Recent Updates
Recently added Catalysts
NUVL

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 2

Key Takeaway: 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 Continue

Full Press Release Details

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
At Nuvalent, we are leveraging our team s 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
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
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
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. Xavier s College at the University of Bombay.
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
(@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 Nuvalent s 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
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: 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 Company s discovery-stage programs; the Company s expectations regarding its management and board additions;
the Company s ability to successfully demonstrate the safety and efficacy of its drug candidates; 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 June 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 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
THRUST Strategic Communications
Sarah Ellinwood, Ph.D.
Verge Scientific Communications
OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per share data)
Three Months Ended June 30, Six Months Ended June 30,
2021 2020 2021 2020
Operating expenses:
Research and development $ 7,826 $ 3,657 $ 13,310 $ 6,983
General and administrative 2,024 349 2,702 668
Total operating expenses 9,850 4,006 16,012 7,651
Loss from operations (9,850 ) (4,006 ) (16,012 ) (7,651 )
Other income (expense):
Change in fair value of preferred stock tranche rights (4,542 ) (635 ) 4,471
Other income (expense), net 12 (9 ) 24 (18 )
Total other income (expense), net 12 (4,551 ) (611 ) 4,453
Net loss and comprehensive loss $ (9,838 ) $ (8,557 ) $ (16,623 ) $ (3,198 )
Net loss per share attributable to common stockholders, basic and diluted $ (3.17 ) $ (2.82 ) $ (5.37 ) $ (1.20 )
Weighted average shares of common stock outstanding, basic and diluted 3,106,152 3,037,974 3,095,639 2,675,827
SELECTED BALANCE SHEET DATA
June 30, 2021 December 31, 2020
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 )
Last updated: Sep 8, 2021