Nuvalent (Nasdaq: NUVL) posts Q1 loss, advances dual lung cancer NDAs
Rhea-AI Filing Summary
Nuvalent, Inc. reported first quarter 2026 results and highlighted major regulatory milestones for its lung cancer pipeline. Cash, cash equivalents and marketable securities were $1.3 billion as of March 31, 2026, and the company expects this to fund operations into 2029.
For the quarter, Nuvalent recorded a net loss of $109.3 million, with research and development expenses of $83.6 million and general and administrative expenses of $35.8 million. An NDA for neladalkib in ALK-positive NSCLC was submitted, and the NDA for zidesamtinib in ROS1-positive NSCLC is under FDA review with a PDUFA target action date of September 18, 2026.
Positive
- Two late-stage regulatory milestones: NDA submitted for neladalkib in ALK-positive NSCLC and zidesamtinib NDA under FDA review with a PDUFA target action date of September 18, 2026, creating multiple potential approval opportunities.
- Strong cash position and runway: Cash, cash equivalents and marketable securities of $1.3 billion as of March 31, 2026, with management expecting this to fund operations into 2029.
Negative
- None.
Insights
Nuvalent pairs heavy R&D spend with dual late-stage regulatory shots in lung cancer.
Nuvalent is transitioning toward a potential commercial stage with two parallel lead assets. The NDA for zidesamtinib in ROS1-positive NSCLC is under FDA review with a PDUFA target action date of September 18, 2026, and an NDA for neladalkib in ALK-positive NSCLC has been submitted.
First quarter 2026 operating expenses reached $119.4 million, driving a net loss of $109.3 million, but the company holds $1.3 billion in cash, cash equivalents and marketable securities and expects funding into 2029. The pipeline also includes ongoing Phase 3 ALKAZAR and early-stage HER2 and discovery programs, indicating a broad clinical agenda with substantial future data and regulatory catalysts.
8-K Event Classification
Key Figures
Key Terms
New Drug Application regulatory
PDUFA target action date regulatory
ROS1-positive NSCLC medical
ALK-positive NSCLC medical
Phase 3 randomized, controlled trial medical
working capital financial
Earnings Snapshot
Nuvalent believes existing cash, cash equivalents and marketable securities will fund operations into 2029.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
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Nuvalent, Inc.
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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) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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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:
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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 2.02. Results of Operations and Financial Condition.
On May 7, 2026, Nuvalent, Inc. announced its financial results for the quarter ended March 31, 2026, 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. |
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Description |
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99.1 |
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Press Release issued by Nuvalent, Inc. on May 7, 2026 |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
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.
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Nuvalent, Inc. |
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Date: |
May 7, 2026 |
By: |
/s/ James R. Porter, Ph.D. |
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James R. Porter, Ph.D. |
Exhibit 99.1
Nuvalent Highlights Recent Pipeline Progress, Reiterates Key Anticipated Milestones, and Reports First Quarter 2026 Financial Results
NDA submitted for neladalkib in TKI pre-treated advanced ALK-positive NSCLC
NDA for zidesamtinib in TKI pre-treated advanced ROS1-positive NSCLC under FDA review with PDUFA target action date of September 18, 2026
Submission for potential label expansion of zidesamtinib in TKI-naïve advanced ROS1-positive NSCLC planned for the second half of 2026
Strengthened leadership team with key internal promotions
CAMBRIDGE, Mass. — May 7, 2026 — Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today outlined pipeline progress, reiterated key anticipated milestones, and reported first quarter 2026 financial results.
“The forward momentum continues at Nuvalent, with both of our parallel-lead programs advancing toward key US regulatory milestones and the opportunity to bring our first new medicine to patients this year,” said James Porter, Ph.D., Chief Executive Officer of Nuvalent. “We recently submitted our NDA for neladalkib in TKI pre-treated ALK-positive NSCLC and are continuing to build our commercial infrastructure in preparation for a potential US launch of zidesamtinib in TKI pre-treated ROS1-positive NSCLC, if approved.”
Dr. Porter continued, “Beyond these initial opportunities, we remain focused on progressing our label expansion strategies for ROS1- and ALK-positive NSCLC, as well as our earlier-stage pipeline, with the goal of driving meaningful, long-term impact in NSCLC and beyond. Through these efforts, we believe we are well positioned to realize our vision of becoming a sustainable biotechnology company capable of designing, developing and delivering precisely targeted therapies for patients with cancer.”
Recent Pipeline Achievements and Anticipated Milestones
ROS1 Program
1Tangpeerachaikul et al. Annals of Oncology 2024; 35(2):S217.
ALK Program
HER2 Program
Discovery Research Programs
Recent Leadership Promotions
Upcoming Events
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.
First Quarter 2026 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 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; Nuvalent's estimated cash runway; the expected timing of potential new product candidate announcements, clinical trial initiations, data presentations, FDA submissions, product approvals and commercial launch; the clinical development programs for zidesamtinib, neladalkib and NVL-330; the potential clinical effects of Nuvalent's product development candidates; the design, timing and enrollment of Nuvalent's clinical trials, including for ALKOVE-1 its intended pivotal registration-directed design; the potential of Nuvalent's pipeline programs, including zidesamtinib, neladalkib and NVL-330 and expectations regarding Nuvalent's discovery pipeline; Nuvalent's potential commercialization of its product candidates, if approved; 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," "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 its clinical trials or that enrollment will take longer than expected; unexpected concerns that may arise from additional data, analysis, or results obtained during preclinical studies and 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 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 zidesamtinib or neladalkib; 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, ALKAZAR 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 Annual Report on Form 10-K for the fiscal year ended December 31, 2025, 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
Josie Butler
1AB
josie@labmedia.com
CONSOLIDATED STATEMENTS OF OPERATIONS |
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(In thousands, except share and per share amounts) |
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(Unaudited) |
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Three Months Ended March 31, |
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2026 |
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2025 |
Operating expenses |
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Research and development |
$ 83,608 |
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$ 74,418 |
General and administrative |
35,799 |
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20,394 |
Total operating expenses |
119,407 |
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94,812 |
Loss from operations |
(119,407) |
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(94,812) |
Other income (expense) |
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Change in fair value of related party revenue share liability |
(2,570) |
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(1,430) |
Interest income and other income (expense), net |
12,866 |
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11,817 |
Total other income (expense), net |
10,296 |
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10,387 |
Loss before income taxes |
(109,111) |
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(84,425) |
Income tax provision |
168 |
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157 |
Net loss |
$ (109,279) |
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$ (84,582) |
Net loss per share attributable to common stockholders, basic and diluted |
$ (1.39) |
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$ (1.18) |
Weighted average shares of common stock outstanding, basic and diluted |
78,670,371 |
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71,607,546 |
SELECTED BALANCE SHEET DATA |
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(In thousands) |
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(Unaudited) |
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March 31, |
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December 31, |
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2026 |
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2025 |
Cash, cash equivalents and marketable securities |
$ 1,287,476 |
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$ 1,371,952 |
Working capital |
$ 1,226,886 |
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$ 1,301,255 |
Total assets |
$ 1,331,148 |
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$ 1,412,705 |
Total liabilities |
$ 156,781 |
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$ 164,366 |
Total stockholders’ equity |
$ 1,174,367 |
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$ 1,248,339 |