Nuvalent, Inc.
Description
Nuvalent, Inc., a clinical stage biopharmaceutical company, engages in the development of therapies for patients with cancer. Its lead product candidates are NVL-520, a novel ROS1-selective inhibitor 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 ROS1 tyrosine kinase inhibitors (TKIs) for patients with ROS proto-oncogene 1 (ROS1)-positive non-small cell lung cancer (NSCLC) which is under the phase 2 portion of the ARROS-1 Phase 1/2 clinical trial; NVL-655, a brain-penetrant ALK-selective inhibitor, to address the clinical challenges of emergent treatment resistance, CNS-related adverse events, and brain metastases that might limit the use of first-, second-, and third-generation ALK inhibitors that is under the phase 2 portion of the ALKOVE-1 Phase 1/2 clinical trial; and NVL-330, a brain-penetrant human epidermal growth factor receptor 2 (HER2)-selective inhibitor designed to treat tumors driven by HER2ex20, brain metastases, and avoiding treatment-limiting adverse events including due to off-target inhibition of wild-type EGFR, which is expected to initiate phase 1 trial. The company was incorporated in 2017 and is headquartered in Cambridge, Massachusetts.
About
CEO
Dr. James R. Porter Ph.D.
Employees
127
Instrument type
Common Stock
Sector
Healthcare
Industry
Biotechnology
MIC code
XNGS
Address
One Broadway, Cambridge, MA 02142, United States
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Summary
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Earnings
| Date | Estimate EPS | Actual EPS | Difference | % Surprise |
|---|---|---|---|---|
| Nov 12, 2024 | -0.94 | -1.28 | -0.34 | 36.17% |
| Aug 8, 2024 | -0.76 | -0.88 | -0.12 | 15.79% |
| May 9, 2024 | -0.68 | -0.69 | -0.01 | 1.47% |
| Feb 27, 2024 | -0.60 | -0.62 | -0.02 | 3.33% |
| Nov 14, 2023 | -0.58 | -0.59 | -0.01 | 1.72% |
Earnings estimate
|
Next Quarter
(Mar 2025)
|
Next Year
(Dec 2025)
|
|||
|---|---|---|---|---|
| Number of analysts | — | 6 | — | 12 |
| Average estimate | — | -1.01 | — | -4.39 |
| Low estimate | — | -1.22 | — | -5.51 |
| High estimate | — | -0.88 | — | -3.28 |
| Last year EPS | — | -0.69 | — | -3.74 |
[stock_revenue_estimate]
Growth estimates
Current qtr
-69.320%
Next qtr. (Mar 2025)
-46.160%
Current year
-72.140%
Next year (Dec 2025)
-17.440%
Next 5 years (per annum)
—
Past 5 years (per annum)
—
Income statement
| 2023 | 2022 | 2021 | 2020 | 2019 | |
|---|---|---|---|---|---|
| Fiscal date | 2023-12-31 | 2022-12-31 | 2021-12-31 | 2020-12-31 | 2019-12-31 |
| Total reported revenue | — | — | — | — | — |
| Cost of revenue | — | — | — | — | — |
| Gross profit | — | — | — | — | — |
| Operating expense | |||||
| Research & development | 113.24M | 63.73M | 35.56M | 15.40M | 9.75M |
| Selling general and admin | 36.25M | 22.38M | 10.26M | 1.50M | 612,000 |
| Other operating expenses | — | — | — | — | — |
| Operating income | -149.49M | -86.11M | -45.82M | -16.91M | -10.36M |
| Non operating interest income | |||||
| Income | 23.27M | 4.25M | — | — | — |
| Expense | — | — | — | — | — |
| Other income expense | — | 4.25M | -521,000 | 2.35M | -1.45M |
| Pretax income | -126.22M | -81.85M | -46.34M | -14.56M | -11.81M |
| Tax provision | — | — | — | — | — |
| Net income | -126.22M | -81.85M | -46.34M | -14.56M | -11.81M |
| Basic EPS | -2.17 | -1.65 | -2.13 | -0.64 | -0.73 |
| Diluted EPS | -2.17 | -1.65 | -2.13 | -0.64 | -0.73 |
| Basic average shares | 58.22M | 49.67M | 21.78M | 22.86M | 16.17M |
| Diluted average shares | 58.22M | 49.67M | 21.78M | 22.86M | 16.17M |
| EBITDA | -149.49M | -86.11M | -45.82M | -16.91M | -10.36M |
| Net income from continuing op. | -126.22M | -81.85M | -46.34M | -14.56M | -11.81M |
| Minority interests | — | — | — | — | — |
| Preferred stock dividends | — | — | — | 2.38M | — |
Balance sheet
| 2023 | 2022 | 2021 | 2020 | 2019 | |
|---|---|---|---|---|---|
| Fiscal date | 2023-12-31 | 2022-12-31 | 2021-12-31 | 2020-12-31 | 2019-12-31 |
| Total assets | 732.38M | 482.46M | 293.82M | 10.65M | 3.32M |
| Current assets | |||||
| Cash | — | — | — | — | — |
| Cash equivalents | — | — | — | — | — |
| Cash and cash equivalents | 335.39M | 241.81M | 68.53M | 10.33M | 3.02M |
| Other short term investments | 384.52M | 230.36M | 219.59M | — | — |
| Accounts receivable | — | — | — | — | — |
| Other receivables | — | — | — | — | — |
| Inventory | — | — | — | — | — |
| Prepaid assets | — | — | 2.52M | 314,000 | 300,000 |
| Restricted cash | — | — | — | — | — |
| Assets held for sale | — | — | — | — | — |
| Hedging assets | — | — | — | — | — |
| Other current assets | 6.58M | 5.83M | 2.52M | 314,000 | 300,000 |
| Non current assets | |||||
| Properties | — | — | — | — | — |
| Land and improvements | — | — | — | — | — |
| Machinery furniture equipment | — | — | — | — | — |
| Construction in progress | — | — | — | — | — |
| Leases | — | — | — | — | — |
| Accumulated depreciation | — | — | — | — | — |
| Goodwill | — | — | — | — | — |
| Investment properties | — | — | — | — | — |
| Financial assets | — | — | — | — | — |
| Intangible assets | — | — | — | — | — |
| Investments and advances | — | — | — | — | — |
| Other non current assets | 5.90M | 4.47M | 3.20M | — | — |
| Total liabilities | 31.82M | 19.48M | 8.79M | 41.97M | 20.57M |
| Current liabilities | |||||
| Accounts payable | 9.27M | 7.20M | 2.89M | 1.25M | 723,000 |
| Accrued expenses | 15.22M | 7.43M | 3.16M | 535,000 | 164,000 |
| Short term debt | — | — | — | — | — |
| Deferred revenue | — | — | — | — | — |
| Tax payable | — | — | — | — | — |
| Pensions | 7.33M | 4.85M | 2.73M | 636,000 | 317,000 |
| Other current liabilities | — | — | — | 1.96M | 3.15M |
| Non current liabilities | |||||
| Long term debt | — | — | — | 2.24M | 2.17M |
| Provision for risks and charges | — | — | — | — | — |
| Deferred liabilities | — | — | — | — | — |
| Derivative product liabilities | — | — | — | — | — |
| Other non current liabilities | — | — | — | — | — |
| Shareholders equity | |||||
| Common stock | 7,000 | 6,000 | 5,000 | — | — |
| Retained earnings | -286.30M | -160.08M | -78.22M | -31.89M | -17.33M |
| Other shareholders equity | 31,000 | -494,000 | -228,000 | — | — |
| Total shareholders equity | 700.56M | 462.98M | 285.04M | -31.32M | -17.26M |
| Additional paid in capital | 986.82M | 623.54M | 363.48M | 842,000 | 98,000 |
| Treasury stock | — | — | — | — | — |
| Minority interest | — | — | — | — | — |
Cash flow statement
| 2023 | 2022 | 2021 | 2020 | 2019 | |
|---|---|---|---|---|---|
| Operating Activities | |||||
| Net Income | -126.22M | -81.85M | -46.34M | -14.56M | -11.81M |
| Depreciation | — | — | — | — | — |
| Deferred Taxes | — | — | — | — | — |
| Stock-Based Compensation | 25.56M | 10.33M | 3.55M | 729,000 | 41,000 |
| Other Non-Cash Items | — | — | 631,000 | -2.39M | 1.57M |
| Accounts Receivable | — | — | — | — | — |
| Accounts Payable | 2.17M | 4.21M | 1.64M | 529,000 | 424,000 |
| Other Assets & Liabilities | -1.43M | -1.27M | -3.20M | — | — |
| Operating Cash Flow | -99.92M | -68.59M | -43.71M | -15.69M | -9.78M |
| Investing Activities | |||||
| Capital Expenditures | — | — | — | — | — |
| Net Intangibles | — | — | — | — | — |
| Net Acquisitions | — | — | — | — | — |
| Purchase of Investments | -459.49M | -212.92M | -221.04M | — | — |
| Sale of Investments | 315.96M | 202.25M | 1.02M | — | — |
| Investing Cash Flow | -143.53M | -10.67M | -220.03M | — | — |
| Financing Activities | |||||
| Long-Term Debt Issuance | — | — | 284,000 | — | — |
| Long-Term Debt Payments | — | — | — | -250,000 | — |
| Other Financing Charges | -1.63M | -1.55M | -4.00M | — | — |
| Financing Cash Flow | 322.67M | 247.08M | 318.21M | 22.25M | — |
| Other Cash Details | |||||
| End Cash Position | 335.39M | 241.81M | 68.53M | 10.33M | 3.02M |
| Income Tax Paid | — | — | — | — | — |
| Interest Paid | — | — | — | — | — |
| Free Cash Flow | -99.74M | -64.97M | -40.00M | -14.95M | -9.64M |
Top Institutional Holders
| Holder | Date Reported | Shares | Value | % Held |
|---|---|---|---|---|
| Fidelity Growth Company Fund | Nov 30, 2024 | 1,859,512 | 159.77M | 2.83% |
| Vanguard Total Stock Market Index Fund | Sep 30, 2024 | 1,326,854 | 114.00M | 2.02% |
| Vanguard Small-Cap Index Fund | Sep 30, 2024 | 1,047,119 | 89.97M | 1.60% |
| iShares Russell 2000 ETF | Nov 30, 2024 | 976,333 | 83.89M | 1.49% |
| Vanguard Small Cap Value Index Fund | Sep 30, 2024 | 724,494 | 62.25M | 1.10% |
| Fidelity Select Portfolios - Health Care | Nov 30, 2024 | 670,000 | 57.57M | 1.02% |
| Fidelity Growth Company K6 Fund | Nov 30, 2024 | 629,224 | 54.06M | 0.96% |
| Vanguard Extended Market Index Fund | Sep 30, 2024 | 558,194 | 47.96M | 0.85% |
| Fidelity Series Growth Company Fund | Nov 30, 2024 | 535,325 | 46.00M | 0.82% |
| Fidelity Small Cap Growth Fund | Oct 31, 2024 | 512,712 | 44.05M | 0.78% |
Article
Nuvalent Details Strategy to Seek First Potential Approval in 2026 and Outlines Key Anticipated 2025 Milestones
Strategy prioritizes most accelerated path to first potential approval Initial NDA submission expected by mid-year for zidesamtinib in TKI pre-treated ROS1-positive NSCLC population, with topline pivotal data anticipated in the first half of 2025 Topline pivotal data for neladalkib (NVL-655) in TKI pre-treated ALK-positive NSCLC population anticipated by year-end 2025 Company to present at 43rd Annual J.P. Morgan Healthcare Conference on Tuesday, January 14 th at 9:00 a.m.
Jan 13, 2025
Article
Nuvalent: A Logical Acquisition Target
Nuvalent's NVL-655 and Zidesamtinib show strong potential as first-line therapies for NSCLC, with impressive Phase I/II trial results and FDA designations. Nuvalent's robust financial position and pipeline make it a prime M&A target, with potential suitors like Pfizer, AstraZeneca, and Novartis. Downside risks include regulatory setbacks, commercialization challenges, strong competition, and financial management, but Nuvalent's cash runway is healthy until 2028.
Jan 10, 2025
Article
Nuvalent to Present at the 43rd Annual J.P. Morgan Healthcare Conference
CAMBRIDGE, Mass. , Dec. 19, 2024 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced that James Porter, Ph.D.
Dec 19, 2024
