AmpliPhi Biosciences Announces Positive Feedback from FDA on Phase 2 Development Proposal

Begins Formal Review of Strategic Options

 

SAN DIEGO -- AmpliPhi Biosciences Corporation (NYSE MKT: APHB), a global leader in the development of therapies for drug-resistant bacterial infections using bacteriophage technology, announces that the U.S. Food and Drug Administration (FDA) provided positive feedback on the Company’s previously submitted detailed development proposal to commence a Phase 2 trial with its proprietary bacteriophage cocktail AB-SA01 for the treatment of antibiotic-resistant Staphylococcus aureus (S. aureus) infections in patients with chronic rhinosinusitis (CRS). The FDA’s feedback followed a Type B telephonic meeting held with AmpliPhi on February 21, 2017. In the official minutes from the meeting, the FDA acknowledged that phage therapy is an exciting approach to treatment of multidrug-resistant organisms and expressed a commitment to addressing the unique regulatory challenges that might arise during product development.

AmpliPhi also announced that following a review of the status of its internal programs, resources and capabilities, the Company has begun to explore a wide range of strategic alternatives to maximize value for its shareholders. The Company has retained H.C. Wainwright & Co., LLC to advise the Company and its board of directors in this effort.

 

“I’m extremely proud of the entire AmpliPhi team, including academic collaborators, clinical investigators and consultants, for their efforts in successfully positioning our phage technology to enter the Phase 2 development stage, which we expect will open additional strategic opportunities for our company,” said M. Scott Salka, CEO of AmpliPhi Biosciences. “Over the past two years we have opened the world’s first cGMP facility dedicated to producing drug-quality phage cocktails and produced the phage materials used to complete two Phase 1 trials, both of which generated favorable results, paving the way for the start of efficacy trials in patients who fail to respond to conventional antibiotics. We are also pleased to be working with the highly-experienced team at H.C. Wainwright & Co. and to tap into their expertise in identifying and evaluating opportunities.”

 

AmpliPhi does not have a defined timeline for the exploration of strategic alternatives and is not confirming that the process will result in any strategic alternative being announced or consummated. AmpliPhi does not intend to discuss or disclose further developments during this process unless and until its board of directors has approved a specific action or otherwise determined that further disclosure is appropriate.

 

About H.C. Wainwright & Co., LLC

H.C. Wainwright is a full-service investment bank dedicated to providing corporate finance, strategic advisory and related services to public and private companies across multiple sectors and regions. H.C. Wainwright & Co. also provides research and sales and trading services to institutional investors. According to Sagient Research Systems, H.C. Wainwright’s team is ranked as the #1 Placement Agent in terms of aggregate CMPO (confidentially marketed public offering), RD (registered direct offering) and PIPE (private investment in public equity) transactions executed cumulatively since 1998. For more information visit H.C. Wainwright & Co. on the Internet at www.hcwco.com.

 

About Antibiotic Resistance

Decades of misuse and over-use of antibiotics has led to the rise of multidrug-resistant and pan-resistant bacteria, commonly known as “superbugs.” These superbugs threaten to render existing antibiotic therapies useless, potentially thrusting the world into a “post-antibiotic” era where common infections may be life threatening. Hospitals regularly expose vulnerable patients to pathogenic bacteria. According to the World Health Organization, each year hundreds of millions of patients worldwide suffer from infections acquired in a hospital setting. The Centers for Disease Control and Prevention (CDC) estimates that drug-resistant bacteria cause hundreds of thousands of infections per year in the U.S. alone, resulting in over 20,000 deaths. The 2016 O’Neill Report commissioned by the UK government projects that the failure to respond to the threat of antibiotic resistance and the rise of superbugs could lead to an estimated 10 million deaths from antibiotic-resistant infections worldwide by 2050, with an accumulated global cost of $100 trillion and a 3.5% reduction in global GDP.

 

About Bacteriophages

Bacteriophages, or more simply “phages,” are the natural predators of bacteria and are thought to be the most abundant life form on earth. Over eons, phages have evolved an incredible diversity of specialist strains that typically prey upon just one strain of bacteria, enabling phage therapies to precisely target pathogenic bacteria while sparing the beneficial microbiota. Phages can infect and kill bacteria, whether they are antibiotic-resistant or not, and even when they have formed protective biofilms.

 

About AmpliPhi Biosciences

AmpliPhi Biosciences Corporation is a biotechnology company pioneering the development and commercialization of therapies for antibiotic-resistant infections using bacteriophage-based technology. AmpliPhi’s product development programs target infections that are often resistant to some or all existing antibiotic treatments. AmpliPhi has reported final results from two Phase 1 clinical trials of AB-SA01, one for the treatment of S. aureus in CRS patients and one to evaluate the safety of AB-SA01 when administered topically to the intact skin of healthy adults. For more information, visit www.ampliphibio.com.

 

Forward Looking Statements

Statements in this press release that are not statements of historical fact are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, without limitation, statements about the possibility of entering into Phase 2 trials, strategic opportunities, the potential use of bacteriophages to treat bacterial infections, including infections that do not respond to antibiotics, the potential benefits of phage therapy, and AmpliPhi’s development of bacteriophage-based therapies. Words such as “believe,” “anticipate,” “plan,” “expect,” “intend,” “will,” “may,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements necessarily contain these identifying words. Among the factors that could cause actual results to differ materially from those indicated in these forward-looking statements are risks and uncertainties associated with AmpliPhi’s business and financial condition and the other risks and uncertainties described in AmpliPhi’s Annual Report on Form 10-K for the year ended December 31, 2016, as filed with the SEC, and other filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and AmpliPhi undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.

 

 

 

 

 

 

 

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Contacts:

 

At the Company:

AmpliPhi Biosciences

Matthew Dansey, (858) 800-4869

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or

Investor Relations:

LHA

Jody Cain, (310) 691-7100

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