Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2022 | Apr. 29, 2022 | |
Document and Entity Information [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2022 | |
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. | |
Entity Address, Address Line Two | 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 | |
Entity Common Stock, Shares Outstanding | 23,253,966 | |
Entity Central Index Key | 0001783032 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q1 | |
Amendment Flag | false |
Condensed Balance Sheets
Condensed Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 53,008 | $ 146,284 |
Marketable securities, available for sale | 79,054 | |
Prepaid expenses and other current assets | 2,187 | 3,140 |
Total current assets | 134,249 | 149,424 |
Property and equipment, net | 34 | 38 |
Other non-current assets | 25 | 32 |
Total assets | 134,308 | 149,494 |
Current liabilities: | ||
Accounts payable | 882 | 5,648 |
Accrued expenses | 9,553 | 3,141 |
Total current liabilities | 10,435 | 8,789 |
Non-current liabilities: | ||
Restricted stock repurchase liability | 7 | 8 |
Total liabilities | 10,442 | 8,797 |
Commitments and contingencies (see note 10) | ||
Stockholders' equity: | ||
Preferred stock, $0.0001 par value; 10,000,000 shares authorized as of March 31, 2022 and December 31, 2021; no shares issued or outstanding as of March 31, 2022 and December 31, 2021, respectively | ||
Common stock, $0.0001 par value; 500,000,000 shares authorized as of March 31, 2022 and December 31, 2021, respectively; 23,269,742 and 23,225,637 issued as of March 31, 2022 and December 31, 2021, respectively; 23,253,966 and 23,205,915 outstanding as of March 31, 2022 and December 31, 2021, respectively | 2 | 2 |
Additional paid-in capital | 196,529 | 195,881 |
Accumulated other comprehensive loss | (204) | |
Accumulated deficit | (72,461) | (55,186) |
Total stockholders' equity | 123,866 | 140,697 |
Total liabilities and stockholders' equity | $ 134,308 | $ 149,494 |
Condensed Balance Sheets (Paren
Condensed Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2022 | Dec. 31, 2021 |
Condensed Balance Sheets | ||
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 | 500,000,000 |
Common stock, shares issued | 23,269,742 | 23,225,637 |
Common stock, shares outstanding | 23,253,966 | 23,205,915 |
Condensed Statements of Operati
Condensed Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Operating expenses: | ||
Research and development | $ 13,575 | $ 4,134 |
General and administrative | 3,793 | 952 |
Total operating expenses | 17,368 | 5,086 |
Loss from operations | (17,368) | (5,086) |
Other income (expense), net | 93 | (5) |
Net loss | $ (17,275) | $ (5,091) |
Net loss per share, basic (in dollars per share) | $ (0.74) | $ (6.36) |
Net loss per share, diluted (in dollars per share) | $ (0.74) | $ (6.36) |
Weighted average common shares outstanding, basic (in shares) | 23,216,206 | 800,679 |
Weighted average common shares outstanding, diluted (in shares) | 23,216,206 | 800,679 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Condensed Consolidated Statements of Comprehensive Loss | ||
Net loss | $ 17,275 | $ 5,091 |
Other comprehensive loss: | ||
Unrealized loss on marketable securities | (204) | |
Total other comprehensive loss | (204) | |
Total comprehensive loss | $ (17,479) | $ (5,091) |
Condensed Statements of Convert
Condensed Statements of Convertible Preferred Stock and Stockholders Equity (Deficit) - USD ($) $ in Thousands | Series A Convertible Preferred StockPreferred Stock | Series B Convertible Preferred StockPreferred Stock | Common Stock | Additional Paid-in Capital | Accumulated Other Comprehensive Loss | Accumulated Deficit | Total |
Stockholders equity, Beginning balance at Dec. 31, 2020 | $ 32,373 | $ 64,815 | $ 66 | $ (23,147) | $ (23,081) | ||
Stockholders equity, Beginning balance (in shares) at Dec. 31, 2020 | 32,450,000 | 34,043,889 | 800,679 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||
Vesting of restricted common stock | 2 | 2 | |||||
Vesting of restricted common stock (in shares) | 3,944 | ||||||
Stock-based compensation | 65 | 65 | |||||
Net loss | (5,091) | (5,091) | |||||
Stockholders equity, Ending balance at Mar. 31, 2021 | $ 32,373 | $ 64,815 | 133 | (28,238) | (28,105) | ||
Stockholders equity, Ending balance (in shares) at Mar. 31, 2021 | 32,450,000 | 34,043,889 | 804,623 | ||||
Stockholders equity, Beginning balance at Dec. 31, 2021 | $ 2 | 195,881 | (55,186) | 140,697 | |||
Stockholders equity, Beginning balance (in shares) at Dec. 31, 2021 | 23,205,915 | ||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||
Vesting of restricted common stock | 2 | 2 | |||||
Vesting of restricted common stock (in shares) | 3,946 | ||||||
Issuance of common stock upon stock option exercises | 19 | $ 19 | |||||
Issuance of common stock upon stock option exercises (in shares) | 44,105 | 44,105 | |||||
Stock-based compensation | 627 | $ 627 | |||||
Unrealized loss on marketable securities | $ (204) | (204) | |||||
Accumulated other comprehensive loss | (204) | ||||||
Net loss | (17,275) | (17,275) | |||||
Stockholders equity, Ending balance at Mar. 31, 2022 | $ 2 | $ 196,529 | $ (204) | $ (72,461) | $ 123,866 | ||
Stockholders equity, Ending balance (in shares) at Mar. 31, 2022 | 23,253,966 |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Operating activities | ||
Net loss | $ (17,275) | $ (5,091) |
Reconciliation of net loss to net cash used in operating activities: | ||
Stock-based compensation | 627 | 65 |
Accretion of premium and interest on marketable securities | 13 | |
Depreciation expense | 4 | 4 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | 960 | (347) |
Accounts payable | (4,765) | (5,007) |
Accrued expenses | 6,412 | 899 |
Net cash used in operating activities | (14,024) | (9,477) |
Investing activities | ||
Purchase of marketable securities | (79,271) | |
Net cash used in investing activities | (79,271) | |
Financing activities | ||
Cash paid for issuance costs of convertible preferred stock | (11) | |
Proceeds from issuance of common stock upon stock option exercises | 19 | |
Net cash provided by (used in) financing activities | 19 | (11) |
Decrease in cash and cash equivalents | (93,276) | (9,488) |
Cash and cash equivalents, beginning of period | 146,284 | 79,400 |
Cash and cash equivalents, end of period | $ 53,008 | 69,912 |
Supplemental disclosure of non-cash financing activities | ||
Deferred offering costs in accrued expenses | $ 448 |
NATURE OF BUSINESS
NATURE OF BUSINESS | 3 Months Ended |
Mar. 31, 2022 | |
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 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 $17.3 million and $5.1 million for the three months ended March 31, 2022 and 2021, respectively, and had an accumulated deficit of $72.5 million as of March 31, 2022. Through March 31, 2022, the Company has funded its operations with proceeds from the sale of convertible preferred stock and proceeds from the initial public offering (“IPO”) completed in June 2021. The Company expects that its cash, cash equivalents and marketable securities will be sufficient to fund its operating expenses and capital expenditure requirements through at least 12 months from the issuance date of the condensed consolidated financial statements. The accompanying condensed consolidated financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business. The financial statements do not reflect any adjustments relating to the recoverability and reclassification of assets and liabilities that might be necessary if the Company is unable to continue as a going concern. |
BASIS OF PRESENTATION AND SIGNI
BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING POLICIES | 3 Months Ended |
Mar. 31, 2022 | |
BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING POLICIES | |
BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING POLICIES | 2. Basis of Presentation and Significant Accounting Policies Principles of Consolidation The condensed consolidated interim 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 transactions have been eliminated in consolidation. Basis of presentation of unaudited interim consolidated financial statements The condensed consolidated interim financial statements have been prepared in conformity with U.S. generally accepted accounting principles ("U.S. GAAP"). The accompanying unaudited condensed consolidated financial statements were prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) and, in the opinion of management, include all normal and recurring adjustments necessary to present fairly the results of the interim periods shown. The December 31, 2021 condensed consolidated balance sheet was derived from the December 31, 2021 audited financial statements. Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to such SEC rules and regulations. Management believes that the disclosures made are adequate to make the information presented not misleading. The results for the interim periods are not necessarily indicative of results to be expected for the fiscal year ending December 31, 2022. The accompanying condensed consolidated interim financial statements should be read in conjunction with the Company’s audited financial statements and the notes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021 (the “Annual Report”). Significant accounting policies Use of estimates The preparation of the Company’s consolidated financial statements in accordance with U.S. 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. 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. Deferred offering costs The Company capitalizes certain legal, accounting and other third-party fees that are directly associated with in-process preferred stock or common stock financings as deferred offering costs until such financings are consummated. After consummation of the equity financing, these costs are recorded as a reduction to the carrying value of convertible preferred stock or in stockholders’ equity (deficit) as a reduction of additional paid-in capital generated as a result of the offering. Should a planned equity financing be abandoned, the deferred offering costs were expensed immediately as a charge to operating expenses in the statements of operations. The Company had $0.5 million of deferred offering costs for the three months ended March 31, 2021. Concentrations of credit risk and significant suppliers Financial instruments that potentially subject the Company to concentration of credit risk consist of cash, cash equivalents and marketable securities. 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. As of March 31, 2022, the Company had two vendors that accounted for approximately 41% of the total accounts payable. During the three months ended March 31, 2022, the Company had two vendors that accounted for approximately 77% of its research and development expense. During the three months ended March 31, 2021, the Company had two vendors that, combined, represented approximately 56% 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. Fair value measurements Certain assets and liabilities are carried at fair value under U.S. 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 carrying amounts of certain of the Company’s financial instruments, including cash and cash equivalents, prepaid expenses and other current assets and accounts payable, approximate fair value due to the short-term nature of these items. Marketable Securities, Available for Sale All marketable securities have been classified as “available-for-sale” and are carried at fair value, based upon quoted market prices. The Company considers its available-for-sale portfolio as available for use in current operations. Accordingly, the Company may classify certain investments as short-term marketable securities, even though the stated maturity date may be one year or more beyond the current balance sheet date. Unrealized gains and losses, net of any related tax effects, are excluded from earnings and are included in other comprehensive income (loss) and reported as a separate component of stockholders’ equity (deficit) until realized. Interest income, realized gains and losses, and declines in value judged to be other than temporary, if any, on available-for-sale securities are included in other income, net. The cost of securities sold is based on the specific-identification method. The amortized cost of securities is adjusted for accretion of premiums and amortization of discounts to maturity. In accordance with the Company’s investment policy, management invests in money market funds, corporate bonds, commercial paper, asset-backed securities and government securities. The Company has not realized any losses on its marketable securities to date. Comprehensive Income (Loss) The Company’s only element of other comprehensive income (loss) is unrealized gains and losses on available-for-sale marketable securities. 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 March 31, 2022 and 2021, the Company has determined that these expenses have not met the criteria to be capitalized. Intellectual property related expenses for the three months ended March 31, 2022 and 2021 were $0.1 million, respectively. Recently adopted accounting pronouncements In June 2016, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") No. 2016-13, Financial Instruments – Credit Losses (Topic 326) In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes |
FAIR VALUE MEASUREMENTS OF FINA
FAIR VALUE MEASUREMENTS OF FINANCIAL ASSETS | 3 Months Ended |
Mar. 31, 2022 | |
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 (in thousands): As of March 31, 2022 Level 1 Level 2 Level 3 Total Marketable Securities Asset-backed securities $ — $ 9,633 $ — $ 9,633 Corporate debt securities — 20,664 — 20,664 Commercial paper — 25,104 — 25,104 U.S. Government debt securities — 23,653 — 23,653 Total $ — $ 79,054 $ — $ 79,054 As of December 31, 2021 Level 1 Level 2 Level 3 Total Cash Equivalents: Money market funds included in cash and cash equivalents $ 106,000 $ — $ — $ 106,000 During the three months ended March 31, 2022 and December 31, 2021, the Company had no transfers between Level 1, Level 2 or Level 3 financial assets. |
MARKETABLE SECURITIES
MARKETABLE SECURITIES | 3 Months Ended |
Mar. 31, 2022 | |
MARKETABLE SECURITIES | |
MARKETABLE SECURITIES | 4. Marketable Securities The following table summarizes the Company’s marketable securities as of March 31, 2022 (in thousands). The Company did not hold any marketable securities as of December 31, 2021. As of March 31, 2022 Amortized Unrealized Unrealized Fair Cost gains losses value Marketable Securities: Asset-backed securities $ 9,676 $ — $ (43) $ 9,633 Corporate debt securities 20,819 — (155) 20,664 Commercial paper 25,104 — — 25,104 U.S. Government debt securities 23,659 2 (8) 23,653 Total $ 79,258 $ 2 $ (206) $ 79,054 |
ACCRUED EXPENSES
ACCRUED EXPENSES | 3 Months Ended |
Mar. 31, 2022 | |
ACCRUED EXPENSES | |
ACCRUED EXPENSES | 5. Accrued Expenses Accrued expenses consist of the following (in thousands): March 31, December 31, 2022 2021 Accrued preclinical and clinical trial costs $ 8,282 $ 1,260 Accrued compensation 565 1,059 Accrued consulting 92 77 Accrued professional services 507 499 Accrued other 107 246 Total accrued expenses $ 9,553 $ 3,141 |
CONVERTIBLE PREFERRED STOCK
CONVERTIBLE PREFERRED STOCK | 3 Months Ended |
Mar. 31, 2022 | |
CONVERTIBLE PREFERRED STOCK | |
CONVERTIBLE PREFERRED STOCK | 6. Convertible Preferred Stock As of November 10, 2020, the Company had issued Series A and Series B convertible preferred stock (collectively, the “Convertible Preferred Stock”). On June 29, 2021, upon the closing of the Company’s IPO, all outstanding convertible preferred stock automatically converted into shares of common stock. |
EQUITY
EQUITY | 3 Months Ended |
Mar. 31, 2022 | |
EQUITY | |
EQUITY | 7. Equity Preferred stock The Company has authorized preferred stock amounting to 10,000,000 shares as of March 31, 2022 and December 31, 2021, respectively. The authorized preferred stock was classified under stockholders’ equity at March 31, 2022 and December 31, 2021. Common stock As of March 31, 2022, 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, if any. No dividends have been declared or paid by the Company since its inception. |
STOCK-BASED COMPENSATION
STOCK-BASED COMPENSATION | 3 Months Ended |
Mar. 31, 2022 | |
STOCK-BASED COMPENSATION | |
STOCK-BASED COMPENSATION | 8. Stock-Based Compensation Stock-based compensation expense as reflected in the Company’s condensed consolidated statements of operations and comprehensive loss was as follows (in thousands): Three months ended March 31, 2022 2021 Research and development $ 83 $ 27 General and administrative 544 38 Stock-based compensation expense included in operating expenses $ 627 $ 65 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, 1,712,174 shares were available for future grants as of March 31, 2022. 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 2022. 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 2022. 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 The following is a summary of the Company’s stock option activity for the three months ended March 31, 2022: Weighted- Weighted- average Aggregate average remaining contractual intrinsic value Options exercise price term (in years) (in thousands) Outstanding at December 31, 2021 3,021,799 $ 3.71 8.94 $ 10,903 Granted 1,314,200 3.46 Exercised (44,105) 0.43 Cancelled (145,787) 4.10 Outstanding at March 31, 2022 4,146,107 2.55 9.31 $ 2,529 Vested at March 31, 2022 760,028 1.37 8.23 $ 1,188 Vested and expected to vest at March 31, 2022 4,146,107 $ 2.55 9.31 $ 2,529 The following is a summary of the Company’s stock option activity for the three months ended March 31, 2021: Weighted- Weighted- average Aggregate average remaining contractual intrinsic value Options exercise price term ( in years) (in thousands) Outstanding at December 31, 2020 1,761,062 $ 0.95 9.54 $ 723 Granted 39,663 1.36 — — Outstanding at March 31, 2021 1,800,725 0.96 9.30 $ 3,842 Vested at March 31, 2021 242,240 0.43 8.57 $ 645 Vested and expected to vest at March 31, 2021 1,701,566 $ 0.94 9.28 $ 3,670 The weighted average grant-date fair value of stock options granted during the three months ended March 31, 2022 and 2021 was $2.31 and $0.90 per share, respectively. The fair value of each stock option was estimated using a Black-Scholes option-pricing model with the following assumptions: Three months ended March 31, 2022 2021 Risk-free interest rate 1.62 - 2.41 % 0.95 % Volatility 75-76 % 77 % Dividend yield 0.00 % 0.00 % Expected term (years) 6 6 The fair value of options that vested during the three months ended March 31, 2022 and 2021 was $0.7 and less than $0.1 million, respectively. The Company recorded stock-based compensation expense associated with stock option awards of $0.4 million and $0.1 million during the three months ended March 31, 2022 and 2021, respectively. As of March 31, 2022, there was $8.4 million of total unrecognized compensation cost related to unvested stock-based awards, which the Company expects to recognize over a remaining weighted-average period of 3.3 years. 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 condensed consolidated balance sheets as of March 31, 2022 and December 31, 2021, respectively. The Company recorded stock-based compensation expense associated with restricted common stock of less than $0.1 million during the three months ended March 31, 2022 and 2021. 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, 2021 200,996 $ 16.00 Granted — — Unvested at March 31, 2022 200,996 16.00 The Company recorded stock-based compensation expense of $0.2 million for the three months ended March 31, 2022, related to RSUs. As of March 31, 2022, the total unrecognized expense related to all RSUs was $2.6 million, which the Company expects to recognize over a weighted-average period of 3.2 years. |
ASSET PURCHASE AND LICENSE AGRE
ASSET PURCHASE AND LICENSE AGREEMENTS | 3 Months Ended |
Mar. 31, 2022 | |
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 (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 CONTENGENCIES
COMMITMENTS AND CONTENGENCIES | 3 Months Ended |
Mar. 31, 2022 | |
COMMITMENTS AND CONTENGENCIES | |
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 condensed consolidated financial statements. |
NET LOSS PER SHARE
NET LOSS PER SHARE | 3 Months Ended |
Mar. 31, 2022 | |
NET LOSS PER SHARE | |
NET LOSS PER SHARE | 11. 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 data): Three months ended March 31, 2022 2021 Net loss $ (17,275) $ (5,091) Weighted average common stock outstanding, basic and diluted 23,216,206 800,679 Net loss per share, basic and diluted $ (0.74) $ (6.36) 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: March 31, 2022 2021 Convertible preferred shares — 15,736,031 Outstanding stock options 4,146,107 1,800,732 Unvested restricted stock 15,776 31,554 Unvested RSUs 200,996 — 4,362,879 17,568,317 |
BASIS OF PRESENTATION AND SIG_2
BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING POLICIES (Policies) | 3 Months Ended |
Mar. 31, 2022 | |
BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING POLICIES | |
Basis of presentation | Basis of presentation of unaudited interim consolidated financial statements The condensed consolidated interim financial statements have been prepared in conformity with U.S. generally accepted accounting principles ("U.S. GAAP"). The accompanying unaudited condensed consolidated financial statements were prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) and, in the opinion of management, include all normal and recurring adjustments necessary to present fairly the results of the interim periods shown. The December 31, 2021 condensed consolidated balance sheet was derived from the December 31, 2021 audited financial statements. Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to such SEC rules and regulations. Management believes that the disclosures made are adequate to make the information presented not misleading. The results for the interim periods are not necessarily indicative of results to be expected for the fiscal year ending December 31, 2022. The accompanying condensed consolidated interim financial statements should be read in conjunction with the Company’s audited financial statements and the notes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021 (the “Annual Report”). |
Use of estimates | Use of estimates The preparation of the Company’s consolidated financial statements in accordance with U.S. 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. 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. |
Deferred offering costs | Deferred offering costs The Company capitalizes certain legal, accounting and other third-party fees that are directly associated with in-process preferred stock or common stock financings as deferred offering costs until such financings are consummated. After consummation of the equity financing, these costs are recorded as a reduction to the carrying value of convertible preferred stock or in stockholders’ equity (deficit) as a reduction of additional paid-in capital generated as a result of the offering. Should a planned equity financing be abandoned, the deferred offering costs were expensed immediately as a charge to operating expenses in the statements of operations. The Company had $0.5 million of deferred offering costs for the three months ended March 31, 2021. |
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, cash equivalents and marketable securities. 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. As of March 31, 2022, the Company had two vendors that accounted for approximately 41% of the total accounts payable. During the three months ended March 31, 2022, the Company had two vendors that accounted for approximately 77% of its research and development expense. During the three months ended March 31, 2021, the Company had two vendors that, combined, represented approximately 56% 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. Fair value measurements Certain assets and liabilities are carried at fair value under U.S. 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 carrying amounts of certain of the Company’s financial instruments, including cash and cash equivalents, prepaid expenses and other current assets and accounts payable, approximate fair value due to the short-term nature of these items. |
Marketable Securities, Available for Sale | Marketable Securities, Available for Sale All marketable securities have been classified as “available-for-sale” and are carried at fair value, based upon quoted market prices. The Company considers its available-for-sale portfolio as available for use in current operations. Accordingly, the Company may classify certain investments as short-term marketable securities, even though the stated maturity date may be one year or more beyond the current balance sheet date. Unrealized gains and losses, net of any related tax effects, are excluded from earnings and are included in other comprehensive income (loss) and reported as a separate component of stockholders’ equity (deficit) until realized. Interest income, realized gains and losses, and declines in value judged to be other than temporary, if any, on available-for-sale securities are included in other income, net. The cost of securities sold is based on the specific-identification method. The amortized cost of securities is adjusted for accretion of premiums and amortization of discounts to maturity. In accordance with the Company’s investment policy, management invests in money market funds, corporate bonds, commercial paper, asset-backed securities and government securities. The Company has not realized any losses on its marketable securities to date. |
Comprehensive Income (Loss) | Comprehensive Income (Loss) The Company’s only element of other comprehensive income (loss) is unrealized gains and losses on available-for-sale marketable securities. |
Patent costs | 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 March 31, 2022 and 2021, the Company has determined that these expenses have not met the criteria to be capitalized. Intellectual property related expenses for the three months ended March 31, 2022 and 2021 were $0.1 million, respectively. |
Recently Adopted Accounting Pronouncements | Recently adopted accounting pronouncements In June 2016, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") No. 2016-13, Financial Instruments – Credit Losses (Topic 326) In December 2019, the FASB issued 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) | 3 Months Ended |
Mar. 31, 2022 | |
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 (in thousands): As of March 31, 2022 Level 1 Level 2 Level 3 Total Marketable Securities Asset-backed securities $ — $ 9,633 $ — $ 9,633 Corporate debt securities — 20,664 — 20,664 Commercial paper — 25,104 — 25,104 U.S. Government debt securities — 23,653 — 23,653 Total $ — $ 79,054 $ — $ 79,054 As of December 31, 2021 Level 1 Level 2 Level 3 Total Cash Equivalents: Money market funds included in cash and cash equivalents $ 106,000 $ — $ — $ 106,000 |
MARKETABLE SECURITIES (Tables)
MARKETABLE SECURITIES (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
MARKETABLE SECURITIES | |
Schedule of marketable securities | The following table summarizes the Company’s marketable securities as of March 31, 2022 (in thousands). The Company did not hold any marketable securities as of December 31, 2021. As of March 31, 2022 Amortized Unrealized Unrealized Fair Cost gains losses value Marketable Securities: Asset-backed securities $ 9,676 $ — $ (43) $ 9,633 Corporate debt securities 20,819 — (155) 20,664 Commercial paper 25,104 — — 25,104 U.S. Government debt securities 23,659 2 (8) 23,653 Total $ 79,258 $ 2 $ (206) $ 79,054 |
ACCRUED EXPENSES (Tables)
ACCRUED EXPENSES (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
ACCRUED EXPENSES | |
Schedule of accrued expenses | Accrued expenses consist of the following (in thousands): March 31, December 31, 2022 2021 Accrued preclinical and clinical trial costs $ 8,282 $ 1,260 Accrued compensation 565 1,059 Accrued consulting 92 77 Accrued professional services 507 499 Accrued other 107 246 Total accrued expenses $ 9,553 $ 3,141 |
STOCK-BASED COMPENSATION (Table
STOCK-BASED COMPENSATION (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
STOCK-BASED COMPENSATION | |
Schedule of stock-based compensation expense | Stock-based compensation expense as reflected in the Company’s condensed consolidated statements of operations and comprehensive loss was as follows (in thousands): Three months ended March 31, 2022 2021 Research and development $ 83 $ 27 General and administrative 544 38 Stock-based compensation expense included in operating expenses $ 627 $ 65 |
Summary of stock option activity | The following is a summary of the Company’s stock option activity for the three months ended March 31, 2022: Weighted- Weighted- average Aggregate average remaining contractual intrinsic value Options exercise price term (in years) (in thousands) Outstanding at December 31, 2021 3,021,799 $ 3.71 8.94 $ 10,903 Granted 1,314,200 3.46 Exercised (44,105) 0.43 Cancelled (145,787) 4.10 Outstanding at March 31, 2022 4,146,107 2.55 9.31 $ 2,529 Vested at March 31, 2022 760,028 1.37 8.23 $ 1,188 Vested and expected to vest at March 31, 2022 4,146,107 $ 2.55 9.31 $ 2,529 The following is a summary of the Company’s stock option activity for the three months ended March 31, 2021: Weighted- Weighted- average Aggregate average remaining contractual intrinsic value Options exercise price term ( in years) (in thousands) Outstanding at December 31, 2020 1,761,062 $ 0.95 9.54 $ 723 Granted 39,663 1.36 — — Outstanding at March 31, 2021 1,800,725 0.96 9.30 $ 3,842 Vested at March 31, 2021 242,240 0.43 8.57 $ 645 Vested and expected to vest at March 31, 2021 1,701,566 $ 0.94 9.28 $ 3,670 |
Schedule of assumptions used in estimation of fair value | The weighted average grant-date fair value of stock options granted during the three months ended March 31, 2022 and 2021 was $2.31 and $0.90 per share, respectively. The fair value of each stock option was estimated using a Black-Scholes option-pricing model with the following assumptions: Three months ended March 31, 2022 2021 Risk-free interest rate 1.62 - 2.41 % 0.95 % Volatility 75-76 % 77 % Dividend yield 0.00 % 0.00 % Expected term (years) 6 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, 2021 200,996 $ 16.00 Granted — — Unvested at March 31, 2022 200,996 16.00 |
NET LOSS PER SHARE (Tables)
NET LOSS PER SHARE (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
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 data): Three months ended March 31, 2022 2021 Net loss $ (17,275) $ (5,091) Weighted average common stock outstanding, basic and diluted 23,216,206 800,679 Net loss per share, basic and diluted $ (0.74) $ (6.36) |
Schedule of antidilutive securities excluded from computation of diluted net loss per share | 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: March 31, 2022 2021 Convertible preferred shares — 15,736,031 Outstanding stock options 4,146,107 1,800,732 Unvested restricted stock 15,776 31,554 Unvested RSUs 200,996 — 4,362,879 17,568,317 |
NATURE OF BUSINESS - Liquidity
NATURE OF BUSINESS - Liquidity (Details) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2022 | Mar. 31, 2021 | Dec. 31, 2021 | |
NATURE OF BUSINESS | |||
Net loss | $ 17,275 | $ 5,091 | |
Accumulated deficit | $ 72,461 | $ 55,186 |
BASIS OF PRESENTATION AND SIG_3
BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING POLICIES (Details) $ in Millions | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2022USD ($)item | Mar. 31, 2021USD ($)item | Dec. 31, 2021item | |
Summary of significant accounting policies | |||
Deferred offering costs | $ | $ 0.5 | ||
Legal and professional costs | $ | $ 0.1 | $ 0.1 | |
Accounts payable | Major suppliers | Supplier Concentration Risk | |||
Summary of significant accounting policies | |||
Number of vendors | item | 2 | 1 | |
Concentration risk | 41.00% | 74.00% | |
Research and development | Major suppliers | Supplier Concentration Risk | |||
Summary of significant accounting policies | |||
Number of vendors | item | 2 | 2 | |
Concentration risk | 77.00% | 56.00% |
FAIR VALUE MEASUREMENTS OF FI_3
FAIR VALUE MEASUREMENTS OF FINANCIAL ASSETS (Details) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2022 | Mar. 31, 2021 | Dec. 31, 2021 | |
Fair value measurements of financial assets | |||
Transfers from Level 1 to Level 2, Assets | $ 0 | $ 0 | |
Transfers from Level 2 to Level 1, Assets | 0 | 0 | |
Transfers into (out of) Level 3, Assets | 0 | $ 0 | |
Recurring | |||
Fair value measurements of financial assets | |||
Marketable Securities | 79,054 | ||
Recurring | Level 2 | |||
Fair value measurements of financial assets | |||
Marketable Securities | 79,054 | ||
Recurring | Asset-backed securities | |||
Fair value measurements of financial assets | |||
Marketable Securities | 9,633 | ||
Recurring | Asset-backed securities | Level 2 | |||
Fair value measurements of financial assets | |||
Marketable Securities | 9,633 | ||
Recurring | Corporate Debt Securities | |||
Fair value measurements of financial assets | |||
Marketable Securities | 20,664 | ||
Recurring | Corporate Debt Securities | Level 2 | |||
Fair value measurements of financial assets | |||
Marketable Securities | 20,664 | ||
Recurring | Commercial Paper | |||
Fair value measurements of financial assets | |||
Marketable Securities | 25,104 | ||
Recurring | Commercial Paper | Level 2 | |||
Fair value measurements of financial assets | |||
Marketable Securities | 25,104 | ||
Recurring | U.S. Government Debt Securities | |||
Fair value measurements of financial assets | |||
Marketable Securities | 23,653 | ||
Recurring | U.S. Government Debt Securities | Level 2 | |||
Fair value measurements of financial assets | |||
Marketable Securities | $ 23,653 | ||
Recurring | Money Market Funds | |||
Fair value measurements of financial assets | |||
Cash Equivalents | $ 106,000 | ||
Recurring | Money Market Funds | Level 1 | |||
Fair value measurements of financial assets | |||
Cash Equivalents | $ 106,000 |
MARKETABLE SECURITIES - Fair Va
MARKETABLE SECURITIES - Fair Value (Details) $ in Thousands | Mar. 31, 2022USD ($) |
Marketable Securities | |
Amortized Cost | $ 79,258 |
Unrealized gains | 2 |
Unrealized losses | (206) |
Fair value | 79,054 |
Asset-backed securities | |
Marketable Securities | |
Amortized Cost | 9,676 |
Unrealized losses | (43) |
Fair value | 9,633 |
Corporate Debt Securities | |
Marketable Securities | |
Amortized Cost | 20,819 |
Unrealized losses | (155) |
Fair value | 20,664 |
Commercial Paper | |
Marketable Securities | |
Amortized Cost | 25,104 |
Fair value | 25,104 |
U.S. Government Debt Securities | |
Marketable Securities | |
Amortized Cost | 23,659 |
Unrealized gains | 2 |
Unrealized losses | (8) |
Fair value | $ 23,653 |
ACCRUED EXPENSES (Details)
ACCRUED EXPENSES (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
ACCRUED EXPENSES | ||
Accrued preclinical and clinical trial costs | $ 8,282 | $ 1,260 |
Accrued compensation | 565 | 1,059 |
Accrued consulting | 92 | 77 |
Accrued professional services | 507 | 499 |
Accrued other | 107 | 246 |
Total accrued expenses | $ 9,553 | $ 3,141 |
EQUITY - Authorized and Reverse
EQUITY - Authorized and Reverse Stock Split (Details) | Mar. 31, 2022Vote$ / sharesshares | Dec. 31, 2021$ / sharesshares |
EQUITY | ||
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Common stock, shares authorized | 500,000,000 | 500,000,000 |
Common stock, par value | $ / shares | $ 0.0001 | $ 0.0001 |
Number of votes per common stock | Vote | 1 |
STOCK-BASED COMPENSATION - Expe
STOCK-BASED COMPENSATION - Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Stock-based compensation | ||
Stock-based compensation expense included in operating expenses | $ 627 | $ 65 |
Research and development | ||
Stock-based compensation | ||
Stock-based compensation expense included in operating expenses | 83 | 27 |
General and administrative | ||
Stock-based compensation | ||
Stock-based compensation expense included in operating expenses | $ 544 | $ 38 |
STOCK-BASED COMPENSATION - Stoc
STOCK-BASED COMPENSATION - Stock incentive plan (Details) - shares | 1 Months Ended | 3 Months Ended | |
Jan. 31, 2022 | Mar. 31, 2022 | Jun. 24, 2021 | |
2021 Equity Incentive Plan | |||
Stock-based compensation | |||
Number of shares authorized | 1,483,445 | ||
Shares available for issuance | 1,712,174 | ||
Additional number of shares authorized (as a percent) | 5.00% | ||
Additional number of shares authorized | 1,160,296 | ||
2021 Employee Stock Purchase Plan | |||
Stock-based compensation | |||
Number of shares authorized | 228,222 | ||
Additional number of shares authorized | 232,059 | ||
2021 Employee Stock Purchase Plan | Maximum | |||
Stock-based compensation | |||
Number of shares authorized | 4,564,440 | ||
Additional number of shares authorized (as a percent) | 1.00% |
STOCK-BASED COMPENSATION - St_2
STOCK-BASED COMPENSATION - Stock options (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2022 | Mar. 31, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | |
Options | ||||
Outstanding at beginning of period (in shares) | 3,021,799 | 1,761,062 | 1,761,062 | |
Granted (in shares) | 1,314,200 | 39,663 | ||
Exercised (in shares) | (44,105) | |||
Cancelled (in shares) | (145,787) | |||
Outstanding at end of period (in shares) | 4,146,107 | 1,800,725 | 3,021,799 | 1,761,062 |
Vested at end of period (in shares) | 760,028 | 242,240 | ||
Vested and expected to vest at end of period (in shares) | 4,146,107 | 1,701,566 | ||
Weighted average exercise price | ||||
Outstanding at beginning of period (in dollars per share) | $ 3.71 | $ 0.95 | $ 0.95 | |
Granted (in dollars per share) | 3.46 | 1.36 | ||
Exercised (in dollars per share) | 0.43 | |||
Cancelled (in dollars per share) | 4.10 | |||
Outstanding at end of period (in dollars per share) | 2.55 | 0.96 | $ 3.71 | $ 0.95 |
Vested at end of period (in dollars per share) | 1.37 | 0.43 | ||
Vested and expected to vest at end of period (in dollars per share) | $ 2.55 | $ 0.94 | ||
Weighted-average remaining contractual term and Aggregate intrinsic value | ||||
Outstanding at end of period (in years) | 9 years 3 months 21 days | 9 years 3 months 18 days | 8 years 11 months 8 days | 9 years 6 months 14 days |
Vested at end of period (in years) | 8 years 2 months 23 days | 8 years 6 months 25 days | ||
Vested and expected to vest at end of period (in years) | 9 years 3 months 21 days | 9 years 3 months 10 days | ||
Outstanding at beginning of period (in dollars) | $ 10,903 | $ 723 | $ 723 | |
Outstanding at end of period (in dollars) | 2,529 | 3,842 | $ 10,903 | $ 723 |
Vested at end of period (in dollars) | 1,188 | 645 | ||
Vested and expected to vest at end of period (in dollars) | $ 2,529 | $ 3,670 | ||
Weighted average grant-date fair value of stock options granted | $ 2.31 | $ 0.90 |
STOCK-BASED COMPENSATION - Assu
STOCK-BASED COMPENSATION - Assumptions (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Fair value assumptions | ||
Fair value of options vested | $ 700 | $ 100 |
Stock-based compensation expense | $ 627 | $ 65 |
Outstanding stock options | ||
Fair value assumptions | ||
Risk-free interest rate, Minimum | 1.62% | |
Risk-free interest rate, Maximum | 2.41% | |
Risk-free interest rate | 0.95% | |
Volatility, Minimum | 75.00% | |
Volatility, Maximum | 76.00% | |
Volatility | 77.00% | |
Dividend yield | 0.00% | 0.00% |
Expected term (years) | 6 years | 6 years |
Stock-based compensation expense | $ 400 | $ 100 |
Unrecognized compensation cost | $ 8,400 | |
Expected remaining weighted-average period for recognition | 3 years 3 months 18 days |
STOCK-BASED COMPENSATION - Rest
STOCK-BASED COMPENSATION - Restricted Common Stock (Details) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2022 | Mar. 31, 2021 | Dec. 31, 2021 | |
Stock-based compensation | |||
Liability from the early exercise | $ 7 | $ 8 | |
Stock-based compensation expense | 627 | $ 65 | |
Early exercise of employee options | |||
Stock-based compensation | |||
Liability from the early exercise | 10 | 10 | |
Stock-based compensation expense | $ 100 | $ 100 |
STOCK-BASED COMPENSATION - Re_2
STOCK-BASED COMPENSATION - Restricted Stock Units (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Weighted-average grant date fair value | ||
Stock-based compensation expense | $ 627 | $ 65 |
Restricted Stock Units | ||
Stock-based compensation | ||
Vesting period | 4 years | |
Vesting percentage | 25.00% | |
Number of shares | ||
Unvested at beginning of period (in shares) | 200,996 | |
Unvested at end of period (in shares) | 200,996 | |
Weighted-average grant date fair value | ||
Unvested at beginning of period (in dollars per share) | $ 16 | |
Unvested at end of period (in dollars per share) | $ 16 | |
Stock-based compensation expense | $ 200 | |
Unrecognized compensation cost | $ 2,600 | |
Expected remaining weighted-average period for recognition | 3 years 2 months 12 days |
ASSET PURCHASE AND LICENSE AG_2
ASSET PURCHASE AND LICENSE AGREEMENTS - Asset Purchase and License Agreements (Details) € in Thousands, $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||
May 31, 2019USD ($) | Mar. 31, 2022USD ($) | Mar. 31, 2022EUR (€) | Mar. 31, 2021USD ($) | Dec. 31, 2019USD ($) | |
Asset Acquisition [Line Items] | |||||
Research and development | $ 13,575 | $ 4,134 | |||
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 | ||||
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 - Caris $ in Millions | 1 Months Ended |
Jun. 30, 2021USD ($) | |
Other Research Arrangements | |
Upfront or milestone payment | $ 0 |
Term of agreement (in years) | 3 years |
Renewal term (in years) | 1 year |
NET LOSS PER SHARE (Details)
NET LOSS PER SHARE (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
NET LOSS PER SHARE | ||
Net loss | $ (17,275) | $ (5,091) |
Weighted average common stock outstanding, basic (in shares) | 23,216,206 | 800,679 |
Weighted average common stock outstanding, diluted (in shares) | 23,216,206 | 800,679 |
Net loss per share, basic (in dollars per share) | $ (0.74) | $ (6.36) |
Net loss per share, diluted (in dollars per share) | $ (0.74) | $ (6.36) |
NET LOSS PER SHARE - Antidiluti
NET LOSS PER SHARE - Antidilutive securities (Details) - shares | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Antidilutive securities | ||
Antidilutive securities excluded from computation (in shares) | 4,362,879 | 17,568,317 |
Convertible preferred shares | ||
Antidilutive securities | ||
Antidilutive securities excluded from computation (in shares) | 15,736,031 | |
Outstanding stock options | ||
Antidilutive securities | ||
Antidilutive securities excluded from computation (in shares) | 4,146,107 | 1,800,732 |
Unvested restricted stock | ||
Antidilutive securities | ||
Antidilutive securities excluded from computation (in shares) | 15,776 | 31,554 |
Restricted Stock Units | ||
Antidilutive securities | ||
Antidilutive securities excluded from computation (in shares) | 200,996 |