<SEC-DOCUMENT>0001193125-21-209002.txt : 20210825
<SEC-HEADER>0001193125-21-209002.hdr.sgml : 20210825
<ACCEPTANCE-DATETIME>20210706211904
<PRIVATE-TO-PUBLIC>
ACCESSION NUMBER:		0001193125-21-209002
CONFORMED SUBMISSION TYPE:	CORRESP
PUBLIC DOCUMENT COUNT:		2
FILED AS OF DATE:		20210706

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Nuvalent, Inc.
		CENTRAL INDEX KEY:			0001861560
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				000000000
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		CORRESP

	BUSINESS ADDRESS:	
		STREET 1:		ONE BROADWAY, 14TH FLOOR
		CITY:			CAMBRIDGE
		STATE:			MA
		ZIP:			02142
		BUSINESS PHONE:		508-446-2272

	MAIL ADDRESS:	
		STREET 1:		ONE BROADWAY, 14TH FLOOR
		CITY:			CAMBRIDGE
		STATE:			MA
		ZIP:			02142
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<TYPE>CORRESP
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<TD VALIGN="top"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Goodwin Procter <SMALL>LLP</SMALL></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">100 Northern
Avenue</P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Boston, MA 02210</P> <P STYLE="font-size:6pt; margin-top:0pt; margin-bottom:0pt">&nbsp;</P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">goodwinlaw.com</P> <P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:10pt; font-family:Times New Roman">+1 617 570 1000</P></TD></TR>
</TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">July&nbsp;6, 2021 </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Jane Park
</P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Jeffrey Gabor </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Franklin Wyman </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Kevin Vaughn </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">Securities and Exchange Commission </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 </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"><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>Nuvalent, Inc. </B></P></TD></TR></TABLE>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:9%; font-size:10pt; font-family:Times New Roman"><B>Draft Registration Statement on Form <FONT STYLE="white-space:nowrap">S-1</FONT></B> </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:9%; font-size:10pt; font-family:Times New Roman"><B>Submitted May&nbsp;28, 2021</B> </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:9%; font-size:10pt; font-family:Times New Roman"><B>CIK No.&nbsp;0001861560</B> </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Dear
Ms.&nbsp;Park: </P> <P STYLE="margin-top:6pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">On behalf of our client, Nuvalent, Inc. (the &#147;<B>Company</B>&#148;), we are responding to the comments from the Staff
(the &#147;<B>Staff</B>&#148;) of the Securities and Exchange Commission (the &#147;<B>Commission</B>&#148;) relating to the Company&#146;s confidential Draft Registration Statement on Form <FONT STYLE="white-space:nowrap">S-1</FONT> (the
&#147;<B>Draft Registration Statement</B>&#148;) contained in the Staff&#146;s letter dated June&nbsp;25, 2021 (the &#147;<B>Comment Letter</B>&#148;). In response to the comments set forth in the Comment Letter, the Company has revised the Draft
Registration Statement and is publicly filing a revised <FONT STYLE="white-space:nowrap">S-1</FONT> Registration Statement (the &#147;<B><FONT STYLE="white-space:nowrap">S-1</FONT> Registration Statement</B>&#148;) together with this response
letter. The <FONT STYLE="white-space:nowrap">S-1</FONT> Registration Statement also contains certain additional updates and revisions. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">Set forth below are the Company&#146;s responses to the Staff&#146;s comments in the Comment Letter. The responses and information below are
based on information provided to us by the Company. For convenience, the Staff&#146;s comments are repeated below in italics, followed by the Company&#146;s response to the comments as well as a summary of the responsive actions taken. We have
included page numbers to refer to the location in the <FONT STYLE="white-space:nowrap">S-1</FONT> Registration Statement submitted herewith where the revised language addressing a particular comment appears. Capitalized terms used but not defined
herein are used herein as defined in the <FONT STYLE="white-space:nowrap">S-1</FONT> Registration Statement. </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B><U>Draft Registration Statement on Form <FONT
STYLE="white-space:nowrap">S-1</FONT> submitted May&nbsp;28, 2021 </U></B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U>Overview, page 1 </U></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"><I>Please revise this opening paragraph to explain that your operations are preclinical. </I>
</P></TD></TR></TABLE> <P STYLE="margin-top:6pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"><B>RESPONSE: </B>The Company respectfully advises the Staff that it has revised the opening paragraph on page 1 of the <FONT
STYLE="white-space:nowrap">S-1</FONT> Registration Statement in response to the Staff&#146;s comment to clarify that the Company&#146;s operations are preclinical. </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"><I>Please clarify the meaning and significance of scientific or technical terms the first time they are used in
order to ensure that lay readers will understand the disclosure. For example, please briefly explain the meaning of kinase targets, ROS1-positive and <FONT STYLE="white-space:nowrap">ALK-</FONT> positive cancers, brain metastasis, as well as the
significance of optimizing brain penetrance and solvent-front mutations.</I> </P></TD></TR></TABLE>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"><B>RESPONSE: </B>The Company respectfully advises the Staff that it has revised its
disclosure beginning on page 1 of the <FONT STYLE="white-space:nowrap">S-1</FONT> Registration Statement and elsewhere to clarify the meaning and significance of scientific or technical terms the first time they are used, including kinase targets,
ROS1-positive and <FONT STYLE="white-space:nowrap">ALK-positive</FONT> cancers, brain metastasis, as well as the significance of optimizing brain penetrance and solvent-front mutations in response to the Staff&#146;s comment. </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"><I>We refer to your disclosure that your therapeutic programs are focused on certain clinically proven kinase
targets. Please revise to clarify that such kinase targets have been developed and clinically proven by third parties, and to the extent known, please identify such third parties.</I> </P></TD></TR></TABLE>
<P STYLE="margin-top:6pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"><B>RESPONSE: </B>The Company respectfully advises the Staff that it has revised the disclosure on pages 3, 4 and 122 of the <FONT
STYLE="white-space:nowrap">S-1</FONT> Registration Statement to clarify that the certain clinically proven kinase targets that the Company is focused on have been developed and clinically proven by third parties, and have identified Novartis, Roche,
Takeda and Pfizer as the third parties who have developed and clinically proven such kinase targets. </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"><I>Please remove </I><I>all references to </I><I>&#147;</I><I>Phase 1/2</I><I>&#148;</I><I> clinical trials
</I><I>throughout the prospectus and instead reference either phase 1, 2, or 3 distinctly or tell us the basis for your belief that have been approved to conduct a Phase 1/2 trial.</I> </P></TD></TR></TABLE>
<P STYLE="margin-top:6pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"><B>RESPONSE: </B>The Company respectfully advises the Staff that it believes &#147;Phase 1/2&#148; is an appropriate description for its
planned clinical trials. In connection with the Company&#146;s lead product candidate, <FONT STYLE="white-space:nowrap">NVL-520,</FONT> the Company has held a <FONT STYLE="white-space:nowrap">pre-IND</FONT> meeting with the U.S. Food and Drug
Administration (&#147; FDA&#148;) and has submitted the related IND for its planned <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">first-in-human</FONT></FONT> clinical trial. As part of these interactions and submissions, the
Company identified its planned <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">first-in-human</FONT></FONT> clinical trial as the &#147;Phase 1/2 Study of the Highly Selective ROS1 Inhibitor
<FONT STYLE="white-space:nowrap">NVL-520</FONT> in Patients with Advanced <FONT STYLE="white-space:nowrap">Non-Small</FONT> Cell Lung Cancer (NSCLC) and Other Solid Tumors&#148; for which no FDA comment was received, and the full protocol has since
also been submitted under the same title. </P> <P STYLE="margin-top:6pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman">The proposed Phase 1/2 trial protocol for <FONT STYLE="white-space:nowrap">NVL-520,</FONT>
includes two portions: a Phase 1 dose escalation portion and a Phase 2 dose expansion portion, each with distinct objectives and endpoints as defined in the protocol. The Phase 1 dose escalation portion is designed to evaluate safety and
tolerability of <FONT STYLE="white-space:nowrap">NVL-520.</FONT> Consistent with a Phase 1 trial, the Company plans to conduct an End of Phase 1 meeting with the FDA and, subject to feedback from the FDA, the trial has the potential to transition
directly into the Phase 2 portion once a safe and tolerable dose is determined as the recommended Phase 2 dose and without the need for a separate IND submission or protocol. The Phase 2 portion is designed as an efficacy evaluation of anti-tumor
activity, as measured by overall response rate, duration of response, progression-free survival per iRECIST, and overall survival, consistent with a Phase 2 trial. Both the Phase 1 and Phase 2 portions of the trial are expected to enroll patients
with ROS1-positive NSCLC and other advanced solid tumors. If the results of the trial are positive and subject to feedback from the FDA, the Company intends to submit a New Drug Application to the FDA for
<FONT STYLE="white-space:nowrap">NVL-520</FONT> utilizing the data from the Phase 1/2 trial in primary support of a potential marketing approval. Unlike with <FONT STYLE="white-space:nowrap">NVL-520,</FONT> the Company has not yet discussed with or
received feedback from the FDA regarding its planned trial design for its second lead program, <FONT STYLE="white-space:nowrap">NVL-655.</FONT> The Company respectfully advises that Staff that it has revised the disclosure throughout the <FONT
STYLE="white-space:nowrap">S-1</FONT> Registration Statement regarding its planned clinical development for <FONT STYLE="white-space:nowrap">NVL-655</FONT> to indicate that, subject to discussions with and feedback from the FDA, the Company plans to
design its clinical trial as a Phase 1/2 trial similar to that of <FONT STYLE="white-space:nowrap">NVL-520.</FONT> </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman">Further, the Company has added disclosure throughout the
<FONT STYLE="white-space:nowrap">S-1</FONT> Registration Statement to clarify the intended meaning of the term &#147;Phase 1/2&#148; as a combined clinical trial protocol, where a Phase 1 dose escalation portion has the potential to transition
directly into a Phase 2 dose expansion portion once a safe and tolerable dose is determined as the recommended Phase 2 dose. The Company has also added disclosure throughout the <FONT STYLE="white-space:nowrap">S-1</FONT> Registration Statement to
clarify that the planned trial initiation dates refer to the initiation of the Phase 1 portion of the planned Phase 1/2 trial. Finally, the Company has also added disclosure in the Government Regulation section to explain that when conducted in
disease-affected patients and including an endpoint of early activity or efficacy, human clinical trials may be combined as a Phase 1/2 trial, comprising a Phase 1 portion and a Phase 2 portion. </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">5.</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><I>We note your statement on pages 3, 118, 130 and elsewhere in the prospectus that your lead product
candidates are &#147;potential <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">best-in-class</FONT></FONT> product candidate[s].&#148; The term &#147;best- <FONT STYLE="white-space:nowrap">in-class&#148;</FONT> suggests that the
product candidates are effective and likely to be approved as a therapy for the treatment of NSCLC and other advanced cancers. Given the early stage of development of <FONT STYLE="white-space:nowrap">NVL-520</FONT> and
<FONT STYLE="white-space:nowrap">NVL-655,</FONT> it is not appropriate to suggest that this product is likely to be effective or receive regulatory approval. Please delete these references throughout your registration statement.</I>
</P></TD></TR></TABLE> <P STYLE="margin-top:6pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"><B>RESPONSE: </B>The Company respectfully advises the Staff that it has deleted all references to &#147;best- <FONT
STYLE="white-space:nowrap">in-class&#148;</FONT> throughout the <FONT STYLE="white-space:nowrap">S-1</FONT> Registration Statement in response to the Staff&#146;s comment. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U>Our pipeline of novel, highly selective kinase inhibitor product candidates, page 3</U> </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">6.</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><I>Please revise your pipeline table on pages 3 and 117 to include separate columns for Phase 2 and 3
trials.</I> </P></TD></TR></TABLE> <P STYLE="margin-top:6pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"><B>RESPONSE: </B>The Company respectfully advises the Staff that it has revised the pipeline table on pages
3 and 122 of the <FONT STYLE="white-space:nowrap">S-1</FONT> Registration Statement in response to the Staff&#146;s comment to create separate columns for Phase 2 and Phase 3 trials. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U>Our team, page 4 </U></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">7.</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><I>We note that you identify certain entities as investors in your company on page 5; however, some do not
appear to be among your principal stockholders as disclosed on page 196. If material, please expand your disclosure to describe the nature of each named entity&#146;s investment in you and explain to us why including this information is appropriate.
Please also explain in your response your plans to update investors about any changes these entities make with respect to their investments in the company.</I> </P></TD></TR></TABLE>
<P STYLE="margin-top:6pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"><B>RESPONSE: </B>The Company respectfully advises the Staff that it has revised the disclosure on pages 5 and 124 of the <FONT
STYLE="white-space:nowrap">S-1</FONT> Registration Statement to remove the identity of investors who are not principal stockholders of the Company. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U>Our Strategy, page 5 </U></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">8.</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><I>We note your disclosure under the first bullet point on pages 5 and 120 that you plan to &#147;rapidly
advance&#148; your two lead product candidates <FONT STYLE="white-space:nowrap">(NVL-520</FONT> and <FONT STYLE="white-space:nowrap">NVL-655)</FONT> through clinical development and regulatory approval. Please revise these statements and any similar
disclosure to remove any implication that you will be successful in advancing your product candidates in a rapid or accelerated manner as such statements are speculative.</I> </P></TD></TR></TABLE>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"><B>RESPONSE: </B>The Company respectfully advises the Staff that it has revised the
disclosure on pages 6 and 121, and throughout the <FONT STYLE="white-space:nowrap">S-1</FONT> Registration Statement in response to the Staff&#146;s comment to remove references to rapidly advancing its product candidates. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U>Risks associated with our business, page 6 </U></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">9.</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><I>Please add a bullet highlighting the risks related to the concentration of ownership of your common stock,
as discussed on page 81. Please include in this bullet and in the corresponding risk factor beginning on page 81 a discussion of the number of your executive officers and directors who are affiliated with your principal stockholders.</I>
</P></TD></TR></TABLE> <P STYLE="margin-top:6pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"><B>RESPONSE: </B>The Company respectfully advises the Staff that it has revised the disclosure on pages 7 and 84 of the <FONT
STYLE="white-space:nowrap">S-1</FONT> Registration Statement in response to the Staff&#146;s comment. </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U>Use of Proceeds, page 92 </U></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">10.</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><I>Please revise your disclosure to indicate how far the proceeds from the offering will allow you to proceed
with continued development of each program referenced.</I> </P></TD></TR></TABLE> <P STYLE="margin-top:6pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"><B>RESPONSE: </B>The Company respectfully advises the Staff
that it has revised the disclosure on pages <FONT STYLE="white-space:nowrap">10-11</FONT> and 95 of the <FONT STYLE="white-space:nowrap">S-1</FONT> Registration Statement in response to the Staff&#146;s comment. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U>Management&#146;s Discussion and Analysis of Financial Condition and Results of Operations Critical accounting policies and significant judgments and
estimates</U> </P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U>Stock-based compensation, page 112 </U></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">11.</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><I>Once you have an estimated offering price range, please explain to us the reasons for any differences
between recent valuations of your common stock leading up to the planned offering and the midpoint of your estimated offering price range. This information will facilitate our review of your accounting for stock compensation and beneficial
conversion features. Please discuss with the Staff how to submit your response.</I> </P></TD></TR></TABLE> <P STYLE="margin-top:6pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"><B>RESPONSE: </B>The Company
respectfully acknowledges the Staff&#146;s comment and will supplementally provide the requested information once the estimated offering price or range has been determined. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U>Our solution: <FONT STYLE="white-space:nowrap">NVL-520,</FONT> a ROS1-selective inhibitor, page 129 </U></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">12.</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><I>On page 129 and elsewhere you discuss your observation of <FONT STYLE="white-space:nowrap">NVL-520</FONT> to
be a &#147;potent, highly selective, and brain-penetrant ROS1 inhibitor.&#148; As safety and efficacy determinations are solely within the FDA&#146;s authority and they continue to be evaluated throughout all phases of clinical trials, please remove
these and any similar references in your prospectus. You may present objective data resulting from your <FONT STYLE="white-space:nowrap">pre-clinical</FONT> trials without including conclusions related to efficacy.</I> </P></TD></TR></TABLE>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"><B>RESPONSE: </B>The Company respectfully advises the Staff that it has added supplemental
disclosure on pages 133 and 144 of the <FONT STYLE="white-space:nowrap">S-1</FONT> Registration Statement to clarify that the term potency as used in the <FONT STYLE="white-space:nowrap">S-1</FONT> Registration Statement refers to the amount of drug
required to produce a pharmacological effect of given intensity, is not a measure of therapeutic efficacy, and that all statements of the potency, selectivity, and brain penetrance of product candidates in the
<FONT STYLE="white-space:nowrap">S-1</FONT> Registration Statement have been based on preclinical <I>in vitro</I> or <I>in vivo</I> studies that are described within the <FONT STYLE="white-space:nowrap">S-1</FONT> Registration Statement and that are
the Company&#146;s observations of such studies rather than assertions of such characteristics. </P> <P STYLE="margin-top:6pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman">The Company respectfully advises the Staff
that &#147;potency,&#148; &#147;selectivity&#148;, and &#147;brain penetrance&#148; are terms that characterize the behavior of a drug in a model system such as a cell line, animal, or human, and are not measures of &#147;safety&#148; or
&#147;efficacy&#148; which judge the therapeutic tolerability and efficacy in humans. In addition, the Company believes it is appropriate to characterize the potency, selectivity, and brain penetrance of product candidates in preclinical models in
order to inform the clinical dose range to be tested and the patient population that the product candidate is most likely to benefit prior to first in human testing. </P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman">Potency is a characterization of the activity of a drug in terms of the concentration or amount of the drug required to produce a defined
pharmacological effect. The Company believes the description of the potency of its product candidates is material information to investors, as their relatively high potency against both the wild-type kinase and resistance variants as compared to
their relatively low potency against <FONT STYLE="white-space:nowrap">off-targets</FONT> such as TRKB is one of the key differentiators that the Company believes will potentially allow its product candidates to be highly selective. Preclinical data
in support of the description of <FONT STYLE="white-space:nowrap">NVL-520</FONT> as a &#147;potent&#148; ROS1 inhibitor is shown in Figures <FONT STYLE="white-space:nowrap">6-7,</FONT> where the Company observed single nanomolar IC<SUB
STYLE="font-size:85%; vertical-align:bottom">50</SUB> against both wild-type ROS1 and ROS1 resistance variants. Preclinical data in support of the description of <FONT STYLE="white-space:nowrap">NVL-655</FONT> as a &#147;potent&#148; ALK inhibitor
is shown in Figures <FONT STYLE="white-space:nowrap">15-16,</FONT> where the Company observed single nanomolar IC<SUB STYLE="font-size:85%; vertical-align:bottom">50</SUB> against both wild-type ALK and ALK resistance variants. </P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman">Selectivity is a characterization of the pharmacodynamic properties of a drug in terms of identifying the targets that it is likely to engage.
The Company believes the description of the selectivity of its product candidates is material information to investors, as selectivity against <FONT STYLE="white-space:nowrap">off-target</FONT> kinases such as TRKB is one of the key differentiators
that the Company believes will potentially enable its product candidates to minimize <FONT STYLE="white-space:nowrap">off-target</FONT> toxicities, such as the CNS adverse events observed with brain-penetrant TRK inhibitors. Preclinical data in
support of the description of <FONT STYLE="white-space:nowrap">NVL-520</FONT> as a &#147;selective&#148; ROS1 inhibitor is shown in Figures <FONT STYLE="white-space:nowrap">8-9,</FONT> where the Company observed relative selectivity of over 50 fold
for wild-type ROS1 over 328 other kinase targets, and in particular 69 to 210 fold higher relative selectivity for ROS1 variants over TRKB with <FONT STYLE="white-space:nowrap">NVL-520.</FONT> Preclinical data in support of the description of <FONT
STYLE="white-space:nowrap">NVL-655</FONT> as a &#147;potent&#148; ALK inhibitor is shown in Figures <FONT STYLE="white-space:nowrap">17-18,</FONT> where the Company observed relative selectivity of over 50 fold for wild-type ALK over 323 other
kinase targets, and in particular 50 to 467 fold higher relative selectivity for ALK variants over TRKB with <FONT STYLE="white-space:nowrap">NVL-655.</FONT> </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman">Brain penetrance is a characterization of the physical-chemical properties of a drug in
terms of its ability to cross the blood-brain-barrier. The Company believes the description of the brain penetrance of the Company&#146;s product candidates, <FONT STYLE="white-space:nowrap">NVL-520</FONT> and
<FONT STYLE="white-space:nowrap">NVL-655,</FONT> is material information to investors, as up to 40% of ROS1-positive or <FONT STYLE="white-space:nowrap">ALK-positive</FONT> NSCLC patients present with brain metastases, which require a brain
penetrant compound to treat. Preclinical data in support of the description of <FONT STYLE="white-space:nowrap">NVL-520</FONT> as a &#147;brain penetrant&#148; ROS1 inhibitor is shown in Figure 10, where the Company observed similar preclinical
brain penetrance of <FONT STYLE="white-space:nowrap">NVL-520</FONT> as seen with lorlatinib, which is known to be a clinically <FONT STYLE="white-space:nowrap">CNS-active</FONT> drug. Preclinical data in support of the description of <FONT
STYLE="white-space:nowrap">NVL-655</FONT> as &#147;brain penetrant&#148; is shown in Figure 19, where the Company observed similar preclinical brain penetrance of <FONT STYLE="white-space:nowrap">NVL-655</FONT> to the preclinical brain penetrance
observed with lorlatinib, which is known to be a clinically <FONT STYLE="white-space:nowrap">CNS-active</FONT> drug. </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">13.</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><I>We note your comparison of <FONT STYLE="white-space:nowrap">NVL-520</FONT> and <FONT
STYLE="white-space:nowrap">NVL-655</FONT> to other inhibitors on pages 130 and 140. As you have not conducted <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">head-to-head</FONT></FONT> clinical trials, please tell us why you
believe it is appropriate to include these comparisons. Include in your response whether you expect to be able to rely on this data to support an application for marketing approval from the FDA or comparable regulatory body for commercialization of <FONT
STYLE="white-space:nowrap">NVL-520</FONT> and <FONT STYLE="white-space:nowrap">NVL-655.</FONT></I> </P></TD></TR></TABLE> <P STYLE="margin-top:6pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"><B>RESPONSE: </B>The
Company respectfully acknowledges the Staff&#146;s comment and has added disclosure throughout the <FONT STYLE="white-space:nowrap">S-1</FONT> Registration Statement to highlight that any comparative information that is presented is based on
preclinical studies of the currently approved and investigational therapies under the same study conditions, that no <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">head-to-head</FONT></FONT> clinical trials have been conducted for
the currently approved and investigational therapies versus <FONT STYLE="white-space:nowrap">NVL-520</FONT> or <FONT STYLE="white-space:nowrap">NVL-655</FONT> nor have any clinical trials been conducted for
<FONT STYLE="white-space:nowrap">NVL-520</FONT> or <FONT STYLE="white-space:nowrap">NVL-655.</FONT> </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman">The Company respectfully advises the Staff that it believes it is appropriate to include
comparisons of <FONT STYLE="white-space:nowrap">NVL-520</FONT> and <FONT STYLE="white-space:nowrap">NVL-655</FONT> to other inhibitors. The tables on pages 136 and 146 summarize the Company&#146;s observations of preclinical studies conducted by the
Company or on its behalf, where the listed compounds were tested in the same experiments and under the same conditions with <FONT STYLE="white-space:nowrap">NVL-520</FONT> or <FONT STYLE="white-space:nowrap">NVL-655,</FONT> respectively. Because <FONT
STYLE="white-space:nowrap">NVL-520</FONT> and <FONT STYLE="white-space:nowrap">NVL-655</FONT> are specifically designed to address the limitations of currently available inhibitors, the Company believes that the inclusion of these preclinical
observations is directly relevant to evaluation of these product candidates by potential investors. </P> <P STYLE="margin-top:6pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman">To characterize the preclinical
activity of the listed compounds against their wild-type or resistance variant targets, the Company conducted preclinical experiments to measure the potency of each listed compound in <I>in vitro</I> cell viability assays against each target of
interest. </P> <P STYLE="margin-top:6pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman">To characterize the preclinical ability of the various compounds to spare TRK, the Company conducted preclinical experiments to
measure the relative potency of each listed compound for its primary development target compared to its potency for TRKB in <I>in vitro</I> assays. Potency in these <I>in vitro</I> assays refers to the amount of drug required to produce a
pharmacological effect of given intensity as described by the demonstrated IC<SUB STYLE="font-size:85%; vertical-align:bottom">50</SUB>, or the concentration of drug required for 50% inhibition of cell viability, and is not a measure of therapeutic
efficacy. The CNS activity of <FONT STYLE="white-space:nowrap">NVL-520</FONT> and <FONT STYLE="white-space:nowrap">NVL-655</FONT> was characterized based on preclinical <I>in vitro</I> and <I>in vivo</I> experiments run by or on behalf of the
Company, as indicated in the table. Where indicated in the table, characterizations for CNS activity for the other approved or investigational agents are summarized as they appear in the FDA approved prescribing information or as they were reported
by the sponsor of the investigational agent in clinical trials. The preclinical experiments for which the observations are summarized on pages 136 and 146 are described in the preclinical results discussions in the
<FONT STYLE="white-space:nowrap">S-1</FONT> Registration Statement. </P> <P STYLE="margin-top:6pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman">The preclinical data described under the heading &#147;Preclinical
results&#148; for <FONT STYLE="white-space:nowrap">NVL-520</FONT> beginning on page 134 were included in the Company&#146;s IND for <FONT STYLE="white-space:nowrap">NVL-520</FONT> submitted with the FDA as support for initiating clinical studies in
humans, including for patients with ROS1-positive NSCLC and other advanced solid tumors.<I> </I>The preclinical data for <FONT STYLE="white-space:nowrap">NVL-655</FONT> is similarly expected to be included in the planned IND submission for <FONT
STYLE="white-space:nowrap">NVL-655</FONT> as support for initiating clinical studies, including patients with <FONT STYLE="white-space:nowrap">ALK-positive</FONT> NSCLC and other advanced cancers. The Company expects to include the preclinical data
in any NDA submission for potential marketing approval for <FONT STYLE="white-space:nowrap">NVL-520</FONT> or <FONT STYLE="white-space:nowrap">NVL-655,</FONT> but notes that any NDA submission will also include clinical data generated from the
Company&#146;s planned trials as described under the heading &#147;Clinical development plan&#148; for each product candidate in the <FONT STYLE="white-space:nowrap">S-1</FONT> Registration Statement. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U>Preclinical results, page 130 </U></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">14.</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><I>For each of the preclinical trials discussed in this section and your preclinical results discussion
starting on page 140, please revise to clarify scope, size, and design; whether the studies were powered to show statistical significance; and revise your characterizations of the <FONT STYLE="white-space:nowrap">pre-clinical</FONT> trials to
discuss the data, rather than drawing conclusions from the results. Please also explain the different color coding used in Figure 7, as well as Figure 15 and Figure 16.</I> </P></TD></TR></TABLE>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"><B>RESPONSE: </B>The Company respectfully advises the Staff that it has revised the
disclosure throughout the preclinical results discussion of the <FONT STYLE="white-space:nowrap">S-1</FONT> Registration Statement in response to the Staff&#146;s comment to include additional details regarding the preclinical studies, including
their experimental design, how the results were measured, and whether the studies were powered to show statistical significance. Language has been revised or removed throughout the preclinical results discussion to discuss the data rather than draw
conclusions from the results. In addition, the Company has added a key to the color coding used in the captions for Figures 6, 7, 15, and 16. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U>Competitors, page 147 </U></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">15.</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><I>We refer to your disclosure on page 148 that there are no approved therapies for second- line treatment of
ROS1-positive NSCLC and that your <FONT STYLE="white-space:nowrap">NVL-520</FONT> product candidate has a differentiated profile compared to TRK treatments. Please expand your disclosure to </I><I>discuss how your
<FONT STYLE="white-space:nowrap">NVL-520</FONT> is differentiated from other first-line treatments that do not appear to be <FONT STYLE="white-space:nowrap">TRK-based,</FONT> such as crizotinib and entrectinib</I><I>.</I> </P></TD></TR></TABLE>
<P STYLE="margin-top:6pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"><B>RESPONSE: </B>The Company respectfully advises the Staff that it has expanded the disclosure on pages 153 and 154 of the <FONT
STYLE="white-space:nowrap">S-1</FONT> Registration Statement to discuss how <FONT STYLE="white-space:nowrap">NVL-520</FONT> is differentiated from other first-line treatments that do not appear to be
<FONT STYLE="white-space:nowrap">TRK-based,</FONT> such as crizotinib and entrectinib. </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">16.</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><I>You disclose on page 149 that while there are five currently approved ALK inhibitors for the treatment of
NSCLC, none have been approved for third-line treatment for NSCLC. Please clarify if any ALK inhibitors have been approved as second-line treatments and also expand your disclosure, where applicable, relating to the differences in the first, second
and third-line treatments and the criteria used in their approval process.</I> </P></TD></TR></TABLE> <P STYLE="margin-top:6pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"><B>RESPONSE: </B>The Company respectfully
advises the Staff that it has clarified the disclosure on page 154 of the <FONT STYLE="white-space:nowrap">S-1</FONT> Registration Statement to identify which ALK inhibitors have been approved by the FDA, noting that such approvals are agnostic as
to the line of therapy. The Company has also expanded the disclosure on page 154 of the <FONT STYLE="white-space:nowrap">S-1</FONT> Registration Statement to discuss the criteria used in their approval process. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U>Intellectual Property, page 149 </U></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">17.</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><I>Please disclose the expected expiration and applicable jurisdiction of the patent applications for your
ROS1, ALK and ErbB programs.</I> </P></TD></TR></TABLE> <P STYLE="margin-top:6pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"><B>RESPONSE</B>: The Company respectfully advises the Staff that it has expanded the
disclosure on page 157 of the <FONT STYLE="white-space:nowrap">S-1</FONT> Registration Statement in response to the Staff&#146;s comment to disclose the expected expiration and applicable jurisdiction of the patent applications for its ROS1, ALK and
ErbB programs. </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U>Agreements with our stockholders, page 194 </U></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">18.</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><I>We note your disclosure of your revenue sharing agreements with Deerfield and Dr.</I><I></I><I>&nbsp;Matthew
Shair. Please expand your disclosure to include the termination provisions, when the <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">last-to-expire</FONT></FONT> patent is scheduled to expire, the aggregate future milestone
payments to be paid and the amounts of any upfront fees, as applicable. Please also include similar disclosure in the Business section.</I> </P></TD></TR></TABLE>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"><B>RESPONSE: </B>The Company respectfully advises the Staff that it has expanded the
disclosure on pages 155, 156, 204 and 205 of the <FONT STYLE="white-space:nowrap">S-1</FONT> Registration Statement in response to the Staff&#146;s comment. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U>General </U></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">19.</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><I>Please provide us with supplemental copies of all written communications, as defined in Rule 405 under the
Securities Act, that you, or anyone authorized to do so on your behalf, have presented or expect to present to potential investors in reliance on Section</I><I></I><I>&nbsp;5(d) of the Securities Act, whether or not you retained, or intend to
retain, copies of those communications.</I> </P></TD></TR></TABLE> <P STYLE="margin-top:6pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"><B>RESPONSE: </B>The Company respectfully advises the Staff that it will
provide the Staff, on a confidential basis under separate cover, copies of all written communications presented to potential investors in reliance on Section&nbsp;5(d)&nbsp;of the Securities Act, whether or not they retain copies of such
communications. </P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; margin-left:1.00em; text-indent:-1.00em; font-size:10pt; font-family:Times New Roman">Sincerely,</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"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; margin-left:1.00em; text-indent:-1.00em; font-size:10pt; font-family:Times New Roman">/s/ Sarah Ashfaq</P></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="bottom"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; margin-left:1.00em; text-indent:-1.00em; font-size:10pt; font-family:Times New Roman">Sarah Ashfaq</P></TD></TR>
</TABLE> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<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">James R. Porter, <I>Nuvalent, Inc.</I> </P></TD></TR></TABLE>
<P STYLE="margin-top:0pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">Alexandra Balcom, <I>Nuvalent, Inc.</I> </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">Richard Hoffman, <I>Goodwin Procter LLP </I> </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">Alicia M. Tschirhart, <I>Goodwin Procter LLP</I> </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">Arthur D. Robinson, <I>Simpson Thacher</I><I></I><I>&nbsp;&amp; Bartlett LLP</I> </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">Jean Park, <I>Simpson Thacher</I><I></I><I>&nbsp;&amp; Bartlett LLP</I> </P>
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