Full Press Release Details
AmpliPhi Biosciences Reports Second Quarter
2017 Financial Results
and Business Highlights
Diego (August 14, 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 three and
six months ended June 30, 2017 and business highlights.
"The establishment of the Global
Antimicrobial Resistance (AMR) Collaboration Hub at the recent G20 summit in July underscores the importance of the AMR issue for
public health," said Paul C. Grint, M.D., CEO of AmpliPhi Biosciences. "I am excited to be at AmpliPhi where we are
pioneering bacteriophage therapies for patients suffering from MDR infections and developing a promising approach to address the
"We are developing our lead therapeutic
candidates through an approach to treat individual patients suffering from serious or life-threatening infections who have failed
multiple courses of antibiotics and have few or no satisfactory treatment options," Dr. Grint added. "We expect this
strategy to validate the clinical utility of our therapies by early 2018 and position us to initiate further efficacy clinical
trials later that year."
"We are executing on the strategy
to provide our therapeutic candidates AB-SA01 and AB-PA01 targeting S. aureus and P. aeruginosa, respectively, to
patients under single-patient expanded access guidelines ("compassionate use")," said Igor P. Bilinsky, Ph.D.,
AmpliPhi's Chief Operating Officer. "Our goal remains to treat at least 10 patients by the end of 2017 and additional
patients in early 2018. Based on this data set, we plan to define indications and optimal treatment regimens for further development
and, in consultation with the FDA and other regulatory agencies, define the potential path to regulatory approval.
"We recently supplied AB-PA01 to
a major U.S. teaching hospital for a patient suffering from a life-threatening MDR P. aeruginosa lung infection,"
added Dr. Bilinsky. "Under an emergency IND allowed by the FDA, multiple doses of AB-PA01 were administered intravenously
and by nebulizer. This was the first-in-human administration of AB-PA01, and the treatment was well tolerated. We expect the results
to be submitted for presentation at a future medical conference."
Second Quarter 2017 and Recent Business
Second Quarter Financial Overview
Second Quarter and Six Months Ended
June 30, 2017 Financial Results
Conference Call and Webcast
AmpliPhi will hold a 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 53278337. 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 53278337 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 AmpliPhi Biosciences
AmpliPhi Biosciences Corporation is a
clinical-stage biotechnology company focused on treating antibiotic-resistant infections using its proprietary bacteriophage-based
technology. AmpliPhi's lead product candidates target multidrug-resistant S. aureus and P. aeruginosa
that are included on the WHO's 2017 Priority Pathogens List. Phage therapeutics are uniquely positioned to address the threat
of antibiotic-resistance as they can be precisely targeted to kill selected bacteria, have a differentiated mechanism of action,
can penetrate and disrupt biofilms (a common bacterial defense mechanism against antibiotics), are potentially synergistic with
antibiotics, and have been shown to restore antibiotic sensitivity to drug-resistant bacteria. For more information visit www.ampliphibio.com.
About Bacteriophages
Bacteriophages (phages) are naturally occurring
viruses that selectively kill bacteria, including antibiotic-resistant bacteria. Phages are the most abundant organisms on Earth
and have evolved to not only directly kill bacteria, but also penetrate and disrupt biofilms, and have been shown to restore antibiotic
sensitivity to drug-resistant bacteria.
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 benefits of phage therapy
and the potential use of bacteriophages to treat bacterial infections, including infections that do not respond to antibiotics;
AmpliPhi's development of bacteriophage-based therapies; AmpliPhi's strategy for developing its lead therapeutic candidates
through treatment of individual patients under compassionate-use guidelines, including the target number of patients to be treated
in 2017, the expected validation of the clinical utility of AmpliPhi's therapies by early 2018, the ability to potentially
initiate efficacy clinical trials in 2018 and other potential benefits expected from this strategy; the expected receipt of funds
from an Australian R&D tax rebate; and the anticipated sufficiency of AmpliPhi's existing cash resources to fund its
planned operations until mid-2018. 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
LHA Investor Relations
David Schull or Maggie Beller
AmpliPhi Biosciences Corporation
Condensed Consolidated Balance Sheets
| June 30, 2017 | December 31, 2016 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Cash and cash equivalents | $ | 8,962,000 | $ | 5,711,000 | ||||
| Prepaids and other current assets | 282,000 | 602,000 | ||||||
| Total current assets | 9,244,000 | 6,313,000 | ||||||
| Property and equipment, net | 909,000 | 1,072,000 | ||||||
| Intangible assets, net | 4,953,000 | 10,768,000 | ||||||
| Total assets | $ | 15,106,000 | $ | 18,153,000 | ||||
| Liabilities and stockholders' equity | ||||||||
| Total current liabilities | $ | 3,711,000 | $ | 3,538,000 | ||||
| Derivative liabilities | 387,000 | 2,443,000 | ||||||
| Deferred tax liability | 1,147,000 | 2,449,000 | ||||||
| Total liabilities | 5,245,000 | 8,430,000 | ||||||
| Stockholders' equity | 9,861,000 | 9,723,000 | ||||||
| Total liabilities and stockholders' equity | $ | 15,106,000 | $ | 18,153,000 |
AmpliPhi Biosciences Corporation
Condensed Consolidated Statements of
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2017 | 2016 | 2017 | 2016 | |||||||||||||
| (Unaudited) | (Unaudited) | (Unaudited) | (Unaudited) | |||||||||||||
| Revenue | $ | 28,000 | $ | 103,000 | $ | 57,000 | $ | 209,000 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 1,130,000 | 1,241,000 | 2,620,000 | 3,221,000 | ||||||||||||
| General and administrative | 2,784,000 | 2,451,000 | 4,682,000 | 5,095,000 | ||||||||||||
| Impairment charges | 5,800,000 | - | 5,800,000 | - | ||||||||||||
| Total operating expenses | 9,714,000 | 3,692,000 | 13,102,000 | 8,316,000 | ||||||||||||
| Loss from operations | (9,686,000 | ) | (3,589,000 | ) | (13,045,000 | ) | (8,107,000 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Change in fair value of derivative liabilities | 1,920,000 | (35,000 | ) | 2,034,000 | 1,371,000 | |||||||||||
| Other income (expense), net | 3,000 | (227,000 | ) | 2,000 | (227,000 | ) | ||||||||||
| Total other income (expense), net | 1,923,000 | (262,000 | ) | 2,036,000 | 1,144,000 | |||||||||||
| Loss before income taxes | (7,763,000 | ) | (3,851,000 | ) | (11,009,000 | ) | (6,963,000 | ) | ||||||||
| Income tax benefit | 1,302,000 | - | 1,302,000 | - | ||||||||||||
| Net loss | (6,461,000 | ) | (3,851,000 | ) | (9,707,000 | ) | (6,963,000 | ) | ||||||||
| Excess of fair value of consideration transferred on conversion of Series B preferred stock | - | (2,366,000 | ) | - | (2,366,000 | ) | ||||||||||
| Accretion of Series B preferred stock | - | (133,000 | ) | - | (1,858,000 | ) | ||||||||||
| Net loss attributable to common stockholders | $ | (6,461,000 | ) | $ | (6,350,000 | ) | $ | (9,707,000 | ) | $ | (11,187,000 | ) | ||||
| Net loss per share of common stock - basic | $ | (1.21 | ) | $ | (7.26 | ) | $ | (2.76 | ) | $ | (15.30 | ) | ||||
| Weighted average number of shares of common stock outstanding - basic | 5,350,930 | 874,062 | 3,514,181 | 731,206 | ||||||||||||
| Net loss per share of common stock - diluted | $ | (1.46 | ) | $ | (7.82 | ) | $ | (3.09 | ) | $ | (15.96 | ) | ||||
| Weighted average number of shares of common stock outstanding - diluted | 5,519,895 | 876,806 | 3,652,501 | 732,578 |
AmpliPhi Biosciences Corporation
Condensed Consolidated Statement of Cash
| Six Months Ended June 30, | ||||||||
| 2017 | 2016 | |||||||
| (Unaudited) | (Unaudited) | |||||||
| Operating activities: | ||||||||
| Net loss | $ | (9,707,000 | ) | $ | (6,963,000 | ) | ||
| Adjustments required to reconcile net loss to net cash used in operating activities: | ||||||||
| Change in fair value of derivative liabilities | (2,034,000 | ) | (1,371,000 | ) | ||||
| Impairment charges | 5,800,000 | - | ||||||
| Stock-based compensation | 470,000 | 1,364,000 | ||||||
| Deferred taxes | (1,302,000 | ) | - | |||||
| Warrants and other allocable expenses | - | 431,000 | ||||||
| Depreciation and amortization | 170,000 | 158,000 | ||||||
| Other non-cash adjustments, net | 33,000 | 15,000 | ||||||
| Changes in operating assets and liabilities, net | 340,000 | 389,000 | ||||||
| Net cash used in operating activities | (6,230,000 | ) | (5,977,000 | ) | ||||
| Investing activities: | ||||||||
| Purchases of property and equipment | (7,000 | ) | (237,000 | ) | ||||
| Net cash used in investing activities | (7,000 | ) | (237,000 | ) | ||||
| Financing activities: | ||||||||
| Proceeds from sale of common stock and related warrants, net of offering costs | 9,690,000 | 4,224,000 | ||||||
| Other financing activities, net | (202,000 | ) | (236,000 | ) | ||||
| Net cash provided by financing activities | 9,488,000 | 3,988,000 | ||||||
| Net increase (decrease) in cash and cash equivalents | 3,251,000 | (2,226,000 | ) | |||||
| Cash and cash equivalents, beginning of period | 5,711,000 | 9,370,000 | ||||||
| Cash and cash equivalents, end of period | $ | 8,962,000 | $ | 7,144,000 |