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SEC Comment Letter for Tempest Therapeutics, Inc. (TPST) (CIK 0001544227) (TPST) — May 9, 2012

Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)
Date: May 9, 2012 · CIK: 0001544227 · Accession: 0000000000-12-024104

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File numbers found in text: 000-54647

Date
May 8, 2012
Author
60 State Street Boston, MA 02109
Form
UPLOAD
Company
Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)

Letter

May 8, 2012 Via E-mail Christopher Bleck Chief Operating Officer OvaScience, Inc. 800 Boylston Street, Suite 1555 Boston, Massachusetts 02199 Re: OvaScience, Inc. Registration Statement on Form 10-12G Filed April 11, 2012 File No. 000-54647

Dear Mr. Bleck: We have reviewed your filing and have the following comments. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure. Please respond to this letter within ten business days by amending your filing, by providing the requested information, or by advi sing us when you will provide the requested response. If you do not believe our comments apply to your fact s and circumstances or do not believe an amendment is appropriate, pl ease tell us why in your response. After reviewing any amendment to your filing and the information you provide in response to these comments, we ma y have additional comments. General

1. Your registration statement will automatica lly become effective and you will become a reporting company by operation of law on J une 11, 2012. Please be advised that if you have not resolved all material comments by that time you should c onsider withdrawing the registration statement prior to June 11, 2012. You can re-file the registration statement when you are in a position to res pond to and resolve any material remaining comments.

2. We note that you have submitted an applicati on for confidential treatment relating to certain of your exhibits. Please be advised th at we will be performing a separate review of this application and that th e review of your registration st atement will not be complete until all comments concerning your confidentia l treatment request, if any, have been cleared.

Christopher Bleck OvaScience, Inc. May 8, 2012 Page 2

3. Since you appear to qualify as an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act, please disclose prominently in the beginning of your registration statement that you are an emerging growth company, and revise your registration statement to:  Describe how and when a company may lose emerging growth company status;  Briefly describe the various exemptions that are available to you, such as exemptions from Section 404(b) of the Sarbanes-Oxl ey Act of 2002 and Section 14A(a) and (b) of the Securities Exchange Act of 1934; and  State your election under Sec tion 107(b) of the JOBS Act: o If you have elected to opt out of the extended transition period for complying with new or revised accounting standards pur suant to Section 107(b), include a statement that the election is irrevocable; or o If you have elected to use the extended transition period for complying with new or revised accounting standards under Sect ion 102(b)(1), provide a risk factor explaining that this election allows you to delay the adoption of new or revised accounting standards that have different effective dates for public and private companies until those standards apply to pr ivate companies. Please state in your risk factor that, as a resu lt of this election, your financial statements may not be comparable to companies that comply with public company effective dates. Include a similar statement in your critical accounting policy disclosures. 4. Please state expressly whether the research pe rformed at Massachusetts General Hospital provides conclusive evidence that egg-produc ing cells exist in adult ovaries, that precursor cells contribute to egg production in adults, and that egg- producing cells can be grown and matured in an environment resemb ling an ovary. If controversy remains in the scientific community as to these hypot heses, you should amend your disclosure to note this and to discuss any potential ramifi cations, particularly how these uncertainties cast doubt upon the possibility of developing AUGMENT and OvaTure. If appropriate, you should amend your disclosure on the first pa ge of your registration statement, in the risk factor beginning at the bottom of pa ge 32, and wherever else you discuss this research and its implications. Item 1. Business

Overview, page 1

5. Please provide additional information about the discovery pro cess relating to egg precursor cells in adult mice, including the name of the laboratory as well as the type of testing and research that was utilized.

Christopher Bleck OvaScience, Inc. May 8, 2012 Page 3

6. Please describe the “subsequent research” performed by your founder and others that confirmed the existence of egg precursor cells in human ovaries , identify the other individuals who performed this research and state the approximate dates that this research was initiated and concluded. AUGMENT, page 7

7. Please identify the independent institutional re view board that approved the protocol for your AUGMENT study in December 2011, and the two IVF clinics where you plan to conduct the first phase of this study.

8. Please identify the database that will incl ude the results of the AUGMENT study and that can be used to compare its results to those of other IVF clinical studies. Government Regulation, page 16

9. In your analysis of whether AUGMENT will qualify as a 361 HCT/P on page 21 please state, if true, either that it has a systemic ef fect or that it is dependent upon the metabolic activity of living cells fo r its primary function.

Item 1A. Risk Factors We will need substantial additional funding. If we are unable to raise capital when needed, we would be forced to delay, reduce or el iminate our product development program or commercialization efforts, page 31

10. Please include in this risk factor an estimate of the expenses you will incur in completing your AUGMENT study and in launching comm ercial activities of this product. Procedures such as IVF, as well as companies that manufacture and store cells and tissues, are the subject of standards and recommendations nu national non-governmental bodies . . .,” page

11. Please describe in this risk factor the voluntary guidelin es that you believe you should either comply with or else potential ly harm your commercial prospects. “If we are not able to obtain, or if there are de lays in obtaining, require d regulatory approvals, we will not be able to commercialize OvaTure or other product candidates, and our ability to generate revenue will be materially impaired,” page 42

12. This risk factor is substantially similar to the one on pages 34- 35. Please condense these risk factors so as to avoid a ny repetition in your disclosure.

Christopher Bleck OvaScience, Inc. May 8, 2012 Page 4

Item 2. Financial Information

Management’s Discussion and Analysis of Fi nancial Condition and Results of Operations

Stock-Based Compensation, page 70

13. Please expand your disclosure to in clude the following information:  For the contemporaneous and retrospectives va luations used to determine fair value, please state, if true, that the valuatio ns were prepared by a related party;

 Please describe the reverse backsolve a pproach to applying the option pricing method, why it was the appropria te method at this stage of your development, and disclose why you believe the most recent preferred stock financing is the best indication of value;  Regarding your disclosure that a liquidity event was possible in three years, please discuss why you believe that a sale was more likely to occur than an IPO or public trading at December 7, 2011 considering your disclosure that in mid-to-late December your financial advisors introduced the possibility of undertaking the filing of a Form 10 registration statemen t to become a public company; and

 Continue to update your disclosure for al l equity related tran sactions through the effectiveness date of th e registration statement. Item 4. Security Ownership of Certain Be neficial Owners and Management, page 80

14. Please identify the individual(s) with voting an d/or dispositive power over the shares of your common stock held by en tities affiliated with BBT Capital Management Advisors LLC. Item 15. Financial Statements

9. License Agreements, page F-18

15. Please revise your disclosure to explain why you classified the reimbursement of patent and related costs incurred by MGH of $336,000 for licensed patents as a general and administrative expense and not research and development. We urge all persons who are responsible for th e accuracy and adequacy of the disclosure in the filing to be certain that the filing include s the information the Securities Exchange Act of 1934 and all applicable Exchange Act rules requir e. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made.

Christopher Bleck OvaScience, Inc. May 8, 2012 Page 5

In responding to our comments, please provi de a written statement from the company acknowledging that:  the company is responsible for the adequacy an d accuracy of the disclo sure in the filing;

 staff comments or changes to disclosure in response to staff comments do not foreclose the Commission from taking any action with respect to the filing; and

 the company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federa l securities laws of the United States.

You may contact Keira Ino at (202) 551-3659 or Donald Abbott at (202) 551-3608 if you have questions regarding comments on the financ ial statements and related matters. Please contact Scot Foley at (202) 551-3383 or me at (202) 551-3715 with any other questions.

Sincerely,
/s/ Jeffrey Riedler
Jeffrey Riedler Assistant Director
cc: Lia Der Marderosian, Esq.
WilmerHale
60 State Street Boston, MA 02109

Show Raw Text
May 8, 2012
 Via E-mail

Christopher Bleck  Chief Operating Officer  OvaScience, Inc.  800 Boylston Street, Suite 1555 Boston, Massachusetts 02199
Re: OvaScience, Inc.
 Registration Statement on Form 10-12G
Filed April 11, 2012 File No. 000-54647

Dear Mr. Bleck:
 We have reviewed your filing and have the following comments.  In some of our
comments, we may ask you to provide us with  information so we may better understand your
disclosure.
 Please respond to this letter within ten business days by amending your filing, by
providing the requested information, or by advi sing us when you will provide the requested
response.  If you do not believe our comments apply to your fact s and circumstances or do not
believe an amendment is appropriate, pl ease tell us why in your response.
 After reviewing any amendment to your filing and the information you provide in
response to these comments, we ma y have additional comments.
            General

1. Your registration statement will automatica lly become effective and you will become a
reporting company by operation of law on J une 11, 2012. Please be advised that if you
have not resolved all material comments by that time you should c onsider withdrawing
the registration statement prior to June  11, 2012. You can re-file the registration
statement when you are in a position to res pond to and resolve any material remaining
comments.

2. We note that you have submitted an applicati on for confidential treatment relating to
certain of your exhibits.  Please be advised th at we will be performing a separate review
of this application and that th e review of your registration st atement will not be complete
until all comments concerning your confidentia l treatment request, if any, have been
cleared.

Christopher Bleck OvaScience, Inc.  May 8, 2012 Page 2

 3. Since you appear to qualify as an “emerging growth company,” as defined in the
Jumpstart Our Business Startups Act, please disclose prominently in the beginning of
your registration statement that you are an emerging growth company, and revise your
registration statement to:
 Describe how and when a company may lose emerging growth company status;
 Briefly describe the various exemptions that  are available to you, such as exemptions
from Section 404(b) of the Sarbanes-Oxl ey Act of 2002 and Section 14A(a) and (b)
of the Securities Exchange Act of 1934; and
 State your election under Sec tion 107(b) of the JOBS Act:
o If you have elected to opt out
 of the extended transition period for complying with
new or revised accounting standards pur suant to Section 107(b), include a
statement that the election is irrevocable; or
o If you have elected to use the extended transition period for complying with new
or revised accounting standards under Sect ion 102(b)(1), provide a risk factor
explaining that this election allows you to  delay the adoption of new or revised
accounting standards that have  different effective dates for public and private
companies until those standards apply to pr ivate companies.  Please state in your
risk factor that, as a resu lt of this election, your financial statements may not be
comparable to companies that comply with public company effective dates.
 Include a similar statement in your critical accounting policy disclosures.
4. Please state expressly whether the research pe rformed at Massachusetts General Hospital
provides conclusive evidence that egg-produc ing cells exist in adult ovaries, that
precursor cells contribute to egg production in  adults, and that egg- producing cells can be
grown and matured in an environment resemb ling an ovary.  If controversy remains in
the scientific community as to these hypot heses, you should amend your disclosure to
note this and to discuss any potential ramifi cations, particularly how these uncertainties
cast doubt upon the possibility of developing AUGMENT and OvaTure.  If appropriate,
you should amend your disclosure on the first pa ge of your registration statement, in the
risk factor beginning at the bottom of pa ge 32, and wherever else you discuss this
research and its implications.
 Item 1. Business

 Overview, page 1

5. Please provide additional information about  the discovery pro cess relating to egg
precursor cells in adult mice, including the name  of the laboratory as well as the type of
testing and research that was utilized.

Christopher Bleck OvaScience, Inc.  May 8, 2012 Page 3

 6. Please describe the “subsequent research” performed by your founder and others that
confirmed the existence of egg precursor cells in human ovaries , identify the other
individuals who performed this research and state the approximate dates that this research
was initiated and concluded.
 AUGMENT, page 7

7. Please identify the independent institutional re view board that approved the protocol for
your AUGMENT study in December 2011, and the two IVF clinics where you plan to conduct the first phase of this study.

8. Please identify the database that will incl ude the results of the AUGMENT study and that
can be used to compare its results to those of other IVF clinical studies.
 Government Regulation, page 16

9. In your analysis of whether AUGMENT will qualify as a 361 HCT/P on page 21 please
state, if true, either that it has a systemic ef fect or that it is dependent upon the metabolic
activity of living cells fo r its primary function.

Item 1A. Risk Factors
 We will need substantial additional funding. If we  are unable to raise capital when needed, we
would be forced to delay, reduce or el iminate our product development program or
commercialization efforts, page 31

10. Please include in this risk factor an estimate of the expenses you will incur in completing
your AUGMENT study and in launching comm ercial activities of this product.
 Procedures such as IVF, as well as companies that manufacture and store cells and tissues, are
the subject of standards and recommendations nu national non-governmental bodies . . .,” page
40

11. Please describe in this risk  factor the voluntary guidelin es that you believe you should
either comply with or else potential ly harm your commercial prospects.
 “If we are not able to obtain, or if there are de lays in obtaining, require d regulatory approvals, we
will not be able to commercialize OvaTure or other product candidates, and our ability to
generate revenue will be materially impaired,” page 42

12. This risk factor is substantially similar to the one on pages 34- 35. Please condense these
risk factors so as to avoid a ny repetition in your disclosure.

Christopher Bleck OvaScience, Inc.  May 8, 2012 Page 4

 Item 2. Financial Information

 Management’s Discussion and Analysis of Fi nancial Condition and Results of Operations

 Stock-Based Compensation, page 70

13. Please expand your disclosure to in clude the following information:
 For the contemporaneous and retrospectives va luations used to determine fair value,
please state, if true, that the valuatio ns were prepared by a related party;

 Please describe the reverse backsolve a pproach to applying the option pricing
method, why it was the appropria te method at this stage of your development, and
disclose why you believe the most recent preferred stock financing is the best
indication of value;
 Regarding your disclosure that a liquidity event was possible in three years, please
discuss why you believe that a sale was more  likely to occur than an IPO or public
trading at December 7, 2011 considering your disclosure that in mid-to-late December your financial advisors introduced  the possibility of undertaking the filing
of a Form 10 registration statemen t to become a public company; and

 Continue to update your disclosure for al l equity related tran sactions through the
effectiveness date of th e registration statement.
 Item 4. Security Ownership of Certain Be neficial Owners and Management, page 80

14. Please identify the individual(s) with voting an d/or dispositive power  over the shares of
your common stock held by en tities affiliated with BBT Capital Management Advisors
LLC.
 Item 15. Financial Statements

 9.  License Agreements, page F-18

15. Please revise your disclosure to explain why you classified the reimbursement of patent
and related costs incurred by MGH of $336,000 for licensed patents as a general and
administrative expense and not research and development.
We urge all persons who are responsible for th e accuracy and adequacy of the disclosure
in the filing to be certain that the filing include s the information the Securities Exchange Act of
1934 and all applicable Exchange Act rules requir e.  Since the company and its management are
in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy
and adequacy of the disclosures they have made.

Christopher Bleck OvaScience, Inc.  May 8, 2012 Page 5

  In responding to our comments, please provi de a written statement from the company
acknowledging that:
 the company is responsible for the adequacy an d accuracy of the disclo sure in the filing;

 staff comments or changes to disclosure in response to staff comments do not foreclose
the Commission from taking any action with respect to the filing; and

 the company may not assert staff comments as  a defense in any proceeding initiated by
the Commission or any person under the federa l securities laws of  the United States.

You may contact Keira Ino at (202) 551-3659 or Donald Abbott at (202) 551-3608 if you
have questions regarding comments on the financ ial statements and related matters.  Please
contact Scot Foley at (202) 551-3383 or me at (202) 551-3715 with any other questions.

Sincerely,
   /s/ Jeffrey Riedler
Jeffrey Riedler Assistant Director
  cc: Lia Der Marderosian, Esq.
WilmerHale
60 State Street Boston, MA 02109