[March 27, 2017] |
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AmpliPhi Biosciences Reports 2016 Fourth-Quarter and Full-Year Results and Provides Corporate Highlights
AmpliPhi Biosciences Corporation (NYSE MKT: APHB), a global leader in
the development of therapies for antibiotic-resistant infections using
bacteriophage technology, today announced financial results for the
quarter and year ended December 31, 2016.
"The growing incidence of antibiotic-resistant bacterial infections is a
major health threat that is recognized by governments and health
authorities around the world," said M. Scott Salka, CEO of AmpliPhi
Biosciences. "AmpliPhi and our collaborators have made significant
progress in advancing the development of bacteriophage therapies for the
treatment of resistant bacterial infections and we are pleased to have
reported favorable results from our first two clinical trials."
Mr. Salka added, "We also strengthened our management team, streamlined
our capital structure and expanded bacteriophage-related intellectual
property in major global markets. We are excited about our role as a
leader in this emerging field and expect 2017 to be a highly productive
year for advancing the development of these much-needed innovative
therapies for patients who are not well served by currently available
antibiotics."
2016 Corporate Highlights
Program Updates
-
Reported favorable Phase 1 trial results demonstrating that AB-SA01
met the primary safety and tolerability endpoints targeting Staphylococcus
aureus (S. aureus) infections in patients suffering from
chronic rhinosinusitis. All patients treated with AB-SA01 showed a
reduction or elimination in S. aureus bacterial load at the end
of the study compared to baseline. A comparison of pre-and
post-treatment endoscopic image scores showed symptomatic improvement,
including reductions in mucosal edema, discharge and polyps.
-
Reported favorable Phase 1 trial results demonstrating that AB-SA01
was well-tolerated when administered topically to the intact skin of
healthy adults. The trial was conducted under a Collaborative Research
and Development Agreement with the U.S. Army.
-
Advanced the development of AB-PA01 targeting Pseudomonas aeruginosa
(P. aeruginosa) infections in patients with cystic fibrosis. We
completed development and manufacturing transfer of the four-phage
cocktail in our cGMP manufacturing facility in Europe.
-
Presented in vitro and in vivo data showing that AB-PA01
was capable of killing 87.8% of 369 P. aeruginosa clinical
isolates from a global population of cystic fibrosis patients at the
European Congress of Clinical Microbiology and Infectious Diseases.
-
Announced a collaboration with The Westmead Institute's Centre for
Infectious Diseases and Microbiology for developing phages targeting Escherichia
coli (E. coli) and Klebsiella pneumoniae (K. pneumoniae)
under a grant from the Australian government.
-
Announced the presentation of in vitro and in vivo data
by our collaborators at the University of Leicester demonstrating
efficacy of our phage cocktail for the treatment and prevention of Clostridium
difficile (C. difficile) infections at the Viruses and
Microbes 2016 Conference. The study was published in the journal Frontiers
in Microbiology.
Intellectual Property
-
Strengthened our portfolio of intellectual property with newly issued
patents in the United States, Europe and Japan including patents
covering the use of bacteriophage-based therapies to re-sensitize
bacteria to antibiotics for which they previously had shown resistance.
-
Acquired bacteriophage IP assets from UK-based Novolytics Ltd. in
January 2016, further broadening our IP portfolio.
Corporate
-
Strengthened our management team with the appointments of Steve Martin
as Chief Financial Officer, Dr. Igor P. Bilinsky as Chief Operating
Officer, and Dr. Carrie-Lynn Langlais Furr as Vice President of
Regulatory Affairs and Program Management.
-
Established our Scientific Advisory Board and named Dr. Timothy K. Lu
of MIT (News - Alert) and Broad Institute as Chairman.
-
Converted all outstanding Series B Preferred stock into common stock.
-
Raised a total of $9 million from equity securities offerings in June
2016 and November 2016.
-
Received a $0.9 million tax incentive payment from the Australian tax
authority in late 2016 based on incurred R&D expenses.
-
Received a Small and Medium Enterprise designation by the European
Medicines Agency, conferring certain benefits for member companies
such as financial support and incentives.
Fourth-Quarter 2016 Financial Highlights
-
Research and development (R&D) expenses for the fourth quarter of 2016
were $0.8 million compared to $1.2 million for the fourth quarter of
2015, with the decrease due to a higher tax incentive payment received
from the Australian tax authority in the fourth quarter of 2016
compared to 2015.
-
General and administrative (G&A) expenses were $1.5 million for the
fourth quarter of 2016 compared to $1.9 million for the fourth quarter
of 2015, with the decrease due to lower accounting, legal and
professional fees in the 2016 period.
-
Operating expenses included non-cash charges totaling $9.6 million for
the impairment of intangible assets for the excess of book value over
the computed fair value of those assets as of December 31, 2016. The
impaired assets were recorded in connection with acquisitions of
predecessor companies in 2011 and 2012.
Full-Year 2016 Financial Highlights
-
R&D expenses for 2016 were $5.7 million compared to $4.0 million for
2015. The increase of $1.7 million was primarily related to increased
personnel costs, the acquisition of Novolytics intellectual property
assets and increased clinical expenses. R&D expenses were offset by
$0.9 million in tax rebates from the Australian government for
qualified R&D expenditures in 2016 compared to $0.5 million in 2015.
-
G&A expenses for 2016 were $8.4 million compared to $6.7 million in
2015. The $1.7 million increase was primarily attributable to higher
stock-based compensation expenses, partially offset by a reduction of
professional and consulting expenses.
-
Net cash used in operating activities for 2016 was $10.6 million
compared to $9.8 million for 2015.
-
Cash and cash equivalents as of December 31, 2016 totaled $5.7 million.
-
As of December 31, 2016, there were 16.5 million shares of common
stock outstanding.
-
The audit opinion included in the Company's Annual Report on Form 10-K
for the year ended December 31, 2016 contains a going concern
explanatory paragraph. The Company is exploring multiple financing
options.
-
AmpliPhi Biosciences will not be conducting a conference call in
conjunction with this financial release.
About Bacteriophages
Bacteriophages, or more simply "phages," are the natural predators of
bacteria and are 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 chronic rhinosinusitis patients
and one to evaluate the safety of AB-SA01 when administered topically to
the intact skin of healthy adults. AmpliPhi is also developing
bacteriophage therapeutics targeting P. aeruginosa and C.
difficile in collaboration with a number of leading research
organizations. 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 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 (News - Alert). 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.
AmpliPhi Biosciences Corporation
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Condensed Consolidated Balance Sheets
|
|
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December 31, 2016
|
|
December 31, 2015
|
|
|
|
|
|
Assets
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
5,711,000
|
|
$
|
9,370,000
|
Accounts receivable, prepaids and other assets
|
|
|
644,000
|
|
|
646,000
|
Total current assets
|
|
|
6,355,000
|
|
|
10,016,000
|
Property and equipment, net
|
|
|
1,072,000
|
|
|
1,131,000
|
Intangible assets, net
|
|
|
10,768,000
|
|
|
20,346,000
|
Total assets
|
|
$
|
18,195,000
|
|
$
|
31,493,000
|
|
|
|
|
|
Liabilities, Series B redeemable convertible preferred stock
and stockholders' equity
|
|
|
|
|
Total current liabilities
|
|
$
|
3,580,000
|
|
$
|
2,385,000
|
Derivative liabilities
|
|
|
2,443,000
|
|
|
1,499,000
|
Deferred tax liability
|
|
|
2,449,000
|
|
|
3,005,000
|
Total liabilities
|
|
|
8,472,000
|
|
|
6,889,000
|
|
|
|
|
|
Series B redeemable convertible preferred stock
|
|
|
-
|
|
|
11,890,000
|
|
|
|
|
|
Stockholders' equity
|
|
|
9,723,000
|
|
|
12,714,000
|
Total liabilities, Series B redeemable convertible preferred
stock and stockholders' equity
|
|
$
|
18,195,000
|
|
$
|
31,493,000
|
|
AmpliPhi Biosciences Corporation
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Condensed Consolidated Statements of Operations
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|
|
|
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Three Months Ended December 31,
|
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Twelve Months Ended December 31,
|
|
|
|
2016
|
|
|
|
2015
|
|
|
|
2016
|
|
|
|
2015
|
|
|
|
(Unaudited)
|
|
(Unaudited)
|
|
|
|
|
Revenue
|
|
$
|
22,000
|
|
|
$
|
128,000
|
|
|
$
|
260,000
|
|
|
$
|
475,000
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
802,000
|
|
|
|
1,215,000
|
|
|
|
5,678,000
|
|
|
|
3,992,000
|
|
General and administrative
|
|
|
1,537,000
|
|
|
|
1,853,000
|
|
|
|
8,413,000
|
|
|
|
6,710,000
|
|
Impairment charges
|
|
|
9,547,000
|
|
|
|
|
|
9,547,000
|
|
|
|
-
|
|
Total operating expenses
|
|
|
11,886,000
|
|
|
|
3,068,000
|
|
|
|
23,638,000
|
|
|
|
10,702,000
|
|
Loss from operations
|
|
|
(11,864,000
|
)
|
|
|
(2,940,000
|
)
|
|
|
(23,378,000
|
)
|
|
|
(10,227,000
|
)
|
Other income (expense):
|
|
|
|
|
|
|
|
|
Change in fair value of derivative liabilities
|
|
|
1,791,000
|
|
|
|
636,000
|
|
|
|
4,538,000
|
|
|
|
9,940,000
|
|
Other income (expense)
|
|
|
17,000
|
|
|
|
-
|
|
|
|
(554,000
|
)
|
|
|
(302,000
|
)
|
Total other income
|
|
|
1,808,000
|
|
|
|
636,000
|
|
|
|
3,984,000
|
|
|
|
9,638,000
|
|
Loss before income taxes
|
|
|
(10,056,000
|
)
|
|
|
(2,304,000
|
)
|
|
|
(19,394,000
|
)
|
|
|
(589,000
|
)
|
Income tax benefit
|
|
|
556,000
|
|
|
|
73,000
|
|
|
|
556,000
|
|
|
|
73,000
|
|
Net loss
|
|
|
(9,500,000
|
)
|
|
|
(2,231,000
|
)
|
|
|
(18,838,000
|
)
|
|
|
(516,000
|
)
|
Excess of fair value of consideration transferred on conversion of
Series B Preferred Stock
|
|
|
-
|
|
|
|
-
|
|
|
|
(3,580,000
|
)
|
|
|
-
|
|
Accretion of Series B redeemable convertible preferred stock
|
|
|
-
|
|
|
|
(949,000
|
)
|
|
|
(1,858,000
|
)
|
|
|
(10,278,000
|
)
|
Net loss attributable to common stockholders
|
|
$
|
(9,500,000
|
)
|
|
$
|
(3,180,000
|
)
|
|
$
|
(24,276,000
|
)
|
|
$
|
(10,794,000
|
)
|
Per share information:
|
|
|
|
|
|
|
|
|
Net loss per share of common stock - basic
|
|
$
|
(0.70
|
)
|
|
$
|
(0.54
|
)
|
|
$
|
(2.47
|
)
|
|
$
|
(1.99
|
)
|
Weighted average number of shares of common stock outstanding -
basic
|
|
|
13,537,668
|
|
|
|
5,886,903
|
|
|
|
9,838,455
|
|
|
|
5,411,204
|
|
Net loss per share of common stock - diluted
|
|
$
|
(0.76
|
)
|
|
$
|
(0.54
|
)
|
|
$
|
(2.47
|
)
|
|
$
|
(1.99
|
)
|
Weighted average number of shares of common stock outstanding -
diluted
|
|
|
14,056,085
|
|
|
|
5,886,903
|
|
|
|
9,838,455
|
|
|
|
5,411,204
|
|
|
AmpliPhi Biosciences Corporation
|
Condensed Consolidated Statement of Cash Flows
|
|
|
|
|
|
Twelve Months Ended December 31,
|
|
|
|
2016
|
|
|
|
2015
|
|
|
|
|
|
|
Operating activities:
|
|
|
|
|
Net loss
|
|
$
|
(18,838,000
|
)
|
|
$
|
(516,000
|
)
|
Adjustments required to reconcile net loss to net cash used in
operating activities:
|
|
|
|
|
Impairment charges
|
|
|
9,547,000
|
|
|
|
-
|
|
Change in fair value of derivative and warrant liabilities
|
|
|
(4,538,000
|
)
|
|
|
(9,940,000
|
)
|
Costs related to equity offerings
|
|
|
773,000
|
|
|
|
213,000
|
|
Depreciation and amortization
|
|
|
369,000
|
|
|
|
330,000
|
|
Stock-based compensation
|
|
|
1,995,000
|
|
|
|
483,000
|
|
Deferred income taxes
|
|
|
(556,000
|
)
|
|
|
(73,000
|
)
|
Other
|
|
|
(11,000
|
)
|
|
|
(120,000
|
)
|
Changes in operating assets and liabilities, net
|
|
|
670,000
|
|
|
|
(158,000
|
)
|
Net cash used in operating activities
|
|
|
(10,589,000
|
)
|
|
|
(9,781,000
|
)
|
Investing activities:
|
|
|
|
|
Purchases of property and equipment
|
|
|
(279,000
|
)
|
|
|
(210,000
|
)
|
Net cash used in investing activities
|
|
|
(279,000
|
)
|
|
|
(210,000
|
)
|
Financing activities:
|
|
|
|
|
Proceeds from issuance of common stock, net
|
|
|
7,566,000
|
|
|
|
12,384,000
|
|
Other financing activities, net
|
|
|
(357,000
|
)
|
|
|
396,000
|
|
Net cash provided by financing activities
|
|
|
7,209,000
|
|
|
|
12,780,000
|
|
Net (decrease) increase in cash and cash equivalents
|
|
|
(3,659,000
|
)
|
|
|
2,789,000
|
|
Cash and cash equivalents, beginning of period
|
|
|
9,370,000
|
|
|
|
6,581,000
|
|
Cash and cash equivalents, end of period
|
|
$
|
5,711,000
|
|
|
$
|
9,370,000
|
|
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