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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): July 22, 2024

NUVALENT, INC.

(Exact name of registrant as specified in its charter)

 

Delaware

001-40671

81-5112298

(State or other jurisdiction
of incorporation)

(Commission
File Number)

(I.R.S. Employer
Identification No.)

Nuvalent, Inc.

One Broadway, 14th Floor, Cambridge, Massachusetts 02142

(Address of principal executive offices, including zip code)

(857) 357-7000

(Registrant’s telephone number, including area code)

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trade
Symbol(s)

Name of each exchange
on which registered

Class A Common Stock, $0.0001 par value per share

NUVL

The Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

Item 8.01. Other Events.

On July 22, 2024, Nuvalent, Inc. announced the initiation of HEROEX-1, its Phase 1a/1b clinical trial evaluating its novel HER2-selective inhibitor, NVL-330, for pre-treated patients with HER2-altered non-small cell lung cancer, with the dosing of the first patient in the trial. The HEROEX-1 trial will evaluate the overall safety and tolerability of NVL-330. Additional objectives include determination of the recommended Phase 2 dose, characterization of the pharmacokinetic profile, and preliminary evaluation of anti-tumor activity.

 

 

 

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Nuvalent, Inc.

 

 

 

Date: July 22, 2024

By:

/s/ Deborah A. Miller

 

 

Deborah A. Miller, Ph.D.

 

 

Chief Legal Officer and Secretary

 

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Document and Entity Information
Jul. 22, 2024
Cover [Abstract]  
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Entity Central Index Key 0001861560
Document Type 8-K
Document Period End Date Jul. 22, 2024
Entity Registrant Name NUVALENT, INC.
Entity Incorporation State Country Code DE
Entity File Number 001-40671
Entity Tax Identification Number 81-5112298
Entity Address, Address Line One One Broadway
Entity Address, Address Line Two 14th Floor
Entity Address, City or Town Cambridge
Entity Address, State or Province MA
Entity Address, Postal Zip Code 02142
City Area Code 857
Local Phone Number 357-7000
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Soliciting Material false
Pre Commencement Tender Offer false
Pre Commencement Issuer Tender Offer false
Security 12b Title Class A Common Stock, $0.0001 par value per share
Trading Symbol NUVL
Security Exchange Name NASDAQ
Entity Emerging Growth Company false
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