Conference call begins at 4:30 p.m. ET
today
AmpliPhi Biosciences Corporation (NYSE MKT: APHB), a leader in
the development of therapies for antibiotic-resistant infections
using bacteriophage technology, announces financial results for the
quarter ended March 31, 2017 and provides business highlights.
“We are enthusiastic about our new strategic emphasis on
utilizing proprietary bacteriophage technology to develop
personalized precision phage therapies for patients who suffer from
serious or life-threatening multidrug-resistant (MDR) bacterial
infections and have limited or no satisfactory treatment options,”
said M. Scott Salka, CEO of AmpliPhi Biosciences. “Our technology
is well suited for precision medicine in infectious diseases due to
its highly selective spectrum of activity, potential efficacy
against MDR bacteria and inherent flexibility, which provides us
with the ability to rapidly manufacture customized therapies.
What’s more, phage kill bacteria differently than do conventional
antibiotics, so phage therapy can be synergistic with antibiotics,
as demonstrated by a number of clinical cases and preclinical
studies.”
The new strategic emphasis on personalized medicine builds upon
AmpliPhi’s prior successes in developing tailored bacteriophage
therapies under emergency investigational new drug applications,
including for a critically ill, comatose patient with an MDR
Acinetobacter baumannii (A. baumannii) infection and for a patient
with an MDR Pseudomonas aeruginosa (P. aeruginosa) infection in the
bladder. AmpliPhi believes that treatment with its phage cocktails
could start within as little as a few days of receiving patient
samples in the case of more common infections or approximately two
weeks for less common pathogens.
“Our objective is to provide targeted phage therapies under
applicable compassionate-use guidelines for at least 10 patients by
the end of 2017, in collaboration with leading hospitals and key
opinion leaders,” said Dr. Igor Bilinsky, COO of AmpliPhi. “We
expect data from these cases to provide further validation of the
clinical utility of our therapeutic approach and to support
discussions with the U.S. Food and Drug Administration (FDA) on
defining a potential path to market approval for personalized
precision phage therapies. We view this path as the most rapid and
cost-efficient one for demonstrating clinical validation.”
“We are exceptionally pleased to have closed an equity financing
last week, which we expect will provide sufficient capital to fund
operations under our new strategic emphasis into mid-2018,” said
Salka. “In parallel, we are seeking opportunities to advance our
chronic rhinosinusitis (CRS) and preclinical cystic fibrosis (CF)
programs, potentially through partnerships and/or non-dilutive
funding.”
First Quarter 2017 and Recent Business Highlights
- Announced positive feedback from a Type
B meeting with the FDA on a detailed development proposal to
commence a Phase 2 trial with AmpliPhi’s proprietary bacteriophage
cocktail, AB-SA01, for the treatment of antibiotic-resistant
Staphylococcus aureus (S. aureus) infections in patients with CRS.
In the official meeting minutes, 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.”
- Hired Igor P. Bilinsky, Ph.D. as Senior
Vice President and Chief Operating Officer. Dr. Bilinsky brings
nearly two decades of experience as a life sciences executive and
consultant, and broad experience in strategic planning, operational
and entrepreneurial management at biopharmaceutical companies.
- Formed a Scientific Advisory Board and
named Timothy K. Lu, M.D., Ph.D. as Chairman of the SAB. Dr. Lu
heads the Massachusetts Institute of Technology’s Synthetic Biology
Group in the Research Laboratory of Electronics, where he applies
proprietary engineering techniques to biological systems, including
bacteriophages, to address global concerns such as the growing
incidence of antibiotic resistance.
- Announced the oral presentation of a
case study highlighting the successful treatment of a critically
ill patient with A. baumannii by Dr. Biswajit Biswas of the U.S.
Navy’s Medical Research Center-Biological Defense Research
Directorate (NMRC-BDRD in Frederick, Maryland) at the Centennial
Celebration of Bacteriophage Research Institut Pasteur in
Paris.
- Announced two presentations at the 2017
Australian Society of Otolaryngology Head and Neck Surgery Meeting,
including an oral presentation of Phase 1 clinical trial results
evaluating the safety, tolerability and preliminary effectiveness
of AB-SA01 in patients with CRS associated with S. aureus infection
and a poster presentation demonstrating in vitro AB-PA01’s broad
activity footprint against P. aeruginosa clinical isolates.
- Presented two oral presentations at the
Solutions for Drug-Resistant Infections Meeting in Brisbane,
Australia, including results from preclinical and clinical trials
supporting the potential for phage therapy to address the rising
tide of antibiotic-resistant infections and data from the Phase 1
study showing that AB-SA01 in CRS patients with active S. aureus
infection was safe, well-tolerated and, among other preliminary
signals of efficacy, decreased S. aureus bacterial load in all nine
patients.
First Quarter 2017 Results and Recent Financial
Highlights
- On May 10, AmpliPhi announced the
closing of an underwritten public offering. Total proceeds to
AmpliPhi from the offering were approximately $9.1 million, after
deducting the underwriting discount and commissions and estimated
offering expenses payable by AmpliPhi. Considering AmpliPhi’s
current cash resources and the proceeds received from the May 2017
offering, AmpliPhi believes its cash resources will be sufficient
to fund its planned operations until the end of the second quarter
of 2018.
- Research and development expenses for
the first quarter of 2017 were $1.5 million, a decrease of $0.5
million from $2.0 million for the first quarter of 2016, primarily
due to $0.4 million in expenses recorded in connection with assets
acquired with Novolytics in January 2016.
- General and administrative expenses for
the first quarter of 2017 were $1.9 million compared with $2.6
million for the same period of 2016. The decrease was attributable
to a $0.5 million reduction in compensation expense primarily
related to non-cash stock-based compensation and $0.2 million for
legal fees and professional recruitment fees in the prior-year
quarter.
- AmpliPhi recorded a gain for the first
quarter of 2017 of $114,000 related to the change in the fair value
of derivative liabilities. AmpliPhi recorded a gain for the first
quarter of 2016 of $1.4 million related to the change in the fair
value of its Series B preferred stock derivative liability.
- Net loss attributable to common
stockholders for the first quarter of 2017 was $3.2 million, or
$1.94 per share, compared with a net loss for the first quarter of
2016 of $4.8 million, or $8.22 per share.
- Cash and cash equivalents were $2.2
million as of March 31, 2017, compared with $5.7 million as of
December 31, 2016.
- Effective on April 24, 2017, AmpliPhi
implemented a 1-for-10 reverse split of its outstanding common
stock.
Conference Call and Webcast
As previously announced, AmpliPhi will hold a business
highlights conference call today beginning at 4:30 p.m. Eastern
time (1:30 p.m. Pacific time). The conference call dial-in number
is (877) 866-5534 for domestic callers and (346) 406-0930 for
international callers, and the passcode is 20313217. A live webcast
of the call will be available on the Investor Relations section of
www.ampliphibio.com.
A recording of the call will be available for 48 hours beginning
approximately two hours after the completion of the call by dialing
(855) 859-2056 for domestic callers and (404) 537-3406 for
international callers. Please use passcode 30920092 to access the
recording. A webcast replay will be available on the Investor
Relations section of www.ampliphibio.com for 30 days, beginning
approximately two hours after the completion of the call.
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 of therapies for antibiotic-resistant
infections using bacteriophage-based technology. In May 2017,
AmpliPhi announced a new strategic emphasis on developing precisely
targeted and personalized bacteriophage therapies for patients with
serious or life-threatening antibiotic-resistant infections.
AmpliPhi has reported results from two Phase 1 clinical trials of
AB-SA01, one for the treatment of S. aureus in CRS patients (safety
and preliminary efficacy) and one to evaluate the safety of AB-SA01
when administered topically to the intact skin of healthy
adults.
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, AmpliPhi’s
development of bacteriophage-based therapies, AmpliPhi’s
personalized phage therapies strategy, including the expected
benefits therefrom and the target number of patients to be treated
under compassionate-use guidelines in 2017. 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 AmpliPhi’s subsequent 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.
AmpliPhi Biosciences Corporation Condensed Consolidated
Balance Sheets March 31, 2017
December 31, 2016 (Unaudited)
Assets Cash and cash
equivalents $ 2,202,000 $ 5,711,000 Accounts receivable, prepaids
and other current assets 358,000 644,000
Total current
assets 2,560,000 6,355,000 Property and equipment, net 982,000
1,072,000 Intangible assets, net 10,760,000 10,768,000
Total
assets $ 14,302,000 $ 18,195,000
Liabilities and
stockholders’ equity Total current liabilities $
2,876,000 $ 3,580,000 Derivative liabilities 2,329,000 2,443,000
Deferred tax liability 2,449,000 2,449,000
Total liabilities
7,654,000 8,472,000
Stockholders’ equity
6,648,000 9,723,000
Total liabilities and stockholders’
equity $ 14,302,000 $ 18,195,000
AmpliPhi
Biosciences Corporation Condensed Consolidated Statements of
Operations Three
Months Ended March 31, 2017 2016
(Unaudited) (Unaudited)
Revenue $ 29,000 $ 106,000
Operating expenses: Research and development 1,490,000
1,980,000 General and administrative 1,898,000 2,644,000
Total operating expenses 3,388,000 4,624,000
Loss from operations (3,359,000 ) (4,518,000 )
Other income (expense): Change in fair value of derivative
liabilities 114,000 1,406,000 Other expense, net (1,000 ) -
Total other income, net 113,000 1,406,000
Net loss (3,246,000 ) (3,112,000 ) Accretion of Series B
redeemable convertible preferred stock - (1,725,000 )
Net
loss attributable to common stockholders $ (3,246,000 ) $
(4,837,000 ) Net loss per share of common stock - basic &
diluted $ (1.94 ) $ (8.22 ) Weighted average number of shares of
common stock outstanding - basic & diluted 1,677,497
588,350
AmpliPhi Biosciences
Corporation Condensed Consolidated Statement of Cash
Flows Three Months
Ended March 31, 2017 2016 (Unaudited)
(Unaudited)
Operating activities: Net loss $ (3,246,000 ) $
(3,112,000 ) Adjustments required to reconcile net loss to net cash
used in operating activities: Change in fair value of derivative
liabilities (114,000 ) (1,406,000 ) Stock-based compensation
171,000 816,000 Warrants expensed to in-process research and
development - 204,000 Depreciation and amortization 85,000 73,000
Other non-cash adjustments 18,000 8,000 Changes in operating assets
and liabilities, net (213,000 ) 332,000
Net cash used in
operating activities (3,299,000 ) (3,085,000 )
Investing
activities: Purchases of property and equipment (5,000 )
(112,000 )
Net cash used in investing activities (5,000 )
(112,000 )
Financing activities: Other financing activities
(205,000 ) -
Net cash used in financing activities
(205,000 ) - Net decrease in cash and cash equivalents
(3,509,000 ) (3,197,000 ) Cash and cash equivalents, beginning of
period 5,711,000 9,370,000 Cash and cash equivalents,
end of period $ 2,202,000 $ 6,173,000
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170515006573/en/
At the Company:AmpliPhi BiosciencesMatthew Dansey(858)
800-4869md@ampliphibio.comorInvestor Relations:LHAJody
Cain(310) 691-7100jcain@lhai.com
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