8-K
Nuvalent, Inc. (NUVL)
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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): March 29, 2022
NUVALENT, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 001-40671 | 81-5112298 |
|---|---|---|
| (State or other jurisdiction<br>of incorporation) | (Commission<br>File Number) | (I.R.S. Employer<br>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<br>Symbol(s) | Name of each exchange<br>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 2.02. Results of Operations and Financial Condition.
On March 29, 2022, Nuvalent, Inc. announced its financial results for the quarter and the year ended December 31, 2021, and other corporate updates. A copy of the press release 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 March 29, 2022 |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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: March 29, 2022 | By: | /s/ James R. Porter |
| James R. Porter | ||
| President and Chief Executive Officer |
EX-99.1
Exhibit 99.1
Nuvalent Reports Pipeline and Business Progress and Fourth Quarter and Full Year 2021 Financial Results
NVL-655 IND cleared by FDA, supporting planned initiation ofALKOVE-1 Phase 1/2 clinical trial in patients with ALK-positive NSCLC and other solid tumors in second quarter of 2022
Enrollment ongoing in ARROS-1 trial of NVL-520 for advancedROS1-positive NSCLC and other solid tumors
Discovery pipeline continues to advance toward two development candidate nominations in2022
CAMBRIDGE, Mass. — March 29, 2022 — Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today reported pipeline and business progress and fourth quarter and full year 2021 financial results.
As part of today’s update, Nuvalent is announcing that its Investigational New Drug (IND) application for NVL-655 for the treatment of ALK-positive NSCLC and other solid tumors was cleared by the U.S. Food and Drug Administration (FDA). NVL-655 is a novel ALK-selective inhibitor designed with the aim to address the clinical challenges of emergent treatment resistance, central nervous system (CNS)-related adverse events, and brain metastases that may limit the use of currently available ALK inhibitors. Nuvalent plans to initiate the ALKOVE-1 Phase 1/2 study of NVL-655 for patients with advanced ALK-positive non-small cell lung cancer (NSCLC) and other solid tumors in the second quarter of 2022.
“The Nuvalent team has continued to demonstrate the ability to discover novel molecules with preclinical profiles suggesting best-in-class potential and to progress them efficiently into clinical development. With the clearance of our IND for NVL-655, Nuvalent is on track to have two parallel lead compounds in clinical trials by mid-year,” said James Porter, Ph.D., Chief Executive Officer at Nuvalent. “We believe we are well positioned with two clinical-stage, novel product candidates in areas of significant medical need, and sustainable internal discovery efforts with the goal of delivering multiple additional product candidates. I am incredibly proud of all that this team has accomplished and their continued dedication to advancing new potential therapeutic options for patients in need.”
Recent Pipeline Highlights
| • | Enrollment Ongoing in ARROS-1 Trial ofNVL-520 for Patients with Advanced ROS1-positive NSCLC: Nuvalent is actively enrolling patients in the Phase 1 portion of its ARROS-1 clinical trial, a Phase 1/2<br>study evaluating NVL-520 in patients with advanced ROS1-positive NSCLC and other solid tumors. NVL-520, Nuvalent’s lead product candidate, is a novel ROS1-selective<br>inhibitor designed with the aim to address the clinical challenges of emergent treatment resistance, CNS adverse events, and brain metastases that may limit the use of currently available ROS1 kinase inhibitors. |
|---|---|
| • | Discovery Pipeline Advancing toward Selection of Next Development Candidates: Nuvalent continues to<br>advance its early pipeline efforts with multiple discovery-stage research programs. The company expects to nominate product candidates in 2022 for its discovery programs directed toward ALK IXDN compound resistance mutations and HER2 exon 20<br>insertions. |
| --- | --- |
Recent Business Highlights
| • | Strengthened Board of Directors with Appointment of Emily Drabant Conley, Ph.D.: In February 2022,<br>Nuvalent appointed Emily Drabant Conley, Ph.D., Chief Executive Officer of Federation Bio, to its Board of Directors. Dr. Conley’s work has contributed to industry-shaping advances in genomics that empower patients and clinicians with<br>actionable health data. Prior to Federation Bio, she spent over a decade at 23andMe where, as Vice President of Business Development, she was instrumental in powering the company’s growth from 30 employees into a household name.<br> |
|---|
Fourth Quarter and Full Year 2021 Financial Results
| • | Cash Position: Cash, cash equivalents and marketable securities were $288.1<br>million as of December 31, 2021. **** Nuvalent expects that its existing cash, cash equivalents and marketable securities will be sufficient to fund its planned operations into 2024. |
|---|---|
| • | R&D Expenses: Research and development (R&D) expenses were $13.2 million for<br>the quarter ended December 31, 2021, and $35.6 million for the year ended December 31, 2021. |
| --- | --- |
| • | G&A Expenses: General and administrative (G&A) expenses were $4.2 million<br>for the quarter ended December 31, 2021, and $10.3 million for the year ended December 31, 2021. |
| --- | --- |
| • | Net Loss: Net loss was $17.3 million for the quarter ended December 31, 2021,<br>and $46.3 million for the year ended December 31, 2021. **** |
| --- | --- |
SELECTED STATEMENTS OF OPERATIONS DATA
(In thousands, except share and per share data)
(Unaudited)
| Three Months EndedDecember 31, | Year Ended December 31, | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2021 | 2020 | 2021 | 2020 | |||||||||
| Operating expenses: | ||||||||||||
| Research and development | $ | 13,194 | $ | 4,699 | $ | 35,559 | $ | 15,403 | ||||
| General and administrative | 4,184 | 515 | 10,258 | 1,502 | ||||||||
| Total operating expenses | 17,378 | 5,214 | 45,817 | 16,905 | ||||||||
| Loss from operations | (17,378 | ) | (5,214 | ) | (45,817 | ) | (16,905 | ) | ||||
| Other income (expense): | ||||||||||||
| Change in fair value of preferred stock tranche rights | — | (1,363 | ) | (635 | ) | 2,384 | ||||||
| Other income (expense), net | 89 | (3 | ) | 114 | (35 | ) | ||||||
| Total other income (expense), net | 89 | (1,366 | ) | (521 | ) | 2,349 | ||||||
| Net loss | $ | (17,289 | ) | $ | (6,580 | ) | $ | (46,338 | ) | $ | (14,556 | ) |
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.36 | ) | $ | (2.14 | ) | $ | (2.13 | ) | $ | (5.08 | ) |
| Weighted average shares of common stock outstanding, basic and diluted | 48,268,256 | 3,070,672 | 21,783,754 | 2,867,221 |
SELECTED BALANCE SHEET DATA
(In thousands)
(Unaudited)
| December 31, | |||||
|---|---|---|---|---|---|
| 2021 | 2020 | ||||
| Cash, cash equivalents and marketable securities | $ | 288,111 | $ | 10,332 | |
| Working capital | $ | 281,841 | $ | 6,266 | |
| Total assets | $ | 293,824 | $ | 10,646 | |
| Total liabilities | $ | 8,787 | $ | 6,615 | |
| Total stockholders’ equity (deficit) | $ | 285,037 | $ | (31,323 | ) |
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 (NSCLC), along with multiple discovery-stage research programs. We routinely post information that may be important to investors on our website at www.nuvalent.com. Follow us on Twitter (@nuvalent) and LinkedIn.
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 clinical development programs for NVL-520, NVL-655, ALK IXDN compound resistance mutations and HER2 exon 20 insertions and the timing thereof; the potential clinical effect of NVL-520 and NVL-655; the design and enrollment of the ARROS-1 study and the timing thereof; the design and initiation of the ALKOVE-1 Phase 1/2 study and the timing thereof; the potential of Nuvalent’s pipeline programs, including NVL-520 and NVL-655; Nuvalent’s research and development programs for the treatment of cancer; risks and uncertainties associated with drug development; capital allocation; and Nuvalent’s future financial and operating results and its expectations related thereto. 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 associated with: risks that Nuvalent may not fully enroll the ARROS-1 study or it will take longer than expected; unexpected concerns that may arise from additional data, analysis, or results obtained during clinical trials; the occurrence of adverse safety events; risks of unexpected costs, delays, or other unexpected hurdles; the impact of
COVID-19 on countries or regions in which Nuvalent has operations or does business, as well as on the timing and anticipated timing and results of its clinical trials, strategy, and future operations, including the global ARROS-1 study and the planned initiation of the ALKOVE-1 Phase 1/2 study; the timing and outcome of Nuvalent’s planned interactions with regulatory authorities; and obtaining, maintaining, and protecting its intellectual property. These and other risks and uncertainties are described in greater detail in the section entitled “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2021, as well as any 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
THRUST Strategic Communications
chelcie@thrustsc.com
Media Contact
Tabatha Thompson
Verge Scientific Communications
tthompson@vergescientific.com