0001144204-16-091929.txt : 20160331 0001144204-16-091929.hdr.sgml : 20160331 20160331160822 ACCESSION NUMBER: 0001144204-16-091929 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20160330 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20160331 DATE AS OF CHANGE: 20160331 FILER: COMPANY DATA: COMPANY CONFORMED NAME: AmpliPhi Biosciences Corp CENTRAL INDEX KEY: 0000921114 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 911549568 STATE OF INCORPORATION: WA FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-37544 FILM NUMBER: 161543380 BUSINESS ADDRESS: STREET 1: 3579 VALLEY CENTRE DRIVE CITY: SAN DIEGO STATE: CA ZIP: 92130 BUSINESS PHONE: 804-827-2524 MAIL ADDRESS: STREET 1: 3579 VALLEY CENTRE DRIVE CITY: SAN DIEGO STATE: CA ZIP: 92130 FORMER COMPANY: FORMER CONFORMED NAME: TARGETED GENETICS CORP /WA/ DATE OF NAME CHANGE: 19940331 8-K 1 v435653_8k.htm FORM 8-K

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): March 30, 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

San Diego, California 92130

(Address of principal executive offices)

 

804-827-2524

(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 March 30, 2016, we announced our financial results for the full year ended December 31, 2015 in the press release attached hereto as Exhibit 99.1 and incorporated herein by reference. As previously announced, we also held a conference call on March 30, 2016 to discuss these financial results. An excerpt of the conference call transcript is attached hereto as Exhibit 99.2 and incorporated herein by reference.

 

The information in this Item 2.02 and the attached Exhibits 99.1 and 99.2 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, or otherwise subject to the liabilities of that Section. The information in this Item 2.02 and the attached exhibits shall not be incorporated by reference into any registration statement or other document pursuant to the Securities Act of 1933, as amended.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit
No.

 

Description

   
99.1   Press release issued by AmpliPhi Biosciences Corporation on March 30, 2016 relating to financial results
99.2   Excerpt of transcript from conference call held on March 30, 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: March 31, 2016 AmpliPhi Biosciences Corporation
   
  By: /s/ Steve R. Martin
  Name:  Steve R. Martin
  Title: Chief Financial Officer

 

 

 

 

 

  

EXHIBIT INDEX

 

Exhibit
No.

 

Description

   
99.1   Press release issued by AmpliPhi Biosciences Corporation on March 30, 2016 relating to financial results
99.2   Excerpt of transcript from conference call held on March 30, 2016 relating to financial results.
   

 

 

 

 

 

EX-99.1 2 v435653_ex99-1.htm EXHIBIT 99.1

 

Exhibit 99.1

 

 

  AmpliPhi Biosciences Corporation
3579 Valley Centre Drive, Suite 100
San Diego, CA 92130
   
Press Release  

  

AmpliPhi Biosciences

Reports Full-Year 2015 Financial Results

 

San Diego, March 30, 2016 – AmpliPhi Biosciences Corporation (NYSEMKT: APHB), a global leader in developing bacteriophage-based antibacterial therapies to treat drug-resistant infections, today announced its financial results for the fiscal year ended December 31, 2015.

 

“AmpliPhi had a very productive 2015, making important advances in our programs, raising capital to support development of our product candidates, and strengthening our management team and Board of Directors,” said M. Scott Salka, CEO of AmpliPhi Biosciences. “We have continued to make progress into 2016, establishing our presence in San Diego, acquiring additional key bacteriophage assets and dosing the first patient in our Phase 1 clinical trial of AB-SA01 for the treatment of Staphylococcus aureus infections in patients with chronic rhinosinusitis.”

 

“Our achievements in 2015 and the anticipated advancement of our pre-clinical and clinical pipeline in 2016 put us in a strong position to realize our vision of delivering innovative phage-based therapies that address the serious and growing challenge of antibiotic-resistant bacterial infections,” concluded Mr. Salka.

 

2015 Highlights

·Completed a $13 million private placement of common stock in March 2015 that was pivotal to advancing our product candidates
·Received a European patent for our bacteriophage therapy to fight Pseudomonas aeruginosa bacterial infections characterized by biofilm formation in March 2015
·Received Good Manufacturing Practices (cGMP) certification for our facility in Slovenia in June 2015
·Up-listed to the NYSE MKT in August 2015
·Presented data demonstrating comparable efficacy between our prototype bacteriophage cocktail and Vancomycin in treating Staphylococcus aureus lung infections in September 2015
·Signed an agreement in November 2015 with the University of Adelaide and the Queen Elizabeth Hospital in Adelaide to conduct a Phase I trial of AB-SA01 in patients with chronic rhinosinusitis associated with Staphylococcus aureus infection, and dosed the first patient in January 2016
·Acquired key bacteriophage assets from Novolytics in January 2016, broadening our IP portfolio and accelerating the development of our phage-based therapies
·AmpliPhi’s collaboration partner, the Westmead Institute’s Centre for Infectious Diseases and Microbiology, received an AUS $860,000 grant from the Australian Government to isolate and develop phages targeting E. Coli and Klebsiella. AmpliPhi will participate in the project by providing its proprietary expertise in bacteriophage isolation, characterization and manufacturing scale-up
·Appointed Vijay B. Samant and Paul C. Grint, M.D. to the AmpliPhi Biosciences Board of Directors in November 2015 and Steve R. Martin as Chief Financial Officer in January 2016, enhancing AmpliPhi’s commercial, development, financial and business management expertise

 

Fiscal Year-End 2015 Financial Results:

·Cash and cash equivalents as of December 31, 2015 totaled $9.4 million. The Company anticipates its current financial resources will provide sufficient cash to fund operations through Q3 2016
·The Company raised $12.4 million in net proceeds from the sale of common stock in 2015 to fund its development programs
·Full-year 2015 research & development expenses totaled $4.0 million, including expenses required to manufacture AB-SA01 clinical trial material for use in the Phase I study and confirm the final component phages for the AB-PA01 cocktail
·General and administrative expenses for the year ended December 31, 2015 were $6.4 million
·Loss from operations for the fiscal year ended December 31, 2015 was $10.2 million compared to $14.1 million for the year ended December 31, 2014
·The Company filed its Annual Report on Form 10-K on March 30, 2016. The audit opinion included in the Company’s Annual Report contains a going concern qualification

 

For more information, visit www.ampliphibio.com.

 

 

 

 

 

  AmpliPhi Biosciences Corporation
3579 Valley Centre Drive, Suite 100
San Diego, CA 92130
   
Press Release  

  

Conference Call Details

AmpliPhi Biosciences will host a conference call and webcast to discuss its year-end 2015 financial results and provide an update on business activities. The event will be held today, March 30, 2016, at 4:30 p.m. Eastern Time (ET). The live event can be accessed through AmpliPhi’s website at www.ampliphibio.com under the Events and Presentations section, or by calling 800-895-0198 (domestic) or +1 785-424-1053 (international). The conference ID is 9429197. A replay of the discussion will be available beginning at approximately 7:30 p.m. ET today on AmpliPhi’s website or by calling 888-203-1112 (domestic) or +1 719-457-0820 (international), using conference ID 9429197.

 

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 collaborating with a number of leading organizations, including Intrexon Corporation (NYSE: XON), the U.S. Army, The Royal Brompton Hospital in London, UK and UK-based University of Leicester, to advance 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 anticipated advancement of AmpliPhi’s pre-clinical and clinical pipelines in 2016, the potential use of bacteriophages to treat bacterial infections, including infections that do not respond to antibiotics, 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 Annual Report on Form 10-K for the year ended December 31, 2015, as filed with the Securities and Exchange Commission. 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.

 

 

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

 

 

 

 

EX-99.2 3 v435653_ex99-2.htm EXHIBIT 99.2

Exhibit 99.2

 

MARCH 30, 2016 / 4:30 PM EDT, APHB – 2015 YEAR-END FINANCIAL RESULTS CALL

 

 

CORPORATE PARTICIPANTS

 

M. Scott Salka AmpliPhi Biosciences Corporation – Chief Executive Officer

 

Steve R. Martin AmpliPhi Biosciences Corporation – Chief Financial Officer

 

Matt Dansey AmpliPhi Biosciences Corporation – Business Development Manager

 

 

CONFERENCE CALL PARTICIPANTS

 

Keith Markey Griffin Securities - Analyst

 

David Bautz Zacks Investment Research - Analyst

 

 

PRESENTATION

 

Operator

 

Good afternoon and welcome to the AmpliPhi Biosciences Full Year 2015 Financial Results conference call. Today’s call is being recorded.

 

For opening remarks and introductions I’d like to turn the call over to Matt Dansey, Business Development Manager. Please go ahead sir.

 

Matt Dansey

 

Thanks. During the call we’ll make statements related to our business that may be considered forward-looking and are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995.

 

All 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 annual report on Form 10K for the year ended December 31, 2015 as filed with the Securities and Exchange Commission.

 

Actual results and the timing of events could differ materially from those anticipated in such a forward-looking statement 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 time they were made. All forward-looking statements are qualified in their entirety by this cautionary statement and we undertake no obligation to revise or update any forward-looking statements.

 

Now I’ll turn the call over to Scott Salka, CEO of AmpliPhi Biosciences.

 

M. Scott Salka

 

Thank you, Matt. With me on the call is Steve Martin, our CFO. We will begin the call by providing an overview of 2015 and recent highlights followed by our fiscal year 2015 financial results. We will then take your questions.

 

. . . .

 

With that said I’ll now review our 2015 year-end financial results.

 

 

 

 

Cash and cash equivalents of December 31, 2015 totaled $9.4 million. The company anticipates its current financial resources will provide sufficient cash to fund operations through the third quarter of 2016.

 

The company raised a net of $12.3 million from the sale of common stock in 2015 to fund its development programs. Revenues related to sublicensing agreement from our legacy gene therapy program were approximately half a million dollars for the year ended December 31, 2015, compared to $400,000 for the prior year.

 

Research and Development expenses for the year ended December 31, 2015 totaled $4 million, compared to $5.8 million for the year ended December 31, 2014.

 

These expenses were attributable to advancing our two clinical programs, AB-SA01 for Staph aureus, and AB-PA01 for pseudomonas. And to successfully manufacture bacteriophage clinical trial material for use in our clinical study in Australia.

 

The year-over-year decrease was primarily attributable to lower non-clinical spending in 2015 as compared to 2014. The inclusion in 2014 of one time startup costs related to the Slovenian cGMP manufacturing facility; the benefit from Australian government research grants of half a million dollars, and the impact of lower average exchange rates in 2015 as compared to 2014.

 

Partially offsetting these factors were higher costs related to our Slovenian facility being operational for a full year in 2015 as compared to a partial year in 2014.

 

General and Administrative expenses for the year ended December 31, 2015 were $6.4 million compared to $6.9 million for the same period in 2014. This decrease was primarily attributable to $600,000 expensed in 2014 related to payments to certain stockholders as required by the terms of our Series B preferred stock purchase agreement. And lower compensation in stock-based compensation expenses which were partially offset by higher legal and accounting expenses.

 

Loss from operations for the fiscal year ended December 31, 2015 was $10.2 million compared to $14.1 million for the year ended December 31, 2014.

 

Based on our current operating plan we believe our existing resources will be sufficient to fund our planned operations through the third quarter of 2016. We are currently evaluating alternatives and opportunities to raise capital needed for the advancement of our business.

 

This completes today’s update and we are happy to take questions at this time. Operator, please begin the question and answer period.

 

 

Operator

 

At this time if you would like to ask a question you may press star and 1 on your touch-tone phone. Again that’s star and 1 on your touch-tone phone. If you find that your question has already been answered you may remove yourself from the queue by pressing the pound key.

 

And we’ll take our first question from Keith Markey with Griffin Securities. Please go ahead. Your line is open.

 

Keith Markey

 

Hi, Scott. Hi, Steve. A couple of questions. I was just wondering if you might elaborate a little bit on the relationship that you have with the Westmead Institute Centre for Infectious Diseases and Microbiology.

 

 

 

 

Scott Salka

 

Sure Keith, thank you. So the Westmead is an institute - a research institute in Australia, and you’re referring to the government grant that we got in conjunction with Westmead from the Australian government. That grant totals just under $900,000 U.S.

 

That work will be spearheaded by the Westmead. We will provide certain phage expertise and phage capabilities. And it’s targeting the development of phage that can target infections, E Coli and Klebsiella infections.

 

. . . .

 

 

 

 

 

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