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): September 8, 2021
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
(Registrants 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 |
Name of each exchange | ||
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 September 8, 2021, Nuvalent, Inc. announced its financial results for the quarter ended June 30, 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 September 8, 2021. |
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: September 8, 2021 | By: | /s/ James R. Porter |
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James R. Porter | ||||||||
President and Chief Executive Officer |
Exhibit 99.1
Nuvalent Announces Business and Program Highlights and Reports Second Quarter 2021 Financial Results
IND Application for NVL-520 Cleared by US FDA; Company Expects to Initiate Phase 1/2 Clinical Trial in Second Half of 2021
$190.6 Million Upsized IPO Completed to Fund Continued Advancement of Novel Portfolio of Precisely Targeted Kinase Inhibitors
Leadership Team Further Strengthened with Appointments of Deborah Miller, Ph.D., J.D., as Chief Legal Officer and Sapna Srivastava, Ph.D., to the Board of Directors
CAMBRIDGE, Mass. Sept. 8, 2021 Nuvalent, Inc., (Nasdaq: NUVL), a biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today reported recent pipeline and business highlights and second quarter 2021 financial results.
At Nuvalent, we are leveraging our teams deep expertise in chemistry and structure-based drug design to advance a novel pipeline of product candidates for patients with cancer. Our therapies are specifically designed to solve for challenges limiting the activity and durability of currently available therapies, such as kinase resistance, adverse events due to off-target activity, and metastases to the brain, said James Porter, Ph.D., Chief Executive Officer at Nuvalent. In the first half of 2021, our team has made meaningful progress to deliver on our clear vision for advancing the field of precision oncology. We have received clearance from the FDA to proceed with the Phase 1/2 study for our ROS1-selective inhibitor NVL-520, advanced our parallel lead product candidate, the ALK-selective inhibitor NVL-655, into IND-enabling studies, and progressed multiple additional discovery-stage research programs. With the recent talented additions to our team and capital raised in our upsized IPO, we stand well positioned to fuel our upcoming transition to a clinical organization and efforts to renew hope for patients in need.
Second Quarter Highlights
| IND Application for NVL-520 Cleared by FDA, Enabling Clinical Trial Initiation: The U.S. Food and Drug Administration (FDA) has cleared the companys Investigational New Drug (IND) application for NVL-520, its brain-penetrant ROS1-selective inhibitor. The company is preparing to initiate the Phase 1 portion of a global, Phase 1/2 clinical trial for NVL-520 in patients with ROS1-positive NSCLC and other advanced solid tumors in the second half of 2021. |
| $190.6 Million Upsized Initial Public Offering (IPO) Successfully Completed: In July 2021, Nuvalent sold 11,212,500 shares of common stock at a price to the public of $17.00 per share. The gross proceeds from the offering were approximately $190.6 million, before deducting underwriting discounts and commissions and other offering expenses. |
| Company Leadership Strengthened through Appointments to Management and Board: Nuvalent recently appointed Deborah Miller, Ph.D., J.D., as Chief Legal Officer, and Sapna Srivastava, Ph.D., Chief Financial Officer of eGenesis, to its Board of Directors. |
Dr. Miller most recently served as Senior Vice President, Deputy General Counsel and Chief IP Counsel for Sumitomo Dainippon Pharma America (SDPA). Prior to that, Dr. Miller served as Deputy General Counsel and Chief IP Counsel at Sunovion Pharmaceuticals Inc., a subsidiary of SDPA. She previously held various roles at Infinity Pharmaceuticals, Inc. including Vice President, Deputy General Counsel and Chief Patent Counsel, where she built and managed the intellectual property group and supported various in-licensing, out-licensing and financing
ventures. Earlier in her career, Dr. Miller was IP corporate counsel at Sepracor Inc. (currently, Sunovion Pharmaceuticals Inc.), and an associate at the law firm Nutter McClennen & Fish LLP. Dr. Miller earned her J.D. from Suffolk University Law School, Ph.D. in biological chemistry and molecular pharmacology from Harvard University, M.S. in medical sciences from Harvard Medical School and B.S. in chemistry from Swarthmore College.
Dr. Srivastava brings over 20 years of experience as a senior executive in the biopharmaceutical industry. She has served as the Chief Financial Officer at eGenesis Bio since April 2021. Prior to eGenesis, she held similar roles as the Chief Financial and Strategy Officer at Abide Therapeutics (acquired by Lundbeck) and at Intellia Therapeutics. Before Intellia, Dr. Srivastava was a senior biotechnology analyst at Goldman Sachs, Morgan Stanley and ThinkEquity Partners, and began her career as a research associate at J.P. Morgan. Dr. Srivastava received her Ph.D. in neuroscience from the New York University School of Medicine and her B.S. in biology from St. Xaviers College at the University of Bombay.
Second Quarter 2021 Financial Results
| As of June 30, 2021, Nuvalent had cash of $138.9 million, which does not include net proceeds from its IPO, which was completed on August 2, 2021. |
| Research & Development expenses for the second quarter of 2021 were $7.8 million. |
| General & Administrative expenses for the second quarter of 2021 were $2.0 million. |
| Net Loss for the second quarter was $9.8 million, or $3.17 per share. |
About Nuvalent
Nuvalent, Inc. (Nasdaq: NUVL) is a preclinical 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 NSCLC, along with multiple discovery-stage research programs. To learn more, visit www.nuvalent.com and 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, Inc.s (Nuvalent, the Company, we, or our) strategy, business plans and focus; the progress and timing of the preclinical and clinical development of Nuvalents programs, including NVL-520 and NVL-655; expectations regarding the planned clinical trial initiation of NVL-520, including timing; expectations regarding Nuvalents use of capital, expenses and other financial results during 2021 and in the future. The words may, might, will, could, would, should, expect, plan, anticipate, 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.
Any forward-looking statements in this press release are based on managements 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: the impact of COVID-19 on countries or regions in which the Company 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 planned initiation of the Phase 1 portion of a global, Phase 1/2 clinical trial for NVL-520, the timing and progress of IND-enabling studies of NVL-655 and progress from the Companys discovery-stage programs; the Companys expectations regarding its management and board additions; the Companys ability to successfully demonstrate the safety and efficacy of its drug candidates; the timing and outcome of Nuvalents 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 Companys Quarterly Report on Form 10-Q for the quarter ended June 30, 2021, as well as any subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent Nuvalents views only as of today and should not be relied upon as representing our views as of any subsequent date. Nuvalent explicitly disclaims any obligation to update any forward-looking statements. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.
Investor Contact
Chelcie Lister
THRUST Strategic Communications
chelcie@thrustsc.com
Media Contact
Sarah Ellinwood, Ph.D.
Verge Scientific Communications
sellinwood@vergescientific.com
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per share data)
(Unaudited)
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||||||
Operating expenses: |
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Research and development |
$ | 7,826 | $ | 3,657 | $ | 13,310 | $ | 6,983 | ||||||||
General and administrative |
2,024 | 349 | 2,702 | 668 | ||||||||||||
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Total operating expenses |
9,850 | 4,006 | 16,012 | 7,651 | ||||||||||||
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Loss from operations |
(9,850 | ) | (4,006 | ) | (16,012 | ) | (7,651 | ) | ||||||||
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Other income (expense): |
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Change in fair value of preferred stock tranche rights |
| (4,542 | ) | (635 | ) | 4,471 | ||||||||||
Other income (expense), net |
12 | (9 | ) | 24 | (18 | ) | ||||||||||
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Total other income (expense), net |
12 | (4,551 | ) | (611 | ) | 4,453 | ||||||||||
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Net loss and comprehensive loss |
$ | (9,838 | ) | $ | (8,557 | ) | $ | (16,623 | ) | $ | (3,198 | ) | ||||
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Net loss per share attributable to common stockholders, basic and diluted |
$ | (3.17 | ) | $ | (2.82 | ) | $ | (5.37 | ) | $ | (1.20 | ) | ||||
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Weighted average shares of common stock outstanding, basic and diluted |
3,106,152 | 3,037,974 | 3,095,639 | 2,675,827 | ||||||||||||
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SELECTED BALANCE SHEET DATA
(In thousands)
(Unaudited)
June 30, 2021 |
December 31, 2020 |
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Cash |
$ | 138,919 | $ | 10,332 | ||||
Working capital |
$ | 133,452 | $ | 6,266 | ||||
Total assets |
$ | 143,502 | $ | 10,646 | ||||
Total liabilities |
$ | 5,829 | $ | 6,615 | ||||
Total stockholders deficit |
$ | (47,740 | ) | $ | (31,323 | ) |