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): November 14, 2023

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 November 14, 2023, Nuvalent, Inc. announced its financial results for the quarter ended September 30, 2023, 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 November 14, 2023
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: November 14, 2023		By:		/s/ James R. Porter, Ph.D.
				James R. Porter, Ph.D.
				President and Chief Executive Officer

 

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Exhibit 99.1

 

 

 

Nuvalent Highlights Corporate and Pipeline Achievements and Reports Third Quarter

2023 Financial Results

Presented preliminary Phase 1 clinical data from ALKOVE-1 trial of NVL-655, initiated Phase 2 portion of ARROS-1 trial of NVL-520, and continued advancement of NVL-330 toward clinical development
 

Appointed industry veteran Perrin Wilson Ph.D. as Senior Vice President of Business Development and Strategy

Net proceeds from $300 million public offering, along with cash, cash equivalents, and marketable securities as of September 30, 2023, expected to extend operating runway into 2027

CAMBRIDGE, Mass. — Nov. 14, 2023 — 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 and reported third quarter 2023 financial results.

“This has been another incredible year of execution for Nuvalent. With our recent presentation at ANE, we have now delivered preliminary proof-of-concept data for both of our novel parallel lead programs in ROS1 and ALK-positive cancers, and our third development candidate, NVL-330, is advancing toward clinical development,” said James Porter, Ph.D., Chief Executive Officer at Nuvalent. “This level of achievement in just over five years since first program inception is only made possible by the tireless dedication of our team to our goal of delivering potential new therapies to patients as quickly as possible.”

Dr. Porter continued, “As we turn our focus towards execution on our global development plans to support potential NDA submission and continued portfolio expansion, we are committed to maintaining the high standard and sense of urgency we have established to date. We continue to grow our team in support of this next phase of development and are thrilled to welcome Dr. Perrin Wilson, who brings deep expertise in both business development and commercial strategy.”

“We are encouraged by the positive reception to our progress and continued support from both new and longstanding stockholders, leading to a successful $300 million public offering,” added Alexandra Balcom, Chief Financial Officer at Nuvalent. “With a strong portfolio, proven team, and meaningful cash runway extension expected into 2027, we believe we are well positioned to evaluate opportunities to further accelerate and expand the potential reach of our programs, and to deliver on our mid- and long-term goals.”

Recent Pipeline Highlights and Key Anticipated Milestones

The ALKOVE-1 clinical trial is continuing to enroll patients in the Phase 1 portion of the trial and is focused on further characterizing the safety, pharmacokinetics, and pharmacodynamic profiles, determining the recommended Phase 2 dose (RP2D), and if applicable, the maximum tolerated dose of NVL-655. Upon RP2D selection, the trial is designed to transition directly into the Phase 2 portion, which will evaluate the safety and

 

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activity of NVL-655 in several expansion cohorts of patients defined based on the number and type of prior anti-cancer therapies they have received. The Phase 2 cohorts are intended to support potential registration in patients with ALK-positive NSCLC who are both lorlatinib-naïve and lorlatinib-treated.

In addition to the planned Phase 2 cohorts, Nuvalent intends to use these preliminary data in patients with heavily pre-treated ALK-positive NSCLC to guide discussions with physicians that will inform development strategies in TKI-naïve ALK-positive NSCLC.

Recent Leadership Appointments

Financing Highlight

Completed Successful Public Offering of Common Stock Raising $300 Million in Gross Proceeds: On October 19, 2023, Nuvalent closed an underwritten public offering of 5,357,143 shares of Class A common stock at a price to the public of $56.00 per share. The gross proceeds from the offering were approximately $300 million, resulting in net proceeds of approximately $282 million after deducting underwriting discounts, commissions and other offering expenses.

Upcoming Events

 

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A live webcast of each fireside chat will be available in the Investors section of Nuvalent's website at www.nuvalent.com, and will be archived for 30 days following the conference.

Third Quarter 2023 Financial Results

About Nuvalent

Nuvalent, Inc. (Nasdaq: NUVL) is a clinical-stage biopharmaceutical company focused on creating precisely targeted 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 parallel lead programs in ROS1-positive and ALK-positive non-small cell lung cancer, a program in HER2 Exon 20 insertion-positive cancers, 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 announcements; the preclinical and clinical development programs for NVL-520, NVL-655 and NVL-330; the potential clinical effect of NVL-520 and NVL-655; the potential benefits of NVL-330; the design and enrollment of the ARROS-1 and ALKOVE-1 trials, including for the ARROS-1 trial its intended pivotal registration-directed design; the potential of Nuvalent's pipeline programs, including NVL-520, NVL-655 and NVL-330; the implications of data readouts and presentations; timing and content of potential discussions with regulators and investigators; the design and timing of the planned Phase 2 portion of the ARROS-1 trial; 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.

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 the ARROS-1 or ALKOVE-1 trials or that enrollment will take longer than expected; unexpected concerns that may arise from additional data, analysis, or results obtained during preclinical studies or 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 the ARROS-1 Phase 2 trial may not be sufficient to support registration and

 

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that Nuvalent may be required to conduct one or more additional studies or trials prior to seeking registration of NVL-520; the occurrence of adverse safety events; 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 and ALKOVE-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 June 30, 2023, 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.

This press release contains hyperlinks to information that is not deemed to be incorporated by reference in this press release.

Investor Contact

Chelcie Lister

THRUST Strategic Communications

chelcie@thrustsc.com

Media Contact

Amanda Sellers
Verge Scientific Communications
asellers@vergescientific.com

SELECTED STATEMENTS OF OPERATIONS DATA
(In thousands, except share and per share data)
(Unaudited)
		Three Months Ended September 30,								Nine Months Ended September 30,
		2023				2022				2023				2022
Operating expenses:
Research and development		$	29,611			$	14,625			$	77,658			$	40,876
General and administrative			9,172				5,763				25,397				15,933
Total operating expenses			38,783				20,388				103,055				56,809
Loss from operations			(38,783	)			(20,388	)			(103,055	)			(56,809	)
Other income (expense):
Interest income and other income    (expense)			5,138				672				15,128				1,078
Total other income, net			5,138				672				15,128				1,078
Net loss		$	(33,645	)		$	(19,716	)		$	(87,927	)		$	(55,731	)
Net loss per share attributable to   common stockholders, basic and diluted		$	(0.59	)		$	(0.41	)		$	(1.55	)		$	(1.15	)
Weighted average shares of common stock   outstanding, basic and diluted			57,091,394				48,410,514				56,888,839				48,338,580

 

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SELECTED BALANCE SHEET DATA
(In thousands)
(Unaudited)
		September 30,				December 31,
		2023				2022
Cash, cash equivalents and marketable securities		$	413,258			$	472,163
Working capital		$	390,670			$	458,510
Total assets		$	425,080			$	482,459
Total liabilities		$	29,103			$	19,481
Total stockholders’ equity		$	395,977			$	462,978

 

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v3.23.3

Document and Entity Information	Nov. 14, 2023
Cover [Abstract]
Amendment Flag	false
Entity Central Index Key	0001861560
Document Type	8-K
Document Period End Date	Nov. 14, 2023
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	true
Entity Ex Transition Period	false

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