Investor Relations

AmpliPhi Biosciences Reports Third Quarter 2016 Financial Results and Provides Corporate Update

Thursday, November 10, 2016 5:27 pm EST

Dateline:

SAN DIEGO

Public Company Information:

NYSEMKT:
APHB
US03211P1030
"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"

SAN DIEGO--(BUSINESS WIRE)--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.

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.

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 expected timing of reporting complete trial results from AmpliPhi’s two AB-SA01 trials, the expected initiation of a Phase 2 clinical trial in 2017, the potential use of bacteriophages to treat bacterial infections, including infections that do not respond to antibiotics, the ability to resensitize antibiotic-resistant bacteria to antibiotics, the potential benefits of phage therapy, the sufficiency of cash to fund future operations 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. These forward-looking statements are based upon AmpliPhi’s current expectations and involve a number of risks and uncertainties, including the risks and uncertainties described in AmpliPhi’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2016, as filed with the Securities and Exchange Commission (SEC) and subsequent filings with the SEC. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties. 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.

Financial tables follow

   
Biosciences Corporation
Condensed Consolidated Balance Sheets
 
September 30, 2016 December 31, 2015
(Unaudited)
Assets
Cash and cash equivalents $ 3,967,000 $ 9,370,000
Accounts receivable, prepaids and other assets   594,000   646,000
Total current assets 4,561,000 10,016,000
Property and equipment, net 1,152,000 1,131,000
Intangible assets, net   20,323,000   20,346,000
Total assets $ 26,036,000 $ 31,493,000
 
Liabilities, Series B redeemable convertible preferred stock and stockholders’ equity
Total current liabilities $ 3,154,000 $ 2,385,000
Derivative liabilities 1,649,000 1,499,000
Deferred tax liability   3,005,000   3,005,000
Total liabilities 7,808,000 6,889,000
 
Series B redeemable convertible preferred stock - 11,890,000
 
Stockholders’ equity   18,228,000   12,714,000
Total liabilities, Series B redeemable convertible preferred stock and stockholders’ equity $ 26,036,000 $ 31,493,000
 
       
AmpliPhi Biosciences Corporation
Condensed Consolidated Statements of Operations
                   
Three Months Ended September 30, Nine Months Ended September 30,
2016 2015 2016 2015
(Unaudited) (Unaudited) (Unaudited) (Unaudited)
Revenue $ 29,000 $ 143,000 $ 238,000 $ 347,000
Operating expenses:
Research and development 1,655,000 728,000 4,876,000 2,777,000
General and administrative   1,781,000     1,843,000     6,876,000     4,857,000  
Total operating expenses   3,436,000     2,571,000     11,752,000     7,634,000  
Loss from operations   (3,407,000 )   (2,428,000 )   (11,514,000 )   (7,287,000 )
Other income (expense):
Change in fair value of derivative liabilities 1,032,000 7,738,000 2,403,000 9,304,000
Other income (expense)   -     129,000     (227,000 )   (302,000 )
Total other income   1,032,000     7,867,000     2,176,000     9,002,000  
Net (loss) income (2,375,000 ) 5,439,000 (9,338,000 ) 1,715,000
Excess of fair value of consideration transferred on conversion of Series B Preferred stock (1,214,000 ) - (3,580,000 ) -
Accretion of Series B redeemable convertible preferred stock   -     (7,163,000 )   (1,858,000 )   (9,329,000 )
Net loss attributable to common stockholders $ (3,589,000 ) $ (1,724,000 ) $ (14,776,000 ) $ (7,614,000 )
Per share information:
Net loss per share of common stock - basic $ (0.32 ) $ (0.30 ) $ (1.72 ) $ (1.45 )
Weighted average number of shares of common stock outstanding - basic   11,120,394     5,813,063     8,590,772     5,247,508  
Net loss per share of common stock - diluted $ (0.32 ) $ (0.30 ) $ (1.77 ) $ (1.45 )
Weighted average number of shares of common stock outstanding - diluted   11,120,394     5,813,063     8,648,914     5,247,508  
 
   
AmpliPhi Biosciences Corporation
Condensed Consolidated Statement of Cash Flows
         
Nine Months Ended September 30,
2016 2015
(Unaudited) (Unaudited)
Operating activities:
Net (loss) income $ (9,338,000 ) $ 1,715,000
Adjustments required to reconcile net (loss) income to net cash used in operating activities:
Change in fair value of derivative and warrant liabilities (2,403,000 ) (9,424,000 )
Warrants and other allocable expenses 431,000 213,000
Depreciation and amortization 268,000 240,000
Stock-based compensation 1,698,000 253,000
Changes in operating assets and liabilities, net   236,000     (461,000 )
Net cash used in operating activities   (9,108,000 )   (7,464,000 )
Investing activities:
Purchases of property and equipment   (266,000 )   (160,000 )
Net cash used in investing activities   (266,000 )   (160,000 )
Financing activities:
Proceeds from issuance of common stock, net 4,224,000 12,384,000
Other financing activities, net   (253,000 )   396,000  
Net cash provided by financing activities   3,971,000     12,780,000  
Net (decrease) increase in cash and cash equivalents (5,403,000 ) 5,156,000
Cash and cash equivalents, beginning of period   9,370,000     6,581,000  
Cash and cash equivalents, end of period $ 3,967,000   $ 11,737,000  
 

Contact:

Company and Investor relations:
AmpliPhi Biosciences
Matt Dansey, +1 858-800-4869
md@ampliphibio.com
or
Media relations (USA)
Lazar Partners
Danielle Lewis/Glenn Silver
+ 1 212-867-1762
ampliphi@lazarpartners.com
or
Media Relations (Europe and ROW)
Instinctif Partners
Gemma Howe/Sue Charles
+44 (0)20 7866 7860
ampliphi@instinctif.com

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