Cover
Cover - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2023 | Feb. 23, 2024 | Jun. 30, 2023 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2023 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Transition Report | false | ||
Entity File Number | 001-38096 | ||
Entity Registrant Name | G1 THERAPEUTICS, INC. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 26-3648180 | ||
Entity Address, Address Line One | 700 Park Offices Drive | ||
Entity Address, Address Line Two | Suite 200 | ||
Entity Address, City or Town | Research Triangle Park | ||
Entity Address, State or Province | NC | ||
Entity Address, Postal Zip Code | 27709 | ||
City Area Code | 919 | ||
Local Phone Number | 213-9835 | ||
Title of 12(b) Security | Common Stock $.0001 par value | ||
Trading Symbol | GTHX | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
ICFR Auditor Attestation Flag | false | ||
Document Financial Statement Error Correction [Flag] | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 127.5 | ||
Entity Common Stock, Shares Outstanding | 52,199,394 | ||
Documents Incorporated by Reference | Portions of the Registrant’s Definitive Proxy Statement relating to the Annual Meeting of Stockholders, scheduled to be held on June 13, 2024, are incorporated by reference into Part III of this report. Such proxy statement will be filed with the Securities and Exchange Commission within 120 days of the Registrant’s fiscal year ended December 31, 2023. | ||
Entity Central Index Key | 0001560241 | ||
Amendment Flag | false | ||
Document Fiscal Period Focus | FY | ||
Document Fiscal Year Focus | 2023 |
Audit Information
Audit Information | 12 Months Ended |
Dec. 31, 2023 | |
Audit Information [Abstract] | |
Auditor Firm ID | 238 |
Auditor Name | PricewaterhouseCoopers LLP |
Auditor Location | New York, NY, United States |
Balance Sheets
Balance Sheets - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Current assets | ||
Cash and cash equivalents | $ 32,218,000 | $ 94,594,000 |
Restricted cash | 63,000 | 63,000 |
Marketable securities | 49,938,000 | 50,476,000 |
Accounts receivable and unbilled receivables, net | 12,687,000 | 11,094,000 |
Inventories, net | 12,442,000 | 16,179,000 |
Prepaid expenses and other current assets | 7,600,000 | 7,094,000 |
Total current assets | 114,948,000 | 179,500,000 |
Property and equipment, net | 1,476,000 | 1,989,000 |
Restricted cash | 187,000 | 250,000 |
Operating lease assets | 4,908,000 | 5,962,000 |
Other assets | 21,000 | 264,000 |
Total assets | 121,540,000 | 187,965,000 |
Current liabilities | ||
Accounts payable | 3,992,000 | 7,431,000 |
Accrued expenses | 21,893,000 | 25,557,000 |
Deferred revenue | 620,000 | 7,000 |
Other current liabilities | 3,211,000 | 2,593,000 |
Total current liabilities | 29,716,000 | 35,588,000 |
Loan payable | 51,557,000 | 77,015,000 |
Deferred revenue | 500,000 | 1,000,000 |
Operating lease liabilities | 4,340,000 | 5,615,000 |
Other liabilities | 41,000 | 0 |
Total liabilities | 86,154,000 | 119,218,000 |
Stockholders’ equity | ||
Common stock, $0.0001 par value, 120,000,000 shares authorized as of December 31, 2023, and December 31, 2022; 51,952,741 and 51,526,100 shares issued as of December 31, 2023, and December 31, 2022, respectively; 51,926,075 and 51,499,434 shares outstanding as of December 31, 2023, and December 31, 2022, respectively | 5,000 | 5,000 |
Treasury stock, 26,666 shares as of December 31, 2023, and December 31, 2022 | (8,000) | (8,000) |
Additional paid-in capital | 815,374,000 | 800,768,000 |
Accumulated deficit | (779,985,000) | (732,018,000) |
Total stockholders’ equity | 35,386,000 | 68,747,000 |
Total liabilities and stockholders' equity | $ 121,540,000 | $ 187,965,000 |
Statements of Operations
Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Revenues [Abstract] | |||
Total revenues | $ 82,511 | $ 51,301 | $ 31,476 |
Operating Expenses [Abstract] | |||
Cost of goods sold | 7,195 | 3,748 | 2,016 |
Research and development | 43,711 | 83,316 | 76,225 |
Selling, general and administrative | 71,132 | 100,415 | 95,692 |
Total operating expenses | 122,038 | 187,479 | 173,933 |
Loss from operations | (39,527) | (136,178) | (142,457) |
Other income (expense) | |||
Interest income | 2,473 | 748 | 43 |
Interest expense | (10,038) | (10,432) | (4,667) |
Other income (expense) | 2,240 | 3 | (346) |
Total other income (expense), net | (5,325) | (9,681) | (4,970) |
Loss before income taxes | (44,852) | (145,859) | (147,427) |
Income tax expense | 3,115 | 1,700 | 925 |
Net loss | $ (47,967) | $ (147,559) | $ (148,352) |
Earnings Per Share [Abstract] | |||
Basic (in usd per share) | $ (0.93) | $ (3.38) | $ (3.54) |
Diluted (in usd per share) | $ (0.93) | $ (3.38) | $ (3.54) |
Weighted Average Common Shares Outstanding [Abstract] | |||
Basic (in shares) | 51,733,487 | 43,626,113 | 41,943,417 |
Diluted (in shares) | 51,733,487 | 43,626,113 | 41,943,417 |
Product sales, net | |||
Revenues [Abstract] | |||
Total revenues | $ 46,344 | $ 31,337 | $ 11,120 |
License revenue | |||
Revenues [Abstract] | |||
Total revenues | $ 36,167 | $ 19,964 | $ 20,356 |
Statements of Stockholders' Equ
Statements of Stockholders' Equity - USD ($) | Total | Common stock | Treasury stock | Additional paid-in capital | Accumulated deficit |
Beginning balance common stock, shares, outstanding (in shares) at Dec. 31, 2020 | 38,140,756 | ||||
Beginning balance at Dec. 31, 2020 | $ 177,351,000 | $ 4,000 | $ (8,000) | $ 613,462,000 | $ (436,107,000) |
Beginning balance treasury stock, shares (in shares) at Dec. 31, 2020 | (26,666) | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Public offering (in shares) | 3,513,027 | ||||
Public offering | 86,378,000 | 86,378,000 | |||
Exercise of common stock options (in shares) | 935,031 | ||||
Exercise of common stock options | 5,845,000 | 5,845,000 | |||
Stock-based compensation | 22,319,000 | 22,319,000 | |||
Net loss | (148,352,000) | (148,352,000) | |||
Ending balance common stock, shares, outstanding (in shares) at Dec. 31, 2021 | 42,588,814 | ||||
Ending balance at Dec. 31, 2021 | 143,541,000 | $ 4,000 | $ (8,000) | 728,004,000 | (584,459,000) |
Ending balance treasury stock, shares (in shares) at Dec. 31, 2021 | (26,666) | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Public offering (in shares) | 8,573,353 | ||||
Public offering | 52,021,000 | $ 1,000 | 52,020,000 | ||
Exercise of common stock options (in shares) | 206,608 | ||||
Exercise of common stock options | 155,000 | 155,000 | |||
Restricted stock units vested (in shares) | 157,325 | ||||
Restricted stock units vested | 0 | ||||
Stock-based compensation | 20,589,000 | 20,589,000 | |||
Net loss | $ (147,559,000) | (147,559,000) | |||
Ending balance common stock, shares, outstanding (in shares) at Dec. 31, 2022 | 51,499,434 | 51,526,100 | |||
Ending balance at Dec. 31, 2022 | $ 68,747,000 | $ 5,000 | $ (8,000) | 800,768,000 | (732,018,000) |
Ending balance treasury stock, shares (in shares) at Dec. 31, 2022 | (26,666) | (26,666) | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Public offering (in shares) | 0 | ||||
Public offering | $ 39,000 | 39,000 | |||
Exercise of common stock options (in shares) | 165,180 | 165,180 | |||
Exercise of common stock options | $ 57,000 | 57,000 | |||
Restricted stock units vested (in shares) | 261,461 | ||||
Restricted stock units vested | 0 | ||||
Stock-based compensation | 14,510,000 | 14,510,000 | |||
Net loss | $ (47,967,000) | (47,967,000) | |||
Ending balance common stock, shares, outstanding (in shares) at Dec. 31, 2023 | 51,926,075 | 51,952,741 | |||
Ending balance at Dec. 31, 2023 | $ 35,386,000 | $ 5,000 | $ (8,000) | $ 815,374,000 | $ (779,985,000) |
Ending balance treasury stock, shares (in shares) at Dec. 31, 2023 | (26,666) | (26,666) |
Statements of Cash Flows
Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Cash flows from operating activities | |||
Net loss | $ (47,967) | $ (147,559) | $ (148,352) |
Adjustments to reconcile net loss to net cash used in operating activities | |||
Stock-based compensation | 14,510 | 20,589 | 22,319 |
Accretion of discount on available for sale securities | (2,272) | (453) | 0 |
Depreciation and amortization | 513 | 530 | 469 |
Amortization of debt issuance costs | 1,473 | 2,233 | 1,113 |
Loss on extinguishment of debt | 0 | 0 | 220 |
Non-cash interest expense | 609 | 850 | 591 |
Non-cash equity interest, net | 0 | 497 | 370 |
Change in operating assets and liabilities | |||
Accounts receivable | (1,593) | (5,406) | (5,451) |
Inventories | 3,737 | (12,708) | (3,471) |
Prepaid expenses and other assets | 548 | 7,184 | (3,380) |
Accounts payable | (3,372) | 4,421 | (675) |
Accrued expenses and other liabilities | (4,636) | 1,226 | 3,345 |
Deferred revenue | 113 | (24) | 794 |
Net cash used in operating activities | (38,337) | (128,620) | (132,108) |
Cash flows from investing activities | |||
Purchases of marketable securities | (124,690) | (65,023) | 0 |
Maturities of marketable securities | 127,500 | 15,000 | 0 |
Purchases of property and equipment | 0 | (506) | 0 |
Net cash provided by/(used in) investing activities | 2,810 | (50,529) | 0 |
Cash flows from financing activities | |||
Proceeds from stock options exercised | 57 | 155 | 5,845 |
Proceeds from loan agreement | 0 | 0 | 55,000 |
Payments of debt issuance costs | 0 | 0 | (1,360) |
Proceeds from public offering, net of underwriting fees and commissions | 0 | 52,383 | 86,429 |
Repayment of debt | (26,688) | 0 | 0 |
Payment of public offering costs | (281) | (43) | (51) |
Net cash (used in)/provided by financing activities | (26,912) | 52,495 | 145,863 |
Net change in cash, cash equivalents and restricted cash | (62,439) | (126,654) | 13,755 |
Cash, cash equivalents and restricted cash | |||
Beginning of period | 94,907 | 221,561 | 207,806 |
End of period | 32,468 | 94,907 | 221,561 |
Supplemental disclosure of cash flow information | |||
Cash paid for interest | 8,807 | 7,924 | 2,908 |
Non-cash operating, investing and financing activities | |||
Upfront project costs and other current assets in accounts payable and accrued expenses | 0 | 47 | 0 |
Public offering costs in accounts payable and accrued expenses | $ 0 | $ 320 | $ 0 |
Balance Sheets (Parenthetical)
Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Common stock, par value (in US dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized (in shares) | 120,000,000 | 120,000,000 |
Common stock, shares issued (in shares) | 51,952,741 | 51,526,100 |
Common stock, shares outstanding (in shares) | 51,926,075 | 51,499,434 |
Treasury stock, common, shares (in shares) | 26,666 | 26,666 |
Description of Business
Description of Business | 12 Months Ended |
Dec. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Description of Business | Description of Business G1 Therapeutics, Inc. (the “Company”) is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel small molecule therapeutics for the treatment of patients with cancer. The Company's first product approved by the U.S. Food and Drug Administration (“FDA”), COSELA® (trilaciclib), is the first and only therapy indicated to proactively help protect bone marrow from the damage of chemotherapy (myeloprotection) is the first innovation in managing myeloprotection in decades. COSELA (trilaciclib hydrochloride for injection) is also conditionally approved by the China National Medical Products Administration (NMPA) for marketing in mainland China and is commercialized by the Company's partner, Simcere Pharmaceutical Co., Ltd. ("Simcere"), in Greater China (mainland China, Hong Kong, Macau and Taiwan). Trilaciclib was developed from a technology platform that targets key cellular pathways including transient arrest of the cell cycle at the G1 phase, prior to the beginning of DNA replication. Controlled administration and clean G1 arrest from transient CDK4/6 inhibition may protect bone marrow and the immune system from cytotoxic damage during treatment. Transient CDK4/6 inhibition also may improve survival in combination with leading and emerging treatments by improving long-term immune surveillance. This can be accomplished through protection of the immune system for improved longer-term function and by potentially increasing the generation of memory T cells, which can provide additional benefit after treatment. The Company is exploring the use of trilaciclib in clinical trials to optimize these potential benefits in combination with leading and emerging treatments for patients. Beyond the Company’s initial ES-SCLC indication in the United States, the Company plans to focus its efforts on two core development paths for trilaciclib in order to optimize the opportunity ahead, including: (1) triple negative breast cancer ("TNBC"), where trilaciclib has demonstrated potential benefits across treatment settings in multiple Phase 2 studies, and (2) in antibody-drug conjugate ("ADC") combinations, in TNBC and potentially other additional tumor types. |
Basis of Presentation and Summa
Basis of Presentation and Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Significant Accounting Policies | Basis of Presentation and Summary of Significant Accounting Policies Basis of Presentation The Company has prepared the accompanying financial statements in conformity with generally accepted accounting principles in the United States of America (“U.S. GAAP”). The Company has experienced net losses since its inception and has an accumulated deficit of $780.0 million and $732.0 million as of December 31, 2023 and December 31, 2022, respectively. The Company expects to incur losses and have negative net cash flows from operating activities as it executes on its strategy including engaging in further research and development activities, particularly conducting non-clinical studies and clinical trials. The success of the Company depends on the ability to successfully commercialize its technologies to support its operations and strategic plan. Management has evaluated actions already taken, the significance of anticipated continued losses, future cash flow projections, and the ability of the Company to remain in compliance with the financial covenants and requirements as defined within the Loan Agreement (as defined below). Based on the foregoing, as of the date of issuance of these financial statements, the Company expects that its cash and cash equivalents and marketable securities as of December 31, 2023 will be sufficient to fund the Company’s planned operations and remain in compliance with its objective financial covenants for at least the next 12 months from the date of issuance of these financial statements. Until such time, if ever, as the Company can generate substantial revenues, the Company expects to finance its cash needs through a combination of equity offerings, debt financings, other third-party funding, marketing and distribution arrangements and other collaborations, strategic alliances and licensing arrangements. There can be no assurances that the Company will be able to secure such additional financing if at all, or on terms that are satisfactory to the Company, and that it will be sufficient to meet its needs. In the event the Company is not successful in obtaining sufficient funding, this could force it to delay, limit, or reduce its product development, commercialization efforts or other operations. The Company’s financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business. The financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of the uncertainties described above. In connection with the Loan Payable described in Note 7, the Company is required to be in compliance with a minimum cash covenant and is subject to a conditional borrowing base measured on a trailing three-month net revenue basis, which began with the financial reporting for the period ended June 30, 2023, and has been tested monthly thereafter. The lender also has the ability to call debt based on a material adverse change clause, which is subjectively defined. If the Company is not in compliance with the minimum cash covenant, conditional borrowing base requirements, or the subjective acceleration clauses are triggered under the agreement, then the lender may call the debt resulting in the Company immediately needing additional funds. As of December 31, 2023, the Company is in compliance with the minimum cash covenant and the conditional borrowing base requirements as set forth in the Loan Agreement. Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and the accompanying notes. On an ongoing basis, the Company’s management evaluates its estimates which include, but are not limited to, estimates related to accrued expenses, accrued external clinical costs, net product sales, common stock valuation, stock-based compensation expense and deferred tax asset valuation allowance. Actual results could differ from those estimates. Cash, Cash Equivalents, and Restricted Cash The Company considers all highly liquid investments purchased with an original maturity of three months or less at the date of purchase to be cash equivalents. Cash and cash equivalents at December 31, 2023 consist of amounts on deposit in banks, including checking accounts and money market accounts and funds. Cash deposits are all in financial institutions in the United States. As part of the lease for the office space which commenced on September 2, 2019, the Company obtained a standby letter of credit in the amount of $0.5 million related to the security deposit. This letter of credit is secured by a money market account at the financial institution and is classified as restricted cash on the Company's balance sheet. The letter of credit will be reduced ratably on each anniversary of the commencement of the lease until the end of the lease term. Restricted cash totaled $250 thousand and $313 thousand for the years ended December 31, 2023 and 2022, respectively. Marketable Securities The Company determines the appropriate classification of marketable securities at the time of purchase and reevaluates such designation at each balance sheet date. The Company classified all of its marketable securities at December 31, 2023 as “available-for-sale” pursuant to ASC Topic 320, Investments – Debt and Equity Securities. Investments not classified as cash equivalents are presented as either short-term or long-term investments based on both their maturities as well as the time period the Company intends to hold such securities. Available-for-sale securities are maintained by an investment manager and primarily consist of fixed income securities. Available-for-sale securities are carried at fair value. Any premium or discount arising at purchase is amortized or accreted to interest income over the life of the instrument. Realized gains and losses are determined using the specific identification method and are included in other (income) expense, net. As of December 31, 2023, the u nrealized gains and losses are not considered to be material. Accounts Receivable The Company’s accounts receivable consists of amounts due from specialty distributors in the U.S. (collectively, its “customers”) related to sales of COSELA and have standard payment terms. Trade receivables are recorded net of the estimated variable consideration for chargebacks based on contractual terms and the Company’s expectation regarding the utilization and earnings of the chargebacks and discounts as well as the net amount expected to be collected from the Company’s customers. Estimates of the Company’s credit losses, of which there are none for the year ended December 31, 2023, are determined based on existing contractual payment terms, individual customer circumstances, and any changes to the economic environment. In addition, the Company’s accounts receivable consists of open invoices issued to its license partners for services rendered by the Company or receivables with its license partners for invoices related to milestones that were completed and recognized as revenue. The Company also has unbilled accounts receivable related to clinical trial reimbursements where the Company has the right to invoice the license partner and accordingly has recognized revenue. Invoicing to the license partner will occur once the Company has been invoiced by the service provider. As of December 31, 2023, unbilled accounts receivable totale d $0.2 million. Inventories Inventories are stated at the lower of cost or net realizable value and recognized on a weighted-average cost method. The Company uses actual cost to determine the cost basis for inventory. Inventory is capitalized based on when future economic benefit is expected to be realized. Due to the nature of the Company’s supply chain process, inventory that is owned by the Company, is physically stored at third-party warehouses, logistics providers, and contract manufacturers. Inventory valuation is established based on a number of factors including, but not limited to, finished goods not meeting product specifications, product excess and obsolescence, or application of the lower of cost or net realizable value concepts. The determination of events requiring the establishment of inventory valuation, together with the calculation of the amount of such adjustments may require judgment. The Company analyzes its inventory levels on a periodic basis to determine if any inventory is at risk for expiration prior to sale or has a cost basis that is greater than its estimated future net realizable value. Any adjustments are recognized through cost of goods sold in the period in which they are incurred. Property and Equipment Property and equipment are stated at cost less accumulated depreciation. Depreciation is generally calculated using the straight-line method over the following estimated useful lives: Computer equipment 5 years Laboratory equipment 5 years Manufacturing equipment 5 years Furniture and fixtures 7 years Leasehold improvements 7 years Costs associated with maintenance and repairs are charged to expense as incurred. Property and equipment held under leasehold improvements are amortized over the shorter of the lease term or the estimated useful life of the related asset. Impairment of Long-lived Assets The Company evaluates its long-lived assets for indicators of possible impairment by comparison of the carrying amounts to future net undiscounted cash flows expected to be generated by such assets when events or changes in circumstances indicate the carrying amount of an asset may not be recoverable. Should an impairment exist, the impairment loss would be measured based on the excess carrying value of the asset over the asset’s fair value based on discounted estimates of future cash flows. For the years ended December 31, 2023, 2022 and 2021, the Company’s management evaluated its long-lived assets and determined no impairment charge was needed. Debt The Company classifies its loan payable in current or long-term liabilities based on the timing of scheduled principal payments. The loan and security agreement with Hercules Capital, Inc. (as amended, the “Loan Agreement”) contains events of default, including a material adverse change, which is subjectively defined, in the Company’s business, payment defaults, and breaches of covenants following any applicable cure period. In the event of default by the Company under the Loan Agreement, the Company may be required to repay all amounts then outstanding under the Loan Agreement. The Company has determined that subjective acceleration under the material adverse events clause included in the Loan Agreement is not probable and, therefore, has classified the outstanding principal amount in long-term liabilities based on the timing of scheduled principal payments. Revenue Recognition For elements of those arrangements that the Company determines should be accounted for under ASC 606, Revenue from Contracts with Customers (“ASC 606”), the Company assesses which activities in its license or collaboration agreements are performance obligations that should be accounted for separately and determines the transaction price of the arrangement, which includes the assessment of the probability of achievement of future milestones and other potential consideration. For arrangements that include multiple performance obligations, such as granting a license or performing manufacturing or research and development activities, the Company allocates the transaction price based on the relative standalone selling price and recognizes revenue that is allocated to the respective performance obligation when (or as) control is transferred to the customer and the performance obligation is satisfied. Accordingly, the Company develops assumptions that require judgment to determine the standalone selling price for each performance obligation identified in the contract. These key assumptions may include revenue forecasts, clinical development timelines and costs, discount rates and probabilities of clinical and regulatory success. License Revenue Licenses of Intellectual Property If a license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenue allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue associated with the bundled performance obligation. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of progress and related revenue recognition. Milestone Payments At the inception of each arrangement that includes developmental and regulatory milestone payments, the Company evaluates whether the achievement of each milestone specifically relates to the Company’s efforts to satisfy a performance obligation or transfer a distinct good or service within a performance obligation. The Company evaluates each milestone to determine when and how much of the milestone to include in the transaction price. The Company first estimates the amount of the milestone payment that the Company could receive using either the expected value or the most likely amount approach. The Company primarily uses the most likely amount approach as that approach is generally most predictive for milestone payments with a binary outcome. Then, the Company considers whether any portion of that estimated amount is subject to the variable consideration constraint (that is, whether it is probable that a significant reversal of cumulative revenue would not occur upon resolution of the uncertainty). The Company updates the estimate of variable consideration included in the transaction price at each reporting date which includes updating the assessment of the likely amount of consideration and the application of the constraint to reflect current facts and circumstances. For regulatory milestones, the Company recognizes revenue at a point in time upon approval, as that is when achievement of the milestone is considered probable. The Company assesses milestones as they are achieved to determine whether they are tied to any other performance obligations in the respective license agreements. Royalties For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company will recognize revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). During the twelve months ended December 31, 2023, the Company recognized $0.6 million in revenue related to sales-based royalties. Product Sales, Net The Company sells COSELA to specialty distributors in the U.S. and, in accordance with ASC 606, recognizes revenue at the point in time when the customer is deemed to have obtained control of the product. The customer is deemed to have obtained control of the product at the time of physical receipt of the product at the customers’ distribution facilities, or Free on Board (“FOB”) destination, the terms of which are designated in the contract. Product sales are recorded at the net selling price, which includes estimates of variable consideration for which reserves are established for (a) rebates and chargebacks, (b) co-pay assistance programs, (c) distribution fees, (d) product returns, (e) GPO fees, and (f) other discounts. Where appropriate, these estimates take into consideration a range of possible outcomes for relevant factors such as current contractual and statutory requirements, and forecasted customer buying and payment patterns. Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the applicable contract. The amount of variable consideration may be constrained and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. Actual amounts of consideration ultimately received may differ from the Company's estimates. If actual results in the future vary from estimates, the Company adjusts these estimates, which would affect net product revenue and earnings in the period such variances become known. Liabilities related to co-pay assistance, rebates, returns, and GPO fees are classified as “Accrued Expenses” in the Balance Sheets. Discounts such as chargebacks and specialty distributor fees are recorded as a reduction to trade accounts receivable, which is included in “Accounts Receivable” in the Balance Sheets. Forms of Variable Consideration Rebates and Chargebacks : The Company estimates reductions to product sales for Public Health Service Institutions, such as Medicaid, Medicare and Veterans Administration (“VA”) programs, as well as certain other qualifying federal and state government programs, and other group purchasing organizations. The Company estimates these reductions based upon the Company’s contracts with government agencies and other organizations, statutorily defined discounts and estimated payor mix. These organizations purchase directly from the Company’s specialty distributors at a discount and the specialty distributors charge the Company back the difference between the wholesaler price and the discounted price. The Company’s liability for Medicaid rebates consists of estimates for claims that a state will make. The Company’s reserve for this discounted pricing is based on expected sales to qualified healthcare providers and the chargebacks that customers have already claimed. Co-pay assistance: Eligible patients who have commercial insurance may receive assistance from the Company to reduce the patient’s out of pocket costs. Liabilities for co-pay assistance are calculated by actual program participation from third-party administrators. Distribution Fees: The Company has written contracts with its customers that include terms for distribution fees and costs for inventory management. The Company estimates and records distribution fees due to its customers based on gross sales. Product Returns: The Company generally offers a right of return based on the product’s expiration date and certain spoilage and damaged instances. The Company estimates the amount of product sales that may be returned and records the estimate as a reduction of product sales in the period the related product sales are recognized. The Company’s estimates for expected returns are based primarily on an ongoing analysis of sales information and visibility into the inventory remaining in the distribution channel. Concentration of Credit Risk Financial instruments that potentially subject the Company to credit risk consist of cash and cash equivalents. Deposits with financial institutions are insured, up to certain limits, by the Federal Deposit Insurance Corporation (“FDIC”). The Company’s cash deposits often exceed the FDIC insurance limit; however, all deposits are maintained with high credit quality institutions and the Company has not experienced any losses in such accounts. The financial condition of financial institutions is periodically reassessed, and the Company believes the risk of any loss is minimal. The Company believes the risk of any loss on cash due to credit risk is minimal. Cost of Goods Sold Cost of goods sold includes direct and indirect costs related to the manufacturing and distribution of COSELA, including third-party manufacturing costs, packaging services, freight-in, third-party logistics costs associated with COSELA, and Company personnel costs. Cost of goods sold may also include period costs related to certain inventory manufacturing services and inventory adjustment charges for excess and obsolete inventory. Research and Development Research and development expenses consist of costs incurred to further the Company’s research and development activities and include salaries and related employee benefits, manufacturing of pharmaceutical active ingredients and drug product, costs associated with clinical trials, nonclinical activities, regulatory activities, research-related overhead expenses and fees paid to expert consultants, external service providers and contract research organizations which conduct certain research and development activities on behalf of the Company. Costs incurred in the research and development of products are charged to research and development expense as incurred. Each reporting period, management estimates and accrues research and development expenses, including external clinical study costs associated with clinical trial activities. The process of estimating and accruing expenses involved reviewing contracts and purchase orders, identifying services that have been provided on the Company’s behalf, and estimating the level of service performed and the associated cost incurred for the service when the Company has not yet been invoiced or otherwise notified of the actual costs. Costs for clinical trial activities were estimated based on an evaluation of vendors’ progress towards completion of specific tasks, using data such as patient enrollment, clinical site activations or information provided by vendors regarding their actual costs incurred. Payments for these activities are based on the terms of individual contracts and payment timing may differ significantly from the period in which the services were performed. The Company determines accrual estimates through reports from and discussions with applicable personnel and outside service providers as to the progress or state of completion of trials, or the services completed. The estimates of accrued external clinical study costs as of each balance sheet date are based on the facts and circumstances known at the time. Fair value of Financial Instruments The Company provides disclosure of financial assets and financial liabilities that are carried at fair value based on the price that would be received upon sale of an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. Fair value measurements may be classified based on the amount of subjectivity associated with the inputs to fair valuation of these assets and liabilities using the following three levels: Level 1 Inputs are unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date. Level 2 Inputs include quoted prices for similar assets and liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, inputs other than quoted prices that are observable for the asset or liability and inputs that are derived principally from or corroborated by observable market data by correlation or other means. Level 3 Unobservable inputs that reflect the Company’s estimates of the assumptions that market participants would use in pricing the asset or liability. The Company develops these inputs based on the best information available, including its own data. The carrying amounts of cash, cash equivalents, accounts payable and accrued liabilities approximate fair value because of their short-term nature. At December 31, 2023 and 2022 these financial instruments and respective fair values have been classified as follows (in thousands): Quoted prices Significant Significant Balance at December 31, Assets: Money market accounts and funds $ 32,110 $ — $ — $ 32,110 Marketable securities: U.S. Treasury Bills 49,938 — — 49,938 Total assets at fair value $ 82,048 $ — $ — $ 82,048 Quoted prices Significant Significant Balance at December 31, Assets: Money market accounts and funds $ 84,167 $ — $ — $ 84,167 Marketable securities: U.S. Treasury Bills 50,476 — — 50,476 Total assets at fair value $ 134,643 $ — $ — $ 134,643 During the twelve months ended December 31, 2023 and December 31, 2022, there were no changes in valuation methodology. The Loan Payable (discussed in Note 7), which is classified as a Level 3 liability, has a variable interest rate and the carrying value approximates its fair value. As of December 31, 2023, the carrying value was $51.6 million. Patent Costs Costs associated with the submission of patent applications are expensed as incurred given the uncertainty of the future economic benefits of the patents. Patent-related legal expenses included in selling, general and administrative costs were approximately $1.8 million, $1.8 million, and $1.9 million for the years ended December 31, 2023, 2022 and 2021, respectively. Stock-Based Compensation The primary type of stock-based payments utilized by the Company are stock options. The Company accounts for stock-based employee compensation arrangements by measuring the cost of employee services received in exchange for all equity awards granted based on the fair value of the award on the grant date. The fair value of each employee stock option is estimated on the date of grant using an options pricing model. The Company currently uses the Black-Scholes valuation model to estimate the fair value of its share-based payments. The model requires management to make a number of assumptions including expected volatility, expected life, risk-free interest rate and expected dividends. The Company also incurs stock-based compensation expense related to restricted stock units (“RSUs”), performance based restricted stock units (“PSUs”), and deferred share units (“DSUs”). The fair value of RSUs, PSUs, and DSUs is determined by the closing market price of the Company’s common stock on the date of grant and then recognized over the requisite service period of the award. As the PSUs have non-market performance and service conditions, compensation expense will be recognized over the requisite service periods if and when the achievement of such performance condition(s) is determined to be probable by the Company. If a performance condition is not determined to be probable or is not met, no stock-based compensation expense is recognized. The Company reassesses the probability of achieving the performance condition(s) at each reporting period. As of December 31, 2023, the Company did not deem the achievement of any performance condition(s) to be probable and no compensation expense related to PSUs was recognized. Income Taxes Income taxes are accounted for using the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to temporary differences between the financial statements carrying amounts of assets and liabilities and their respective tax bases, operating loss carryforwards, and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. In accordance with Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) 740, Accounting for Income Taxes, the Company reflects in the financial statements the benefit of positions taken in a previously filed tax return or expected to be taken in a future tax return only when it is considered ‘more-likely-than-not’ that the position taken will be sustained by a taxing authority. As of December 31, 2023 and December 31, 2022, the Company had no unrecognized income tax benefits and correspondingly there is no impact on the Company’s effective income tax rate associated with these items. The Company’s policy for recording interest and penalties relating to uncertain income tax positions is to record them as a component of income tax expense in the accompanying statements of operations. As of December 31, 2023 and December 31, 2022, the Company had no such accruals. Segment Information The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions. All of the Company’s assets are held in the United States. Comprehensive Loss Comprehensive loss includes net loss as well as other changes in stockholders’ equity (deficit) that result from transactions and economic events other than those with stockholders. There was no difference between net loss and comprehensive loss for each of the periods presented in the accompanying financial statements. Leases The Company determines if an arrangement is a lease at inception. Operating lease assets represent the Company's right to use an underlying asset for the lease term and lease liabilities represent the Company's obligation to make lease payments arising from the lease. Operating leases are included in operating lease assets, other current liabilities, and operating lease liabilities on the Company's balance sheet at December 31, 2023. Operating lease assets and operating lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at commencement date. As most of the Company's leases do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at commencement date to determine the present value of future payments. The Company's lease terms may include options to extend or terminate the lease when it is reasonably certain that it will exercise that option. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term. Debt Issuance Costs Debt issuance costs are amortized to interest expense over the estimated life of the related debt based on the effective interest method. In accordance with ASC 835, Interest, the Company presents debt issuance costs on the balance sheet as a direct deduction from the associated debt. Recent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies and adopted by the Company as of the specified effective date. The Company did not adopt any new accounting pronouncements during the year ended December 31, 2023, that had a material effect on its financial statements. In November 2023, the FASB issued ASU 2023-07, "Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures." ASU 2023-07 is intended to improve disclosures about a public entity's reportable segment by requiring additional, more detailed incremental segment information to be disclosed on an annual and interim basis. ASU 2023-07 requires that a public entity with a single reportable segment provide all the disclosures required by the amendments of ASU 2023-07 and all existing segment disclosures in FASB ASC Topic 280. The amendments of ASU 2023-07 require a public entity to disclose, on an annual and interim basis, significant segment expenses that are regularly provided to the chief operating decision maker (CODM) and included within each reported measure of segment profit or loss, and an amount for other segment items by reportable segment and a description of its composition. In additional, ASU 2023-07 requires a public entity to disclose the title and position of the CODM, together with an explanation of how the CODM uses the reported measure(s) of segment profit or loss in assessing segment performance and deciding how to allocate resources. ASU 2023-07 also requires a public entity to provide all annual disclosures about a reportable segment profit or loss and assets currently required under FASB ASC Topic 280 in interim periods. The amendments of ASU 2023-07 are effective for annual periods beginning after December 15, 2023, and for interim periods with fiscal years beginning after December 15, 2024, with early adoption permitted. The Company intends to |
Inventories
Inventories | 12 Months Ended |
Dec. 31, 2023 | |
Inventory Disclosure [Abstract] | |
Inventories | Inventories Inventories consist of the following (in thousands): December 31, 2023 December 31, 2022 Raw materials $ 2,422 $ 2,790 Work in process 9,593 10,153 Finished goods 427 3,236 Inventories, net $ 12,442 $ 16,179 The Company uses third party contract manufacturing organizations for the production of its raw materials, active pharmaceutical ingredients, and finished drug product which the Company owns. The Company evaluates the risk of excess inventory and product expiry by evaluating current and future product demand relative to product shelf life. |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | Property and Equipment Property and equipment consists of the following (in thousands): December 31, 2023 December 31, 2022 Computer equipment $ 327 $ 327 Laboratory equipment 334 334 Furniture and fixtures 866 866 Leasehold improvements 1,782 1,782 Manufacturing equipment 506 506 Accumulated depreciation (2,339) (1,826) Property and equipment, net $ 1,476 $ 1,989 |
Accrued Expenses
Accrued Expenses | 12 Months Ended |
Dec. 31, 2023 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | Accrued Expenses Accrued expenses are comprised as follows (in thousands): December 31, 2023 December 31, 2022 Accrued external research $ 109 $ 268 Accrued professional fees and other 5,854 4,304 Accrued external clinical study costs 10,944 15,566 Accrued compensation expense 4,986 5,419 Accrued expenses $ 21,893 $ 25,557 |
Leases
Leases | 12 Months Ended |
Dec. 31, 2023 | |
Leases [Abstract] | |
Leases | Leases The Company adopted ASC 842 as of January 1, 2019. Prior period amounts have not been adjusted and continue to be reported in accordance with the Company's historic accounting under ASC 840. Pursuant to a lease agreement dated January 10, 2014 (the “Lease”), on April 1, 2014, the Company leased office and lab space with a free rent period and escalating rent payments; the Lease had an expiration date of July 31, 2017. The Lease was amended on January 27, 2016 to lease new larger office and lab space beginning in August 2016 with a discounted rent period and escalating rent payments and the Lease term was extended to December 31, 2022. The amendment also contained an option for a five-year renewal and a right of first refusal to lease adjacent office space. The Lease was further amended on March 27, 2017 to lease additional office space beginning in August 2017 with a discounted rent period and escalating rent payments. The Lease was amended again in January 2018 to lease additional adjacent office space beginning in August 2018 with a discounted rent period and escalating rent payments. The term of the renewal option contained in the Lease, as amended, was not included in the measurement of the operating lease asset and liability since exercise of the option was uncertain. On March 20, 2020, the Lease was amended to surrender three of the office spaces previously entered into above, with a termination date of May 31, 2020 and in consideration of a termination fee to be paid. The lease payments and term for the remaining occupied space will remain the same. Due to these changes in lease terms for the three office spaces, in March 2020 the Company modified the operating lease liabilities and operating lease assets of these three office spaces to reflect the new terms. The Lease term ended on December 31, 2022 and was not renewed. In November 2018, the Company signed a new lease to secure approximately 60,000 square feet of laboratory and office space at 700 Park Offices Drive in Research Triangle Park, NC (“700 Lease”). The 700 Lease commenced on September 2, 2019 and has an expiration date of September 30, 2027 for the initial term with the Company having the option to renew for an additional 5 years. The term of the renewal option contained in the Lease was not included in the measurement of the operating lease asset and liability since exercise of the option was uncertain. As part of the 700 Lease, the Company obtained a standby letter of credit in the amount of $0.5 million related to the security deposit. This letter of credit is secured by a money market account at the financial institution. Therefore, these funds are classified as restricted cash on the balance sheet. The letter of credit will be reduced ratably on each anniversary of the commencement of the 700 Lease until the end of the lease term. The tables below reflect the Company’s lease position and weighted-average lease terms and discount rates for its operating leases as of December 31, 2023. Operating lease liabilities are based on the net present value of the remaining lease payments over the remaining lease term. In determining the present value of lease payments, the Company used its incremental borrowing rate based on the information available at the lease commencement date. (in thousands) Classification on the Balance Sheet December 31, 2023 Assets Operating lease assets Operating lease assets $ 4,908 Total lease assets $ 4,908 Liabilities Current Operating Other current liabilities $ 1,276 Non-current Operating Operating lease liabilities 4,340 Total lease liabilities $ 5,616 Lease Term and Discount Rate December 31, 2023 Weighted-average remaining lease term (years) Operating leases 3.8 Weighted-average discount rate Operating leases 8.0 % The table below presents information related to the lease costs for operating leases (in thousands): Year Ended December 31, (in thousands) Classification 2023 2022 2021 Operating lease costs 1 Research and development $ 630 $ 618 $ 799 Selling, general and administrative 924 1,048 870 Total operating lease costs $ 1,554 $ 1,666 $ 1,669 1 Includes variable lease costs which are immaterial. The table below reconciles the undiscounted cash flow for each of the first five years and total of the remaining years to the operating lease liabilities recorded on the balance sheet as of December 31, 2023 (in thousands): Operating leases Years ending December 31, 2024 $ 1,679 2025 1,725 2026 1,773 2027 1,357 Total future minimum lease payments 6,534 Less: present value adjustment (918) Total operating lease liabilities $ 5,616 Cash payments included in the measurement of the Company's operating leases were $1.6 million, $1.7 million and $1.7 million for the twelve months ended December 31, 2023, 2022, and 2021, respectively. On November 1, 2023, the Company entered into an agreement (“Sublease”) to sublease approximately 20,830 square feet of office space at 700 Park Offices Drive in Research Triangle Park, NC. Upon signing of the Sublease, the Company received a security deposit equal to one month's rent, which has been recorded within other non-current liabilities on the balance sheet as of December 31, 2023. The initial fixed rental rate is $24 per rentable square foot of the premises per annum and will increase at a rate of 2.75% per rentable square foot each year. The term of the sublease commences on January 1, 2024, with base rent first becoming due on April 1, 2024, and has an expiration date of August 31, 2027. No sublease income was recognized during the twelve months ended December 31, 2023, 2022, or 2021. |
Loan Payable
Loan Payable | 12 Months Ended |
Dec. 31, 2023 | |
Debt Disclosure [Abstract] | |
Loan Payable | Loan Payable On May 29, 2020, the Company entered into a loan and security agreement (the “Loan Agreement”) with Hercules Capital, Inc. (“Hercules”), under which Hercules agreed to lend the Company up to $100.0 million, to be made available in a series of tranches, subject to certain terms and conditions. The first tranche totals $30.0 million, of which the Company received $20.0 million at closing. Upon initiation of the Phase 3 trial of COSELA for metastatic colorectal cancer and receiving FDA approval for COSELA for small cell lung cancer (the "Performance Milestone”), the second tranche of $20.0 million became available to the Company for drawdown through December 15, 2021. The third tranche of $30.0 million was available through December 31, 2022. The fourth tranche of $20.0 million was available at Hercules’ approval through December 31, 2022. On March 31, 2021, the Company entered into the First Amendment to Loan and Security Agreement (the “First Amendment”) with Hercules whereby the Company drew the remaining $10.0 million of the first tranche and the interest rate and financial covenants were amended. Unless loan advances exceeded $40.0 million, no financial covenants were required. Amounts initially borrowed under the original terms of the Loan Agreement bore an interest rate equal to the greater of either (i) (a) the prime rate as reported in The Wall Street Journal, plus (b) 6.40%, and (ii) 9.65%. Based on original terms of the Loan Agreement, the Company agreed to make interest only payments through June 1, 2022 and following the interest only period, the Company agreed to repay the principal balance and interest of the advances in equal monthly installments through June 1, 2024. Based on the original terms of the Loan Agreement, upon satisfaction of the Performance Milestone, the interest only period was extended through January 1, 2023 and the maturity date was extended to June 1, 2025. Upon entering into the First Amendment on March 31, 2021, the interest rate was amended to the greater of either (i) (a) the prime rate as reported in The Wall Street Journal, plus (b) 6.20%, and (ii) 9.45%. The Company may prepay advances under the Loan Agreement, in whole or in part, at any time subject to a prepayment charge equal to (a) 3.0% of the prepayment amount in the first year; (b) 2.0% of the prepayment amount in the second year; and (c) 1.0% of the prepayment amount in the third year. Upon prepayment or repayment of all or any of the advances under the Loan Agreement, the Company agreed to pay (in addition to the prepayment charge) an end of term charge of 6.95% of the aggregate funded amount. With respect to the first tranche, the end of term charge of $2.1 million would be payable upon any prepayment or repayment. To the extent that the Company was provided additional advances under the Loan Agreement, the 6.95% end of term charge would be applied to such additional amounts. These amounts have been accrued over the term of the loan using effective-interest method. On November 1, 2021, the Company entered into a Second Amendment to Loan and Security Agreement (the “Second Amendment”) under which Hercules agreed to lend the Company up to $150.0 million, to be made available in a series of tranches, subject to certain terms and conditions. The first tranche was increased to $100.0 million. At close of the Second Amendment, the Company borrowed an additional $45.0 million from the first tranche. The Company had the right to request that Hercules make the remaining $25.0 million term loan advances under the first tranche to the Company by September 15, 2022, which the Company did not exercise. The second tranche of $20.0 million will become available to the Company upon achievement of $50.0 million trailing six-month net product revenue of COSELA no later than June 30, 2023 and will be available through December 15, 2023. The third tranche of $15.0 million will become available upon achievement of certain development performance milestones and available through December 15, 2023. The fourth tranche of $15.0 million will be available at Hercules’ approval through June 30, 2024. Amounts borrowed under the Second Amendment bore an interest rate equal to the greater of either (i) (a) the prime rate as reported in The Wall Street Journal, plus (b) 5.90%, and (ii) 9.15%. The Company will make interest only payments through December 1, 2024 and may be extended through December 1, 2025, in quarterly increments, subject to compliance with covenants of the Second Amendment. Following the interest only period, the Company will repay the principal balance and interest of the advances in equal monthly installments through November 1, 2026. The Company may prepay advances under the Second Amendment, in whole or in part, at any time subject to a prepayment charge equal to (a) 3.0% of the prepayment amount in the first year from the closing of the Second Amendment; (b) 2.0% of the prepayment amount in the second year from the closing of the Second Amendment; and (c) 1.0% of the prepayment amount in the third year from the closing of the Second Amendment. Upon prepayment or repayment of all or any of the advances under the Second Amendment, the Company will pay (in addition to the prepayment charge) an end of term charge of 6.75% of the aggregate amount funded. The Company will be required to make a final payment to Hercules in the amount of 6.75% of the amounts funded, less any amount previously paid. In addition, the Company will be required to make a payment to Hercules for $2.1 million on the earliest occurrence of (i) June 1, 2025, (ii) the date the Company repays the outstanding principal amount in full, or (iii) the date that the principal amount becomes due and payable in full. The Second Amendment is secured by substantially all of the Company’s assets, including intellectual property, subject to certain exemptions. The Company out-licensed lerociclib as permitted in the Loan Agreement. The Second Amendment contains a minimum revenue covenant. Beginning August 15, 2022, with the reporting of the financial results for the second fiscal quarter ended June 30, 2022, and tested monthly, the Company must have achieved net product revenue of COSELA of at least 65% of the amounts projected in the Company’s forecast. Testing of the minimum revenue covenant shall be waived at any time in which either (a) the Company’s market capitalization exceeds $750.0 million and the Company maintains unrestricted cash equal to at least 50% of the total amounts funded, or (b) the Company maintains unrestricted cash equal to at least 100% of the total amounts funded. The Company evaluated the Second Amendment under the guidance found in ASC 470-50 Modification and Extinguishment. The Company concluded that the previous debt under the Loan Agreement was extinguished based on the difference in present value of the cash flows of the Loan Agreement and the Second Amendment. Accordingly, the difference between the carrying value of the Loan Agreement as of November 1, 2021, including the unamortized debt issuance costs, and the fair value of the Second Amendment was recorded as a $0.2 million loss on extinguishment of debt for the twelve months ended December 31, 2021. Fees paid to third parties directly related to the funded portion of the Second Amendment have been capitalized as debt issuance costs and will be amortized to interest expense over the life of the Second Amendment using the effective interest method. Fees paid that were directly related to the unfunded portion is accounted for as a deferred financing charge and amortized to interest expense over the period the unfunded portions are available. The end of term charges associated with the Second Amendment are being accreted through interest expense using the effective interest method over the related term of the debt. On June 24, 2022, the Company entered into a Third Amendment to Loan and Security Agreement (the “Third Amendment”) with Hercules, which extended the time for drawing the remainder of the first tranche advance of up to $25.0 million from September 15, 2022 to December 31, 2022, which the Company did not exercise. The Third Amendment also added a minimum cash covenant whereby the Company must maintain unrestricted cash equal to at least 50% of the outstanding debt, and such percentage shall decrease upon the Company achieving specified net product revenue of COSELA. It further provided for a minimum revenue covenant that, beginning August 15, 2022 with the reporting of the financial results for the second fiscal quarter ended June 30, 2022, and tested monthly, the Company must have achieved net product revenue of COSELA of at least 80% of the amounts projected in the Company’s forecast. Testing of the minimum revenue covenant shall be waived at any time in which either (a) the Company’s market capitalization exceeds $750.0 million and the Company maintains unrestricted cash equal to at least 50% of the total amounts funded, or (b) the Company maintains unrestricted cash equal to at least 100% of the total amounts funded. The Company evaluated the Third Amendment under the guidance found in ASC 470-50 Modification and Extinguishment. The Company concluded that the Third Amendment was a modification and there was no impact to the financial statements. On November 1, 2022, the Company entered into a Fourth Amendment to Loan and Security Agreement (the “Fourth Amendment”) with Hercules, which extended the time for drawing the remainder of the first tranche advance of up to $25.0 million from December 31, 2022 to June 30, 2023. The Fourth Amendment continued to provide for a minimum revenue covenant, tested monthly, where the Company must achieve net product revenue of COSELA of at least 80% of the amounts projected in the Company's forecast. The Fourth Amendment also amended the minimum cash covenant such that if the outstanding debt is less than or equal to $75.0 million, the Company must maintain unrestricted cash equal to at least 65% of the outstanding debt in addition to meeting the required revenue covenant. In addition, if the outstanding debt is greater than $75.0 million, the Company must maintain unrestricted cash equal to at least 70% of the outstanding debt while meeting the revenue covenant. If the Company achieves the specified net revenue of COSELA, the cash percentage will decrease to 45% of the outstanding debt. Testing of the minimum revenue covenant shall be waived at any time in which either (a) the Company's market capitalization exceeds $750.0 million and the Company maintains unrestricted cash equal to at least 50% of the total amounts funded, or (b) the Company maintains unrestricted cash equal to at least 100% of the total amounts funded. The Fourth Amendment also re-set the prepayment premiums associated with any prepayment of the loans under the Loan Agreement. The Company evaluated the Fourth Amendment under the guidance found in ASC 470-50 Modification and Extinguishment . The Company concluded that the Fourth Amendment was a modification and there was no impact to the financial statements. On June 6, 2023, the Company entered into a Fifth Amendment to Loan and Security Agreement (the “Fifth Amendment”) with Hercules, under which Hercules agreed to lend the Company up to $75.0 million, subject to specified conditions. In conjunction with the closing of the Fifth Amendment, the Company repaid $25.0 million of the outstanding debt such that the total loan amount outstanding upon closing of the Fifth Amendment is $50.0 million. In addition to the $25.0 million principal prepayment, upon closing of the Fifth Amendment, the Company made a $1.7 million pro-rata payment of the end-of-term charge. The Company continues to be required to make a payment to Hercules for $2.1 million on the earliest occurrence of (i) June 1, 2025, (ii) the date the Company repays the outstanding principal amount in full, or (iii) the date that the principal amount becomes due and payable in full. The Fifth Amendment eliminated advances under Tranches 2 and 3 and increased the advance available under Tranche 4 from $15.0 million to $25.0 million and extended the time for drawing the Tranche 4 Advance (as defined in the Loan and Security Agreement) from June 30, 2024 to December 15, 2024. Amounts borrowed under the Fifth Amendment will bear an interest rate equal to the greater of either (i) (a) the prime rate as reported in The Wall Street Journal, plus (b) 5.65%, and (ii) 9.15%. The Company will make interest only payments through December 1, 2024 and may be extended through December 1, 2025, in quarterly increments, subject to conditional borrowing base compliance. Following the interest only period, the Company will repay the principal balance and interest of the advances in equal monthly installments through November 1, 2026. The Company may prepay advances under the Fifth Amendment, in whole or in part, at any time subject to a prepayment charge equal to (a) 3.0% of the prepayment amount in the first year from the effective date of the Fourth Amendment; (b) 2.0% of the prepayment amount in the second year from the effective date of the Fourth Amendment; and (c) 1.0% of the prepayment amount in the third year from the effective date of the Fourth Amendment. For the avoidance of doubt, no prepayment charge shall be applicable when repayments are required to maintain compliance with the conditional borrowing base limit as discussed below. The Fifth Amendment amended the minimum cash covenant such that the Company must maintain unrestricted cash equal to at least 35% of the outstanding debt at all times. The minimum cash covenant shall be eliminated upon the Company's achievement of quarterly net product revenue of $45.0 million or trailing six months net product revenue of $85.0 million. The Fifth Amendment removed the existing minimum revenue covenant and provided for a conditional borrowing base limit, beginning with the financial reporting for the period ended June 30, 2023, and tested monthly thereafter. The Fifth Amendment also provides that the Company’s debt outstanding shall not exceed certain thresholds of trailing three month net product revenue of COSELA. The Company evaluated the Fifth Amendment under the guidance found in ASC 470-50 Modification and Extinguishment . The Company concluded that the Fifth Amendment was a modification; accordingly, no gain or loss was recorded. A new effective interest rate of 18.33% was established based on the carrying value of the debt and the revised cash flows. The remaining end of term charges are accreted through interest expense through the maturity date using the updated effective interest rate. The borrowing capacity of the new arrangement is less than the old arrangement. As such, the existing unamortized deferred financing costs of the new arrangement were written off in proportion to the decrease in the borrowing capacity of the unfunded portion of the arrangement. The remaining unamortized deferred financing costs are amortized to interest expense and deferred over the commitment term of the new arrangement. The Loan Agreement contains events of default, including a material adverse change, which is subjectively defined, in the Company’s business, payment defaults, and breaches of covenants following any applicable cure period. In the event of default by the Company under the Loan Agreement, the Company may be required to repay all amounts then outstanding under the Loan Agreement. The Company has determined that subjective acceleration under the material adverse events clause included in the Loan Agreement is not probable and, therefore, has classified the outstanding principal amount in long-term liabilities based on the timing of scheduled principal payments. As of December 31, 2023, the outstanding debt of $50.0 million does not exceed the required threshold of trailing three month revenue for the period ended December 31, 2023. Additionally, as of December 31, 2023 the Company maintained unrestricted cash equal to more than 35% of the total outstanding debt and has not been notified of an event of default by the lender under the Loan Agreement. As of December 31, 2023, the future principal payments due under the Loan Agreement, excluding interest, are as follows (in thousands): Amount 2024 $ 1,819 2025 23,469 2026 24,712 Total principal outstanding 50,000 End of term charge 2,011 Unamortized debt issuance costs (454) Total $ 51,557 |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2023 | |
Equity [Abstract] | |
Stockholders' Equity | Stockholders’ Equity Common stock The Company’s common stock has a par value of 0.0001 per share and consists of 120,000,000 authorized shares as of December 31, 2023 and 2022. Holders of common stock are entitled to one vote per share and are entitled to receive dividends, as if and when declared by the Company’s Board of Directors. On July 2, 2021, the Company filed an automatic shelf registration statement on Form S-3ASR with the Securities and Exchange Commission (the “SEC”), which became effective upon filing, pursuant to which the Company registered for sale an unlimited amount of any combination of its common stock, preferred stock, debt securities, warrants, rights and/or units from time to time and at prices and on terms that the Company may determine, so long as the Company continued to satisfy the requirements of a “well-known seasoned issuer” under SEC rules (the “2021 Form S-3”). The 2021 Form S-3 also included a prospectus covering up to an aggregate of $150.0 million in shares of common stock that the Company may issue and sell from time to time through Cowen and Company, LLC (“Cowen”), acting as its agent, pursuant to a sales agreement for “at the market offerings” the Company entered into with Cowen in July 2021 (the “2021 Sales Agreement”). The Company did not sell any shares of common stock under the 2021 Sales Agreement. At the time of the filing of the Company's Annual Report on Form 10-K for the year ended December 31, 2021 filed with the SEC on February 23, 2022, the Company no longer qualified as a “well-known seasoned issuer” as such term is defined in Rule 405 under the Securities Act. As a result, in February 2022, the Company amended the 2021 Form S-3 to register for sale up to $300.0 million of any combination of its common stock, preferred stock, debt securities, warrants, rights and/or units from time to time and at prices and on terms that the Company may determine. The 2021 Form S-3, as amended, will remain in effect for up to three years from the date it originally became effective, which was July 2, 2021. The amended 2021 Form S-3 also includes a prospectus covering up to an aggregate of $100.0 million in common stock that the Company may issue and sell from time to time, through Cowen acting as its sales agent, pursuant to that certain sales agreement that the Company entered into with Cowen on February 23, 2022 (the “2022 Sales Agreement”). In connection with the Company entering into the 2022 Sales Agreement with Cowen, the Company terminated the 2021 Sales Agreement. As of the date hereof, the Company has not sold any shares of common stock or other securities under the 2022 Sales Agreement for “at the market offerings.” On November 17, 2022, the Company entered into an underwriting agreement related to a public offering of 7,700,000 shares of common stock at a public offering price of $6.50 per share less the underwriting discounts and commissions, pursuant to the shelf registration statement on Form S-3. The Company received approximately $50.1 million in gross proceeds from this offering, before deducting underwriting discounts and commissions and offering expenses. The offering closed on November 22, 2022. In addition, 873,353 shares of common stock were issued upon exercise by the underwriters of their option to purchase additional shares at the same offering price, which closed on December 20, 2022. The gross proceeds from the offering of the aggregate of 8,573,353 shares of the Company's common stock were $55.7 million and net proceeds of $52.0 million, after deducting underwriting discounts and commissions and other offering expenses payable by the Company. Preferred stock The Company is authorized to issue 5,000,000 shares of undesignated preferred stock in one or more series. As of December 31, 2023, no shares of preferred stock were issued or outstanding. Shares Reserved for Future Issuance The Company has reserved authorized shares of common stock for future issuance as follows: December 31, 2023 December 31, 2022 Common stock options outstanding 6,774,186 7,372,028 RSUs outstanding (1) 1,613,215 675,406 PSUs outstanding (1) 218,450 — DSUs outstanding (1) 50,000 — Options, RSUs, PSUs and DSUs available for grant under Equity Incentive Plans (1) 2,385,034 2,323,539 11,040,885 10,370,973 (1) RSUs, PSUs, and DSUs are further defined in Note 9. |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation | Stock-Based Compensation 2011 Equity Incentive Plan In March 2011, the Company adopted the 2011 Equity Incentive Plan (the “2011 Plan”). The 2011 Plan provided for the direct award or sale of the Company’s common stock and for the grant of stock options to employees, directors, officers, consultants and advisors of the Company. The 2011 Plan was subsequently amended in August 2012, October 2013, February 2015, December 2015, April 2016 and November 2016 to allow for the issuance of additional shares of common stock. In connection with the adoption of the 2017 Plan (as defined below), the 2011 Plan was terminated and no further awards will be made under the 2011 Plan. 2017 Equity Incentive Plan In May 2017, the Company adopted the 2017 Equity Incentive Plan (the “2017 Plan”). The 2017 Plan provided for the direct award or sale of the Company’s common stock and for the grant of up to 1,932,000 stock options to employees, directors, officers, consultants and advisors of the Company. The 2017 Plan provides for the grant of incentive stock options, non-statutory stock options or restricted stock. Effective January 1, 2023, and in accordance with the “evergreen” provision of the 2017 Plan, an additional 1,096,553 shares were made available for issuance. Under both the 2011 Plan and the 2017 Plan, options to purchase the Company’s common stock may be granted at a price no less than the fair market value of a share of common stock on the date of grant. The fair value shall be the closing sales price for a share as quoted on any established securities exchange for such grant date or the last preceding date for which such quotation exists. Vesting terms of options issued are determined by the Board of Directors or Compensation Committee of the Board. The Company’s stock options vest based on terms in the stock option agreements. Stock options have a maximum term of ten years. In January 2021, the Company began granting RSUs under the 2017 Plan. RSUs are granted at the fair market value of a share of common stock on the date of grant. In January 2023, the Company began granting PSUs, which are subject to non-market performance and service conditions, to Company executives under the 2017 Plan. PSUs are granted at the fair market value of a share of common stock on the date of grant. In May 2023, the Company adopted the G1 Therapeutics, Inc. Deferred Compensation Plan for Non-Employee Directors to enable non-employee directors of the Company (each a “Non-Employee Director”) to elect to defer annually the receipt of shares that vest in accordance with the terms of RSUs granted under the 2017 Plan (the “Vested RSUs”) for service as a Non-Employee Director (the “Deferred Compensation Plan”). The Deferred Compensation Plan is intended to comply with the requirements of Section 409A of the Internal Revenue Code of 1986, as amended. Under the Deferred Compensation Plan, the Non-Employee Directors shall be entitled to file with the Compensation Committee of the Board prior to December 31 of each Plan Year (as defined therein) an election form so as to make an election under the Deferred Compensation Plan effective for the following Plan Year, pursuant to which a Non-Employee Director may elect to defer receipt of shares underlying Vested RSUs with respect to RSUs granted in the following Plan Year. The Deferred Compensation Plan is unfunded and unsecured. As of December 31, 2023, there were a total of 1,473,163 shares of common stock available for future issuance under the 2017 Plan. Amended and Restated 2021 Inducement Equity Incentive Plan In February 2021, the Company adopted the 2021 Inducement Equity Incentive Plan (the “2021 Inducement Plan”). The 2021 Inducement Plan provides for the grant of up to 500,000 non-qualified options, stock grants, and stock-based awards to employees and directors of the Company. The 2021 Inducement Plan does not include an evergreen provision. In September 2021, the Company adopted the 2021 Sales Force Inducement Equity Incentive Plan (the “2021 Sales Force Inducement Plan”). The 2021 Sales Force Inducement Plan provides for the grant of up to 500,000 non-qualified options, stock grants, and stock-based awards to sales force individuals and support staff that were not previously employees or directors of the Company. The 2021 Sales Force Inducement Plan does not include an evergreen provision. In March 2022, the Company merged the 2021 Sales Force Inducement Plan into the 2021 Inducement Plan and amended and restated the 2021 Inducement Plan to create the Amended and Restated 2021 Inducement Equity Incentive Plan (the “Amended and Restated 2021 Plan”). In addition, the number of shares reserved for issuance under the Amended and Restated 2021 Plan was increased by 750,000 shares of the Company’s common stock, for an aggregate of 1,750,000 shares of the Company’s common stock authorized to issue under the Amended and Restated 2021 Plan. The Amended and Restated 2021 Plan does not include an evergreen provision. As of December 31, 2023, there was a total of 911,870 shares of common stock available for future issuance under the Amended and Restated 2021 Plan. Stock-based Compensation The Company recognizes compensation costs related to stock options granted to employees based on the estimated fair value of the awards on the date of grant. The grant date fair value of the stock-based awards is generally recognized on a straight-line basis over the requisite service period, which is generally the vesting period of the respective awards. Share-based awards granted to non-employee directors as compensation for serving on the Company’s Board of Directors are accounted for in the same manner as employee share-based compensation awards. The Company calculates the fair value of stock options using the Black-Scholes option pricing model. The Black-Scholes option-pricing model requires the use of subjective assumptions, including the expected volatility of the Company’s common stock, the assumed dividend yield, the expected term of the Company’s stock options and the fair value of the underlying common stock on the date of grant. The Company also incurs stock-based compensation expense related to RSUs, PSUs, and DSUs. The fair value of RSUs, PSUs, and DSUs is determined by the closing market price of the Company’s common stock on the date of grant and then recognized over the requisite service period of the award. As the PSUs have non-market performance and service conditions, compensation expense will be recognized over the requisite service periods if and when the achievement of such performance condition(s) is determined to be probable by the Company. If a performance condition is not determined to be probable or is not met, no stock-based compensation expense is recognized. The Company reassesses the probability of achieving the performance condition(s) at each reporting period. As of December 31, 2023, the Company did not deem the achievement of any performance condition(s) to be probable and no compensation expense related to PSUs was recognized. The table below summarizes the stock-based compensation expense recognized in the Company’s statement of operations by classification (in thousands): Year Ended December 31, 2023 2022 2021 Cost of goods sold $ 243 $ 207 $ 252 Research and development 2,177 3,956 $ 4,811 Selling, general and administrative 12,090 16,426 $ 17,256 Total stock-based compensation expense $ 14,510 $ 20,589 $ 22,319 Stock options – Black-Scholes inputs The fair value of each option grant is estimated on the grant date using the Black-Scholes option-pricing model, using the following weighted average assumptions: Year Ended December 31, 2023 2022 2021 Expected volatility 81.4% - 88.4% 76.7% - 81.4% 76.8% - 79.6% Weighted-average risk free rate 3.4% - 4.2% 1.4% - 4.2% 0.4% - 1.3% Dividend yield —% —% —% Expected term (in years) 6.00 6.00 6.00 Weighted-average grant-date fair value per share $3.47 $6.50 $11.93 The expected term of stock options granted was determined using the simplified method under SAB 107 which represents the mid-point between the vesting term and the contractual term. The expected stock price volatility assumptions for the Company’s stock options were determined by examining the historical volatilities for industry peers as the Company does not have sufficient history to estimate volatility using only its common stock. In 2019, the Company began incorporating its historical stock price in conjunction with selected similar publicly traded companies. The Company continued to use the guideline peer group volatility information until April 2023, when the historical volatility of its common stock became sufficient to measure expected volatility for future option grants. The risk-free interest rate assumption at the date of grant is based on the U.S. Treasury instruments whose term was consistent with the expected term of the Company’s stock options. The expected dividend assumption is based on the Company’s history and expectation of dividend payouts. Stock Option Activity The following table is a summary of stock option activity for the twelve months ended December 31, 2023: Weighted average Options Weighted Remaining Aggregate (in thousands) Balance as of December 31, 2022 7,372,028 $ 16.15 6.9 $ 3,281 Granted 1,369,330 4.79 Cancelled (1,801,992) 18.56 Exercised (165,180) 0.34 Balance as of December 31, 2023 6,774,186 $ 13.60 6.4 $ 944 Exercisable at December 31, 2023 4,813,088 $ 15.80 5.5 $ 859 Vested at December 31, 2023 and expected to vest 6,774,186 $ 13.60 6.4 $ 944 As of December 31, 2023, unrecognized compensation expense related to unvested stock options totaled $9.7 million, which is expected to be recognized over a weighted-average period of approximately 1.9 years. Since the IPO, the board of directors has determined the fair value of each common share underlying share-based awards based on the closing price of the common shares as reported by Nasdaq on the date of grant. Restricted Stock Units The Company’s restricted stock units (“RSUs”) are considered nonvested share awards and require no payment from the employee. For each RSU, employees receive one common share at the end of the vesting period. Compensation cost is recorded based on the market price of the Company’s common stock on the grant date and is recognized on a straight-line basis over the requisite service period. The following table is a summary of the RSU activity for the twelve months ended December 31, 2023: Number of Weighted – Average Balance as of December 31, 2022 675,406 $ 12.31 Granted 1,617,050 3.76 Cancelled (417,780) 6.41 Vested (261,461) 12.38 Balance as of December 31, 2023 1,613,215 $ 5.25 As of December 31, 2023, there was $5.4 million of total unrecognized compensation cost related to the Company's RSUs that are expected to vest. These costs are expected to be recognized over a weighted-average period of approximately 2.2 years. Performance Based Restricted Stock Units The Company's performance based restricted stock units (“PSUs”) are considered nonvested share awards and require no payment from the employee. For each PSU, employees receive one common share at the end of the vesting period, subject to non-market performance and service conditions. Compensation cost is recorded based on the market price of the Company's common stock on the grant date and is recognized over the requisite service if and when the achievement of such performance condition(s) is determined to be probable by the Company. The Company reassesses the probability of achieving the performance condition(s) at each reporting period. As of December 31, 2023, the Company did not deem the achievement of any performance condition(s) to be probable and compensation expense related to PSUs was not recognized. The following table is a summary of the PSU activity for the twelve months ended December 31, 2023: Number of Weighted – Average Balance as of December 31, 2022 — $ — Granted 218,450 5.73 Cancelled — — Vested — — Balance as of December 31, 2023 218,450 $ 5.73 As of December 31, 2023, there was $1.3 million of total unrecognized compensation cost related to the Company's PSUs that are expected to vest. These costs are expected to be recognized over a weighted-average period of approximately 2.0 years. Deferred Share Units The Company's DSUs are considered nonvested share awards and require no payment from the holders. For each DSU, holders receive one common share on a future date, generally upon “Separation from Service” (within the meaning of Section 409A of the Code) as a Non-Employee Director of the Company for any reason. Upon settlement, holders will receive one fully paid and non-assessable common share in respect of each vested DSU. Compensation cost is recorded based on the market price of the Company’s common stock on the grant date and is recognized on a straight-line basis over the requisite service period. The following table is a summary of the DSU activity for the twelve months ended December 31, 2023: Number of Weighted – Average Balance as of December 31, 2022 — $ — Granted 50,000 2.83 Cancelled — — Vested — — Balance as of December 31, 2023 50,000 $ 2.83 As of December 31, 2023, there was $0.1 million of total unrecognized compensation cost related to the Company's DSUs that are expected to vest. These costs are expected to be recognized over a weighted-average period of approximately 0.5 years. |
License Revenue
License Revenue | 12 Months Ended |
Dec. 31, 2023 | |
Revenue Recognition and Deferred Revenue [Abstract] | |
License Revenue | License Revenue Incyclix License Agreement On May 22, 2020, the Company entered into an exclusive license agreement with Incyclix Bio, LLC (“Incyclix”), formerly ARC Therapeutics, LLC, a company primarily owned by a former board member, whereby the Company granted to Incyclix an exclusive, worldwide, royalty-bearing license, with the right to sublicense, solely to make, have made, use, sell, offer for sale, import, export, and commercialize products related to its cyclin dependent kinase 2 (“CDK2”) inhibitor compounds. At close, the Company received consideration in the form of an upfront payment of $1.0 million and an equity interest in Incyclix equal to 10% of its issued and outstanding units valued at $1.1 million. In addition, the Company may receive a future development milestone payment totaling $2.0 million and royalty payments in the mid-single digits based on net sales of the licensed compound after commercialization. The Company has right of first negotiation to re-acquire these assets. In the first quarter of 2022, Incyclix announced a new round of financing which the Company did not participate. Following the financing, the Company's equity interest is now approximately 6.5%. The Company assessed the license agreement in accordance with ASC 606 and identified one performance obligation in the contract, which is the transfer of the license, as Incyclix can benefit from the license using its own resources. The Company recognized $2.1 million in license revenue consisting of the upfront payment and the 10% equity interest in Incyclix upon the effective date as the Company determined the license was a right to use the intellectual property and the Company had provided all necessary information to Incyclix to benefit from the license. The Company considers the future potential development milestone and sales-based royalties to be variable consideration. The development milestone is excluded from the transaction price because it determined the payment to be fully constrained under ASC 606 due to the inherent uncertainty in the achievement of such milestone due to factors outside of the Company’s control. As sales-based royalties are all related to the license of the intellectual property, the Company will recognize revenue in the period when subsequent sales are made pursuant to the sales-based royalty exception. The Company will re-evaluate the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur. There was no revenue recognized during the twelve months ended December 31, 2023. Genor License Agreement On June 15, 2020, the Company entered into an exclusive license agreement with Genor Biopharma Co. Inc. (“Genor”) for the development and commercialization of lerociclib in Australia, Bangladesh, China, Hong Kong, India, Indonesia, Macau, Malaysia, Myanmar, New Zealand, Pakistan, Philippines, Singapore, South Korea, Sri Lanka, Taiwan, Thailand, and Vietnam (the “Genor Territory”). Under the license agreement, the Company granted to Genor an exclusive, royalty-bearing, non-transferable license, with the right to grant sublicenses, to develop, obtain, hold and maintain regulatory approvals for, and commercialize lerociclib, in the Genor Territory. Under the license agreement, Genor agreed to pay the Company a non-refundable, upfront cash payment of $6.0 million with the potential to pay an additional $40.0 million upon reaching certain development and commercial milestones. In addition, Genor will pay the Company tiered royalties ranging from high single to low double-digits based on annual net sales of lerociclib in the Genor Territory. In September 2020, the Company transferred to Genor the related technology and know-how that is necessary to develop, seek regulatory approval for, and commercialize lerociclib in the Genor Territory, which resulted in the recognition of $6.0 million in revenue in accordance with ASC 606. Since then, through December 31, 2022, the Company had recognized an additional $3.0 million in revenue for the achievement of development and commercial milestones as defined by the license agreement. There was no milestone revenue recognized during the twelve months ended December 31, 2023. EQRx License Agreement On July 22, 2020, the Company entered into an exclusive license agreement with EQRx, Inc. (“EQRx”) for the development and commercialization of lerociclib in the U.S., Europe, Japan and all other global markets, excluding the Asia-Pacific region (except Japan) (the “EQRx Territory”). Under the license agreement, the Company granted to EQRx an exclusive, royalty-bearing, non-transferable license, with the right to grant sublicenses, to develop, obtain, hold and maintain regulatory approvals for, and commercialize lerociclib in the EQRx Territory. Under the license agreement, EQRx agreed to pay the Company a non-refundable, upfront cash payment of $20.0 million with the potential to pay an additional $290.0 million upon reaching certain development and commercial milestones. In addition, EQRx would pay the Company tiered royalties ranging from mid-single digits to mid-teens based on annual net sales of lerociclib in the EQRx Territory. In September 2020, the Company transferred to EQRx the related technology and know-how that was necessary to develop, seek regulatory approval for, and commercialize lerociclib in the EQRx Territory which resulted in the recognition of $20.0 million in revenue in accordance with ASC 606. EQRx was responsible for the development of the product in the EQRx Territory. The Company agreed to continue until completion, as the clinical trial sponsor, its two primary clinical trials and EQRx agreed to reimburse the Company for all related out-of-pocket costs incurred after the effective date of the license agreement. On August 1, 2023, the Company received from EQRx formal notice of termination of the lerociclib license agreement in connection with the acquisition of EQRx by Revolution Medicines, Inc. The notice stated the intention to revert the lerociclib product rights back to the Company. Under the terms of the license agreement, EQRx is responsible for winding down its development activities. On September 13, 2023, the parties entered into a letter agreement whereby EQRx would pay the Company $1.6 million to reimburse anticipated wind down costs; the payment was received during the third quarter of 2023. No milestones were previously achieved through the date of termination of the lerociclib license agreement, and as a result of the termination, the Company will not receive any further milestone payments or future royalties from EQRx. During the twelve months ended December 31, 2023, the Company recognized revenue of $1.7 million for the reimbursement of patent and clinical trial costs, including $1.4 million of the $1.6 million payment received during the third quarter of 2023 following notice from EQRx of termination of the license agreement. As of December 31, 2023, the remaining $0.2 million is held as short-term deferred revenue on the balance sheet and will be recognized as revenue as clinical trial costs associated with the wind down are incurred. Simcere License Agreement On August 3, 2020, the Company entered into an exclusive license agreement with Simcere for the development and commercialization of trilaciclib in all indications in Greater China (mainland China, Hong Kong, Macau, and Taiwan) (the “Simcere Territory”). Under the license agreement, the Company granted to Simcere an exclusive, royalty-bearing, non-transferable license, with the right to grant sublicenses, to develop, obtain, hold and maintain regulatory approvals for, and commercialize trilaciclib in the Simcere Territory. Since entering into the license agreement, the Company had received an upfront payment of $14.0 million and an additional $22.0 million for the achievement of development milestones through December 31, 2022. On April 28, 2023, the Company amended the license agreement with Simcere, whereby the Company received a one-time, non-refundable payment of $30.0 million in exchange for the relief of future royalty payments from the sale of COSELA in Greater China. In addition, the milestone payments under the license agreement were adjusted such that the Company will be eligible to receive a $5.0 million payment upon Simcere’s filing an NDA of TNBC in mainland China and a $13.0 million payment upon Simcere receiving regulatory approval of TNBC in mainland China. Under the amended license agreement, Simcere is not responsible for any sales milestone payments or any royalties accrued after April 28, 2023. Following the amendment, the Company continues to own all the global development and commercial rights to trilaciclib, excluding Greater China. During the twelve months ended December 31, 2023, the Company recognized $30.0 million in revenue from the one-time payment for the relief of future royalty payments, $2.9 million in supply and manufacturing services, $0.6 million in royalty revenue, and $0.7 million in patent and clinical trial reimbursable costs. |
Net Loss Per Common Share
Net Loss Per Common Share | 12 Months Ended |
Dec. 31, 2023 | |
Earnings Per Share [Abstract] | |
Net Loss Per Common Share | Net Loss per Common Share Basic net loss per common share is computed using the weighted average number of common shares outstanding during the period including nominal issuances of common stock warrants. Diluted net loss per common share is computed using the sum of the weighted average number of common shares outstanding during the period and, if dilutive, the weighted average number of potential shares of common stock, including the assumed exercise of stock options, stock warrants and unvested restricted common stock. For the twelve months ended December 31, 2023, 2022 and 2021, the following potentially dilutive securities have been excluded from the computations of diluted weighted-average shares outstanding because the effect would be anti-dilutive: Year Ended December 31, 2023 2022 2021 Stock options issued and outstanding 7,507,583 7,692,064 7,056,745 Unvested RSUs 1,458,341 636,978 451,138 Unvested PSUs 216,655 — — Unvested DSUs 27,260 — — Total potential dilutive shares 9,209,839 8,329,042 7,507,883 Amounts in the table above reflect the common stock equivalents of the noted instruments. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes Income taxes are accounted for using the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to temporary differences between the financial statements carrying amounts of assets and liabilities and their respective tax bases, operating loss carryforwards, and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. The components of income tax expense (benefit) attributable to continuing operations are as follows (in thousands): Year Ended December 31, 2023 2022 2021 Current Expense: Federal $ — $ — $ — State — — — Foreign 3,115 1,700 925 3,115 1,700 925 Deferred Expense: Federal — — — State — — — Foreign — — — $ 3,115 $ 1,700 $ 925 The differences between the company’s income tax expense attributable to continuing operations and the expense computed at the 21% U.S. statutory income tax rate were as follows (in thousands): Year Ended December 31, 2023 2022 2021 Federal income tax benefit at statutory rate: $ (9,419) $ (30,631) $ (30,960) Increase (reduction) in income tax resulting from: State Income Taxes (706) (5,372) (1,923) Increase in Valuation Allowance 9,868 36,472 27,618 Stock Compensation 3,873 2,879 108 Research and Development Credit (2,835) (3,521) (3,030) NC Tax Rate Change — — 8,359 Foreign Withholding Tax 3,115 1,700 925 Foreign Tax Deduction (654) — — Other (127) 173 (172) $ 3,115 $ 1,700 $ 925 On November 18, 2021, North Carolina enacted the 2021 Appropriations Act, which included a gradual corporate income tax rate decrease from the current 2.5% to 0% by 2030. The Company is in a cumulative loss position and does not have significant deferred tax liabilities that can be utilized as a source of taxable income in the future. Therefore, the Company has reduced its North Carolina deferred tax assets, including the NOLs, to zero, as no benefit is expected to be realized from these deferred tax assets prior to 2030 when there would be no income tax in North Carolina. The reduction in the value of the deferred tax assets resulted in $8.4 million of tax expense in the year ended December 31, 2021, which was offset fully by the reduction in the corresponding valuation allowance. To the extent the Company becomes profitable prior to 2030, the Company will recognize an income tax benefit related to the portion of its North Carolina deferred tax assets utilized. The tax effects of temporary differences and operating loss carryforwards that gave rise to significant portions of the deferred tax assets and deferred tax liabilities were as follows at December 31, 2023 and 2022 (in thousands): Year Ended December 31, 2023 2022 Deferred tax assets Accrued expenses $ 2,966 $ 4,127 Operating lease liabilities 1,337 1,596 Stock compensation 9,223 10,518 R&D credits 23,351 20,516 Net operating loss carryforwards 120,626 117,896 Nondeductible Interest 3,691 2,178 Research and experimentation costs 21,546 17,945 Other 2,160 571 Deferred tax assets 184,900 175,347 Deferred tax liabilities Operating lease assets (1,160) (1,410) Other — (65) Deferred tax liabilities (1,160) (1,475) Valuation allowance (183,740) (173,872) Net deferred tax assets $ — $ — At December 31, 2023 and December 31, 2022, the Company evaluated all significant available positive and negative evidence, including the existence of losses in recent years and management’s forecast of future taxable income, and, as a result, determined it was more likely than not that federal and state deferred tax assets, including benefits related to net operating loss carryforwards, would not be realized. The valuation allowance increased $9.9 million from $173.9 million at December 31, 2022 to $183.7 million at December 31, 2023. The increase in valuation allowance was due primarily to the increase in net operating loss carryforwards, capitalized research and experimentation costs, and income tax credits. The table below summarizes changes in the deferred tax valuation allowance (in thousands): 2023 2022 2021 Balance at beginning of year $ 173,872 $ 137,400 $ 109,782 Charges to costs and expenses 9,868 36,472 35,961 Write-offs 1 — — (8,343) Balance at end of year $ 183,740 $ 173,872 $ 137,400 1. Includes impact of NC enacted tax rate change At December 31, 2023, the Company has federal net operating loss carryforwards (“NOLs”) of approximately $550.7 million, which are available to offset future taxable income. Of the $550.7 million available, $93.5 million will begin to expire in 2029. The remaining $457.2 million has an indefinite carryforward period. Under the Tax Cuts and Jobs Act (“Tax Act”), federal NOLs arising after December 31, 2017 may be carried forward indefinitely. However, for NOLs arising after December 31, 2017, NOL carryforwards will be limited to 80% of taxable income. The Company’s NOLs generated in 2017 and in prior years will not be subject to the 80% limitation under the Tax Act. In addition, the Company has state net operating loss carryforwards totaling approximately $401.2 million, which are available to offset future state taxable income. The state net operating loss carryforwards are inclusive of North Carolina net operating losses, which are recorded at zero benefit, as discussed in this footnote. State net operating losses begin to expire in 2024. Because the Company has incurred cumulative net operating losses since inception, all tax years remain open to examination by U.S. federal and state income tax authorities. As of December 31, 2023, the Company also had federal research and development (R&D) credit carryforwards of approximately $23.4 million available to offset future income tax which begin to expire in 2035. In accordance with FASB ASC 740, Accounting for Income Taxes , the Company reflects in the financial statements the benefit of positions taken in a previously filed tax return or expected to be taken in a future tax return only when it is considered ‘more-likely-than-not’ that the position taken will be sustained by a taxing authority. As of December 31, 2023 and 2022, the Company had no unrecognized income tax benefits and correspondingly there is no impact on the Company’s effective income tax rate associated with these items. The Company’s policy for recording interest and penalties relating to uncertain income tax positions is to record them as a component of income tax expense in the accompanying statements of income. As of December 31, 2023 and 2022, the Company had no such accruals. Section 382 Limitation The Company’s ability to utilize its net operating loss and research and development credit carryforwards may be substantially limited due to ownership changes that may have occurred or that could occur in the future, as required by Section 382 of the Internal Revenue Code of 1986, as amended (the "Code"), as well as similar state provisions. These ownership changes may limit the amount of NOL and R&D credit carryforwards that can be utilized annually to offset future taxable income and tax, respectively. In general, an “ownership change,” as defined by Section 382 of the Code, results from a transaction or series of transactions over a three-year period resulting in an ownership change of more than 50 percent of the outstanding stock of a company by certain stockholders or public groups. In April 2019, the Company completed an evaluation study as to whether an “ownership change” had occurred and determined that the limitation would be approximately $8.0 million on federal net operating loss carryforwards, $1.2 million on state net operating loss carryforwards, and $0.1 million on R&D tax credit carryforwards. The carryforward amounts reported above have already been reduced for these limitations. The Company continues to maintain a valuation allowance on the remaining NOLs as it believes that it is more likely than not that all of the deferred tax assets associated with them will not be realized regardless of whether an “ownership change” has occurred. |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2023 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | Related Party Transactions On September 19, 2023, Mark A. Velleca, M.D., Ph.D., notified the Company of his decision to resign from the Company's Board of Directors, effective as of September 30, 2023. Dr. Velleca was a member of the Board since May 2014. Dr. Velleca’s decision to resign was not due to any disagreement with the Company on any matter relating to the Company’s operations, policies or practices. Dr. Velleca will continue to serve as a senior advisor to the Company pursuant to the terms of a Senior Advisor Agreement dated September 29, 2020 (the “Agreement”), as amended by that certain First Amendment to Senior Advisor Agreement, dated as of September 20, 2023 (the “Amendment”). Pursuant to the terms of the Agreement, Dr. Velleca was paid in equal quarterly installments, for his services, of which one final installment of $50,000 has not been paid as of December 31, 2023. Pursuant to the Amendment, the term of the Agreement has been extended from December 31, 2023 to December 31, 2024. Dr. Velleca will not receive any cash or equity compensation for his services during the period from January 1, 2024 through December 31, 2024 (the “Extended Term”). However, any stock options held by Dr. Velleca will continue to vest in accordance with their terms during the Extended Term. |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Pay vs Performance Disclosure | |||
Net loss | $ (47,967) | $ (147,559) | $ (148,352) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Dec. 31, 2023 | |
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 Sum_2
Basis of Presentation and Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The Company has prepared the accompanying financial statements in conformity with generally accepted accounting principles in the United States of America (“U.S. GAAP”). The Company has experienced net losses since its inception and has an accumulated deficit of $780.0 million and $732.0 million as of December 31, 2023 and December 31, 2022, respectively. The Company expects to incur losses and have negative net cash flows from operating activities as it executes on its strategy including engaging in further research and development activities, particularly conducting non-clinical studies and clinical trials. The success of the Company depends on the ability to successfully commercialize its technologies to support its operations and strategic plan. Management has evaluated actions already taken, the significance of anticipated continued losses, future cash flow projections, and the ability of the Company to remain in compliance with the financial covenants and requirements as defined within the Loan Agreement (as defined below). Based on the foregoing, as of the date of issuance of these financial statements, the Company expects that its cash and cash equivalents and marketable securities as of December 31, 2023 will be sufficient to fund the Company’s planned operations and remain in compliance with its objective financial covenants for at least the next 12 months from the date of issuance of these financial statements. Until such time, if ever, as the Company can generate substantial revenues, the Company expects to finance its cash needs through a combination of equity offerings, debt financings, other third-party funding, marketing and distribution arrangements and other collaborations, strategic alliances and licensing arrangements. There can be no assurances that the Company will be able to secure such additional financing if at all, or on terms that are satisfactory to the Company, and that it will be sufficient to meet its needs. In the event the Company is not successful in obtaining sufficient funding, this could force it to delay, limit, or reduce its product development, commercialization efforts or other operations. The Company’s financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business. The financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of the uncertainties described above. |
Use of Estimates | Use of Estimates |
Cash, Cash Equivalents, and Restricted Cash | Cash, Cash Equivalents, and Restricted Cash The Company considers all highly liquid investments purchased with an original maturity of three months or less at the date of purchase to be cash equivalents. Cash and cash equivalents at December 31, 2023 consist of amounts on deposit in banks, including checking accounts and money market accounts and funds. Cash deposits are all in financial institutions in the United States. As part of the lease for the office space which commenced on September 2, 2019, the Company obtained a standby letter of credit in the amount of $0.5 million related to the security deposit. This letter of credit is secured by a money market account at the financial institution and is classified as restricted cash on the Company's balance sheet. The letter of credit will be reduced ratably on each anniversary of the commencement of the lease until the end of the lease term. Restricted cash totaled $250 thousand and $313 thousand for the years ended December 31, 2023 and 2022, respectively. |
Marketable Securities | Marketable Securities |
Accounts Receivable | Accounts Receivable The Company’s accounts receivable consists of amounts due from specialty distributors in the U.S. (collectively, its “customers”) related to sales of COSELA and have standard payment terms. Trade receivables are recorded net of the estimated variable consideration for chargebacks based on contractual terms and the Company’s expectation regarding the utilization and earnings of the chargebacks and discounts as well as the net amount expected to be collected from the Company’s customers. Estimates of the Company’s credit losses, of which there are none for the year ended December 31, 2023, are determined based on existing contractual payment terms, individual customer circumstances, and any changes to the economic environment. |
Inventories | Inventories Inventories are stated at the lower of cost or net realizable value and recognized on a weighted-average cost method. The Company uses actual cost to determine the cost basis for inventory. Inventory is capitalized based on when future economic benefit is expected to be realized. Due to the nature of the Company’s supply chain process, inventory that is owned by the Company, is physically stored at third-party warehouses, logistics providers, and contract manufacturers. Inventory valuation is established based on a number of factors including, but not limited to, finished goods not meeting product specifications, product excess and obsolescence, or application of the lower of cost or net realizable value concepts. The determination of events requiring the establishment of inventory valuation, together with the calculation of the amount of such adjustments may require judgment. The Company analyzes its inventory levels on a periodic basis to determine if any inventory is at risk for expiration prior to sale or has a cost basis that is greater than its estimated future net realizable value. Any adjustments are recognized through cost of goods sold in the period in which they are incurred. |
Property and Equipment | Property and Equipment Property and equipment are stated at cost less accumulated depreciation. Depreciation is generally calculated using the straight-line method over the following estimated useful lives: Computer equipment 5 years Laboratory equipment 5 years Manufacturing equipment 5 years Furniture and fixtures 7 years Leasehold improvements 7 years |
Impairment of Long-Lived Assets | Impairment of Long-lived Assets |
Debt and Debt Issuance Costs | Debt The Company classifies its loan payable in current or long-term liabilities based on the timing of scheduled principal payments. The loan and security agreement with Hercules Capital, Inc. (as amended, the “Loan Agreement”) contains events of default, including a material adverse change, which is subjectively defined, in the Company’s business, payment defaults, and breaches of covenants following any applicable cure period. In the event of default by the Company under the Loan Agreement, the Company may be required to repay all amounts then outstanding under the Loan Agreement. The Company has determined that subjective acceleration under the material adverse events clause included in the Loan Agreement is not probable and, therefore, has classified the outstanding principal amount in long-term liabilities based on the timing of scheduled principal payments. Debt Issuance Costs Debt issuance costs are amortized to interest expense over the estimated life of the related debt based on the effective interest method. In accordance with ASC 835, Interest, the Company presents debt issuance costs on the balance sheet as a direct deduction from the associated debt. |
Revenue Recognition | Revenue Recognition For elements of those arrangements that the Company determines should be accounted for under ASC 606, Revenue from Contracts with Customers (“ASC 606”), the Company assesses which activities in its license or collaboration agreements are performance obligations that should be accounted for separately and determines the transaction price of the arrangement, which includes the assessment of the probability of achievement of future milestones and other potential consideration. For arrangements that include multiple performance obligations, such as granting a license or performing manufacturing or research and development activities, the Company allocates the transaction price based on the relative standalone selling price and recognizes revenue that is allocated to the respective performance obligation when (or as) control is transferred to the customer and the performance obligation is satisfied. Accordingly, the Company develops assumptions that require judgment to determine the standalone selling price for each performance obligation identified in the contract. These key assumptions may include revenue forecasts, clinical development timelines and costs, discount rates and probabilities of clinical and regulatory success. License Revenue Licenses of Intellectual Property If a license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenue allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue associated with the bundled performance obligation. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of progress and related revenue recognition. Milestone Payments At the inception of each arrangement that includes developmental and regulatory milestone payments, the Company evaluates whether the achievement of each milestone specifically relates to the Company’s efforts to satisfy a performance obligation or transfer a distinct good or service within a performance obligation. The Company evaluates each milestone to determine when and how much of the milestone to include in the transaction price. The Company first estimates the amount of the milestone payment that the Company could receive using either the expected value or the most likely amount approach. The Company primarily uses the most likely amount approach as that approach is generally most predictive for milestone payments with a binary outcome. Then, the Company considers whether any portion of that estimated amount is subject to the variable consideration constraint (that is, whether it is probable that a significant reversal of cumulative revenue would not occur upon resolution of the uncertainty). The Company updates the estimate of variable consideration included in the transaction price at each reporting date which includes updating the assessment of the likely amount of consideration and the application of the constraint to reflect current facts and circumstances. For regulatory milestones, the Company recognizes revenue at a point in time upon approval, as that is when achievement of the milestone is considered probable. The Company assesses milestones as they are achieved to determine whether they are tied to any other performance obligations in the respective license agreements. Royalties For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company will recognize revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). During the twelve months ended December 31, 2023, the Company recognized $0.6 million in revenue related to sales-based royalties. Product Sales, Net The Company sells COSELA to specialty distributors in the U.S. and, in accordance with ASC 606, recognizes revenue at the point in time when the customer is deemed to have obtained control of the product. The customer is deemed to have obtained control of the product at the time of physical receipt of the product at the customers’ distribution facilities, or Free on Board (“FOB”) destination, the terms of which are designated in the contract. Product sales are recorded at the net selling price, which includes estimates of variable consideration for which reserves are established for (a) rebates and chargebacks, (b) co-pay assistance programs, (c) distribution fees, (d) product returns, (e) GPO fees, and (f) other discounts. Where appropriate, these estimates take into consideration a range of possible outcomes for relevant factors such as current contractual and statutory requirements, and forecasted customer buying and payment patterns. Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the applicable contract. The amount of variable consideration may be constrained and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. Actual amounts of consideration ultimately received may differ from the Company's estimates. If actual results in the future vary from estimates, the Company adjusts these estimates, which would affect net product revenue and earnings in the period such variances become known. Liabilities related to co-pay assistance, rebates, returns, and GPO fees are classified as “Accrued Expenses” in the Balance Sheets. Discounts such as chargebacks and specialty distributor fees are recorded as a reduction to trade accounts receivable, which is included in “Accounts Receivable” in the Balance Sheets. Forms of Variable Consideration Rebates and Chargebacks : The Company estimates reductions to product sales for Public Health Service Institutions, such as Medicaid, Medicare and Veterans Administration (“VA”) programs, as well as certain other qualifying federal and state government programs, and other group purchasing organizations. The Company estimates these reductions based upon the Company’s contracts with government agencies and other organizations, statutorily defined discounts and estimated payor mix. These organizations purchase directly from the Company’s specialty distributors at a discount and the specialty distributors charge the Company back the difference between the wholesaler price and the discounted price. The Company’s liability for Medicaid rebates consists of estimates for claims that a state will make. The Company’s reserve for this discounted pricing is based on expected sales to qualified healthcare providers and the chargebacks that customers have already claimed. Co-pay assistance: Eligible patients who have commercial insurance may receive assistance from the Company to reduce the patient’s out of pocket costs. Liabilities for co-pay assistance are calculated by actual program participation from third-party administrators. Distribution Fees: The Company has written contracts with its customers that include terms for distribution fees and costs for inventory management. The Company estimates and records distribution fees due to its customers based on gross sales. Product Returns: The Company generally offers a right of return based on the product’s expiration date and certain spoilage and damaged instances. The Company estimates the amount of product sales that may be returned and records the estimate as a reduction of product sales in the period the related product sales are recognized. The Company’s estimates for expected returns are based primarily on an ongoing analysis of sales information and visibility into the inventory remaining in the distribution channel. |
Concentration of Credit Risk | Concentration of Credit Risk Financial instruments that potentially subject the Company to credit risk consist of cash and cash equivalents. Deposits with financial institutions are insured, up to certain limits, by the Federal Deposit Insurance Corporation (“FDIC”). The Company’s cash deposits often exceed the FDIC insurance limit; however, all deposits are maintained with high credit quality institutions and the Company has not experienced any losses in such accounts. The financial condition of financial institutions is periodically reassessed, and the Company believes the risk of any loss is minimal. The Company believes the risk of any loss on cash due to credit risk is minimal. |
Cost of Goods Sold | Cost of Goods Sold Cost of goods sold includes direct and indirect costs related to the manufacturing and distribution of COSELA, including third-party manufacturing costs, packaging services, freight-in, third-party logistics costs associated with COSELA, and Company personnel costs. Cost of goods sold may also include period costs related to certain inventory manufacturing services and inventory adjustment charges for excess and obsolete inventory. |
Research and Development | Research and Development Research and development expenses consist of costs incurred to further the Company’s research and development activities and include salaries and related employee benefits, manufacturing of pharmaceutical active ingredients and drug product, costs associated with clinical trials, nonclinical activities, regulatory activities, research-related overhead expenses and fees paid to expert consultants, external service providers and contract research organizations which conduct certain research and development activities on behalf of the Company. Costs incurred in the research and development of products are charged to research and development expense as incurred. Each reporting period, management estimates and accrues research and development expenses, including external clinical study costs associated with clinical trial activities. The process of estimating and accruing expenses involved reviewing contracts and purchase orders, identifying services that have been provided on the Company’s behalf, and estimating the level of service performed and the associated cost incurred for the service when the Company has not yet been invoiced or otherwise notified of the actual costs. Costs for clinical trial activities were estimated based on an evaluation of vendors’ progress towards completion of specific tasks, using data such as patient enrollment, clinical site activations or information provided by vendors regarding their actual costs incurred. Payments for these activities are based on the terms of individual contracts and payment timing may differ significantly from the period in which the services were performed. The Company determines accrual estimates through reports from and discussions with applicable personnel and outside service providers as to the progress or state of completion of trials, or the services completed. The estimates of accrued external clinical study costs as of each balance sheet date are based on the facts and circumstances known at the time. |
Fair Value of Financial Instruments | Fair value of Financial Instruments The Company provides disclosure of financial assets and financial liabilities that are carried at fair value based on the price that would be received upon sale of an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. Fair value measurements may be classified based on the amount of subjectivity associated with the inputs to fair valuation of these assets and liabilities using the following three levels: Level 1 Inputs are unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date. Level 2 Inputs include quoted prices for similar assets and liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, inputs other than quoted prices that are observable for the asset or liability and inputs that are derived principally from or corroborated by observable market data by correlation or other means. Level 3 Unobservable inputs that reflect the Company’s estimates of the assumptions that market participants would use in pricing the asset or liability. The Company develops these inputs based on the best information available, including its own data. The carrying amounts of cash, cash equivalents, accounts payable and accrued liabilities approximate fair value because of their short-term nature. At December 31, 2023 and 2022 these financial instruments and respective fair values have been classified as follows (in thousands): Quoted prices Significant Significant Balance at December 31, Assets: Money market accounts and funds $ 32,110 $ — $ — $ 32,110 Marketable securities: U.S. Treasury Bills 49,938 — — 49,938 Total assets at fair value $ 82,048 $ — $ — $ 82,048 Quoted prices Significant Significant Balance at December 31, Assets: Money market accounts and funds $ 84,167 $ — $ — $ 84,167 Marketable securities: U.S. Treasury Bills 50,476 — — 50,476 Total assets at fair value $ 134,643 $ — $ — $ 134,643 During the twelve months ended December 31, 2023 and December 31, 2022, there were no changes in valuation methodology. The Loan Payable (discussed in Note 7), which is classified as a Level 3 liability, has a variable interest rate and the carrying value approximates its fair value. As of December 31, 2023, the carrying value was $51.6 million. |
Patent Costs Policy | Patent Costs |
Stock Based Compensation | Stock-Based Compensation The primary type of stock-based payments utilized by the Company are stock options. The Company accounts for stock-based employee compensation arrangements by measuring the cost of employee services received in exchange for all equity awards granted based on the fair value of the award on the grant date. The fair value of each employee stock option is estimated on the date of grant using an options pricing model. The Company currently uses the Black-Scholes valuation model to estimate the fair value of its share-based payments. The model requires management to make a number of assumptions including expected volatility, expected life, risk-free interest rate and expected dividends. |
Income Taxes | Income Taxes Income taxes are accounted for using the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to temporary differences between the financial statements carrying amounts of assets and liabilities and their respective tax bases, operating loss carryforwards, and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. |
Segment Information | Segment Information The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions. All of the Company’s assets are held in the United States. |
Comprehensive Loss | Comprehensive Loss Comprehensive loss includes net loss as well as other changes in stockholders’ equity (deficit) that result from transactions and economic events other than those with stockholders. There was no difference between net loss and comprehensive loss for each of the periods presented in the accompanying financial statements. |
Leases | Leases The Company determines if an arrangement is a lease at inception. Operating lease assets represent the Company's right to use an underlying asset for the lease term and lease liabilities represent the Company's obligation to make lease payments arising from the lease. Operating leases are included in operating lease assets, other current liabilities, and operating lease liabilities on the Company's balance sheet at December 31, 2023. Operating lease assets and operating lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at commencement date. As most of the Company's leases do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at commencement date to determine the present value of future payments. The Company's lease terms may include options to extend or terminate the lease when it is reasonably certain that it will exercise that option. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies and adopted by the Company as of the specified effective date. The Company did not adopt any new accounting pronouncements during the year ended December 31, 2023, that had a material effect on its financial statements. In November 2023, the FASB issued ASU 2023-07, "Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures." ASU 2023-07 is intended to improve disclosures about a public entity's reportable segment by requiring additional, more detailed incremental segment information to be disclosed on an annual and interim basis. ASU 2023-07 requires that a public entity with a single reportable segment provide all the disclosures required by the amendments of ASU 2023-07 and all existing segment disclosures in FASB ASC Topic 280. The amendments of ASU 2023-07 require a public entity to disclose, on an annual and interim basis, significant segment expenses that are regularly provided to the chief operating decision maker (CODM) and included within each reported measure of segment profit or loss, and an amount for other segment items by reportable segment and a description of its composition. In additional, ASU 2023-07 requires a public entity to disclose the title and position of the CODM, together with an explanation of how the CODM uses the reported measure(s) of segment profit or loss in assessing segment performance and deciding how to allocate resources. ASU 2023-07 also requires a public entity to provide all annual disclosures about a reportable segment profit or loss and assets currently required under FASB ASC Topic 280 in interim periods. The amendments of ASU 2023-07 are effective for annual periods beginning after December 15, 2023, and for interim periods with fiscal years beginning after December 15, 2024, with early adoption permitted. The Company intends to adopt the amendments of ASU 2023-07 related to annual disclosure requirements effective January 1, 2024, and will present any newly required annual disclosures in its Annual Report on Form 10-K for the year ending December 31, 2024. The Company intends to adopt the amendments of ASU 2023-07 related to interim disclosure requirements effective January 1, 2025, an will present any newly required interim disclosures beginning with its Quarterly Report on Form 10-Q for the period ending March 31, 2025. The Company is currently evaluating the changes to disclosures required by ASU 2023-07; however, adoption of ASU 2023-07 is not expected to have a material impact to its financial position or results of operations. |
Basis of Presentation and Sum_3
Basis of Presentation and Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Schedule of Property and Equipment | Property and equipment are stated at cost less accumulated depreciation. Depreciation is generally calculated using the straight-line method over the following estimated useful lives: Computer equipment 5 years Laboratory equipment 5 years Manufacturing equipment 5 years Furniture and fixtures 7 years Leasehold improvements 7 years Property and equipment consists of the following (in thousands): December 31, 2023 December 31, 2022 Computer equipment $ 327 $ 327 Laboratory equipment 334 334 Furniture and fixtures 866 866 Leasehold improvements 1,782 1,782 Manufacturing equipment 506 506 Accumulated depreciation (2,339) (1,826) Property and equipment, net $ 1,476 $ 1,989 |
Summary of Financial Instruments and Respective Fair Values | At December 31, 2023 and 2022 these financial instruments and respective fair values have been classified as follows (in thousands): Quoted prices Significant Significant Balance at December 31, Assets: Money market accounts and funds $ 32,110 $ — $ — $ 32,110 Marketable securities: U.S. Treasury Bills 49,938 — — 49,938 Total assets at fair value $ 82,048 $ — $ — $ 82,048 Quoted prices Significant Significant Balance at December 31, Assets: Money market accounts and funds $ 84,167 $ — $ — $ 84,167 Marketable securities: U.S. Treasury Bills 50,476 — — 50,476 Total assets at fair value $ 134,643 $ — $ — $ 134,643 |
Inventories (Tables)
Inventories (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventories | Inventories consist of the following (in thousands): December 31, 2023 December 31, 2022 Raw materials $ 2,422 $ 2,790 Work in process 9,593 10,153 Finished goods 427 3,236 Inventories, net $ 12,442 $ 16,179 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment | Property and equipment are stated at cost less accumulated depreciation. Depreciation is generally calculated using the straight-line method over the following estimated useful lives: Computer equipment 5 years Laboratory equipment 5 years Manufacturing equipment 5 years Furniture and fixtures 7 years Leasehold improvements 7 years Property and equipment consists of the following (in thousands): December 31, 2023 December 31, 2022 Computer equipment $ 327 $ 327 Laboratory equipment 334 334 Furniture and fixtures 866 866 Leasehold improvements 1,782 1,782 Manufacturing equipment 506 506 Accumulated depreciation (2,339) (1,826) Property and equipment, net $ 1,476 $ 1,989 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses are comprised as follows (in thousands): December 31, 2023 December 31, 2022 Accrued external research $ 109 $ 268 Accrued professional fees and other 5,854 4,304 Accrued external clinical study costs 10,944 15,566 Accrued compensation expense 4,986 5,419 Accrued expenses $ 21,893 $ 25,557 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Leases [Abstract] | |
Summary of Lease Position and Weighted-Average Lease Term and Discount Rate of Operating Leases | The tables below reflect the Company’s lease position and weighted-average lease terms and discount rates for its operating leases as of December 31, 2023. Operating lease liabilities are based on the net present value of the remaining lease payments over the remaining lease term. In determining the present value of lease payments, the Company used its incremental borrowing rate based on the information available at the lease commencement date. (in thousands) Classification on the Balance Sheet December 31, 2023 Assets Operating lease assets Operating lease assets $ 4,908 Total lease assets $ 4,908 Liabilities Current Operating Other current liabilities $ 1,276 Non-current Operating Operating lease liabilities 4,340 Total lease liabilities $ 5,616 Lease Term and Discount Rate December 31, 2023 Weighted-average remaining lease term (years) Operating leases 3.8 Weighted-average discount rate Operating leases 8.0 % |
Summary of Lease Costs for Operating Leases | The table below presents information related to the lease costs for operating leases (in thousands): Year Ended December 31, (in thousands) Classification 2023 2022 2021 Operating lease costs 1 Research and development $ 630 $ 618 $ 799 Selling, general and administrative 924 1,048 870 Total operating lease costs $ 1,554 $ 1,666 $ 1,669 1 Includes variable lease costs which are immaterial. |
Reconciliation of Undiscounted Cash Flow to Operating Lease Liabilities | The table below reconciles the undiscounted cash flow for each of the first five years and total of the remaining years to the operating lease liabilities recorded on the balance sheet as of December 31, 2023 (in thousands): Operating leases Years ending December 31, 2024 $ 1,679 2025 1,725 2026 1,773 2027 1,357 Total future minimum lease payments 6,534 Less: present value adjustment (918) Total operating lease liabilities $ 5,616 |
Loan Payable (Tables)
Loan Payable (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Debt Disclosure [Abstract] | |
Schedule of Outstanding Debt Obligations | As of December 31, 2023, the future principal payments due under the Loan Agreement, excluding interest, are as follows (in thousands): Amount 2024 $ 1,819 2025 23,469 2026 24,712 Total principal outstanding 50,000 End of term charge 2,011 Unamortized debt issuance costs (454) Total $ 51,557 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Equity [Abstract] | |
Summary of Common Stock Shares Reserved for Future Issuance | The Company has reserved authorized shares of common stock for future issuance as follows: December 31, 2023 December 31, 2022 Common stock options outstanding 6,774,186 7,372,028 RSUs outstanding (1) 1,613,215 675,406 PSUs outstanding (1) 218,450 — DSUs outstanding (1) 50,000 — Options, RSUs, PSUs and DSUs available for grant under Equity Incentive Plans (1) 2,385,034 2,323,539 11,040,885 10,370,973 (1) RSUs, PSUs, and DSUs are further defined in Note 9. |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Summary of Share-Based Compensation Expense Included in Statement of Operations | The table below summarizes the stock-based compensation expense recognized in the Company’s statement of operations by classification (in thousands): Year Ended December 31, 2023 2022 2021 Cost of goods sold $ 243 $ 207 $ 252 Research and development 2,177 3,956 $ 4,811 Selling, general and administrative 12,090 16,426 $ 17,256 Total stock-based compensation expense $ 14,510 $ 20,589 $ 22,319 |
Summary of Fair Value of Stock Options Granted Using Black-Scholes Options Pricing Model | The fair value of each option grant is estimated on the grant date using the Black-Scholes option-pricing model, using the following weighted average assumptions: Year Ended December 31, 2023 2022 2021 Expected volatility 81.4% - 88.4% 76.7% - 81.4% 76.8% - 79.6% Weighted-average risk free rate 3.4% - 4.2% 1.4% - 4.2% 0.4% - 1.3% Dividend yield —% —% —% Expected term (in years) 6.00 6.00 6.00 Weighted-average grant-date fair value per share $3.47 $6.50 $11.93 |
Summary of Stock Option Activity | The following table is a summary of stock option activity for the twelve months ended December 31, 2023: Weighted average Options Weighted Remaining Aggregate (in thousands) Balance as of December 31, 2022 7,372,028 $ 16.15 6.9 $ 3,281 Granted 1,369,330 4.79 Cancelled (1,801,992) 18.56 Exercised (165,180) 0.34 Balance as of December 31, 2023 6,774,186 $ 13.60 6.4 $ 944 Exercisable at December 31, 2023 4,813,088 $ 15.80 5.5 $ 859 Vested at December 31, 2023 and expected to vest 6,774,186 $ 13.60 6.4 $ 944 |
Summary of Restricted Stock Units Activity | The following table is a summary of the RSU activity for the twelve months ended December 31, 2023: Number of Weighted – Average Balance as of December 31, 2022 675,406 $ 12.31 Granted 1,617,050 3.76 Cancelled (417,780) 6.41 Vested (261,461) 12.38 Balance as of December 31, 2023 1,613,215 $ 5.25 |
Summary of Performance Stock Units Activity | The following table is a summary of the PSU activity for the twelve months ended December 31, 2023: Number of Weighted – Average Balance as of December 31, 2022 — $ — Granted 218,450 5.73 Cancelled — — Vested — — Balance as of December 31, 2023 218,450 $ 5.73 |
Share-Based Payment Arrangement, Deferred Shares, Activity | The following table is a summary of the DSU activity for the twelve months ended December 31, 2023: Number of Weighted – Average Balance as of December 31, 2022 — $ — Granted 50,000 2.83 Cancelled — — Vested — — Balance as of December 31, 2023 50,000 $ 2.83 |
Net Loss Per Common Share (Tabl
Net Loss Per Common Share (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Earnings Per Share [Abstract] | |
Schedule of Potentially Dilutive Securities Excluded from Computations of Diluted Weighted-average Shares Outstanding | For the twelve months ended December 31, 2023, 2022 and 2021, the following potentially dilutive securities have been excluded from the computations of diluted weighted-average shares outstanding because the effect would be anti-dilutive: Year Ended December 31, 2023 2022 2021 Stock options issued and outstanding 7,507,583 7,692,064 7,056,745 Unvested RSUs 1,458,341 636,978 451,138 Unvested PSUs 216,655 — — Unvested DSUs 27,260 — — Total potential dilutive shares 9,209,839 8,329,042 7,507,883 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Schedule of Components of Income Tax Expense (Benefit) | The components of income tax expense (benefit) attributable to continuing operations are as follows (in thousands): Year Ended December 31, 2023 2022 2021 Current Expense: Federal $ — $ — $ — State — — — Foreign 3,115 1,700 925 3,115 1,700 925 Deferred Expense: Federal — — — State — — — Foreign — — — $ 3,115 $ 1,700 $ 925 |
Schedule of Effective Income Tax Rate Reconciliation | The differences between the company’s income tax expense attributable to continuing operations and the expense computed at the 21% U.S. statutory income tax rate were as follows (in thousands): Year Ended December 31, 2023 2022 2021 Federal income tax benefit at statutory rate: $ (9,419) $ (30,631) $ (30,960) Increase (reduction) in income tax resulting from: State Income Taxes (706) (5,372) (1,923) Increase in Valuation Allowance 9,868 36,472 27,618 Stock Compensation 3,873 2,879 108 Research and Development Credit (2,835) (3,521) (3,030) NC Tax Rate Change — — 8,359 Foreign Withholding Tax 3,115 1,700 925 Foreign Tax Deduction (654) — — Other (127) 173 (172) $ 3,115 $ 1,700 $ 925 |
Schedule of Deferred Tax Assets and Liabilities | The tax effects of temporary differences and operating loss carryforwards that gave rise to significant portions of the deferred tax assets and deferred tax liabilities were as follows at December 31, 2023 and 2022 (in thousands): Year Ended December 31, 2023 2022 Deferred tax assets Accrued expenses $ 2,966 $ 4,127 Operating lease liabilities 1,337 1,596 Stock compensation 9,223 10,518 R&D credits 23,351 20,516 Net operating loss carryforwards 120,626 117,896 Nondeductible Interest 3,691 2,178 Research and experimentation costs 21,546 17,945 Other 2,160 571 Deferred tax assets 184,900 175,347 Deferred tax liabilities Operating lease assets (1,160) (1,410) Other — (65) Deferred tax liabilities (1,160) (1,475) Valuation allowance (183,740) (173,872) Net deferred tax assets $ — $ — |
Summary of Valuation Allowance | The table below summarizes changes in the deferred tax valuation allowance (in thousands): 2023 2022 2021 Balance at beginning of year $ 173,872 $ 137,400 $ 109,782 Charges to costs and expenses 9,868 36,472 35,961 Write-offs 1 — — (8,343) Balance at end of year $ 183,740 $ 173,872 $ 137,400 1. Includes impact of NC enacted tax rate change |
Basis of Presentation and Sum_4
Basis of Presentation and Summary of Significant Accounting Policies - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Sep. 02, 2019 | |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||||
Accumulated deficit | $ 779,985 | $ 732,018 | ||
Restricted cash | 250 | 313 | ||
Unbilled receivables, current | 200 | |||
Impairment, long-lived asset, held-for-use | 0 | 0 | $ 0 | |
Total revenues | 82,511 | 51,301 | 31,476 | |
Long-term debt | 51,557 | |||
Patent Related Legal Expenses | 1,800 | 1,800 | 1,900 | |
Unrecognized tax benefits | 0 | 0 | ||
Accrued income taxes | 0 | 0 | ||
Total stock-based compensation expense | 14,510 | $ 20,589 | $ 22,319 | |
Performance Shares | ||||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||||
Total stock-based compensation expense | 0 | |||
Nanjing Simcere Dongyuan Pharmaceutical Co Ltd | Royalty | ||||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||||
Total revenues | $ 600 | |||
Restricted Cash | Standby Letters of Credit | ||||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||||
Security deposit | $ 500 |
Basis of Presentation and Sum_5
Basis of Presentation and Summary of Significant Accounting Policies - Summary of Property and Equipment Useful Life (Details) | Dec. 31, 2023 |
Computer equipment | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, useful life | 5 years |
Laboratory equipment | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, useful life | 5 years |
Manufacturing equipment | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, useful life | 5 years |
Furniture and fixtures | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, useful life | 7 years |
Leasehold improvements | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, useful life | 7 years |
Basis of Presentation and Sum_6
Basis of Presentation and Summary of Significant Accounting Policies - Summary of Fair Value (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
U.S. Treasury Bills | $ 49,938 | $ 50,476 |
Total assets at fair value | 82,048 | 134,643 |
Loan payable | 51,557 | 77,015 |
Money Market Funds | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Money market accounts and funds | 32,110 | 84,167 |
Quoted prices in active markets for identical assets (Level 1) | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
U.S. Treasury Bills | 49,938 | 50,476 |
Total assets at fair value | 82,048 | 134,643 |
Quoted prices in active markets for identical assets (Level 1) | Money Market Funds | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Money market accounts and funds | 32,110 | 84,167 |
Significant other observable inputs (Level 2) | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
U.S. Treasury Bills | 0 | 0 |
Total assets at fair value | 0 | 0 |
Significant other observable inputs (Level 2) | Money Market Funds | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Money market accounts and funds | 0 | 0 |
Significant other unobservable inputs (Level 3) | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
U.S. Treasury Bills | 0 | 0 |
Total assets at fair value | 0 | 0 |
Significant other unobservable inputs (Level 3) | Money Market Funds | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Money market accounts and funds | $ 0 | $ 0 |
Inventories (Details)
Inventories (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 2,422 | $ 2,790 |
Work in process | 9,593 | 10,153 |
Finished goods | 427 | 3,236 |
Inventories, net | $ 12,442 | $ 16,179 |
Property and Equipment - Schedu
Property and Equipment - Schedule of Property and Equipment (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Property, Plant and Equipment [Line Items] | ||
Accumulated depreciation | $ (2,339) | $ (1,826) |
Property and equipment, net | 1,476 | 1,989 |
Computer equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 327 | 327 |
Laboratory equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 334 | 334 |
Furniture and fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 866 | 866 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 1,782 | 1,782 |
Manufacturing equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 506 | $ 506 |
Property, Plant, and Equipment
Property, Plant, and Equipment - Narrative (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Property, Plant and Equipment [Abstract] | |||
Depreciation expenses relating to property and equipment | $ 513 | $ 530 | $ 469 |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Payables and Accruals [Abstract] | ||
Accrued external research | $ 109 | $ 268 |
Accrued professional fees and other | 5,854 | 4,304 |
Accrued external clinical study costs | 10,944 | 15,566 |
Accrued compensation expense | 4,986 | 5,419 |
Accrued expenses | $ 21,893 | $ 25,557 |
Leases - Narrative (Details)
Leases - Narrative (Details) $ in Thousands | 1 Months Ended | 12 Months Ended | |||||
Nov. 30, 2018 ft² | Dec. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | Nov. 01, 2023 ft² $ / ft² | Mar. 20, 2020 office | Sep. 02, 2019 USD ($) | |
Operating Leased Assets [Line Items] | |||||||
Renewal term | 5 years | 5 years | |||||
Number of office spaces surrendered | office | 3 | ||||||
Laboratory and office space lease to secure | ft² | 60,000 | ||||||
Current operating lease liabilities | $ 1,276 | ||||||
Cash payments for measurement of Operating leases | $ 1,600 | $ 1,700 | $ 1,700 | ||||
Sublease (in square feet) | ft² | 20,830 | ||||||
Rental rate (in US dollars per square foot) | $ / ft² | 24 | ||||||
Annual rate increase (as a percent) | 2.75% | ||||||
Restricted Cash | Standby Letters of Credit | |||||||
Operating Leased Assets [Line Items] | |||||||
Security deposit | $ 500 |
Leases - Summary of Lease Posit
Leases - Summary of Lease Position and Weighted-Average Lease Term and Discount Rate of Operating Leases (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Assets | ||
Operating lease assets | $ 4,908 | $ 5,962 |
Total lease assets | $ 4,908 | |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible Enumeration] | Other current liabilities | |
Liabilities | ||
Current operating lease liabilities | $ 1,276 | |
Non-current operating lease liabilities | 4,340 | $ 5,615 |
Total operating lease liabilities | $ 5,616 | |
Weighted-average remaining lease term (years) | ||
Operating lease, weighted average remaining lease term (in years) | 3 years 9 months 18 days | |
Weighted-average discount rate | ||
Operating lease, weighted average discount rate, percent | 8% |
Leases - Summary of Lease Costs
Leases - Summary of Lease Costs for Operating Leases (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Operating Leased Assets [Line Items] | |||
Total operating lease costs | $ 1,554 | $ 1,666 | $ 1,669 |
Research and development | |||
Operating Leased Assets [Line Items] | |||
Operating lease costs | 630 | 618 | 799 |
Selling, general and administrative | |||
Operating Leased Assets [Line Items] | |||
Operating lease costs | $ 924 | $ 1,048 | $ 870 |
Leases - Reconciliation of Undi
Leases - Reconciliation of Undiscounted Cash Flow to Operating Lease Liabilities (Details) $ in Thousands | Dec. 31, 2023 USD ($) |
Leases [Abstract] | |
2024 | $ 1,679 |
2025 | 1,725 |
2026 | 1,773 |
2027 | 1,357 |
Total future minimum lease payments | 6,534 |
Less: present value adjustment | (918) |
Total operating lease liabilities | $ 5,616 |
Loan Payable - Narrative (Detai
Loan Payable - Narrative (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | ||||||||||
Jun. 06, 2023 | Nov. 01, 2022 | Jun. 24, 2022 | Nov. 01, 2021 | Mar. 31, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Sep. 30, 2023 | Jun. 05, 2023 | Jun. 30, 2021 | May 29, 2020 | |
Debt Instrument [Line Items] | ||||||||||||
Repayments of debt | $ 26,688 | $ 0 | $ 0 | |||||||||
Loan payable | 51,557 | 77,015 | ||||||||||
Interest expense | $ (10,038) | $ (10,432) | $ (4,667) | |||||||||
Loan Agreement | Hercules Capital Inc | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Loan agreement, basis spread on variable rate | 6.40% | |||||||||||
Loan agreement, interest rate, stated percentage | 9.65% | |||||||||||
Percentage of prepayment loan amount for first year | 3% | |||||||||||
Percentage of prepayment loan amount for second year | 2% | |||||||||||
Percentage of prepayment loan amount for third year | 1% | |||||||||||
Extinguishment of debt, amount | $ 200 | |||||||||||
Loan Agreement | Hercules Capital Inc | First Amendment To Loan And Security Agreement | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Loan agreement, basis spread on variable rate | 6.20% | |||||||||||
Loan agreement, interest rate, stated percentage | 9.45% | |||||||||||
Loan Agreement | Hercules Capital Inc | Tranche One | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Loan amount | $ 30,000 | |||||||||||
Percentage of aggregate amount of all loan advances payment | 6.95% | |||||||||||
End of term fee | $ 2,100 | |||||||||||
Loan Agreement | Hercules Capital Inc | Tranche One | First Amendment To Loan And Security Agreement | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Remaining loan amount | $ 10,000 | |||||||||||
Loan Agreement | Hercules Capital Inc | Tranche Two | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Loan amount | 20,000 | |||||||||||
Loan Agreement | Hercules Capital Inc | Tranche Three | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Loan amount | 30,000 | |||||||||||
Loan Agreement | Hercules Capital Inc | Tranche Four | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Loan amount | 20,000 | |||||||||||
Loan Agreement | Hercules Capital Inc | Maximum | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Loan amount | $ 100,000 | |||||||||||
Loan Agreement | Hercules Capital Inc | Minimum | First Amendment To Loan And Security Agreement | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Borrowing capacity without financial covenants | $ 40,000 | |||||||||||
Third Amendment | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Loan amount | $ 25,000 | |||||||||||
Debt instrument percentage of net product revenue | 80% | |||||||||||
Debt instrument minimum revenue of covenant market capitalization amount | $ 750,000 | |||||||||||
Debt instrument percentage of unrestricted cash | 100% | |||||||||||
Debt instrument, covenant, unrestricted cash balance, percentage | 50% | |||||||||||
Loan And Security Agreement | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Debt instrument percentage of net product revenue | 65% | |||||||||||
Debt instrument percentage of minimum revenue of covenant unrestricted cash | 50% | |||||||||||
Debt instrument percentage of unrestricted cash | 100% | |||||||||||
Loan And Security Agreement | Hercules Capital Inc | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Loan agreement, basis spread on variable rate | 5.90% | |||||||||||
Loan agreement, interest rate, stated percentage | 9.15% | |||||||||||
Percentage of prepayment loan amount for first year | 3% | |||||||||||
Percentage of prepayment loan amount for second year | 2% | |||||||||||
Percentage of prepayment loan amount for third year | 1% | |||||||||||
Loan And Security Agreement | Hercules Capital Inc | Tranche One | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Loan amount | $ 100,000 | |||||||||||
Remaining loan amount | $ 25,000 | |||||||||||
Percentage of aggregate amount of all loan advances payment | 6.75% | |||||||||||
End of term fee | $ 2,100 | |||||||||||
Debt instrument additional borrowing amount | 45,000 | |||||||||||
Loan And Security Agreement | Hercules Capital Inc | Tranche Two | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Loan amount | 20,000 | |||||||||||
Debt instrument available upon achievement of net product revenue | $ 50,000 | |||||||||||
Debt instrument trailing net product revenue | 6 months | |||||||||||
Loan And Security Agreement | Hercules Capital Inc | Tranche Three | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Loan amount | $ 15,000 | |||||||||||
Loan And Security Agreement | Hercules Capital Inc | Tranche Four | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Loan amount | 15,000 | |||||||||||
Loan And Security Agreement | Hercules Capital Inc | Maximum | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Loan amount | $ 150,000 | |||||||||||
Fourth Amendment | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Debt instrument additional borrowing amount | $ 25,000 | |||||||||||
Debt instrument percentage of net product revenue | 80% | |||||||||||
Debt instrument minimum revenue of covenant market capitalization amount | $ 750,000 | |||||||||||
Debt instrument percentage of unrestricted cash | 100% | |||||||||||
Debt instrument, covenant, unrestricted cash balance, percentage | 50% | |||||||||||
Debt instrument, covenant, outstanding debt threshold | $ 75,000 | |||||||||||
Fourth Amendment | Outstanding Debt Less Than Or Equal To 75.0 Million | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Debt instrument, covenant, unrestricted cash balance, percentage | 65% | |||||||||||
Fourth Amendment | Outstanding Debt Greater Than 75.0 Million | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Debt instrument, covenant, unrestricted cash balance, percentage | 70% | |||||||||||
Fourth Amendment | Achievement Of Net Revenue Milestones | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Debt instrument, covenant, unrestricted cash balance, percentage | 45% | |||||||||||
Fifth Amendment | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Debt instrument, covenant, outstanding debt threshold | $ 50,000 | |||||||||||
End of term fee, pro-rata payment | $ 1,700 | |||||||||||
Effective interest rate (as a percent) | 18.33% | |||||||||||
Fifth Amendment | Hercules Capital Inc | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Loan amount | $ 75,000 | |||||||||||
Loan agreement, interest rate, stated percentage | 9.15% | |||||||||||
Percentage of prepayment loan amount for first year | 3% | |||||||||||
Percentage of prepayment loan amount for second year | 2% | |||||||||||
Percentage of prepayment loan amount for third year | 1% | |||||||||||
Debt instrument trailing net product revenue | 6 months | |||||||||||
Debt instrument, covenant, unrestricted cash balance, percentage | 35% | |||||||||||
Repayments of debt | $ 25,000 | |||||||||||
Loan payable | 50,000 | |||||||||||
Minimum quarterly net product revenue covenant | 45,000 | |||||||||||
Trailing six month product revenue covenant | $ 85,000 | |||||||||||
Fifth Amendment | Hercules Capital Inc | Prime Rate | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Loan agreement, basis spread on variable rate | 5.65% | |||||||||||
Fifth Amendment | Hercules Capital Inc | Tranche Four | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Loan amount | $ 25,000 | $ 15,000 |
Loan Payable - Schedule of Outs
Loan Payable - Schedule of Outstanding Debt Obligations (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2023 USD ($) | |
Debt Disclosure [Abstract] | |
2024 | $ 1,819 |
2025 | 23,469 |
2026 | 24,712 |
Total principal outstanding | 50,000 |
End of term charge | 2,011 |
Unamortized debt issuance costs | (454) |
Total | $ 51,557 |
Stockholders' Equity - Narrativ
Stockholders' Equity - Narrative (Details) $ / shares in Units, $ in Millions | Dec. 20, 2022 USD ($) shares | Nov. 17, 2022 USD ($) $ / shares shares | Feb. 23, 2022 USD ($) | Jul. 02, 2021 USD ($) | Dec. 31, 2023 vote $ / shares shares | Dec. 31, 2022 $ / shares shares |
Class of Stock [Line Items] | ||||||
Common stock, par value (in US dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | ||||
Common stock, shares authorized (in shares) | 120,000,000 | 120,000,000 | ||||
Common stock, number of votes per share | vote | 1 | |||||
Undesignated preferred stock, shares authorized to issue | 5,000,000 | |||||
Preferred stock, shares outstanding (in shares) | 0 | |||||
Preferred stock, shares issued (in shares) | 0 | |||||
2021 Sales Agreement | ||||||
Class of Stock [Line Items] | ||||||
Maximum gross proceeds of common stock allowed from issuance and sell | $ | $ 150 | |||||
Common stock | ||||||
Class of Stock [Line Items] | ||||||
Common stock, shares authorized (in shares) | 120,000,000 | 120,000,000 | ||||
Cowen And Company L L C | 2022 Sales Agreement | ||||||
Class of Stock [Line Items] | ||||||
Maximum gross proceeds of common stock allowed from issuance and sell | $ | $ 300 | |||||
Proceeds from issuance of common stock | $ | $ 55.7 | $ 50.1 | $ 100 | |||
Sale of stock, number of shares issued in transaction | 8,573,353 | 7,700,000 | ||||
Sale of stock, price per share | $ / shares | $ 6.50 | |||||
Consideration received on transaction | $ | $ 52 | |||||
Cowen And Company L L C | Over-Allotment Option | ||||||
Class of Stock [Line Items] | ||||||
Sale of stock, number of shares issued in transaction | 873,353 |
Stockholders' Equity - Summary
Stockholders' Equity - Summary of Shares Reserved for Future Issuance (Details) - shares | Dec. 31, 2023 | Dec. 31, 2022 |
Class of Stock [Line Items] | ||
Common stock, shares reserved for future issuance (in shares) | 11,040,885 | 10,370,973 |
Common stock options outstanding | ||
Class of Stock [Line Items] | ||
Common stock, shares reserved for future issuance (in shares) | 6,774,186 | 7,372,028 |
Restricted Stock Unit Outstanding | ||
Class of Stock [Line Items] | ||
Common stock, shares reserved for future issuance (in shares) | 1,613,215 | 675,406 |
Performance Share Unit Outstanding | ||
Class of Stock [Line Items] | ||
Common stock, shares reserved for future issuance (in shares) | 218,450 | 0 |
Options, RSUs and PSUs Available For Grant Under Equity Incentive Plan | ||
Class of Stock [Line Items] | ||
Common stock, shares reserved for future issuance (in shares) | 2,385,034 | 2,323,539 |
Deferred Shares | ||
Class of Stock [Line Items] | ||
Common stock, shares reserved for future issuance (in shares) | 50,000 | 0 |
Stock-Based Compensation - Narr
Stock-Based Compensation - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | |||||
Jan. 01, 2023 | Dec. 31, 2023 | Mar. 31, 2022 | Sep. 30, 2021 | Feb. 28, 2021 | May 31, 2017 | |
Employee Stock Options | ||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||
Stock options, maximum term | 10 years | |||||
Unrecognized stock-based compensation costs | $ 9,700 | |||||
Weighted-average recognition period | 1 year 10 months 24 days | |||||
Restricted Stock Units (RSUs) | ||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||
Weighted-average recognition period | 2 years 2 months 12 days | |||||
Number of common shares received upon vesting (in shares) | 1 | |||||
Unrecognized compensation cost | $ 5,400 | |||||
Performance Shares | ||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||
Weighted-average recognition period | 2 years | |||||
Number of common shares received upon vesting (in shares) | 1 | |||||
Unrecognized compensation cost | $ 1,300 | |||||
Deferred Shares | ||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||
Weighted-average recognition period | 6 months | |||||
Number of common shares received upon vesting (in shares) | 1 | |||||
Unrecognized compensation cost | $ 100 | |||||
2011 Equity Incentive Plan | ||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||
Number of shares available for grant under equity incentive plan (in shares) | 0 | |||||
2017 Equity Incentive Plan | ||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||
Number of shares available for grant under equity incentive plan (in shares) | 1,473,163 | |||||
Number of shares approved for grant under equity incentive plan (in shares) | 1,932,000 | |||||
Number of additional shares approved for grant under equity incentive plan (in shares) | 1,096,553 | |||||
2021 Sales Force Inducement Plan | Maximum | ||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||
Number of shares approved for grant under equity incentive plan (in shares) | 500,000 | 500,000 | ||||
Amended And Restated 2021 Inducement Equity Incentive Plan | ||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||
Number of shares available for grant under equity incentive plan (in shares) | 911,870 | |||||
Amended And Restated 2021 Inducement Equity Incentive Plan | Maximum | ||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||
Number of shares approved for grant under equity incentive plan (in shares) | 1,750,000 | |||||
Additional number of shares reserved for future issuance under equity incentive plan (in shares) | 750,000 |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Share-Based Compensation Expense Included in Statements of Operations (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Total stock-based compensation expense | $ 14,510 | $ 20,589 | $ 22,319 |
Cost of goods sold | |||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Total stock-based compensation expense | 243 | 207 | 252 |
Research and development | |||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Total stock-based compensation expense | 2,177 | 3,956 | 4,811 |
Selling, general and administrative | |||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Total stock-based compensation expense | $ 12,090 | $ 16,426 | $ 17,256 |
Stock-Based Compensation - Fair
Stock-Based Compensation - Fair Value of Stock Options Granted Using Black-Scholes Options Pricing Model (Details) - Stock options issued and outstanding - $ / shares | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Expected volatility, minimum | 81.40% | 76.70% | 76.80% |
Expected volatility, maximum | 88.40% | 81.40% | 79.60% |
Weighted-average risk free rate, minimum | 3.40% | 1.40% | 0.40% |
Weighted-average risk free rate, maximum | 4.20% | 4.20% | 1.30% |
Dividend yield | 0% | 0% | 0% |
Expected term (in years) | 6 years | 6 years | 6 years |
Weighted average grant date fair value (in US dollars per share) | $ 3.47 | $ 6.50 | $ 11.93 |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary of Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | |
Options outstanding | |||
Beginning balance (in shares) | 7,372,028 | 7,372,028 | |
Granted (in shares) | 1,369,330 | ||
Cancelled (in shares) | (1,801,992) | ||
Exercised (in shares) | (165,180) | ||
Ending balance (in shares) | 6,774,186 | 7,372,028 | |
Exercisable (in shares) | 4,813,088 | ||
Vested and expected to vest (in shares) | 6,774,186 | ||
Weighted average exercise price | |||
Beginning balance (in US dollars per share) | $ 16.15 | $ 16.15 | |
Granted (in US dollars per share) | 4.79 | ||
Cancelled (in US dollars per share) | 18.56 | ||
Exercised (in US dollars per share) | 0.34 | ||
Ending balance (in US dollars per share) | 13.60 | $ 16.15 | |
Exercisable (in US dollars per share) | 15.80 | ||
Vested and expected to vest (in US dollars per share) | $ 13.60 | ||
Weighted average, remaining contractual for life (years) | |||
Beginning, end of period | 6 years 10 months 24 days | 6 years 4 months 24 days | |
Exercisable | 5 years 6 months | ||
Vested and expected to vest | 6 years 4 months 24 days | ||
Weighted average, aggregate intrinsic value | |||
Balance | $ 944 | $ 3,281 | |
Exercisable | 859 | ||
Vested and expected to vest | $ 944 |
Stock-Based Compensation - Su_3
Stock-Based Compensation - Summary of Restricted Stock Units Activity (Details) - Restricted Stock Units (RSUs) | 12 Months Ended |
Dec. 31, 2023 $ / shares shares | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward] | |
Beginning balance (in shares) | shares | 675,406 |
Granted (in shares) | shares | 1,617,050 |
Cancelled (in shares) | shares | (417,780) |
Vested (in shares) | shares | (261,461) |
Ending balance (in shares) | shares | 1,613,215 |
Weighted-Average Fair Value per Share | |
Beginning balance (in US dollars per share) | $ / shares | $ 12.31 |
Granted (in US dollars per share) | $ / shares | 3.76 |
Cancelled (in US dollars per share) | $ / shares | 6.41 |
Vested (in US dollars per share) | $ / shares | 12.38 |
Ending balance (in US dollars per share) | $ / shares | $ 5.25 |
Stock-Based Compensation - Su_4
Stock-Based Compensation - Summary of Performance Stock Units Activity (Details) - Performance Shares | 12 Months Ended |
Dec. 31, 2023 $ / shares shares | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward] | |
Beginning balance (in shares) | shares | 0 |
Granted (in shares) | shares | 218,450 |
Cancelled (in shares) | shares | 0 |
Vested (in shares) | shares | 0 |
Ending balance (in shares) | shares | 218,450 |
Weighted-Average Fair Value per Share | |
Beginning balance (in US dollars per share) | $ / shares | $ 0 |
Granted (in US dollars per share) | $ / shares | 5.73 |
Cancelled (in US dollars per share) | $ / shares | 0 |
Vested (in US dollars per share) | $ / shares | 0 |
Ending balance (in US dollars per share) | $ / shares | $ 5.73 |
Stock-Based Compensation - Su_5
Stock-Based Compensation - Summary of Deferred Share Units Activity (Details) - Deferred Shares | 12 Months Ended |
Dec. 31, 2023 $ / shares shares | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward] | |
Beginning balance (in shares) | shares | 0 |
Granted (in shares) | shares | 50,000 |
Cancelled (in shares) | shares | 0 |
Vested (in shares) | shares | 0 |
Ending balance (in shares) | shares | 50,000 |
Weighted-Average Fair Value per Share | |
Beginning balance (in US dollars per share) | $ / shares | $ 0 |
Granted (in US dollars per share) | $ / shares | 2.83 |
Cancelled (in US dollars per share) | $ / shares | 0 |
Vested (in US dollars per share) | $ / shares | 0 |
Ending balance (in US dollars per share) | $ / shares | $ 2.83 |
License Revenue (Details)
License Revenue (Details) | 1 Months Ended | 3 Months Ended | 12 Months Ended | 29 Months Ended | |||||||||
Sep. 13, 2023 USD ($) | Aug. 03, 2020 USD ($) | Jul. 22, 2020 USD ($) | May 22, 2020 USD ($) performance_obligation | Sep. 30, 2020 USD ($) | Sep. 30, 2023 USD ($) | Mar. 31, 2023 USD ($) | Dec. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | Dec. 31, 2022 USD ($) | Apr. 28, 2023 USD ($) | Jun. 15, 2020 USD ($) | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||||||||||||
Milestone revenue | $ 82,511,000 | $ 51,301,000 | $ 31,476,000 | ||||||||||
A R C Therapeutics L L C | |||||||||||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||||||||||||
Upfront payment received | $ 1,000,000 | ||||||||||||
Percentage of equity interest received | 10% | ||||||||||||
Value of equity interest received | $ 1,100,000 | ||||||||||||
Milestone payments receivable | $ 2,000,000 | ||||||||||||
Percentage of equity interest | 10% | 6.50% | |||||||||||
Number of performance obligations | performance_obligation | 1 | ||||||||||||
Milestone revenue | $ 2,100,000 | $ 0 | |||||||||||
Genor Biopharma Co Inc | |||||||||||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||||||||||||
Milestone payments receivable | $ 40,000,000 | ||||||||||||
Milestone revenue | $ 6,000,000 | $ 3,000,000 | 0 | ||||||||||
Upfront cash payment receivable under agreement | $ 6,000,000 | ||||||||||||
E Q Rx Inc | |||||||||||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||||||||||||
Upfront payment received | $ 1,600,000 | $ 20,000,000 | |||||||||||
Milestone payments receivable | $ 290,000,000 | ||||||||||||
Milestone revenue | $ 20,000,000 | ||||||||||||
Revenue recognized for reimbursement of clinical trials costs | 1,700,000 | ||||||||||||
Revenue recognized | $ 1,400,000 | ||||||||||||
Deferred revenue | 200,000 | ||||||||||||
Nanjing Simcere Dongyuan Pharmaceutical Co Ltd | |||||||||||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||||||||||||
Upfront payment received | $ 14,000,000 | ||||||||||||
Revenue recognized for reimbursement of clinical trials costs | 700,000 | ||||||||||||
Revenue recognized for reimbursement of supply, manufacturing services and patent costs | 2,900,000 | ||||||||||||
Nanjing Simcere Dongyuan Pharmaceutical Co Ltd | Royalty | |||||||||||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||||||||||||
Upfront payment received | 30,000,000 | ||||||||||||
Milestone revenue | $ 600,000 | ||||||||||||
Nanjing Simcere Dongyuan Pharmaceutical Co Ltd | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | |||||||||||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||||||||||||
Milestone revenue | $ 22,000,000 | ||||||||||||
Upfront cash payment receivable under agreement | $ 30,000,000 | ||||||||||||
Nanjing Simcere Dongyuan Pharmaceutical Co Ltd | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | Filing of NDA of TNBC | |||||||||||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||||||||||||
Revenue, remaining performance obligation, variable consideration amount | 5,000,000 | ||||||||||||
Nanjing Simcere Dongyuan Pharmaceutical Co Ltd | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | Regulatory Approval of TNBC | |||||||||||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||||||||||||
Revenue, remaining performance obligation, variable consideration amount | $ 13,000,000 |
Net Loss Per Common Share (Deta
Net Loss Per Common Share (Details) - shares | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Total potential dilutive shares | 9,209,839 | 8,329,042 | 7,507,883 |
Stock options issued and outstanding | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Total potential dilutive shares | 7,507,583 | 7,692,064 | 7,056,745 |
Restricted Stock Units (RSUs) | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Total potential dilutive shares | 1,458,341 | 636,978 | 451,138 |
Performance Shares | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Total potential dilutive shares | 216,655 | 0 | 0 |
Deferred Shares | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Total potential dilutive shares | 27,260 | 0 | 0 |
Income Taxes - Narrative (Detai
Income Taxes - Narrative (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | |||
Nov. 18, 2021 | Apr. 30, 2019 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Income Taxes [Line Items] | |||||
Unrecognized tax benefits | $ 0 | $ 0 | |||
NC Tax Rate Change | 0 | 0 | $ 8,359 | ||
Research and experimentation costs | 21,546 | 17,945 | |||
Valuation allowance, deferred tax asset, Increase, amount | (9,900) | ||||
Deferred tax assets, valuation allowance | 183,740 | 173,872 | |||
Tax credit carryforwards, research | 23,351 | $ 20,516 | |||
Federal | |||||
Income Taxes [Line Items] | |||||
Net operating loss carryforwards | 550,700 | ||||
Operating loss carryforwards subject to expiration | 93,500 | ||||
Operating loss carryforwards not subject to expiration | 457,200 | ||||
Tax credit carryforwards, research | 23,400 | ||||
Operating loss carryforwards limitation | $ 8,000 | ||||
State | |||||
Income Taxes [Line Items] | |||||
Net operating loss carryforwards | $ 401,200 | ||||
Operating loss carryforwards limitation | 1,200 | ||||
Research Tax Credit Carryforward | |||||
Income Taxes [Line Items] | |||||
Tax credit carryforward limitation | $ 100 | ||||
NORTH CAROLINA | |||||
Income Taxes [Line Items] | |||||
Reduction in deferred tax assets including non operating loss | $ 0 | ||||
Benefits expected to be realized from deferred tax assets | $ 0 |
Income Taxes - Components of In
Income Taxes - Components of Income Tax Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Current Expense: | |||
Federal | $ 0 | $ 0 | $ 0 |
State | 0 | 0 | 0 |
Foreign | 3,115 | 1,700 | 925 |
Current income tax expense | 3,115 | 1,700 | 925 |
Deferred Expense: | |||
Federal | 0 | 0 | 0 |
State | 0 | 0 | 0 |
Foreign | 0 | 0 | 0 |
Income tax expense | $ 3,115 | $ 1,700 | $ 925 |
Income Taxes - Effective Income
Income Taxes - Effective Income Tax Rate Reconciliation (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |||
Federal income tax benefit at statutory rate: | $ (9,419) | $ (30,631) | $ (30,960) |
Increase (reduction) in income tax resulting from: | |||
State Income Taxes | (706) | (5,372) | (1,923) |
Increase in Valuation Allowance | 9,868 | 36,472 | 27,618 |
Stock Compensation | 3,873 | 2,879 | 108 |
Research and Development Credit | (2,835) | (3,521) | (3,030) |
NC Tax Rate Change | 0 | 0 | 8,359 |
Foreign Withholding Tax | 3,115 | 1,700 | 925 |
Foreign Tax Deduction | (654) | 0 | 0 |
Other | (127) | 173 | (172) |
Income tax expense | $ 3,115 | $ 1,700 | $ 925 |
Income Taxes - Summary of Tax E
Income Taxes - Summary of Tax Effects of Temporary Differences and Operating Loss Carryforwards (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Deferred tax assets | ||
Accrued expenses | $ 2,966 | $ 4,127 |
Operating lease liabilities | 1,337 | 1,596 |
Stock compensation | 9,223 | 10,518 |
R&D credits | 23,351 | 20,516 |
Net operating loss carryforwards | 120,626 | 117,896 |
Nondeductible Interest | 3,691 | 2,178 |
Research and experimentation costs | 21,546 | 17,945 |
Other | 2,160 | 571 |
Deferred tax assets | 184,900 | 175,347 |
Deferred tax liabilities | ||
Operating lease assets | (1,160) | (1,410) |
Other | 0 | (65) |
Deferred tax liabilities | (1,160) | (1,475) |
Valuation allowance | (183,740) | (173,872) |
Net deferred tax assets | $ 0 | $ 0 |
Income Taxes - Summary of Chang
Income Taxes - Summary of Changes in Deferred Tax Valuation Allowance (Details) - Valuation Allowance of Deferred Tax Assets - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | |||
Beginning balance | $ 173,872 | $ 137,400 | $ 109,782 |
SEC Schedule, 12-09, Valuation Allowances and Reserves, Additions, Charge to Cost and Expense | 9,868 | 36,472 | 35,961 |
Write-offs | 0 | 0 | (8,343) |
Ending balance | $ 183,740 | $ 173,872 | $ 137,400 |
Related Party Transactions (Det
Related Party Transactions (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2023 USD ($) | |
Senior Advisor Agreement | Board of Directors Chairman | |
Related Party Transaction [Line Items] | |
Related party payments | $ 50 |