Cover
Cover - shares | 3 Months Ended | |
Mar. 31, 2024 | Apr. 26, 2024 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Annual Report | true | |
Document Period End Date | Mar. 31, 2024 | |
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 $.0001 par value | |
Trading Symbol | GTHX | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 52,281,391 | |
Entity Central Index Key | 0001560241 | |
Amendment Flag | false | |
Document Fiscal Period Focus | Q1 | |
Document Fiscal Year Focus | 2024 |
Condensed Balance Sheets (unaud
Condensed Balance Sheets (unaudited) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Current assets | ||
Cash and cash equivalents | $ 19,887 | $ 32,218 |
Restricted cash | 63 | 63 |
Marketable securities | 45,299 | 49,938 |
Accounts receivable and unbilled receivables, net | 11,654 | 12,687 |
Inventories, net | 12,548 | 12,442 |
Prepaid expenses and other current assets | 6,388 | 7,600 |
Total current assets | 95,839 | 114,948 |
Property and equipment, net | 1,355 | 1,476 |
Restricted cash | 187 | 187 |
Operating lease assets | 4,630 | 4,908 |
Other assets | 15 | 21 |
Total assets | 102,026 | 121,540 |
Current liabilities | ||
Accounts payable | 5,109 | 3,992 |
Accrued expenses | 17,867 | 21,893 |
Deferred revenue | 396 | 620 |
Loan payable, current portion | 5,946 | 0 |
Other current liabilities | 3,285 | 3,211 |
Total current liabilities | 32,603 | 29,716 |
Loan payable, net of current portion | 37,147 | 51,557 |
Deferred revenue | 500 | 500 |
Operating lease liabilities | 3,996 | 4,340 |
Other liabilities | 41 | 41 |
Total liabilities | 74,287 | 86,154 |
Stockholders’ equity | ||
Common stock, $0.0001 par value, 120,000,000 shares authorized as of March 31, 2024, and December 31, 2023; 52,261,051 and 51,952,741 shares issued as of March 31, 2024, and December 31, 2023, respectively; 52,234,385 and 51,926,075 shares outstanding as of March 31, 2024, and December 31, 2023, respectively | 5 | 5 |
Treasury stock, 26,666 shares as of March 31, 2024, and December 31, 2023 | (8) | (8) |
Additional paid-in capital | 817,946 | 815,374 |
Accumulated deficit | (790,204) | (779,985) |
Total stockholders’ equity | 27,739 | 35,386 |
Total liabilities and stockholders' equity | $ 102,026 | $ 121,540 |
Condensed Statements of Operati
Condensed Statements of Operations (unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Revenues [Abstract] | ||
Total revenues | $ 14,476 | $ 12,946 |
Operating Expenses [Abstract] | ||
Cost of goods sold | 1,079 | 1,459 |
Research and development | 7,318 | 15,480 |
Selling, general and administrative | 15,127 | 21,753 |
Total operating expenses | 23,524 | 38,692 |
Loss from operations | (9,048) | (25,746) |
Other income (expense) | ||
Interest income | 281 | 716 |
Interest expense | (1,978) | (3,089) |
Other income (expense) | 526 | 524 |
Total other income (expense), net | (1,171) | (1,849) |
Loss before income taxes | (10,219) | (27,595) |
Income tax expense | 0 | 0 |
Net loss | $ (10,219) | $ (27,595) |
Earnings Per Share [Abstract] | ||
Basic (in usd per share) | $ (0.20) | $ (0.53) |
Diluted (in usd per share) | $ (0.20) | $ (0.53) |
Weighted Average Common Shares Outstanding [Abstract] | ||
Basic (in shares) | 52,171,684 | 51,647,934 |
Diluted (in shares) | 52,171,684 | 51,647,934 |
Product sales, net | ||
Revenues [Abstract] | ||
Total revenues | $ 14,079 | $ 10,492 |
License revenue | ||
Revenues [Abstract] | ||
Total revenues | $ 397 | $ 2,454 |
Condensed Statements of Stockho
Condensed Statements of Stockholders' Equity (unaudited) - USD ($) $ in Thousands | Total | Common stock | Treasury stock | Additional paid-in capital | Accumulated deficit |
Beginning balance common stock, shares, outstanding (in shares) at Dec. 31, 2022 | 51,526,100 | ||||
Beginning balance at Dec. 31, 2022 | $ 68,747 | $ 5 | $ (8) | $ 800,768 | $ (732,018) |
Beginning balance treasury stock, shares (in shares) at Dec. 31, 2022 | (26,666) | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Public offering | (1) | (1) | |||
Exercise of common stock options (in shares) | 3,008 | ||||
Exercise of common stock options | 1 | 1 | |||
Restricted stock units vested (in shares) | 156,855 | ||||
Restricted stock units vested | 0 | ||||
Stock-based compensation | 3,836 | 3,836 | |||
Net loss | (27,595) | (27,595) | |||
Ending balance common stock, shares, outstanding (in shares) at Mar. 31, 2023 | 51,685,963 | ||||
Ending balance at Mar. 31, 2023 | $ 44,988 | $ 5 | $ (8) | 804,604 | (759,613) |
Ending balance treasury stock, shares (in shares) at Mar. 31, 2023 | (26,666) | ||||
Beginning balance common stock, shares, outstanding (in shares) at Dec. 31, 2023 | 51,926,075 | 51,952,741 | |||
Beginning balance at Dec. 31, 2023 | $ 35,386 | $ 5 | $ (8) | 815,374 | (779,985) |
Beginning balance treasury stock, shares (in shares) at Dec. 31, 2023 | (26,666) | (26,666) | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Public offering | $ 0 | 0 | |||
Exercise of common stock options (in shares) | 90,266 | 90,266 | |||
Exercise of common stock options | $ 26 | 26 | |||
Restricted stock units vested (in shares) | 218,044 | ||||
Restricted stock units vested | 0 | ||||
Stock-based compensation | 2,546 | 2,546 | |||
Net loss | $ (10,219) | (10,219) | |||
Ending balance common stock, shares, outstanding (in shares) at Mar. 31, 2024 | 52,234,385 | 52,261,051 | |||
Ending balance at Mar. 31, 2024 | $ 27,739 | $ 5 | $ (8) | $ 817,946 | $ (790,204) |
Ending balance treasury stock, shares (in shares) at Mar. 31, 2024 | (26,666) | (26,666) |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows (unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Cash flows from operating activities | ||
Net loss | $ (10,219) | $ (27,595) |
Adjustments to reconcile net loss to net cash used in operating activities | ||
Stock-based compensation | 2,546 | 3,836 |
Accretion of discount on available for sale securities | (649) | (513) |
Depreciation and amortization | 120 | 132 |
Amortization of debt issuance costs | 290 | 541 |
Non-cash interest expense | 509 | 886 |
Change in operating assets and liabilities | ||
Accounts receivable | 1,033 | (4,931) |
Inventories | (106) | 636 |
Prepaid expenses and other assets | 1,928 | 1,673 |
Accounts payable | 679 | (2,327) |
Accrued expenses and other liabilities | (4,805) | (1,389) |
Deferred revenue | (224) | (2) |
Net cash used in operating activities | (8,898) | (29,053) |
Cash flows from investing activities | ||
Purchases of marketable securities | (17,212) | (25,090) |
Maturities of marketable securities | 22,500 | 28,000 |
Proceeds from disposal of property and equipment | 1 | 0 |
Net cash provided by investing activities | 5,289 | 2,910 |
Cash flows from financing activities | ||
Proceeds from stock options exercised | 26 | 1 |
Repayment of debt | (8,748) | 0 |
Payment of public offering costs | 0 | (215) |
Net cash used in financing activities | (8,722) | (214) |
Net change in cash, cash equivalents and restricted cash | (12,331) | (26,357) |
Cash, cash equivalents and restricted cash | ||
Beginning of period | 32,468 | 94,907 |
End of period | 20,137 | 68,550 |
Supplemental disclosure of cash flow information | ||
Cash paid for interest | 1,823 | 2,512 |
Supplemental disclosure of non-cash operating activities | ||
Prepaid expenses and other current assets in accounts payable and accrued expenses | $ 126 | $ 341 |
Condensed Balance Sheets (una_2
Condensed Balance Sheets (unaudited) (Parenthetical) - $ / shares | Mar. 31, 2024 | Dec. 31, 2023 |
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) | 52,261,051 | 51,952,741 |
Common stock, shares outstanding (in shares) | 52,234,385 | 51,926,075 |
Treasury stock, common, shares (in shares) | 26,666 | 26,666 |
Description of Business
Description of Business | 3 Months Ended |
Mar. 31, 2024 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Description of Business | Description of BusinessG1 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) in patients with extensive-stage small cell lung cancer (“ES-SCLC”), and is the first innovation in managing myeloprotection in decades. In October 2023, COSELA (trilaciclib hydrochloride for injection) was granted full approval by the China National Medical Products Administration (NMPA) for marketing in mainland China. The Company is also exploring the potential use of trilaciclib in certain cancers, focused in the core areas of metastatic triple negative breast cancer (“mTNBC”) and treatment combinations with targeted chemotherapy medicines called antibody-drug conjugates (“ADCs”) including other indications. |
Basis of Presentation and Summa
Basis of Presentation and Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2024 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Significant Accounting Policies | Basis of Presentation and Summary of Significant Accounting Policies Basis of Presentation The accompanying condensed financial statements of the Company have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”). In the opinion of management, the Company has made all necessary adjustments, which include normal recurring adjustments necessary for a fair statement of the Company’s financial position and results of operations for the interim periods presented. The information presented in the condensed financial statements and related notes as of March 31, 2024, and for the three months ended March 31, 2024, and 2023, is unaudited. The results for the three months ended March 31, 2024, are not necessarily indicative of the results expected for the full fiscal year or any future period. These interim financial statements should be read in conjunction with the financial statements and notes set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC on February 28, 2024 (the “2023 Form 10-K”). The December 31, 2023 condensed balance sheet included herein was derived from the audited financial statements as of that date, but does not include all disclosures, including notes, required by U.S. GAAP for complete financial statements. The Company has experienced net losses since its inception and had an accumulated deficit of $790.2 million and $780.0 million as of March 31, 2024 and December 31, 2023, 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 condensed financial statements, the Company expects that its cash and cash equivalents and marketable securities as of March 31, 2024 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 condensed 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 condensed financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business. The condensed 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 March 31, 2024, the Company was 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 condensed financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed 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, and stock-based compensation expense. 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 March 31, 2024 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. As of March 31, 2024, restricted cash totaled $250 thousand. 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 March 31, 2024 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 March 31, 2024, the u nrealized gains and losses were 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 were none for the quarter ended March 31, 2024, 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 March 31, 2024, unbilled accounts receivable totale d $0.1 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. 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). 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 Condensed 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 Condensed Balance Sheets. 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. 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 March 31, 2024, 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 condensed 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 condensed 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 March 31, 2024 and December 31, 2023, 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 condensed statements of operations. As of March 31, 2024 and December 31, 2023, the Company had no such accruals. 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. |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 3 Months Ended |
Mar. 31, 2024 | |
Fair Value Disclosures [Abstract] | |
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 March 31, 2024 and December 31, 2023, these financial instruments and respective fair values have been classified as follows (in thousands): Quoted prices Significant Significant Balance at March 31, Assets: Money market accounts and funds $ 19,696 $ — $ — $ 19,696 Marketable securities: U.S. Treasury Bills 45,299 — — 45,299 Total assets at fair value $ 64,995 $ — $ — $ 64,995 Quoted prices Significant Significant Balance at December 31, 2023 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 During the three months ended March 31, 2024, and the year ended December 31, 2023, there were no changes in valuation methodology. As of March 31, 2024, the carrying value of the Loan Payable (discussed in Note 7) was $43.1 million, and approximates fair value as the variable interest rate re-prices frequently. |
Inventories
Inventories | 3 Months Ended |
Mar. 31, 2024 | |
Inventory Disclosure [Abstract] | |
Inventories | Inventories Inventories consist of the following (in thousands): March 31, 2024 December 31, 2023 Raw materials $ 2,419 $ 2,422 Work in process 9,343 9,593 Finished goods 786 427 Inventories, net $ 12,548 $ 12,442 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 | 3 Months Ended |
Mar. 31, 2024 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | Property and Equipment Property and equipment consists of the following (in thousands): March 31, 2024 December 31, 2023 Computer equipment $ 327 $ 327 Laboratory equipment 331 334 Furniture and fixtures 866 866 Leasehold improvements 1,782 1,782 Manufacturing equipment 506 506 Accumulated depreciation (2,457) (2,339) Property and equipment, net $ 1,355 $ 1,476 |
Accrued Expenses
Accrued Expenses | 3 Months Ended |
Mar. 31, 2024 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | Accrued Expenses Accrued expenses are comprised as follows (in thousands): March 31, 2024 December 31, 2023 Accrued external research $ 19 $ 109 Accrued professional fees and other 5,923 5,854 Accrued external clinical study costs 10,345 10,944 Accrued compensation expense 1,580 4,986 Accrued expenses $ 17,867 $ 21,893 |
Loan Payable
Loan Payable | 3 Months Ended |
Mar. 31, 2024 | |
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. The Loan Agreement was subsequently amended via First, Second, Third, and Fourth Amendments throughout 2021 and 2022. 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 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. During the quarter ended March 31, 2024, the Company repaid $8.2 million in principal and $0.5 million in a pro-rata portion of the end of term charge. As of March 31, 2024, the outstanding principal of $41.8 million does not exceed the required threshold of trailing three month revenue for the period ended March 31, 2024. Additionally, as of March 31, 2024 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 March 31, 2024 and December 31, 2023, the carrying value of the debt under the Loan Agreement, which approximates its fair value, consisted of the following (in thousands): March 31, 2024 December 31, 2023 Loan payable, principal $ 41,805 $ 50,000 End of term charges 4,907 5,460 Loan payable, including end of term charges 46,712 55,460 Unamortized debt discount, issuance costs, and unaccreted value of end of term charges (3,619) (3,903) Carrying value of loan payable $ 43,093 $ 51,557 As of March 31, 2024, the Company classified $5.9 million of the loan payable as current, which represents $6.1 million of principal payments due, net of $0.2 million in amortization of the debt discount and debt issuance costs from the period ended March 31, 2024 through March 31, 2025. The effective interest rate of the outstanding debt under the Loan Agreement was approximately 20.7% and 17.3% as of March 31, 2024 and 2023, respectively. The Company recognized $2.0 million of interest expense related to the debt for the three months ended March 31, 2024. Included in such expense was $0.2 million related to accretion of the end of term charges and an immaterial amount of debt discount and debt issuance cost amortization. During the three months ended March 31, 2023, the Company recognized $3.1 million of interest expense related to the debt, of which $0.4 million related to accretion of the end of term charges and an immaterial amount related to debt discount and debt issuance cost amortization. Interest expense is reflected in other income (expense), net on the statement of operations. Estimated future principal payments due under the Loan Agreement, including the contractual end of term charges and excluding interest, are as follows as of March 31, 2024 (in thousands): Future Payments 2024 $ 1,517 2025 21,685 2026 23,510 Total principal payments, including end of term charges $ 46,712 |
Stockholders' Equity
Stockholders' Equity | 3 Months Ended |
Mar. 31, 2024 | |
Equity [Abstract] | |
Stockholders' Equity | Stockholders’ Equity Common stock The Company is authorized to issue 120,000,000 shares of common stock. 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. Preferred stock The Company is authorized to issue 5,000,000 shares of undesignated preferred stock in one or more series. As of March 31, 2024, 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 at March 31, 2024 and December 31, 2023 as follows: March 31, 2024 December 31, 2023 Common stock options outstanding 7,490,294 6,774,186 RSUs outstanding (1) 1,970,668 1,613,215 PSUs outstanding (1) 310,200 218,450 DSUs outstanding (1) 50,000 50,000 Options, RSUs, PSUs and DSUs available for grant under Equity Incentive Plans (1) 2,007,966 2,385,034 11,829,128 11,040,885 (1) RSUs, PSUs, and DSUs are further defined in Note 9. |
Stock-Based Compensation
Stock-Based Compensation | 3 Months Ended |
Mar. 31, 2024 | |
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 provides 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, 2024, 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. Beginning in January 2024, PSUs will be granted solely to the Company’s Chief Executive Officer. 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 March 31, 2024, there were a total of 961,972 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 March 31, 2024, there was a total of 1,045,994 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. The table below summarizes the stock-based compensation expense recognized in the Company’s statement of operations by classification (in thousands): Three Months Ended March 31, 2024 2023 Cost of goods sold $ 19 $ 35 Research and development 379 674 Selling, general and administrative 2,148 3,127 Total stock-based compensation expense $ 2,546 $ 3,836 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: Three Months Ended March 31, 2024 2023 Expected volatility 88.8% - 97.9% 81.4% - 86.8% Weighted-average risk free rate 3.9% - 4.1% 3.4% - 3.9% Dividend yield —% —% Expected term (in years) 6.08 6.08 Stock Option Activity The following table is a summary of stock option activity for the three months ended March 31, 2024: Weighted average Options Weighted Remaining Aggregate (in thousands) Balance as of December 31, 2023 6,774,186 $ 13.60 6.4 $ 944 Granted 1,126,430 2.97 Cancelled (320,056) 7.28 Exercised (90,266) 0.30 Balance as of March 31, 2024 7,490,294 $ 12.43 6.6 $ 2,992 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 Exercisable at March 31, 2024 5,029,643 $ 15.67 5.5 $ 1,054 Vested at March 31, 2024 and expected to vest 7,490,294 $ 12.43 6.6 $ 2,992 As of March 31, 2024, unrecognized compensation expense related to unvested stock options totaled $9.3 million, which is expected to be recognized over a weighted-average period of approximately 2.1 years. 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 three months ended March 31, 2024: Number of Weighted – Average Balance as of December 31, 2023 1,613,215 $ 5.25 Granted 813,898 3.12 Cancelled (238,401) 4.36 Vested (218,044) 10.54 Balance as of March 31, 2024 1,970,668 $ 3.89 As of March 31, 2024, there was $6.2 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 2.3 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 March 31, 2024, 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 three months ended March 31, 2024: Number of Weighted – Average Balance as of December 31, 2023 218,450 $ 5.73 Granted 100,700 2.97 Cancelled (8,950) 5.73 Vested — — Balance as of March 31, 2024 310,200 $ 4.83 As of March 31, 2024, there was $1.5 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 three months ended March 31, 2024: Number of Weighted – Average Balance as of December 31, 2023 50,000 $ 2.83 Granted — — Cancelled — — Vested — — Balance as of March 31, 2024 50,000 $ 2.83 As of March 31, 2024, unrecognized compensation cost related to the Company's DSUs that are expected to vest was immaterial. These costs are expected to be recognized over a weighted-average period of approximately 0.2 years. |
License Revenue
License Revenue | 3 Months Ended |
Mar. 31, 2024 | |
Revenue Recognition and Deferred Revenue [Abstract] | |
License Revenue | License Revenue Incyclix License Agreement On May 22, 2020 (the "effective date"), 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 three months ended March 31, 2024 or 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 three months ended March 31, 2024 or 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 three months ended March 31, 2024, the remaining $0.2 million previously held as short-term deferred revenue on the balance sheet for the year-ended December 31, 2023 was recognized as revenue as the remaining clinical trial wind down costs following EQRx's termination of the license agreement were incurred. During the three months ended March 31, 2023, the Company recognized revenue of $0.4 million for the reimbursement of patent and clinical trial costs. No development and commercial milestones, as defined by the license agreement, were achieved through March 31, 2024 or 2023. 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 three months ended March 31, 2024, the Company recognized revenue of $0.1 million in patent and clinical trial reimbursable costs. During the three months ended March 31, 2023 , the Company recognized $1.4 million in revenue from supply and manufacturing services and $0.5 million in royalty revenue. No milestone revenue was recognized during the three months ended March 31, 2024 or 2023. |
Net Loss Per Common Share
Net Loss Per Common Share | 3 Months Ended |
Mar. 31, 2024 | |
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 three months ended March 31, 2024 and 2023 the following potentially dilutive securities have been excluded from the computations of diluted weighted-average shares outstanding because the effect would be anti-dilutive: Three Months Ended March 31, 2024 2023 Stock options issued and outstanding 7,715,721 8,085,891 Unvested RSUs 1,959,536 952,481 Unvested PSUs 314,749 211,168 Unvested DSUs 50,000 — Total potential dilutive shares 10,040,006 9,249,540 Amounts in the table above reflect the common stock equivalents of the noted instruments. |
Income Taxes
Income Taxes | 3 Months Ended |
Mar. 31, 2024 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes The Company’s effective income tax rate was 0% for the three months ended March 31, 2024 and 2023. The Company continues to recognize losses in the United States and therefore, has recorded no tax benefit associated with these losses. |
Related Party Transactions
Related Party Transactions | 3 Months Ended |
Mar. 31, 2024 | |
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 continues 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 Amendment, the term of the Agreement was 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. |
Subsequent Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2024 | |
Subsequent Events [Abstract] | |
Subsequent Events | Subsequent Events |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Pay vs Performance Disclosure | ||
Net loss | $ (10,219) | $ (27,595) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Mar. 31, 2024 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Basis of Presentation and Sum_2
Basis of Presentation and Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2024 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying condensed financial statements of the Company have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”). In the opinion of management, the Company has made all necessary adjustments, which include normal recurring adjustments necessary for a fair statement of the Company’s financial position and results of operations for the interim periods presented. The information presented in the condensed financial statements and related notes as of March 31, 2024, and for the three months ended March 31, 2024, and 2023, is unaudited. The results for the three months ended March 31, 2024, are not necessarily indicative of the results expected for the full fiscal year or any future period. These interim financial statements should be read in conjunction with the financial statements and notes set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC on February 28, 2024 (the “2023 Form 10-K”). The December 31, 2023 condensed balance sheet included herein was derived from the audited financial statements as of that date, but does not include all disclosures, including notes, required by U.S. GAAP for complete financial statements. The Company has experienced net losses since its inception and had an accumulated deficit of $790.2 million and $780.0 million as of March 31, 2024 and December 31, 2023, 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 condensed financial statements, the Company expects that its cash and cash equivalents and marketable securities as of March 31, 2024 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 condensed 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 condensed financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business. The condensed 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 March 31, 2024 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. As of March 31, 2024, restricted cash totaled $250 thousand. |
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 were none for the quarter ended March 31, 2024, 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. |
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). 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 Condensed 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 Condensed Balance Sheets. |
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. |
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 condensed 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. |
Basis of Presentation and Sum_3
Basis of Presentation and Summary of Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Accounting Policies [Abstract] | |
Schedule of Property and Equipment | Property and equipment consists of the following (in thousands): March 31, 2024 December 31, 2023 Computer equipment $ 327 $ 327 Laboratory equipment 331 334 Furniture and fixtures 866 866 Leasehold improvements 1,782 1,782 Manufacturing equipment 506 506 Accumulated depreciation (2,457) (2,339) Property and equipment, net $ 1,355 $ 1,476 |
Summary of Financial Instruments and Respective Fair Values | At March 31, 2024 and December 31, 2023, these financial instruments and respective fair values have been classified as follows (in thousands): Quoted prices Significant Significant Balance at March 31, Assets: Money market accounts and funds $ 19,696 $ — $ — $ 19,696 Marketable securities: U.S. Treasury Bills 45,299 — — 45,299 Total assets at fair value $ 64,995 $ — $ — $ 64,995 Quoted prices Significant Significant Balance at December 31, 2023 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 |
Fair Value of Financial Instr_2
Fair Value of Financial Instruments (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Fair Value Disclosures [Abstract] | |
Summary of Financial Instruments and Respective Fair Values | At March 31, 2024 and December 31, 2023, these financial instruments and respective fair values have been classified as follows (in thousands): Quoted prices Significant Significant Balance at March 31, Assets: Money market accounts and funds $ 19,696 $ — $ — $ 19,696 Marketable securities: U.S. Treasury Bills 45,299 — — 45,299 Total assets at fair value $ 64,995 $ — $ — $ 64,995 Quoted prices Significant Significant Balance at December 31, 2023 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 |
Inventories (Tables)
Inventories (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventories | Inventories consist of the following (in thousands): March 31, 2024 December 31, 2023 Raw materials $ 2,419 $ 2,422 Work in process 9,343 9,593 Finished goods 786 427 Inventories, net $ 12,548 $ 12,442 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment | Property and equipment consists of the following (in thousands): March 31, 2024 December 31, 2023 Computer equipment $ 327 $ 327 Laboratory equipment 331 334 Furniture and fixtures 866 866 Leasehold improvements 1,782 1,782 Manufacturing equipment 506 506 Accumulated depreciation (2,457) (2,339) Property and equipment, net $ 1,355 $ 1,476 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses are comprised as follows (in thousands): March 31, 2024 December 31, 2023 Accrued external research $ 19 $ 109 Accrued professional fees and other 5,923 5,854 Accrued external clinical study costs 10,345 10,944 Accrued compensation expense 1,580 4,986 Accrued expenses $ 17,867 $ 21,893 |
Loan Payable (Tables)
Loan Payable (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Debt Disclosure [Abstract] | |
Schedule of Carrying Values of Debt Instruments | As of March 31, 2024 and December 31, 2023, the carrying value of the debt under the Loan Agreement, which approximates its fair value, consisted of the following (in thousands): March 31, 2024 December 31, 2023 Loan payable, principal $ 41,805 $ 50,000 End of term charges 4,907 5,460 Loan payable, including end of term charges 46,712 55,460 Unamortized debt discount, issuance costs, and unaccreted value of end of term charges (3,619) (3,903) Carrying value of loan payable $ 43,093 $ 51,557 |
Schedule of Outstanding Debt Obligations | Estimated future principal payments due under the Loan Agreement, including the contractual end of term charges and excluding interest, are as follows as of March 31, 2024 (in thousands): Future Payments 2024 $ 1,517 2025 21,685 2026 23,510 Total principal payments, including end of term charges $ 46,712 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Equity [Abstract] | |
Summary of Common Stock Shares Reserved for Future Issuance | The Company has reserved authorized shares of common stock for future issuance at March 31, 2024 and December 31, 2023 as follows: March 31, 2024 December 31, 2023 Common stock options outstanding 7,490,294 6,774,186 RSUs outstanding (1) 1,970,668 1,613,215 PSUs outstanding (1) 310,200 218,450 DSUs outstanding (1) 50,000 50,000 Options, RSUs, PSUs and DSUs available for grant under Equity Incentive Plans (1) 2,007,966 2,385,034 11,829,128 11,040,885 (1) RSUs, PSUs, and DSUs are further defined in Note 9. |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
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): Three Months Ended March 31, 2024 2023 Cost of goods sold $ 19 $ 35 Research and development 379 674 Selling, general and administrative 2,148 3,127 Total stock-based compensation expense $ 2,546 $ 3,836 |
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: Three Months Ended March 31, 2024 2023 Expected volatility 88.8% - 97.9% 81.4% - 86.8% Weighted-average risk free rate 3.9% - 4.1% 3.4% - 3.9% Dividend yield —% —% Expected term (in years) 6.08 6.08 |
Summary of Stock Option Activity | The following table is a summary of stock option activity for the three months ended March 31, 2024: Weighted average Options Weighted Remaining Aggregate (in thousands) Balance as of December 31, 2023 6,774,186 $ 13.60 6.4 $ 944 Granted 1,126,430 2.97 Cancelled (320,056) 7.28 Exercised (90,266) 0.30 Balance as of March 31, 2024 7,490,294 $ 12.43 6.6 $ 2,992 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 Exercisable at March 31, 2024 5,029,643 $ 15.67 5.5 $ 1,054 Vested at March 31, 2024 and expected to vest 7,490,294 $ 12.43 6.6 $ 2,992 |
Summary of Restricted Stock Units Activity | The following table is a summary of the RSU activity for the three months ended March 31, 2024: Number of Weighted – Average Balance as of December 31, 2023 1,613,215 $ 5.25 Granted 813,898 3.12 Cancelled (238,401) 4.36 Vested (218,044) 10.54 Balance as of March 31, 2024 1,970,668 $ 3.89 |
Summary of Performance Stock Units Activity | The following table is a summary of the PSU activity for the three months ended March 31, 2024: Number of Weighted – Average Balance as of December 31, 2023 218,450 $ 5.73 Granted 100,700 2.97 Cancelled (8,950) 5.73 Vested — — Balance as of March 31, 2024 310,200 $ 4.83 |
Share-Based Payment Arrangement, Deferred Shares, Activity | The following table is a summary of the DSU activity for the three months ended March 31, 2024: Number of Weighted – Average Balance as of December 31, 2023 50,000 $ 2.83 Granted — — Cancelled — — Vested — — Balance as of March 31, 2024 50,000 $ 2.83 |
Net Loss Per Common Share (Tabl
Net Loss Per Common Share (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Earnings Per Share [Abstract] | |
Schedule of Potentially Dilutive Securities Excluded from Computations of Diluted Weighted-average Shares Outstanding | For the three months ended March 31, 2024 and 2023 the following potentially dilutive securities have been excluded from the computations of diluted weighted-average shares outstanding because the effect would be anti-dilutive: Three Months Ended March 31, 2024 2023 Stock options issued and outstanding 7,715,721 8,085,891 Unvested RSUs 1,959,536 952,481 Unvested PSUs 314,749 211,168 Unvested DSUs 50,000 — Total potential dilutive shares 10,040,006 9,249,540 |
Basis of Presentation and Sum_4
Basis of Presentation and Summary of Significant Accounting Policies - Narrative (Details) - USD ($) $ in Thousands | 3 Months Ended | |||
Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | Sep. 02, 2019 | |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||||
Accumulated deficit | $ 790,204 | $ 779,985 | ||
Restricted cash | 250 | |||
Unbilled receivables, current | 100 | |||
Total stock-based compensation expense | 2,546 | $ 3,836 | ||
Unrecognized tax benefits | 0 | 0 | ||
Accrued income taxes | 0 | $ 0 | ||
Performance Shares | ||||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||||
Total stock-based compensation expense | $ 0 | |||
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 Fair Value (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
U.S. Treasury Bills | $ 45,299 | $ 49,938 |
Total assets at fair value | 64,995 | 82,048 |
Money Market Funds | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Money market accounts and funds | 19,696 | 32,110 |
Quoted prices in active markets for identical assets (Level 1) | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
U.S. Treasury Bills | 45,299 | 49,938 |
Total assets at fair value | 64,995 | 82,048 |
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 | 19,696 | 32,110 |
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 |
Loan payable, net of current portion | 43,100 | |
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 |
Fair Value of Financial Instr_3
Fair Value of Financial Instruments (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
U.S. Treasury Bills | $ 45,299 | $ 49,938 |
Total assets at fair value | 64,995 | 82,048 |
Quoted prices in active markets for identical assets (Level 1) | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
U.S. Treasury Bills | 45,299 | 49,938 |
Total assets at fair value | 64,995 | 82,048 |
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 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 |
Loan payable, net of current portion | 43,100 | |
Money Market Funds | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Money market accounts and funds | 19,696 | 32,110 |
Money Market Funds | Quoted prices in active markets for identical assets (Level 1) | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Money market accounts and funds | 19,696 | 32,110 |
Money Market Funds | Significant other observable inputs (Level 2) | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Money market accounts and funds | 0 | 0 |
Money Market Funds | Significant other unobservable inputs (Level 3) | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Money market accounts and funds | $ 0 | $ 0 |
Inventories (Details)
Inventories (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 2,419 | $ 2,422 |
Work in process | 9,343 | 9,593 |
Finished goods | 786 | 427 |
Inventories, net | $ 12,548 | $ 12,442 |
Property and Equipment - Schedu
Property and Equipment - Schedule of Property and Equipment (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Property, Plant and Equipment [Line Items] | ||
Accumulated depreciation | $ (2,457) | $ (2,339) |
Property and equipment, net | 1,355 | 1,476 |
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 | 331 | 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 | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation expenses relating to property and equipment | $ 120 | $ 132 |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Payables and Accruals [Abstract] | ||
Accrued external research | $ 19 | $ 109 |
Accrued professional fees and other | 5,923 | 5,854 |
Accrued external clinical study costs | 10,345 | 10,944 |
Accrued compensation expense | 1,580 | 4,986 |
Accrued expenses | $ 17,867 | $ 21,893 |
Loan Payable - Narrative (Detai
Loan Payable - Narrative (Details) - USD ($) $ in Thousands | 3 Months Ended | ||||||
Jun. 06, 2023 | Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | Jun. 05, 2023 | Nov. 01, 2021 | May 29, 2020 | |
Debt Instrument [Line Items] | |||||||
Repayments of debt | $ 8,748 | $ 0 | |||||
End of term fee | 200 | $ 400 | |||||
Loan payable, principal | 41,805 | $ 50,000 | |||||
Loan payable, current portion | 5,946 | $ 0 | |||||
Current maturities, gross | 6,100 | ||||||
Current unamortized discount and debt issuance costs, net | $ (200) | ||||||
Effective interest rate (as a percent) | 20.70% | 17.30% | |||||
Interest expense, debt | $ 2,000 | $ 3,100 | |||||
Loan Agreement | Hercules Capital Inc | Tranche One | |||||||
Debt Instrument [Line Items] | |||||||
Loan amount | $ 30,000 | ||||||
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 And Security Agreement | Hercules Capital Inc | Tranche One | |||||||
Debt Instrument [Line Items] | |||||||
End of term fee | $ 2,100 | ||||||
Fifth Amendment | |||||||
Debt Instrument [Line Items] | |||||||
End of term fee, pro-rata payment | $ 1,700 | ||||||
Repurchased face amount | 8,200 | ||||||
Debt prepayment cost | $ 500 | ||||||
Fifth Amendment | Hercules Capital Inc | |||||||
Debt Instrument [Line Items] | |||||||
Loan amount | 75,000 | ||||||
Repayments of debt | 25,000 | ||||||
Loan payable, net of current portion | $ 50,000 | ||||||
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, covenant, unrestricted cash balance, percentage | 35% | ||||||
Minimum quarterly net product revenue covenant | $ 45,000 | ||||||
Debt instrument trailing net product revenue | 6 months | ||||||
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 Loan
Loan Payable - Schedule of Loan Payable Carrying Value (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Debt Disclosure [Abstract] | ||
Loan payable, principal | $ 41,805 | $ 50,000 |
End of term charges | 4,907 | 5,460 |
Total principal payments, including end of term charges | 46,712 | 55,460 |
Unamortized debt discount, issuance costs, and unaccreted value of end of term charges | (3,619) | (3,903) |
Total principal payments, including end of term charges | $ 43,093 | $ 51,557 |
Loan Payable - Schedule of Outs
Loan Payable - Schedule of Outstanding Debt Obligations (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Debt Disclosure [Abstract] | ||
2024 | $ 1,517 | |
2025 | 21,685 | |
2026 | 23,510 | |
Total principal payments, including end of term charges | $ 46,712 | $ 55,460 |
Stockholders' Equity - Narrativ
Stockholders' Equity - Narrative (Details) | Mar. 31, 2024 vote shares | Dec. 31, 2023 shares |
Class of Stock [Line Items] | ||
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 | |
Common stock | ||
Class of Stock [Line Items] | ||
Common stock, shares authorized (in shares) | 120,000,000 | 120,000,000 |
Stockholders' Equity - Summary
Stockholders' Equity - Summary of Shares Reserved for Future Issuance (Details) - shares | Mar. 31, 2024 | Dec. 31, 2023 |
Class of Stock [Line Items] | ||
Common stock, shares reserved for future issuance (in shares) | 11,829,128 | 11,040,885 |
Common stock options outstanding | ||
Class of Stock [Line Items] | ||
Common stock, shares reserved for future issuance (in shares) | 7,490,294 | 6,774,186 |
Restricted Stock Unit Outstanding | ||
Class of Stock [Line Items] | ||
Common stock, shares reserved for future issuance (in shares) | 1,970,668 | 1,613,215 |
Performance Share Unit Outstanding | ||
Class of Stock [Line Items] | ||
Common stock, shares reserved for future issuance (in shares) | 310,200 | 218,450 |
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) | 2,007,966 | 2,385,034 |
Deferred Shares | ||
Class of Stock [Line Items] | ||
Common stock, shares reserved for future issuance (in shares) | 50,000 | 50,000 |
Stock-Based Compensation - Narr
Stock-Based Compensation - Narrative (Details) - USD ($) $ in Thousands | 3 Months Ended | |||||
Jan. 01, 2023 | Mar. 31, 2024 | 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 | $ 9,300 | |||||
Weighted-average recognition period | 2 years 1 month 6 days | |||||
Restricted Stock Units (RSUs) | ||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||
Weighted-average recognition period | 2 years 3 months 18 days | |||||
Number of common shares received upon vesting (in shares) | 1 | |||||
Unrecognized compensation cost | $ 6,200 | |||||
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 | $ 1,500 | |||||
Deferred Shares | ||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||
Weighted-average recognition period | 2 months 12 days | |||||
Number of common shares received upon vesting (in shares) | 1 | |||||
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) | 961,972 | |||||
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) | 1,045,994 | |||||
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 | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Total stock-based compensation expense | $ 2,546 | $ 3,836 |
Cost of goods sold | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Total stock-based compensation expense | 19 | 35 |
Research and development | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Total stock-based compensation expense | 379 | 674 |
Selling, general and administrative | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Total stock-based compensation expense | $ 2,148 | $ 3,127 |
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 | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Expected volatility, minimum | 88.80% | 81.40% |
Expected volatility, maximum | 97.90% | 86.80% |
Weighted-average risk free rate, minimum | 3.90% | 3.40% |
Weighted-average risk free rate, maximum | 4.10% | 3.90% |
Dividend yield | 0% | 0% |
Expected term (in years) | 6 years 29 days | 6 years 29 days |
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, 2024 | Dec. 31, 2023 | |
Options outstanding | ||
Beginning balance (in shares) | 6,774,186 | |
Granted (in shares) | 1,126,430 | |
Cancelled (in shares) | (320,056) | |
Exercised (in shares) | (90,266) | |
Ending balance (in shares) | 7,490,294 | 6,774,186 |
Exercisable (in shares) | 5,029,643 | 4,813,088 |
Vested and expected to vest (in shares) | 7,490,294 | 6,774,186 |
Weighted average exercise price | ||
Beginning balance (in US dollars per share) | $ 13.60 | |
Granted (in US dollars per share) | 2.97 | |
Cancelled (in US dollars per share) | 7.28 | |
Exercised (in US dollars per share) | 0.30 | |
Ending balance (in US dollars per share) | 12.43 | $ 13.60 |
Exercisable (in US dollars per share) | 15.67 | 15.80 |
Vested and expected to vest (in US dollars per share) | $ 12.43 | $ 13.60 |
Weighted average, remaining contractual for life (years) | ||
Beginning, end of period | 6 years 7 months 6 days | 6 years 4 months 24 days |
Exercisable | 5 years 6 months | 5 years 6 months |
Vested and expected to vest | 6 years 7 months 6 days | 6 years 4 months 24 days |
Weighted average, aggregate intrinsic value | ||
Balance | $ 2,992 | $ 944 |
Exercisable | 1,054 | 859 |
Vested and expected to vest | $ 2,992 | $ 944 |
Stock-Based Compensation - Su_3
Stock-Based Compensation - Summary of Restricted Stock Units Activity (Details) - Restricted Stock Units (RSUs) | 3 Months Ended |
Mar. 31, 2024 $ / 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 | 1,613,215 |
Granted (in shares) | shares | 813,898 |
Cancelled (in shares) | shares | (238,401) |
Vested (in shares) | shares | (218,044) |
Ending balance (in shares) | shares | 1,970,668 |
Weighted-Average Fair Value per Share | |
Beginning balance (in US dollars per share) | $ / shares | $ 5.25 |
Granted (in US dollars per share) | $ / shares | 3.12 |
Cancelled (in US dollars per share) | $ / shares | 4.36 |
Vested (in US dollars per share) | $ / shares | 10.54 |
Ending balance (in US dollars per share) | $ / shares | $ 3.89 |
Stock-Based Compensation - Su_4
Stock-Based Compensation - Summary of Performance Stock Units Activity (Details) - Performance Shares | 3 Months Ended |
Mar. 31, 2024 $ / 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 | 218,450 |
Granted (in shares) | shares | 100,700 |
Cancelled (in shares) | shares | (8,950) |
Vested (in shares) | shares | 0 |
Ending balance (in shares) | shares | 310,200 |
Weighted-Average Fair Value per Share | |
Beginning balance (in US dollars per share) | $ / shares | $ 5.73 |
Granted (in US dollars per share) | $ / shares | 2.97 |
Cancelled (in US dollars per share) | $ / shares | 5.73 |
Vested (in US dollars per share) | $ / shares | 0 |
Ending balance (in US dollars per share) | $ / shares | $ 4.83 |
Stock-Based Compensation - Su_5
Stock-Based Compensation - Summary of Deferred Share Units Activity (Details) - Deferred Shares | 3 Months Ended |
Mar. 31, 2024 $ / 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 | 50,000 |
Granted (in shares) | shares | 0 |
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 | $ 2.83 |
Granted (in US dollars per share) | $ / shares | 0 |
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 ($) | Mar. 31, 2024 USD ($) | Mar. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) | Dec. 31, 2022 USD ($) | Apr. 28, 2024 USD ($) | Apr. 28, 2023 USD ($) | Jun. 15, 2020 USD ($) | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||||||||||
Milestone revenue | $ 14,476,000 | $ 12,946,000 | ||||||||||
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 | 0 | 0 | $ 3,000,000 | ||||||||
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) | (400,000) | |||||||||
Milestone payments receivable | $ 290,000,000 | |||||||||||
Milestone revenue | $ 20,000,000 | |||||||||||
Deferred revenue | 200,000 | |||||||||||
Nanjing Simcere Dongyuan Pharmaceutical Co Ltd | ||||||||||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||||||||||
Upfront payment received | $ (14,000,000) | |||||||||||
Milestone revenue | 0 | 0 | ||||||||||
Revenue recognized for reimbursement of supply, manufacturing services and patent costs | $ (100,000) | (1,400,000) | ||||||||||
Nanjing Simcere Dongyuan Pharmaceutical Co Ltd | Royalty | ||||||||||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||||||||||
Milestone revenue | $ (500,000) | |||||||||||
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 | |||||||||||
Nanjing Simcere Dongyuan Pharmaceutical Co Ltd | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | Subsequent Event | ||||||||||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||||||||||
Up-front payment | $ 30,000,000 | |||||||||||
Nanjing Simcere Dongyuan Pharmaceutical Co Ltd | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | Filing 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 | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total potential dilutive shares | 10,040,006 | 9,249,540 |
Stock options issued and outstanding | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total potential dilutive shares | 7,715,721 | 8,085,891 |
Restricted Stock Units (RSUs) | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total potential dilutive shares | 1,959,536 | 952,481 |
Performance Shares | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total potential dilutive shares | 314,749 | 211,168 |
Deferred Shares | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total potential dilutive shares | 50,000 | 0 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Income Tax Disclosure [Abstract] | ||
Effective income tax rate reconciliation, percent | 0% | 0% |
Related Party Transactions (Det
Related Party Transactions (Details) $ in Thousands | 3 Months Ended |
Mar. 31, 2024 USD ($) | |
Senior Advisor Agreement | Board of Directors Chairman | |
Related Party Transaction [Line Items] | |
Related party payments | $ 0 |
Subsequent Events (Details)
Subsequent Events (Details) $ in Thousands | Apr. 30, 2024 USD ($) |
Subsequent Event | Pepper Bio, Inc | |
Subsequent Event [Line Items] | |
Revenue, remaining performance obligation, variable consideration amount | $ 135,000 |