SEC Company Response from Akari Therapeutics Plc (AKTX) (CIK 0001541157) (AKTX) — Aug 31, 2012
Akari Therapeutics Plc (AKTX) (CIK 0001541157)
Date: Aug. 31, 2012 · CIK: 0001541157 · Accession: 0001144204-12-049130
AI Filing Summary & Sentiment
Reasoning
File numbers found in text: 000-54749
Letter
Jeffrey Schultz | 212 692 6732 | jschultz@mintz.com
Chrysler Center
666 Third Avenue
New York, NY 10017
212-935-3000
212-983-3115 fax
www.mintz.com
August 31, 2012
Via EDGAR and by Federal Express
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re: Morria Biopharmaceuticals PLC
Registration Statement on Form 20-F
Originally Filed on August 8, 2012
File No. 000-54749
Ladies and Gentleman:
On behalf of Morria Biopharmaceuticals PLC (the “Company”), we hereby file with the Securities and Exchange Commission (the “Commission”) Amendment No. 2 to the Company’s Registration Statement on Form 20-FR12G (the “Amendment”), as initially filed with the Commission on June 28, 2012 and as amended by Amendment No. 1 on August 8, 2012 and subsequently withdrawn on August 24, 2012. We are also delivering five clean and marked complete courtesy copies of the Amendment to the attention of Scot Foley, Esq.
Set forth below are the Company’s responses to the Commission’s comments provided by a letter (the “Comment Letter”) dated August 21, 2012, from the staff at the Commission (the “Staff”). The Company’s responses are numbered to correspond to the comments, as set forth in the Comment Letter, which, for convenience, we have incorporated into this response letter.
Item 3. Key Information
D. Risk Factors, page 5
“We will require additional capital to fund our operations, and if we are unable to obtain such capital, we will be unable to successfully develop and commercialize our product candidates,” page 6
1. We note your response to prior comment 7. It is unclear from your disclosure how you believe you can execute your operating plan for the fiscal year, which you estimate to cost $1.7 million, without additional funding when the balance of your cash and investment securities is currently $280,000. Please clarify and/or revise this disclosure both here and on page 45.
Response: We have revised the disclosure on pages 6 and 45 of the Amendment in response to the Staff’s comment.
“Our product candidates are still in the early stages of development and remain subject to clinical testing and regulatory approval…,” page 10
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Boston | Washington | New York | Stamford | Los Angeles | Palo Alto | San Diego | London
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Securities and Exchange Commission August 31, Page
2. We note your response to prior comment 9. Based on your disclosure on pages 41 and 51, please expand your disclosure in this risk factor to disclose that the clinical trials you have performed to date for MRX-6 were not conducted in the United States, were not compliant with either ICH or FDA regulations, and that you are required to complete a new clinical trial that will be acceptable to the FDA in order to advance this product candidate’s development.
Response: We have expanded the disclosure in this risk factor to provide that MRX-6 is currently being conducted as an academic study, which is neither FDA- nor ICH-compliant, and that the Company is required to execute another clinical trial that will be either FDA compliant or ICH-compliant (and, thus, FDA-compliant), in order to advance this product candidate’s development. Please see page 10 of the Amendment.
“U.S. investors may not be able to enforce their civil liabilities against our company or our directors, controlling persons and officers,” page 35
3. Please consider including discussion of the availability of a treaty or reciprocity between the U.S. and the United Kingdom.
Response: We have revised the disclosure in response to the Staff’s comment. Please see page 35 of the Amendment.
Item 4. Information on the Company
B. Business Overview
Product Candidates, page 41
4. We note your response to prior comment 20. Please include both in this discussion and in your related disclosure on page 50 a brief description of the ICH and the reasons why clinical trials conducted according to its rules are acceptable to the FDA. Please also disclose the circumstances in which foreign clinical trials can be used to support an IND, including if: (a) they are performed in accordance with good clinical practice, including review and approval by an independent ethics committee and informed consent from subjects, and (b) the FDA is able to validate the data from the study through an onsite inspection, if necessary.
Response: We have revised the disclosure on page 50 of the Amendment as set forth below to briefly describe the ICH and the reasons why clinical trials conducted subject to its guidelines are acceptable to the FDA and to describe that foreign clinical trials can be used to support an IND, including if they are performed in accordance with good clinical practice, including review and approval by an independent ethics committee and informed consent from subjects, and the FDA is able to validate the data from the study through an onsite inspection, if necessary.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Securities and Exchange Commission August 31, Page
Beginning in 1990, the FDA and corresponding regulatory agencies of the EU and Japan commenced discussions to develop harmonized standards for preclinical and clinical studies and the format and content of applications for new drug approvals through a process known as the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Data from multinational studies adhering to ICH- Good Clinical Practice (GCP) are now generally acceptable to the FDA and regulators in Australia, Canada, the EU, Japan and Latin American countries and the World Health Organization (WHO). GCP is a standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials in a way that provides assurance that the data are credible and accurate and that the rights, safety, and well-being of trial subjects are protected. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible. GCP includes review and approval (or provision of a favorable opinion) by an independent ethics committee, or IEC, before initiating a study, continuing review of an ongoing study by an IEC, and obtaining and documenting the freely given informed consent of the subject (or a subject's legally authorized representative, if the subject is unable to provide informed consent) before initiating a study. The FDA enforces these GCP guidelines through periodic onsite inspections of trial sponsors, principal investigators, CRO trial sites, laboratories, and any entity having to do with the completion of the study protocol and processing of data.
The MRX-4 clinical trial was a non-IND foreign study performed in accordance with ICH GCP standards, including review and approval by an independent ethics committee and the obtaining of the informed consent from its subjects in compliance with the requirements in the FDA’s regulations. Moreover, the FDA is able to validate the data from the study through onsite inspection of the clinical site, if necessary.
Scientific Background to Inflammation and Our Product Candidates, page 45
5. We note your response to prior comment 22. You state that the role of PLA2 in inflammatory diseases has been “universally” accepted in the scientific community. Please provide the factual basis for this assertion, particularly in light of your next sentence claiming that this role has become “increasingly better understood” since the 1980s, which calls into question the universality of its acceptance.
Response: We have revised the disclosure in response to the Staff’s comment and included references to certain scholarly articles and textbooks on the subject. Please see page 45 of the Amendment.
6. You state that your principal shareholder’s work in this field has been “generally” accepted by his peers. To the extent that you are aware of any dissents in the scientific community relating to his conclusions, please describe them here and note, if applicable, where these dissents have been published.
Response: We have revised the disclosure in response to the Staff’s comment to reflect that Professor Yedgar’s work has been “widely” accepted by his peers, as evidenced by the publication of his work in this area in various peer-reviewed publications cited in the Amendment. Please see page 45 of the Amendment.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Securities and Exchange Commission August 31, Page
7. If your principal shareholder or any of your other affiliates were engaged in any of the clinical programs using PLA2 indicators that were launched in the 1990s, please revise your disclosure to state this.
Response: Neither the Company’s principal shareholder nor any of its other affiliates were engaged in any of the clinical programs using PLA2 indicators that were launched in the 1990s. Accordingly, we have not revised the disclosure.
Item 6. Directors, Senior Management and Employees
B. Compensation
Employment and Consulting Agreements, page 83
8. Please expand your discussion of your agreements with Prof. Saul Yedgar to disclose that you also entered into a director agreement on February 21, 2005, which is filed as Exhibit 4.13.
Response: We have revised the disclosure to include a description of the director agreement with Professor Yedgar dated February 21, 2005. Please see pages 82 and 84 of the Amendment.
9. You disclose that you entered into a consulting agreement with Dr. Joseph Bondi effective June 1, 2007. Based on the agreement filed as Exhibit 4.19, it appears that this was an employment agreement. Please revise your filing for this inconsistency. Alternatively, please provide us with an analysis that supports your conclusion that this was a consulting agreement rather than an employment agreement.
Response: Dr. Bondi is an independent contractor who provides consulting services to ot
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filename1.htm
Jeffrey Schultz | 212 692
6732 | jschultz@mintz.com
Chrysler Center
666 Third Avenue
New York, NY 10017
212-935-3000
212-983-3115 fax
www.mintz.com
August 31, 2012
Via EDGAR and by Federal Express
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Morria Biopharmaceuticals PLC
Registration Statement on Form 20-F
Originally Filed on August 8, 2012
File No. 000-54749
Ladies and Gentleman:
On
behalf of Morria Biopharmaceuticals PLC (the “Company”), we hereby file with
the Securities and Exchange Commission (the “Commission”) Amendment No. 2 to the Company’s Registration
Statement on Form 20-FR12G (the “Amendment”), as initially filed with the Commission on June 28, 2012 and as
amended by Amendment No. 1 on August 8, 2012 and subsequently withdrawn on August 24, 2012. We are also delivering five clean and
marked complete courtesy copies of the Amendment to the attention of Scot Foley, Esq.
Set forth below are
the Company’s responses to the Commission’s comments provided by a letter (the “Comment Letter”)
dated August 21, 2012, from the staff at the Commission (the “Staff”). The Company’s responses are numbered
to correspond to the comments, as set forth in the Comment Letter, which, for convenience, we have incorporated into this response
letter.
Item 3. Key Information
D. Risk Factors, page 5
“We will require additional
capital to fund our operations, and if we are unable to obtain such capital, we will be unable to successfully develop and commercialize
our product candidates,” page 6
1. We note your response to prior comment 7. It is unclear from your disclosure how you believe you
can execute your operating plan for the fiscal year, which you estimate to cost $1.7 million, without additional funding when the
balance of your cash and investment securities is currently $280,000. Please clarify and/or revise this disclosure both here and
on page 45.
Response: We have revised
the disclosure on pages 6 and 45 of the Amendment in response to the Staff’s comment.
“Our product candidates are
still in the early stages of development and remain subject to clinical testing and regulatory approval…,” page 10
Mintz, Levin, Cohn, Ferris, Glovsky and
Popeo, P.C.
Boston
| Washington | New York | Stamford | Los Angeles | Palo Alto | San Diego | London
Mintz,
Levin,
Cohn,
Ferris,
Glovsky
and
Popeo,
P.C.
Securities
and
Exchange
Commission
August
31,
2012
Page
2
2. We note your response to prior comment 9. Based on your disclosure on pages 41 and 51, please expand
your disclosure in this risk factor to disclose that the clinical trials you have performed to date for MRX-6 were not conducted
in the United States, were not compliant with either ICH or FDA regulations, and that you are required to complete a new clinical
trial that will be acceptable to the FDA in order to advance this product candidate’s development.
Response: We have expanded the disclosure in this risk
factor to provide that MRX-6 is currently being conducted as an academic study, which is neither FDA- nor ICH-compliant, and that
the Company is required to execute another clinical trial that will be either FDA compliant or ICH-compliant (and, thus, FDA-compliant),
in order to advance this product candidate’s development. Please see page 10 of the Amendment.
“U.S. investors may not be able
to enforce their civil liabilities against our company or our directors, controlling persons and officers,” page 35
3. Please consider including discussion of the availability of a treaty or reciprocity between the U.S. and the United Kingdom.
Response: We have revised the disclosure in response
to the Staff’s comment. Please see page 35 of the Amendment.
Item 4. Information on the Company
B. Business Overview
Product Candidates, page 41
4. We note your response to prior comment 20. Please include both in this discussion and in your related
disclosure on page 50 a brief description of the ICH and the reasons why clinical trials conducted according to its rules are acceptable
to the FDA. Please also disclose the circumstances in which foreign clinical trials can be used to support an IND, including if:
(a) they are performed in accordance with good clinical practice, including review and approval by an independent ethics committee
and informed consent from subjects, and (b) the FDA is able to validate the data from the study through an onsite inspection, if
necessary.
Response: We
have revised the disclosure on page 50 of the Amendment as set forth below to briefly describe the ICH and the reasons why clinical
trials conducted subject to its guidelines are acceptable to the FDA and to describe that foreign clinical trials can be used to
support an IND, including if they are performed in accordance with good clinical practice, including review and approval by an
independent ethics committee and informed consent from subjects, and the FDA is able to validate the data from the study through
an onsite inspection, if necessary.
Mintz,
Levin,
Cohn,
Ferris,
Glovsky
and
Popeo,
P.C.
Securities
and
Exchange
Commission
August
31,
2012
Page
3
Beginning in 1990, the FDA and corresponding
regulatory agencies of the EU and Japan commenced discussions to develop harmonized standards for preclinical and clinical studies
and the format and content of applications for new drug approvals through a process known as the International Conference on Harmonisation
of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Data from multinational studies adhering to
ICH- Good Clinical Practice (GCP) are now generally acceptable to the FDA and regulators in Australia, Canada, the EU, Japan and
Latin American countries and the World Health Organization (WHO). GCP is a
standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials in a
way that provides assurance that the data are credible and accurate and that the rights, safety, and well-being of trial subjects
are protected. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects
are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial
data are credible. GCP includes review and approval (or provision of a
favorable opinion) by an independent ethics committee, or IEC, before initiating a study, continuing review of an ongoing
study by an IEC, and obtaining and documenting the freely given informed consent of the subject (or a subject's legally authorized
representative, if the subject is unable to provide informed consent) before initiating a study. The FDA enforces these GCP guidelines
through periodic onsite inspections of trial sponsors, principal investigators, CRO trial sites, laboratories, and any entity having
to do with the completion of the study protocol and processing of data.
The MRX-4 clinical trial was a non-IND
foreign study performed in accordance with ICH GCP standards, including review and approval by an independent ethics committee
and the obtaining of the informed consent from its subjects in compliance with the requirements in the FDA’s regulations.
Moreover, the FDA is able to validate the data from the study through onsite inspection of the clinical site, if necessary.
Scientific Background to Inflammation
and Our Product Candidates, page 45
5. We note your response to prior comment 22. You state that the role of PLA2 in inflammatory diseases
has been “universally” accepted in the scientific community. Please provide the factual basis for this assertion, particularly
in light of your next sentence claiming that this role has become “increasingly better understood” since the 1980s,
which calls into question the universality of its acceptance.
Response: We have revised the disclosure
in response to the Staff’s comment and included references to certain scholarly articles and textbooks on the subject. Please
see page 45 of the Amendment.
6. You state that your principal shareholder’s work in this field has been “generally”
accepted by his peers. To the extent that you are aware of any dissents in the scientific community relating to his conclusions,
please describe them here and note, if applicable, where these dissents have been published.
Response: We have revised the disclosure
in response to the Staff’s comment to reflect that Professor Yedgar’s work has been “widely” accepted by
his peers, as evidenced by the publication of his work in this area in various peer-reviewed publications cited in the Amendment.
Please see page 45 of the Amendment.
Mintz,
Levin,
Cohn,
Ferris,
Glovsky
and
Popeo,
P.C.
Securities
and
Exchange
Commission
August
31,
2012
Page
4
7. If your principal shareholder or any of your other affiliates were engaged in any of the clinical
programs using PLA2 indicators that were launched in the 1990s, please revise your disclosure to state this.
Response: Neither the Company’s
principal shareholder nor any of its other affiliates were engaged in any of the clinical programs using PLA2 indicators that were
launched in the 1990s. Accordingly, we have not revised the disclosure.
Item 6. Directors, Senior
Management and Employees
B. Compensation
Employment
and Consulting Agreements, page 83
8. Please expand your discussion of your agreements with Prof. Saul Yedgar to disclose that you also
entered into a director agreement on February 21, 2005, which is filed as Exhibit 4.13.
Response: We have revised the disclosure
to include a description of the director agreement with Professor Yedgar dated February 21, 2005. Please see pages 82 and 84 of
the Amendment.
9. You disclose that you entered into a consulting agreement with Dr. Joseph Bondi effective June
1, 2007. Based on the agreement filed as Exhibit 4.19, it appears that this was an employment agreement. Please revise your filing
for this inconsistency. Alternatively, please provide us with an analysis that supports your conclusion that this was a consulting
agreement rather than an employment agreement.
Response: Dr.
Bondi is an independent contractor who provides consulting services to ot