AmpliPhi Bio Reports Third Quarter 2016 Financial Results And Provides Corporate Update
San Diego - November 10, 2016 - AmpliPhi Biosciences Corporation (NYSEMKT: APHB), a biotechnology company focused on the development and commercialization of novel bacteriophage-based antibacterial therapeutics, today announced financial results for the third quarter ended September 30, 2016.
“AmpliPhi has made tremendous progress this quarter, demonstrated by the announcement of topline data from clinical trials of both of our lead development programs, including the first U.S.-based trial of AB-SA01,” said M. Scott Salka, CEO of AmpliPhi Biosciences. “We are expecting to announce further data from both of these trials by the end of the year, and to initiate a Phase 2 clinical trial in the second half of 2017, as we continue to explore the potential of our proprietary platform to enable the development of therapeutics to treat a broad range of bacterial infections that are resistant or have suboptimal responses to current antibiotic therapies.”
Recent Corporate Highlights
• Announced topline results from a Phase 1 trial to evaluate the safety and tolerability of AB-SA01 in targeting Staphylococcus aureus (S. aureus) infections in patients suffering from chronic rhinosinusitis (CRS). Enrollment in the trial has been completed and the safety monitoring committee overseeing the trial has determined that AB-SA01 was well-tolerated by all nine patients and that there were no drug-related serious adverse events. AmpliPhi expects to report complete trial results by the end of 2016
• Announced topline results from a Phase 1 trial to evaluate the safety and tolerability of AB-SA01, AmpliPhi’s proprietary investigational phage cocktail targeting S. aureus infections. A safety committee reviewed the trial data and concluded AB-SA01 was well-tolerated by subjects in the trial and there were no drug-related serious adverse events. AmpliPhi expects to report complete trial results by the end of 2016
• Reported the publication of data from a preclinical study conducted by AmpliPhi’s partner at the University of Leicester demonstrating the therapeutic and prophylactic efficacy of AmpliPhi’s proprietary phage cocktail, in vitro and in vivo, for the treatment and prevention of Clostridium difficile (C. difficile) infections
• Appointed Carrie-Lynn Langlais Furr, Ph.D., RAC, as the Company’s Vice President of Regulatory Affairs and Program Management. Dr. Furr brings over a decade of integrated product development and regulatory affairs experience to this new position
Third Quarter 2016 Financial Results
• Cash and cash equivalents as of September 30, 2016 totaled $4.0 million and in October 2016, the Company received a $0.9 million Australian tax incentive payment. AmpliPhi anticipates that its current financial resources will provide sufficient cash to fund operations through the end of 2016
• Research and development expenses for the quarter ended September 30, 2016 totaled $1.7 million compared to $0.7 million for the same period of 2015. The increase of $1.0 million was primarily related to increased personnel costs and clinical development costs in the 2016 period
• General and administrative expenses for the quarter ended September 30, 2016 and 2015 were $1.8 million
• Net cash used in operating activities for the nine months ended September 30, 2016 was $9.1 million, as compared to $7.5 million for the nine months ended September 30, 2015
• There are currently 11.1 million shares of common stock outstanding
For more information, visit www.ampliphibio.com.
Conference Call Details
AmpliPhi management will provide a detailed corporate update during a conference call and webcast in the near future. The Company will announce the date of the event, and will provide information on how to access the event, once the date of the event has been determined. The information will also be available through AmpliPhi’s website at http://investor.ampliphibio.com/events-and-presentations.
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Notes to Editors
About AmpliPhi Biosciences
AmpliPhi Biosciences Corporation (NYSEMKT: APHB) is a biotechnology company focused on the development and commercialization of novel bacteriophage-based antibacterial therapeutics. AmpliPhi's product development programs target infections that are often resistant to existing antibiotic treatments. AmpliPhi has reported topline results from two Phase 1 clinical trials of AB-SA01, one for the treatment of S. aureus in chronic rhinosinusitis patients and one to evaluate the safety of AB-SA01 when administered topically to the intact skin of healthy adults. AmpliPhi expects to report final data from each trial by the end of 2016. AmpliPhi is also developing bacteriophage therapeutics targeting Pseudomonas aeruginosa (P. aeruginosa) and C. difficile in collaboration with a number of leading organizations focused on the advancement of bacteriophage-based therapies.
About Bacteriophage
Bacteriophage are naturally occurring viruses that are highly specific for the bacterial hosts they infect. They can rapidly kill their host, amplifying themselves in the process. Bacteriophage are unaffected by antibiotic resistance and are able to disrupt bacterial biofilms. Such biofilms are a major line of defense for bacteria, contributing to antibiotic resistance. Bacteriophage are able to penetrate biofilms and replicate locally to high levels, to produce strong local therapeutic effects without destroying bacteria important to normal human health.
“AmpliPhi has made tremendous progress this quarter, demonstrated by the announcement of topline data from clinical trials of both of our lead development programs, including the first U.S.-based trial of AB-SA01,” said M. Scott Salka, CEO of AmpliPhi Biosciences. “We are expecting to announce further data from both of these trials by the end of the year, and to initiate a Phase 2 clinical trial in the second half of 2017, as we continue to explore the potential of our proprietary platform to enable the development of therapeutics to treat a broad range of bacterial infections that are resistant or have suboptimal responses to current antibiotic therapies.”
Recent Corporate Highlights
• Announced topline results from a Phase 1 trial to evaluate the safety and tolerability of AB-SA01 in targeting Staphylococcus aureus (S. aureus) infections in patients suffering from chronic rhinosinusitis (CRS). Enrollment in the trial has been completed and the safety monitoring committee overseeing the trial has determined that AB-SA01 was well-tolerated by all nine patients and that there were no drug-related serious adverse events. AmpliPhi expects to report complete trial results by the end of 2016
• Announced topline results from a Phase 1 trial to evaluate the safety and tolerability of AB-SA01, AmpliPhi’s proprietary investigational phage cocktail targeting S. aureus infections. A safety committee reviewed the trial data and concluded AB-SA01 was well-tolerated by subjects in the trial and there were no drug-related serious adverse events. AmpliPhi expects to report complete trial results by the end of 2016
• Reported the publication of data from a preclinical study conducted by AmpliPhi’s partner at the University of Leicester demonstrating the therapeutic and prophylactic efficacy of AmpliPhi’s proprietary phage cocktail, in vitro and in vivo, for the treatment and prevention of Clostridium difficile (C. difficile) infections
• Appointed Carrie-Lynn Langlais Furr, Ph.D., RAC, as the Company’s Vice President of Regulatory Affairs and Program Management. Dr. Furr brings over a decade of integrated product development and regulatory affairs experience to this new position
Third Quarter 2016 Financial Results
• Cash and cash equivalents as of September 30, 2016 totaled $4.0 million and in October 2016, the Company received a $0.9 million Australian tax incentive payment. AmpliPhi anticipates that its current financial resources will provide sufficient cash to fund operations through the end of 2016
• Research and development expenses for the quarter ended September 30, 2016 totaled $1.7 million compared to $0.7 million for the same period of 2015. The increase of $1.0 million was primarily related to increased personnel costs and clinical development costs in the 2016 period
• General and administrative expenses for the quarter ended September 30, 2016 and 2015 were $1.8 million
• Net cash used in operating activities for the nine months ended September 30, 2016 was $9.1 million, as compared to $7.5 million for the nine months ended September 30, 2015
• There are currently 11.1 million shares of common stock outstanding
For more information, visit www.ampliphibio.com.
Conference Call Details
AmpliPhi management will provide a detailed corporate update during a conference call and webcast in the near future. The Company will announce the date of the event, and will provide information on how to access the event, once the date of the event has been determined. The information will also be available through AmpliPhi’s website at http://investor.ampliphibio.com/events-and-presentations.
- ENDS -
Notes to Editors
About AmpliPhi Biosciences
AmpliPhi Biosciences Corporation (NYSEMKT: APHB) is a biotechnology company focused on the development and commercialization of novel bacteriophage-based antibacterial therapeutics. AmpliPhi's product development programs target infections that are often resistant to existing antibiotic treatments. AmpliPhi has reported topline results from two Phase 1 clinical trials of AB-SA01, one for the treatment of S. aureus in chronic rhinosinusitis patients and one to evaluate the safety of AB-SA01 when administered topically to the intact skin of healthy adults. AmpliPhi expects to report final data from each trial by the end of 2016. AmpliPhi is also developing bacteriophage therapeutics targeting Pseudomonas aeruginosa (P. aeruginosa) and C. difficile in collaboration with a number of leading organizations focused on the advancement of bacteriophage-based therapies.
About Bacteriophage
Bacteriophage are naturally occurring viruses that are highly specific for the bacterial hosts they infect. They can rapidly kill their host, amplifying themselves in the process. Bacteriophage are unaffected by antibiotic resistance and are able to disrupt bacterial biofilms. Such biofilms are a major line of defense for bacteria, contributing to antibiotic resistance. Bacteriophage are able to penetrate biofilms and replicate locally to high levels, to produce strong local therapeutic effects without destroying bacteria important to normal human health.