Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2024 | Aug. 02, 2024 | |
Document and Entity Information [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2024 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2024 | |
Document Transition Report | false | |
Securities Act 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 | 101 Federal Street | |
Entity Address, Address Line Two | Suite 1900 | |
Entity Address, City or Town | Boston | |
Entity Address, State or Province | MA | |
Entity Address, Postal Zip Code | 02110 | |
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, par value $0.0001 per share | |
Trading Symbol | ELEV | |
Security Exchange Name | NASDAQ | |
Entity Common Stock, Shares Outstanding | 59,106,809 | |
Entity Central Index Key | 0001783032 | |
Document Fiscal Period Focus | Q2 | |
Amendment Flag | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Current assets: | ||
Cash and cash equivalents | $ 59,447 | $ 49,255 |
Marketable securities, available for sale | 51,402 | 33,852 |
Prepaid expenses and other current assets | 2,720 | 4,857 |
Total current assets | 113,569 | 87,964 |
Property and equipment, net | 45 | 59 |
Other non-current assets | 983 | 1,068 |
Total assets | 114,597 | 89,091 |
Current liabilities: | ||
Accounts payable | 344 | 507 |
Accrued expenses | 2,419 | 3,638 |
Total current liabilities | 2,763 | 4,145 |
Non-current liabilities: | ||
Long-term debt, net of discount | 30,916 | 30,137 |
Total liabilities | 33,679 | 34,282 |
Commitments and contingencies | ||
Stockholders' equity: | ||
Preferred stock, $0.0001 par value; 10,000,000 shares authorized as of June 30, 2024 and December 31, 2023; no shares issued or outstanding as of June 30, 2024 and December 31, 2023 | 0 | 0 |
Common stock, $0.0001 par value; 500,000,000 shares authorized as of June 30, 2024 and December 31, 2023, respectively; 54,712,132 and 42,470,264 shares issued as of June 30, 2024 and December 31, 2023, respectively; 54,654,495 and 42,422,531 shares outstanding as of June 30, 2024 and December 31, 2023, respectively | 5 | 4 |
Additional paid-in capital | 298,178 | 250,825 |
Accumulated other comprehensive income (loss) | (26) | 9 |
Treasury stock, 57,637 and 47,733 shares as of June 30, 2024 and December 31, 2023, respectively; at cost | (101) | (59) |
Accumulated deficit | (217,138) | (195,970) |
Total stockholders' equity | 80,918 | 54,809 |
Total liabilities and stockholders' equity | $ 114,597 | $ 89,091 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2024 | Dec. 31, 2023 |
Condensed Consolidated 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 | 54,712,132 | 42,470,264 |
Common stock, shares outstanding | 54,654,495 | 42,422,531 |
Treasury Stock, Common, Shares | 57,637 | 47,733 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Operating expenses: | ||||
Research and development | $ 6,551 | $ 6,029 | $ 12,562 | $ 13,321 |
General and administrative | 4,412 | 3,805 | 8,270 | 8,151 |
Restructuring charges | 0 | 0 | 0 | 5,107 |
Total operating expenses | 10,963 | 9,834 | 20,832 | 26,579 |
Loss from operations | (10,963) | (9,834) | (20,832) | (26,579) |
Interest income (expense), net | 513 | (271) | 628 | (580) |
Loss on extinguishment of debt | 0 | 0 | (942) | 0 |
Total other income (expense), net | 513 | (271) | (314) | (580) |
Loss before income taxes | (10,450) | (10,105) | (21,146) | (27,159) |
Income tax expense | 11 | 5 | 22 | 10 |
Net loss | $ (10,461) | $ (10,110) | $ (21,168) | $ (27,169) |
Net Loss Per Share | ||||
Net loss per share, basic (in dollars per share) | $ (0.18) | $ (0.36) | $ (0.38) | $ (1.04) |
Net loss per share, diluted (in dollars per share) | $ (0.19) | $ (0.37) | $ (0.42) | $ (1.06) |
Weighted average common shares outstanding, basic (in shares) | 59,018,340 | 28,405,046 | 55,415,111 | 26,025,025 |
Weighted average common shares outstanding, diluted (in shares) | 54,578,340 | 27,575,596 | 50,975,111 | 25,608,008 |
Other comprehensive income (loss): | ||||
Unrealized (loss) gain on marketable securities | $ (26) | $ 49 | $ (35) | $ 159 |
Total other comprehensive income (loss) | (26) | 49 | (35) | 159 |
Total comprehensive loss | $ (10,487) | $ (10,061) | $ (21,203) | $ (27,010) |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' Equity - USD ($) | Common Stock | Additional Paid-in Capital | Treasury Stock, Common | Accumulated Other Comprehensive Loss | Accumulated Deficit | Total |
Stockholders equity, Beginning balance at Dec. 31, 2022 | $ 2,000 | $ 199,492,000 | $ (35,000) | $ (161,000) | $ (150,266,000) | $ 49,032,000 |
Stockholders equity, Beginning balance (in shares) at Dec. 31, 2022 | 23,312,529 | |||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Issuance of common stock upon stock option exercises | $ 0 | 1,466,000 | 0 | 0 | 0 | $ 1,466,000 |
Issuance of common stock upon stock option exercises (in shares) | 1,239,899 | 1,239,899 | ||||
Stock-based compensation | $ 0 | 2,208,000 | 0 | 0 | 0 | $ 2,208,000 |
Stock based compensation (in shares) | 0 | |||||
Vesting of restricted common stock | $ 0 | 1,000 | 0 | 0 | 0 | 1,000 |
Vesting of restricted common stock (in shares) | 3,946 | |||||
Vesting of restricted stock units, net of withholding | $ 0 | 0 | (19,000) | 0 | 0 | (19,000) |
Vesting of restricted stock units, net of withholding (in shares) | 15,578 | |||||
Unrealized (loss) gain on marketable securities | $ 0 | 0 | 0 | 159,000 | 0 | 159,000 |
Net Income (Loss) | 0 | 0 | 0 | 0 | (27,169,000) | (27,169,000) |
Stockholders equity, Ending balance at Jun. 30, 2023 | $ 4,000 | 249,668,000 | (54,000) | (2,000) | (177,435,000) | 72,181,000 |
Stockholders equity, Ending balance (in shares) at Jun. 30, 2023 | 42,381,952 | |||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Issuance of common stock, purchase warrants and pre-funded warrants for the purchase of common stock, net of underwriting discounts, commissions and offering costs | $ 2,000 | 46,501,000 | 0 | 0 | 0 | 46,503,000 |
Issuance of common stock, purchase warrants and pre-funded warrants for the purchase of common stock, net of underwriting discounts, commissions and offering costs (in shares) | 17,810,000 | |||||
Stockholders equity, Beginning balance at Mar. 31, 2023 | $ 2,000 | 201,185,000 | (47,000) | (51,000) | (167,325,000) | 33,764,000 |
Stockholders equity, Beginning balance (in shares) at Mar. 31, 2023 | 23,786,337 | |||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Issuance of common stock upon at-the-market offering, net of issuance costs | $ 2,000 | 46,501,000 | 46,503,000 | |||
Issuance of common stock upon at-the-market offering, net of issuance costs (in shares) | 17,810,000 | |||||
Issuance of common stock upon stock option exercises | 1,238,000 | 1,238,000 | ||||
Issuance of common stock upon stock option exercises (in shares) | 777,826 | |||||
Stock-based compensation | 744,000 | 744,000 | ||||
Vesting of restricted stock units, net of withholding | (7,000) | (7,000) | ||||
Vesting of restricted stock units, net of withholding (in shares) | 7,789 | |||||
Unrealized (loss) gain on marketable securities | 49,000 | 49,000 | ||||
Net Income (Loss) | (10,110,000) | (10,110,000) | ||||
Stockholders equity, Ending balance at Jun. 30, 2023 | $ 4,000 | 249,668,000 | (54,000) | (2,000) | (177,435,000) | 72,181,000 |
Stockholders equity, Ending balance (in shares) at Jun. 30, 2023 | 42,381,952 | |||||
Stockholders equity, Beginning balance at Dec. 31, 2023 | $ 4,000 | 250,825,000 | (59,000) | 9,000 | (195,970,000) | 54,809,000 |
Stockholders equity, Beginning balance (in shares) at Dec. 31, 2023 | 42,422,531 | |||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Issuance of common stock upon at-the-market offering, net of issuance costs | $ 1,000 | 44,206,000 | 0 | 0 | 44,207,000 | |
Issuance of common stock upon at-the-market offering, net of issuance costs (in shares) | 11,625,295 | |||||
Issuance of common stock upon stock option exercises | $ 0 | 487,000 | 0 | 0 | $ 487,000 | |
Issuance of common stock upon stock option exercises (in shares) | 366,947 | 366,947 | ||||
Issuance of common stock upon exercise of common warrants | $ 0 | 450,000 | 0 | 0 | $ 450,000 | |
Issuance of common stock upon exercise of common warrants (in shares) | 200,000 | |||||
Warrant issuance | $ 0 | 261,000 | 0 | 0 | 261,000 | |
Stock-based compensation | $ 0 | 1,949,000 | 0 | 0 | 1,949,000 | |
Stock based compensation (in shares) | 0 | |||||
Vesting of restricted stock units, net of withholding | $ 0 | 0 | (42,000) | 0 | (42,000) | |
Vesting of restricted stock units, net of withholding (in shares) | 39,722 | |||||
Unrealized (loss) gain on marketable securities | $ 0 | 0 | 0 | (35,000) | (35,000) | |
Net Income (Loss) | 0 | 0 | 0 | 0 | (21,168,000) | (21,168,000) |
Stockholders equity, Ending balance at Jun. 30, 2024 | $ 5,000 | 298,178,000 | (101,000) | (26,000) | (217,138,000) | 80,918,000 |
Stockholders equity, Ending balance (in shares) at Jun. 30, 2024 | 54,654,495 | |||||
Stockholders equity, Beginning balance at Mar. 31, 2024 | $ 5,000 | 282,575,000 | (85,000) | (206,677,000) | 75,818,000 | |
Stockholders equity, Beginning balance (in shares) at Mar. 31, 2024 | 51,679,383 | |||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Issuance of common stock upon at-the-market offering, net of issuance costs | 14,551,000 | 14,551,000 | ||||
Issuance of common stock upon at-the-market offering, net of issuance costs (in shares) | 2,958,879 | |||||
Issuance of common stock upon stock option exercises | 5,000 | 5,000 | ||||
Issuance of common stock upon stock option exercises (in shares) | 4,000 | |||||
Stock-based compensation | 1,047,000 | 1,047,000 | ||||
Vesting of restricted stock units, net of withholding | (16,000) | (16,000) | ||||
Vesting of restricted stock units, net of withholding (in shares) | 12,233 | |||||
Unrealized (loss) gain on marketable securities | (26,000) | (26,000) | ||||
Net Income (Loss) | (10,461,000) | (10,461,000) | ||||
Stockholders equity, Ending balance at Jun. 30, 2024 | $ 5,000 | $ 298,178,000 | $ (101,000) | $ (26,000) | $ (217,138,000) | $ 80,918,000 |
Stockholders equity, Ending balance (in shares) at Jun. 30, 2024 | 54,654,495 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Operating activities | ||
Net loss | $ (21,168) | $ (27,169) |
Reconciliation of net loss to net cash used in operating activities: | ||
Stock-based compensation | 1,949 | 2,208 |
Non-cash interest expense | 268 | 337 |
Amortization of premium and interest on marketable securities | (625) | (175) |
Depreciation expense | 14 | 20 |
Loss on extinguishment of debt | 942 | 0 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other assets | 2,222 | 1,413 |
Accounts payable | (163) | (1,122) |
Accrued expenses | (1,219) | (6,154) |
Net cash used in operating activities | (17,780) | (30,642) |
Investing activities | ||
Purchase of marketable securities | (46,960) | 0 |
Proceeds from sales and maturities of marketable securities | 30,000 | 43,100 |
Net cash (used in) provided by investing activities | (16,960) | 43,100 |
Financing activities | ||
Proceeds from issuance of common stock, purchase warrants and pre-funded warrants for the purchase of common stock, net of underwriting discounts, commissions, and offering costs | 0 | 46,503 |
Proceeds from issuance of common stock upon at-the-market offering, net of issuance costs | 44,207 | 0 |
Proceeds from issuance of common stock upon stock option exercises | 487 | 1,466 |
Proceeds from issuance of common stock upon exercise of common warrants | 450 | 0 |
Common stock repurchase | (42) | (19) |
Payment of debt extinguishment costs | (170) | 0 |
Net cash provided by financing activities | 44,932 | 47,950 |
Increase in cash and cash equivalents | 10,192 | 60,408 |
Cash and cash equivalents, beginning of period | 49,255 | 45,917 |
Cash and cash equivalents, end of period | 59,447 | 106,325 |
Supplemental disclosure of cash flow information | ||
Cash paid for interest | 1,784 | 1,392 |
Supplemental disclosure of non-cash financing activities | ||
Offering costs in accounts payable and accrued expenses | $ 0 | $ 390 |
Nature of Business
Nature of Business | 6 Months Ended |
Jun. 30, 2024 | |
Nature of Business | |
Nature of Business | ELEVATION ONCOLOGY, INC. Notes to Condensed Consolidated Financial Statements (dollars in thousands, except share and per share data) (unaudited) 1. Nature of Business Elevation Oncology, Inc. (the “Company”), which was formerly known as 14ner Oncology, Inc., was incorporated under the laws of the State of Delaware on April 29, 2019 (“Inception”). The Company is an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs. The Company is leveraging its antibody-drug conjugate (“ADC”) expertise to advance a novel pipeline, initially targeting two validated targets in oncology, Claudin 18.2 and HER3. The Company‘s lead candidate, EO-3021, is a potential best-in-class ADC designed to target Claudin 18.2 and is currently being evaluated in a Phase 1 clinical trial in patients with advanced, unresectable or metastatic solid tumors likely to express Claudin 18.2 including gastric, gastroesophageal junction, pancreatic or esophageal cancers. In addition to its monotherapy approach, the Company plans to expand its ongoing Phase 1 clinical trial to evaluate EO-3021 in combination with ramucirumab, a VEGFR2 inhibitor, and dostarlimab, a PD-1 inhibitor. Additionally, the Company expects to nominate a development candidate for its second program, a HER3-targeting ADC for the treatment of patients with solid tumors that overexpress HER3. 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. Liquidity The Company has incurred recurring net losses since inception and has funded its operations to date through the proceeds from the sale of convertible preferred stock, proceeds from public offerings of common stock and warrants, and borrowings under a debt facility. The Company incurred net losses of $10.5 million and $10.1 million for the three months ended June 30, 2024 and 2023, respectively, and $21.2 million and $27.2 million for the six months ended June 30, 2024 and 2023, respectively. As of June 30, 2024, the Company had an accumulated deficit of $217.1 million and cash, cash equivalents, and marketable securities totaling $110.8 million. 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 condensed consolidated 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 | 6 Months Ended |
Jun. 30, 2024 | |
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. All significant intercompany balances and transactions have been eliminated in consolidation. Basis of Presentation of Unaudited Interim Condensed Consolidated Financial Statements The condensed consolidated interim financial statements have been prepared by the Company in conformity with U.S. generally accepted accounting principles (“U.S. GAAP”) and 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, 2023 condensed consolidated balance sheet was derived from the December 31, 2023 audited consolidated 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, 2024. The accompanying condensed consolidated interim financial statements should be read in conjunction with the Company’s audited consolidated financial statements and the notes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023 (the “Annual Report”). Significant Accounting Policies Use of Estimates The preparation of 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. Significant estimates and assumptions reflected in these condensed consolidated financial statements include, but are not limited to, the accruals for research and development expenses 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. 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 June 30, 2024 and December 31, 2023, cash equivalents consisted of money market funds, U.S. government debt securities, and corporate debt securities. The Company places its cash with high-credit-quality financial institutions domiciled in the United States, which are insured by the Federal Deposit Insurance Corporation (“FDIC”). Deferred Financing Costs The incremental cost, including the fair value of warrants, directly associated with obtaining debt financing is capitalized as deferred financing costs upon the issuance of the debt and amortized over the term of the related debt agreement using the effective-interest method with such amortized amounts included as a component of interest expense in the condensed consolidated statements of operations. Unamortized deferred financing costs are presented on the condensed consolidated balance sheets as a direct deduction from the carrying amount of the related debt obligation. 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 three months ended June 30, 2024 and 2023, the Company had one and two vendor(s) that accounted for approximately 65% and 67% of its research and development expense, respectively. During the six months ended June 30, 2024 and 2023, the Company had one and two vendor(s) that accounted for approximately 65% and 62% of its research and development expense, respectively. As of June 30, 2024 and December 31, 2023, the Company had four and two vendors that accounted for approximately 72% and 39% of total accounts payable, respectively. 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 Company’s cash equivalents and marketable securities are carried at fair value, determined according to the fair value hierarchy described above (see Note 3). The carrying amount of the Company’s accounts payable approximates fair value due to its short-term nature. The carrying value of the Company’s long-term debt approximates its fair value due to its variable interest rate. 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 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 amortization of premiums and accretion 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. When the fair value is below the amortized cost of a marketable security, an estimate of expected credit losses is made. The credit-related impairment amount is recognized in the condensed consolidated statements of operations. Credit losses are recognized through the use of an allowance for credit losses account in the condensed consolidated balance sheet and subsequent improvements in expected credit losses are recognized as a reversal of an amount in the allowance account. If the Company has the intent to sell the security or it is more likely than not that the Company will be required to sell the security prior to recovery of its amortized cost basis, then the allowance for the credit loss is written-off and the excess of the amortized cost basis of the asset over its fair value is recorded in the condensed consolidated statements of operations. There were no credit losses recorded during the six months ended June 30, 2024 and 2023. 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 are expensed and included as part of general and administrative expenses. As of June 30, 2024 and 2023, the Company has determined that these expenses have not met the criteria to be capitalized. Recently Issued but Not Yet Adopted Accounting Pronouncements In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which requires disclosure of incremental segment information on an annual and interim basis. This ASU is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024 on a retrospective basis. The Company is currently evaluating the effect of this pronouncement on its disclosures. In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which expands the disclosures required for income taxes. This ASU is effective for fiscal years beginning after December 15, 2024, with early adoption permitted. The amendment should be applied on a prospective basis while retrospective application is permitted. The Company is currently evaluating the effect of this pronouncement on its disclosures. |
Fair Value Measurements of Fina
Fair Value Measurements of Financial Assets | 6 Months Ended |
Jun. 30, 2024 | |
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 June 30, 2024 Level 1 Level 2 Level 3 Total Cash Equivalents: Money market funds $ 39,499 $ — $ — $ 39,499 U.S. Government debt securities — 2,370 — 2,370 Corporate debt securities — 995 — 995 Total $ 39,499 $ 3,365 $ — $ 42,864 Marketable Securities: Corporate debt securities $ — $ 22,714 $ — $ 22,714 Commercial paper — 3,337 — 3,337 U.S. Government debt securities — 25,351 — 25,351 Total $ — $ 51,402 $ — $ 51,402 As of December 31, 2023 Level 1 Level 2 Level 3 Total Cash Equivalents: Money market funds $ 45,287 $ — $ — $ 45,287 Total $ 45,287 $ — $ — $ 45,287 Marketable Securities: Corporate debt securities $ — $ 4,571 $ — $ 4,571 Commercial paper — 12,442 — 12,442 U.S. Government debt securities — 16,839 — 16,839 Total $ — $ 33,852 $ — $ 33,852 There were no transfers into or out of Level 3 during the six months ended June 30, 2024 and 2023. |
Marketable Securities
Marketable Securities | 6 Months Ended |
Jun. 30, 2024 | |
Investments, Debt and Equity Securities [Abstract] | |
Marketable Securities | 4. Marketable Securities The following table summarizes the Company’s marketable securities (in thousands): As of June 30, 2024 Amortized Unrealized Unrealized Fair Cost gains losses value Marketable Securities: Corporate debt securities $ 22,732 $ — $ (18) $ 22,714 Commercial paper 3,339 — (2) 3,337 U.S. Government debt securities 25,357 1 (7) 25,351 Total $ 51,428 $ 1 $ (27) $ 51,402 As of December 31, 2023 Amortized Unrealized Unrealized Fair Cost gains losses value Marketable Securities: Corporate debt securities $ 4,569 $ 3 $ (1) $ 4,571 Commercial paper 12,444 — (2) 12,442 U.S. Government debt securities 16,830 9 — 16,839 Total $ 33,843 $ 12 $ (3) $ 33,852 |
Accrued Expenses
Accrued Expenses | 6 Months Ended |
Jun. 30, 2024 | |
Accrued Expenses | |
Accrued Expenses | 5. Accrued Expenses Accrued expenses consisted of the following (in thousands): June 30, December 31, 2024 2023 Accrued compensation $ 1,077 $ 2,393 Accrued preclinical and clinical trial costs 688 756 Accrued consulting 151 68 Accrued professional services 141 17 Accrued restructuring charges — 3 Accrued other 362 401 Total accrued expenses $ 2,419 $ 3,638 |
Restructuring Charges
Restructuring Charges | 6 Months Ended |
Jun. 30, 2024 | |
Restructuring Charges. | |
Restructuring Charges | 6. Restructuring Charges On January 6, 2023, the Company announced a pipeline prioritization and realignment of resources to advance its EO-3021 product candidate. The Company paused further investment in the clinical development of its seribantumab product candidate and realigned its resources to focus on advancing EO-3021 and other pipeline programs. The Company intends to pursue further development of seribantumab only in collaboration with a partner. Concurrently with this announcement, the Board of Directors of the Company (the “Board”) approved a reduction of the Company’s workforce across all areas of the Company. The workforce reduction was substantially completed in January 2023 and was fully completed in April 2023. These actions reflect the Company’s determination to refocus its strategic priorities around EO-3021 and other pipeline programs. Additionally, on January 5, 2023, the Company and the former President and Chief Executive Officer (the “former CEO”) of the Company, entered into a Separation Agreement (the “Separation Agreement”) following the mutual agreement between the Board and the former CEO regarding his departure from his positions with the Company. Pursuant to the Separation Agreement, the former CEO ceased his role as the Company’s President and CEO and resigned as a director of the Board, effective January 5, 2023. The reprioritization and realignment of resources included total restructuring charges of approximately $5.1 million, which included $1.6 million of one-time termination and contractual termination benefits for severance, healthcare and related benefits. The one-time termination benefits were recorded in January 2023 under the provisions of Accounting Standards Codification (“ASC”) 420, Exit or Disposal Cost Obligation Compensation-Nonretirement Postemployment Benefits All restructuring charges have been paid as of June 30, 2024. |
Debt
Debt | 6 Months Ended |
Jun. 30, 2024 | |
Debt | |
Debt | 7. Debt K2 HealthVentures Loan and Security Agreement In July 2022, the Company entered into a loan and security agreement (as amended, the “Loan Agreement”) with K2 HealthVentures LLC (together with its affiliates, “K2HV”, and together with any other lender from time to time party thereto, the “Lenders”), as administrative agent for the Lenders, and Ankura Trust Company, LLC, as collateral agent for the Lenders. The Loan Agreement provides up to $50.0 million principal in term loans (the “Term Loan”) consisting of a first tranche of $30.0 million funded at closing and a subsequent second tranche of up to $20.0 million upon the Company’s request before March 1, 2025, subject to review by the Lenders of certain information from the Company and discretionary approval by the Lenders. In connection with entering into the Loan Agreement, the Company also issued to K2HV a warrant to purchase shares of common stock (see Note 8), which was an incremental cost to the Loan Agreement; thus, the allocated fair value of the warrant was recorded as part of the debt issuance cost . In March 2024, the Company entered into an amendment to the Loan Agreement with K2HV (the “Loan Agreement Amendment”), pursuant to which: . The Term Loan will mature on August 1, 2026, with interest-only payments until June 1, 2026 The Company may prepay, at its option, all, but not less than all, of the outstanding principal balance and all accrued and unpaid interest with respect to the principal balance being prepaid of the Term Loan, subject to a prepayment premium as follows: 3% of the loan amounts prepaid if such prepayment occurs in the first year after funding; 2% if such prepayment occurs in the second year after funding; 1% if such prepayment occurs in the third year after funding; and 0% thereafter. The Lenders may elect at any time following the closing and prior to the full repayment of the Term Loan to convert any portion of the principal amount of the Term Loan then outstanding, up to an aggregate of $3.25 million in principal amount, into shares of the Company’s common stock, $0.0001 par value per share, and a warrant to purchase an equal number of shares of the Company’s common stock (the “Conversion Warrant”), at a conversion price of $2.25, subject to customary 19.99% Nasdaq beneficial ownership limitations (the “Conversion Election”). The Company also granted registration rights to the Lenders with respect to shares received upon such conversion. Further, the Lenders may elect to invest up to $5.0 million in future equity financings of the Company, provided such investment is limited to no more than 10% of the total amount raised in such equity financing. The Loan Agreement contains customary representations and warranties, events of default and affirmative and negative covenants, including covenants that limit or restrict the Company’s ability to, among other things, dispose of assets, make changes to the Company’s business, management, ownership or business locations, merge or consolidate, incur additional indebtedness, pay dividends or other distributions or repurchase equity, make investments, and enter into certain transactions with affiliates, in each case subject to certain exceptions. The Loan Agreement also contains covenants requiring that the Company maintain cash, cash equivalents and marketable securities balance of at least $25.0 million so long as the Company’s total market capitalization is less than $250.0 million. As security for its obligations under the Loan Agreement, the Company granted the Lenders a first priority security interest on substantially all of the Company’s assets (other than intellectual property), subject to certain exceptions. The Company analyzed the Loan Agreement Amendment under ASC 470-50 to determine if extinguishment accounting was applicable. Under ASC 470-50-40-10, debt instruments are considered to be substantially different if a modification or an exchange affects the terms of a conversion option, from which the change in the fair value of the conversion option is at least 10% of the carrying amount of the original debt instrument immediately before the modification or exchange. Since the change of the fair value of the conversion option exceeded 10% upon the execution of Loan Agreement Amendment, the Company determined the modification to be substantive, and extinguishment accounting was applicable. In accordance with the extinguishment accounting guidance, the Company recorded $0.9 million as loss on extinguishment of debt, which represents unamortized debt issuance costs of the original loan as of the amendment date (including the unamortized allocated fair value of the warrant issued to K2HV in connection with entering into the Loan Agreement), new lender fees, and the fair value of the Amendment Warrant upon issuance. As of June 30, 2024, the effective interest rate is 12.76% for the first tranche of the Term Loan. The book value of debt approximates its fair value given the variable interest rate. Long-term debt and the unamortized discount balances are as follows (in thousands): June 30, 2024 December 31, 2023 Outstanding principal amount $ 30,000 $ 30,000 Add: accreted liability of final payment fee 916 686 Less: unamortized debt discount, long-term — (549) Long-term debt, net of discount $ 30,916 $ 30,137 The Company’s total interest expenses were $1.0 million for the three months ended June 30, 2024 and 2023. Total interest expenses were $2.0 million for the six months ended June 30, 2024 and 2023. The following Three months ended June 30, Six months ended June 30, 2024 2023 2024 2023 Interest paid or accrued $ 887 $ 862 $ 1,774 $ 1,678 Non-cash amortization of debt discount (including warrants) — 53 38 103 Non-cash accrued back-end fee 107 119 230 234 $ 994 $ 1,034 $ 2,042 $ 2,015 Scheduled future principal payments on total outstanding debt, as of June 30, 2024, are as follows (in thousands): Year Ending December 31, 2024 (remainder of the year) $ — 2025 — 2026 30,000 $ 30,000 |
K2 Warrant and Amendment Warran
K2 Warrant and Amendment Warrant | 6 Months Ended |
Jun. 30, 2024 | |
K2 Warrant and Amendment Warrant | |
K2 Warrant | 8. K2 Warrant and Amendment Warrant In connection with the Loan Agreement (see Note 7), the Company issued a warrant to purchase 339,725 shares of the Company’s common stock with an exercise price of $1.3246 (the “K2 Warrant”). In connection with the Loan Agreement Amendment executed March 2024 (see Note 7), the Company issued an additional warrant to purchase 55,249 shares of the Company’s common stock, with an exercise price per warrant of $2.7150 (the “Amendment Warrant”). Additionally, pursuant to the Conversion Election, the Lenders may receive the Conversion Warrant (see Note 7). K2HV may from time to time exercise the K2 Warrant, Amendment Warrant, or Conversion Warrant (after the Conversion Election), in whole or in part, by delivering to the Company the original copy of the respective warrant, together with a duly executed notice of exercise. The Company also granted registration rights to the Lenders with respect to shares issuable upon exercise of the K2 Warrant, Amendment Warrant, and Conversion Warrant (after the Conversion Election). All 394,974 shares subject to the K2 Warrant and Amendment Warrant are outstanding as of June 30, 2024. Shares Initial Recognition Date Exercise Price Expiration Date K2 Warrant 339,725 July 27, 2022 $ 1.3246 July 27, 2032 Amendment Warrant 55,249 March 1, 2024 2.7150 March 1, 2034 Total warrants outstanding 394,974 The allocated fair value upon issuance of the K2 Warrant and Amendment Warrant was estimated to be approximately $0.4 million and $0.3 million, respectively, and was recorded as additional paid-in capital on the Company’s condensed consolidated balance sheets. The fair value of the K2 Warrant and Amendment Warrant was estimated using a Black-Scholes option-pricing model with the following assumptions: K2 Warrant Amendment Warrant Stock price $1.41 $5.01 Strike price $1.32 $2.72 Volatility (annual) 75.30% 105.00% Risk-free rate 2.74% 4.10% Estimated time to expiration (years) 10 10 Dividend yield —% —% |
Equity
Equity | 6 Months Ended |
Jun. 30, 2024 | |
Equity | |
Equity | 9. Equity Preferred Stock The Company has authorized preferred stock amounting to 10,000,000 shares as of June 30, 2024 and December 31, 2023. Common Stock The Company has authorized common stock amounting to 500,000,000 shares of $0.0001 par value as of June 30, 2024 and December 31, 2023. 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, if any. No dividends have been declared or paid At-the-Market Offering In July 2022, the Company entered into the Sales Agreement (the “2022 Sales Agreement”) with Cowen and Company, LLC (“Cowen”), under which the Company was permitted to offer and sell, from time to time, shares of common stock having aggregate gross proceeds of up to $50.0 million (the “2022 ATM Shares”) at market prices (the “2022 ATM Facility”). The Company agreed to pay Cowen a commission of up to 3% of the gross proceeds of any sales of the 2022 ATM Shares pursuant to the 2022 Sales Agreement. During the six months ended June 30, 2024, the Company sold 11,625,295 of the 2022 ATM Shares pursuant to the 2022 Sales Agreement, with net proceeds of approximately $44.2 million after deducting $1.4 million of issuance costs. In May 2024, the Company entered into a new sales agreement (the “2024 Sales Agreement”) with TD Securities (USA) LLC (“TD Cowen”), under which the Company may offer and sell, from time to time, shares of common stock having aggregate gross proceeds of up to $75.0 million (the “2024 ATM Shares”) at market prices (the “2024 ATM Facility”). The Company will pay TD Cowen a commission of up to 3% of the gross proceeds of any sales of the 2024 ATM Shares pursuant to the 2024 Sales Agreement. As of June 30, 2024, the Company has not sold any 2024 ATM Shares pursuant to the 2024 Sales Agreement. June 2023 Public Offering On June 8, 2023, the Company entered into an Underwriting Agreement (the “Purchase Agreement”) with SVB Securities LLC and Cowen, as representatives of the several underwriters named therein (the “Underwriters”), pursuant to which the Company agreed to issue and sell an aggregate of 17,810,000 shares of its common stock, par value $0.0001 per share (each a “Share” and collectively the “Shares”), pre-funded warrants to purchase 4,440,000 shares of its common stock (the “Pre-Funded Warrants”) and common stock warrants (the “Common Warrants” and collectively with the Pre-Funded Warrants, the “Warrants”) to purchase 22,250,000 shares of its common stock to the Underwriters. Each full share was sold together with one Common Warrant at the public offering price of $2.25 per share, less underwriting discounts and commissions. Each full Pre-Funded Warrant was sold together with one Common Warrant at a public offering price of $2.2499 per Pre-Funded Warrant, which represents the per Share and Common Warrant public offering price less a $0.0001 per share exercise price for each such Pre-Funded Warrant. The Common Warrants are exercisable at any time after the date of issuance and have an exercise price of $2.25 per share, subject to adjustment. The Common Warrants expire five years from the date of issuance. The Pre-Funded Warrants are exercisable at any time after the date of issuance and do not expire. The aggregate exercise price of the Pre-Funded Warrants, except for a nominal exercise price of $0.0001 per share of common stock, was pre-funded to the Company and, consequently, no additional consideration (other than the nominal exercise price of $0.0001 per share of common stock) is required for the exercise of the Pre-Funded Warrants. The offering closed on June 13, 2023, and the Company received gross proceeds of $50.1 million before deducting underwriting discounts, commissions and offering expenses. As of the close of the offering, the Company issued 17,810,000 shares of common stock and Common Warrants to purchase 17,810,000 shares of common stock for a total consideration of $40.1 million and 4,440,000 shares of common stock and Pre-Funded Warrants to purchase 4,440,000 shares of common stock for a total consideration of $10.0 million. The terms and conditions of the Warrants are as noted and governed by the agreements entered into with the holders on June 13, 2023. Underwriting discount and commissions and other offering expenses of approximately $3.6 million incurred directly related to the offering were reflected as a reduction in additional paid-in capital. As of June 30, 2024, 200,000 shares subject to the Common Warrants have been exercised and no shares subject to the Pre-Funded Warrants have been exercised. The following is a summary of warrants outstanding pursuant to the purchase agreement as of June 30, 2024: Shares Initial Recognition Date Exercise Price Expiration Date Common Warrants 22,050,000 June 13, 2023 $ 2.2500 June 13, 2028 Pre-Funded Warrants 4,440,000 June 13, 2023 $ 0.0001 None The fair value of the Warrants issued to the Investors in the offering was approximately $35.6 million. The fair value of the Common Warrants was measured using a Monte Carlo simulation model with the following assumptions: Stock price $1.65 Strike price $2.25 Volatility (annual) 110.00% Risk-free rate 3.93% Estimated time to expiration (years) 5 Dividend yield —% Total proceeds were allocated between the Shares and Warrants on a relative fair value basis given both securities are equity classified. |
Stock-Based Compensation
Stock-Based Compensation | 6 Months Ended |
Jun. 30, 2024 | |
Stock-Based Compensation | |
Stock-Based Compensation | 10. 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 June 30, Six months ended June 30, 2024 2023 2024 2023 Research and development $ 307 $ 106 $ 540 $ 301 General and administrative 740 638 1,409 1,907 Stock-based compensation expense included in operating expenses $ 1,047 $ 744 $ 1,949 $ 2,208 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 the Company is able to issue equity awards 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 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. The number of shares reserved for issuance under the 2021 Plan will increase automatically on January 1 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 the Company’s Board in any particular year. As such, 2,121,127 shares were added to the 2021 Plan in January 2024. As of June 30, 2024, 654,698 shares remained available for future issuance under the 2021 Plan. 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 or compensation committee. The ESPP is intended to qualify under Section 423 of the Internal Revenue Code. The Company 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 1 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 in any particular year. As such, 424,225 shares were added to the ESPP in January 2024. As of June 30, 2024, no offering periods have commenced, and 1,117,631 shares remained available for future issuance under the ESPP. 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 six months ended June 30, 2024: Weighted- Weighted- average Aggregate average remaining contractual intrinsic value Options exercise price term (in years) (in thousands) Outstanding at December 31, 2023 4,178,194 $ 2.98 8.22 $ 11 Granted 2,520,450 3.02 Exercised (366,947) 1.33 Cancelled (163,259) 2.63 Outstanding at June 30, 2024 6,168,438 $ 3.10 8.61 $ 3,751 Vested at June 30, 2024 2,356,788 $ 3.61 $ 1,976 Vested and expected to vest at June 30, 2024 6,168,438 $ 3.10 8.61 $ 3,751 The following is a summary of the Company’s stock option activity for the six months ended June 30, 2023: Weighted- Weighted- average Aggregate average remaining contractual intrinsic value Options exercise price term (in years) (in thousands) Outstanding at December 31, 2022 4,408,274 $ 3.44 8.52 $ 350 Granted 2,257,506 1.08 Exercised (1,239,899) 1.18 Cancelled (1,006,332) 2.73 Outstanding at June 30, 2023 4,419,549 $ 3.03 8.70 $ 1,454 Vested at June 30, 2023 2,132,303 $ 3.34 5.37 $ 476 Vested and expected to vest at June 30, 2023 4,419,549 $ 3.03 8.70 $ 1,454 The weighted average grant-date fair value of stock options granted during the six months ended June 30, 2024 and 2023 was $2.05 and $0.63 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 June 30, Six months ended June 30, 2024 2023 2024 2023 Risk-free interest rate 4.24 - 4.65 % 3.94 % 4.07 - 4.65 % 3.67 - 4.24 % Volatility 72 - 76 % 72 % 72 - 76 % 72 - 74 % Dividend yield 0.00 % 0.00 % 0.00 % 0.00 % Expected term (years) 6 - 7 7 6 - 7 2 - 7 The fair value of options that vested during the six months ended June 30, 2024 and 2023 was $5.7 million and $4.3 million, respectively. The Company recorded stock-based compensation expense associated with stock option awards of $0.7 million and $0.5 million during the three months ended June 30, 2024 and 2023, respectively, and $1.4 million and $1.8 million during the six months ended June 30, 2024 and 2023, respectively. As of June 30, 2024, there was $6.9 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 2.7 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 as common stock and additional paid-in capital as the shares vest and the repurchase right lapses. As of March 31, 2023, all the shares issued as a result of early exercise were fully vested. The Company has no such liabilities from the early exercise in the accompanying condensed consolidated balance sheets as of June 30, 2024 and December 31, 2023. The Company recorded no stock-based compensation expense associated with restricted common stock during the six months ended June 30, 2024 and 2023. 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 RSUs: Weighted- average grant date Number of shares fair value Unvested at December 31, 2023 155,797 $ 8.25 Granted 437,025 $ 2.77 Vested (49,626) $ 8.58 Cancelled (27,400) $ 2.28 Unvested at June 30, 2024 515,796 $ 3.89 The Company recorded stock-based compensation expense associated with RSU awards of $0.3 million and $0.2 million for the three months ended June 30, 2024 and 2023, respectively, and $0.5 million and $0.4 million for the six months ended June 30, 2024 and 2023, respectively. As of June 30, 2024, the total unrecognized expense related to all RSUs was $1.9 million, which the Company expects to recognize over a weighted-average period of 2.5 years. In connection with the vesting of RSUs, the Company adopted a net settlement method whereby shares of common stock are withheld to satisfy tax withholding and remittance obligations. As of June 30, 2024, the Company withheld 57,637 shares, which are held in Treasury Stock, for $0.1 million. |
Asset Purchase and License Agre
Asset Purchase and License Agreements | 6 Months Ended |
Jun. 30, 2024 | |
Asset Purchase and License Agreements | |
Asset Purchase and License Agreements | 11. Asset Purchase and License Agreements CSPC License Agreement In July 2022, the Company entered into a license agreement (the “CSPC License Agreement”) with CSPC Megalith Biopharmaceutical Co., Ltd., a subsidiary of CSPC Pharmaceutical Group Limited (the “Licensor”), with an effective date of July 27, 2022 (the “Effective Date”), pursuant to which the Licensor granted to the Company a worldwide exclusive right and license (outside of the People’s Republic of China, Hong Kong, Taiwan and Macau) under certain patents identified in the CSPC License Agreement (the “Licensed Patents”) and know-how (collectively, the “Licensed IP”) to develop and commercialize products (“Licensed Products”) containing EO-3021 (SYSA1801) (the “Licensed Compound”) in the treatment of cancer (the “Field”). Subject to certain conditions set forth in the CSPC License Agreement, the Company may grant sublicenses (including the right to grant further sublicenses) to its rights under the CSPC License Agreement to any of its affiliates or any third party. Either party to the CSPC License Agreement may assign its rights under the CSPC License Agreement (i) in connection with the sale or transfer of all or substantially all of its assets to a third party, (ii) in the event of a merger or consolidation with a third party or (iii) to an affiliate; in each case contingent upon the assignee assuming in writing all of the obligations of its assignor under the CSPC License Agreement. Under the terms of CSPC License Agreement, the Company paid to the Licensor a one-time upfront license fee of $27.0 million, and is required to pay to the Licensor milestone payments of up to $148.0 million following the achievement of certain development and regulatory milestones and additional milestone payments of up to approximately $1.0 billion following the achievement of certain commercial milestones. During the Term (as defined below), the Company is also required to pay to the Licensor (i) royalties ranging from mid-single digits through low double digits on net sales of each Licensed Product and (ii) a percentage of non-royalty sublicense income received by the Company of up to an aggregate of $50.0 million. Under the terms of the CSPC License Agreement, the development of the Licensed Compound and the first Licensed Product will be governed by a clinical development plan, including anticipated timeline goals in connection with the clinical trials for the first Licensed Product (the “Development Plan”). The Development Plan may be amended by a joint steering committee established by the Company and the Licensor. The Company will purchase Licensed Products for any clinical or commercial supply from the Licensor under the terms of a supply agreement. Until the Company has completed the first Phase 2 clinical trial for the first Licensed Product in the United States, the Licensor shall supply the Licensed Compound to the Company for clinical purposes as the Company requests, but only to the extent necessary for the Company to conduct such clinical trial, at no cost to the Company. The CSPC License Agreement will expire automatically upon the expiration of the last royalty term of the last Licensed Product (the “Term”), with each royalty term expiring on a country-by-country basis upon the later of: (i) the expiration or abandonment of the last-to-expire Licensed Patent covering a Licensed Product; (ii) 10 years after the date of first commercial sale in the applicable country; and (iii) expiration of regulatory exclusivity for the Licensed Product in the applicable country. Following the expiration of the Term, the License will become non-exclusive and fully-paid. The CSPC License Agreement may be terminated by the Company for any reason upon 180 days prior written notice to the Licensor. The Licensor may terminate the CSPC License Agreement if the Company or any sublicensee commences an action challenging the Licensed Patents or following the occurrence of certain change of control transactions. Either party may terminate the CSPC License Agreement (i) for an uncured material breach of the CSPC License Agreement by the other party or (ii) if, at any time, the other party undergoes certain bankruptcy, insolvency or dissolution proceedings. Merrimack Asset Purchase Agreement In May 2019, the Company entered into an asset purchase agreement with Merrimack Pharmaceuticals, Inc. (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 finding a partner to develop and commercialize 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 €0.9 million, 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 2021, the Selexis agreement was assigned to Ligand Pharmaceuticals Incorporated. ● National Institute of Health —The Company assumed certain 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”). If certain development and regulatory milestones are achieved, the Company may be obligated to pay NIH 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, |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2024 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 12. 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 as of June 30, 2024. |
Net Loss Per Share
Net Loss Per Share | 6 Months Ended |
Jun. 30, 2024 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 13. 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 Six months ended June 30, June 30, 2024 2023 2024 2023 Net loss $ (10,461) $ (10,110) $ (21,168) $ (27,169) Weighted average common stock outstanding, basic and diluted 59,018,340 28,405,046 55,415,111 26,025,025 Net loss per share, basic and diluted $ (0.18) $ (0.36) $ (0.38) $ (1.04) As discussed in Note 9, as part of its June 2023 underwritten public offering, the Company issued and sold pre-funded warrants to purchase 4.4 million shares of its common stock and are exercisable immediately and are exercisable for one share of the Company's common stock. The exercise price of each pre-funded warrant is $0.0001 per share of common stock. As the $0.0001 price per share represents nominal consideration and are immediately exercisable with no further vesting conditions or contingencies associated with them, the weighted average common stock outstanding, basic and diluted and net loss per share, basic and diluted, for three and six months ended June 30, 2023 as previously disclosed have been adjusted to reflect the impact of the pre-funded warrants. The Company’s potentially dilutive securities have been excluded from the computation of diluted net loss per share as the effect would be to reduce the net loss per share. Therefore, the weighted average number of common shares outstanding used to calculate both basic and diluted net loss per share is the same. The Company excluded the following potential common shares, presented based on amounts outstanding at each period end, from the computation of diluted net loss per share attributable to common stockholders for the periods indicated because including them would have had an anti-dilutive effect: June 30, 2024 2023 Outstanding Stock Options 6,168,438 4,419,549 Unvested RSUs 515,796 196,522 K2 Warrant and Amendment Warrant 394,974 339,725 Common Warrants 22,050,000 22,250,000 Conversion Warrant 1,444,444 — Convertible Debt (as-converted to common stock) 1,444,444 1,444,444 32,018,096 28,650,240 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Pay vs Performance Disclosure | ||||
Net Income (Loss) | $ (10,461) | $ (10,110) | $ (21,168) | $ (27,169) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Jun. 30, 2024 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Basis of Presentation and Sig_2
Basis of Presentation and Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2024 | |
Basis of Presentation and Significant Accounting Policies | |
Principles of Consolidation | Principles of Consolidation The condensed consolidated interim financial statements include the accounts of the Company and its wholly-owned subsidiary, Elevation Oncology Securities Corporation. All significant intercompany balances and transactions have been eliminated in consolidation. |
Basis of Presentation | Basis of Presentation of Unaudited Interim Condensed Consolidated Financial Statements The condensed consolidated interim financial statements have been prepared by the Company in conformity with U.S. generally accepted accounting principles (“U.S. GAAP”) and 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, 2023 condensed consolidated balance sheet was derived from the December 31, 2023 audited consolidated 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, 2024. The accompanying condensed consolidated interim financial statements should be read in conjunction with the Company’s audited consolidated financial statements and the notes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023 (the “Annual Report”). |
Use of Estimates | Use of Estimates The preparation of 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. Significant estimates and assumptions reflected in these condensed consolidated financial statements include, but are not limited to, the accruals for research and development expenses 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. |
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 June 30, 2024 and December 31, 2023, cash equivalents consisted of money market funds, U.S. government debt securities, and corporate debt securities. The Company places its cash with high-credit-quality financial institutions domiciled in the United States, which are insured by the Federal Deposit Insurance Corporation (“FDIC”). |
Deferred Financing Costs | Deferred Financing Costs The incremental cost, including the fair value of warrants, directly associated with obtaining debt financing is capitalized as deferred financing costs upon the issuance of the debt and amortized over the term of the related debt agreement using the effective-interest method with such amortized amounts included as a component of interest expense in the condensed consolidated statements of operations. Unamortized deferred financing costs are presented on the condensed consolidated balance sheets as a direct deduction from the carrying amount of the related debt obligation. |
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 three months ended June 30, 2024 and 2023, the Company had one and two vendor(s) that accounted for approximately 65% and 67% of its research and development expense, respectively. During the six months ended June 30, 2024 and 2023, the Company had one and two vendor(s) that accounted for approximately 65% and 62% of its research and development expense, respectively. As of June 30, 2024 and December 31, 2023, the Company had four and two vendors that accounted for approximately 72% and 39% of total accounts payable, respectively. |
Fair Value Measurements | 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 Company’s cash equivalents and marketable securities are carried at fair value, determined according to the fair value hierarchy described above (see Note 3). The carrying amount of the Company’s accounts payable approximates fair value due to its short-term nature. The carrying value of the Company’s long-term debt approximates its fair value due to its variable interest rate. |
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 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 amortization of premiums and accretion 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. When the fair value is below the amortized cost of a marketable security, an estimate of expected credit losses is made. The credit-related impairment amount is recognized in the condensed consolidated statements of operations. Credit losses are recognized through the use of an allowance for credit losses account in the condensed consolidated balance sheet and subsequent improvements in expected credit losses are recognized as a reversal of an amount in the allowance account. If the Company has the intent to sell the security or it is more likely than not that the Company will be required to sell the security prior to recovery of its amortized cost basis, then the allowance for the credit loss is written-off and the excess of the amortized cost basis of the asset over its fair value is recorded in the condensed consolidated statements of operations. There were no credit losses recorded during the six months ended June 30, 2024 and 2023. |
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 are expensed and included as part of general and administrative expenses. As of June 30, 2024 and 2023, the Company has determined that these expenses have not met the criteria to be capitalized. |
Recently Issued Accounting Pronouncements | Recently Issued but Not Yet Adopted Accounting Pronouncements In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which requires disclosure of incremental segment information on an annual and interim basis. This ASU is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024 on a retrospective basis. The Company is currently evaluating the effect of this pronouncement on its disclosures. In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which expands the disclosures required for income taxes. This ASU is effective for fiscal years beginning after December 15, 2024, with early adoption permitted. The amendment should be applied on a prospective basis while retrospective application is permitted. The Company is currently evaluating the effect of this pronouncement on its disclosures. |
Fair Value Measurements of Fi_2
Fair Value Measurements of Financial Assets (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
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 June 30, 2024 Level 1 Level 2 Level 3 Total Cash Equivalents: Money market funds $ 39,499 $ — $ — $ 39,499 U.S. Government debt securities — 2,370 — 2,370 Corporate debt securities — 995 — 995 Total $ 39,499 $ 3,365 $ — $ 42,864 Marketable Securities: Corporate debt securities $ — $ 22,714 $ — $ 22,714 Commercial paper — 3,337 — 3,337 U.S. Government debt securities — 25,351 — 25,351 Total $ — $ 51,402 $ — $ 51,402 As of December 31, 2023 Level 1 Level 2 Level 3 Total Cash Equivalents: Money market funds $ 45,287 $ — $ — $ 45,287 Total $ 45,287 $ — $ — $ 45,287 Marketable Securities: Corporate debt securities $ — $ 4,571 $ — $ 4,571 Commercial paper — 12,442 — 12,442 U.S. Government debt securities — 16,839 — 16,839 Total $ — $ 33,852 $ — $ 33,852 |
Marketable Securities (Tables)
Marketable Securities (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Investments, Debt and Equity Securities [Abstract] | |
Schedule of marketable securities | The following table summarizes the Company’s marketable securities (in thousands): As of June 30, 2024 Amortized Unrealized Unrealized Fair Cost gains losses value Marketable Securities: Corporate debt securities $ 22,732 $ — $ (18) $ 22,714 Commercial paper 3,339 — (2) 3,337 U.S. Government debt securities 25,357 1 (7) 25,351 Total $ 51,428 $ 1 $ (27) $ 51,402 As of December 31, 2023 Amortized Unrealized Unrealized Fair Cost gains losses value Marketable Securities: Corporate debt securities $ 4,569 $ 3 $ (1) $ 4,571 Commercial paper 12,444 — (2) 12,442 U.S. Government debt securities 16,830 9 — 16,839 Total $ 33,843 $ 12 $ (3) $ 33,852 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Accrued Expenses | |
Schedule of accrued expenses | Accrued expenses consisted of the following (in thousands): June 30, December 31, 2024 2023 Accrued compensation $ 1,077 $ 2,393 Accrued preclinical and clinical trial costs 688 756 Accrued consulting 151 68 Accrued professional services 141 17 Accrued restructuring charges — 3 Accrued other 362 401 Total accrued expenses $ 2,419 $ 3,638 |
Debt (Tables)
Debt (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Debt | |
Schedule of long term debt and unamortized discount balances | June 30, 2024 December 31, 2023 Outstanding principal amount $ 30,000 $ 30,000 Add: accreted liability of final payment fee 916 686 Less: unamortized debt discount, long-term — (549) Long-term debt, net of discount $ 30,916 $ 30,137 |
Schedule of interest expense | Three months ended June 30, Six months ended June 30, 2024 2023 2024 2023 Interest paid or accrued $ 887 $ 862 $ 1,774 $ 1,678 Non-cash amortization of debt discount (including warrants) — 53 38 103 Non-cash accrued back-end fee 107 119 230 234 $ 994 $ 1,034 $ 2,042 $ 2,015 |
Schedule of future principal payments | Three months ended June 30, Six months ended June 30, 2024 2023 2024 2023 Interest paid or accrued $ 887 $ 862 $ 1,774 $ 1,678 Non-cash amortization of debt discount (including warrants) — 53 38 103 Non-cash accrued back-end fee 107 119 230 234 $ 994 $ 1,034 $ 2,042 $ 2,015 |
K2 Warrant and Amendment Warr_2
K2 Warrant and Amendment Warrant (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
K2 Warrant and Amendment Warrant | |
Schedule of warrant outstanding | Shares Initial Recognition Date Exercise Price Expiration Date K2 Warrant 339,725 July 27, 2022 $ 1.3246 July 27, 2032 Amendment Warrant 55,249 March 1, 2024 2.7150 March 1, 2034 Total warrants outstanding 394,974 |
Schedule of fair value assumptions | K2 Warrant Amendment Warrant Stock price $1.41 $5.01 Strike price $1.32 $2.72 Volatility (annual) 75.30% 105.00% Risk-free rate 2.74% 4.10% Estimated time to expiration (years) 10 10 Dividend yield —% —% |
Equity (Tables)
Equity (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Class of Warrant or Right [Line Items] | |
Schedule of warrant outstanding | Shares Initial Recognition Date Exercise Price Expiration Date K2 Warrant 339,725 July 27, 2022 $ 1.3246 July 27, 2032 Amendment Warrant 55,249 March 1, 2024 2.7150 March 1, 2034 Total warrants outstanding 394,974 |
Common Warrants and Pre-Funded Warrants | |
Class of Warrant or Right [Line Items] | |
Schedule of warrant outstanding | Shares Initial Recognition Date Exercise Price Expiration Date Common Warrants 22,050,000 June 13, 2023 $ 2.2500 June 13, 2028 Pre-Funded Warrants 4,440,000 June 13, 2023 $ 0.0001 None |
Schedule of fair value assumptions | Stock price $1.65 Strike price $2.25 Volatility (annual) 110.00% Risk-free rate 3.93% Estimated time to expiration (years) 5 Dividend yield —% |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
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 June 30, Six months ended June 30, 2024 2023 2024 2023 Research and development $ 307 $ 106 $ 540 $ 301 General and administrative 740 638 1,409 1,907 Stock-based compensation expense included in operating expenses $ 1,047 $ 744 $ 1,949 $ 2,208 |
Summary of stock option activity | The following is a summary of the Company’s stock option activity for the six months ended June 30, 2024: Weighted- Weighted- average Aggregate average remaining contractual intrinsic value Options exercise price term (in years) (in thousands) Outstanding at December 31, 2023 4,178,194 $ 2.98 8.22 $ 11 Granted 2,520,450 3.02 Exercised (366,947) 1.33 Cancelled (163,259) 2.63 Outstanding at June 30, 2024 6,168,438 $ 3.10 8.61 $ 3,751 Vested at June 30, 2024 2,356,788 $ 3.61 $ 1,976 Vested and expected to vest at June 30, 2024 6,168,438 $ 3.10 8.61 $ 3,751 The following is a summary of the Company’s stock option activity for the six months ended June 30, 2023: Weighted- Weighted- average Aggregate average remaining contractual intrinsic value Options exercise price term (in years) (in thousands) Outstanding at December 31, 2022 4,408,274 $ 3.44 8.52 $ 350 Granted 2,257,506 1.08 Exercised (1,239,899) 1.18 Cancelled (1,006,332) 2.73 Outstanding at June 30, 2023 4,419,549 $ 3.03 8.70 $ 1,454 Vested at June 30, 2023 2,132,303 $ 3.34 5.37 $ 476 Vested and expected to vest at June 30, 2023 4,419,549 $ 3.03 8.70 $ 1,454 |
Schedule of assumptions used in estimation of fair value | Three months ended June 30, Six months ended June 30, 2024 2023 2024 2023 Risk-free interest rate 4.24 - 4.65 % 3.94 % 4.07 - 4.65 % 3.67 - 4.24 % Volatility 72 - 76 % 72 % 72 - 76 % 72 - 74 % Dividend yield 0.00 % 0.00 % 0.00 % 0.00 % Expected term (years) 6 - 7 7 6 - 7 2 - 7 |
Summary of restricted stock units activity | The following table summarizes activity related to RSUs: Weighted- average grant date Number of shares fair value Unvested at December 31, 2023 155,797 $ 8.25 Granted 437,025 $ 2.77 Vested (49,626) $ 8.58 Cancelled (27,400) $ 2.28 Unvested at June 30, 2024 515,796 $ 3.89 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Earnings Per Share [Abstract] | |
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 Six months ended June 30, June 30, 2024 2023 2024 2023 Net loss $ (10,461) $ (10,110) $ (21,168) $ (27,169) Weighted average common stock outstanding, basic and diluted 59,018,340 28,405,046 55,415,111 26,025,025 Net loss per share, basic and diluted $ (0.18) $ (0.36) $ (0.38) $ (1.04) |
Schedule of antidilutive securities excluded from computation of diluted net loss per share | June 30, 2024 2023 Outstanding Stock Options 6,168,438 4,419,549 Unvested RSUs 515,796 196,522 K2 Warrant and Amendment Warrant 394,974 339,725 Common Warrants 22,050,000 22,250,000 Conversion Warrant 1,444,444 — Convertible Debt (as-converted to common stock) 1,444,444 1,444,444 32,018,096 28,650,240 |
Nature of Business (Details)
Nature of Business (Details) | 6 Months Ended |
Jun. 30, 2024 | |
Nature of Business | |
Date of Incorporation | Apr. 29, 2019 |
Nature Of Business - Liquidity
Nature Of Business - Liquidity (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Dec. 31, 2023 | |
Nature of Business | |||||
Net loss | $ 10,461 | $ 10,110 | $ 21,168 | $ 27,169 | |
Accumulated deficit | 217,138 | 217,138 | $ 195,970 | ||
Cash, Cash Equivalents And Marketable Securities | $ 110,800 | $ 110,800 |
Basis of Presentation and Sig_3
Basis of Presentation and Significant Accounting Policies (Details) - Major suppliers - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Dec. 31, 2023 | |
Accounts payable | |||||
Product Information [Line Items] | |||||
Number of vendors | 4 | 2 | |||
Accounts payable | Supplier Concentration Risk | |||||
Product Information [Line Items] | |||||
Concentration risk | 72% | 39% | |||
Research and development | |||||
Product Information [Line Items] | |||||
Number of vendors | 1 | 2 | 1 | 2 | |
Research and development | Supplier Concentration Risk | |||||
Product Information [Line Items] | |||||
Concentration risk | 65% | 67% | 65% | 62% |
Fair Value Measurements of Fi_3
Fair Value Measurements of Financial Assets (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Mar. 31, 2024 | Mar. 31, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Dec. 31, 2023 | |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |||||
Transfers into (out of) Level 3, Assets | $ 0 | $ 0 | $ 0 | $ 0 | |
Recurring | |||||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |||||
Cash and Cash Equivalents | 42,864 | $ 45,287 | |||
Marketable Securities | 51,402 | 33,852 | |||
Recurring | Corporate debt securities | |||||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |||||
Cash and Cash Equivalents | 995 | ||||
Marketable Securities | 22,714 | 4,571 | |||
Recurring | Commercial paper | |||||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |||||
Marketable Securities | 3,337 | 12,442 | |||
Recurring | U.S. Government debt securities | |||||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |||||
Cash and Cash Equivalents | 2,370 | ||||
Marketable Securities | 25,351 | 16,839 | |||
Recurring | Money market funds | |||||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |||||
Cash and Cash Equivalents | 39,499 | 45,287 | |||
Level 1 | Recurring | |||||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |||||
Cash and Cash Equivalents | 39,499 | 45,287 | |||
Marketable Securities | 0 | 0 | |||
Level 1 | Recurring | Corporate debt securities | |||||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |||||
Cash and Cash Equivalents | 0 | ||||
Marketable Securities | 0 | 0 | |||
Level 1 | Recurring | Commercial paper | |||||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |||||
Marketable Securities | 0 | 0 | |||
Level 1 | Recurring | U.S. Government debt securities | |||||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |||||
Cash and Cash Equivalents | 0 | ||||
Marketable Securities | 0 | 0 | |||
Level 1 | Recurring | Money market funds | |||||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |||||
Cash and Cash Equivalents | 39,499 | 45,287 | |||
Level 2 | Recurring | |||||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |||||
Cash and Cash Equivalents | 3,365 | 0 | |||
Marketable Securities | 51,402 | 33,852 | |||
Level 2 | Recurring | Corporate debt securities | |||||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |||||
Cash and Cash Equivalents | 995 | ||||
Marketable Securities | 22,714 | 4,571 | |||
Level 2 | Recurring | Commercial paper | |||||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |||||
Marketable Securities | 3,337 | 12,442 | |||
Level 2 | Recurring | U.S. Government debt securities | |||||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |||||
Cash and Cash Equivalents | 2,370 | ||||
Marketable Securities | 25,351 | 16,839 | |||
Level 2 | Recurring | Money market funds | |||||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |||||
Cash and Cash Equivalents | 0 | 0 | |||
Level 3 | Recurring | |||||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |||||
Cash and Cash Equivalents | 0 | 0 | |||
Marketable Securities | 0 | 0 | |||
Level 3 | Recurring | Corporate debt securities | |||||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |||||
Cash and Cash Equivalents | 0 | ||||
Marketable Securities | 0 | 0 | |||
Level 3 | Recurring | Commercial paper | |||||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |||||
Marketable Securities | 0 | 0 | |||
Level 3 | Recurring | U.S. Government debt securities | |||||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |||||
Cash and Cash Equivalents | 0 | ||||
Marketable Securities | 0 | 0 | |||
Level 3 | Recurring | Money market funds | |||||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |||||
Cash and Cash Equivalents | $ 0 | $ 0 |
Marketable Securities - Fair Va
Marketable Securities - Fair Value (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Marketable Securities [Line Items] | ||
Amortized Cost | $ 51,428 | $ 33,843 |
Unrealized gains | 1 | 12 |
Unrealized losses | (27) | (3) |
Fair value | 51,402 | 33,852 |
Corporate debt securities | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 22,732 | 4,569 |
Unrealized gains | 0 | 3 |
Unrealized losses | (18) | (1) |
Fair value | 22,714 | 4,571 |
Commercial paper | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 3,339 | 12,444 |
Unrealized gains | 0 | 0 |
Unrealized losses | (2) | (2) |
Fair value | 3,337 | 12,442 |
U.S. Government debt securities | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 25,357 | 16,830 |
Unrealized gains | 1 | 9 |
Unrealized losses | (7) | 0 |
Fair value | $ 25,351 | $ 16,839 |
Accrued Expenses - Schedule (De
Accrued Expenses - Schedule (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Accrued Expenses | ||
Accrued preclinical and clinical trial costs | $ 688 | $ 756 |
Accrued restructuring charges | 0 | 3 |
Accrued compensation | 1,077 | 2,393 |
Accrued consulting | 151 | 68 |
Accrued professional services | 141 | 17 |
Accrued other | 362 | 401 |
Total accrued expenses | $ 2,419 | $ 3,638 |
Restructuring Charges - Narrati
Restructuring Charges - Narrative (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jan. 06, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Restructuring Cost and Reserve [Line Items] | |||||
Restructuring charges | $ 5,100 | $ 0 | $ 0 | $ 0 | $ 5,107 |
Stock-based compensation | $ 1,047 | $ 744 | $ 1,949 | $ 2,208 | |
One-Time Stock-Based Compensation Charge | |||||
Restructuring Cost and Reserve [Line Items] | |||||
Stock-based compensation | 500 | ||||
Employee severance, benefits and related costs | |||||
Restructuring Cost and Reserve [Line Items] | |||||
Restructuring charges | $ 1,600 |
Debt - Narrative (Details)
Debt - Narrative (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||||
Mar. 31, 2024 | Jul. 31, 2022 | Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Dec. 31, 2023 | |
Debt Instrument [Line Items] | |||||||
Loan Agreement Amendment Fee Paid | $ (200) | $ (170) | $ 0 | ||||
Common stock, par value | $ 0.0001 | $ 0.0001 | $ 0.0001 | ||||
Loss on extinguishment of debt | $ 0 | $ 0 | $ 942 | 0 | |||
K2 HealthVentures LLC | Maximum | |||||||
Debt Instrument [Line Items] | |||||||
Investment from lenders in future equity financings | $ 5,000 | ||||||
Percent of equity investment from lenders | 10% | ||||||
Term loan | K2 HealthVentures LLC | |||||||
Debt Instrument [Line Items] | |||||||
Principal amount | $ 50,000 | ||||||
Interest rate (as a percent) | 7.95% | ||||||
Interest only payments term | 30 months | ||||||
Period of interest and principal payments | 3 months | ||||||
Threshold interest rate | 3.20% | ||||||
End of term charge (as a percent) | 6.45% | ||||||
Principal amount for debt conversion | $ 3,250 | ||||||
Common stock, par value | $ 0.0001 | ||||||
Conversion price | $ 2.25 | ||||||
Nasdaq beneficial ownership limitations, percentage | 19.99% | ||||||
Loss on extinguishment of debt | 900 | ||||||
Interest expense | $ 994 | $ 1,034 | $ 2,042 | $ 2,015 | |||
Term loan | K2 HealthVentures LLC | Repayment in first year after funding | |||||||
Debt Instrument [Line Items] | |||||||
Percent of prepayment premium | 3% | ||||||
Term loan | K2 HealthVentures LLC | Repayment in second year after funding | |||||||
Debt Instrument [Line Items] | |||||||
Percent of prepayment premium | 2% | ||||||
Term loan | K2 HealthVentures LLC | Repayment in third year after funding | |||||||
Debt Instrument [Line Items] | |||||||
Percent of prepayment premium | 1% | ||||||
Term loan | K2 HealthVentures LLC | Repayment after third year of funding | |||||||
Debt Instrument [Line Items] | |||||||
Percent of prepayment premium | 0% | ||||||
Term loan | K2 HealthVentures LLC | Minimum | |||||||
Debt Instrument [Line Items] | |||||||
Cash, cash equivalents and marketable securities balances to be maintained | $ 25,000 | ||||||
Term loan | K2 HealthVentures LLC | Maximum | |||||||
Debt Instrument [Line Items] | |||||||
Total market capitalization | 250,000 | ||||||
Term loan tranche one | K2 HealthVentures LLC | |||||||
Debt Instrument [Line Items] | |||||||
Principal amount | 30,000 | ||||||
Effective interest rate | 12.76% | 12.76% | |||||
Term loan tranche two | K2 HealthVentures LLC | |||||||
Debt Instrument [Line Items] | |||||||
Principal amount | $ 20,000 |
Debt- Long term debt and unamor
Debt- Long term debt and unamortized discount balances (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Debt Instrument [Line Items] | ||
Long-term debt, net of discount | $ 30,916 | $ 30,137 |
Term loan | K2 HealthVentures LLC | ||
Debt Instrument [Line Items] | ||
Outstanding principal amount | 30,000 | 30,000 |
Add: accreted liability of final payment fee | 916 | 686 |
Less: unamortized debt discount, long term | (549) | |
Long-term debt, net of discount | $ 30,916 | $ 30,137 |
Debt - Interest Expense (Detail
Debt - Interest Expense (Details) - Term loan - K2 HealthVentures LLC - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Components of interest expense | ||||
Interest paid or accrued | $ 887 | $ 862 | $ 1,774 | $ 1,678 |
Non-cash amortization of debt discount (including warrants) | 53 | 38 | 103 | |
Non-cash accrued back-end fee | 107 | 119 | 230 | 234 |
Interest expense | $ 994 | $ 1,034 | $ 2,042 | $ 2,015 |
Debt - Future principal payment
Debt - Future principal payments schedule (Details) - Term loan - K2 HealthVentures LLC $ in Thousands | Jun. 30, 2024 USD ($) |
Future principal payments schedule | |
2024 (remainder of the year) | $ 0 |
2025 | 0 |
2026 | 30,000 |
Total | $ 30,000 |
K2 Warrant and Amendment Warr_3
K2 Warrant and Amendment Warrant - Narrative (Details) - $ / shares | Jun. 30, 2024 | Jul. 31, 2022 | Jul. 22, 2022 |
Class of Warrant or Right [Line Items] | |||
Number of shares purchased by warrants | 394,974 | ||
Warrant outstanding | 394,974 | ||
K2 HealthVentures LLC | |||
Class of Warrant or Right [Line Items] | |||
Warrant outstanding | 394,974 | ||
K2 Warrant | |||
Class of Warrant or Right [Line Items] | |||
Number of shares purchased by warrants | 339,725 | ||
Warrants exercise price | $ 1.3246 | ||
K2 Warrant | K2 HealthVentures LLC | |||
Class of Warrant or Right [Line Items] | |||
Number of shares purchased by warrants | 339,725 | ||
Warrants exercise price | $ 1.3246 | ||
K2 Warrant Amendment | |||
Class of Warrant or Right [Line Items] | |||
Number of shares purchased by warrants | 55,249 | ||
Warrants exercise price | $ 2.7150 | ||
K2 Warrant Amendment | K2 HealthVentures LLC | |||
Class of Warrant or Right [Line Items] | |||
Number of shares purchased by warrants | 55,249 | ||
Warrants exercise price | $ 2.7150 |
K2 Warrant and Amendment Warr_4
K2 Warrant and Amendment Warrant - Fair value assumptions (Details) | Jun. 30, 2024 USD ($) $ / shares |
K2 Warrant | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Fair value of warrants issued | $ | $ 400,000 |
K2 Warrant | Stock price | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Warrants, measurement input | $ / shares | 1.41 |
K2 Warrant | Strike price | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Warrants, measurement input | $ / shares | 1.32 |
K2 Warrant | Volatility (annual) | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Warrants, measurement input | 75.30 |
K2 Warrant | Risk-free rate | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Warrants, measurement input | 2.74 |
K2 Warrant | Estimated time to expiration (years) | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Warrants, measurement input | $ | 10 |
K2 Warrant Amendment | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Fair value of warrants issued | $ | $ 300,000 |
K2 Warrant Amendment | Stock price | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Warrants, measurement input | $ / shares | 5.01 |
K2 Warrant Amendment | Strike price | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Warrants, measurement input | $ / shares | 2.72 |
K2 Warrant Amendment | Volatility (annual) | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Warrants, measurement input | 105 |
K2 Warrant Amendment | Risk-free rate | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Warrants, measurement input | 4.10 |
K2 Warrant Amendment | Estimated time to expiration (years) | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Warrants, measurement input | $ | 10 |
Equity - Narrative (Details)
Equity - Narrative (Details) | 6 Months Ended | |
Jun. 30, 2024 Vote $ / shares shares | Dec. 31, 2023 $ / shares shares | |
Equity | ||
Preferred stock, shares authorized | shares | 10,000,000 | 10,000,000 |
Common stock, shares authorized | shares | 500,000,000 | 500,000,000 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Number of votes per common stock | Vote | 1 | |
Dividends declared | $ 0 | |
Dividends paid | $ 0 |
Equity - At-the-Market Offering
Equity - At-the-Market Offering (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 6 Months Ended | |||||
Jun. 13, 2023 | May 31, 2024 | Jul. 31, 2022 | Jun. 30, 2024 | Jun. 30, 2023 | Dec. 31, 2023 | Jun. 08, 2023 | |
Class of Stock [Line Items] | |||||||
Common stock, par value | $ 0.0001 | $ 0.0001 | |||||
Number of securities called by warrants or rights | 394,974 | ||||||
Warrants expiration term | 5 years | ||||||
Gross proceeds | $ 44,207 | $ 0 | |||||
Common Warrant | |||||||
Class of Stock [Line Items] | |||||||
Public offering price | $ 2.2500 | ||||||
Pre-funded Warrant | |||||||
Class of Stock [Line Items] | |||||||
Public offering price | $ 0.0001 | ||||||
June 2023 Public Offering | SVB Securities LLC and Cowen and Company, LLC | |||||||
Class of Stock [Line Items] | |||||||
Aggregate number of shares to issue and sell | 17,810,000 | ||||||
Common stock, par value | $ 0.0001 | ||||||
Number of common warrants per share | 1 | ||||||
Public offering price | $ 2.25 | ||||||
Gross proceeds from warrants issuance | $ 50,100 | ||||||
Underwriting discount and commissions and other offering expenses | $ 3,600 | ||||||
June 2023 Public Offering | SVB Securities LLC and Cowen and Company, LLC | Common Warrant | |||||||
Class of Stock [Line Items] | |||||||
Number of securities called by warrants or rights | 17,810,000 | 22,250,000 | |||||
Gross proceeds from warrants issuance | $ 40,100 | ||||||
Issuance of common stock and warrants for purchase of common stock | 17,810,000 | ||||||
June 2023 Public Offering | SVB Securities LLC and Cowen and Company, LLC | Pre-funded Warrant | |||||||
Class of Stock [Line Items] | |||||||
Number of securities called by warrants or rights | 4,440,000 | 4,440,000 | |||||
Public offering price | $ 2.2499 | ||||||
Number of common warrant per prefunded warrant | 1 | ||||||
Nominal amount of warrant exercise price | $ 0.0001 | ||||||
Gross proceeds from warrants issuance | $ 10,000 | ||||||
Issuance of common stock and warrants for purchase of common stock | 4,440,000 | ||||||
At-The-Market offering | Cowen and Company, LLC | |||||||
Class of Stock [Line Items] | |||||||
Gross proceeds | $ 50,000 | ||||||
Commission fee percentage | 3% | ||||||
Issuance of common stock upon at-the-market offering, net of issuance costs (in shares) | 11,625,295 | ||||||
Stock issuance costs | $ 1,400 | ||||||
Principal amount | $ 44,200 | ||||||
At-The-Market offering | TD Cowen | |||||||
Class of Stock [Line Items] | |||||||
Gross proceeds | $ 75,000 | ||||||
Commission fee percentage | 3% | ||||||
Issuance of common stock upon at-the-market offering, net of issuance costs (in shares) | 0 |
Equity - Warrants outstanding (
Equity - Warrants outstanding (Details) | Jun. 30, 2024 $ / shares shares |
Class of Warrant or Right [Line Items] | |
Warrant outstanding | 394,974 |
Common Warrant | |
Class of Warrant or Right [Line Items] | |
Warrant outstanding | 22,050,000 |
Warrant exercised | 200,000 |
Warrants exercise price | $ / shares | $ 2.2500 |
Pre-funded Warrant | |
Class of Warrant or Right [Line Items] | |
Warrant outstanding | 4,440,000 |
Warrants exercise price | $ / shares | $ 0.0001 |
Equity - Fair value assumptions
Equity - Fair value assumptions (Details) - Common Warrants and Pre-Funded Warrants $ in Millions | Jun. 30, 2024 USD ($) Y $ / shares |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Fair value of Common Warrants and Pre-Funded Warrants | $ | $ 35.6 |
Stock price | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Warrants, measurement input | 1.65 |
Strike price | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Warrants, measurement input | 2.25 |
Volatility (annual) | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Warrants, measurement input | 1.1000 |
Risk-free rate | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Warrants, measurement input | 0.0393 |
Estimated time to expiration (years) | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Warrants, measurement input | Y | 5 |
Dividend yield | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Warrants, measurement input | 0 |
Stock-Based Compensation - Expe
Stock-Based Compensation - Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Stock-based compensation expense included in operating expenses | $ 1,047 | $ 744 | $ 1,949 | $ 2,208 |
Research and development | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Stock-based compensation expense included in operating expenses | 307 | 106 | 540 | 301 |
General and administrative | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Stock-based compensation expense included in operating expenses | $ 740 | $ 638 | $ 1,409 | $ 1,907 |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock incentive plans (Details) - shares | 1 Months Ended | 6 Months Ended | |
Jan. 31, 2024 | Jun. 30, 2024 | Jun. 24, 2021 | |
2021 Equity Incentive Plan | |||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Number of shares authorized | 1,483,445 | ||
Shares available for issuance | 654,698 | ||
Additional number of shares authorized (as a percent) | 5% | ||
Additional number of shares authorized | 2,121,127 | ||
2021 Employee Stock Purchase Plan | |||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Number of shares authorized | 1,117,631 | 228,222 | |
Additional number of shares authorized | 424,225 | ||
2021 Employee Stock Purchase Plan | Maximum | |||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Number of shares authorized | 4,564,440 | ||
Additional number of shares authorized (as a percent) | 1% |
Stock-Based Compensation - St_2
Stock-Based Compensation - Stock options (Details) - USD ($) $ / shares in Units, $ in Thousands | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | |
Options | ||||
Outstanding at beginning of period (in shares) | 4,178,194 | 4,408,274 | 4,408,274 | |
Granted (in shares) | 2,520,450 | 2,257,506 | ||
Exercised (in shares) | (366,947) | (1,239,899) | ||
Cancelled (in shares) | (163,259) | (1,006,332) | ||
Outstanding at end of period (in shares) | 6,168,438 | 4,419,549 | 4,178,194 | 4,408,274 |
Vested at end of period (in shares) | 2,356,788 | 2,132,303 | ||
Vested and expected to vest at end of period (in shares) | 6,168,438 | 4,419,549 | ||
Weighted average exercise price | ||||
Outstanding at beginning of period (in dollars per share) | $ 2.98 | $ 3.44 | $ 3.44 | |
Granted (in dollars per share) | 3.02 | 1.08 | ||
Exercised (in dollars per share) | 1.33 | 1.18 | ||
Cancelled (in dollars per share) | 2.63 | 2.73 | ||
Outstanding at end of period (in dollars per share) | 3.10 | 3.03 | $ 2.98 | $ 3.44 |
Vested at end of period (in dollars per share) | 3.61 | 3.34 | ||
Vested and expected to vest at end of period (in dollars per share) | $ 3.10 | $ 3.03 | ||
Weighted-average remaining contractual term and Aggregate intrinsic value | ||||
Outstanding at end of period (in years) | 8 years 7 months 9 days | 8 years 8 months 12 days | 8 years 2 months 19 days | 8 years 6 months 7 days |
Vested at end of period (in years) | 5 years 4 months 13 days | |||
Vested and expected to vest at end of period (in years) | 8 years 7 months 9 days | 8 years 8 months 12 days | ||
Outstanding at beginning of period (in dollars) | $ 11 | $ 350 | $ 350 | |
Outstanding at end of period (in dollars) | 3,751 | 1,454 | $ 11 | $ 350 |
Vested at end of period (in dollars) | 1,976 | 476 | ||
Vested and expected to vest at end of period (in dollars) | $ 3,751 | $ 1,454 | ||
Weighted average grant-date fair value of stock options granted | $ 2.05 | $ 0.63 |
Stock-Based Compensation - Assu
Stock-Based Compensation - Assumptions (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Fair value assumptions | ||||
Risk-free interest rate, Minimum | 4.07% | |||
Risk-free interest rate, Maximum | 4.65% | |||
Volatility, Minimum | 72% | |||
Volatility, Maximum | 76% | |||
Fair value of options vested | $ 5,700 | $ 4,300 | ||
Stock-based compensation expense | $ 1,047 | $ 744 | $ 1,949 | $ 2,208 |
Minimum | ||||
Fair value assumptions | ||||
Expected term (years) | 6 years | |||
Maximum | ||||
Fair value assumptions | ||||
Expected term (years) | 7 years | |||
Employee Stock Option | ||||
Fair value assumptions | ||||
Risk-free interest rate, Minimum | 4.24% | 3.67% | ||
Risk-free interest rate, Maximum | 4.65% | 4.24% | ||
Risk-free interest rate | 3.94% | |||
Volatility, Minimum | 72% | 72% | ||
Volatility, Maximum | 76% | 74% | ||
Volatility | 72% | |||
Dividend yield | 0% | 0% | 0% | 0% |
Expected term (years) | 7 years | |||
Stock-based compensation expense | $ 700 | $ 500 | $ 1,400 | $ 1,800 |
Unrecognized compensation cost | $ 6,900 | $ 6,900 | ||
Expected remaining weighted-average period for recognition | 2 years 8 months 12 days | |||
Employee Stock Option | Minimum | ||||
Fair value assumptions | ||||
Expected term (years) | 6 years | 2 years | ||
Employee Stock Option | Maximum | ||||
Fair value assumptions | ||||
Expected term (years) | 7 years | 7 years |
Stock-Based Compensation - Rest
Stock-Based Compensation - Restricted Common Stock (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Stock-Based Compensation | ||||
Stock-based compensation expense | $ 1,047 | $ 744 | $ 1,949 | $ 2,208 |
Stock-Based Compensation - Re_2
Stock-Based Compensation - Restricted Stock Units (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Dec. 31, 2023 | |
Weighted-average grant date fair value | |||||
Stock-based compensation expense | $ 1,047 | $ 744 | $ 1,949 | $ 2,208 | |
Treasury stock, common (in shares) | 57,637 | 57,637 | 47,733 | ||
Treasury stock, common, value | $ 101 | $ 101 | $ 59 | ||
Restricted Stock Units (RSUs) | |||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||
Vesting period | 4 years | ||||
Vesting percentage | 25% | ||||
Number of shares | |||||
Unvested at beginning of period (in shares) | 155,797 | ||||
Granted (in shares) | 437,025 | ||||
Vested (in shares) | (49,626) | ||||
Cancelled (in shares) | (27,400) | ||||
Unvested at end of period (in shares) | 515,796 | 515,796 | |||
Weighted-average grant date fair value | |||||
Unvested at beginning of period (in dollars per share) | $ 8.25 | ||||
Granted (in dollars per share) | 2.77 | ||||
Vested (in dollars per share) | 8.58 | ||||
Cancelled (in dollars per share) | 2.28 | ||||
Unvested at end of period (in dollars per share) | $ 3.89 | $ 3.89 | |||
Stock-based compensation expense | $ 300 | $ 200 | $ 500 | $ 400 | |
Unrecognized compensation cost | $ 1,900 | $ 1,900 | |||
Expected remaining weighted-average period for recognition | 2 years 6 months |
Asset Purchase and License Ag_2
Asset Purchase and License Agreements - CSPC License Agreement (Details) - License Agreement - CSPC Megalith Biopharmaceutical Co., Ltd $ in Millions | 1 Months Ended |
Jul. 31, 2022 USD ($) | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |
Upfront license fee | $ 27 |
Term of agreement (in years) | 10 years |
Number of days written prior notice to terminate agreement | 180 days |
Maximum | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |
Development and regulatory milestone payments | $ 148 |
Commercial milestone payments | 1,000 |
Payments as percentage of non-royalty sublicense income | $ 50 |
Asset Purchase and License Ag_3
Asset Purchase and License Agreements - (Details) $ in Thousands, € in Millions | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||
May 31, 2019 USD ($) | May 31, 2019 EUR (€) | Jun. 30, 2024 USD ($) | Jun. 30, 2023 USD ($) | Jun. 30, 2024 USD ($) | Jun. 30, 2023 USD ($) | Dec. 31, 2023 USD ($) | |
Asset Acquisition [Line Items] | |||||||
Research and development | $ 6,551 | $ 6,029 | $ 12,562 | $ 13,321 | |||
Dyax | |||||||
Asset Acquisition [Line Items] | |||||||
Number of days written prior notice to terminate agreement | 90 days | 90 days | |||||
Selexis | |||||||
Asset Acquisition [Line Items] | |||||||
Milestone payments payable | € | € 0.2 | ||||||
Number of days written prior notice to terminate agreement | 60 days | 60 days | |||||
Percentage of royalty on net sales of licensed products | 1% | 1% | |||||
Asset Purchase Agreement relating to Seribantumab | |||||||
Asset Acquisition [Line Items] | |||||||
Upfront payment | $ 3,500 | ||||||
Milestone payments payable | 54,500 | ||||||
Research and development | 3,500 | ||||||
Milestone payments paid | $ 0 | $ 0 | |||||
Maximum | Dyax | |||||||
Asset Acquisition [Line Items] | |||||||
Milestone payments payable | 9,300 | ||||||
Maximum | Selexis | |||||||
Asset Acquisition [Line Items] | |||||||
Milestone payments payable, per licensed product | € | € 0.9 | ||||||
Maximum | National Institute of Health | |||||||
Asset Acquisition [Line Items] | |||||||
Milestone payments payable | $ 400 |
Net Loss Per Share (Details)
Net Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Jun. 13, 2023 | Jun. 08, 2023 | |
Earnings Per Share, Basic And Diluted [Line Items] | ||||||
Net Income (Loss) | $ (10,461) | $ (10,110) | $ (21,168) | $ (27,169) | ||
Weighted average common stock outstanding, basic (in shares) | 59,018,340 | 28,405,046 | 55,415,111 | 26,025,025 | ||
Weighted average common stock outstanding, diluted (in shares) | 54,578,340 | 27,575,596 | 50,975,111 | 25,608,008 | ||
Net loss per share, basic (in dollars per share) | $ (0.18) | $ (0.36) | $ (0.38) | $ (1.04) | ||
Net loss per share, diluted (in dollars per share) | $ (0.19) | $ (0.37) | $ (0.42) | $ (1.06) | ||
Number of securities called by warrants or rights | 394,974 | 394,974 | ||||
June 2023 Public Offering | SVB Securities LLC and Cowen and Company, LLC | ||||||
Earnings Per Share, Basic And Diluted [Line Items] | ||||||
Number of Common Warrants Per Share | 1 | |||||
June 2023 Public Offering | SVB Securities LLC and Cowen and Company, LLC | Pre-funded Warrant | ||||||
Earnings Per Share, Basic And Diluted [Line Items] | ||||||
Number of securities called by warrants or rights | 4,440,000 | 4,440,000 | ||||
Nominal amount of warrant exercise price | $ 0.0001 |
Net Loss Per Share - Antidiluti
Net Loss Per Share - Antidilutive securities (Details) - shares | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation (in shares) | 32,018,096 | 28,650,240 |
Employee Stock Option | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation (in shares) | 6,168,438 | 4,419,549 |
Restricted Stock Units (RSUs) | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation (in shares) | 515,796 | 196,522 |
K2 Warrant | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation (in shares) | 394,974 | 339,725 |
Common Warrant | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation (in shares) | 22,050,000 | 22,250,000 |
Conversion Warrant | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation (in shares) | 1,444,444 | 0 |
Convertible debt (as-converted to common stock) | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation (in shares) | 1,444,444 | 1,444,444 |