Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Feb. 28, 2022 | Jun. 30, 2021 | |
Document and Entity Information [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2021 | ||
Document Transition Report | false | ||
Entity File Number | 001-40523 | ||
Entity Registrant Name | ELEVATION ONCOLOGY, INC. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 84-1771427 | ||
Entity Address, Address Line One | 888 Seventh Ave, 12th Floor | ||
Entity Address, City or Town | New York | ||
Entity Address State Or Province | NY | ||
Entity Address, Postal Zip Code | 10106 | ||
City Area Code | 716 | ||
Local Phone Number | 371-1125 | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | true | ||
Entity Ex Transition Period | false | ||
Entity Shell Company | false | ||
Title of 12(b) Security | Common stock | ||
Trading Symbol | ELEV | ||
Security Exchange Name | NASDAQ | ||
ICFR Auditor Attestation Flag | false | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Public Float | $ 210.6 | ||
Entity Common Stock, Shares Outstanding | 23,205,915 | ||
Auditor Name | CohnReznick LLP | ||
Auditor Firm ID | 596 | ||
Auditor Location | Tysons, Virginia | ||
Entity Central Index Key | 0001783032 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Year Focus | 2021 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 146,284 | $ 79,400 |
Prepaid expenses and other current assets | 3,140 | 1,386 |
Total current assets | 149,424 | 80,786 |
Property and equipment, net | 38 | 56 |
Other assets, net | 32 | 65 |
Total assets | 149,494 | 80,907 |
Current liabilities: | ||
Accounts payable | 5,648 | 5,679 |
Accrued expenses | 3,141 | 1,106 |
Total current liabilities | 8,789 | 6,785 |
Non-current liabilities: | ||
Restricted stock repurchase liability | 8 | 15 |
Total liabilities | 8,797 | 6,800 |
Commitments and contingencies | ||
Stockholders' equity (deficit): | ||
Preferred stock, $0.0001 par value; 10,000,000 shares authorized as of December 31, 2021; no shares issued or outstanding as of December 31, 2021 and 2020, respectively | ||
Common stock, $0.0001 par value; 500,000,000 and 86,000,000 shares authorized as of December 31, 2021 and 2020, respectively; 23,225,637 and 836,177 issued as of December 31, 2021 and 2020, respectively; 23,205,915 and 800,679 outstanding as of December 31, 2021 and 2020, respectively | 2 | |
Additional paid-in capital | 195,881 | 66 |
Accumulated deficit | (55,186) | (23,147) |
Total stockholders' equity (deficit) | 140,697 | (23,081) |
Total liabilities, convertible preferred stock and stockholders' equity (deficit) | $ 149,494 | 80,907 |
Series A Convertible Preferred Stock [Member] | ||
Non-current liabilities: | ||
Convertible preferred stock | 32,373 | |
Series B Convertible Preferred Stock [Member] | ||
Non-current liabilities: | ||
Convertible preferred stock | $ 64,815 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Convertible preferred stock, par value | $ 0.0001 | |
Convertible preferred stock, shares authorized | 66,493,889 | |
Preferred stock, par value | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 500,000,000 | 86,000,000 |
Common stock, shares issued | 23,225,637 | 836,177 |
Common stock, shares outstanding | 23,205,915 | 800,679 |
Series A Convertible Preferred Stock [Member] | ||
Convertible preferred stock, par value | $ 0.0001 | $ 0.0001 |
Convertible preferred stock, shares authorized | 0 | 32,450,000 |
Convertible preferred stock, shares issued | 0 | 32,450,000 |
Convertible preferred stock, shares outstanding | 0 | 32,450,000 |
Convertible preferred stock, liquidation preference | $ 0 | $ 32,450 |
Series B Convertible Preferred Stock [Member] | ||
Convertible preferred stock, par value | $ 0.0001 | $ 0.0001 |
Convertible preferred stock, shares authorized | 0 | 34,043,889 |
Convertible preferred stock, shares issued | 0 | 34,043,889 |
Convertible preferred stock, shares outstanding | 0 | 34,043,889 |
Convertible preferred stock, liquidation preference | $ 0 | $ 65,000 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Operating expenses: | ||
Research and development | $ 23,595 | $ 15,476 |
General and administrative | 8,451 | 1,800 |
Total operating expenses | 32,046 | 17,276 |
Loss from operations | (32,046) | (17,276) |
Other income (expenses), net | 7 | 11 |
Net loss | $ (32,039) | $ (17,265) |
Net loss per share, basic (in dollars per share) | $ (2.64) | $ (21.80) |
Net loss per share, diluted (in dollars per share) | $ (2.64) | $ (21.80) |
Weighted average common shares outstanding, basic (in shares) | 12,132,610 | 791,821 |
Weighted average common shares outstanding, diluted (in shares) | 12,132,610 | 791,821 |
Consolidated Statements of Conv
Consolidated Statements of Convertible Preferred Stock and Stockholders Equity (Deficit) - USD ($) $ in Thousands | Series A Convertible Preferred Stock [Member] | Series B Convertible Preferred Stock [Member] | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Total |
Temporary equity, Beginning balance at Dec. 31, 2019 | $ 7,190 | |||||
Temporary equity, Beginning balance (in shares) at Dec. 31, 2019 | 7,266,750 | |||||
Increase (Decrease) in Temporary Equity [Roll Forward] | ||||||
Issuance of convertible preferred stock, net of issuance costs | $ 25,183 | $ 64,815 | ||||
Issuance of convertible preferred stock, net of issuance costs (in shares) | 25,183,250 | 34,043,889 | ||||
Temporary equity, Ending balance at Dec. 31, 2020 | $ 32,373 | $ 64,815 | ||||
Temporary equity, Ending balance (in shares) at Dec. 31, 2020 | 32,450,000 | 34,043,889 | ||||
Stockholders equity, Beginning balance at Dec. 31, 2019 | $ 9 | $ (5,882) | $ (5,873) | |||
Stockholders equity, Beginning balance (in shares) at Dec. 31, 2019 | 788,847 | |||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Vesting of restricted common stock | 5 | 5 | ||||
Vesting of restricted common stock (in shares) | 11,832 | |||||
Stock based compensation | 52 | 52 | ||||
Net loss | (17,265) | (17,265) | ||||
Stockholders equity, Ending balance at Dec. 31, 2020 | 66 | (23,147) | (23,081) | |||
Stockholders equity, Ending balance (in shares) at Dec. 31, 2020 | 800,679 | |||||
Increase (Decrease) in Temporary Equity [Roll Forward] | ||||||
Issuance of initial public offering common stock, net | $ (32,373) | $ (64,815) | ||||
Issuance of initial public offering common stock, net (in shares) | (32,450,000) | (34,043,889) | ||||
Temporary equity, Ending balance (in shares) at Dec. 31, 2021 | 0 | 0 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Vesting of restricted common stock | 7 | 7 | ||||
Vesting of restricted common stock (in shares) | 15,776 | |||||
Stock based compensation | 1,571 | 1,571 | ||||
Issuance of initial public offering common stock, net | $ 2 | 194,237 | 194,239 | |||
Issuance of initial public offering common stock, net (in shares) | 22,389,460 | |||||
Net loss | (32,039) | (32,039) | ||||
Stockholders equity, Ending balance at Dec. 31, 2021 | $ 2 | $ 195,881 | $ (55,186) | $ 140,697 | ||
Stockholders equity, Ending balance (in shares) at Dec. 31, 2021 | 23,205,915 |
Consolidated Statements of Co_2
Consolidated Statements of Convertible Preferred Stock and Stockholders Equity (Deficit) (Parenthetical) $ in Thousands | 12 Months Ended |
Dec. 31, 2020USD ($) | |
Series A Convertible Preferred Stock [Member] | |
Issuance costs | $ 0 |
Series B Convertible Preferred Stock [Member] | |
Issuance costs | $ 185 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Operating activities | ||
Net loss | $ (32,039) | $ (17,265) |
Reconciliation of net loss to net cash used in operating activities: | ||
Stock-based compensation | 1,571 | 52 |
Depreciation expense | 18 | 15 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | (1,722) | (1,212) |
Other assets, net | (65) | |
Accounts payable | (30) | 5,219 |
Accrued expenses | 2,035 | 958 |
Net cash used in operating activities | (30,167) | (12,298) |
Investing activities | ||
Purchases of property and equipment | (71) | |
Net cash used in investing activities | (71) | |
Financing activities | ||
Proceeds from the issuance of restricted common stock | 20 | |
Proceeds from issuance of common stock upon initial public offering, net of issuance costs | 97,062 | |
Proceeds from the issuance of convertible preferred stock | 90,183 | |
Cash paid for issuance costs of convertible preferred stock | (11) | (174) |
Net cash provided by financing activities | 97,051 | 90,029 |
Increase in cash and cash equivalents | 66,884 | 77,660 |
Cash and cash equivalents, beginning of year | 79,400 | 1,740 |
Cash and cash equivalents, end of year | 146,284 | 79,400 |
Supplemental disclosure of non-cash financing activities | ||
Issuance costs in accrued expenses | $ 11 | |
Conversion of convertible preferred stock upon IPO | $ 97,188 |
NATURE OF BUSINESS
NATURE OF BUSINESS | 12 Months Ended |
Dec. 31, 2021 | |
NATURE OF BUSINESS | |
NATURE OF BUSINESS | 1. NATURE OF BUSINESS Elevation Oncology, Inc. (the “Company” or “Elevation”), which was formerly known as 14ner, Inc., was incorporated under the laws of the State of Delaware on April 29, 2019 (“Inception”). The Company is a clinical-stage biopharmaceutical company focused on the development of precision medicines for patients with genomically defined cancers. The Company acquired its lead product candidate, seribantumab, pursuant to an asset purchase agreement executed with Merrimack Pharmaceuticals, Inc. (the “previous sponsor”) during the period ended December 31, 2019 (see Note 9). Seribantumab has been shown preclinically to inhibit tumor growth driven by NRG1 fusions and is currently being tested in the Company’s Phase 2 CRESTONE clinical trial for patients with tumors of any origin that have an NRG1 fusion. The Company is actively evaluating opportunities for pipeline expansion including prioritizing additional targeted therapy approaches in tumor types defined by genomic driver alterations. Risks and Uncertainties The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, development by competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations and the ability to secure additional capital to fund operations. Product candidates currently under development will require significant additional research and development efforts, including preclinical and clinical testing and regulatory approval, prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel and infrastructure, and extensive compliance-reporting capabilities. There can be no assurance that the Company’s research and development of its product candidates will be successfully completed, that adequate protection for the Company’s intellectual property will be obtained, that any products developed will obtain necessary government regulatory approval or that any approved products will be commercially viable. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will generate significant revenue from product sales. The Company operates in an environment of rapid change in technology and substantial competition from pharmaceutical and biotechnology companies. The current COVID-19 pandemic has presented a substantial public health and economic challenge around the world and is affecting our employees, patients, communities and business operations, as well as contributing to significant volatility and negative pressure on the U.S. economy and in financial markets. The extent of the impact of COVID-19 on the Company’s operational and financial performance will continue to depend on certain developments, including the duration and spread of the outbreak, new variants, the vaccination and booster rate, impact on the Company’s clinical studies, employee or industry events, and effect on our suppliers and manufacturers, all of which are uncertain and cannot be predicted. COVID-19 has not had a significant impact on the operations or financial results of the Company to date. Liquidity In July 2019 and November 2020, the Company received gross proceeds of $97.2 million from the issuance and sale of its Series A and Series B convertible preferred stock (see Note 6). On June 17, 2021, the Company effected a 1.0 for 4.225582 On June 29, 2021, the Company closed its initial public offering (“IPO”) and issued 6,250,000 shares of its common stock at a price of $16.00 per share for net proceeds of $91.1 million, after deducting underwriting discounts and commissions and expenses of $8.9 million. In connection with the IPO, all shares of Series A and Series B convertible preferred stock converted into 15,736,053 shares of common stock. On July 19, 2021, in connection with the Company’s IPO, the underwriters exercised the right to purchase 403,407 shares of the Company’s common stock at a price of $16.00 per share for net proceeds of $6.0 million, after deduction underwriting discounts of $0.5 million. The Company has historical losses from operations and anticipates that it will continue to incur losses for the foreseeable future as it continues the research and development of its product candidates. The Company incurred net losses of $32.0 million and $17.3 million for the years ended December 31, 2021 and 2020, respectively, and had an accumulated deficit of $55.2 million as of December 31, 2021. Through December 31, 2021, the Company has funded its operations with proceeds from the sale of convertible preferred stock and common stock. The Company expects that its cash and cash equivalents will be sufficient to fund its operating expenses and capital expenditure requirements through at least 12 months from the issuance date of the consolidated financial statements. |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2021 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Basis of Presentation The accompanying consolidated financial statements of the Company have been prepared in accordance with generally accepted accounting principles in the United States (“GAAP”). Principles of Consolidation The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary, Elevation Oncology Securities Corporation, which was established on November 19, 2021. All significant intercompany balances and transaction have been eliminated in consolidation. Use of Estimates The preparation of financial statements in accordance with GAAP requires the use of estimates and assumptions, based on judgments considered reasonable, which affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. The Company bases its estimates and assumptions on known trends and events and various other factors that management believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Significant estimates and assumptions reflected in these consolidated financial statements include, but are not limited to, the accruals for research and development expenses, the valuation of common stock and the assumptions used in the valuation of share-based compensation awards. Changes in estimates are recorded in the period in which they become known. Due to the risks and uncertainties involved in the Company’s business and evolving market conditions and, given the subjective element of the estimates and assumptions made, actual results may differ from estimated results. Segment Information Operating segments are defined as components of an enterprise about which separate discrete information is available and regularly reviewed by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one operating segment, which is the development of precision medicines for patients with genomically defined cancers. All material long-lived assets of the Company reside in the United States. Cash and Cash Equivalents The Company considers all highly liquid investments with an original maturity of three months or less to be cash equivalents. As of December 31, 2021 and 2020, cash equivalents consisted of money-market funds. The Company places its cash with a high-credit-quality financial institution domiciled in the United States. Concentrations of Credit Risk and Significant Suppliers Financial instruments that potentially subject the Company to concentration of credit risk consist of cash and cash equivalents. The Company’s money market funds are invested in highly rated funds. Periodically, the Company maintains deposits in accredited financial institutions in excess of federally insured limits. The Company has not experienced any losses on its deposits of cash and cash equivalents and does not believe that it is exposed to any unusual credit risk beyond the normal credit risk associated with commercial banking relationships. The Company is dependent on third-party manufacturers to supply products for research and development activities of its programs, including preclinical and clinical testing. These programs could be adversely affected by a significant interruption in the supply of such drug substance and drug products. During the year ended December 31, 2021, the Company had two vendors that accounted for approximately 61% of its research and development expense. As of December 31, 2021, the Company had one vendor that accounted for approximately 74% of the total accounts payable. During the year ended December 31, 2020, the Company had one vendor that accounted for approximately 46% of its research and development expense. The same Property and Equipment Property and equipment consist of computer software that is recorded at cost and depreciated on a straight-line basis over the estimated useful lives of the assets. Upon retirement or sale, the cost of the disposed asset and the related accumulated depreciation are removed from the accounts and any resulting gain or loss is recognized. The Company reviews its long-lived assets for impairment whenever events or changes in business circumstances indicate that the carrying value of assets may not be recoverable. Recoverability is measured by comparison of the asset’s book value to future net undiscounted cash flows that the assets are expected to generate. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the book value of the assets exceed their fair value, which is measured based on the projected discounted future net cash flows arising from the assets. No impairment losses have been recorded through December 31, 2021. Cloud Computing Arrangements The Company defers implementation costs incurred in cloud computing hosting arrangements in accordance with Accounting Standards Update (“ASU”) 2018-15 and amortizes these costs over the noncancelable term of the cloud computing arrangement, plus any optional renewal periods (1) that are reasonably certain to be exercised by the Company or (2) for which exercises of the renewal option is controlled by the cloud service provider. Costs incurred during the application development stage are capitalized within either prepaid expenses and other current assets, or in other assets, net on the Company’s balance sheet. Amortization of implementation costs are on a straight-line basis over the related hosting arrangement term and is reflected in research and development expenses in the consolidated statements of operations. Classification and Accretion of Convertible Preferred Stock The Company’s convertible preferred stock is classified outside of stockholders’ deficit on the balance sheet because the holders of such shares have liquidation rights in the event of a deemed liquidation that, in certain situations, are not solely within the control of the Company and would require the redemption of the then-outstanding convertible preferred stock. The convertible preferred stock is not redeemable, except in the event of a deemed liquidation (see Note 6). Because the occurrence of a deemed liquidation event is not currently probable, the carrying values of the convertible preferred stock are not being accreted to their redemption values. Subsequent adjustments to the carrying values of the convertible preferred stock would be made only when a deemed liquidation event becomes probable. Upon the closing the Company’s IPO in June 2021, all outstanding convertible preferred stock automatically converted into shares of common stock. Fair Value Measurements Certain assets and liabilities are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable: ● Level 1—Quoted prices in active markets for identical assets or liabilities. ● Level 2—Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data. ● Level 3—Non-observable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques. The Company's cash equivalents are carried at fair value, determined according to the fair value hierarchy described above (see Note 3). Patent Costs The legal and professional costs incurred by the Company to maintain its patent rights have been expensed as part of general and administrative expenses since inception. As of December 31, 2021 and 2020, the Company has determined that these expenses have not met the criteria to be capitalized. Intellectual property-related expenses for the year ended December 31, 2021 and 2020 were $0.2 million and $0.1 million, respectively. Research and Development Costs Research and development costs consist of salaries and benefits, including associated stock-based compensation, and fees paid to other entities that conduct certain research and development activities on the Company’s behalf. Research and development costs are expensed as incurred. The Company estimates preclinical study and clinical trial expenses based on the services performed pursuant to contracts with research institutions and contract research organizations and clinical manufacturing organizations that conduct and manage preclinical studies and clinical trials on the Company’s behalf based on actual time and expenses incurred by them. Further, the Company accrues expenses related to clinical trials based on the level of patient activity according to the related agreement. The Company monitors patient enrollment levels and related activity to the extent reasonably possible and adjusts estimates accordingly. The Company accounts for nonrefundable advance payments for goods and services that will be used in future research and development activities as expenses when the services have been performed or when the goods have been received rather than when the payment is made. Although the Company does not expect its estimates to be materially different from amounts actually incurred, its understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in reporting amounts that are too high or too low in any particular period. To date, there have not been any material adjustments to the Company’s prior estimates of accrued research and development expenses. Stock-Based Compensation The Company measures stock-based compensation cost at the accounting measurement date based on the fair value of the award and recognizes the expense on a straight-line basis over the requisite service period of the award, which is typically the vesting period. Compensation expense is measured using the fair value of the award at the grant date and is adjusted to reflect actual forfeitures as they occur. The Company estimates the fair value of stock options using the Black-Scholes option pricing model that takes into account the exercise price, the fair value of the Company’s common stock, the expected term of the option, the expected volatility of the Company’s common stock, expected dividends on the Company’s common stock, and the risk-free interest rate over the expected life of the option. Fair value of common stock— Expected term— Expected volatility— Risk-free interest rate— Expected dividend— The Company classifies stock-based compensation expense in its consolidated statements of operations in the same manner in which the award recipient’s payroll costs or service payments are classified. Net Loss per Common Share The Company’s net loss is equivalent to net loss attributable to common stockholders for all periods presented. Basic net loss per share is computed using the weighted average number of common shares outstanding during the period. Diluted net loss per share is computed using the sum of the weighted average number of common shares outstanding during the period and the effect of dilutive securities. The Company applies the two-class method to calculate its basic and diluted net loss per share as the Company has issued shares that meet the definition of participating securities. The two-class method is an earnings allocation formula that treats a participating security as having rights to earnings that otherwise would have been available to common stockholders. The Company’s participating securities contractually entitle the holders of such shares to participate in dividends; but do not contractually require the holders of such shares to participate in losses of the Company. Accordingly, in periods in which the Company reports a net loss, diluted net loss per share is the same as basic net loss per share, since dilutive common shares are not assumed to have been issued if their effect is anti-dilutive. Income Taxes The Company accounts for income taxes using the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the consolidated financial statements or in the Company’s tax returns. Deferred tax assets and liabilities are determined on the basis of the differences between the consolidated financial statements and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Changes in deferred tax assets and liabilities are recorded in the provision for income taxes. The Company assesses the likelihood that its deferred tax assets will be recovered from future taxable income and, to the extent it believes, based upon the weight of available evidence, that it is more likely than not that all or a portion of the deferred tax assets will not be realized, a valuation allowance is established through a charge to income tax expense. The Company accounts for uncertainty in income taxes recognized. If the tax position is deemed more likely than not to be sustained, it would then be assessed to determine the amount of benefit to recognize in the consolidated financial statements. The amount of the benefit that may be recognized is the largest amount that has a greater than 50% likelihood of being realized upon ultimate settlement. To date the Company has no uncertain tax positions and there have been no interest and penalties. Recently issued accounting pronouncements In December 2019, the Financial Accounting Standards Board issued Accounting Standards Update (“ASU”) 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes |
FAIR VALUE MEASUREMENTS OF FINA
FAIR VALUE MEASUREMENTS OF FINANCIAL ASSETS | 12 Months Ended |
Dec. 31, 2021 | |
FAIR VALUE MEASUREMENTS OF FINANCIAL ASSETS. | |
FAIR VALUE MEASUREMENTS OF FINANCIAL ASSETS | 3. FAIR VALUE MEASUREMENTS OF FINANCIAL ASSETS The Company’s financial assets subject to fair value measurements on a recurring basis and the level of inputs used for such measurements were as follows: As of December 31, 2021 Level 1 Level 2 Level 3 Total (in thousands) Money market funds included in cash and cash equivalents $ 106,000 $ — $ — $ 106,000 As of December 31, 2020 Level 1 Level 2 Level 3 Total (in thousands) Money market funds included in cash and cash equivalents $ 76,013 $ — $ — $ 76,013 During the years ended December 31, 2021and 2020, the Company had no transfers between Level 1, Level 2 Level 3 |
PROPERTY AND EQUIPMENT, NET
PROPERTY AND EQUIPMENT, NET | 12 Months Ended |
Dec. 31, 2021 | |
PROPERTY AND EQUIPMENT, NET | |
PROPERTY AND EQUIPMENT, NET | 4. PROPERTY AND EQUIPMENT, NET Property and equipment, net, consisted of the following (in thousands): Estimated December 31, Useful Life 2021 2020 (in thousands) Computer software 4 years $ 71 $ 71 Less: Accumulated depreciation (33) (15) Property and equipment, net $ 38 $ 56 The Company recorded less than $0.1 million of depreciation expense during the years ended December 31, 2021 and 2020. |
ACCRUED EXPENSES
ACCRUED EXPENSES | 12 Months Ended |
Dec. 31, 2021 | |
ACCRUED EXPENSES | |
ACCRUED EXPENSES | 5. ACCRUED EXPENSES Accrued expenses consist of the following (in thousands): December 31, 2021 2020 (in thousands) Accrued preclinical and clinical trial costs $ 1,260 $ 505 Accrued compensation 1,059 429 Accrued consulting 77 127 Accrued professional services 499 28 Accrued other 246 17 Total accrued expenses $ 3,141 $ 1,106 |
CONVERTIBLE PREFERRED STOCK
CONVERTIBLE PREFERRED STOCK | 12 Months Ended |
Dec. 31, 2021 | |
CONVERTIBLE PREFERRED STOCK | |
CONVERTIBLE PREFERRED STOCK | 6. CONVERTIBLE PREFERRED STOCK The Company had issued Series A and Series B convertible preferred stock (collectively, the “Convertible Preferred Stock”). As of December 31, 2020, the Company’s certificate of incorporation, as amended and restated, authorized the Company to issue 66,493,889 shares of $0.0001 par value convertible preferred stock, of which 32,450,000 were designated as Series A convertible preferred stock (“Series A”) and 34,043,889 were designated as Series B convertible preferred stock (“Series B”). As of December 31, 2020, all of the Company’s Convertible Preferred Stock was classified outside of stockholders’ deficit because the shares contained deemed liquidation rights that were a contingent redemption feature not solely within the control of the Company. Series A On July 12, 2019, the Company sold 5,450,000 shares of Series A at a price of $1.00 per share (“Series A Original Issue Price”) pursuant to the Series A stock purchase agreement (the “Series A Purchase Agreement”), for gross proceeds of $5.5 million. On August 7, 2019, investors purchased an additional 1,816,750 shares of Series A at the Series A Original Issue Price, for gross proceeds of $1.8 million. Upon achievement of the Milestone Closing (as defined in the Series A Purchase Agreement) and approval by the Company’s board of directors, the Company issued an additional 25,183,250 shares of Series A at the Series A Original Issue Price on January 9, 2020 for gross proceeds of $25.2 million. Series B On November 10, 2020, the Company sold 34,043,889 shares of Series B at a price of $1.9093 per share (“Series B Original Issue Price”), pursuant to the Series B stock purchase agreement for gross proceeds of $65.0 million. Conversion Upon the closing the Company’s IPO in June 2021, all outstanding convertible preferred stock automatically converted into shares of common stock. There are 10,000,000 authorized preferred shares of December 31, 2021. |
COMMON STOCK
COMMON STOCK | 12 Months Ended |
Dec. 31, 2021 | |
COMMON STOCK. | |
COMMON STOCK | 7. COMMON STOCK As of December 31, 2021, the Company’s certificate of incorporation, as amended and restated, authorized the Company to issue 500,000,000 shares of $0.0001 par value common stock. Each share of common stock entitles the holder to one vote on all matters submitted to a vote of the Company’s stockholders. Common stockholders are entitled to receive dividends, as may be declared by the board of directors. Initial Public Offering On June 29, 2021, the Company closed its IPO and issued 6,250,000 shares of its common stock at a price of $16.00 per share for net proceeds of $91.1 million, after deducting underwriting discounts and commissions and expenses of $8.9 million. In connection with the IPO, all shares of Series A and Series B convertible preferred stock converted into 15,736,053 shares of common stock. On July 19, 2021, in connection with the Company’s IPO, the underwriters exercised the right to purchase 403,407 shares of the Company’s common stock at a price of $16.00 per share for net proceeds of $6.0 million, after deduction underwriting discounts of $0.5 million. The Company has reserved a total of 27,565,320 shares of common stock as of December 31, 2021 for common stock outstanding, the exercise of outstanding stock options and the number of shares remaining available for future grant under the Company’s 2021 Stock Incentive Plan. The Company had reserved a total of 19,831,875 shares of common stock as of December 31, 2020 for common stock outstanding, the conversion of the outstanding shares of Convertible Preferred Stock, the exercise of outstanding stock options and the number of shares remaining available for future grant under the Company’s 2019 Stock Incentive Plan. |
STOCK-BASED COMPENSATION
STOCK-BASED COMPENSATION | 12 Months Ended |
Dec. 31, 2021 | |
STOCK-BASED COMPENSATION | |
STOCK-BASED COMPENSATION | 8. STOCK-BASED COMPENSATION Stock-based compensation expense as reflected in the Company’s consolidated statements of operations was as follows (in thousand): Year Ended December 31, 2021 2020 (in thousands) Research and development $ 244 $ 24 General and administrative 1,327 28 Stock-based compensation expense included in operating expenses $ 1,571 $ 52 2021 Equity Incentive Plan The Company has two equity incentive plans: the 2019 Equity Incentive Plan (“2019 Plan”), and the 2021 Equity Incentive Plan (“2021 Plan”). New awards can only be granted under the 2021 Plan, under which it is able to issue equity to employees, board members, consultants, and advisors. The 2021 Plan became effective on June 24, 2021, the date the prospectus related to the Company's IPO was deemed effective by the SEC. The 2021 Plan authorizes the award of stock options, restricted stock awards (“RSAs”), stock appreciation rights (“SARs”), restricted stock units (“RSUs”), cash awards, performance awards and stock bonus awards. The Company has initially reserved 1,483,445 shares of its common stock, plus any reserved shares not issued or subject to outstanding grants under the 2019 Plan on the effective date of the 2021 Plan, for issuance pursuant to awards granted under the 2021 Plan. Of this amount, 1,720,291 shares were available for future grants as of December 31, 2021. The number of shares reserved for issuance under the 2021 Plan will increase automatically on January 1 of each of 2022 through 2031 by the number of shares equal to the lesser of 5% of the aggregate number of outstanding shares of the Company’s common stock as of the immediately preceding December 31, or a number as may be determined by our board of directors. As such, 1,160,296 shares were added to the Plan in January 2021. 2019 Stock Incentive Plan The total number of shares of common stock available for issuance under the 2019 Plan was 1,972,114 shares when the 2019 Plan was adopted. In December 2019 and November 2020, the Company increased the number of shares of common stock reserved for issuance under the 2019 Plan by 144,950 shares and 1,189,911 shares, respectively. Shares underlying any awards that were forfeited, canceled, or reacquired by the Company prior to vesting, satisfied without the issuance of stock or otherwise terminated or shares that were withheld upon exercise of an option or settlement of an award to cover the exercise price or tax withholding were to be added back to the shares available for issuance under the 2019 Plan. For the year ended December 31, 2021, 1,016,337 options were granted under the 2019 Plan. The 2019 Plan was terminated in connection with the Company’s IPO. The Company will not grant any additional awards under the 2019 Plan thereafter. 2021 Employee Stock Purchase Plan The Company has adopted the Employee Stock Purchase Plan (“ESPP”) which became effective June 24, 2021, the date the prospectus related to the Company's IPO was deemed effective by the SEC, to enable eligible employees to purchase shares of its common stock with accumulated payroll deductions at a discount beginning on a date to be determined by the board of directors or compensation committee. The ESPP is intended to qualify under Section 423 of the Code. The Company has initially reserved 228,222 shares of its common stock for sale under the ESPP. The aggregate number of shares reserved for sale under the ESPP will increase automatically on January 1st of each of 2022 through 2031 by the number of shares equal to the lesser of 1% of the total outstanding shares of the Company’s common stock as of the immediately preceding December 31 (rounded to the nearest whole share) or a number of shares as may be determined by the board of directors in any particular year. As such, 232,059 shares were added to the Plan in January 2021. The aggregate number of shares issued over the term of the ESPP, subject to stock-splits, recapitalizations or similar events, may not exceed 4,564,440 shares of the Company’s common stock. Stock Options A summary of stock option activity for employee and nonemployee awards under the 2019 and 2021 Plans is presented below: Weighted Weighted Average Average Remaining Contractual Aggregate Options Exercise Price Term (years) Intrinsic Value Outstanding at December 31, 2020 1,761,062 $ 0.95 9.54 $ 723 Granted 1,309,400 $ 7.80 Cancelled (48,663) 3.98 Outstanding at December 31, 2021 3,021,799 $ 3.71 8.94 $ 10,903 Vested at December 31, 2021 680,951 $ 1.23 8.39 $ 3,437 Vested and expected to vest at December 31, 2021 3,021,799 $ 3.71 8.94 $ 10,903 The weighted average grant-date fair value of stock options granted during the year ended December 31, 2021 and 2020 was $4.60 and $0.73 per share, respectively. The fair value of each stock option was estimated using a Black-Scholes option-pricing model with the following assumptions: Year Ended December 31, 2021 2020 Risk-free interest rate 0.95 - 1.35 % 0.2−0.75 % Volatility 75-77 % 74%−79 % Dividend yield — % — % Expected term (years) 6 3 6 The fair value of options that vested during the years ended December 31, 2021 and 2020 was $0.6 million and $0 million, respectively. The Company recorded stock-based compensation expense associated with stock option awards of $1.1 million and $0.1 million during the 12 months ended December 31, 2021 and 2020, respectively. As of December 31, 2021, there was Restricted Common Stock The terms of the 2019 Plan permitted certain option holders to exercise options before their options were vested, subject to certain limitations. Upon early exercise, the awards become subject to a restricted stock agreement and are subject to the same vesting provisions in the original stock option awards. Shares issued as a result of early exercise that have not vested are subject to repurchase by the Company upon termination of the purchaser’s employment, at the lesser of the price paid by the purchaser or the fair value of the shares at the time of repurchase. Such shares are not deemed to be issued for accounting purposes until they vest and are therefore excluded from shares outstanding until the repurchase right lapses and the shares are no longer subject to the repurchase feature. The liability is reclassified into common stock and additional paid-in capital as the shares vest and the repurchase right lapses. Accordingly, the Company has recorded the unvested portion of the exercise proceeds of less than $0.01 million as a liability from the early exercise in the accompanying consolidated balance sheets as of December 31, 2021 and 2020, respectively. The Company recorded stock-based compensation expense associated with restricted common stock of less than $0.1 million during the 12 months ended December 31, 2021 and 2020. Restricted Stock Units The Company issues RSUs to employees that generally vest over a four-year period with 25% of awards vesting after one year and then quarterly thereafter. Any unvested shares will be forfeited upon termination of services. The fair value of an RSU is equal to the fair market value price of the Company’s common stock on the date of grant. RSU expense is amortized straight-line over the vesting period. The following table summarizes activity related to restricted stock units: Weighted average grant date Number of shares fair value Unvested at December 31, 2020 — $ — Granted 200,996 16.00 Unvested at December 31, 2021 200,996 16.00 The Company recorded stock-based compensation expense of $0.4 million for the 12 months ended December 31, 2021, related to RSUs. As of December 31, 2021, the total unrecognized expense related to all RSUs was $2.8 million, which the Company expects to recognize over a weighted-average period of 3.4 years. |
ASSET PURCHASE AND LICENSE AGRE
ASSET PURCHASE AND LICENSE AGREEMENTS | 12 Months Ended |
Dec. 31, 2021 | |
ASSET PURCHASE AND LICENSE AGREEMENTS | |
ASSET PURCHASE AND LICENSE AGREEMENTS | 9. ASSET PURCHASE AND LICENSE AGREEMENTS In May 2019, the Company entered into an asset purchase agreement with the previous sponsor, pursuant to which it acquired all rights and interest to patents, know-how, and inventory for assets related to seribantumab, a fully humanized immunoglobulin G2 monoclonal antibody against HER3. Pursuant to the asset purchase agreement, the Company made an upfront, non-refundable payment of $3.5 million at closing. If the Company succeeds in developing and commercializing seribantumab, the Company may be obligated to pay the previous sponsor up to $54.5 million in development, regulatory and sales milestone payments. Under the terms of the asset purchase agreement, the Company assumed the rights and obligations of the following collaboration and license agreements previously held by the previous sponsor: ● Dyax— The Company assumed all rights and obligations provided for under the amended and restated collaboration agreement executed between Dyax Corp. (“Dyax”) and the previous sponsor (the “Dyax Agreement”). Pursuant to the Dyax Agreement, Dyax utilized its proprietary phage technology to identify antibodies that would bind to targets of interest to the previous sponsor. Additionally, Dyax granted to the previous sponsor a world-wide, non-exclusive, royalty free right to use and make any and all of the antibodies identified by Dyax for certain research purposes. Seribantumab was identified as a result of the research activities performed under the Dyax Agreement. Pursuant to the terms of the Dyax Agreement, the Company may be obligated to pay Dyax milestone payments of up to approximately $9.3 million if certain development and regulatory milestones are achieved. In addition, Dyax is entitled to mid-single digit royalties based on net sales of seribantumab. The Company’s obligation to pay royalties to Dyax continues on a product-by-product and country-by-country basis until the later of a specified number of years after the first commercial sale in such country and the expiration of the patent rights covering seribantumab in such country. The Dyax Agreement will remain in effect, unless earlier terminated, for so long as the Company continues to develop or commercialize seribantumab. Either party may terminate the agreement in the event of an uncured material breach by the other party. The Company also has the right to terminate the agreement in its entirety or on a product-by-product basis at any time upon 90 days’ prior written notice. ● Ligand Pharmaceuticals— The Company assumed all rights and obligations provided for under the amended commercial license agreement executed between Selexis SA (“Selexis”) and the previous sponsor (the “Selexis Agreement”). Pursuant to the Selexis Agreement, the Company received non-exclusive rights to technology for use in the manufacture of seribantumab and may be required to make milestone payments of up to approximately €900 , per licensed product, if certain development and regulatory milestones are achieved. Additionally, Selexis may have the right to obtain a royalty of the greater of €0.2 million annually and less than one percent on net sales of seribantumab. The obligation to pay royalties with respect to each product sold in a country continues until the expiration of the patent rights covering the product in such country. Either party may terminate the agreement in the event of an uncured material breach by the other party. The Company also has the right to terminate the agreement at any time upon 60 days ’ prior written notice. In November of 2021, the Selexis agreement was assigned to Ligand Pharmaceuticals Incorporated. ● National Institute of Health —The Company assumed all rights and obligations provided for under the amended commercial license agreement executed between the U.S. Public Health Service, a division of the U.S. Department of Health and Human Services (the “NIH”) and the previous sponsor (the “NIH Agreement”). Pursuant to the NIH Agreement, the Company received non-exclusive rights in the United States to patents related to certain antibodies associated with seribantumab. If certain development and regulatory milestones are achieved, the Company may be obligated to pay NIH additional milestone payments of up to approximately $0.4 million per licensed product. The Company evaluated the asset purchase agreement with the previous sponsor under ASC Topic 805 , Business Combinations, Other Research Arrangements In June 2021, the Company entered into a collaboration agreement with Caris, or the Caris Agreement. Under the terms of the Caris Agreement, Caris will identify targets for the collaboration and provide those targets to the Company at regular intervals for review and approval. Once a target is selected by the collaboration’s joint steering committee, the collaboration will retain access to the selected targets. The financial terms surrounding development and commercialization of each product candidate identified for the collaboration and included in the Caris Agreement vary based on the level of participation elected by each party in the development and commercialization efforts following identification of a target. There are no upfront or milestone payments or royalties due to either party under the collaboration. With respect to proceeds from any potential commercial transaction related to a product resulting from the collaboration, Caris will be entitled to a tiered initial percentage ranging from the mid-single digits to low teens based on the product candidate’s potential peak sales revenue with the remaining proceeds allocated based on each party’s pro rata share of expenses incurred in development of the product. In the case of an out-licensing transaction of an asset instead of a sale, Caris and the Company will split all consideration received in the transaction in a similar manner. The Caris Agreement provides flexibility for Caris and the Company to jointly develop and commercialize, or for either the Company or Caris to incur development and commercialization expenses. The ultimate percentage of proceeds payable to the Company and Caris will depend on the level of development and commercialization participation elected by each party. The Company will own the intellectual property rights to the therapeutics developed under the collaboration, and Caris will own the intellectual property rights to the diagnostics developed under the collaboration. Either party may terminate the Caris Agreement for uncured material breach by the other party or in the case of the other party’s insolvency. The term of the Caris Agreement is three years, automatically renewing for one-year terms. Either party may terminate the agreement at the end of a term by written notice to the other, subject to the continuation of exclusivity with respect to any target selected by the Joint Steering Committee, so long as commercially reasonable efforts are used to discover, identify, develop and/or commercialize a therapeutic related to such target. |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 12 Months Ended |
Dec. 31, 2021 | |
COMMITMENTS AND CONTINGENCIES | |
COMMITMENTS AND CONTINGENCIES | 10. COMMITMENTS AND CONTINGENCIES The Company, from time to time, may be involved in legal proceedings, regulatory actions, claims and litigation arising in the ordinary course of business. The Company was not a defendant in any lawsuits from Inception to the date of these consolidated financial statements. |
INCOME TAXES
INCOME TAXES | 12 Months Ended |
Dec. 31, 2021 | |
INCOME TAXES | |
INCOME TAXES | 11. INCOME TAXES No provision for income taxes was recorded for the years ended December 31, 2021 and 2020. The Company has incurred net pre-tax losses in the United States only for all periods presented. The Company has not reflected any benefit of such net operating loss (“NOL”) carryforwards in the accompanying consolidated financial statements. The provision for income taxes differs from the amount expected by applying the federal statutory rate to the loss before taxes as follows: Year Ended December 31, 2021 2020 Profit before tax at federal statutory rate 21.0 % 21.0 % State tax benefit, net of federal benefit 0.4 % 0.3 % Research and development credit carryovers 4.4 % 1.7 % Permanent differences (1.4) % (0.6) % Return to Provision True Ups 0.1 % — % Change in valuation allowance (24.5) % (22.4) % Effective income tax rate — % — % In assessing the realizability of the net deferred tax assets, the Company considers all relevant positive and negative evidence in determining whether it is more likely than not that some portion or all of the deferred income tax assets will not be realized. The realization of the gross deferred tax assets is dependent on several factors, including the generation of sufficient taxable income prior to the expiration of the NOL carryforwards. The Company has recorded a valuation allowance against its deferred tax assets on December 31, 2021 and 2020 because the Company’s management believes that it is more likely than not that these assets will not be fully realized in the near future. The increase in the valuation allowance of approximately $7.9 million in the year ended December 31, 2021 primarily relates to the generation of net operating losses and research and development credits. As of December 31, 2021, the Company had federal NOL carryforwards of approximately $48.2 million, all of which can be carried forward indefinitely, and state NOL carryforwards of $3.5 million, which begin to expire in 2040. The Company also has federal tax credits of $1.5 million and state tax credits of $0.2 million which may be used to offset future tax liabilities and will begin to expire in 2040. NOL and tax credit carryforwards are subject to review and possible adjustment by the Internal Revenue Service and state tax authorities. Net deferred tax asset (liability) in the accompanying consolidated balance sheets consists of the following (in thousands): December 31, 2021 2020 (in thousands) Deferred tax assets and (liabilities) Net operating losses $ 10,303 $ 4,138 Research and development credit 1,697 295 Accrued expenses 130 — Stock-based compensation 151 — Intangible assets 666 664 Gross deferred tax asset 12,947 5,097 Valuation allowance (12,945) (5,083) Net deferred tax asset 2 14 Stock based compensation — (2) Fixed assets (2) (12) Deferred tax liabilities (2) (14) Net deferred tax asset (liability) $ — $ — Subsequent ownership changes may further affect the limitation in future years. The Company has not conducted a study to assess whether a change of ownership has occurred or whether there have been multiple changes of ownership since Inception due to the significant complexity and cost associated with such a study. If the Company has experienced a change of ownership, as defined by Section 382 and 383 of the Internal Revenue Code, at any time since Inception, utilization of the NOL carryforwards or research and development tax credit carryforwards would be subject to the annual limitations under Section 382 and 383 of the Internal Revenue Code. The Company will recognize both accrued interest and penalties related to uncertain tax positions in income tax expense. As of December 31, 2021, the Company had no accrued interest or penalties related to uncertain tax positions and no amounts have been recognized in the Company’s statements of operations. Since the Company is in a loss carryforward position, the Company is generally subject to examination by the U.S. federal, state and local income tax authorities for all tax years in which a loss carryforward is available. As of December 31, 2021, all tax returns remain open. In response to the COVID-19 pandemic, the Coronavirus Aid, Relief, and Economic Security Act (“the CARES Act”), was signed into law in March 2020. The CARES Act lifts certain deduction limitations originally imposed by the Tax Cuts and Jobs Act of 2017 (“2017 Tax Act”). Corporate taxpayers may carryback NOLs originating during 2018 through 2020 for up to five years, which was not previously allowed under the 2017 Tax Act. The CARES Act also eliminates the 80% of taxable income limitations by allowing corporate entities to fully utilize NOL carryforwards to offset taxable income in 2018, 2019 or 2020. Taxpayers may generally deduct interest up to the sum of 50% of adjusted taxable income plus business interest income (30% limit under the 2017 Tax Act) for tax years beginning January 1, 2019 and 2020. The CARES Act allows taxpayers with alternative minimum tax credits to claim a refund in 2020 for the entire amount of the credits instead of recovering the credits through refunds over a period of years, as originally enacted by the 2017 Tax Act. The Company notes that these provisions did not have a material impact to the amounts recorded within this footnote. |
NET LOSS PER SHARE
NET LOSS PER SHARE | 12 Months Ended |
Dec. 31, 2021 | |
NET LOSS PER SHARE | |
NET LOSS PER SHARE | 12. NET LOSS PER SHARE The following table summarizes the computation of basic and diluted net loss per share of the Company (in thousands, except share and per share amounts): Year Ended December 31, 2021 2020 Net loss $ (32,039) $ (17,265) Weighted average common stock outstanding, basic and diluted 12,132,610 791,821 Net loss per share, basic and diluted $ (2.64) $ (21.80) The Company’s potentially dilutive securities, which include convertible preferred stock, options to purchase common stock and unvested restricted stock, have been excluded from the computation of diluted net loss per share as the effect would be to reduce the net loss per share. Therefore, the weighted average number of common shares outstanding used to calculate both basic and diluted net loss per share is the same. The Company excluded the following potential common shares, presented based on amounts outstanding at each period end, from the computation of diluted net loss per share for the periods indicated because including them would have had an anti-dilutive effect: December 31, 2021 2020 Convertible preferred shares — 15,736,053 Outstanding stock options 3,021,799 1,761,062 Unvested restricted stock 19,721 34,498 Unvested RSUs 200,996 — 3,242,516 17,531,613 |
RETIREMENT PLAN
RETIREMENT PLAN | 12 Months Ended |
Dec. 31, 2021 | |
RETIREMENT PLAN | |
RETIREMENT PLAN | 13. DEFINED CONTRIBUTION PLAN The Company has a defined-contribution plan under Section 401(k) of the Internal Revenue Code (the “401(k) Plan”). The 401(k) Plan covers all employees who meet defined minimum age and service requirements and allows participants to defer a portion of their annual compensation on a pre-tax basis. As currently established, the Company is not required to make contributions to the 401(k) Plan. The Company made matching contributions of $0.1 million for the year ended December 31, 2021. No contributions were made for the year ended December 31, 2020. |
SUMMARY OF SIGNIFICANT ACCOUN_2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2021 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
Basis of presentation | Basis of Presentation The accompanying consolidated financial statements of the Company have been prepared in accordance with generally accepted accounting principles in the United States (“GAAP”). |
Principles of Consolidation | Principles of Consolidation The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary, Elevation Oncology Securities Corporation, which was established on November 19, 2021. All significant intercompany balances and transaction have been eliminated in consolidation. |
Use of estimates | Use of Estimates The preparation of financial statements in accordance with GAAP requires the use of estimates and assumptions, based on judgments considered reasonable, which affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. The Company bases its estimates and assumptions on known trends and events and various other factors that management believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Significant estimates and assumptions reflected in these consolidated financial statements include, but are not limited to, the accruals for research and development expenses, the valuation of common stock and the assumptions used in the valuation of share-based compensation awards. Changes in estimates are recorded in the period in which they become known. Due to the risks and uncertainties involved in the Company’s business and evolving market conditions and, given the subjective element of the estimates and assumptions made, actual results may differ from estimated results. |
Segment Information | Segment Information Operating segments are defined as components of an enterprise about which separate discrete information is available and regularly reviewed by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one operating segment, which is the development of precision medicines for patients with genomically defined cancers. All material long-lived assets of the Company reside in the United States. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid investments with an original maturity of three months or less to be cash equivalents. As of December 31, 2021 and 2020, cash equivalents consisted of money-market funds. The Company places its cash with a high-credit-quality financial institution domiciled in the United States. |
Concentrations of credit risk and significant suppliers | Concentrations of Credit Risk and Significant Suppliers Financial instruments that potentially subject the Company to concentration of credit risk consist of cash and cash equivalents. The Company’s money market funds are invested in highly rated funds. Periodically, the Company maintains deposits in accredited financial institutions in excess of federally insured limits. The Company has not experienced any losses on its deposits of cash and cash equivalents and does not believe that it is exposed to any unusual credit risk beyond the normal credit risk associated with commercial banking relationships. The Company is dependent on third-party manufacturers to supply products for research and development activities of its programs, including preclinical and clinical testing. These programs could be adversely affected by a significant interruption in the supply of such drug substance and drug products. During the year ended December 31, 2021, the Company had two vendors that accounted for approximately 61% of its research and development expense. As of December 31, 2021, the Company had one vendor that accounted for approximately 74% of the total accounts payable. During the year ended December 31, 2020, the Company had one vendor that accounted for approximately 46% of its research and development expense. The same |
Property and Equipment | Property and Equipment Property and equipment consist of computer software that is recorded at cost and depreciated on a straight-line basis over the estimated useful lives of the assets. Upon retirement or sale, the cost of the disposed asset and the related accumulated depreciation are removed from the accounts and any resulting gain or loss is recognized. The Company reviews its long-lived assets for impairment whenever events or changes in business circumstances indicate that the carrying value of assets may not be recoverable. Recoverability is measured by comparison of the asset’s book value to future net undiscounted cash flows that the assets are expected to generate. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the book value of the assets exceed their fair value, which is measured based on the projected discounted future net cash flows arising from the assets. No impairment losses have been recorded through December 31, 2021. |
Cloud Computing Arrangements | Cloud Computing Arrangements The Company defers implementation costs incurred in cloud computing hosting arrangements in accordance with Accounting Standards Update (“ASU”) 2018-15 and amortizes these costs over the noncancelable term of the cloud computing arrangement, plus any optional renewal periods (1) that are reasonably certain to be exercised by the Company or (2) for which exercises of the renewal option is controlled by the cloud service provider. Costs incurred during the application development stage are capitalized within either prepaid expenses and other current assets, or in other assets, net on the Company’s balance sheet. Amortization of implementation costs are on a straight-line basis over the related hosting arrangement term and is reflected in research and development expenses in the consolidated statements of operations. |
Classification and Accretion of Convertible Preferred Stock | Classification and Accretion of Convertible Preferred Stock The Company’s convertible preferred stock is classified outside of stockholders’ deficit on the balance sheet because the holders of such shares have liquidation rights in the event of a deemed liquidation that, in certain situations, are not solely within the control of the Company and would require the redemption of the then-outstanding convertible preferred stock. The convertible preferred stock is not redeemable, except in the event of a deemed liquidation (see Note 6). Because the occurrence of a deemed liquidation event is not currently probable, the carrying values of the convertible preferred stock are not being accreted to their redemption values. Subsequent adjustments to the carrying values of the convertible preferred stock would be made only when a deemed liquidation event becomes probable. Upon the closing the Company’s IPO in June 2021, all outstanding convertible preferred stock automatically converted into shares of common stock. |
Fair Value Measurements | Fair Value Measurements Certain assets and liabilities are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable: ● Level 1—Quoted prices in active markets for identical assets or liabilities. ● Level 2—Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data. ● Level 3—Non-observable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques. |
Patent costs | The Company's cash equivalents are carried at fair value, determined according to the fair value hierarchy described above (see Note 3). Patent Costs The legal and professional costs incurred by the Company to maintain its patent rights have been expensed as part of general and administrative expenses since inception. As of December 31, 2021 and 2020, the Company has determined that these expenses have not met the criteria to be capitalized. Intellectual property-related expenses for the year ended December 31, 2021 and 2020 were $0.2 million and $0.1 million, respectively. |
Research and Development Costs | Research and Development Costs Research and development costs consist of salaries and benefits, including associated stock-based compensation, and fees paid to other entities that conduct certain research and development activities on the Company’s behalf. Research and development costs are expensed as incurred. The Company estimates preclinical study and clinical trial expenses based on the services performed pursuant to contracts with research institutions and contract research organizations and clinical manufacturing organizations that conduct and manage preclinical studies and clinical trials on the Company’s behalf based on actual time and expenses incurred by them. Further, the Company accrues expenses related to clinical trials based on the level of patient activity according to the related agreement. The Company monitors patient enrollment levels and related activity to the extent reasonably possible and adjusts estimates accordingly. The Company accounts for nonrefundable advance payments for goods and services that will be used in future research and development activities as expenses when the services have been performed or when the goods have been received rather than when the payment is made. Although the Company does not expect its estimates to be materially different from amounts actually incurred, its understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in reporting amounts that are too high or too low in any particular period. To date, there have not been any material adjustments to the Company’s prior estimates of accrued research and development expenses. |
Stock-Based Compensation | Stock-Based Compensation The Company measures stock-based compensation cost at the accounting measurement date based on the fair value of the award and recognizes the expense on a straight-line basis over the requisite service period of the award, which is typically the vesting period. Compensation expense is measured using the fair value of the award at the grant date and is adjusted to reflect actual forfeitures as they occur. The Company estimates the fair value of stock options using the Black-Scholes option pricing model that takes into account the exercise price, the fair value of the Company’s common stock, the expected term of the option, the expected volatility of the Company’s common stock, expected dividends on the Company’s common stock, and the risk-free interest rate over the expected life of the option. Fair value of common stock— Expected term— Expected volatility— Risk-free interest rate— Expected dividend— The Company classifies stock-based compensation expense in its consolidated statements of operations in the same manner in which the award recipient’s payroll costs or service payments are classified. |
Net Loss per Common Share | Net Loss per Common Share The Company’s net loss is equivalent to net loss attributable to common stockholders for all periods presented. Basic net loss per share is computed using the weighted average number of common shares outstanding during the period. Diluted net loss per share is computed using the sum of the weighted average number of common shares outstanding during the period and the effect of dilutive securities. The Company applies the two-class method to calculate its basic and diluted net loss per share as the Company has issued shares that meet the definition of participating securities. The two-class method is an earnings allocation formula that treats a participating security as having rights to earnings that otherwise would have been available to common stockholders. The Company’s participating securities contractually entitle the holders of such shares to participate in dividends; but do not contractually require the holders of such shares to participate in losses of the Company. Accordingly, in periods in which the Company reports a net loss, diluted net loss per share is the same as basic net loss per share, since dilutive common shares are not assumed to have been issued if their effect is anti-dilutive. |
Income Taxes | Income Taxes The Company accounts for income taxes using the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the consolidated financial statements or in the Company’s tax returns. Deferred tax assets and liabilities are determined on the basis of the differences between the consolidated financial statements and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Changes in deferred tax assets and liabilities are recorded in the provision for income taxes. The Company assesses the likelihood that its deferred tax assets will be recovered from future taxable income and, to the extent it believes, based upon the weight of available evidence, that it is more likely than not that all or a portion of the deferred tax assets will not be realized, a valuation allowance is established through a charge to income tax expense. The Company accounts for uncertainty in income taxes recognized. If the tax position is deemed more likely than not to be sustained, it would then be assessed to determine the amount of benefit to recognize in the consolidated financial statements. The amount of the benefit that may be recognized is the largest amount that has a greater than 50% likelihood of being realized upon ultimate settlement. To date the Company has no uncertain tax positions and there have been no interest and penalties. |
Recently Adopted Accounting Pronouncements | Recently issued accounting pronouncements In December 2019, the Financial Accounting Standards Board issued Accounting Standards Update (“ASU”) 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes |
FAIR VALUE MEASUREMENTS OF FI_2
FAIR VALUE MEASUREMENTS OF FINANCIAL ASSETS (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
FAIR VALUE MEASUREMENTS OF FINANCIAL ASSETS. | |
Schedule of fair value measurements of financial assets | The Company’s financial assets subject to fair value measurements on a recurring basis and the level of inputs used for such measurements were as follows: As of December 31, 2021 Level 1 Level 2 Level 3 Total (in thousands) Money market funds included in cash and cash equivalents $ 106,000 $ — $ — $ 106,000 As of December 31, 2020 Level 1 Level 2 Level 3 Total (in thousands) Money market funds included in cash and cash equivalents $ 76,013 $ — $ — $ 76,013 |
PROPERTY AND EQUIPMENT, NET (Ta
PROPERTY AND EQUIPMENT, NET (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
PROPERTY AND EQUIPMENT, NET | |
Schedule of property and equipment, net | Property and equipment, net, consisted of the following (in thousands): Estimated December 31, Useful Life 2021 2020 (in thousands) Computer software 4 years $ 71 $ 71 Less: Accumulated depreciation (33) (15) Property and equipment, net $ 38 $ 56 |
ACCRUED EXPENSES (Tables)
ACCRUED EXPENSES (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
ACCRUED EXPENSES | |
Schedule of accrued expenses | Accrued expenses consist of the following (in thousands): December 31, 2021 2020 (in thousands) Accrued preclinical and clinical trial costs $ 1,260 $ 505 Accrued compensation 1,059 429 Accrued consulting 77 127 Accrued professional services 499 28 Accrued other 246 17 Total accrued expenses $ 3,141 $ 1,106 |
STOCK-BASED COMPENSATION (Table
STOCK-BASED COMPENSATION (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
STOCK-BASED COMPENSATION | |
Schedule of stock-based compensation expense | Stock-based compensation expense as reflected in the Company’s consolidated statements of operations was as follows (in thousand): Year Ended December 31, 2021 2020 (in thousands) Research and development $ 244 $ 24 General and administrative 1,327 28 Stock-based compensation expense included in operating expenses $ 1,571 $ 52 |
Summary of stock option activity | A summary of stock option activity for employee and nonemployee awards under the 2019 and 2021 Plans is presented below: Weighted Weighted Average Average Remaining Contractual Aggregate Options Exercise Price Term (years) Intrinsic Value Outstanding at December 31, 2020 1,761,062 $ 0.95 9.54 $ 723 Granted 1,309,400 $ 7.80 Cancelled (48,663) 3.98 Outstanding at December 31, 2021 3,021,799 $ 3.71 8.94 $ 10,903 Vested at December 31, 2021 680,951 $ 1.23 8.39 $ 3,437 Vested and expected to vest at December 31, 2021 3,021,799 $ 3.71 8.94 $ 10,903 |
Schedule of assumptions used in estimation of fair value | The weighted average grant-date fair value of stock options granted during the year ended December 31, 2021 and 2020 was $4.60 and $0.73 per share, respectively. The fair value of each stock option was estimated using a Black-Scholes option-pricing model with the following assumptions: Year Ended December 31, 2021 2020 Risk-free interest rate 0.95 - 1.35 % 0.2−0.75 % Volatility 75-77 % 74%−79 % Dividend yield — % — % Expected term (years) 6 3 6 |
Summary of restricted stock units activity | The following table summarizes activity related to restricted stock units: Weighted average grant date Number of shares fair value Unvested at December 31, 2020 — $ — Granted 200,996 16.00 Unvested at December 31, 2021 200,996 16.00 |
INCOME TAXES (Tables)
INCOME TAXES (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
INCOME TAXES | |
Schedule of effective income tax rate reconciliation | Year Ended December 31, 2021 2020 Profit before tax at federal statutory rate 21.0 % 21.0 % State tax benefit, net of federal benefit 0.4 % 0.3 % Research and development credit carryovers 4.4 % 1.7 % Permanent differences (1.4) % (0.6) % Return to Provision True Ups 0.1 % — % Change in valuation allowance (24.5) % (22.4) % Effective income tax rate — % — % |
Schedule of net deferred tax asset (liability) | Net deferred tax asset (liability) in the accompanying consolidated balance sheets consists of the following (in thousands): December 31, 2021 2020 (in thousands) Deferred tax assets and (liabilities) Net operating losses $ 10,303 $ 4,138 Research and development credit 1,697 295 Accrued expenses 130 — Stock-based compensation 151 — Intangible assets 666 664 Gross deferred tax asset 12,947 5,097 Valuation allowance (12,945) (5,083) Net deferred tax asset 2 14 Stock based compensation — (2) Fixed assets (2) (12) Deferred tax liabilities (2) (14) Net deferred tax asset (liability) $ — $ — |
NET LOSS PER SHARE (Tables)
NET LOSS PER SHARE (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
NET LOSS PER SHARE | |
Summary of computation of basic and diluted net loss per share | The following table summarizes the computation of basic and diluted net loss per share of the Company (in thousands, except share and per share amounts): Year Ended December 31, 2021 2020 Net loss $ (32,039) $ (17,265) Weighted average common stock outstanding, basic and diluted 12,132,610 791,821 Net loss per share, basic and diluted $ (2.64) $ (21.80) |
Schedule of antidilutive securities excluded from computation of diluted net loss per share | December 31, 2021 2020 Convertible preferred shares — 15,736,053 Outstanding stock options 3,021,799 1,761,062 Unvested restricted stock 19,721 34,498 Unvested RSUs 200,996 — 3,242,516 17,531,613 |
NATURE OF BUSINESS - Liquidity
NATURE OF BUSINESS - Liquidity (Details) $ / shares in Units, $ in Thousands | Jul. 19, 2021USD ($)$ / sharesshares | Jun. 29, 2021USD ($)$ / sharesshares | Jun. 17, 2021 | Nov. 30, 2020USD ($) | Jul. 31, 2019USD ($) | Dec. 31, 2021USD ($) | Dec. 31, 2020USD ($) |
Initial Public Offering | |||||||
Reverse stock split ratio | 0.2367 | ||||||
Stock issuance costs | $ 11 | $ 174 | |||||
Net loss | 32,039 | 17,265 | |||||
Accumulated deficit | $ 55,186 | 23,147 | |||||
Gross proceeds | $ 90,183 | ||||||
Series A and Series B convertible preferred stock | |||||||
Initial Public Offering | |||||||
Gross proceeds | $ 97,200 | $ 97,200 | |||||
IPO | |||||||
Initial Public Offering | |||||||
Shares issued (in shares) | shares | 6,250,000 | ||||||
Share price (in dollars per share) | $ / shares | $ 16 | ||||||
Net proceeds from sale of stock | $ 91,100 | ||||||
Stock issuance costs | $ 8,900 | ||||||
Number of shares from conversion of preferred stock (in shares) | shares | 15,736,053 | ||||||
IPO | Underwriters | |||||||
Initial Public Offering | |||||||
Shares issued (in shares) | shares | 403,407 | ||||||
Share price (in dollars per share) | $ / shares | $ 16 | ||||||
Net proceeds from sale of stock | $ 6,000 | ||||||
Stock issuance costs | $ 500 |
SUMMARY OF SIGNIFICANT ACCOUN_3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021USD ($)segmentitem | Dec. 31, 2020USD ($)item | |
Summary of significant accounting policies | ||
Number of operating segments | segment | 1 | |
Impairment losses | $ 0 | |
Legal and professional costs | 200 | $ 100 |
Uncertain tax positions | 0 | |
Interest and penalties | $ 0 | |
Percentage of dividend yielded | 0 | |
Accounts payable | Major suppliers | Supplier Concentration Risk | ||
Summary of significant accounting policies | ||
Number of vendors | item | 1 | 1 |
Concentration risk | 74.00% | 95.00% |
Research and development | Major suppliers | Supplier Concentration Risk | ||
Summary of significant accounting policies | ||
Number of vendors | item | 2 | 1 |
Concentration risk | 61.00% | 46.00% |
FAIR VALUE MEASUREMENTS OF FI_3
FAIR VALUE MEASUREMENTS OF FINANCIAL ASSETS (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Fair value measurements of financial assets | ||
Transfers from Level 1 to Level 2, Assets | $ 0 | |
Transfers from Level 2 to Level 1, Assets | 0 | |
Transfers into (out of) Level 3, Assets | 0 | |
Recurring | Money Market Funds | ||
Fair value measurements of financial assets | ||
Fair value | 106,000 | $ 76,013 |
Recurring | Money Market Funds | Level 1 | ||
Fair value measurements of financial assets | ||
Fair value | $ 106,000 | $ 76,013 |
PROPERTY AND EQUIPMENT, NET (De
PROPERTY AND EQUIPMENT, NET (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Property and equipment, net | ||
Less: Accumulated depreciation | $ (33) | $ (15) |
Property and equipment, net | 38 | 56 |
Depreciation expense | 18 | 15 |
Maximum | ||
Property and equipment, net | ||
Depreciation expense | $ 100 | |
Computer software | ||
Property and equipment, net | ||
Estimated Useful Life | 4 years | |
Property, Plant and Equipment, Gross | $ 71 | $ 71 |
ACCRUED EXPENSES (Details)
ACCRUED EXPENSES (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
ACCRUED EXPENSES | ||
Accrued preclinical and clinical trial costs | $ 1,260 | $ 505 |
Accrued compensation | 1,059 | 429 |
Accrued consulting | 77 | 127 |
Accrued professional services | 499 | 28 |
Accrued other | 246 | 17 |
Total accrued expenses | $ 3,141 | $ 1,106 |
CONVERTIBLE PREFERRED STOCK (De
CONVERTIBLE PREFERRED STOCK (Details) - USD ($) $ / shares in Units, $ in Thousands | Nov. 10, 2020 | Jan. 09, 2020 | Aug. 07, 2019 | Jul. 12, 2019 | Dec. 31, 2020 | Dec. 31, 2021 |
Convertible preferred stock | ||||||
Shares authorized | 66,493,889 | |||||
Par value of convertible preferred stock | $ 0.0001 | |||||
Gross proceeds | $ 90,183 | |||||
IPO | ||||||
Convertible preferred stock | ||||||
Shares authorized | 10,000,000 | |||||
Series A Convertible Preferred Stock [Member] | ||||||
Convertible preferred stock | ||||||
Shares authorized | 32,450,000 | 0 | ||||
Par value of convertible preferred stock | $ 0.0001 | $ 0.0001 | ||||
Shares issued | 25,183,250 | 1,816,750 | 5,450,000 | 25,183,250 | ||
Original issue price | $ 1 | |||||
Gross proceeds | $ 25,200 | $ 1,800 | $ 5,500 | |||
Series B Convertible Preferred Stock [Member] | ||||||
Convertible preferred stock | ||||||
Shares authorized | 34,043,889 | 0 | ||||
Par value of convertible preferred stock | $ 0.0001 | $ 0.0001 | ||||
Shares issued | 34,043,889 | 34,043,889 | ||||
Original issue price | $ 1.9093 | |||||
Gross proceeds | $ 65,000 |
COMMON STOCK (Details)
COMMON STOCK (Details) | Dec. 31, 2021Vote$ / sharesshares | Dec. 31, 2020$ / sharesshares |
COMMON STOCK. | ||
Common stock, shares authorized | shares | 500,000,000 | 86,000,000 |
Common stock, par value | $ / shares | $ 0.0001 | $ 0.0001 |
Number of votes per common stock | Vote | 1 |
COMMON STOCK - Initial Public O
COMMON STOCK - Initial Public Offering (Details) - USD ($) $ / shares in Units, $ in Thousands | Jul. 19, 2021 | Jun. 29, 2021 | Dec. 31, 2021 | Dec. 31, 2020 |
Initial Public Offering | ||||
Stock issuance costs | $ 11 | $ 174 | ||
Common stock reserved | 27,565,320 | 19,831,875 | ||
IPO | ||||
Initial Public Offering | ||||
Shares issued (in shares) | 6,250,000 | |||
Share price (in dollars per share) | $ 16 | |||
Net proceeds from sale of stock | $ 91,100 | |||
Stock issuance costs | $ 8,900 | |||
Number of shares from conversion of preferred stock (in shares) | 15,736,053 | |||
IPO | Underwriters | ||||
Initial Public Offering | ||||
Shares issued (in shares) | 403,407 | |||
Share price (in dollars per share) | $ 16 | |||
Net proceeds from sale of stock | $ 6,000 | |||
Stock issuance costs | $ 500 |
STOCK-BASED COMPENSATION - Expe
STOCK-BASED COMPENSATION - Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Stock-based compensation | ||
Stock-based compensation expense included in operating expenses | $ 1,571 | $ 52 |
Research and development | ||
Stock-based compensation | ||
Stock-based compensation expense included in operating expenses | 244 | 24 |
General and administrative | ||
Stock-based compensation | ||
Stock-based compensation expense included in operating expenses | $ 1,327 | $ 28 |
STOCK-BASED COMPENSATION - Stoc
STOCK-BASED COMPENSATION - Stock incentive plan (Details) - shares | Jun. 24, 2021 | Jan. 31, 2021 | Nov. 30, 2020 | Dec. 31, 2019 | Dec. 31, 2021 |
Stock-based compensation | |||||
Granted (in shares) | 1,309,400 | ||||
2021 Equity Incentive Plan | |||||
Stock-based compensation | |||||
Additional number of shares authorized | 1,160,296 | ||||
Remained available for future grant | 1,720,291 | ||||
2021 Equity Incentive Plan | Maximum | |||||
Stock-based compensation | |||||
Additional number of shares authorized (as a percent) | 5.00% | ||||
2019 Stock incentive plan | |||||
Stock-based compensation | |||||
Total number of shares authorized | 1,483,445 | 1,972,114 | |||
Additional number of shares authorized | 1,189,911 | 144,950 | |||
Granted (in shares) | 1,016,337 | ||||
2021 Employee Stock Purchase Plan | |||||
Stock-based compensation | |||||
Total number of shares authorized | 228,222 | ||||
Additional number of shares authorized | 232,059 | ||||
Additional number of shares authorized (as a percent) | 1.00% | ||||
2021 Employee Stock Purchase Plan | Maximum | |||||
Stock-based compensation | |||||
Total number of shares authorized | 4,564,440 |
STOCK-BASED COMPENSATION - St_2
STOCK-BASED COMPENSATION - Stock options (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Options | ||
Outstanding at beginning of period (in shares) | 1,761,062 | |
Granted (in shares) | 1,309,400 | |
Cancelled (in shares) | (48,663) | |
Outstanding at end of period (in shares) | 3,021,799 | 1,761,062 |
Vested at end of period (in shares) | 680,951 | |
Vested and expected to vest at end of period (in shares) | 3,021,799 | |
Weighted average exercise price | ||
Outstanding at beginning of period (in dollars per share) | $ 0.95 | |
Granted (in dollars per share) | 7.80 | |
Cancelled (in dollars per share) | 3.98 | |
Outstanding at end of period (in dollars per share) | 3.71 | $ 0.95 |
Vested at end of period (in dollars per share) | 1.23 | |
Vested and expected to vest at end of period (in dollars per share) | $ 3.71 | |
Weighted-average remaining contractual term and Aggregate intrinsic value | ||
Outstanding at end of period (in years) | 8 years 11 months 8 days | 9 years 6 months 14 days |
Vested at end of period (in years) | 8 years 4 months 20 days | |
Vested and expected to vest at end of period (in years) | 8 years 11 months 8 days | |
Outstanding at beginning of period (in dollars) | $ 723 | |
Outstanding at end of period (in dollars) | 10,903 | $ 723 |
Vested at end of period (in dollars) | 3,437 | |
Vested and expected to vest at end of period (in dollars) | $ 10,903 | |
Weighted average grant-date fair value of stock options granted | $ 4.60 | $ 0.73 |
STOCK-BASED COMPENSATION - Assu
STOCK-BASED COMPENSATION - Assumptions (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Fair value assumptions | ||
Risk-free interest rate, Minimum | 0.95% | 0.20% |
Risk-free interest rate, Maximum | 1.35% | 0.75% |
Volatility, Minimum | 75.00% | 74.00% |
Volatility, Maximum | 77.00% | 79.00% |
Expected term (years) | 6 years | |
Fair value of options vested | $ 600 | $ 0 |
Stock-based compensation expense | 1,571 | $ 52 |
Unrecognized compensation cost | $ 6,400 | |
Expected remaining weighted-average period for recognition | 3 years 2 months 12 days | |
Minimum | ||
Fair value assumptions | ||
Expected term (years) | 3 years | |
Maximum | ||
Fair value assumptions | ||
Expected term (years) | 6 years | |
Outstanding stock options | ||
Fair value assumptions | ||
Stock-based compensation expense | $ 1,100 | $ 100 |
STOCK-BASED COMPENSATION - Earl
STOCK-BASED COMPENSATION - Early Exercise of Employee Options (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Stock-based compensation | ||
Liability from the early exercise | $ 8 | $ 15 |
Stock-based compensation expense | 1,571 | 52 |
Unvested restricted stock | ||
Stock-based compensation | ||
Liability from the early exercise | 10 | 10 |
Stock-based compensation expense | $ 100 | $ 100 |
STOCK-BASED COMPENSATION - Rest
STOCK-BASED COMPENSATION - Restricted Stock Units (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Weighted-average grant date fair value | ||
Stock-based compensation expense | $ 1,571 | $ 52 |
Unrecognized compensation cost | $ 6,400 | |
Expected remaining weighted-average period for recognition | 3 years 2 months 12 days | |
Unvested RSUs | ||
Stock-based compensation | ||
Vesting period | 4 years | |
Vesting percentage | 25.00% | |
Number of shares | ||
Granted (in shares) | 200,996 | |
Unvested at end of period (in shares) | 200,996 | |
Weighted-average grant date fair value | ||
Granted (in dollars per share) | $ 16 | |
Unvested at end of period (in dollars per share) | $ 16 | |
Stock-based compensation expense | $ 400 | |
Unrecognized compensation cost | $ 2,800 | |
Expected remaining weighted-average period for recognition | 3 years 4 months 24 days |
ASSET PURCHASE AND LICENSE AG_2
ASSET PURCHASE AND LICENSE AGREEMENTS (Details) $ in Thousands | 1 Months Ended | 12 Months Ended | ||
May 31, 2019USD ($) | Dec. 31, 2021USD ($) | Dec. 31, 2021EUR (€) | Dec. 31, 2020USD ($) | |
Asset Acquisition [Line Items] | ||||
Research and development | $ 23,595 | $ 15,476 | ||
Asset Purchase Agreement relating to Seribantumab | ||||
Asset Acquisition [Line Items] | ||||
Upfront payment | $ 3,500 | |||
Research and development | 3,500 | |||
Milestone payments paid | 0 | $ 0 | ||
Asset Purchase Agreement relating to Seribantumab | Maximum | ||||
Asset Acquisition [Line Items] | ||||
Milestone payments payable | $ 54,500 | |||
Dyax | ||||
Asset Acquisition [Line Items] | ||||
Number of days written prior notice to terminate agreement | 90 days | 90 days | ||
Dyax | Maximum | ||||
Asset Acquisition [Line Items] | ||||
Milestone payments payable | $ 9,300 | |||
Selexis | ||||
Asset Acquisition [Line Items] | ||||
Number of days written prior notice to terminate agreement | 60 days | 60 days | ||
Royalty payments payable | € | € 200,000 | |||
Percentage of royalty on net sales of licensed products | 1.00% | 1.00% | ||
Selexis | Maximum | ||||
Asset Acquisition [Line Items] | ||||
Milestone payments payable, per licensed product | € | € 900 | |||
National Institute of Health | Maximum | ||||
Asset Acquisition [Line Items] | ||||
Milestone payments payable | $ 400 |
ASSET PURCHASE AND LICENSE AG_3
ASSET PURCHASE AND LICENSE AGREEMENTS - Other Research Arrangements (Details) - Caris Agreement | 12 Months Ended |
Dec. 31, 2021 | |
Other Research Arrangements | |
Term of agreement (in years) | 3 years |
Renewal term (in years) | 1 year |
INCOME TAXES (Details)
INCOME TAXES (Details) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
INCOME TAXES | ||
Provision for income taxes | $ 0 | $ 0 |
INCOME TAXES - Schedule of effe
INCOME TAXES - Schedule of effective income tax rate reconciliation (Details) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Effective Income Tax Rate Reconciliation, Percent [Abstract] | ||
Profit before tax at federal statutory rate | 21.00% | 21.00% |
State tax benefit, net of federal benefit | 0.40% | 0.30% |
Research and development credit carryovers | 4.40% | 1.70% |
Permanent differences | (1.40%) | (0.60%) |
Return to Provision True Ups | 0.10% | |
Change in valuation allowance | (24.50%) | (22.40%) |
INCOME TAXES - Narrative (Detai
INCOME TAXES - Narrative (Details) $ in Millions | 12 Months Ended |
Dec. 31, 2021USD ($) | |
Operating Loss Carryforwards [Line Items] | |
Increase in valuation allowance | $ 7.9 |
Federal | |
Operating Loss Carryforwards [Line Items] | |
Net operating loss carry forwards | 48.2 |
Tax credits | 1.5 |
State | |
Operating Loss Carryforwards [Line Items] | |
Net operating loss carry forwards | 3.5 |
Tax credits | $ 0.2 |
INCOME TAXES - Schedule of net
INCOME TAXES - Schedule of net deferred tax asset (liability) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Deferred tax assets and (liabilities) | ||
Net operating losses | $ 10,303 | $ 4,138 |
Research and development credit | 1,697 | 295 |
Accrued Expenses | 130 | |
Stock-based compensation | 151 | |
Intangible assets | 666 | 664 |
Gross deferred tax asset | 12,947 | 5,097 |
Valuation allowance | (12,945) | (5,083) |
Net deferred tax asset | 2 | 14 |
Stock-based compensation | (2) | |
Fixed assets | (2) | (12) |
Deferred tax liabilities | (2) | $ (14) |
Accrued interest and penalties | 0 | |
Unrecognized tax benefits, income tax penalties and interest expense | $ 0 |
NET LOSS PER SHARE (Details)
NET LOSS PER SHARE (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
NET LOSS PER SHARE | ||
Net loss | $ (32,039) | $ (17,265) |
Weighted average common stock outstanding, basic (in shares) | 12,132,610 | 791,821 |
Weighted average common stock outstanding, diluted (in shares) | 12,132,610 | 791,821 |
Net loss per share, basic (in dollars per share) | $ (2.64) | $ (21.80) |
Net loss per share, diluted (in dollars per share) | $ (2.64) | $ (21.80) |
NET LOSS PER SHARE - Antidiluti
NET LOSS PER SHARE - Antidilutive securities (Details) - shares | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Antidilutive securities | ||
Antidilutive securities excluded from computation (in shares) | 3,242,516 | 17,531,613 |
Convertible preferred shares | ||
Antidilutive securities | ||
Antidilutive securities excluded from computation (in shares) | 15,736,053 | |
Outstanding stock options | ||
Antidilutive securities | ||
Antidilutive securities excluded from computation (in shares) | 3,021,799 | 1,761,062 |
Unvested restricted stock | ||
Antidilutive securities | ||
Antidilutive securities excluded from computation (in shares) | 19,721 | 34,498 |
Unvested RSUs | ||
Antidilutive securities | ||
Antidilutive securities excluded from computation (in shares) | 200,996 |
RETIREMENT PLAN (Details)
RETIREMENT PLAN (Details) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
RETIREMENT PLAN | ||
Matching contributions | $ 0.1 | $ 0 |