Cover
Cover - shares | 3 Months Ended | |
Mar. 31, 2023 | Apr. 28, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2023 | |
Current Fiscal Year End Date | --12-31 | |
Document Transition Report | false | |
Entity File Number | 001-38096 | |
Entity Registrant Name | G1 THERAPEUTICS, INC. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 26-3648180 | |
Entity Address, Address Line One | 700 Park Offices Drive | |
Entity Address, Address Line Two | Suite 200 | |
Entity Address, City or Town | Research Triangle Park | |
Entity Address, State or Province | NC | |
Entity Address, Postal Zip Code | 27709 | |
City Area Code | 919 | |
Local Phone Number | 213-9835 | |
Title of 12(b) Security | Common Stock $.0001 par value | |
Trading Symbol | GTHX | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 51,660,547 | |
Entity Central Index Key | 0001560241 | |
Amendment Flag | false | |
Document Fiscal Period Focus | Q1 | |
Document Fiscal Year Focus | 2023 |
Condensed Balance Sheets (unaud
Condensed Balance Sheets (unaudited) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Current assets | ||
Cash and cash equivalents | $ 68,237 | $ 94,594 |
Restricted cash | 63 | 63 |
Marketable securities | 48,080 | 50,476 |
Accounts receivable and unbilled receivables, net | 16,025 | 11,094 |
Inventories | 15,543 | 16,179 |
Prepaid expenses and other current assets | 6,017 | 7,094 |
Total current assets | 153,965 | 179,500 |
Property and equipment, net | 1,857 | 1,989 |
Restricted cash | 250 | 250 |
Operating lease assets | 5,707 | 5,962 |
Other assets | 178 | 264 |
Total assets | 161,957 | 187,965 |
Current liabilities | ||
Accounts payable | 5,380 | 7,431 |
Accrued expenses | 22,767 | 25,557 |
Deferred revenue | 505 | 7 |
Other current liabilities | 5,038 | 2,593 |
Total current liabilities | 33,690 | 35,588 |
Loan payable | 77,470 | 77,015 |
Deferred revenue | 500 | 1,000 |
Operating lease liabilities | 5,309 | 5,615 |
Total liabilities | 116,969 | 119,218 |
Stockholders’ equity | ||
Common stock, $0.0001 par value, 120,000,000 shares authorized as of March 31, 2023, and December 31, 2022; 51,685,963 and 51,526,100 shares issued as of March 31, 2023, and December 31, 2022, respectively; 51,659,297 and 51,499,434 shares outstanding as of March 31, 2023, and December 31, 2022, respectively | 5 | 5 |
Treasury stock, 26,666 shares as of March 31, 2023, and December 31, 2022 | (8) | (8) |
Additional paid-in capital | 804,604 | 800,768 |
Accumulated deficit | (759,613) | (732,018) |
Total stockholders’ equity | 44,988 | 68,747 |
Total liabilities and stockholders' equity | $ 161,957 | $ 187,965 |
Condensed Statements of Operati
Condensed Statements of Operations (unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Revenues [Abstract] | ||
Total revenues | $ 12,946 | $ 6,902 |
Operating Expenses [Abstract] | ||
Cost of goods sold | 1,459 | 669 |
Research and development | 15,480 | 26,305 |
Selling, general and administrative | 21,753 | 26,709 |
Total operating expenses | 38,692 | 53,683 |
Loss from operations | (25,746) | (46,781) |
Other income (expense) | ||
Interest income | 716 | 9 |
Interest expense | (3,089) | (2,265) |
Other income (expense) | 524 | (155) |
Total other income (expense), net | (1,849) | (2,411) |
Loss before income taxes | (27,595) | (49,192) |
Income tax expense | 0 | 0 |
Net loss | $ (27,595) | $ (49,192) |
Net loss per share, basic (in US dollars per share) | $ (0.53) | $ (1.15) |
Net loss per share, diluted (in US dollars per share) | $ (0.53) | $ (1.15) |
Weighted average common shares outstanding, basic (in shares) | 51,647,934 | 42,687,201 |
Weighted average common shares outstanding, diluted (in shares) | 51,647,934 | 42,687,201 |
Product sales, net | ||
Revenues [Abstract] | ||
Total revenues | $ 10,492 | $ 5,480 |
License revenue | ||
Revenues [Abstract] | ||
Total revenues | $ 2,454 | $ 1,422 |
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, 2021 | 42,588,814 | ||||
Beginning balance at Dec. 31, 2021 | $ 143,541 | $ 4 | $ (8) | $ 728,004 | $ (584,459) |
Beginning balance treasury stock, shares (in shares) at Dec. 31, 2021 | (26,666) | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Exercise of common stock options (in shares) | 27,333 | ||||
Exercise of common stock options | 18 | 18 | |||
Restricted stock units vested (in shares) | 116,051 | ||||
Restricted stock units vested | 0 | ||||
Stock-based compensation | 5,765 | 5,765 | |||
Net loss | (49,192) | (49,192) | |||
Ending balance common stock, shares, outstanding (in shares) at Mar. 31, 2022 | 42,732,198 | ||||
Ending balance at Mar. 31, 2022 | $ 100,132 | $ 4 | $ (8) | 733,787 | (633,651) |
Ending balance treasury stock, shares (in shares) at Mar. 31, 2022 | (26,666) | ||||
Beginning balance common stock, shares, outstanding (in shares) at Dec. 31, 2022 | 51,499,434 | 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) | (26,666) | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Public offering | $ (1) | (1) | |||
Exercise of common stock options (in shares) | 3,008 | 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 | 51,659,297 | 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) | (26,666) |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows (unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Cash flows from operating activities | ||
Net loss | $ (27,595) | $ (49,192) |
Adjustments to reconcile net loss to net cash used in operating activities | ||
Stock-based compensation | 3,836 | 5,765 |
Accretion of discount on available for sale securities | (513) | 0 |
Depreciation and amortization | 132 | 115 |
Amortization of debt issuance costs | 541 | 541 |
Non-cash interest expense | 886 | 599 |
Non-cash equity interest, net | 0 | 166 |
Change in operating assets and liabilities | ||
Accounts receivable | (4,931) | (1,927) |
Inventories | 636 | (4,389) |
Prepaid expenses and other assets | 1,673 | 3,639 |
Accounts payable | (2,327) | 8,121 |
Accrued expenses and other liabilities | (1,389) | (1,608) |
Deferred revenue | (2) | (14) |
Net cash used in operating activities | (29,053) | (38,184) |
Cash flows from investing activities | ||
Purchases of marketable securities | (25,090) | 0 |
Maturities of marketable securities | 28,000 | 0 |
Net cash provided by investing activities | 2,910 | 0 |
Cash flows from financing activities | ||
Proceeds from stock options exercised | 1 | 18 |
Payment of public offering costs | (215) | 0 |
Net cash (used in)/provided by financing activities | (214) | 18 |
Net change in cash, cash equivalents and restricted cash | (26,357) | (38,166) |
Cash, cash equivalents and restricted cash | ||
Beginning of period | 94,907 | 221,561 |
End of period | 68,550 | 183,395 |
Supplemental disclosure of cash flow information | ||
Cash paid for interest | 2,512 | 1,716 |
Non-cash operating, investing and financing activities | ||
Upfront project costs and other current assets in accounts payable and accrued expenses | $ 341 | $ 0 |
Condensed Balance Sheets (una_2
Condensed Balance Sheets (unaudited) (Parenthetical) - $ / shares | Mar. 31, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Common stock, par value (in US dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized (in shares) | 120,000,000 | 120,000,000 |
Common stock, shares issued (in shares) | 51,685,963 | 51,526,100 |
Common stock, shares outstanding (in shares) | 51,659,297 | 51,499,434 |
Treasury stock, common, shares (in shares) | 26,666 | 26,666 |
Description of Business
Description of Business | 3 Months Ended |
Mar. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Description of Business | Description of Business G1 Therapeutics, Inc. (the “Company”) is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel small molecule therapeutics for the treatment of patients with cancer. The Company's first product approved by the U.S. Food and Drug Administration (“FDA”), COSELA® (trilaciclib), is the first and only therapy indicated to proactively help protect bone marrow from the damage of chemotherapy (myeloprotection) and is the first innovation in managing myeloprotection in decades. In July 2022, COSELA (trilaciclib hydrochloride for injection) was conditionally approved by the China National Medical Products Administration (NMPA) for marketing in China. Trilaciclib was developed from a technology platform that targets key cellular pathways including transient arrest of the cell cycle at the G1 phase, prior to the beginning of DNA replication. Controlled administration and clean G1 arrest from transient CDK4/6 inhibition can protect bone marrow and reduce hematologic adverse events (“AEs”) caused by cytotoxic therapy and may increase the ability to receive longer treatment durations. Transient CDK4/6 inhibition also may improve survival in combination with leading and emerging treatments through myeloprotection, enabling increased cytotoxic exposure while protecting the immune system, and/or through immunomodulation, which may improve patients’ overall anti-tumor immune responses. The Company is exploring the use of trilaciclib in a variety of trials across multiple tumor types and treatment combinations to optimize these potential benefits of proactive multi-lineage myeloprotection and survival in combination with leading and emerging treatments for patients globally. The Company was incorporated on May 19, 2008 in the State of Delaware. The Company uses “COSELA” when referring to its FDA approved drug and “trilaciclib” when referring to the development of COSELA for additional indications. Product Portfolio The Company’s first commercial product, COSELA® (trilaciclib), is a first-in-class therapy approved to help protect hematopoietic stem and progenitor cells (“HSPCs”) in bone marrow against chemotherapy-induced myelosuppression by transiently inhibiting CDK4/6 in patients with extensive-stage small cell lung cancer ("ES-SCLC"). This action leads to temporary arrest of susceptible host cells during chemotherapy. This reduces the duration and severity of neutropenia and other myelosuppressive consequences of chemotherapy. Trilaciclib was developed from a technology platform that targets key cellular pathways including transient arrest of the cell cycle at the G1 phase, prior to the beginning of DNA replication. Controlled administration and clean G1 arrest from transient CDK4/6 inhibition can protect bone marrow and reduce hematologic AEs caused by cytotoxic therapy and may increase the ability to receive longer treatment durations. Transient CDK4/6 inhibition also may improve survival in combination with leading and emerging treatments through myeloprotection, enabling increased cytotoxic exposure while protecting the immune system, and/or through immunomodulation, which may improve patients’ overall anti-tumor immune responses. The Company is exploring the use of trilaciclib in a variety of trials across multiple tumor types and treatment combinations to optimize these potential benefits of proactive multi-lineage myeloprotection and survival in combination with leading and emerging treatments for patients globally. The Company’s clinical approach to designing its clinical program includes monitoring the evolution of future standards of care and develop trilaciclib with these in mind, allowing it to conduct or support trials that will generate important data to maximize future usage in a variety of future settings. The Company’s robust clinical pipeline includes four ongoing trials: • Phase 3 trial in 1L mTNBC (interim overall survival (OS) analysis expected in 1Q 2024) • Phase 2 trial in combination with the ADC sacituzumab govitecan-hziy (additional results expected in 2Q 2023; OS endpoints expected 1Q 2024) • Phase 2 trial to confirm the immune-based mechanism of action (MOA) of trilaciclib in early-stage neoadjuvant TNBC (additional results expected in 2Q 2023) • Phase 2 trial in 1L bladder cancer (additional results expected midyear 2023; OS endpoints expected 1Q 2024) The Company is also conducting extensive preclinical development work to assess the synergistic potential of trilaciclib with a variety of new anti-cancer mechanisms. On February 13, 2023, the Company announced top line results from its pivotal Phase 3 PRESERVE 1 trial showing that the trial achieved its co-primary endpoints related to severe neutropenia with statistical significance, including clinically meaningful and statistically significant reductions in both occurrence of severe neutropenia during induction and mean duration of severe neutropenia in Cycles 1 through 4. However, despite the achievement of the co-primary endpoints and other secondary measures of myeloprotection and tolerability, early anti-tumor efficacy data, including overall response rate (ORR), favor patients receiving placebo compared to trilaciclib. Given the differential in these anti-tumor efficacy metrics and the low likelihood of achieving the progression-free survival (PFS) and OS endpoints, the Company made the decision to discontinue the PRESERVE 1 trial. The Data Monitoring Committee independently reached the same conclusion. Trilaciclib Development Pipeline Candidate Indication Current Status Initial Results Additional Results Endpoints Development & trilaciclib 1L metastatic Triple negative breast cancer (mTNBC) Registrational Phase 3 trial (enrollment complete) Interim OS analysis expected in 1Q 2024 Primary: OS* G1 Therapeutics owns all global development and commercial rights across all indications, with the exception of Greater China (Simcere) Antibody-drug conjugate (ADC) combination trial in mTNBC Phase 2 trial (enrollment complete) Initial safety results announced in 4Q 2022 Initial efficacy results** expected in 2Q 2023; OS endpoint expected in 1Q 2024 Primary: PFS Mechanism of action (MOA) trial in early-stage neoadjuvant TNBC Phase 2 trial (enrollment complete) MOA data presented in 4Q 2022 Results** including pCR expected in 2Q 2023 Primary: Immune-based MOA 1L Bladder cancer (mUC) Phase 2 trial Initial ORR results announced in 1Q 2023 Results** including preliminary PFS results expected in mid-2023; OS endpoint expected in 1Q 2024 Primary: PFS PFS=progression-free survival; OS=overall survival; PRO=patient reported outcome; ORR=overall response rate; pCR=pathological complete response; MOA=mechanism of action. *Initial results expected: (i) Phase 3 1L mTNBC trial: interim OS analysis; if the trial meets the interim analysis stopping rule, it will terminate and the Company will report the topline results. If it does not, the trial will continue to the final analysis. **Additional results to include tumor Programmed Cell Death-Ligand 1 ("PD-L1") status. The Company also has an Investigator Initiated Studies (“ISS”) program. An ISS is a study that is developed and conducted by a qualified physician external to the Company who assumes full responsibility for the conduct of the study. The Company supports investigator sponsored studies that align with its areas of scientific interest. In the fourth quarter of 2022, the Company announced that it was supporting a new Phase 2 ISS of trilaciclib and lurbinectedin in patients with ES-SCLC. This is a prospective, non-randomized, single-arm Phase 2 study, to evaluate trilaciclib administered intravenously prior to lurbinectedin in subjects with platinum refractory ES-SCLC. The primary endpoint is the rate of grade 4 neutropenia in any cycle. Secondary endpoints include mean duration (days) of grade 4 neutropenia in cycle 1, overall survival (OS), progression-free survival (PFS), overall rate of response (ORR), quality of life assessments, and the use of secondary/reactive supportive measures including G-CSF administration. In August 2020, the Company entered into an exclusive license agreement with Nanjing Simcere Dongyuan Pharmaceutical Co., Ltd (“Simcere”) for development and commercialization rights for trilaciclib in all indications in Greater China (mainland China, Hong Kong, Macau and Taiwan). Under the terms of the agreement, the Company received an upfront payment of $14.0 million in September 2020 with the potential to receive up to $156.0 million in development and commercial milestone payments. Since receiving the upfront payment, through December 31, 2022, the Company had recognized $22.0 million in revenue for the achievement of development and commercial milestones as defined by the license agreement. The Company did not receive any development milestone payments during the three months ended March 31, 2023. Under the terms of the agreement the Company is able to receive tiered low double-digit royalties on annual net sales of trilaciclib in Greater China. As part of this agreement, Simcere agreed to participate in global clinical trials of trilaciclib and the companies agreed to be responsible for all development and commercialization costs in their respective territories. On February 9, 2023, Simcere and G1 announced the issuance of the first prescription for COSELA® (trilaciclib) in China. On April 28, 2023, the Company amended the license agreement with Simcere. Refer to Note 15 for further details. The Company is evaluating the potential benefits of trilaciclib to patients with other tumors and to continuously develop new data with trilaciclib in a variety of chemotherapeutic settings and in combination with other agents to maximize the applicability of the drug to potential future treatment paradigms. The Company out-licensed global rights to lerociclib, an internally discovered and differentiated oral CDK4/6 inhibitor designed to enable more effective combination treatment strategies across multiple oncology indications. In addition, the Company out-licensed global rights to an internally discovered CDK2 inhibitor for all human and veterinary uses. The Company also has intellectual property focused on cyclin-dependent kinase targets. |
Basis of Presentation and Summa
Basis of Presentation and Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Significant Accounting Policies | Basis of Presentation and Summary of Significant Accounting Policies Basis of Presentation The 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, 2023, and for the three months ended March 31, 2023, and 2022, is unaudited. The results for the three months ended March 31, 2023, 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, 2022 filed with the SEC on March 1, 2023, (the “2022 Form 10-K”). The December 31, 2022 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 has an accumulated deficit of $759.6 million and $732.0 million as of March 31, 2023 and December 31, 2022, respectively. The Company expects to incur losses and have negative net cash flows from operating activities as it executes on its strategy including engaging in further research and development activities, particularly conducting non-clinical studies and clinical trials. The success of the Company depends on the ability to successfully commercialize its technologies to support its operations and strategic plan. 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, 2023 will not be sufficient to fund the Company’s planned operations and remain in compliance with its financial covenants for the next 12 months from the date of issuance of these condensed financial statements. Based on the foregoing, the Company has concluded that substantial doubt exists about the Company’s ability to continue as a going concern for a period of at least 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, and could result in the default on the Company's loan payable. 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, unless the Company maintains 100% of the outstanding debt balance in cash, cash equivalents and marketable securities, the Company is required to be in compliance with a minimum cash covenant and a minimum monthly net product revenue covenant (determined in accordance with U.S. GAAP), measured on a trailing six-month basis. The lender also has the ability to call debt based on a material adverse change clause, which is subjectively defined. If the Company maintains less than 100% of the outstanding debt in cash, cash equivalents and marketable securities and is not in compliance with the minimum cash covenant, monthly net revenue covenants, 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, 2023, the Company did not achieve the minimum monthly net product revenue as set forth in the Loan Agreement. However, the Company is not in default under the Loan Agreement as it maintained 100% of the outstanding debt balance of $75.0 million in cash, cash equivalents and marketable securities. On February 22, 2023, the Company approved a reduction in its workforce to streamline operations and reduce operating expenses. The Company recognized $1.4 million in severance and termination-related costs in the first quarter of 2023. See Note 14 for further discussion on this restructuring activity. Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and the accompanying notes. On an ongoing basis, the Company’s management evaluates its estimates which include, but are not limited to, estimates related to accrued expenses, accrued external clinical costs, net product sales, common stock valuation, stock-based compensation expense and deferred tax asset valuation allowance. Actual results could differ from those estimates. Cash and Cash Equivalents 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, 2023 consist of amounts on deposit in banks, including checking accounts and money market accounts. 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 money market funds at the financial institution. Therefore, these funds are classified as restricted cash on the balance sheet. The letter of credit will be reduced ratably on each anniversary of the commencement of the lease until the end of the lease term. As of March 31, 2023, restricted cash totaled $0.3 million. As discussed in Note 7, unless the Company maintains 100% of the outstanding debt balance in cash, cash equivalents and marketable securities, the Company is required to be in compliance with a minimum cash covenant and a minimum monthly net product revenue covenant (determined in accordance with U.S. GAAP), measured on a trailing six-month basis. 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, 2023 as “available-for-sale” pursuant to ASC Topic 320, Investments – Debt and Equity Securities. Investments not classified as cash equivalents are presented as either short-term or long-term investments based on both their maturities as well as the time period the Company intends to hold such securities. Available-for-sale securities are maintained by an investment manager and primarily consist of fixed income securities. Available-for-sale securities are carried at fair value. Any premium or discount arising at purchase is amortized or accreted to interest income over the life of the instrument. Realized gains and losses are determined using the specific identification method and are included in other (income) expense, net. As of March 31, 2023 the u nrealized gains and losses are not considered to be material. Accounts Receivable The Company’s accounts receivable consists of amounts due from specialty distributors in the U.S. (collectively, its “customers”) related to sales of COSELA and have standard payment terms. Trade receivables are recorded net of the estimated variable consideration for chargebacks based on contractual terms and the Company’s expectation regarding the utilization and earnings of the chargebacks and discounts as well as the net amount expected to be collected from the Company’s customers. Estimates of the Company’s credit losses 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, 2023, unbilled accounts receivable totaled $2.1 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. The Company began capitalizing inventory upon receiving FDA approval for COSELA on February 12, 2021. Prior to FDA approval of COSELA, expenses associated with the manufacturing of the Company's products were recorded as research and development expense. 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 sales in the period in which they are incurred. No inventory valuation adjustments have been recorded for any periods presented. 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). To date, the Company has recognized $0.5 million in revenue related to sales-based royalties. Product Sales, Net The Company sells COSELA to specialty distributors in the U.S. and, in accordance with ASC 606, recognizes revenue at the point in time when the customer is deemed to have obtained control of the product. The customer is deemed to have obtained control of the product at the time of physical receipt of the product at the customers’ distribution facilities, or Free on Board (“FOB”) destination, the terms of which are designated in the contract. Product sales are recorded at the net selling price, which includes estimates of variable consideration for which reserves are established for (a) rebates and chargebacks, (b) co-pay assistance programs, (c) distribution fees, (d) product returns, and (e) other discounts. Where appropriate, these estimates take into consideration a range of possible outcomes which are probability-weighted 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. Forms of Variable Consideration Rebates and Chargebacks : The Company estimates reductions to product sales for Public Health Service Institutions, such as Medicaid, Medicare and Veterans Administration (“VA”) programs, as well as certain other qualifying federal and state government programs, and other group purchasing organizations. The Company estimates these reductions based upon the Company’s contracts with government agencies and other organizations, statutorily defined discounts and estimated payor mix. These organizations purchase directly from the Company’s specialty distributors at a discount and the specialty distributors charge the Company back the difference between the wholesaler price and the discounted price. The Company’s liability for Medicaid rebates consists of estimates for claims that a state will make. The Company’s reserve for this discounted pricing is based on expected sales to qualified healthcare providers and the chargebacks that customers have already claimed. Co-Pay Assistance: Eligible patients who have commercial insurance may receive assistance from the Company to reduce the patient’s out of pocket costs. Liabilities for co-pay assistance are calculated by actual program participation from third-party administrators. Distribution Fees: The Company has written contracts with its customers that include terms for distribution fees and costs for inventory management. The Company estimates and records distribution fees due to its customers based on gross sales. Product Returns: The Company generally offers a right of return based on the product’s expiration date and certain spoilage and damaged instances. The Company estimates the amount of product sales that may be returned and records the estimate as a reduction of product sales in the period the related product sales are recognized. The Company’s estimates for expected returns are based primarily on an ongoing analysis of sales information and visibility into the inventory remaining in the distribution channel. Concentration of Credit Risk Financial instruments that potentially subject the Company to credit risk consist of cash and cash equivalents. Deposits with financial institutions are insured, up to certain limits, by the Federal Deposit Insurance Corporation (“FDIC”). The Company’s cash deposits often exceed the FDIC insurance limit; however, all deposits are maintained with high credit quality institutions and the Company has not experienced any losses in such accounts. The financial condition of financial institutions is periodically reassessed, and the Company believes the risk of any loss is minimal. The Company believes the risk of any loss on cash due to credit risk is minimal. Cost of Goods Sold Cost of goods sold includes direct and indirect costs related to the manufacturing and distribution of COSELA, including third-party manufacturing costs, packaging services, freight-in, third-party logistics costs associated with COSELA, and Company personnel costs. Cost of goods sold may also include period costs related to certain inventory manufacturing services and inventory adjustment charges. In connection with the FDA approval of COSELA on February 12, 2021, the Company subsequently began capitalizing inventory manufactured or purchased after this date. As a result, certain manufacturing costs associated with product shipments of COSELA were expensed prior to FDA approval and, therefore, are not included in cost of goods sold during the current period. 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 products, 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 estimated and accrued 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. Income Taxes Income taxes are accounted for using the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to temporary differences between the financial statements carrying amounts of assets and liabilities and their respective tax bases, operating loss carryforwards, and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. In accordance with Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) 740, Accounting for Income Taxes , the Company reflects in the financial statements the benefit of positions taken in a previously filed tax return or expected to be taken in a future tax return only when it is considered ‘more-likely-than-not’ that the position taken will be sustained by a taxing authority. As of March 31, 2023 and December 31, 2022, the Company had no unrecognized income tax benefits and correspondingly there is no impact on the Company’s effective income tax rate associated with these items. The Company’s policy for recording interest and penalties relating to uncertain income tax positions is to record them as a component of income tax expense in the accompanying statements of operations. As of March 31, 2023 and December 31, 2022, the Company had no such accruals. 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") and performance based restricted stock units ("PSUs"). The fair value of RSUs and PSUs 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, 2023, the Company did not deem the achievement of any performance condition(s) to be probable and no compensation expense related to PSUs was recognized. 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, 2023 | |
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, 2023 and December 31, 2022, 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 funds $ 64,779 $ — $ — $ 64,779 Marketable securities: U.S. Treasury Bills 48,080 — — 48,080 Total assets at fair value $ 112,859 $ — $ — $ 112,859 Quoted prices Significant Significant Balance at December 31, Assets: Money market funds $ 84,167 $ — $ — $ 84,167 Marketable securities: U.S. Treasury Bills 50,476 — — 50,476 Total assets at fair value $ 134,643 $ — $ — $ 134,643 During the three months ended March 31, 2023, and the year ended December 31, 2022, there were no changes in valuation methodology. The Loan Payable (discussed in Note 7) has a variable interest rate and is carried at amortized cost, which approximates its fair value that is determined using Level 3 inputs. As of March 31, 2023, the carrying value was $77.5 million. |
Inventory
Inventory | 3 Months Ended |
Mar. 31, 2023 | |
Inventory Disclosure [Abstract] | |
Inventories | Inventories Inventories consists of the following (in thousands): March 31, 2023 December 31, 2022 Raw materials $ 2,715 $ 2,790 Work in process 10,026 10,153 Finished goods 2,802 3,236 Inventories $ 15,543 $ 16,179 The Company uses third party contract manufacturing organizations for the production of its raw materials, active pharmaceutical ingredients, and finished drug product which the Company owns. Costs incurred by the Company for manufacturing of initial commercial product of COSELA in preparation of commercial launch were expensed prior to FDA approval. |
Property and Equipment
Property and Equipment | 3 Months Ended |
Mar. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | Property and Equipment Property and equipment consists of the following (in thousands): March 31, 2023 December 31, 2022 Computer equipment $ 327 $ 327 Laboratory equipment 334 334 Furniture and fixtures 866 866 Leasehold improvements 1,782 1,782 Manufacturing equipment 506 506 Accumulated depreciation (1,958) (1,826) Property and equipment, net $ 1,857 $ 1,989 Depreciation expenses relating to property and equipment were $132 thousand and $115 thousand for the three months ended March 31, 2023 and 2022, respectively. |
Accrued Expenses
Accrued Expenses | 3 Months Ended |
Mar. 31, 2023 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | Accrued Expenses Accrued expenses are comprised as follows (in thousands): March 31, 2023 December 31, 2022 Accrued external research $ 207 $ 268 Accrued professional fees and other 5,394 4,304 Accrued external clinical study costs 15,063 15,566 Accrued compensation expense 2,103 5,419 Accrued expenses $ 22,767 $ 25,557 |
Loan Payable
Loan Payable | 3 Months Ended |
Mar. 31, 2023 | |
Debt Disclosure [Abstract] | |
Loan Payable | Loan Payable On May 29, 2020, the Company entered into a loan and security agreement (the “Loan Agreement”) with Hercules Capital, Inc. (“Hercules”), under which Hercules agreed to lend the Company up to $100.0 million, to be made available in a series of tranches, subject to certain terms and conditions. The first tranche totals $30.0 million, of which the Company received $20.0 million at closing. Upon initiation of the Phase 3 trial of COSELA for metastatic colorectal cancer and receiving FDA approval for COSELA for small cell lung cancer (the "Performance Milestone”), the second tranche of $20.0 million became available to the Company for drawdown through December 15, 2021. The third tranche of $30.0 million was available through December 31, 2022. The fourth tranche of $20.0 million was available at Hercules’ approval through December 31, 2022. On March 31, 2021, the Company entered into the First Amendment to Loan and Security Agreement (the “First Amendment”) with Hercules whereby the Company drew the remaining $10.0 million of the first tranche and the interest rate and financial covenants were amended. Unless loan advances exceeded $40.0 million, no financial covenants were required. Amounts initially borrowed under the original terms of the Loan Agreement bore an interest rate equal to the greater of either (i) (a) the prime rate as reported in The Wall Street Journal, plus (b) 6.40%, and (ii) 9.65%. Based on original terms of the Loan Agreement, the Company agreed to make interest only payments through June 1, 2022 and following the interest only period, the Company agreed to repay the principal balance and interest of the advances in equal monthly installments through June 1, 2024. Based on the original terms of the Loan Agreement, upon satisfaction of the Performance Milestone, the interest only period was extended through January 1, 2023 and the maturity date was extended to June 1, 2025. Upon entering into the First Amendment on March 31, 2021, the interest rate was amended to the greater of either (i) (a) the prime rate as reported in The Wall Street Journal, plus (b) 6.20%, and (ii) 9.45%. The Company may prepay advances under the Loan Agreement, in whole or in part, at any time subject to a prepayment charge equal to (a) 3.0% of the prepayment amount in the first year; (b) 2.0% of the prepayment amount in the second year; and (c) 1.0% of the prepayment amount in the third year. Upon prepayment or repayment of all or any of the advances under the Loan Agreement, the Company agreed to pay (in addition to the prepayment charge) an end of term charge of 6.95% of the aggregate funded amount. With respect to the first tranche, the end of term charge of $2.1 million would be payable upon any prepayment or repayment. To the extent that the Company was provided additional advances under the Loan Agreement, the 6.95% end of term charge would be applied to such additional amounts. These amounts have been accrued over the term of the loan using effective-interest method. On November 1, 2021, the Company entered into a Second Amendment to Loan and Security Agreement (the “Second Amendment”) under which Hercules agreed to lend the Company up to $150.0 million, to be made available in a series of tranches, subject to certain terms and conditions. The first tranche was increased to $100.0 million. At close of the Second Amendment, the Company borrowed an additional $45.0 million from the first tranche. The Company had the right to request that Hercules make the remaining $25.0 million term loan advances under the first tranche to the Company by September 15, 2022, which the Company did not exercise. The second tranche of $20.0 million will become available to the Company upon achievement of $50.0 million trailing six-month net product revenue of COSELA no later than June 30, 2023 and will be available through December 15, 2023. The third tranche of $15.0 million will become available upon achievement of certain development performance milestones and available through December 15, 2023. The fourth tranche of $15.0 million will be available at Hercules’ approval through June 30, 2024. Amounts borrowed under the Second Amendment 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) 5.90%, and (ii) 9.15%. The Company will make interest only payments through December 1, 2024 and may be extended through December 1, 2025, in quarterly increments, subject to compliance with covenants of the Second Amendment. Following the interest only period, the Company will repay the principal balance and interest of the advances in equal monthly installments through November 1, 2026. The Company may prepay advances under the Second Amendment, in whole or in part, at any time subject to a prepayment charge equal to (a) 3.0% of the prepayment amount in the first year from the closing of the Second Amendment; (b) 2.0% of the prepayment amount in the second year from the closing of the Second Amendment; and (c) 1.0% of the prepayment amount in the third year from the closing of the Second Amendment. Upon prepayment or repayment of all or any of the advances under the Second Amendment, the Company will pay (in addition to the prepayment charge) an end of term charge of 6.75% of the aggregate amount funded. The Company will be required to make a final payment to Hercules in the amount of 6.75% of the amounts funded, less any amount previously paid. In addition, the Company will be required to make a payment to Hercules for $2.1 million on the earliest occurrence of (i) June 1, 2025, (ii) the date the Company repays the outstanding principal amount in full, or (iii) the date that the principal amount becomes due and payable in full. The Second Amendment is secured by substantially all of the Company’s assets, including intellectual property, subject to certain exemptions. The Company out-licensed lerociclib as permitted in the Loan Agreement. The Second Amendment contains a minimum revenue covenant. Beginning August 15, 2022, with the reporting of the financial results for the second fiscal quarter ended June 30, 2022, and tested monthly, the Company must have achieved net product revenue of COSELA of at least 65% of the amounts projected in the Company’s forecast. Testing of the minimum revenue covenant shall be waived at any time in which either (a) the Company’s market capitalization exceeds $750.0 million and the Company maintains unrestricted cash equal to at least 50% of the total amounts funded, or (b) the Company maintains unrestricted cash equal to at least 100% of the total amounts funded. The Company evaluated the Second Amendment under the guidance found in ASC 470-50 Modification and Extinguishment. The Company concluded that the previous debt under the Loan Agreement was extinguished based on the difference in present value of the cash flows of the Loan Agreement and the Second Amendment. Accordingly, the difference between the carrying value of the Loan Agreement as of November 1, 2021, including the unamortized debt issuance costs, and the fair value of the Second Amendment was recorded as a $0.2 million loss on extinguishment of debt for the twelve months ended December 31, 2021. Fees paid to third parties directly related to the funded portion of the Second Amendment have been capitalized as debt issuance costs and will be amortized to interest expense over the life of the Second Amendment using the effective interest method. Fees paid that were directly related to the unfunded portion is accounted for as a deferred financing charge and amortized to interest expense over the period the unfunded portions are available. The end of term charges associated with the Second Amendment are being accreted through interest expense using the effective interest method over the related term of the debt. On June 24, 2022, the Company entered into a Third Amendment to Loan and Security Agreement (the “Third Amendment”) with Hercules, which extended the time for drawing the remainder of the first tranche advance of up to $25.0 million from September 15, 2022 to December 31, 2022, which the Company did not exercise. The Third Amendment also added a minimum cash covenant whereby the Company must maintain unrestricted cash equal to at least 50% of the outstanding debt, and such percentage shall decrease upon the Company achieving specified net product revenue of COSELA. It further provides for a minimum revenue covenant that, beginning August 15, 2022 with the reporting of the financial results for the second fiscal quarter ended June 30, 2022, and tested monthly, the Company must have achieved net product revenue of COSELA of at least 80% of the amounts projected in the Company’s forecast. Testing of the minimum revenue covenant shall be waived at any time in which either (a) the Company’s market capitalization exceeds $750.0 million and the Company maintains unrestricted cash equal to at least 50% of the total amounts funded, or (b) the Company maintains unrestricted cash equal to at least 100% of the total amounts funded. The Company evaluated the Third Amendment under the guidance found in ASC 470-50 Modification and Extinguishment. The Company concluded that the Third Amendment was a modification and there was no impact to the financial statements. On November 1, 2022, the Company entered into a Fourth Amendment to Loan and Security Agreement (the “Fourth Amendment”) with Hercules, which extended the time for drawing the remainder of the first tranche advance of up to $25.0 million from December 31, 2022 to June 30, 2023. The Fourth Amendment continues to provide for a minimum revenue covenant, tested monthly, where the Company must achieve net product revenue of COSELA of at least 80% of the amounts projected in the Company's forecast. The Fourth Amendment also amended the minimum cash covenant such that if the outstanding debt is less than or equal to $75.0 million, the Company must maintain unrestricted cash equal to at least 65% of the outstanding debt in addition to meeting the required revenue covenant. In addition, if the outstanding debt is greater than $75.0 million, the Company must maintain unrestricted cash equal to at least 70% of the outstanding debt while meeting the revenue covenant. If the Company achieves specified net revenue of COSELA, the cash percentage will decrease to 45% of the outstanding debt. Testing of the minimum revenue covenant shall be waived at any time in which either (a) the Company's market capitalization exceeds $750.0 million and the Company maintains unrestricted cash equal to at least 50% of the total amounts funded, or (b) the Company maintains unrestricted cash equal to at least 100% of the total amounts funded. The Fourth Amendment also re-set the prepayment premiums associated with any prepayment of the loans under the Loan Agreement. The Company evaluated the Fourth Amendment under the guidance found in ASC 470-50 Modification and Extinguishment . The Company concluded that the Fourth Amendment was a modification and there was no impact to the financial statements. The Loan Agreement contains events of default, including a material adverse change, which is subjectively defined, in the Company’s business, payment defaults, and breaches of covenants following any applicable cure period. In the event of default by the Company under the Loan Agreement, the Company may be required to repay all amounts then outstanding under the Loan Agreement. The Company has determined that subjective acceleration under the material adverse events clause included in the Loan Agreement is not probable and, therefore, has classified the outstanding principal amount in long-term liabilities based on the timing of scheduled principal payments. As of March 31, 2023 and as of the date of the issuance of these condensed financial statements, the Company did not meet the minimum monthly net product revenue as set forth in the Loan Agreement. However, the Company was not in default under the Loan Agreement as it maintained 100% of the outstanding debt of $75.0 million in cash, cash equivalents, and marketable securities and has not been notified of an event of default by the lender under the Loan Agreement. The Company recognized $3.1 million and $2.3 million of interest expense related to the debt for the three months ended March 31, 2023 and 2022, respectively. Interest expense is reflected in other income (expense), net on the statement of operations. As of March 31, 2023, the future principal payments due under the Loan Agreement, excluding interest, are as follows (in thousands): Amount 2023 $ — 2024 2,729 2025 35,204 2026 37,067 Total principal outstanding 75,000 End of term charge 3,106 Unamortized debt issuance costs (636) Total $ 77,470 |
Stockholders' Equity
Stockholders' Equity | 3 Months Ended |
Mar. 31, 2023 | |
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. On July 2, 2021, the Company filed an automatic shelf registration statement on Form S-3ASR with the Securities and Exchange Commission (the “SEC”), which became effective upon filing, pursuant to which the Company registered for sale an unlimited amount of any combination of its common stock, preferred stock, debt securities, warrants, rights and/or units from time to time and at prices and on terms that the Company may determine, so long as the Company continued to satisfy the requirements of a “well-known seasoned issuer” under SEC rules (the “2021 Form S-3”). The 2021 Form S-3 also included a prospectus covering up to an aggregate of $150.0 million in shares of common stock that the Company may issue and sell from time to time through Cowen and Company, LLC ("Cowen"), acting as its agent, pursuant to a sales agreement for "at the market offerings" the Company entered into with Cowen in July 2021 (the “2021 Sales Agreement”). The Company did not sell any shares of common stock under the 2021 Sales Agreement. At the time of the filing of the Company's Annual Report on Form 10-K for the year ended December 31, 2021 filed with the SEC on February 23, 2022, the Company no longer qualified as a “well-known seasoned issuer” as such term is defined in Rule 405 under the Securities Act of 1933, as amended. As a result, in February 2022, the Company amended the 2021 Form S-3 to register for sale up to $300.0 million of any combination of its common stock, preferred stock, debt securities, warrants, rights and/or units from time to time and at prices and on terms that the Company may determine. The 2021 Form S-3, as amended, will remain in effect for up to three years from the date it originally became effective, which was July 2, 2021. The amended 2021 Form S-3 also includes a prospectus covering up to an aggregate of $100.0 million in common stock that the Company may issue and sell from time to time, through Cowen acting as its sales agent, pursuant to that certain sales agreement that the Company entered into with Cowen on February 23, 2022 (the “2022 Sales Agreement”). In connection with the Company entering into the 2022 Sales Agreement with Cowen, the Company terminated the 2021 Sales Agreement. As of the date hereof, the Company has not sold any shares of common stock or other securities under the 2022 Sales Agreement for “at the market offerings.” On November 17, 2022, the Company entered into an underwriting agreement related to a public offering of 7,700,000 shares of common stock at a public offering price of $6.50 per share less the underwriting discounts and commissions, pursuant to the shelf registration statement on Form S-3. The Company received approximately $50.1 million in gross proceeds from this offering, before deducting underwriting discounts and commissions and offering expenses. The offering closed on November 22, 2022. In addition, 873,353 shares of common stock were issued upon exercise by the underwriters of their option to purchase additional shares at the same offering price, which closed on December 20, 2022. The gross proceeds from the offering of the aggregate of 8,573,353 shares of the Company's common stock were $55.7 million and net proceeds of $52.0 million, after deducting underwriting discounts and commissions and other offering expenses payable by the Company. Preferred stock The Company is authorized to issue 5,000,000 shares of undesignated preferred stock in one or more series. As of March 31, 2023, no shares of preferred stock were issued or outstanding. Shares Reserved for Future Issuance The Company has reserved authorized shares of common stock for future issuance at March 31, 2023 and December 31, 2022 as follows: March 31, 2023 December 31, 2022 Common stock options outstanding 7,871,249 7,372,028 RSUs outstanding 956,273 675,406 PSUs outstanding 218,450 — Options, RSUs and PSUs available for grant under Equity Incentive Plans 2,261,691 2,323,539 11,307,663 10,370,973 |
Stock-Based Compensation
Stock-Based Compensation | 3 Months Ended |
Mar. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation | Stock-Based Compensation 2011 Equity Incentive Plan In March 2011, the Company adopted the 2011 Equity Incentive Plan (the “2011 Plan”). The 2011 Plan provided for the direct award or sale of the Company’s common stock and for the grant of stock options to employees, directors, officers, consultants and advisors of the Company. The 2011 Plan was subsequently amended in August 2012, October 2013, February 2015, December 2015, April 2016 and November 2016 to allow for the issuance of additional shares of common stock. In connection with the adoption of the 2017 Plan (as defined below), the 2011 Plan was terminated and no further awards will be made under the 2011 Plan. 2017 Equity Incentive Plan In May 2017, the Company adopted the 2017 Equity Incentive Plan (the “2017 Plan”). The 2017 Plan provided for the direct award or sale of the Company’s common stock and for the grant of up to 1,932,000 stock options to employees, directors, officers, consultants and advisors of the Company. The 2017 Plan provides for the grant of incentive stock options, non-statutory stock options or restricted stock. Effective January 1, 2023, and in accordance with the “evergreen” provision of the 2017 Plan, an additional 1,096,553 shares were made available for issuance. Under both the 2011 Plan and the 2017 Plan, options to purchase the Company’s common stock may be granted at a price no less than the fair market value of a share of common stock on the date of grant. The fair value shall be the closing sales price for a share as quoted on any established securities exchange for such grant date or the last preceding date for which such quotation exists. Vesting terms of options issued are determined by the Board of Directors or Compensation Committee of the Board. The Company’s stock options vest based on terms in the stock option agreements. Stock options have a maximum term of ten years. In January 2021, the Company began granting RSUs under the 2017 Plan. RSUs are granted at the fair market value of a share of common stock on the date of grant. In January 2023, the Company began granting PSUs, which are subject to non-market performance and service conditions, to Company executives under the 2017 Plan. PSUs are granted at the fair market value of a share of common stock on the date of grant. As of March 31, 2023, there were a total of 1,438,251 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, 2023, there was a total of 823,440 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, net of estimated forfeitures. 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 and PSUs. The fair value of RSUs and PSUs 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, 2023, the Company did not deem the achievement of any performance condition(s) to be probable and no compensation expense related to PSUs was recognized. The table below summarizes the stock-based compensation expense recognized in the Company’s statement of operations by classification (in thousands): Three Months Ended March 31, 2023 2022 Cost of goods sold $ 35 $ 51 Research and development 674 1,149 Selling, general and administrative 3,127 4,565 Total stock-based compensation expense $ 3,836 $ 5,765 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, 2023 2022 Expected volatility 81.4% - 86.8% 76.7% - 77.1% Weighted-average risk free rate 3.4% - 3.9% 1.4% - 1.7% Dividend yield —% —% Expected term (in years) 6.08 6.07 Stock Option Activity The following table is a summary of stock option activity for the three months ended March 31, 2023: Weighted average Options Weighted Remaining Aggregate (in thousands) Balance as of December 31, 2022 7,372,028 $ 16.15 6.9 $ 3,281 Granted 1,011,730 5.49 Cancelled (509,501) 11.04 Exercised (3,008) 0.30 Balance as of March 31, 2023 7,871,249 $ 15.12 6.9 $ 1,122 Exercisable at December 31, 2022 4,562,674 $ 17.85 5.8 $ 3,248 Vested at December 31, 2022 and expected to vest 7,372,028 $ 16.15 6.9 $ 3,281 Exercisable at March 31, 2023 5,052,581 $ 17.46 5.8 $ 1,122 Vested at March 31, 2023 and expected to vest 7,871,249 $ 15.12 6.9 $ 1,122 As of March 31, 2023, unrecognized compensation expense related to unvested stock options totaled $19.4 million, which is expected to be recognized over a weighted-average period of approximately 2.2 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, 2023: Number of Weighted – Average Balance as of December 31, 2022 675,406 $ 12.31 Granted 590,650 5.23 Cancelled (152,928) 8.64 Vested (156,855) 14.81 Balance as of March 31, 2023 956,273 $ 8.11 As of March 31, 2023, there was $6.7 million of total unrecognized compensation cost related to Company RSUs that are expected to vest. These costs are expected to be recognized over a weighted-average period of approximately 2.8 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, 2023, the Company did not deem the achievement of any performance condition(s) to be probable and compensation expense related to PSUs was not recognized. The following table is a summary of the PSU activity for the three months ended March 31, 2023: Number of Weighted – Average Balance as of December 31, 2022 — $ — Granted 218,450 5.73 Cancelled — — Vested — — Balance as of March 31, 2023 218,450 $ 5.73 As of March 31, 2023, there was $1.3 million of total unrecognized compensation cost related to Company PSUs that are expected to vest. These costs are expected to be recognized over a weighted-average period of approximately 2.8 years. |
License Revenue
License Revenue | 3 Months Ended |
Mar. 31, 2023 | |
Revenue Recognition and Deferred Revenue [Abstract] | |
License Revenue | License Revenue Incyclix License Agreement On May 22, 2020, the Company entered into an exclusive license agreement with Incyclix Bio, LLC (“Incyclix”), formerly ARC Therapeutics, LLC, a company primarily owned by a former board member, whereby the Company granted to Incyclix an exclusive, worldwide, royalty-bearing license, with the right to sublicense, solely to make, have made, use, sell, offer for sale, import, export, and commercialize products related to its cyclin dependent kinase 2 (“CDK2”) inhibitor compounds. At close, the Company received consideration in the form of an upfront payment of $1.0 million and an equity interest in Incyclix equal to 10% of its issued and outstanding units valued at $1.1 million. In addition, the Company may receive a future development milestone payment totaling $2.0 million and royalty payments in the mid-single digits based on net sales of the licensed compound after commercialization. The Company has right of first negotiation to re-acquire these assets. In the first quarter of 2022, Incyclix announced a new round of financing which the Company did not participate. Following the financing, the Company's equity interest is now approximately 6.5%. The Company assessed the license agreement in accordance with ASC 606 and identified one performance obligation in the contract, which is the transfer of the license, as Incyclix can benefit from the license using its own resources. The Company recognized $2.1 million in license revenue consisting of the upfront payment and the 10% equity interest in Incyclix upon the effective date as the Company determined the license was a right to use the intellectual property and the Company had provided all necessary information to Incyclix to benefit from the license. The Company considers the future potential development milestones 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, 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 the Asia-Pacific region, excluding Japan (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, 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 will 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 is 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 will be responsible for the development of the product in the EQRx Territory. The Company will continue until completion, as the clinical trial sponsor, its two primary clinical trials at EQRx’s sole cost and expense. EQRx will reimburse the Company for all of its out-of-pocket costs incurred after the effective date of the license agreement in connection with these clinical trials. The Company will invoice EQRx within 30 days following the end of the quarter, and EQRx will pay within 30 days after its receipt of such invoice. 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, have been achieved through March 31, 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. Under the license agreement, Simcere agreed to pay the Company a non-refundable, upfront cash payment of $14.0 million with the potential to pay an additional $156.0 million upon reaching certain development and commercial milestones. In addition, the Company had the potential to receive tiered low double-digit royalties on annual net sales of trilaciclib in the Simcere Territory. In 2020, the Company transferred the license and related technology and know-how to Simcere, which resulted in the recognition of $14.0 million in revenue in accordance with ASC 606. Since then, through December 31, 2022, the Company had recognized an additional $22.0 million in revenue for the achievement of development and commercial milestones as defined by the license agreement. During the three months ended March 31, 2023, the Company recognized $1.4 million in supply and manufacturing services and $0.5 million in royalty revenue. No milestone revenue was recognized during the three months ended March 31, 2023. |
Net Loss Per Common Share
Net Loss Per Common Share | 3 Months Ended |
Mar. 31, 2023 | |
Earnings Per Share [Abstract] | |
Net Loss Per Common Share | Net Loss per Common Share Basic net loss per common share is computed using the weighted average number of common shares outstanding during the period including nominal issuances of common stock warrants. Diluted net loss per common share is computed using the sum of the weighted average number of common shares outstanding during the period and, if dilutive, the weighted average number of potential shares of common stock, including the assumed exercise of stock options, stock warrants and unvested restricted common stock. For the three months ended March 31, 2023 and 2022 and 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, 2023 2022 Stock options issued and outstanding 8,085,891 7,736,333 Unvested RSUs 952,481 606,371 Unvested PSUs 211,168 — Total potential dilutive shares 9,249,540 8,342,704 Amounts in the table above reflect the common stock equivalents of the noted instruments. |
Income Taxes
Income Taxes | 3 Months Ended |
Mar. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income TaxesThe Company’s effective income tax rate was 0% for the three months ended March 31, 2023 and 2022. 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, 2023 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | Related Party TransactionsThe Company entered into a senior advisor agreement on September 29, 2020 with Mark A. Velleca, M.D., Ph.D., a member of the Board of Directors, with an effective date of January 1, 2021. Pursuant to the terms of the agreement, Dr. Velleca will receive $200,000 annually, paid in equal quarterly installments, for his services. The senior advisor agreement will expire on December 31, 2023. |
Restructuring Charges
Restructuring Charges | 3 Months Ended |
Mar. 31, 2023 | |
Restructuring and Related Activities [Abstract] | |
Restructuring Charges | Restructuring Charges On February 13, 2023, the Company made the decision to discontinue the PRESERVE 1 trial following the announcement of top-line results. In connection with the announcement, on February 22, 2023, the Company approved changes to the Company's organization as well as a broader operational cost reduction plan. As part of this plan, the Company approved a reduction in the Company's workforce by approximately 30% across different areas and functions in the Company effective on March 1, 2023. Affected employees were offered separation benefits, including severance payments. As a result of these reductions in workforce, the Company recorded the following expenses, primarily related to severance, employee benefits and termination-related costs during the three months ended March 31, 2023 (in thousands): Amount Cost of goods sold $ 94 Research and development 510 Selling, general and administrative 811 Total $ 1,415 The following table is a reconciliation of the beginning and ending restructuring liability for the three months ended March 31, 2023 (in thousands): Termination-related costs Benefits Severance Total Balance as of December 31, 2022 $ — $ — $ — $ — Expense recognized 85 50 1,280 1,415 Cash payments (85) (50) (1,174) (1,309) Balance as of March 31, 2023 $ — $ — $ 106 $ 106 The outstanding balance above is reflected in accrued expenses within the condensed balance sheets as of March 31, 2023 and is composed of severance payout to terminated employees who had not signed their severance agreement prior to March 31, 2023, and thus were not paid as of that date. The Company expects the liabilities as of March 31, 2023 to be substantially paid out in cash by the end of the second quarter of 2023. |
Subsequent Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2023 | |
Subsequent Events [Abstract] | |
Subsequent Events | Subsequent EventOn April 28, 2023, the Company entered into the third amendment to the license agreement with Simcere, whereby the Company will receive a one-time, non-refundable payment of $30.0 million, within the second quarter of 2023, to monetize the future royalties from the sale of COSELA in Greater China. In addition, the milestone payments under the license agreement have been 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. |
Basis of Presentation and Sum_2
Basis of Presentation and Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2023 | |
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, 2023, and for the three months ended March 31, 2023, and 2022, is unaudited. The results for the three months ended March 31, 2023, 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, 2022 filed with the SEC on March 1, 2023, (the “2022 Form 10-K”). The December 31, 2022 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 has an accumulated deficit of $759.6 million and $732.0 million as of March 31, 2023 and December 31, 2022, respectively. The Company expects to incur losses and have negative net cash flows from operating activities as it executes on its strategy including engaging in further research and development activities, particularly conducting non-clinical studies and clinical trials. The success of the Company depends on the ability to successfully commercialize its technologies to support its operations and strategic plan. 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, 2023 will not be sufficient to fund the Company’s planned operations and remain in compliance with its financial covenants for the next 12 months from the date of issuance of these condensed financial statements. Based on the foregoing, the Company has concluded that substantial doubt exists about the Company’s ability to continue as a going concern for a period of at least 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, and could result in the default on the Company's loan payable. 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, unless the Company maintains 100% of the outstanding debt balance in cash, cash equivalents and marketable securities, the Company is required to be in compliance with a minimum cash covenant and a minimum monthly net product revenue covenant (determined in accordance with U.S. GAAP), measured on a trailing six-month basis. The lender also has the ability to call debt based on a material adverse change clause, which is subjectively defined. If the Company maintains less than 100% of the outstanding debt in cash, cash equivalents and marketable securities and is not in compliance with the minimum cash covenant, monthly net revenue covenants, 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, 2023, the Company did not achieve the minimum monthly net product revenue as set forth in the Loan Agreement. However, the Company is not in default under the Loan Agreement as it maintained 100% of the outstanding debt balance of $75.0 million in cash, cash equivalents and marketable securities. On February 22, 2023, the Company approved a reduction in its workforce to streamline operations and reduce operating expenses. The Company recognized $1.4 million in severance and termination-related costs in the first quarter of 2023. See Note 14 for further discussion on this restructuring activity. |
Use of Estimates | Use of EstimatesThe preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and the accompanying notes. On an ongoing basis, the Company’s management evaluates its estimates which include, but are not limited to, estimates related to accrued expenses, accrued external clinical costs, net product sales, common stock valuation, stock-based compensation expense and deferred tax asset valuation allowance. Actual results could differ from those estimates. |
Cash and Cash Equivalents | Cash and Cash Equivalents 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, 2023 consist of amounts on deposit in banks, including checking accounts and money market accounts. 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 money market funds at the financial institution. Therefore, these funds are classified as restricted cash on the balance sheet. The letter of credit will be reduced ratably on each anniversary of the commencement of the lease until the end of the lease term. As of March 31, 2023, restricted cash totaled $0.3 million. |
Marketable Securities | Marketable SecuritiesThe 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, 2023 as “available-for-sale” pursuant to ASC Topic 320, Investments – Debt and Equity Securities. Investments not classified as cash equivalents are presented as either short-term or long-term investments based on both their maturities as well as the time period the Company intends to hold such securities. Available-for-sale securities are maintained by an investment manager and primarily consist of fixed income securities. Available-for-sale securities are carried at fair value. Any premium or discount arising at purchase is amortized or accreted to interest income over the life of the instrument. Realized gains and losses are determined using the specific identification method and are included in other (income) expense, net. |
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 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. The Company began capitalizing inventory upon receiving FDA approval for COSELA on February 12, 2021. Prior to FDA approval of COSELA, expenses associated with the manufacturing of the Company's products were recorded as research and development expense. 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 sales in the period in which they are incurred. No inventory valuation adjustments have been recorded for any periods presented. |
Debt, 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). To date, the Company has recognized $0.5 million in revenue related to sales-based royalties. Product Sales, Net The Company sells COSELA to specialty distributors in the U.S. and, in accordance with ASC 606, recognizes revenue at the point in time when the customer is deemed to have obtained control of the product. The customer is deemed to have obtained control of the product at the time of physical receipt of the product at the customers’ distribution facilities, or Free on Board (“FOB”) destination, the terms of which are designated in the contract. Product sales are recorded at the net selling price, which includes estimates of variable consideration for which reserves are established for (a) rebates and chargebacks, (b) co-pay assistance programs, (c) distribution fees, (d) product returns, and (e) other discounts. Where appropriate, these estimates take into consideration a range of possible outcomes which are probability-weighted 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. Forms of Variable Consideration Rebates and Chargebacks : The Company estimates reductions to product sales for Public Health Service Institutions, such as Medicaid, Medicare and Veterans Administration (“VA”) programs, as well as certain other qualifying federal and state government programs, and other group purchasing organizations. The Company estimates these reductions based upon the Company’s contracts with government agencies and other organizations, statutorily defined discounts and estimated payor mix. These organizations purchase directly from the Company’s specialty distributors at a discount and the specialty distributors charge the Company back the difference between the wholesaler price and the discounted price. The Company’s liability for Medicaid rebates consists of estimates for claims that a state will make. The Company’s reserve for this discounted pricing is based on expected sales to qualified healthcare providers and the chargebacks that customers have already claimed. Co-Pay Assistance: Eligible patients who have commercial insurance may receive assistance from the Company to reduce the patient’s out of pocket costs. Liabilities for co-pay assistance are calculated by actual program participation from third-party administrators. Distribution Fees: The Company has written contracts with its customers that include terms for distribution fees and costs for inventory management. The Company estimates and records distribution fees due to its customers based on gross sales. Product Returns: The Company generally offers a right of return based on the product’s expiration date and certain spoilage and damaged instances. The Company estimates the amount of product sales that may be returned and records the estimate as a reduction of product sales in the period the related product sales are recognized. The Company’s estimates for expected returns are based primarily on an ongoing analysis of sales information and visibility into the inventory remaining in the distribution channel. |
Concentration of Credit Risk | Concentration of Credit Risk Financial instruments that potentially subject the Company to credit risk consist of cash and cash equivalents. Deposits with financial institutions are insured, up to certain limits, by the Federal Deposit Insurance Corporation (“FDIC”). The Company’s cash deposits often exceed the FDIC insurance limit; however, all deposits are maintained with high credit quality institutions and the Company has not experienced any losses in such accounts. The financial condition of financial institutions is periodically reassessed, and the Company believes the risk of any loss is minimal. The Company believes the risk of any loss on cash due to credit risk is minimal. |
Cost of Goods Sold | Cost of Goods Sold Cost of goods sold includes direct and indirect costs related to the manufacturing and distribution of COSELA, including third-party manufacturing costs, packaging services, freight-in, third-party logistics costs associated with COSELA, and Company personnel costs. Cost of goods sold may also include period costs related to certain inventory manufacturing services and inventory adjustment charges. In connection with the FDA approval of COSELA on February 12, 2021, the Company subsequently began capitalizing inventory manufactured or purchased after this date. As a result, certain manufacturing costs associated with product shipments of COSELA were expensed prior to FDA approval and, therefore, are not included in cost of goods sold during the current period. |
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 products, 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 estimated and accrued 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. |
Income Taxes | Income Taxes Income taxes are accounted for using the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to temporary differences between the financial statements carrying amounts of assets and liabilities and their respective tax bases, operating loss carryforwards, and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. In accordance with Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) 740, Accounting for Income Taxes |
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. |
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. |
Description of Business (Tables
Description of Business (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Summary Of Product Development | Candidate Indication Current Status Initial Results Additional Results Endpoints Development & trilaciclib 1L metastatic Triple negative breast cancer (mTNBC) Registrational Phase 3 trial (enrollment complete) Interim OS analysis expected in 1Q 2024 Primary: OS* G1 Therapeutics owns all global development and commercial rights across all indications, with the exception of Greater China (Simcere) Antibody-drug conjugate (ADC) combination trial in mTNBC Phase 2 trial (enrollment complete) Initial safety results announced in 4Q 2022 Initial efficacy results** expected in 2Q 2023; OS endpoint expected in 1Q 2024 Primary: PFS Mechanism of action (MOA) trial in early-stage neoadjuvant TNBC Phase 2 trial (enrollment complete) MOA data presented in 4Q 2022 Results** including pCR expected in 2Q 2023 Primary: Immune-based MOA 1L Bladder cancer (mUC) Phase 2 trial Initial ORR results announced in 1Q 2023 Results** including preliminary PFS results expected in mid-2023; OS endpoint expected in 1Q 2024 Primary: PFS PFS=progression-free survival; OS=overall survival; PRO=patient reported outcome; ORR=overall response rate; pCR=pathological complete response; MOA=mechanism of action. *Initial results expected: (i) Phase 3 1L mTNBC trial: interim OS analysis; if the trial meets the interim analysis stopping rule, it will terminate and the Company will report the topline results. If it does not, the trial will continue to the final analysis. **Additional results to include tumor Programmed Cell Death-Ligand 1 ("PD-L1") status. |
Fair Value of Financial Instr_2
Fair Value of Financial Instruments (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Summary of Financial Instruments and Respective Fair Values | At March 31, 2023 and December 31, 2022, 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 funds $ 64,779 $ — $ — $ 64,779 Marketable securities: U.S. Treasury Bills 48,080 — — 48,080 Total assets at fair value $ 112,859 $ — $ — $ 112,859 Quoted prices Significant Significant Balance at December 31, Assets: Money market funds $ 84,167 $ — $ — $ 84,167 Marketable securities: U.S. Treasury Bills 50,476 — — 50,476 Total assets at fair value $ 134,643 $ — $ — $ 134,643 |
Inventories (Tables)
Inventories (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventories | Inventories consists of the following (in thousands): March 31, 2023 December 31, 2022 Raw materials $ 2,715 $ 2,790 Work in process 10,026 10,153 Finished goods 2,802 3,236 Inventories $ 15,543 $ 16,179 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment | Property and equipment consists of the following (in thousands): March 31, 2023 December 31, 2022 Computer equipment $ 327 $ 327 Laboratory equipment 334 334 Furniture and fixtures 866 866 Leasehold improvements 1,782 1,782 Manufacturing equipment 506 506 Accumulated depreciation (1,958) (1,826) Property and equipment, net $ 1,857 $ 1,989 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses are comprised as follows (in thousands): March 31, 2023 December 31, 2022 Accrued external research $ 207 $ 268 Accrued professional fees and other 5,394 4,304 Accrued external clinical study costs 15,063 15,566 Accrued compensation expense 2,103 5,419 Accrued expenses $ 22,767 $ 25,557 |
Loan Payable (Tables)
Loan Payable (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Debt Disclosure [Abstract] | |
Schedule of Outstanding Debt Obligations | As of March 31, 2023, the future principal payments due under the Loan Agreement, excluding interest, are as follows (in thousands): Amount 2023 $ — 2024 2,729 2025 35,204 2026 37,067 Total principal outstanding 75,000 End of term charge 3,106 Unamortized debt issuance costs (636) Total $ 77,470 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Equity [Abstract] | |
Summary of Common Stock Shares Reserved for Future Issuance | The Company has reserved authorized shares of common stock for future issuance at March 31, 2023 and December 31, 2022 as follows: March 31, 2023 December 31, 2022 Common stock options outstanding 7,871,249 7,372,028 RSUs outstanding 956,273 675,406 PSUs outstanding 218,450 — Options, RSUs and PSUs available for grant under Equity Incentive Plans 2,261,691 2,323,539 11,307,663 10,370,973 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Summary of Share-Based Compensation Expense Included in Statement of Operations | The table below summarizes the stock-based compensation expense recognized in the Company’s statement of operations by classification (in thousands): Three Months Ended March 31, 2023 2022 Cost of goods sold $ 35 $ 51 Research and development 674 1,149 Selling, general and administrative 3,127 4,565 Total stock-based compensation expense $ 3,836 $ 5,765 |
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, 2023 2022 Expected volatility 81.4% - 86.8% 76.7% - 77.1% Weighted-average risk free rate 3.4% - 3.9% 1.4% - 1.7% Dividend yield —% —% Expected term (in years) 6.08 6.07 |
Summary of Stock Option Activity | The following table is a summary of stock option activity for the three months ended March 31, 2023: Weighted average Options Weighted Remaining Aggregate (in thousands) Balance as of December 31, 2022 7,372,028 $ 16.15 6.9 $ 3,281 Granted 1,011,730 5.49 Cancelled (509,501) 11.04 Exercised (3,008) 0.30 Balance as of March 31, 2023 7,871,249 $ 15.12 6.9 $ 1,122 Exercisable at December 31, 2022 4,562,674 $ 17.85 5.8 $ 3,248 Vested at December 31, 2022 and expected to vest 7,372,028 $ 16.15 6.9 $ 3,281 Exercisable at March 31, 2023 5,052,581 $ 17.46 5.8 $ 1,122 Vested at March 31, 2023 and expected to vest 7,871,249 $ 15.12 6.9 $ 1,122 |
Summary of Restricted Stock Units Activity | The following table is a summary of the RSU activity for the three months ended March 31, 2023: Number of Weighted – Average Balance as of December 31, 2022 675,406 $ 12.31 Granted 590,650 5.23 Cancelled (152,928) 8.64 Vested (156,855) 14.81 Balance as of March 31, 2023 956,273 $ 8.11 |
Summary of Performance Stock Units Activity | The following table is a summary of the PSU activity for the three months ended March 31, 2023: Number of Weighted – Average Balance as of December 31, 2022 — $ — Granted 218,450 5.73 Cancelled — — Vested — — Balance as of March 31, 2023 218,450 $ 5.73 |
Net Loss Per Common Share (Tabl
Net Loss Per Common Share (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
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, 2023 and 2022 and 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, 2023 2022 Stock options issued and outstanding 8,085,891 7,736,333 Unvested RSUs 952,481 606,371 Unvested PSUs 211,168 — Total potential dilutive shares 9,249,540 8,342,704 |
Restructuring Charges (Tables)
Restructuring Charges (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Restructuring and Related Activities [Abstract] | |
Details for Restructuring Activities | As a result of these reductions in workforce, the Company recorded the following expenses, primarily related to severance, employee benefits and termination-related costs during the three months ended March 31, 2023 (in thousands): Amount Cost of goods sold $ 94 Research and development 510 Selling, general and administrative 811 Total $ 1,415 |
Details for Restructuring Accrual | The following table is a reconciliation of the beginning and ending restructuring liability for the three months ended March 31, 2023 (in thousands): Termination-related costs Benefits Severance Total Balance as of December 31, 2022 $ — $ — $ — $ — Expense recognized 85 50 1,280 1,415 Cash payments (85) (50) (1,174) (1,309) Balance as of March 31, 2023 $ — $ — $ 106 $ 106 |
Description of Business (Detail
Description of Business (Details) - Nanjing Simcere Dongyuan Pharmaceutical Co Ltd $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||
Aug. 03, 2020 USD ($) | Sep. 30, 2020 USD ($) | Mar. 31, 2023 USD ($) payment | Dec. 31, 2022 USD ($) | Dec. 31, 2020 USD ($) | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Upfront payment received | $ 14,000 | ||||
License revenue recognized | $ 0 | ||||
Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Upfront payment received | $ 14,000 | $ 14,000 | |||
Revenue, remaining performance obligation, variable consideration amount | $ 156,000 | ||||
License revenue recognized | $ 22,000 | ||||
Milestone payments, number of payments received | payment | 0 |
Basis of Presentation and Sum_3
Basis of Presentation and Summary of Significant Accounting Policies - Narrative (Details) - USD ($) $ in Thousands | 3 Months Ended | ||||
Nov. 01, 2022 | Jun. 24, 2022 | Mar. 31, 2023 | Dec. 31, 2022 | Nov. 30, 2018 | |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |||||
Accumulated deficit | $ 759,613 | $ 732,018 | |||
Restructuring charges | 1,415 | ||||
Restricted cash | 300 | ||||
Unbilled receivables, current | 2,100 | ||||
Unrecognized tax benefits | 0 | 0 | |||
Accrued income taxes | $ 0 | $ 0 | |||
Third Amendment | |||||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |||||
Debt instrument percentage of unrestricted cash | 100% | 100% | |||
Fourth Amendment | |||||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |||||
Debt instrument percentage of unrestricted cash | 100% | ||||
Debt instrument, covenant, outstanding debt threshold | $ 75,000 | $ 75,000 | |||
Nanjing Simcere Dongyuan Pharmaceutical Co Ltd | |||||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |||||
License revenue recognized | 0 | ||||
Nanjing Simcere Dongyuan Pharmaceutical Co Ltd | Royalty | |||||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |||||
License revenue recognized | $ 500 | ||||
Restricted Cash | Standby Letters of Credit | |||||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |||||
Security deposit | $ 500 |
Fair Value of Financial Instr_3
Fair Value of Financial Instruments (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
U.S. Treasury Bills | $ 48,080 | $ 50,476 |
Total assets at fair value | 112,859 | 134,643 |
Loan payable | 77,470 | 77,015 |
Quoted prices in active markets for identical assets (Level 1) | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
U.S. Treasury Bills | 48,080 | 50,476 |
Total assets at fair value | 112,859 | 134,643 |
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 | 77,500 | |
Money Market Funds | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Money market funds | 64,779 | 84,167 |
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 funds | 64,779 | 84,167 |
Money Market Funds | Significant other observable inputs (Level 2) | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Money market funds | 0 | 0 |
Money Market Funds | Significant other unobservable inputs (Level 3) | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Money market funds | $ 0 | $ 0 |
Inventories (Details)
Inventories (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 2,715 | $ 2,790 |
Work in process | 10,026 | 10,153 |
Finished goods | 2,802 | 3,236 |
Inventories | $ 15,543 | $ 16,179 |
Property and Equipment - Schedu
Property and Equipment - Schedule of Property and Equipment (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Property, Plant and Equipment [Line Items] | ||
Accumulated depreciation | $ (1,958) | $ (1,826) |
Property and equipment, net | 1,857 | 1,989 |
Computer equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 327 | 327 |
Laboratory equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 334 | 334 |
Furniture and fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 866 | 866 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 1,782 | 1,782 |
Manufacturing equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 506 | $ 506 |
Property, Plant, and Equipment
Property, Plant, and Equipment - Narrative (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation expenses relating to property and equipment | $ 132 | $ 115 |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Payables and Accruals [Abstract] | ||
Accrued external research | $ 207 | $ 268 |
Accrued professional fees and other | 5,394 | 4,304 |
Accrued external clinical study costs | 15,063 | 15,566 |
Accrued compensation expense | 2,103 | 5,419 |
Accrued expenses | $ 22,767 | $ 25,557 |
Loan Payable - Narrative (Detai
Loan Payable - Narrative (Details) - USD ($) $ in Thousands | 3 Months Ended | |||||||
Nov. 01, 2022 | Jun. 24, 2022 | Nov. 01, 2021 | Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2021 | Mar. 31, 2021 | May 29, 2020 | |
Debt Instrument [Line Items] | ||||||||
Other Nonoperating Interest Expense | $ 3,089 | $ 2,265 | ||||||
Loan Agreement | Hercules Capital Inc | ||||||||
Debt Instrument [Line Items] | ||||||||
Loan agreement, basis spread on variable rate | 6.40% | |||||||
Loan agreement, interest rate, stated percentage | 9.65% | |||||||
Percentage of prepayment loan amount for first year | 3% | |||||||
Percentage of prepayment loan amount for second year | 2% | |||||||
Percentage of prepayment loan amount for third year | 1% | |||||||
Extinguishment of debt, amount | $ 200 | |||||||
Loan Agreement | Hercules Capital Inc | First Amendment To Loan And Security Agreement | ||||||||
Debt Instrument [Line Items] | ||||||||
Loan agreement, basis spread on variable rate | 6.20% | |||||||
Loan agreement, interest rate, stated percentage | 9.45% | |||||||
Loan Agreement | Hercules Capital Inc | Tranche One | ||||||||
Debt Instrument [Line Items] | ||||||||
Loan amount | $ 30,000 | |||||||
Percentage of aggregate amount of all loan advances payment | 6.95% | |||||||
End of term fee | $ 2,100 | |||||||
Loan Agreement | Hercules Capital Inc | Tranche One | First Amendment To Loan And Security Agreement | ||||||||
Debt Instrument [Line Items] | ||||||||
Remaining loan amount | $ 10,000 | |||||||
Loan Agreement | Hercules Capital Inc | Tranche Two | ||||||||
Debt Instrument [Line Items] | ||||||||
Loan amount | 20,000 | |||||||
Loan Agreement | Hercules Capital Inc | Tranche Three | ||||||||
Debt Instrument [Line Items] | ||||||||
Loan amount | 30,000 | |||||||
Loan Agreement | Hercules Capital Inc | Tranche Four | ||||||||
Debt Instrument [Line Items] | ||||||||
Loan amount | 20,000 | |||||||
Loan Agreement | Hercules Capital Inc | Maximum | ||||||||
Debt Instrument [Line Items] | ||||||||
Loan amount | $ 100,000 | |||||||
Loan Agreement | Hercules Capital Inc | Minimum | First Amendment To Loan And Security Agreement | ||||||||
Debt Instrument [Line Items] | ||||||||
Borrowing capacity without financial covenants | $ 40,000 | |||||||
Third Amendment | ||||||||
Debt Instrument [Line Items] | ||||||||
Loan amount | $ 25,000 | |||||||
Debt instrument percentage of net product revenue | 80% | |||||||
Debt instrument minimum revenue of covenant market capitalization amount | $ 750,000 | |||||||
Debt instrument percentage of unrestricted cash | 100% | 100% | ||||||
Debt instrument, covenant, unrestricted cash balance, percentage | 50% | |||||||
Loan And Security Agreement | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt instrument percentage of net product revenue | 65% | |||||||
Debt instrument percentage of minimum revenue of covenant unrestricted cash | 50% | |||||||
Debt instrument percentage of unrestricted cash | 100% | |||||||
Loan And Security Agreement | Hercules Capital Inc | ||||||||
Debt Instrument [Line Items] | ||||||||
Loan agreement, basis spread on variable rate | 5.90% | |||||||
Loan agreement, interest rate, stated percentage | 9.15% | |||||||
Percentage of prepayment loan amount for first year | 3% | |||||||
Percentage of prepayment loan amount for second year | 2% | |||||||
Percentage of prepayment loan amount for third year | 1% | |||||||
Loan And Security Agreement | Hercules Capital Inc | Tranche One | ||||||||
Debt Instrument [Line Items] | ||||||||
Loan amount | $ 100,000 | |||||||
Remaining loan amount | $ 25,000 | |||||||
Percentage of aggregate amount of all loan advances payment | 6.75% | |||||||
End of term fee | $ 2,100 | |||||||
Debt instrument additional borrowing amount | 45,000 | |||||||
Loan And Security Agreement | Hercules Capital Inc | Tranche Two | ||||||||
Debt Instrument [Line Items] | ||||||||
Loan amount | 20,000 | |||||||
Debt instrument available upon achievement of net product revenue | $ 50,000 | |||||||
Debt instrument trailing net product revenue | 6 months | |||||||
Loan And Security Agreement | Hercules Capital Inc | Tranche Three | ||||||||
Debt Instrument [Line Items] | ||||||||
Loan amount | $ 15,000 | |||||||
Loan And Security Agreement | Hercules Capital Inc | Tranche Four | ||||||||
Debt Instrument [Line Items] | ||||||||
Loan amount | 15,000 | |||||||
Loan And Security Agreement | Hercules Capital Inc | Maximum | ||||||||
Debt Instrument [Line Items] | ||||||||
Loan amount | $ 150,000 | |||||||
Fourth Amendment | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt instrument additional borrowing amount | $ 25,000 | |||||||
Debt instrument percentage of net product revenue | 80% | |||||||
Debt instrument minimum revenue of covenant market capitalization amount | $ 750,000 | |||||||
Debt instrument percentage of unrestricted cash | 100% | |||||||
Debt instrument, covenant, unrestricted cash balance, percentage | 50% | |||||||
Debt instrument, covenant, outstanding debt threshold | $ 75,000 | $ 75,000 | ||||||
Fourth Amendment | Outstanding Debt Less Than Or Equal To 75.0 Million | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt instrument, covenant, unrestricted cash balance, percentage | 65% | |||||||
Fourth Amendment | Outstanding Debt Greater Than 75.0 Million | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt instrument, covenant, unrestricted cash balance, percentage | 70% | |||||||
Fourth Amendment | Achievement Of Net Revenue Milestones | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt instrument, covenant, unrestricted cash balance, percentage | 45% |
Loan Payable - Schedule of Outs
Loan Payable - Schedule of Outstanding Debt Obligations (Details) $ in Thousands | 3 Months Ended |
Mar. 31, 2023 USD ($) | |
Debt Disclosure [Abstract] | |
2023 | $ 0 |
2023 | 2,729 |
2024 | 35,204 |
2025 | 37,067 |
Total principal outstanding | 75,000 |
End of term charge | 3,106 |
Unamortized debt issuance costs | (636) |
Total | $ 77,470 |
Stockholders' Equity - Narrativ
Stockholders' Equity - Narrative (Details) $ / shares in Units, $ in Millions | Dec. 20, 2022 USD ($) shares | Nov. 17, 2022 USD ($) $ / shares shares | Feb. 23, 2022 USD ($) | Jul. 02, 2021 USD ($) | Mar. 31, 2023 vote shares | Dec. 31, 2022 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 | |||||
2021 Sales Agreement | ||||||
Class of Stock [Line Items] | ||||||
Maximum gross proceeds of common stock allowed from issuance and sell | $ | $ 150 | |||||
Common stock | ||||||
Class of Stock [Line Items] | ||||||
Common stock, shares authorized (in shares) | 120,000,000 | |||||
Cowen And Company L L C | 2022 Sales Agreement | ||||||
Class of Stock [Line Items] | ||||||
Maximum gross proceeds of common stock allowed from issuance and sell | $ | $ 300 | |||||
Proceeds from issuance of common stock | $ | $ 55.7 | $ 50.1 | $ 100 | |||
Sale of stock, number of shares issued in transaction | 8,573,353 | 7,700,000 | ||||
Sale of stock, price per share | $ / shares | $ 6.50 | |||||
Sale of Stock, Consideration Received on Transaction | $ | $ 52 | |||||
Cowen And Company L L C | Over-Allotment Option | ||||||
Class of Stock [Line Items] | ||||||
Sale of stock, number of shares issued in transaction | 873,353 |
Stockholders' Equity - Summary
Stockholders' Equity - Summary of Shares Reserved for Future Issuance (Details) - shares | Mar. 31, 2023 | Dec. 31, 2022 |
Class of Stock [Line Items] | ||
Common stock, shares reserved for future issuance (in shares) | 11,307,663 | 10,370,973 |
Common stock options outstanding | ||
Class of Stock [Line Items] | ||
Common stock, shares reserved for future issuance (in shares) | 7,871,249 | 7,372,028 |
RSUs outstanding | ||
Class of Stock [Line Items] | ||
Common stock, shares reserved for future issuance (in shares) | 956,273 | 675,406 |
PSUs outstanding | ||
Class of Stock [Line Items] | ||
Common stock, shares reserved for future issuance (in shares) | 218,450 | 0 |
Options, RSUs and PSUs available for grant under Equity Incentive Plans | ||
Class of Stock [Line Items] | ||
Common stock, shares reserved for future issuance (in shares) | 2,261,691 | 2,323,539 |
Stock-Based Compensation - Narr
Stock-Based Compensation - Narrative (Details) - USD ($) $ in Thousands | 3 Months Ended | |||||
Jan. 01, 2023 | Mar. 31, 2023 | Mar. 31, 2022 | Sep. 30, 2021 | Feb. 28, 2021 | May 31, 2017 | |
Employee Stock Options | ||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||
Stock options, maximum term | 10 years | |||||
Unrecognized stock-based compensation costs | $ 19,400 | |||||
Weighted-average recognition period | 2 years 2 months 12 days | |||||
Restricted Stock Units (RSUs) | ||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||
Weighted-average recognition period | 2 years 9 months 18 days | |||||
Number of common shares received upon vesting | 1 | |||||
Unrecognized compensation cost | $ 6,700 | |||||
Performance Shares | ||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||
Weighted-average recognition period | 2 years 9 months 18 days | |||||
Number of common shares received upon vesting | 1 | |||||
Unrecognized compensation cost | $ 1,300 | |||||
2011 Equity Incentive Plan | ||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||
Number of shares available for grant under equity incentive plan (in shares) | 0 | |||||
2017 Equity Incentive Plan | ||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||
Number of shares available for grant under equity incentive plan (in shares) | 1,438,251 | |||||
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) | 823,440 | |||||
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, 2023 | Mar. 31, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Total stock-based compensation expense | $ 3,836 | $ 5,765 |
Cost of goods sold | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Total stock-based compensation expense | 35 | 51 |
Research and development | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Total stock-based compensation expense | 674 | 1,149 |
Selling, general and administrative | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Total stock-based compensation expense | $ 3,127 | $ 4,565 |
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, 2023 | Mar. 31, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Expected volatility, minimum | 81.40% | 76.70% |
Expected volatility, maximum | 86.80% | 77.10% |
Weighted-average risk free rate, minimum | 3.40% | 1.40% |
Weighted-average risk free rate, maximum | 3.90% | 1.70% |
Dividend yield | 0% | 0% |
Expected term (in years) | 6 years 29 days | 6 years 25 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, 2023 | Dec. 31, 2022 | |
Options outstanding | ||
Beginning balance (in shares) | 7,372,028 | |
Granted (in shares) | 1,011,730 | |
Cancelled (in shares) | (509,501) | |
Exercised (in shares) | (3,008) | |
Ending balance (in shares) | 7,871,249 | 7,372,028 |
Exercisable (in shares) | 5,052,581 | 4,562,674 |
Vested and expected to vest (in shares) | 7,871,249 | 7,372,028 |
Weighted average exercise price | ||
Beginning balance (in US dollars per share) | $ 16.15 | |
Granted (in US dollars per share) | 5.49 | |
Cancelled (in US dollars per share) | 11.04 | |
Exercised (in US dollars per share) | 0.30 | |
Ending balance (in US dollars per share) | 15.12 | $ 16.15 |
Exercisable (in US dollars per share) | 17.46 | 17.85 |
Vested and expected to vest (in US dollars per share) | $ 15.12 | $ 16.15 |
Weighted average, remaining contractual for life (years) | ||
Beginning, end of period | 6 years 10 months 24 days | 6 years 10 months 24 days |
Exercisable | 5 years 9 months 18 days | 5 years 9 months 18 days |
Vested and expected to vest | 6 years 10 months 24 days | 6 years 10 months 24 days |
Weighted average, aggregate intrinsic value | ||
Balance | $ 1,122 | $ 3,281 |
Exercisable | 1,122 | 3,248 |
Vested and expected to vest | $ 1,122 | $ 3,281 |
Stock-Based Compensation - Su_3
Stock-Based Compensation - Summary of Restricted Stock Units Activity (Details) - Restricted Stock Units (RSUs) | 3 Months Ended |
Mar. 31, 2023 $ / shares shares | |
Number of RSUs | |
Beginning balance (in shares) | shares | 675,406 |
Granted (in shares) | shares | 590,650 |
Cancelled (in shares) | shares | (152,928) |
Vested (in shares) | shares | (156,855) |
Ending balance (in shares) | shares | 956,273 |
Weighted-Average Fair Value per Share | |
Beginning balance (in US dollars per share) | $ / shares | $ 12.31 |
Granted (in US dollars per share) | $ / shares | 5.23 |
Cancelled (in US dollars per share) | $ / shares | 8.64 |
Vested (in US dollars per share) | $ / shares | 14.81 |
Ending balance (in US dollars per share) | $ / shares | $ 8.11 |
Stock-Based Compensation - Su_4
Stock-Based Compensation - Summary of Performance Stock Units Activity (Details) - Performance Shares | 3 Months Ended |
Mar. 31, 2023 $ / shares shares | |
Number of Performance Shares | |
Beginning balance (in shares) | shares | 0 |
Granted (in shares) | shares | 218,450 |
Cancelled (in shares) | shares | 0 |
Vested (in shares) | shares | 0 |
Ending balance (in shares) | shares | 218,450 |
Weighted-Average Fair Value per Share | |
Beginning balance (in US dollars per share) | $ / shares | $ 0 |
Granted (in US dollars per share) | $ / shares | 5.73 |
Cancelled (in US dollars per share) | $ / shares | 0 |
Vested (in US dollars per share) | $ / shares | 0 |
Ending balance (in US dollars per share) | $ / shares | $ 5.73 |
License Revenue (Details)
License Revenue (Details) | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||||
Aug. 03, 2020 USD ($) | Jul. 22, 2020 USD ($) | May 22, 2020 USD ($) performanceObligation | Sep. 30, 2020 USD ($) | Mar. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) | Dec. 31, 2020 USD ($) | Mar. 31, 2022 | Jun. 15, 2020 USD ($) | |
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 | performanceObligation | 1 | ||||||||
Revenue recognized | $ 2,100,000 | $ 0 | |||||||
Genor Biopharma Co Inc | |||||||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||||||||
Milestone payments receivable | $ 40,000,000 | ||||||||
Revenue recognized | $ 6,000,000 | 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 | $ 20,000,000 | ||||||||
Milestone payments receivable | $ 290,000,000 | ||||||||
Revenue recognized | 20,000,000 | 0 | |||||||
Period for payment on invoice terms | 30 days | ||||||||
Number of days due from invoice date | 30 days | ||||||||
Revenue recognized for reimbursement of clinical trials costs | 400,000 | ||||||||
Nanjing Simcere Dongyuan Pharmaceutical Co Ltd | |||||||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||||||||
Upfront payment received | $ 14,000,000 | ||||||||
Revenue recognized | 0 | ||||||||
Revenue recognized for reimbursement of supply, manufacturing services and patent costs | 1,400,000 | ||||||||
Nanjing Simcere Dongyuan Pharmaceutical Co Ltd | Royalty | |||||||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||||||||
Revenue recognized | $ 500,000 | ||||||||
Nanjing Simcere Dongyuan Pharmaceutical Co Ltd | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | |||||||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||||||||
Upfront payment received | $ 14,000,000 | $ 14,000,000 | |||||||
Revenue recognized | $ 22,000,000 | ||||||||
Revenue, remaining performance obligation, variable consideration amount | $ 156,000,000 |
Net Loss Per Common Share (Deta
Net Loss Per Common Share (Details) - shares | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total potential dilutive shares | 9,249,540 | 8,342,704 |
Stock options issued and outstanding | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total potential dilutive shares | 8,085,891 | 7,736,333 |
Restricted Stock Units (RSUs) | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total potential dilutive shares | 952,481 | 606,371 |
Performance Shares | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total potential dilutive shares | 211,168 | 0 |
Income Taxes - Narrative (Detai
Income Taxes - Narrative (Details) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Income Tax Disclosure [Abstract] | ||
Effective Income Tax Rate Reconciliation, Percent | 0% | 0% |
Related Party Transactions (Det
Related Party Transactions (Details) $ in Thousands | Jan. 01, 2021 USD ($) |
Senior Advisor Agreement | Board of Directors Chairman | |
Related Party Transaction [Line Items] | |
Related party payments | $ 200 |
Restructuring Charges - Summary
Restructuring Charges - Summary of Restructuring Expenses (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 01, 2023 | Mar. 31, 2023 | |
Restructuring Cost and Reserve [Line Items] | ||
Restructuring and related cost, number of positions eliminated, period percent | 30% | |
Restructuring charges | $ 1,415 | |
Cost of goods sold | ||
Restructuring Cost and Reserve [Line Items] | ||
Restructuring charges | 94 | |
Research and development | ||
Restructuring Cost and Reserve [Line Items] | ||
Restructuring charges | 510 | |
Selling, general and administrative | ||
Restructuring Cost and Reserve [Line Items] | ||
Restructuring charges | $ 811 |
Restructuring Charges - Summa_2
Restructuring Charges - Summary of Restructuring Liability (Details) $ in Thousands | 3 Months Ended |
Mar. 31, 2023 USD ($) | |
Restructuring Reserve [Roll Forward] | |
Restructuring reserve, beginning balance | $ 0 |
Restructuring charges | 1,415 |
Cash payments | (1,309) |
Restructuring reserve, ending balance | 106 |
Termination-related costs | |
Restructuring Reserve [Roll Forward] | |
Restructuring reserve, beginning balance | 0 |
Restructuring charges | 85 |
Cash payments | (85) |
Restructuring reserve, ending balance | 0 |
Benefits | |
Restructuring Reserve [Roll Forward] | |
Restructuring reserve, beginning balance | 0 |
Restructuring charges | 50 |
Cash payments | (50) |
Restructuring reserve, ending balance | 0 |
Severance | |
Restructuring Reserve [Roll Forward] | |
Restructuring reserve, beginning balance | 0 |
Restructuring charges | 1,280 |
Cash payments | (1,174) |
Restructuring reserve, ending balance | $ 106 |
Subsequent Events (Details)
Subsequent Events (Details) - Nanjing Simcere Dongyuan Pharmaceutical Co Ltd - Collaborative Arrangement, Transaction with Party to Collaborative Arrangement - USD ($) $ in Millions | Apr. 28, 2023 | Aug. 03, 2020 |
Subsequent Event [Line Items] | ||
Revenue, remaining performance obligation, variable consideration amount | $ 156 | |
Subsequent Event | ||
Subsequent Event [Line Items] | ||
Upfront cash payment receivable under agreement | $ 30 | |
Subsequent Event | Filing of NDA of TNBC | ||
Subsequent Event [Line Items] | ||
Revenue, remaining performance obligation, variable consideration amount | 5 | |
Subsequent Event | Regulatory Approval of TNBC | ||
Subsequent Event [Line Items] | ||
Revenue, remaining performance obligation, variable consideration amount | $ 13 |