<SEC-DOCUMENT>0001193125-22-022278.txt : 20220304
<SEC-HEADER>0001193125-22-022278.hdr.sgml : 20220304
<ACCEPTANCE-DATETIME>20220131061031
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ACCESSION NUMBER:		0001193125-22-022278
CONFORMED SUBMISSION TYPE:	CORRESP
PUBLIC DOCUMENT COUNT:		3
FILED AS OF DATE:		20220131

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Arcellx, Inc.
		CENTRAL INDEX KEY:			0001786205
		STANDARD INDUSTRIAL CLASSIFICATION:	BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
		IRS NUMBER:				472855917
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		CORRESP

	BUSINESS ADDRESS:	
		STREET 1:		25 WEST WATKINS MILL ROAD
		STREET 2:		SUITE A
		CITY:			GAITHERSBURG
		STATE:			MD
		ZIP:			20878
		BUSINESS PHONE:		240-723-6641

	MAIL ADDRESS:	
		STREET 1:		25 WEST WATKINS MILL ROAD
		STREET 2:		SUITE A
		CITY:			GAITHERSBURG
		STATE:			MD
		ZIP:			20878
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<TYPE>CORRESP
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<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" NOWRAP>Wilson&nbsp;Sonsini&nbsp;Goodrich&nbsp;&amp;&nbsp;Rosati<BR> <P STYLE="margin-bottom:0pt; margin-top:0pt; font-size:10pt; font-family:Times New Roman">Professional Corporation</P>
<P STYLE="font-size:6pt; margin-top:0pt; margin-bottom:0pt">&nbsp;</P> <P STYLE="margin-bottom:0pt; margin-top:0pt; font-size:10pt; font-family:Times New Roman">12235 El Camino Real</P>
<P STYLE="margin-bottom:0pt; margin-top:0pt; font-size:10pt; font-family:Times New Roman">San Diego, CA 92130</P> <P STYLE="font-size:6pt; margin-top:0pt; margin-bottom:0pt">&nbsp;</P>
<P STYLE="margin-bottom:0pt; margin-top:0pt; font-size:10pt; font-family:Times New Roman">O: <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">858-350-2300</FONT></FONT></P>
<P STYLE="margin-bottom:1pt; margin-top:0pt; font-size:10pt; font-family:Times New Roman">F: 866.974.7329</P></TD></TR>
</TABLE> <P STYLE="margin-top:24pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center">January&nbsp;31, 2022 </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B><U>VIA EDGAR </U></B></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">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 Life Sciences
</P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">100 F Street, N.E. </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Washington, D.C. 20549-3720 </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">Abby Adams </P></TD></TR></TABLE>
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<TD WIDTH="9%" VALIGN="top" ALIGN="left">&nbsp;&nbsp;&nbsp;&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left">Joe McCann </P></TD></TR></TABLE>
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<TD WIDTH="9%" VALIGN="top" ALIGN="left">&nbsp;&nbsp;&nbsp;&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left">Tracey Houser </P></TD></TR></TABLE>
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<TD WIDTH="9%" VALIGN="top" ALIGN="left">&nbsp;&nbsp;&nbsp;&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left">Al Pavot </P></TD></TR></TABLE> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="4%">&nbsp;</TD>
<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>Arcellx, Inc. </B></P></TD></TR></TABLE>
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<TD WIDTH="4%">&nbsp;</TD>
<TD WIDTH="5%" VALIGN="top" ALIGN="left"><B>&nbsp;&nbsp;&nbsp;&nbsp;</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>Registration Statement on Form <FONT STYLE="white-space:nowrap">S-1</FONT> </B></P></TD></TR></TABLE>
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<TD WIDTH="5%" VALIGN="top" ALIGN="left"><B>&nbsp;&nbsp;&nbsp;&nbsp;</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>Filed January&nbsp;14, 2022 </B></P></TD></TR></TABLE>
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<TD WIDTH="4%">&nbsp;</TD>
<TD WIDTH="5%" VALIGN="top" ALIGN="left"><B>&nbsp;&nbsp;&nbsp;&nbsp;</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>File <FONT STYLE="white-space:nowrap">No.&nbsp;333-262191</FONT> </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">On behalf of our client,
Arcellx, Inc. (the &#147;<B>Company</B>&#148;), we submit this letter in response to comments from the staff (the &#147;<B>Staff</B>&#148;) of the Securities and Exchange Commission (the &#147;<B>Commission</B>&#148;) contained in its letter dated
January&nbsp;24, 2022 (the &#147;<B>Comment Letter</B>&#148;), relating to the above-referenced Registration Statement on Form <FONT STYLE="white-space:nowrap">S-1</FONT> (File <FONT STYLE="white-space:nowrap">No.&nbsp;333-262191)</FONT> filed on
January&nbsp;14, 2022 (the &#147;<B>Registration Statement</B>&#148;). We are concurrently confidentially submitting via EDGAR this letter and filing via EDGAR a revised draft of the Registration Statement (the &#147;<B>Amended Registration
Statement</B>&#148;). </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">In this letter, we have recited the comments from the Staff in italicized, bold type and have followed each comment
with the Company&#146;s response. Except for the page references contained in the comments of the Staff, or as otherwise specifically indicated, page references herein correspond to the page of the revised draft of the Amended Registration
Statement. </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B><U>Registration Statement on Form <FONT STYLE="white-space:nowrap">S-1</FONT> Filed January&nbsp;14, 2022 </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:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B><U>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"><B><I>1.</I></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><I>We note your response to prior comment 1. Please revise the fourth sentence of the Overview to clarify
that you &#147;are engineering&#148; the platform to avoid the implication that the engineering work is complete. With reference again to the first full risk factor on page 16, please balance your statements about the preliminary results by revising
the first sentence of the second paragraph on page 2 to clarify that the positive preliminary results address cover only a &#147;small number of patients&#148; that have been treated to date. Similarly, revise the fourth bullet point on page 4 to
provide similar context to the statements and claims made there. </I></B></P></TD></TR></TABLE>
 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Securities and Exchange Commission </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">January 31, 2022 </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"> Page
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 </P> <P STYLE="font-size:12pt; margin-top:0pt; margin-bottom:0pt">&nbsp;</P>
 <P STYLE="margin-top:0pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">The Company respectfully advises the Staff that in response to the Staff&#146;s comments, the
Company has revised the disclosures on pages 1, 94 and 110 of the Amended Registration Statement to clarify that the <FONT STYLE="white-space:nowrap">D-Domain</FONT> was <I>designed</I> with the intent of overcoming the limitations of traditional <FONT
STYLE="white-space:nowrap">CAR-Ts,</FONT> and avoid any implication that engineering work is complete and to further clarify that the positive preliminary results reported relate to the initial 24 patients dosed in the trial. The Company has also
revised the disclosures on pages 4 and 116 of the Amended Registration Statement to clarify that the 100% ORR and the durable responses are based on preliminary clinical data relating to the 19 patients who were evaluable for efficacy as of the data
cutoff date. </P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="4%" VALIGN="top" ALIGN="left"><B><I>2.</I></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><I>We note your revisions in response to prior comment 2. Please revise the summary to explain the terms
&#147;stringent complete response&#148; and &#147;very good partial response. </I></B></P></TD></TR></TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">The Company respectfully advises
the Staff that in response to the Staff&#146;s comments, the Company has revised the disclosures on pages 1, 110 and 111 of the Amended Registration Statement to explain the terms &#147;stringent complete response&#148; and &#147;very good partial
response&#148; are efficacy criteria defined by the 2016 International Working Group (IMWG), which are further described on page 132 of the Amended Registration Statement, and to clarify that the achievement of these criteria do not suggest that any
patient is cured, as the disease is currently incurable. </P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="4%" VALIGN="top" ALIGN="left"><B><I>3.</I></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><I>We note your revised disclosures in response to prior comment 4. Please revise to remove the Discovery
Pipeline programs from the Summary presentation or, alternatively, revise the Business section to discuss each of these programs in greater detail, including the work that you have conducted to date for each program. In addition, revise the
anticipated milestone for ddCAR to replace &#147;Pivotal&#148; with Phase 3, or, if &#147;pivotal&#148; is intended to mean something other than Phase 3, please provide disclosure to clarify. </I></B></P></TD></TR></TABLE>
<P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">The Company respectfully advises the Staff that in response to the Staff&#146;s comments, the Company has revised the disclosures on pages 3,
112, and 130 of the Amended Registration Statement to remove the Discovery Pipeline programs pipeline chart and to clarify that &#147;Pivotal&#148; as used in the pipeline chart refers to the Company&#146;s planned iMMagine Phase 2 trial, which the
Company believes, in combination with the Phase 1 trial and based on its current discussions with the FDA, will be sufficient to support the filing of a BLA for CART-ddBCMA for r/r MM. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B><U>Prospectus Summary </U></B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B><U>Our Key Investors and
Our Financing History, page 5 </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"><B><I>4.</I></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><I>We note the addition of a list of investors on page 5. Please limit the disclosure of specific investors
to those identified in the Principal Stockholder table on page 199. Additionally, indicate that prospective investors should not rely on the named investors&#146; investment decision, that these investors may have different risk tolerances and, if
true, that these investors received their shares in offerings that were conducted at a significant discount to the IPO price. </I></B></P></TD></TR></TABLE>
<P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">The Company respectfully advises the Staff that in response to the Staff&#146;s comments, the Company has revised the disclosures on pages 6
and 113 of the Amended Registration Statement to limit the investors listed therein to those identified in the Principal Stockholder table and to remind prospective investors that they should not rely on past investment decisions of the
Company&#146;s existing investors who may have different risk tolerances and have received their shares in prior offerings at lower prices. </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Securities and Exchange Commission </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">January 31, 2022 </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"> Page
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B><U>Summary Financial Data, page 12 </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"><B><I>5.</I></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><I>We note that you intend to grant various equity-based compensation awards in connection with your IPO
based on your disclosures on page 176 and 182. Please tell us your consideration for including the compensation expense associated with these grants in your pro forma presentations here and with your capitalization and dilution presentations.
</I></B></P></TD></TR></TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">The Company respectfully advises the Staff that in response to the Staff&#146;s comments, the Company has
revised the disclosures on pages 11, 13, 14, 87, 88, 89, and 92 of the Amended Registration Statement. </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B><U>Management&#146;s Discussion and Analysis of
Financial Condition and Results of Operations Critical Accounting Policies and Estimates </U></B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B><U>Determining the fair value of our common stock and
fair value of total equity, page 103 </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"><B><I>6.</I></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><I>We note the additional disclosure you provided regarding the allocation of the enterprise value to
determine the estimated fair value of our common stock and total equity value in response to comment 6. Please further expand your disclosures to provide the specific valuation approaches and methods along with the corresponding material estimates
and assumptions used in each method to estimate the enterprise value that is being allocated to your various equity instruments. </I></B></P></TD></TR></TABLE>
<P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">The Company respectfully advises the Staff that in response to the Staff&#146;s comments, the Company has revised the disclosures on pages 107
and 108 of the Amended Registration Statement. </P> <P STYLE="margin-top:18pt; 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">Securities and Exchange Commission </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">January 31, 2022 </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"> Page
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">Please direct any questions with respect to this confidential submission to me at (858) <FONT
STYLE="white-space:nowrap">350-2393</FONT> or dkoeppen@wsgr.com. </P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><DIV ALIGN="right">
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<TD VALIGN="top">Sincerely,</TD></TR>
<TR STYLE="font-size:1pt">
<TD HEIGHT="16"></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">WILSON SONSINI GOODRICH&nbsp;&amp; ROSATI</P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:10pt; font-family:Times New Roman">Professional Corporation</P></TD></TR>
<TR STYLE="font-size:1pt">
<TD HEIGHT="16"></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top" STYLE="BORDER-BOTTOM:1px solid #000000">/s/ Daniel R. Koeppen</TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="bottom">Daniel R. Koeppen</TD></TR>
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<TR style = "page-break-inside:avoid">
<TD WIDTH="4%" 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">Rami Elghandour, Arcellx, Inc. </P></TD></TR></TABLE>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman">Christopher Heery, M.D., Arcellx, Inc. </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman">Megan J. Baier, Wilson Sonsini Goodrich&nbsp;&amp; Rosati, P.C. </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman">Jennifer Fang, Wilson Sonsini Goodrich&nbsp;&amp; Rosati, P.C. </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman">Lisa Firenze, Wilmer Cutler Pickering Hale and Dorr LLP </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman">Jeffries L. <FONT STYLE="white-space:nowrap">Oliver-Li,</FONT> Wilmer Cutler Pickering Hale and Dorr LLP </P>
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