NUVL Nuvalent Inc

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): August 8, 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. ☐

 

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Item 2.02. Results of Operations and Financial Condition.

On August 8, 2024, Nuvalent, Inc. announced its financial results for the quarter ended June 30, 2024, and other corporate updates. A copy of the press release issued in connection with the announcement is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information in this Current Report on Form 8-K (including Exhibit 99.1 attached hereto) is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

The following exhibit relating to Item 2.02 of this Form 8-K shall be deemed to be furnished and not filed:

Exhibit No.		Description
99.1		Press Release issued by Nuvalent, Inc. on August 8, 2024
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

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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: August 8, 2024		By:		/s/ James R. Porter, Ph.D.
				James R. Porter, Ph.D.
				President and Chief Executive Officer

 

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Nuvalent Highlights Pipeline Progress, Reiterates Key Anticipated Milestones, and Reports Second Quarter 2024 Financial Results

Company plans to host a conference call in conjunction with oral presentations at ESMO on September 14, 2024, at 8:30 a.m. ET/2:30 p.m. CEST

$658.0 million in cash, cash equivalents and marketable securities expected to

support operating runway into 2027

CAMBRIDGE, Mass. — August 8, 2024 — Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today highlighted pipeline progress, reiterated key anticipated milestones, and reported second quarter 2024 financial results.

“The focused efforts of our team have led to strong execution across our pipeline in 2024 to date, including the initiation of the Phase 2 portion of our ALKOVE-1 trial for NVL-655 with registrational intent, receipt of FDA breakthrough therapy designation for both zidesamtinib and NVL-655, and initiation of the HEROEX-1 trial for our third development program, NVL-330,” said James Porter, Ph.D., Chief Executive Officer at Nuvalent. “We’ve entered the second half of 2024 with significant enrollment progress in the global Phase 2 portions of our ARROS-1 and ALKOVE-1 clinical trials, and plan to provide a status update for both trials concurrent with the presentations of updated Phase 1 dose-escalation datasets at ESMO. We also expect to outline our broader front-line development strategy for our ALK program later this year. Guided by our OnTarget 2026 operating plan and an unwavering commitment to our goal of bringing precisely targeted therapies to patients with cancer, we remain confident in our ability to deliver at least one pivotal dataset in 2025 towards our first potential approved product in 2026.”

Recent Pipeline Progress and Anticipated Milestones

ALK Program

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ROS1 Program

HER2 Program

ESMO Conference Call Information

Management will host a live webcast and conference call in conjunction with its data presentations at the ESMO Congress 2024 in Barcelona, Spain on Saturday, September 14, 2024, at 8:30 a.m. ET/2:30 p.m. CEST.

To access the call, register online here for the live webcast or dial +1 (800) 836-8184 (domestic) or +1 (646) 357-8785 (international) at least 10 minutes prior to the start time and ask to be joined to the Nuvalent call. Accompanying slides and a live video webcast will be available in the Investors section of the Nuvalent website at https://investors.nuvalent.com/events. A replay and accompanying slides will be archived on the Nuvalent website for 30 days.

Second Quarter 2024 Financial Results

About OnTarget 2026

OnTarget 2026 delineates Nuvalent's 3-year operating plan towards bringing new, potential best-in-class medicines to patients with cancer. As part of this plan announced in January 2024, Nuvalent outlined the

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following anticipated milestones throughout 2024, leading to the company's first potential pivotal data in 2025 and first potential approved product in 2026:

About Nuvalent

Nuvalent, Inc. (Nasdaq: NUVL) is a clinical-stage biopharmaceutical company focused on creating preciselytargeted therapies for patients with cancer, designed to overcome the limitations of existing therapies for clinically proven kinase targets. Leveraging deep expertise in chemistry and structure-based drug design, we develop innovative small molecules that have the potential to overcome resistance, minimize adverse events, address brain metastases, and drive more durable responses. Nuvalent is advancing a robust pipeline with investigational candidates for ROS1-positive, ALK-positive, and HER2-altered non-small cell lung cancer, and multiple discovery-stage research programs.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding Nuvalent's strategy, business plans, and focus; the period over which Nuvalent estimates its cash, cash equivalents and marketable securities will be sufficient to fund its future operating expenses and capital expenditure requirements; the expected timing of data and development strategy announcements and FDA product approvals, including the projections in our OnTarget 2026 operating plan; the clinical development programs for zidesamtinib, NVL-655 and NVL-330; the potential clinical effects of Nuvalent's product development candidates; the design and enrollment of Nuvalent’s clinical trials, including for ARROS-1 and ALKOVE-1 their intended pivotal registration-directed design; the potential of Nuvalent's pipeline programs, including zidesamtinib, NVL-655 and NVL-330; the implications of data readouts and presentations; Nuvalent's research and development programs for the treatment of cancer; and risks and uncertainties associated with drug development. The words "may," "might," "will," "could," "would," "should," "expect," "plan," "anticipate," "aim," "goal," "intend," "believe," "expect," "estimate," "seek," "predict," "future," "project," "potential," "continue," "target" or the negative of these terms and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. You should not place undue reliance on these statements or the scientific data presented.

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Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties, and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation: risks that Nuvalent may not fully enroll its clinical trials or that enrollment will take longer than expected; unexpected concerns that may arise from additional data, analysis, or results obtained during clinical trials; the risk that results of earlier clinical trials may not be predictive of the results of later-stage clinical trials; the risk that data from our ARROS-1 and ALKOVE-1 clinical trials may not be sufficient to support registration and that Nuvalent may be required to conduct one or more additional studies or trials prior to seeking registration of our zidesamtinib or NVL-655 product candidates; risks that Nuvalent may not achieve the goals and milestones set forth in its OnTarget 2026 operating plan; the occurrence of adverse safety events; risks that the FDA may not approve our potential products on the timelines we expect, or at all; risks of unexpected costs, delays, or other unexpected hurdles; risks that Nuvalent may not be able to nominate drug candidates from its discovery programs; the direct or indirect impact of public health emergencies or global geopolitical circumstances on the timing and anticipated timing and results of Nuvalent's clinical trials, strategy, and future operations, including the ARROS-1, ALKOVE-1 and HEROEX-1 trials; the timing and outcome of Nuvalent's planned interactions with regulatory authorities; and risks related to obtaining, maintaining, and protecting Nuvalent's intellectual property. These and other risks and uncertainties are described in greater detail in the section entitled "Risk Factors" in Nuvalent's Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2024, as well as any prior and subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent Nuvalent's views only as of today and should not be relied upon as representing its views as of any subsequent date. Nuvalent explicitly disclaims any obligation to update any forward-looking statements.

Investor Contact

Chelcie Lister

Nuvalent, Inc.

clister@nuvalent.com

Media Contact

Amanda Sellers
Deerfield Group
amanda.sellers@deerfieldgroup.com

 

CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except share and per share amounts)
(Unaudited)
		Three Months Ended June 30,				Six Months Ended June 30,
		2024		2023		2024		2023
Operating expenses
Research and development		$ 49,166		$ 25,922		$ 87,800		$ 48,047
General and administrative		15,984		8,140		29,938		16,225
Total operating expenses		65,150		34,062		117,738		64,272
Loss from operations		(65,150)		(34,062)		(117,738)		(64,272)

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Other income (expense)
Interest income and other income (expense), net		8,154		4,972		16,643		9,990
Total other income (expense), net		8,154		4,972		16,643		9,990
Loss before income taxes		(56,996)		(29,090)		(101,095)		(54,282)
Income tax provision		170		—		553		—
Net loss		$ (57,166)		$ (29,090)		$ (101,648)		$ (54,282)
Net loss per share attributable to common stockholders, basic and diluted		$ (0.88)		$ (0.51)		$ (1.58)		$ (0.96)
Weighted average shares of common stock outstanding, basic and diluted		64,605,308		56,866,991		64,377,948		56,785,883

SELECTED BALANCE SHEET DATA
(In thousands)
(Unaudited)
		June 30,		December 31,
		2024		2023
Cash, cash equivalents and marketable securities		$ 657,994		$ 719,905
Working capital		$ 628,066		$ 694,665
Total assets		$ 675,230		$ 732,384
Total liabilities		$ 38,192		$ 31,823
Total stockholders’ equity		$ 637,038		$ 700,561

 

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v3.24.2.u1

Document and Entity Information	Aug. 08, 2024
Cover [Abstract]
Amendment Flag	false
Entity Central Index Key	0001861560
Document Type	8-K
Document Period End Date	Aug. 08, 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
Written Communications	false
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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