SEC Company Response from Armata Pharmaceuticals, Inc. (ARMP) (CIK 0000921114) (ARMP) — Feb 4, 2014
Armata Pharmaceuticals, Inc. (ARMP) (CIK 0000921114)
Date: Feb. 4, 2014 · CIK: 0000921114 · Accession: 0001144204-14-005940
AI Filing Summary & Sentiment
File numbers found in text: 000-23930
Referenced dates: January 13, 2014
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CORRESP
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filename1.htm
February 4, 2014
BY EDGAR
Jeffrey Riedler
Assistant Director Healthcare and Insurance
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
Re: AmpliPhi Biosciences Corporation
Registration Statement on Form 10-12G
Filed December 16, 2013
File No. 000-23930
Dear Mr. Riedler:
This letter is submitted by AmpliPhi Biosciences
Corporation (the “Company”) in response to the comments of the staff of the Division of Corporation Finance
of the Securities and Exchange Commission (the “Staff”) with respect to the Company’s Form 10-12G filed
December 16, 2013 (File No. 000-23930) (the “Form 10”), as set forth in your letter dated January 13, 2014.
We also enclose with this letter clean and marked copies of Amendment No. 1 to the Form 10, as amended and filed on February 4,
2014 (the “Form 10/A”). Below are responses to each of the Staff’s comments. The text of each comment
contained in the Staff’s letter is set forth in italics below, followed by the Company’s response.
General
1. Please note that your registration statement will become effective by operation of law 60 days from the date you filed it
and that you will then be responsible for filing reports required by Section 13 of the Securities Exchange Act of 1934, even if
we have not completed the review process of your filing. If you do not wish to incur those obligations until all of the following
issues are resolved, you should withdraw your registration statement and resubmit a new registration statement when you have revised
your document
RESPONSE:
We acknowledge the Staff’s comment. We believe
that we have addressed each of the Staff’s comments in the Form 10/A and as further discussed below. In the event that the
Staff still has significant comments after review of the Form 10/A we will then evaluate whether to withdraw the registration statement.
US: 4870 Sadler Rd, Suite 300, Glen Allen, VA 23060
AU: Unit 7 27 Dale Street, Brookvale 2100 NSW
2. Please note that where we provide examples or references to portions of your filing to illustrate what we mean by our comments,
they are examples and not exhaustive lists. If our comments are applicable to portions of the filings that we have not cited as
examples, please make the appropriate changes elsewhere in the filing in accordance with our comments.
RESPONSE:
We acknowledge the Staff’s comment and have
included modifications to the Form 10/A where appropriate.
Form 10-12G
Item 1. Business
AmpliPhage-001: Lung Infections in Cystic Fibrosis (CF) Patients
Caused by P. aeruginosa, page 5
3. Please revise your disclosure to explain what you mean by “clinical isolates,” “phage titers,” and
“the MHRA” the first time you use each such term.
RESPONSE:
We acknowledge the Staff’s comment and have
expanded the disclosure on page 5, 7, and 8 of the Form 10/A.
4. Please define the term “Pa01,” as used
in the chart on page 7.
RESPONSE:
We acknowledge the Staff’s comment and have
expanded the disclosure on page 8 of the Form 10/A.
5. You state that you have demonstrated the effectiveness of phages in multiple preclinical studies. Please expand your disclosure
to state whether you have conducted studies in addition to the three studies presented on pages 6 and 7 of your registration statement.
If you have completed other studies, please describe whether the results of those other studies were consistent with the three
studies described.
RESPONSE:
We acknowledge the Staff’s comment and have
revised the disclosure on page 6 of the Form 10/A to clarify the preclinical studies we have conducted.
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6. Please expand your description of the Institut Pasteur study described on page 6 of your registration statement to state
whether the groups shown in the graphic constitute the full groups, i.e., that each group included eight mice, and, if not, disclose
the actual size of the groups and whether the results pictured are a representative sample of the full group.
In addition, please state whether the results of
this study were statistically significant, disclose the p-values, and explain what those p-values measure.
RESPONSE:
We acknowledge the Staff’s comment and have
expanded the disclosure on page 8 of the Form 10/A.
7. Please expand your description of the Brompton Clinic study to disclose the size of each study group.
RESPONSE:
We acknowledge the Staff’s comment and have
expanded the disclosure on page 8 of the Form 10/A.
8. Please expand your description of the Institut Pasteur study described on page 7 of your registration statement to disclose
the size of the groups and the p-values.
RESPONSE:
We acknowledge the Staff’s comment and have
expanded the disclosure on page 8 of the Form 10/A.
AmpliPhage- 004: Gastrointestinal (GI) Infection Caused by
C. difficile Infection (CDI), page 8
9. You state that deaths in the United States from C. dificile infections increased over 400%, with 90% of them occurring in
hospitalized or confined patients over 65. Please expand this disclosure to provide an estimate of the size of the affected population.
RESPONSE:
We acknowledge the Staff’s comment and have
expanded the disclosure on page 9 of the Form 10/A.
Anti-Infective Treatments with Bacteriophages—Life
Cycle of a Lytic Phage, page 10
10. Please explain what you mean by “lytic phage.”
RESPONSE:
We acknowledge the Staff’s comment and have
revised the disclosure on page 11 of the Form 10/A to eliminate the use of this term.
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11. Please expand your disclosure to discuss the prior misunderstandings with respect to the biology of phages and how such
misunderstanding impacted the development of bacteriophage technology.
RESPONSE:
We acknowledge the Staff’s comment and have
expanded the disclosure on page 11 of the Form 10/A.
12. Please identify the party that conducted the 2009 clinical trial for treatment of venous ulcers using phages.
RESPONSE:
We acknowledge the Staff’s comment and have
expanded the disclosure on page 12 of the Form 10/A.
13. Please revise your disclosure to discuss the status and indication of on-going clinical trials involving the use of phages
and identify the parties conducting such trials.
RESPONSE:
We acknowledge the Staff’s comment and have
revised the disclosure on page 12 of the Form 10/A.
Exclusive Channel Collaboration Agreement with Intrexon,
page 13
14. Please expand your description of your Intrexon agreement in the Business section to disclose:
· the technology access fee;
· the milestone fees;
· the range of royalties payable expressed as a percentage within ten percent (i.e., single digits, teens, twenties, etc.).
RESPONSE:
We acknowledge the Staff’s comment and have
revised the disclosure on page 14 of the Form 10/A.
University of Leicester Development Agreements, page 14
15. Please expand your description of your Leicester agreements in the Business section to disclose:
· the range of royalties payable expressed as a percentage within ten percent (i.e., single digits, teens, twenties, etc.);
and
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· the aggregate amount of milestone payments payable under the agreement.
RESPONSE:
We acknowledge the Staff’s comment and have
revised the disclosure on page 4 of the Form 10/A.
Sale of Assets to Celladon Corporation, page 15
16. Please expand your description of your Celladon agreement in the Business section to describe:
· the 1.75% royalty and the option to cancel that royalty for a one-time payment of $1.75 million; and
· the sublicense fee disclosed on page 50.
RESPONSE:
We acknowledge the Staff’s comment and have
revised the disclosure on page 16 of the Form 10/A.
Intellectual Property, page 16
17. Please expand your description of your U.K. Health Protection Agency license agreement to describe the material terms of
the agreement, and file a copy of that agreement as an exhibit to your registration statement.
RESPONSE:
We acknowledge the Staff’s comment and have
revised the disclosure on page 17 of the Form 10/A and have filed a copy of the U.K. Health Protection Agency license agreement
as Exhibit 10.18 to our Registration Statement on Form S-1, filed on January 21, 2014, which exhibit is incorporated by reference
in the Form 10/A.
Item 1A. Risk Factors
“We do not have a sales force and do not currently
have plans to develop one.” page 31
18. We note that this risk factor indicates that you do not have plans to develop a sales force. However, your disclosure at
page 18 indicates that you expect to commence commercialization by building a sales and marketing organization. Accordingly, please
revise your disclosure in one or both places to clarify whether you intend to build an internal sales organization or to engage
a third-party sales force.
RESPONSE:
We acknowledge the Staff’s comment and have
revised the disclosure on page 19 of the Form 10/A.
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“We will rely on third parties
to conduct some clinical trials…,” page 34
19. We note your disclosure in this risk factor that you may seek to conduct clinical trials outside of the United States. Please
revise your disclosure to include a separate risk factor which highlights this disclosure and discusses any risks the Company may
face as a result of the conduct of clinical trials outside of the United States. For example, you should discuss the possibility
that the FDA may not accept the results of such trials and how such lack of acceptance could impact the regulatory approval process.
RESPONSE:
We acknowledge the Staff’s comment and have
revised the disclosure on page 30 of the Form 10/A.
Risks Related to Our Common Stock
20. Please revise your risk factor disclosure to include a separate risk factor discussing the extent to which your common stock
is characterized as a “penny stock” under Section 3(a)(51) of the Exchange Act and any risks the Company may face as
a result. For example, you should highlight the steps that broker-dealers must take prior to effect transactions in penny stocks
under Section 15(h) of the Exchange Act. You should also discuss the specific legal remedies available to investors in penny stocks
if broker-dealers do not meet their obligations under the penny stock rules or if penny stock is sold in violation of the investor’s
rights or otherwise in a fraudulent manner.
RESPONSE:
We acknowledge the Staff’s comment and have
expanded the disclosure on page 45 of the Form 10/A.
“The price of our common stock has been and may continue
to be volatile.” page 40
21. We note your reference to your stock being volatile even if you are listed on the NYSE MKT. Please revise this risk factor:
· to clarify that your stock is currently quoted on the OTC Markets and indicate the specific tier on which it current trades;
and
· to state whether you intend to apply to list your stock on the NYSE or other exchange.
RESPONSE:
We acknowledge the Staff’s comment and have
revised the disclosure on page 41, 43, and 44 of the Form 10/A.
“Maintaining and improving our financial controls and
the requirements of being a public company…” page 42
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22. Please revise this risk factor to clarify that should you be listed on an exchange other than the NYSE, then you would be
subject to the rules of that exchange.
RESPONSE:
We acknowledge the Staff’s comment and have
revised the disclosure on pages 43 and 44 of the Form 10/A.
Item 5. Directors and Executive Officers, page 54
23. Please revise your registration statement to include the biographical information required by Item 401(e) of Regulation
S-K for Mr. Harper.
RESPONSE:
We acknowledge the Staff’s comment and have
included the requested disclosure on pages 58 and 59 of the Form 10/A.
Non-Employee Directors, page 55
24. Please expand your disclosure to discuss briefly the specific experience, qualifications, attributes or skills that led
to the conclusion that each director should serve in that capacity pursuant to Item 401(e)(1) of Regulation S-K.
RESPONSE:
We acknowledge the Staff’s comment and have
included the requested disclosures on pages 59 and 60 of the Form 10/A.
Item 6. Executive Compensation, page 56
25. In your next amendment, please include the information required by Item 402 of Regulation S-K for the fiscal years ended
December 31, 2012 and 2013.
RESPONSE:
We acknowledge the Staff’s comment and have
included the requested disclosures on page 60 of the Form 10/A.
Item 15. Financial Statements and Exhibits
Statement of Operations, page F-3
26. Diluted net loss per share for 2013 reflects antidilution. Please tell us how loss per share for 2013 complies with ASC
260-10-45-17. Also provide the disclosure specified by ASC 260-10-50.
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RESPONSE:
We acknowledge the Staff’s comment and have
made appropriate adjustments to the financial statements. The Company believes that these adjustments comply with both ASC
260-10-45-17 and ASC 260-10-50.
27. Tell us the supporting authoritative accounting literature that supports including dividend expense of preferred stock in
net income (loss) or revise as necessary.
RESPONSE:
We acknowledge the Staff’s comment. As dividends
have not been declared, dividend expense has been removed.
Statement of Stockholders’ Equity, page F-4
28. The statement on page F-4 indicates 102,235,274 common shares outstanding as of September 30, 2013. You state on page 63
that as of December 6, 2013 10,528,505 shares of common stock were outstanding. Please reconcile and revise the disclosure as necessary.
RESPONSE:
We acknowledge the Staff’s comment and advise
the Staff that, as of December 6, 2013, there were 110,528,505 shares of common stock outstanding. We supplementally advise the
Staff that these two amounts may be reconciled as follows:
Shares Outstanding as of September 30, 2013
102,235,274
Escrow shares released on November 8, 2013
8,000,000
Shares of Series B Convertible Preferred Stock converted to common stock
232,270
Shares issued upon option exercises by former employees
61,018
Escheat shares
(57 )
Shares Outstanding as of December 6, 2013
110,528,505
We have also revised the disclosure on pages 56, 70,
and 73 of the Form 10/A to reflect the fact that there were 182,535,505 shares outstanding as of January 10, 2014.
Statement of Cash Flows, page F-5
29. It appears that “conversion of loan notes” of $5,809,000 and $507,000 and “issuance of Series B Convertible
Preferred Stock for loan notes” of $6,220,000 are not cash transactions and should not be included on the statement of cash
flows but reported separately pursuant to ASC 230-10-50-3. Please revise or tell us why you believe no revision is necessary.
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RESPONSE:
We acknowledge the Staff’s comment and have
revised the disclosure on page F-5 of the Form 10/A.
4. Collaborative and Other Agreements, page F-9
30. You state that, in March 2013, the Company entered into an Exclusive Channel Collaboration Agreement with Intrexon Corporation.
In accordance with the agreement, the Company paid a one-time technology access fee to Intrexon of $3,000,000 in common stock.
Please describe what methods, models and assumptions you used to determine the fair value of your common stock given as consideration
for the fee. Include whether an independent valuation specialist was used and to what extent.
RESPONSE:
The Company supplementally informs the Staff that
the Company determined the fair value of the common stock given as consideration for the technology access fee by reference to
the price per share quoted on the OTC marketplace on the date the Exclusive Channel Collaboration Agreement was executed. The Company
supplementally advises the Staff that no independent valuation specialist was used in making such determination.
7. Stock Options and Warrants, page F-10
31. Some of the warrants appear to contain pricing variability features (section 10(e) of Exhib