Full Press Release Details
AmpliPhi Biosciences Reports First Quarter
2017 Financial Results
and Provides Business Highlights
Conference call begins at 4:30 p.m. ET
Diego (May 15, 2017) - 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
First Quarter 2017 Results and Recent
Financial Highlights
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
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
AmpliPhi Biosciences
| 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 |