<SEC-DOCUMENT>0001193125-19-155321.txt : 20190717
<SEC-HEADER>0001193125-19-155321.hdr.sgml : 20190717
<ACCEPTANCE-DATETIME>20190523160703
<PRIVATE-TO-PUBLIC>
ACCESSION NUMBER:		0001193125-19-155321
CONFORMED SUBMISSION TYPE:	CORRESP
PUBLIC DOCUMENT COUNT:		2
FILED AS OF DATE:		20190523

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Stoke Therapeutics, Inc.
		CENTRAL INDEX KEY:			0001623526
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				471144582
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		CORRESP

	BUSINESS ADDRESS:	
		STREET 1:		3 PRESTON COURT
		CITY:			BEDFORD
		STATE:			MA
		ZIP:			01730
		BUSINESS PHONE:		781-430-8200

	MAIL ADDRESS:	
		STREET 1:		3 PRESTON COURT
		CITY:			BEDFORD
		STATE:			MA
		ZIP:			01730

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	ASOthera Pharmaceuticals, Inc.
		DATE OF NAME CHANGE:	20141028
</SEC-HEADER>
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<TD VALIGN="top" ALIGN="center">May 23, 2019</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
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<TD VALIGN="top">R<SMALL>OBERT</SMALL> A. F<SMALL>REEDMAN</SMALL></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
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<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top" ALIGN="right">E<SMALL>MAIL</SMALL>: <SMALL>RFREEDMAN</SMALL>@<SMALL>FENWICK</SMALL>.<SMALL>COM<BR></SMALL>Direct Dial: +1 (650) <FONT STYLE="white-space:nowrap">335-7292</FONT></TD></TR>
</TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B><U>VIA EDGAR AND OVERNIGHT DELIVERY </U></B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">U.S. Securities and Exchange Commission </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Division of Corporation
Finance </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Office of Healthcare&nbsp;&amp; Insurance </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">100 F
Street, NE </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Washington, DC 20549 </P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="9%" VALIGN="top" ALIGN="left">Attention:</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left">Sonia Bednarowski <BR>Justin Dobbie <BR>Rolf Sundwall <BR>Jim Rosenberg </P></TD></TR></TABLE>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="5%" VALIGN="top" ALIGN="left"><B>Re:</B></TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><B>Stoke Therapeutics, Inc. <BR>Amendment No.&nbsp;1 to Draft Registration Statement on Form <FONT
STYLE="white-space:nowrap">S-1</FONT> <BR>Submitted April&nbsp;30, 2019 <BR>CIK No.&nbsp;0001623526 </B></P></TD></TR></TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Ladies and Gentlemen: </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">We are submitting this letter on behalf of Stoke Therapeutics, Inc. (the &#147;<B><I>Company</I></B>&#148;) in response to the comments of the
staff (the &#147;<B><I>Staff</I></B>&#148;) of the U.S. Securities and Exchange Commission (the &#147;<B><I>Commission</I></B>&#148;) in its letter dated May&nbsp;14, 2019 (the &#147;<B><I>Letter</I></B>&#148;) regarding Amendment No.&nbsp;1 to the
Company&#146;s Draft Registration Statement on Form <FONT STYLE="white-space:nowrap">S-1</FONT> (CIK No.&nbsp;0001623526) as confidentially submitted to the Commission on April&nbsp;30, 2019 (&#147;<B><I>Amendment No.&nbsp;1</I></B>&#148;). The
Company advises the Staff that it publicly filed its Registration Statement on Form <FONT STYLE="white-space:nowrap">S-1</FONT> (the &#147;<B><I>Registration Statement</I></B>&#148;) on May&nbsp;23, 2019. The numbered paragraphs below correspond to
the numbered comments in the Staff&#146;s letter and the Staff&#146;s comments are presented in bolded italics. For the convenience of the Staff, we are also sending, by overnight courier, a copy of this letter and two copies of the Registration
Statement in paper format, marked to show changes from Amendment No.&nbsp;1. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">In addition to addressing the comments raised by the Staff
in the Letter, the Company has revised the Registration Statement to update certain other disclosures. </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">May 23, 2019 </P>
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 2
 </P> <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P>
 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B><U>Amendment No.&nbsp;1 to Draft Registration Statement on Form
<FONT STYLE="white-space:nowrap">S-1</FONT> </U></B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B><U>Prospectus Summary </U></B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B><U>Company overview, page 1 </U></B></P> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="4%" VALIGN="top" ALIGN="left">1.</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><B><I>Please balance your statement that you believe you have the first genetic medicine with the potential to
significantly reduce the occurrence of seizures for Dravet syndrome patients and to address the severe intellectual and developmental disabilities of the disease by clarifying here that you are in an early stage of your development and that to date
you have only conducted preclinical studies for your product candidate. </I></B> </P></TD></TR></TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The Company acknowledges the Staff&#146;s comment and
advises the Staff that it has revised its disclosure on page 1 of the Registration Statement to balance this statement as indicated. </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B><U>Business
</U></B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B><U><FONT STYLE="white-space:nowrap">STK-001:</FONT> Preclinical data, page 100 </U></B></P>
<P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="4%" VALIGN="top" ALIGN="left">2.</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><B><I>Please disclose how many groups of <FONT STYLE="white-space:nowrap">pre-pubescent</FONT> monkeys were
administered with a single dose of <FONT STYLE="white-space:nowrap">STK-001</FONT> and how many control groups you used in the preclinical study described on page 103.</I></B> </P></TD></TR></TABLE>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The Company acknowledges the Staff&#146;s comment and advises the Staff that it has revised its disclosure on page 105 of the Registration Statement to
provide additional detail about the monkey groups. </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B><U>Description of capital stock </U></B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B><U>Anti-takeover provisions </U></B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B><U>Restated
certificate of incorporation and restated bylaw provisions, page 147 </U></B></P> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="4%" VALIGN="top" ALIGN="left">3.</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><B><I>We continue to consider your response to our prior comment 8. Please note that we may have additional
comments. </I></B> </P></TD></TR></TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The Company acknowledges that the Staff will continue to consider the Company&#146;s response to prior comment 8 and
may have further comments. </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B><U>Notes to Consolidated Financial Statements </U></B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B><U>8. Convertible preferred stock </U></B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B><U>Liquidation,
page <FONT STYLE="white-space:nowrap">F-18</FONT> </U></B></P> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="4%" VALIGN="top" ALIGN="left">4.</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><B><I>Please demonstrate to us why you believe that common shareholders hold a majority of the board seats and,
as such, that the company controls the vote of the Board of Directors and any deemed liquidation event. As of December</I></B><B><I></I></B><B><I>&nbsp;31, 2018, it appears that only two board seats elected are controlled by common shareholders. In
this regard, it appears that pursuant to articles 3.2.3 and 3.2.4 of your certificate of incorporation (exhibit 3.1) that the other four board seats elected are controlled by the preferred shareholders or effectively controlled by preferred
shareholders voting together with common stock as a single class given the number of shares of preferred entitled to vote on an <FONT STYLE="white-space:nowrap">as-converted</FONT> basis. </I></B> </P></TD></TR></TABLE>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">May 23, 2019 </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The Company acknowledges the Staff&#146;s comment and provides the Staff with the following explanation: </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The Company&#146;s Second Amended and Restated Voting Agreement dated October&nbsp;22, 2018, among the Company, the preferred stockholders and certain common
stockholders (the &#147;<B><I>Agreement</I></B>&#148;) contractually dictates how the preferred stockholders and other stockholders must vote their shares with respect to the election of members of the Board of Directors (the
&#147;<B><I>Board</I></B>&#148;) in connection with any voting rights they have set forth in the Company&#146;s certificate of incorporation. Despite the fact that the preferred stockholders hold a majority of the outstanding shares of the Company,
the parties to the Agreement must vote all of their shares for members of the Board as follows: </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Section&nbsp;1.2 (a) of the Agreement indicates that two
people designated by the preferred shareholders shall be elected as directors to the Board, &#147;Two people designated by Apple Tree Partners IV, L.P., a Cayman Islands limited partnership (&#147;<B><I>ATP</I></B>&#148;), which individuals shall
initially be Seth L. Harrison, M.D. and Samuel W. Hall, Ph.D., for so long as such Stockholder and its Affiliates continue to own beneficially, in the aggregate, at least a number of shares of Preferred Stock equal to 25% of the total number of
shares of Preferred Stock issued to such Stockholder and its Affiliates calculated as of the date of this Agreement, in the aggregate&#148;; </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Section&nbsp;1.2 (b) of the Agreement references the appointment of Adrian R. Krainer by the holders of the common stock as a director to the Board, &#147;One
person designated by the holders of a majority of the Shares of Common Stock held by the Key Holders, which individual shall initially be Adrian R. Krainer, for so long as the Key Holders who are then providing services to the Company as officers,
employees or consultants hold at least 15% of the then-outstanding shares of Common Stock (as adjusted for any stock splits, stock dividends, recapitalizations or the like)&#148;; </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Section&nbsp;1.2 (c) of the Agreement references the appointment of Edward Kaye, M.D. as CEO Director to the Board of Directors, &#147;The Company&#146;s
Chief Executive Officer, who shall initially be Edward Kaye, M.D. (the &#147;<B><I>CEO Director</I></B>&#148;), provided that if for any reason the CEO Director shall cease to serve as the Chief Executive Officer of the Company, each of the
Stockholders shall promptly vote their respective Shares (i)&nbsp;to remove the former Chief Executive Officer from the Board if such person has not resigned as a member of the Board; and (ii)&nbsp;to elect such person&#146;s replacement as Chief
Executive Officer of the Company as the new CEO Director&#148;; </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Section&nbsp;1.2 (d) references the appointment of Arthur A. Levin, Ph.D. and Arthur
Tzianabos, Ph.D. as Directors to the Board, &#147;Three individuals not otherwise Affiliates (as defined below) of the Company or of any Investor, two of whom shall be mutually acceptable to the Company and ATP, which individuals shall initially be
Arthur A. Levin, Ph.D. and Arthur Tzianabos, Ph.D., and one of whom shall be nominated by a majority of the remaining members of the Board and mutually acceptable to the holders of a majority of the outstanding shares of Series B Preferred Stock,
which seat shall initially be vacant.&#148; </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Section&nbsp;1.2, last paragraph, defines an &#147;Affiliate&#148;. &#147;For purposes of this Agreement, an
individual, firm, corporation, partnership, association, limited liability company, trust or any other entity (collectively, a &#147;<B><I>Person</I></B>&#148;) shall be deemed an &#147;Affiliate&#148; of another Person who, directly or indirectly,
controls, is controlled by or is under common control with such Person, including, without limitation, any general partner, managing member, officer or director of such Person or any account, fund, venture capital fund or registered investment
company now or hereafter existing that is controlled by one or more general partners, managing members or investment advisers of, or shares the same management company or investment adviser with, such Person.&#148; </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">May 23, 2019 </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">As of December&nbsp;31, 2018, the Company had, and as of today the Company has, six directors. None of the
directors referenced in Sections 1.2(b), (c) or (d)&nbsp;of the Agreement were or are affiliated with the preferred shareholders nor do any of those directors hold preferred shares. As a result, the Company considers that the preferred stockholders
hold a minority of the seats, two, on the Board, while the common shareholders combined with the mutually agreed upon members of the Board hold a majority, four, of such seats. In our view, at the balance sheet date of December&nbsp;31, 2018, the
composition of the Board is such that the preferred shareholders did not control the Board through direct representation or through other rights. Accordingly, as of December&nbsp;31, 2018, the preferred stockholders could not control the vote of the
Board and could not effectuate a deemed liquidation and cause a redemption. As such, redemption provision events were in the control of the Company and as of December&nbsp;31, 2018, the Company therefore considered permanent equity classification
for its preferred stock to be appropriate under these facts and circumstances. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Given the above explanation, the Company advises the Staff that it has
revised its disclosure on page 129 of the Registration Statement to modify the board composition language. The Company also advises the Staff that it has revised its disclosure on page <FONT STYLE="white-space:nowrap">F-19</FONT> of the Registration
Statement to conform the redemption language. Under separate cover, the Company has concurrently herewith supplementally provided the Staff with a copy of the Agreement. The Company respectfully requests that the Staff destroy such materials upon
completion of its review. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center">* * * * * * * </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">May 23, 2019 </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"> Page
 5
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">Should the Staff have additional questions or comments regarding the foregoing, please do not
hesitate to contact the undersigned at <FONT STYLE="white-space:nowrap">(650)&nbsp;335-7292,</FONT> or, in his absence, Julia Forbess at (415) <FONT STYLE="white-space:nowrap">875-2420.</FONT> </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; margin-left:54%; text-indent:-2%; font-size:10pt; font-family:Times New Roman">Sincerely, </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; margin-left:54%; text-indent:-2%; font-size:10pt; font-family:Times New Roman">/s/ Robert A. Freedman </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; margin-left:54%; text-indent:-2%; font-size:10pt; font-family:Times New Roman">Robert A. Freedman </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:54%; text-indent:-2%; font-size:10pt; font-family:Times New Roman">Partner </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; margin-left:54%; text-indent:-2%; font-size:10pt; font-family:Times New Roman">FENWICK&nbsp;&amp; WEST LLP </P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="5%" VALIGN="top" ALIGN="left">cc:</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left">Edward M. Kaye, Chief Executive Officer <BR>Stephen J. Tulipano, Chief Financial Officer <BR><B>Stoke
Therapeutics, Inc.</B> </P></TD></TR></TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; margin-left:5%; font-size:10pt; font-family:Times New Roman">Effie Toshav, Esq. </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:5%; font-size:10pt; font-family:Times New Roman">Julia Forbess, Esq. </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:5%; font-size:10pt; font-family:Times New Roman"><B>Fenwick&nbsp;&amp; West LLP</B> </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; margin-left:5%; font-size:10pt; font-family:Times New Roman">Deanna Kirkpatrick, Esq. </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:5%; font-size:10pt; font-family:Times New Roman">Marcel
Fausten, Esq. </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:5%; font-size:10pt; font-family:Times New Roman"><B>Davis Polk&nbsp;&amp; Wardwell LLP </B></P>
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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
