UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of report (Date of earliest event reported): August 15, 2016
Commission File Number: 001-37544
AmpliPhi Biosciences Corporation
(Exact name of Registrant as specified in its charter)
| Washington | 91-1549568 |
| (State or other jurisdiction of incorporation or organization) |
(IRS Employer Identification No.) |
3579 Valley Centre Drive, Suite 100
San Diego, California 92130
(Address of principal executive offices)
(858) 829-0829
(Registrant’s Telephone number)
N/A
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the Registrant under any of the following provisions (see General Instruction A.2. below):
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
| Item 2.02 | Results of Operations and Financial Condition. |
On August 15, 2016, we announced our financial results for the quarter ended June 30, 2016 in the press release attached hereto as Exhibit 99.1.
The information in this Item 2.02 and the attached Exhibit 99.1 is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities and Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section. The information in this Item 2.02 and the attached Exhibit 99.1 shall not be incorporated by reference into any registration statement or other document pursuant to the Securities Act of 1933, as amended, or the Exchange Act.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
|
Exhibit |
Description | |
| 99.1 | Press release issued by AmpliPhi Biosciences Corporation on August 15, 2016 relating to financial results | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: August 15, 2016 | AmpliPhi Biosciences Corporation | |
| By: | /s/ Steve R. Martin | |
| Name: | Steve R. Martin | |
| Title: | Chief Financial Officer | |
EXHIBIT INDEX
|
Exhibit |
Description | |
| 99.1 | Press release issued by AmpliPhi Biosciences Corporation on August 15, 2016 relating to financial results | |
Exhibit 99.1
AmpliPhi Biosciences Reports Second Quarter 2016 Financial Results and
Provides Corporate Update
San Diego, August 15, 2016 – AmpliPhi Biosciences Corporation (NYSEMKT: APHB), a global leader in the development of bacteriophage-based antibacterial therapies to treat drug-resistant infections, today announced its financial results for the second quarter ended June 30, 2016.
“We have made significant progress executing on our clinical programs and look forward to presenting top-line data for both clinical trials later this year,” said M. Scott Salka, CEO of AmpliPhi Biosciences. “The threat posed by drug-resistant infections is universally acknowledged. World leaders from government, medical and scientific communities continue to stress the importance of addressing this threat, and we remain confident that bacteriophage-based therapies will not only provide a potential alternative to existing broad-spectrum antibiotics, but will also be used to resensitize antibiotic-resistant infections to increasingly ineffective drugs, thereby ensuring the continued effectiveness of the drugs we currently use to treat serious, life-threatening infections.”
Recent Corporate Highlights
| · | Announced AB-SA01, our investigational phage therapy targeting Staphylococcus aureus (S. aureus) infections, was well-tolerated and caused no drug-related adverse events in the first cohort of our Phase 1 trial in patients with chronic rhinosinusitis (CRS). AmpliPhi remains on track to report final data later in 2016 |
| · | Initiated the first Phase 1 phage therapy trial under a United States IND to evaluate the safety of AB-SA01 administered topically to the intact skin of 12 healthy adult volunteers in May. The trial is now fully enrolled and top-line results are expected before the end of the third quarter with the complete study report following later this year |
| · | The outstanding Series B Preferred stock was converted into common stock, streamlining AmpliPhi’s capital structure |
| · | Presented data at the European Congress of Clinical Microbiology and Infectious Diseases demonstrating that in a lung infection model, AB-PA01, our investigational phage therapy targeting Pseudomonas aeruginosa (P. aeruginosa) infections, was capable of infecting and killing 87.2% of the 429 clinical isolates in vitro, including those with multi-drug resistant strains of P. aeruginosa isolated from patients with cystic fibrosis |
| · | Strengthened our portfolio of intellectual property related to our proprietary bacteriophage platform with two new patents; one granted by the European Patent Office covering the treatment of all species of antibiotic-resistant bacterial infections through the staged use of bacteriophage preparations followed by the antibiotic to which the bacteria were initially resistant, and the second granted by the Japanese Patent Office that covers the same staged treatment regimen for P. aeruginosa infections |
| · | Completed a registered direct public offering of common stock and warrants in June, which yielded aggregate net proceeds of $4.2 million after fees and expenses |
Second Quarter 2016 Financial Results
| · | Cash and cash equivalents as of June 30, 2016 totaled $7.1 million. AmpliPhi anticipates that its current financial resources will provide sufficient cash to fund operations into the fourth quarter of 2016 |
| · | Revenues related to sublicensing agreements from AmpliPhi’s former gene therapy program were $0.1 million for the quarter ended June 30, 2016 and for the same period in 2015 |
| · | Research and development expenses for the quarter ended June 30, 2016 totaled $1.2 million compared to $1.1 in the same period of 2015. The increase was primarily attributable to an increase in personnel costs |
| · | General and administrative expenses for the quarter ended June 30, 2016 were $2.5 million compared to $1.6 million for the same period of 2015. The increase was primarily attributable to an increase in compensation costs and primarily for non-cash stock-based compensation expenses |
| · | Net cash used in operations was $6.0 million during the six month period ended June 30, 2016 |
| · | There are currently 11.1 million shares of common stock outstanding |
For more information, visit www.ampliphibio.com.
Conference Call Details
AmpliPhi Biosciences will host a conference call and webcast to discuss its second quarter 2016 financial results and provide an update on business activities. The event will be held today, August 15, 2016, at 4:30 p.m. EDT. The live event can be accessed through AmpliPhi’s website at http://investor.ampliphibio.com/events-and-presentations, or by calling 888-727-7690 (US) or 913-312-0978 (outside of the US). The passcode is 9616475. A replay of the discussion will be available on AmpliPhi’s website or by calling 888-727-7690 (US) or 913-312-0978 (outside of the US), using conference ID 9616475.
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 is currently conducting a Phase 1 clinical trial of AB-SA01 for the treatment of S. aureus in chronic rhinosinusitis patients and another Phase 1 clinical trial to evaluate the safety of AB-SA01 when administered topically to the intact skin of healthy adults. AmpliPhi expects to report final data for both trials in the second half of 2016. AmpliPhi is also developing bacteriophage therapeutics targeting P. aeruginosa and Clostridium 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.
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 data from AmpliPhi’s two AB-SA01 trials, 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 March 31, 2016, as filed with the Securities and Exchange Commission (SEC) 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.
# # #
AmpliPhi Biosciences Corporation
Condensed Consolidated Balance Sheets
| June 30, 2016 | December 31, 2015 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Cash and cash equivalents | $ | 7,144,000 | $ | 9,370,000 | ||||
| Accounts receivable, prepaids and other assets | 594,000 | 646,000 | ||||||
| Total current assets | 7,738,000 | 10,016,000 | ||||||
| Property and equipment, net | 1,210,000 | 1,131,000 | ||||||
| Intangible assets, net | 20,331,000 | 20,346,000 | ||||||
| Total assets | $ | 29,279,000 | $ | 31,493,000 | ||||
| Liabilities, Series B redeemable convertible preferred stock and stockholders’ equity | ||||||||
| Total current liabilities | $ | 3,324,000 | $ | 2,385,000 | ||||
| Derivative liabilities | 1,466,000 | 1,499,000 | ||||||
| Deferred tax liability | 3,005,000 | 3,005,000 | ||||||
| Total liabilities | 7,795,000 | 6,889,000 | ||||||
| Series B redeemable convertible preferred stock | - | 11,890,000 | ||||||
| Stockholders’ equity | ||||||||
| Common stock (11.1 million and 5.9 million shares outstanding, respectively) | 111,000 | 59,000 | ||||||
| Additional paid-in capital | 390,858,000 | 375,177,000 | ||||||
| Accumulated deficit | (369,485,000 | ) | (362,522,000 | ) | ||||
| Total stockholders’ equity | 21,484,000 | 12,714,000 | ||||||
| Total liabilities, Series B redeemable convertible preferred stock and stockholders’ equity | $ | 29,279,000 | $ | 31,493,000 | ||||
AmpliPhi Biosciences Corporation
Consolidated Statements of Operations
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2016 | 2015 | 2016 | 2015 | |||||||||||||
| (Unaudited) | (Unaudited) | (Unaudited) | (Unaudited) | |||||||||||||
| Revenue | $ | 103,000 | $ | 102,000 | $ | 209,000 | $ | 204,000 | ||||||||
| Operating expenses | ||||||||||||||||
| Research and development | 1,241,000 | 1,077,000 | 3,221,000 | 2,049,000 | ||||||||||||
| General and administrative | 2,451,000 | 1,617,000 | 5,095,000 | 3,014,000 | ||||||||||||
| Total operating expenses | 3,692,000 | 2,694,000 | 8,316,000 | 5,063,000 | ||||||||||||
| Loss from operations | (3,589,000 | ) | (2,592,000 | ) | (8,107,000 | ) | (4,859,000 | ) | ||||||||
| Other income (expense) | ||||||||||||||||
| Change in fair value of derivative liabilities | (35,000 | ) | 13,361,000 | 1,371,000 | 1,566,000 | |||||||||||
| Other expense | (227,000 | ) | - | (227,000 | ) | (431,000 | ) | |||||||||
| Total other income (expense) | (262,000 | ) | 13,361,000 | 1,144,000 | 1,135,000 | |||||||||||
| Net income (loss) | (3,851,000 | ) | 10,769,000 | (6,963,000 | ) | (3,724,000 | ) | |||||||||
| Excess of fair value of consideration transferred on conversion of Series B Preferred Stock | (2,366,000 | ) | - | (2,366,000 | ) | - | ||||||||||
| Accretion of Series B redeemable convertible preferred stock | (133,000 | ) | (1,828,000 | ) | (1,858,000 | ) | (2,166,000 | ) | ||||||||
| Net income (loss) attributable to common stockholders | $ | (6,350,000 | ) | $ | 8,941,000 | $ | (11,187,000 | ) | $ | (5,890,000 | ) | |||||
| Per share information: | ||||||||||||||||
| Net income (loss) per share of common stock - basic | $ | (0.73 | ) | $ | 1.27 | $ | (1.53 | ) | $ | (1.19 | ) | |||||
| Weighted average number of shares of common stock outstanding - basic | 8,740,621 | 5,667,170 | 7,312,062 | 4,960,416 | ||||||||||||
| Net loss per share of common stock - diluted | $ | (0.78 | ) | $ | (0.33 | ) | $ | (1.60 | ) | $ | (1.19 | ) | ||||
| Weighted average number of shares of common stock outstanding - diluted | 8,768,059 | 7,545,487 | 7,325,781 | 4,960,416 | ||||||||||||
AmpliPhi Biosciences Corporation
Condensed Consolidated Statement of Cash Flows
| Six Months Ended June 30, | ||||||||
| 2016 | 2015 | |||||||
| (Unaudited) | (Unaudited) | |||||||
| Operating activities: | ||||||||
| Net loss | $ | (6,963,000 | ) | $ | (3,724,000 | ) | ||
| Adjustments required to reconcile net loss to net cash used in operating activities: | ||||||||
| Change in fair value of derivative liabilities | (1,371,000 | ) | (1,566,000 | ) | ||||
| Warrants and other allocable expenses | 431,000 | 213,000 | ||||||
| Depreciation and amortization | 173,000 | 132,000 | ||||||
| Stock-based compensation | 1,364,000 | 105,000 | ||||||
| Changes in operating assets and liabilities, net | 389,000 | (127,000 | ) | |||||
| Net cash used in operating activities | (5,977,000 | ) | (4,967,000 | ) | ||||
| Investing activities: | ||||||||
| Purchases of property and equipment | (237,000 | ) | (44,000 | ) | ||||
| Net cash used in investing activities | (237,000 | ) | (44,000 | ) | ||||
| Financing activities: | ||||||||
| Proceeds from issuance of common stock, net | 4,224,000 | 12,384,000 | ||||||
| Other financing activities, net | (236,000 | ) | 397,000 | |||||
| Net cash provided by financing activities | 3,988,000 | 12,781,000 | ||||||
| Net (decrease) increase in cash and cash equivalents | (2,226,000 | ) | 7,770,000 | |||||
| Cash and cash equivalents, beginning of period | 9,370,000 | 6,581,000 | ||||||
| Cash and cash equivalents, end of period | $ | 7,144,000 | $ | 14,351,000 | ||||
| For further information please contact | ||
| Company and Investor relations: | Media relations (USA) | Media Relations (Europe and ROW) |
|
Matt Dansey AmpliPhi Biosciences +1 858-800-4869 md@ampliphibio.com |
Danielle Lewis/Glenn Silver Lazar Partners + 1 212-867-1762 ampliphi@lazarpartners.com |
Gemma Howe/Sue Charles Instinctif Partners +44 (0)20 7866 7860 ampliphi@instinctif.com |