| [November 10, 2016] |
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AmpliPhi Biosciences Reports Third Quarter 2016 Financial Results and Provides Corporate Update
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 (News - Alert)) 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
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Biosciences Corporation
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Condensed Consolidated Balance Sheets
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September 30, 2016
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December 31, 2015
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(Unaudited)
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Assets
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Cash and cash equivalents
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$
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3,967,000
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$
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9,370,000
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Accounts receivable, prepaids and other assets
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594,000
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646,000
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Total current assets
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4,561,000
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10,016,000
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Property and equipment, net
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1,152,000
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1,131,000
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Intangible assets, net
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20,323,000
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20,346,000
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Total assets
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$
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26,036,000
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$
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31,493,000
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Liabilities, Series B redeemable convertible preferred stock and
stockholders' equity
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Total current liabilities
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$
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3,154,000
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$
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2,385,000
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Derivative liabilities
|
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1,649,000
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|
1,499,000
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Deferred tax liability
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3,005,000
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3,005,000
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Total liabilities
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7,808,000
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6,889,000
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Series B redeemable convertible preferred stock
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|
-
|
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11,890,000
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|
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Stockholders' equity
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18,228,000
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12,714,000
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Total liabilities, Series B redeemable convertible preferred
stock and stockholders' equity
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$
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26,036,000
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$
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31,493,000
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AmpliPhi Biosciences Corporation
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Condensed Consolidated Statements of Operations
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Three Months Ended September 30,
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Nine Months Ended September 30,
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2016
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2015
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2016
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2015
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(Unaudited)
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(Unaudited)
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(Unaudited)
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(Unaudited)
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Revenue
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$
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29,000
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$
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143,000
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$
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238,000
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$
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347,000
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Operating expenses:
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Research and development
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1,655,000
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728,000
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4,876,000
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2,777,000
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General and administrative
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1,781,000
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1,843,000
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6,876,000
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4,857,000
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Total operating expenses
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3,436,000
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2,571,000
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11,752,000
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7,634,000
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Loss from operations
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(3,407,000
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)
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(2,428,000
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)
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(11,514,000
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)
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(7,287,000
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)
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Other income (expense):
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|
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|
|
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Change in fair value of derivative liabilities
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1,032,000
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7,738,000
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2,403,000
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9,304,000
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Other income (expense)
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|
-
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129,000
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(227,000
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)
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(302,000
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)
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Total other income
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1,032,000
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7,867,000
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2,176,000
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9,002,000
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Net (loss) income
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(2,375,000
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)
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5,439,000
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(9,338,000
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)
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1,715,000
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Excess of fair value of consideration transferred on conversion of
Series B Preferred stock
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(1,214,000
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)
|
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|
-
|
|
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(3,580,000
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)
|
|
|
-
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Accretion of Series B redeemable convertible preferred stock
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|
|
-
|
|
|
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(7,163,000
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)
|
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(1,858,000
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)
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(9,329,000
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)
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Net loss attributable to common stockholders
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$
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(3,589,000
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)
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$
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(1,724,000
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)
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$
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(14,776,000
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)
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|
$
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(7,614,000
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)
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Per share information:
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Net loss per share of common stock - basic
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$
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(0.32
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)
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$
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(0.30
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)
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$
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(1.72
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)
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$
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(1.45
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)
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Weighted average number of shares of common stock outstanding - basic
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11,120,394
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5,813,063
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8,590,772
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5,247,508
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Net loss per share of common stock - diluted
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$
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(0.32
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)
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$
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(0.30
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)
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$
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(1.77
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)
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$
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(1.45
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)
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Weighted average number of shares of common stock outstanding -
diluted
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11,120,394
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5,813,063
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|
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8,648,914
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5,247,508
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AmpliPhi Biosciences Corporation
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Condensed Consolidated Statement of Cash Flows
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Nine Months Ended September 30,
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2016
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2015
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(Unaudited)
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(Unaudited)
|
|
Operating activities:
|
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|
|
|
|
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Net (loss) income
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$
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(9,338,000
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)
|
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$
|
1,715,000
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Adjustments required to reconcile net (loss) income to net cash used
in operating activities:
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Change in fair value of derivative and warrant liabilities
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(2,403,000
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)
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(9,424,000
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)
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Warrants and other allocable expenses
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431,000
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|
|
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213,000
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Depreciation and amortization
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|
268,000
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|
|
240,000
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Stock-based compensation
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1,698,000
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|
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253,000
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Changes in operating assets and liabilities, net
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236,000
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|
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(461,000
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)
|
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Net cash used in operating activities
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(9,108,000
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)
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(7,464,000
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)
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Investing activities:
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Purchases of property and equipment
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(266,000
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)
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(160,000
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)
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Net cash used in investing activities
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(266,000
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)
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|
|
(160,000
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)
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Financing activities:
|
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|
|
|
|
|
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Proceeds from issuance of common stock, net
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4,224,000
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12,384,000
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Other financing activities, net
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(253,000
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)
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396,000
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Net cash provided by financing activities
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|
3,971,000
|
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|
|
12,780,000
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Net (decrease) increase in cash and cash equivalents
|
|
|
(5,403,000
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)
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|
5,156,000
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Cash and cash equivalents, beginning of period
|
|
|
9,370,000
|
|
|
|
6,581,000
|
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Cash and cash equivalents, end of period
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|
$
|
3,967,000
|
|
|
$
|
11,737,000
|
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View source version on businesswire.com: http://www.businesswire.com/news/home/20161110006647/en/
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