPhi Biosciences, NOV 14, 2017, View Source [SID1234522059]).
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"I’m excited to report on the progress AmpliPhi made in the third quarter of 2017," said Paul C. Grint, M.D., CEO of AmpliPhi Biosciences. "We have dosed six patients suffering from life-threatening infections under expanded access programs at two major teaching hospitals and remain on track to meet our previously announced goal of treating ten patients by year end. We have also continued our engagement with the scientific community to increase awareness of phage-based therapies as a promising technology to combat increasing antibiotic resistance. Looking forward, we expect to be well-positioned to treat up to an additional twenty patients by the end of first half of 2018, as we collect the data to prioritize lead indications for potential Phase 2 and/or registrational studies, while working with the FDA on a potential pathway to registration."
Third Quarter 2017 and Recent Business Highlights
Administered first-in-human intravenous treatment of AB-SA01 for a patient suffering from a life-threatening Staphylococcus aureus (S. aureus) infection of the heart (endocarditis). AB-SA01 was administered intravenously to the patient over two weeks and was well tolerated.
Announced the publication of preclinical data demonstrating the activity of AB-PA01 in reducing biofilms. The paper, titled "Activity of Bacteriophages in Removing Biofilms of Pseudomonas aeruginosa Isolates from Chronic Rhinosinusitis Patients," was published in the journal Frontiers in Cellular and Infection Microbiology in September 2017.
Announced publication of a case study detailing the successful treatment of a critically ill patient with a multidrug-resistant (MDR) Acinetobacter baumannii (A. baumannii) infection in the journal Antimicrobial Agents and Chemotherapy in August 2017.
Received a Research and Development (R&D) Tax Incentive cash rebate of USD $2.0 million from the Australian Tax Office based on the company’s R&D spending in Australia during 2016.
Third Quarter 2017 Financial Results
Cash and cash equivalents as of September 30, 2017 totaled $7.7 million. AmpliPhi anticipates that its current financial resources will provide sufficient cash to fund operations until mid-2018.
R&D expenses for the quarter ended September 30, 2017 totaled a net benefit of $0.8 million compared to an expense of $1.7 million for the same period of 2016. The decrease reflects receipt during the quarter of approximately $2.0 million from the Australian tax authority. R&D expenses, excluding any benefit from tax incentive payments, for the three months ended September 30, 2017 and 2016 were $1.2 million and $1.7 million, respectively. The decrease of $0.5 million was primarily attributable to a decrease in professional and consulting fees as well as decreased clinical expenses.
R&D expenses for the nine months ended September 30, 2017 were $1.8 million, net of approximately $2.0 million of tax incentive payments received from the Australian tax authority. There were no similar tax incentive payments recognized during the same period of the prior year. R&D expenses, excluding any benefit from tax incentive payments, for the nine months ended September 30, 2017 and 2016 were $3.8 million and $4.9 million, respectively. The decrease of $1.1 million was primarily related to decreases in consulting fees, professional recruitment fees and clinical expenses.
General and administrative (G&A) expenses for the quarter ended September 30, 2017 totaled $1.6 million compared to $1.8 million for the same period of 2016. G&A expenses for the nine months ended September 30, 2017 were $6.3 million compared to $6.9 million for the same period of 2016.
Net cash used in operating activities for the nine months ended September 30, 2017 was $6.8 million, as compared to $9.1 million for the nine months ended September 30, 2016.
There were 9.5 million shares of common stock outstanding as of November 8, 2017.
Conference Call and Webcast
AmpliPhi will hold a conference call today beginning at 4:30 p.m. Eastern time (1:30 p.m. Pacific time). The conference call dial-in number is (866) 652-5200 for domestic callers and (412) 317-6060 for international callers, and the passcode is 10114360. A live webcast of the call will be available on the Investor Relations section of www.ampliphibio.com.
A recording of the call will be available for 48 hours beginning approximately two hours after the completion of the call by dialing (877) 344-7529 for domestic callers and (412) 317-0088 for international callers. Please use passcode 10114360 to access the recording. A webcast replay will be available on the Investor Relations section of www.ampliphibio.com for 30 days, beginning approximately two hours after the completion of the call.