Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2021 | Oct. 29, 2021 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2021 | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q3 | |
Trading Symbol | GTHX | |
Entity Registrant Name | G1 THERAPEUTICS, INC. | |
Entity Central Index Key | 0001560241 | |
Current Fiscal Year End Date | --12-31 | |
Title of 12(b) Security | Common Stock, par value $0.0001 per share | |
Security Exchange Name | NASDAQ | |
Entity Incorporation, State or Country Code | DE | |
Entity Filer Category | Large Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 42,522,148 | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Current Reporting Status | Yes | |
Entity Shell Company | false | |
Entity File Number | 001-38096 | |
Entity Address, Address Line One | 700 Park Offices Drive | |
Entity Address, Address Line Two | Suite 200 | |
Entity Address, City or Town | Research Triangle Park | |
Entity Address, State or Province | NC | |
Entity Address, Postal Zip Code | 27709 | |
City Area Code | (919) | |
Local Phone Number | 213-9835 | |
Entity Tax Identification Number | 26-3648180 | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity Interactive Data Current | Yes |
Condensed Balance Sheets (unaud
Condensed Balance Sheets (unaudited) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Current assets | ||
Cash and cash equivalents | $ 212,089 | $ 207,306 |
Restricted cash | 63 | 63 |
Accounts Receivable | 5,240 | 237 |
Inventories | 1,375 | |
Prepaid expenses and other current assets | 14,216 | 8,786 |
Total current assets | 232,983 | 216,392 |
Property and equipment, net | 2,127 | 2,482 |
Restricted cash | 312 | 437 |
Operating lease assets | 7,290 | 8,026 |
Other assets | 785 | 1,215 |
Total assets | 243,497 | 228,552 |
Current liabilities | ||
Accounts payable | 3,577 | 3,572 |
Accrued expenses | 22,013 | 16,486 |
Deferred revenue | 26 | 237 |
Other current liabilities | 1,223 | 3,148 |
Total current liabilities | 26,839 | 23,443 |
Loan payable | 30,273 | 19,893 |
Deferred revenue | 1,000 | |
Operating lease liabilities | 7,046 | 7,865 |
Total liabilities | 65,158 | 51,201 |
Stockholders’ equity | ||
Common stock, $0.0001 par value, 120,000,000 shares authorized as of September 30, 2021 and December 31, 2020, respectively; 42,548,814 and 38,140,756 shares issued as of September 30, 2021 and December 31, 2020, respectively; 42,522,148 and 38,114,090 shares outstanding as of September 30, 2021 and December 31, 2020, respectively | 4 | 4 |
Treasury stock, 26,666 shares | (8) | (8) |
Additional paid-in capital | 722,782 | 613,462 |
Accumulated deficit | (544,439) | (436,107) |
Total stockholders’ equity | 178,339 | 177,351 |
Total liabilities and stockholders' equity | $ 243,497 | $ 228,552 |
Condensed Balance Sheets (Paren
Condensed Balance Sheets (Parenthetical) (unaudited) - $ / shares | Sep. 30, 2021 | Dec. 31, 2020 |
Statement Of Financial Position [Abstract] | ||
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 120,000,000 | 120,000,000 |
Common stock, shares, issued | 42,548,814 | 38,140,756 |
Common stock, shares, outstanding | 42,522,148 | 38,114,090 |
Treasury stock, shares | 26,666 | 26,666 |
Condensed Statements of Operati
Condensed Statements of Operations (unaudited) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Revenues: | ||||
Total revenues | $ 4,858 | $ 26,599 | $ 25,680 | $ 28,739 |
Operating expenses: | ||||
Cost of goods sold | 591 | 1,642 | ||
Research and development | 21,143 | 17,932 | 56,435 | 56,897 |
Selling, general and administrative | 24,268 | 18,412 | 72,474 | 44,230 |
Total operating expenses | 46,002 | 36,344 | 130,551 | 101,127 |
Loss from operations | (41,144) | (9,745) | (104,871) | (72,388) |
Other income (expense): | ||||
Interest income | 7 | 50 | 35 | 922 |
Interest expense | (934) | (757) | (2,609) | (1,022) |
Other income (expense) | (76) | (291) | (208) | (488) |
Total other income (expense), net | (1,003) | (998) | (2,782) | (588) |
Loss before income taxes | (42,147) | (10,743) | (107,653) | (72,976) |
Income tax expense | 321 | 931 | 679 | 931 |
Net loss | $ (42,468) | $ (11,674) | $ (108,332) | $ (73,907) |
Net loss per share, basic and diluted | $ (1) | $ (0.31) | $ (2.60) | $ (1.95) |
Weighted average common shares outstanding, basic and diluted | 42,383,573 | 38,009,204 | 41,740,911 | 37,819,071 |
Product Sales, Net | ||||
Revenues: | ||||
Total revenues | $ 3,576 | $ 6,717 | ||
License Revenue | ||||
Revenues: | ||||
Total revenues | $ 1,282 | $ 26,599 | $ 18,963 | $ 28,739 |
Condensed Statements of Stockho
Condensed Statements of Stockholders' Equity (unaudited) - USD ($) $ in Thousands | Total | Common Stock | Treasury Stock | Additional Paid-in Capital | Accumulated Deficit |
Balance at Dec. 31, 2019 | $ 255,527 | $ 4 | $ (8) | $ 592,384 | $ (336,853) |
Balance (in shares) at Dec. 31, 2019 | 37,638,260 | (26,666) | |||
Exercise of common stock options | 219 | 219 | |||
Exercise of common stock options (in shares) | 125,666 | ||||
Stock-based compensation | 4,727 | 4,727 | |||
Net loss during quarter | (31,023) | (31,023) | |||
Balance at Mar. 31, 2020 | 229,450 | $ 4 | $ (8) | 597,330 | (367,876) |
Balance (in shares) at Mar. 31, 2020 | 37,763,926 | (26,666) | |||
Balance at Dec. 31, 2019 | 255,527 | $ 4 | $ (8) | 592,384 | (336,853) |
Balance (in shares) at Dec. 31, 2019 | 37,638,260 | (26,666) | |||
Net loss during quarter | (73,907) | ||||
Balance at Sep. 30, 2020 | 197,472 | $ 4 | $ (8) | 608,236 | (410,760) |
Balance (in shares) at Sep. 30, 2020 | 38,056,601 | (26,666) | |||
Balance at Mar. 31, 2020 | 229,450 | $ 4 | $ (8) | 597,330 | (367,876) |
Balance (in shares) at Mar. 31, 2020 | 37,763,926 | (26,666) | |||
Exercise of common stock options | 1,238 | 1,238 | |||
Exercise of common stock options (in shares) | 175,140 | ||||
Stock-based compensation | 4,367 | 4,367 | |||
Net loss during quarter | (31,210) | (31,210) | |||
Balance at Jun. 30, 2020 | 203,845 | $ 4 | $ (8) | 602,935 | (399,086) |
Balance (in shares) at Jun. 30, 2020 | 37,939,066 | (26,666) | |||
Exercise of common stock options | 379 | 379 | |||
Exercise of common stock options (in shares) | 117,535 | ||||
Stock-based compensation | 4,922 | 4,922 | |||
Net loss during quarter | (11,674) | (11,674) | |||
Balance at Sep. 30, 2020 | 197,472 | $ 4 | $ (8) | 608,236 | (410,760) |
Balance (in shares) at Sep. 30, 2020 | 38,056,601 | (26,666) | |||
Balance at Dec. 31, 2020 | 177,351 | $ 4 | $ (8) | 613,462 | (436,107) |
Balance (in shares) at Dec. 31, 2020 | 38,140,756 | (26,666) | |||
Public offering (ATM) | 86,378 | 86,378 | |||
Public offering (ATM), shares | 3,513,027 | ||||
Exercise of common stock options | 2,264 | 2,264 | |||
Exercise of common stock options (in shares) | 388,857 | ||||
Stock-based compensation | 5,892 | 5,892 | |||
Net loss during quarter | (26,442) | (26,442) | |||
Balance at Mar. 31, 2021 | 245,443 | $ 4 | $ (8) | 707,996 | (462,549) |
Balance (in shares) at Mar. 31, 2021 | 42,042,640 | (26,666) | |||
Balance at Dec. 31, 2020 | $ 177,351 | $ 4 | $ (8) | 613,462 | (436,107) |
Balance (in shares) at Dec. 31, 2020 | 38,140,756 | (26,666) | |||
Exercise of common stock options (in shares) | 895,031 | ||||
Net loss during quarter | $ (108,332) | ||||
Balance at Sep. 30, 2021 | 178,339 | $ 4 | $ (8) | 722,782 | (544,439) |
Balance (in shares) at Sep. 30, 2021 | 42,548,814 | (26,666) | |||
Balance at Mar. 31, 2021 | 245,443 | $ 4 | $ (8) | 707,996 | (462,549) |
Balance (in shares) at Mar. 31, 2021 | 42,042,640 | (26,666) | |||
Exercise of common stock options | 1,481 | 1,481 | |||
Exercise of common stock options (in shares) | 230,347 | ||||
Stock-based compensation | 5,694 | 5,694 | |||
Net loss during quarter | (39,422) | (39,422) | |||
Balance at Jun. 30, 2021 | 213,196 | $ 4 | $ (8) | 715,171 | (501,971) |
Balance (in shares) at Jun. 30, 2021 | 42,272,987 | (26,666) | |||
Exercise of common stock options | 2,083 | 2,083 | |||
Exercise of common stock options (in shares) | 275,827 | ||||
Stock-based compensation | 5,528 | 5,528 | |||
Net loss during quarter | (42,468) | (42,468) | |||
Balance at Sep. 30, 2021 | $ 178,339 | $ 4 | $ (8) | $ 722,782 | $ (544,439) |
Balance (in shares) at Sep. 30, 2021 | 42,548,814 | (26,666) |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows (unaudited) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Cash flows from operating activities | ||
Net loss | $ (108,332) | $ (73,907) |
Adjustments to reconcile net loss to net cash used in operating activities | ||
Stock-based compensation | 17,114 | 14,016 |
Depreciation and amortization | 355 | 462 |
Loss on disposal of fixed assets | 303 | |
Amortization of debt issuance costs | 682 | 351 |
Non-cash interest expense | 236 | 161 |
Non-cash equity interest, net | 228 | (926) |
Change in operating assets and liabilities | ||
Accounts receivable | (5,003) | |
Inventories | (1,375) | |
Prepaid expenses and other assets | (4,580) | (4,316) |
Accounts payable | (109) | (1,375) |
Accrued expenses and other liabilities | 2,547 | (1,034) |
Deferred revenue | 789 | 14,031 |
Net cash used in operating activities | (97,448) | (52,234) |
Cash flows from investing activities | ||
Proceeds from disposal of property and equipment | 152 | |
Net cash provided/used in investing activities | 152 | |
Cash flows from financing activities | ||
Proceeds from stock options exercised | 5,828 | 1,836 |
Proceeds from loan agreement | 10,000 | 20,000 |
Payments of debt issuance costs | (100) | (620) |
Proceeds from public offering, net of underwriting fees and commissions | 86,429 | |
Payment of public offering costs | (51) | |
Net cash provided by financing activities | 102,106 | 21,216 |
Net change in cash, cash equivalents and restricted cash | 4,658 | (30,866) |
Cash, cash equivalents and restricted cash | ||
Beginning of period | 207,806 | 269,708 |
End of period | 212,464 | 238,842 |
Supplemental disclosure of cash flow information | ||
Cash paid for interest | 1,856 | $ 509 |
Non-cash operating, investing and financing activities | ||
Upfront project costs and other current assets in accounts payable and accrued expenses | $ 114 |
Business Description
Business Description | 9 Months Ended |
Sep. 30, 2021 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Business Description | 1. Business Description G1 Therapeutics, Inc. (the “Company”) is a commercial-stage biopharmaceutical company based in Research Triangle Park, North Carolina focused on the development and commercialization of novel small molecule therapeutics for the treatment of patients with cancer. The Company’s first FDA-approved product, COSELA™ (trilaciclib) is the first and only therapy indicated to proactively help protect bone marrow from the damage of chemotherapy and is the first innovation in managing myelosuppression in decades. 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. The Company is advancing its lead clinical compound trilaciclib, a first-in-class therapy designed to improve outcomes for patients who are treated with chemotherapy, in clinical trials assessing myeloprotection and anti-tumor efficacy endpoints in a variety of tumors including colorectal cancer (“CRC”), metastatic triple negative breast cancer (“mTNBC”), neoadjuvant breast cancer, and bladder cancer. During the fourth quarter of 2021, the Company has decided to discontinue the non-small cell lung cancer trial as the competitive landscape has changed. The Company is in the process of evaluating partnering options for rintodestrant, an oral selective estrogen receptor degrader (SERD) for the potential treatment of ER+, HER2- breast cancer. In addition, 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. The Company also has intellectual property focused on cyclin-dependent kinase targets. Trilaciclib The Company’s lead compound, 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 a temporary arrest of susceptible host cells during chemotherapy. This reduces the duration and severity of neutropenia and other myelosuppressive consequences of chemotherapy. Also, clinical trials have shown that trilaciclib has the potential to activate and enhance the immune system response driving increased anti-tumor efficacy, which the Company continues to explore in additional clinical trials in a variety of solid tumor types. Trilaciclib is a novel therapeutic approach, which is given before chemotherapy, that temporarily blocks progression through the cell cycle. This provides two benefits. First, it proactively helps protect HSPCs in bone marrow leading to preservation of neutrophils, erythrocytes, and platelets (called myeloprotection) which reduces the occurrences and severity of neutropenia and other myelosuppressive consequences of chemotherapy. This myeloprotection benefit has been conclusively proven in double-blind placebo-controlled clinical trials in extensive-stage small cell lung cancer. Second, trilaciclib activates and enhances the immune system response driving increased anti-tumor efficacy, which the Company is exploring in clinical trials. On February 12, 2021, COSELA for injection was approved by the U.S. Food and Drug Administration (“FDA”) to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for ES-SCLC. On March 2, 2021, COSELA became commercially available through the Company’s specialty distributor network. COSELA is administered intravenously as a 30-minute infusion completed within four (4) hours prior to the start of chemotherapy and is the first FDA-approved therapy to provide proactive, multilineage protection from chemotherapy-induced myelosuppression. The approval of COSELA is based on data from three (3) randomized, placebo-controlled trials that showed patients receiving COSELA prior to chemotherapy had clinically meaningful and statistically significant reduction in the duration and severity of neutropenia, reduction of red blood cell transfusions, as well as improvements in other myeloprotection measures, compared to patients receiving chemotherapy without COSELA. The Company announced on March 25, 2021 that COSELA had been included in two updated National Comprehensive Cancer Network® (“NCCN”) Clinical Practice Guidelines in Oncology (NCCN Guidelines®): The Treatment Guidelines for Small Cell Lung Cancer and the Supportive Care Guidelines for Hematopoietic Growth Factors. These guidelines document evidence-based, consensus-driven management to ensure that all patients receive preventive, diagnostic, treatment, and supportive services that are most likely to lead to optimal outcomes. On October 1, 2021, the Company announced that the permanent J-code for COSELA that was issued in July 2021 by the Centers for Medicare & Medicaid Services (CMS) is now effective for provider billing for all sites of care. All hospital outpatient departments, ambulatory surgery centers and physician offices in the United States have one consistent Healthcare Common Procedure Coding System (HCPCS) code to standardize the submission and payment of COSELA insurance claims across Medicare, Medicare Advantage, Medicaid and commercial plans. G1’s new technology add-on payment (NTAP) for COSELA which provides additional payment to inpatient hospitals above the standard Medicare Severity Diagnosis-Related Group (MS-DRG) payment amount also became effective for provider billing on October 1, 2021. In June 2020, the Company entered into a three-year co-promotion agreement for COSELA in the United States and Puerto Rico with Boehringer Ingelheim. The agreement is limited to support for SCLC. Under the terms of the agreement, the Company will record revenue in the United States and Puerto Rico and retain development and commercialization rights to trilaciclib. The Company leads marketing, market access and medical engagement initiatives; Boehringer Ingelheim will lead s sales force engagements. In September 2021, the Company announced that it would hire and deploy up to a 15-person oncology sales force to supplement the Boehringer Ingelheim oncology commercial team. The expansion is expected to allow the Company to target top tier accounts in order to accelerate sales activities and help maximize the adoption of COSELA. 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, and will be eligible to receive up to $156.0 million in development and commercial milestone payments. During the nine months ended September 30, 2021, the Company received three development milestone payments totaling $8.0 million. Simcere will also pay the Company tiered low double-digit royalties on annual net sales of trilaciclib in Greater China. As part of this agreement, Simcere will participate in global clinical trials of trilaciclib and the companies will be responsible for all development and commercialization costs in their respective territories. The Company is also executing on its tumor-agnostic strategy to evaluate the potential benefits of providing 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’s on-going clinical trials include: a pivotal trial in 1L CRC, a pivotal trial in mTNBC (including 1L and 2L patients), a Phase 2 trial in neoadjuvant breast cancer (I-SPY 2), and a Phase 2 trial in 1L bladder cancer with chemotherapy and a checkpoint inhibitor. These studies across treatment settings and tumor types will evaluate trilaciclib’s dual benefits in both multi-lineage myeloprotection and anti-tumor efficacy. We also intend to initiate the following two new Phase 2 trials in the fourth quarter of 2021: (i) a trial designed to validate trilaciclib’s immune-based mechanism of action (MOA); and (ii) a trial designed to evaluate the antitumor efficacy and myeloprotective benefit of COSELA administered prior to an antibody-drug conjugate (ADC). Rintodestrant Rintodestrant is an oral selective estrogen receptor degrader (“SERD”) for the treatment of estrogen receptor-positive (“ER+”) breast cancer. It is a Phase 2 compound being developed as a monotherapy and in combination with CDK4/6 inhibitors, initially Ibrance® (palbociclib), for the treatment of ER+ breast cancer. In 2018, the Company initiated a Phase 1/2a (dose escalation/dose expansion) clinical trial in ER+, HER2- breast cancer. Preliminary data from the Phase 1 portion of this trial were presented at the 2019 ESMO Congress, showing that rintodestrant was well tolerated and demonstrated evidence of anti-tumor activity in heavily pre-treated patients. The mature monotherapy data were presented at the 2020 San Antonio Breast Cancer Symposium (“SABCS”) conference, confirming the safety and efficacy results of the preliminary analysis . Based on these findings the Company advanced an 800 mg dose of rintodestrant into a 40-patient Phase 1b combination arm with palbociclib, a CDK4/6 inhibitor, safety and antitumor activity data from which were presented at the 2021 American Society of Clinical Oncology (ASCO) annual virtual meeting. The Company is in the process of evaluating partnering options for rintodestrant. Lerociclib Lerociclib is a differentiated clinical-stage oral CDK4/6 inhibitor for use in combination with other targeted therapies in multiple oncology indications. In 2020, the Company entered into separate, exclusive agreements with EQRx, Inc. (rights for U.S., Europe, Japan and all markets outside Asia-Pacific) and Genor Biopharma Co. Inc. (rights for Asia-Pacific, excluding Japan) for the development and commercialization of lerociclib in all indications. Combined, these agreements provided $26.0 million in upfront payments to the Company in 2020, and provide up to $330.0 million in potential milestone payments, plus sales-based royalties. EQRx, Inc. and Genor Biopharma Co. Inc. are responsible for all costs related to the development and commercialization of lerociclib in their respective territories. |
Basis of Presentation and Summa
Basis of Presentation and Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2021 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Summary of Significant Accounting Policies | 2. 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 September 30, 2021, and for the three and nine months ended September 30, 2021 and 2020, is unaudited. The results for the three and nine months ended September 30, 2021 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, 2020 filed with the SEC on February 24, 2021, (the “2020 Form 10-K”). The December 31, 2020 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. 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, stock-based compensation expense and deferred tax asset valuation allowance. The Company bases its estimates on historical experience and other market specific or other relevant assumptions it believes to be reasonable under the circumstances. Actual results could differ from those estimates. 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. Inventories Inventories are stated at the lower of cost or net realizable value and recognized on a weighted-average cost method. The Company uses actual cost to determine the cost basis for inventory. Inventory is capitalized based on when future economic benefit is expected to be realized. Due to the nature of the Company’s supply chain process, inventory that is owned by the Company, is physically stored at third-party warehouses, logistics providers, and contract manufacturers. Inventory valuation is established based on a number of factors including, but not limited to, finished goods not meeting product specifications, product excess and obsolescence, or application of the lower of cost or net realizable value concepts. The determination of events requiring the establishment of inventory valuation, together with the calculation of the amount of such adjustments may require judgment. The Company analyzes its inventory levels on a periodic basis to determine if any inventory is at risk for expiration prior to sale or has a cost basis that is greater than its estimated future net realizable value. Any adjustments are recognized through cost of sales in the period in which they are incurred. No inventory valuation adjustments have been recorded for any periods presented. Revenue Recognition For elements of those arrangements that the Company determines should be accounted for under ASC 606, Revenue from Contracts with Customers multiple performance obligations, such as granting a license or performing manufacturing or research and development activities , the Company allocate s the transaction price based on the relative standalone selling price and recognize s 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 develop s 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. 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 not recognized any revenue related to sales-based royalties or milestone payments based on the level of sales. 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, and GPO fees are classified as “Accrued Expenses” in the Condensed Balance Sheets. Discounts such as chargebacks, returns, 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 : 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. 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 involves 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 Income tax expense recognized during the three and nine months ended September 30, 2021 related to the foreign withholding taxes incurred as a result of the Simcere milestone payments received during the period. See Note 11 for further detail. 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”) granted to employees. The fair value of RSUs 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. 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 Coronavirus (COVID-19) Impact on Operations The Company has implemented business continuity plans to address the COVID-19 pandemic and minimize disruptions to ongoing operations. Enrollment of patients in current and future clinical trials may be impacted by COVID-19. Although the Company did not have any significant supply chain delays or shortages as a result of the COVID-19 pandemic to date, it did experience delays in the delivery of its investigational product to certain investigative sites due to shortages of ancillary materials and the delay of governmental inspections. To date, the Company is on track to meet all of its previously announced clinical milestones. If the COVID-19 pandemic continues for an extended period of time or increases in severity, the Company could experience disruptions to its clinical development timelines. If the Company experiences delays in patient enrollment, it could incur increased clinical program expense if it is deemed necessary or advisable to improve patient recruitment by opening additional clinical sites. COVID-19 travel limitations and government-mandated work-from-home or shelter-in-place orders, may reduce the number of in-person meetings with prescribers and fewer patient visits with physicians, potentially resulting in fewer new prescriptions. The Company established a COVID-19 response team which continually monitors the impact of COVID-19 on our operations. The COVID-19 response team manages the workplace protocols that governs the employees’ use of the office. To mitigate the impact of COVID-19 on the business, the Company put in place the following safety measures for its employees, patients, healthcare professionals, and suppliers to limit exposure: the Company substantially restricted travel, supplied personal protective equipment to employees, limited access to its headquarters and asked most of their staff to work remotely. As of September 30, 2021, the majority of the Company’s employees are still working remotely, which may negatively impact their ability to conduct research and development activities, engage in sales-related initiatives, or efficiently conduct day-to-day operations. In addition, the Company added bandwidth and VPN capacity to its infrastructure to facilitate remote work arrangements. With the Company’s employees mostly working-from-home, this creates a heightened risk of cyber-attacks, which may make it more difficult for the Company to protect its confidential information. The Company will continue to monitor the impact of COVID-19 on its operations, including how it will impact its employees, clinical trials, development programs, supply chain, and other aspects of its operations, and report to its Board of Directors regularly on the progress of its response to the COVID-19 outbreak. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2021 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 3. Fair Value Measurements 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 September 30, 2021 and December 31, 2020 these financial instruments and respective fair values have been classified as follows (in thousands): Quoted prices in active markets for identical assets (Level 1) Significant other observable inputs (Level 2) Significant other unobservable inputs (Level 3) Balance at September 30, 2021 Assets Money market funds $ 101,103 $ — $ — $ 101,103 Certificates of Deposit — — — - Total assets at fair value: $ 101,103 $ — $ — $ 101,103 Quoted prices in active markets for identical assets (Level 1) Significant other observable inputs (Level 2) Significant other unobservable inputs (Level 3) Balance at December 31, 2020 Assets Money market funds $ 190,180 $ — $ — $ 190,180 Certificates of Deposit 15,970 — — 15,970 Total assets at fair value: $ 206,150 $ — $ — $ 206,150 During the three and nine months ended September 30, 2021 and the year ended December 31, 2020, there were no changes in valuation methodology. The Loan Payable (discussed in Note 8), which is classified as a Level 3 liability, has a variable interest rate and the carrying value approximates its fair value. As of September 30, 2021, the carrying value was $30.3 million. |
Inventories
Inventories | 9 Months Ended |
Sep. 30, 2021 | |
Inventory Disclosure [Abstract] | |
Inventories | 4. Inventories Inventories as of September 30, 2021 and December 31, 2020 consist of the following (in thousands): September 30, 2021 December 31, 2020 Raw materials $ — $ — Work in process 1,341 — Finished goods 34 — Inventories $ 1,375 $ — 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 | 9 Months Ended |
Sep. 30, 2021 | |
Property Plant And Equipment [Abstract] | |
Property and Equipment | 5. Property and Equipment Property and equipment consists of the following (in thousands): September 30, 2021 December 31, 2020 Computer equipment $ 327 $ 327 Laboratory equipment 334 334 Furniture and fixtures 866 866 Leasehold improvements 1,782 1,782 Accumulated depreciation (1,182 ) (827 ) Property and equipment, net $ 2,127 $ 2,482 Depreciation expense relating to property and equipment was $117 thousand and $355 thousand for the three and nine months ended September 30, 2021, respectively, and $145 thousand and $462 thousand for the three and nine months ended September 30, 2020, respectively. |
Patent License Agreement
Patent License Agreement | 9 Months Ended |
Sep. 30, 2021 | |
Patent License Agreement [Abstract] | |
Patent License Agreement | 6. Patent License Agreement On November 23, 2016, the Company entered into a license agreement with the Board of Trustees of the University of Illinois (“the University”), which was amended on March 24, 2017. Pursuant to the license agreement, as amended, the University licensed patent rights to the Company, with rights of sublicense, to make, have made, use, import, sell and offer for sale products covered by certain patent rights owned by the University. The rights licensed to the Company are exclusive, worldwide, non-transferable rights, for all fields of use. Under the terms of the agreement the Company paid a one-time only, non-refundable license issue fee in the amount of $0.5 million which was charged to research and development expense in the fourth quarter of 2016. The Company is also obligated to pay annual maintenance fees to the University. All annual minimum payments are fully creditable against any royalty payments made by the Company. Under the terms of the agreement, the Company must pay the University a royalty percentage on all net sales of products and a share of sublicensing revenues. In addition, the University is eligible to receive milestone payments of up to $2.6 million related to the initiation and execution of clinical trials and the first commercial sale of a product in another country. To date, the Company has made milestone payments totaling $0.6 million, all of which were made, prior to the current quarter. The Company will be responsible for any future patent prosecution costs that may arise. The term of the license agreement will continue until the later of (i) the expiration of the last valid claim within the patent rights covering the product in such country, (ii) the expiration of market exclusivity in such country and (iii) the 10th anniversary of the first commercial sale in such country. The University may terminate the agreement in the event (i) the Company fails to pay any amount or make any report when required to be made and fails to cure such failure within thirty (30) days after receipt of notice from the University, (ii) is in breach of any provision of the agreement and fails to remedy within forty-five (45) days after receipt of notice, (iii) makes a report to the University under the agreement that is determined to be materially false, (iv) declares insolvency or bankruptcy or (v) takes an action that causes patent rights or technical information to be subject to lien or encumbrance and fails to remedy any such breach within forty-five (45) days of receipt of notice from the University. The Company may terminate the agreement at any time on written notice to the University at least ninety (90) days prior to the termination date specified in the notice. Upon expiration or termination of the agreement, all r ights revert to the University. |
Accrued Expenses
Accrued Expenses | 9 Months Ended |
Sep. 30, 2021 | |
Payables And Accruals [Abstract] | |
Accrued Expenses | 7. Accrued Expenses Accrued expenses are comprised as follows (in thousands): September 30, 2021 December 31, 2020 Accrued external research $ 2,205 $ 3,219 Accrued professional fees and other 7,337 3,920 Accrued external clinical study costs 8,992 5,683 Accrued compensation expense 3,479 3,664 Accrued expenses $ 22,013 $ 16,486 |
Loan Payable
Loan Payable | 9 Months Ended |
Sep. 30, 2021 | |
Debt Disclosure [Abstract] | |
Loan Payable | 8. 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 has 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 will be available through December 31, 2022. The fourth tranche of $20.0 million will be 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 by the Company exceed $40.0 million, no financial covenants are required. As of September 30, 2021, no financial covenants apply as the Company had only drawn down on the first tranche Amounts borrowed under the original Loan Agreement 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) 6.40%, and (ii) 9.65% 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 will 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 will be payable upon any prepayment or repayment. To the extent that the Company is provided additional advances under the Loan Agreement, the 6.95% end of term charge will be applied to such additional amounts. These amounts will be accrued over the term of the loan using effective-interest method. The Loan Agreement 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 and the Company may out-license rintodestrant upon approval of the licensing terms by Hercules. The Company incurred financing expenses of $0.4 million related to the Loan Agreement which are recorded as debt issuance costs and as a direct reduction to long-term debt on the Company’s unaudited condensed balance sheet. Upon issuance, the Company treat ed $ 0.2 million of the upfront facility fee that related to the initial $ 20.0 million drawn as a debt discount and treating it in the same way as debt issuance costs. The remainder of the facility fee is related to future undrawn tranches and is accounted for as a deferred financing charge . Upon entering into the First Amendment, the C ompany incurred additional financing expenses of $ 0.1 million which were recorded as debt issuance costs. Also, in conjunction with the First Amendment, $ 0.1 million of the upfront facility fee previously recorded as a deferred financing charge was reclassified as a debt issuance cost since that amount related to the remainder of the first tranche which was drawn at the amendment date. Upon issuance, the first tranche was recorded as a liability with an initial carrying value of $19.4 million, net of debt discount and debt issuance costs. Upon entering into the First Amendment, the carrying value increased by $9.8 million, net of debt discount and debt issuance costs. The carrying value is accreted to the repayment amount, which includes the outstanding principal plus the end of term charge, through interest expense using the effective-interest method over the term of the debt. During the nine months ended September 30, 2021, the Company recognized $2.6 million of interest expense related to the Loan Agreement, which is reflected in other income (expense), net on the unaudited condensed statements of operations. As of September 30, 2021 the carrying value and repayment maturities due under the Loan Agreement, excluding interest, is as follows: Amount Remainder of 2020 $ — 2021 — 2022 — 2023 11,127 2024 12,236 2025 6,637 Total principal outstanding 30,000 End of term charge 817 Unamortized debt issuance costs (544 ) Total $ 30,273 |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2021 | |
Equity [Abstract] | |
Stockholders' Equity | 9. Stockholders’ Equity Common Stock The Company is authorized to issue 120.0 million shares of common stock. Holders of common stock are entitled to one vote per share. Holders of common stock are entitled to receive dividends, as, if and when declared by the Company’s Board of Directors. On June 15, 2018, the Company entered into a sales agreement for “at the market offerings” with Cowen and Company, LLC (“Cowen”), which allowed the Company to issue and sell shares of common stock pursuant to a shelf registration statement for total gross sales proceeds of up to $125.0 million from time to time through Cowen, acting as its agent. Between January 14, 2021 and February 9, 2021, the Company sold 3,513,027 shares of common stock pursuant to this agreement resulting in $86.4 million in net proceeds. As of February 9, 2021, the Company has used the entirety of the remaining availability under the 2018 sales agreement with Cowen. On July 2, 2021, the Company entered into a new sales agreement for “at the market offerings” with Cowen, which allows the Company to issue and sell shares of common stock pursuant to a shelf registration statement for total gross sales proceeds of up to $150.0 million from time to time through Cowen, acting as its agent. The Company has not sold any shares of common stock under the 2021 sales agreement. Preferred Stock The Company is authorized to issue 5.0 million shares of undesignated preferred stock in one or more series. As of September 30, 2021, 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 September 30, 2021 and December 31, 2020 as follows: September 30, 2021 December 31, 2020 Common stock options outstanding 6,683,154 6,644,780 RSUs outstanding 432,591 — Options and RSUs available for grant under Equity Incentive Plans 1,812,608 932,051 8,928,353 7,576,831 |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2021 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock-Based Compensation | 10. 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. 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. Beginning in January 2021, the Company began granting Restricted Stock Units (“RSUs”) under the 2017 Plan. RSUs are granted at the fair market value of a share of common stock on the date of grant. As of September 30, 2021, there were a total of 1,081,208 shares of common stock available for future issuance under the 2017 Plan 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. As of September 30, 2021, there were a total of 231,400 shares of common stock available for future issuance under the 2021 Inducement Plan. 2021 Sales Force Inducement Equity Incentive Plan 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. As of September 30, 2021, there were a total of 500,000 shares of common stock available for future issuance under the 2021 Sales Force Inducement 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. The fair value of RSUs 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. The table below summarizes the stock-based compensation expense recognized in the Company’s statement of operations by classification (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Cost of goods sold $ 68 $ — $ 237 $ — Research and development 1,142 1,733 3,775 5,367 Selling, general and administrative 4,318 3,189 13,102 8,649 Total stock-based compensation expense $ 5,528 $ 4,922 $ 17,114 $ 14,016 Stock options— Black-Scholes inputs The fair value of stock options was estimated using the following weighted-average assumptions for the three and nine months ended September 30, 2021 and September 30, 2020: Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Expected volatility 77.7-78.4% 79.0 - 80.2% 77.7-79.6% 74.8-80.2% Weighted-average risk free rate 0.9-1.1% 0.3-0.4% 0.4-1.2% 0.3-1.7% Dividend yield —% —% —% —% Expected term (in years) 6.05 6.06 6.00 6.02 Stock Option Activity The following table is a summary of the Stock option activity for the nine months ended September 30, 2021: Weighted average Weighted average Remaining Aggregate Options exercise contractual intrinsic outstanding price life (Years) value (in thousands) Balance as of December 31, 2020 6,644,780 $ 16.91 7.3 $ 35,464 Granted 1,886,253 $ 18.43 Cancelled (952,848 ) 20.65 Exercised (895,031 ) 6.51 Balance as of September 30, 2021 6,683,154 $ 18.20 7.4 $ 15,424 Exercisable at December 31, 2020 3,542,190 12.94 6.0 $ 31,686 Vested at December 31, 2020 and expected to vest 6,644,780 16.91 7.3 $ 35,464 Exercisable at September 30, 2021 3,594,284 16.46 6.1 $ 15,235 Vested at September 30, 2021 and expected to vest 6,683,154 18.20 7.4 $ 15,424 As of September 30, 2021, unrecognized compensation expense related to unvested stock options totaled $37.4 million, which the Company expects to be recognized over a weighted-average period of approximately 2.4 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 nine months ended September 30, 2021: Weighted - Average Number of Fair Value RSUs per Share Balance as of December 31, 2020 — $ — Granted 507,906 18.20 Cancelled (75,315 ) 18.07 Vested — Balance as of September 30, 2021 432,591 $ 18.23 As of September 30, 2021, there was $6.1 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 2.6 years. |
License Revenue
License Revenue | 9 Months Ended |
Sep. 30, 2021 | |
Revenue Recognition [Abstract] | |
License Revenue | 11. License Revenue 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 . During the first quarter of 2021, the Company recognized $3.0 million of revenue related to a development milestone which occurred during the period. Payment was received in April 2021. 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. For the nine months ended September 30, 2021 the Company recognized revenue of $4.8 million related to the delivery of clinical drug supply and manufacturing services and $2.0 million for the reimbursement of costs associated with the two primary clinical trials for lerociclib. The amounts for clinical drug supply and manufacturing services have been invoiced and paid. The amounts for clinical trial reimbursements that occurred during the quarter are recognized as accounts receivable on the balance sheet as of September 30, 2021. No development and commercial milestones, as defined by the agreement, have been achieved through September 30, 2021. Simcere License Agreement On August 3, 2020, the Company entered into an exclusive license agreement with Nanjing Simcere Dongyuan Pharmaceutical Co., Ltd (“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, Simcere will pay the Company tiered low double-digit royalties on annual net sales of trilaciclib in the Simcere Territory. In accordance with ASC 606, the Company recognized the non-refundable, upfront cash payment of $14.0 million (less applicable withholding taxes of $1.4 million) in 2020 as the Company had transferred the license and related technology and know-how to Simcere. Further, during the nine months ended September 30, 2021, the Company recognized $8.0 million (less applicable withholding taxes of $0.8 million) related to development milestones which were met during the period. As of September 30, 2021, cash was received for all development milestones. |
Net Loss Per Common Share
Net Loss Per Common Share | 9 Months Ended |
Sep. 30, 2021 | |
Earnings Per Share [Abstract] | |
Net Loss Per Common Share | 12. 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 and nine months ended September 30, 2021 and 2020 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 September 30, Nine Months Ended September 30, 2021 2020 2021 2020 (unaudited) (unaudited) Stock options issued and outstanding 6,892,488 6,648,285 7,162,589 6,525,810 Unvested RSUs 476,735 — 461,337 — Total potential dilutive shares 7,369,223 6,648,285 7,623,926 6,525,810 Amounts in the table above reflect the common stock equivalents of the noted instrument. |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2021 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 13. Income Taxes The Company’s effective income tax rate was (0.8)% and (8.4)% for the three months ended September 30, 2021 and 2020 and (0.6%) and (1.3)% for the nine months ended September 30, 2021 and 2020, respectively. The Company continues to recognize losses in the United States and therefore, has recorded no tax benefit associated with these losses. The only income tax expense recognized related to the foreign withholding taxes incurred as a result of the Simcere licensing agreement. See Note 11 for further discussion on this transaction. |
Related Party Transactions
Related Party Transactions | 9 Months Ended |
Sep. 30, 2021 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 14. Related Party Transactions The Company maintained a consulting agreement with a Seth A. Rudnick, M.D., a member of the Board of Directors, for scientific advisory services outside of his role on the Board of Directors that expired on June 30, 2021. Effective July 1, 2021, the Company renewed its agreement with the member of the Board of Directors for scientific, clinical and regulatory advisory services outside of his role on the Board of Directors through June 30, 2022. On October 13, 2021, Seth A. Rudnick, M.D., notified the Company of his decision to resign from the Board of Directors of the Company effectively immediately as of October 13, 2021. The 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. |
Subsequent Event
Subsequent Event | 9 Months Ended |
Sep. 30, 2021 | |
Subsequent Events [Abstract] | |
Subsequent Event | 15. Subsequent Event On November 1, 2021, the Company entered into a second amendment to the existing loan and security agreement (the “Second Amendment”) with Hercules Capital, Inc. (“Hercules”). As part of the amendment, the total commitment was increased to $150.0 million, of which $100.0 million from Tranche 1 was fully available at closing. At closing, the Company received $45.0 million, resulting in total proceeds of $75.0 million received to date under Tranche 1. The Second Amendment is filed as Exhibit 10.2 hereto and incorporated herein by reference. |
Basis of Presentation and Sum_2
Basis of Presentation and Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2021 | |
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 September 30, 2021, and for the three and nine months ended September 30, 2021 and 2020, is unaudited. The results for the three and nine months ended September 30, 2021 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, 2020 filed with the SEC on February 24, 2021, (the “2020 Form 10-K”). The December 31, 2020 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. |
Use of Estimates | 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, stock-based compensation expense and deferred tax asset valuation allowance. The Company bases its estimates on historical experience and other market specific or other relevant assumptions it believes to be reasonable under the circumstances. Actual results could differ from those estimates. |
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. 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. |
Inventories | Inventories Inventories are stated at the lower of cost or net realizable value and recognized on a weighted-average cost method. The Company uses actual cost to determine the cost basis for inventory. Inventory is capitalized based on when future economic benefit is expected to be realized. Due to the nature of the Company’s supply chain process, inventory that is owned by the Company, is physically stored at third-party warehouses, logistics providers, and contract manufacturers. Inventory valuation is established based on a number of factors including, but not limited to, finished goods not meeting product specifications, product excess and obsolescence, or application of the lower of cost or net realizable value concepts. The determination of events requiring the establishment of inventory valuation, together with the calculation of the amount of such adjustments may require judgment. The Company analyzes its inventory levels on a periodic basis to determine if any inventory is at risk for expiration prior to sale or has a cost basis that is greater than its estimated future net realizable value. Any adjustments are recognized through cost of sales in the period in which they are incurred. No inventory valuation adjustments have been recorded for any periods presented. |
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 multiple performance obligations, such as granting a license or performing manufacturing or research and development activities , the Company allocate s the transaction price based on the relative standalone selling price and recognize s 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 develop s 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. 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 not recognized any revenue related to sales-based royalties or milestone payments based on the level of sales. 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, and GPO fees are classified as “Accrued Expenses” in the Condensed Balance Sheets. Discounts such as chargebacks, returns, 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 : 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. |
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 involves 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 Income tax expense recognized during the three and nine months ended September 30, 2021 related to the foreign withholding taxes incurred as a result of the Simcere milestone payments received during the period. See Note 11 for further detail. |
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. The Company also incurs stock-based compensation expense related to restricted stock units (“RSUs”) granted to employees. The fair value of RSUs 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. |
Debt Issuance Costs | 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 |
Coronavirus (COVID-19) Impact on Operations | Coronavirus (COVID-19) Impact on Operations The Company has implemented business continuity plans to address the COVID-19 pandemic and minimize disruptions to ongoing operations. Enrollment of patients in current and future clinical trials may be impacted by COVID-19. Although the Company did not have any significant supply chain delays or shortages as a result of the COVID-19 pandemic to date, it did experience delays in the delivery of its investigational product to certain investigative sites due to shortages of ancillary materials and the delay of governmental inspections. To date, the Company is on track to meet all of its previously announced clinical milestones. If the COVID-19 pandemic continues for an extended period of time or increases in severity, the Company could experience disruptions to its clinical development timelines. If the Company experiences delays in patient enrollment, it could incur increased clinical program expense if it is deemed necessary or advisable to improve patient recruitment by opening additional clinical sites. COVID-19 travel limitations and government-mandated work-from-home or shelter-in-place orders, may reduce the number of in-person meetings with prescribers and fewer patient visits with physicians, potentially resulting in fewer new prescriptions. The Company established a COVID-19 response team which continually monitors the impact of COVID-19 on our operations. The COVID-19 response team manages the workplace protocols that governs the employees’ use of the office. To mitigate the impact of COVID-19 on the business, the Company put in place the following safety measures for its employees, patients, healthcare professionals, and suppliers to limit exposure: the Company substantially restricted travel, supplied personal protective equipment to employees, limited access to its headquarters and asked most of their staff to work remotely. As of September 30, 2021, the majority of the Company’s employees are still working remotely, which may negatively impact their ability to conduct research and development activities, engage in sales-related initiatives, or efficiently conduct day-to-day operations. In addition, the Company added bandwidth and VPN capacity to its infrastructure to facilitate remote work arrangements. With the Company’s employees mostly working-from-home, this creates a heightened risk of cyber-attacks, which may make it more difficult for the Company to protect its confidential information. The Company will continue to monitor the impact of COVID-19 on its operations, including how it will impact its employees, clinical trials, development programs, supply chain, and other aspects of its operations, and report to its Board of Directors regularly on the progress of its response to the COVID-19 outbreak. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Fair Value Disclosures [Abstract] | |
Summary of Financial Instruments and Respective Fair Values | At September 30, 2021 and December 31, 2020 these financial instruments and respective fair values have been classified as follows (in thousands): Quoted prices in active markets for identical assets (Level 1) Significant other observable inputs (Level 2) Significant other unobservable inputs (Level 3) Balance at September 30, 2021 Assets Money market funds $ 101,103 $ — $ — $ 101,103 Certificates of Deposit — — — - Total assets at fair value: $ 101,103 $ — $ — $ 101,103 Quoted prices in active markets for identical assets (Level 1) Significant other observable inputs (Level 2) Significant other unobservable inputs (Level 3) Balance at December 31, 2020 Assets Money market funds $ 190,180 $ — $ — $ 190,180 Certificates of Deposit 15,970 — — 15,970 Total assets at fair value: $ 206,150 $ — $ — $ 206,150 |
Inventories (Tables)
Inventories (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventories | Inventories as of September 30, 2021 and December 31, 2020 consist of the following (in thousands): September 30, 2021 December 31, 2020 Raw materials $ — $ — Work in process 1,341 — Finished goods 34 — Inventories $ 1,375 $ — |
Property and Equipment (Tables)
Property and Equipment (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Property Plant And Equipment [Abstract] | |
Schedule of Property and Equipment | Property and equipment consists of the following (in thousands): September 30, 2021 December 31, 2020 Computer equipment $ 327 $ 327 Laboratory equipment 334 334 Furniture and fixtures 866 866 Leasehold improvements 1,782 1,782 Accumulated depreciation (1,182 ) (827 ) Property and equipment, net $ 2,127 $ 2,482 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Payables And Accruals [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses are comprised as follows (in thousands): September 30, 2021 December 31, 2020 Accrued external research $ 2,205 $ 3,219 Accrued professional fees and other 7,337 3,920 Accrued external clinical study costs 8,992 5,683 Accrued compensation expense 3,479 3,664 Accrued expenses $ 22,013 $ 16,486 |
Loan Payable (Tables)
Loan Payable (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Debt Disclosure [Abstract] | |
Schedule of Outstanding Debt Obligations | As of September 30, 2021 the carrying value and repayment maturities due under the Loan Agreement, excluding interest, is as follows: Amount Remainder of 2020 $ — 2021 — 2022 — 2023 11,127 2024 12,236 2025 6,637 Total principal outstanding 30,000 End of term charge 817 Unamortized debt issuance costs (544 ) Total $ 30,273 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Equity [Abstract] | |
Summary of Common Stock Shares Reserved for Future Issuance | The Company has reserved authorized shares of common stock for future issuance at September 30, 2021 and December 31, 2020 as follows: September 30, 2021 December 31, 2020 Common stock options outstanding 6,683,154 6,644,780 RSUs outstanding 432,591 — Options and RSUs available for grant under Equity Incentive Plans 1,812,608 932,051 8,928,353 7,576,831 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Summary of Stock Option Activity | The following table is a summary of the Stock option activity for the nine months ended September 30, 2021: Weighted average Weighted average Remaining Aggregate Options exercise contractual intrinsic outstanding price life (Years) value (in thousands) Balance as of December 31, 2020 6,644,780 $ 16.91 7.3 $ 35,464 Granted 1,886,253 $ 18.43 Cancelled (952,848 ) 20.65 Exercised (895,031 ) 6.51 Balance as of September 30, 2021 6,683,154 $ 18.20 7.4 $ 15,424 Exercisable at December 31, 2020 3,542,190 12.94 6.0 $ 31,686 Vested at December 31, 2020 and expected to vest 6,644,780 16.91 7.3 $ 35,464 Exercisable at September 30, 2021 3,594,284 16.46 6.1 $ 15,235 Vested at September 30, 2021 and expected to vest 6,683,154 18.20 7.4 $ 15,424 |
Summary of Restricted Stock Units Activity | The following table is a summary of the RSU activity for the nine months ended September 30, 2021: Weighted - Average Number of Fair Value RSUs per Share Balance as of December 31, 2020 — $ — Granted 507,906 18.20 Cancelled (75,315 ) 18.07 Vested — Balance as of September 30, 2021 432,591 $ 18.23 |
Employee and Non-employee Stock Options | |
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 September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Cost of goods sold $ 68 $ — $ 237 $ — Research and development 1,142 1,733 3,775 5,367 Selling, general and administrative 4,318 3,189 13,102 8,649 Total stock-based compensation expense $ 5,528 $ 4,922 $ 17,114 $ 14,016 |
Summary of Fair Value of Stock Options Granted Using Black-Scholes Options Pricing Model | The fair value of stock options was estimated using the following weighted-average assumptions for the three and nine months ended September 30, 2021 and September 30, 2020: Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Expected volatility 77.7-78.4% 79.0 - 80.2% 77.7-79.6% 74.8-80.2% Weighted-average risk free rate 0.9-1.1% 0.3-0.4% 0.4-1.2% 0.3-1.7% Dividend yield —% —% —% —% Expected term (in years) 6.05 6.06 6.00 6.02 |
Net Loss Per Common Share (Tabl
Net Loss Per Common Share (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Earnings Per Share [Abstract] | |
Schedule of Potentially Dilutive Securities Excluded from Computations of Diluted Weighted-average Shares Outstanding | For the three and nine months ended September 30, 2021 and 2020 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 September 30, Nine Months Ended September 30, 2021 2020 2021 2020 (unaudited) (unaudited) Stock options issued and outstanding 6,892,488 6,648,285 7,162,589 6,525,810 Unvested RSUs 476,735 — 461,337 — Total potential dilutive shares 7,369,223 6,648,285 7,623,926 6,525,810 |
Business Description - Addition
Business Description - Additional Information (Details) $ in Millions | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2021USD ($) | Sep. 30, 2020USD ($) | Dec. 31, 2020USD ($) | |
Maximum | |||
Description Of Business [Line Items] | |||
Oncology sales force | 15 | ||
Simcere License Agreement | |||
Description Of Business [Line Items] | |||
Upfront payments along with sales based royalties | $ 14 | ||
Milestone payments | $ 8 | $ 156 | |
EQRx License Agreement | |||
Description Of Business [Line Items] | |||
Upfront payments along with sales based royalties | $ 26 | ||
Milestone payments | $ 330 |
Basis of Presentation and Sum_3
Basis of Presentation and Summary of Significant Accounting Policies - Additional Information (Details) - USD ($) | Sep. 30, 2021 | Dec. 31, 2020 |
Accounting Policies [Abstract] | ||
Unrecognized income tax benefits | $ 0 | $ 0 |
Accrued income taxes | $ 0 | $ 0 |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Financial Instruments and Respective Fair Values (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Assets | ||
Assets at fair value | $ 101,103 | $ 206,150 |
Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Assets | ||
Assets at fair value | 101,103 | 206,150 |
Money Market Funds | ||
Assets | ||
Assets at fair value | 101,103 | 190,180 |
Money Market Funds | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Assets | ||
Assets at fair value | $ 101,103 | 190,180 |
Certificates of Deposit | ||
Assets | ||
Assets at fair value | 15,970 | |
Certificates of Deposit | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Assets | ||
Assets at fair value | $ 15,970 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Sep. 30, 2021 | Dec. 31, 2020 | |
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | |||
Changes in valuation methodology | $ 0 | $ 0 | $ 0 |
Loan payable | 30,273,000 | 30,273,000 | $ 19,893,000 |
Significant Other Unobservable Inputs (Level 3) | |||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | |||
Loan payable | $ 30,300,000 | $ 30,300,000 |
Inventories - Schedule of Inven
Inventories - Schedule of Inventories (Details) $ in Thousands | Sep. 30, 2021USD ($) |
Inventory Disclosure [Abstract] | |
Work in process | $ 1,341 |
Finished goods | 34 |
Inventories | $ 1,375 |
Property and Equipment - Schedu
Property and Equipment - Schedule of Property and Equipment (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Property Plant And Equipment [Line Items] | ||
Accumulated depreciation | $ (1,182) | $ (827) |
Property and equipment, net | 2,127 | 2,482 |
Computer Equipment | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 327 | 327 |
Laboratory Equipment | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 334 | 334 |
Furniture and Fixtures | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 866 | 866 |
Leasehold Improvements | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 1,782 | $ 1,782 |
Property and Equipment - Additi
Property and Equipment - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Property Plant And Equipment [Abstract] | ||||
Depreciation expenses relating to property and equipment | $ 117 | $ 145 | $ 355 | $ 462 |
Patent License Agreement - Addi
Patent License Agreement - Additional Information (Details) - USD ($) | 3 Months Ended | 9 Months Ended | 58 Months Ended | |||
Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2016 | Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | |
Patent License Agreement [Line Items] | ||||||
Non-refundable license issue fee | $ 21,143,000 | $ 17,932,000 | $ 56,435,000 | $ 56,897,000 | ||
Milestone payments | $ 600,000 | |||||
University | ||||||
Patent License Agreement [Line Items] | ||||||
License agreement date | Nov. 23, 2016 | |||||
License agreement amendment date | Mar. 24, 2017 | |||||
Term of license agreement description | The term of the license agreement will continue until the later of (i) the expiration of the last valid claim within the patent rights covering the product in such country, (ii) the expiration of market exclusivity in such country and (iii) the 10th anniversary of the first commercial sale in such country. The University may terminate the agreement in the event (i) the Company fails to pay any amount or make any report when required to be made and fails to cure such failure within thirty (30) days after receipt of notice from the University, (ii) is in breach of any provision of the agreement and fails to remedy within forty-five (45) days after receipt of notice, (iii) makes a report to the University under the agreement that is determined to be materially false, (iv) declares insolvency or bankruptcy or (v) takes an action that causes patent rights or technical information to be subject to lien or encumbrance and fails to remedy any such breach within forty-five (45) days of receipt of notice from the University. The Company may terminate the agreement at any time on written notice to the University at least ninety (90) days prior to the termination date specified in the notice. Upon expiration or termination of the agreement, all rights revert to the University. | |||||
License agreement termination notice period | 90 days | |||||
University | Maximum | ||||||
Patent License Agreement [Line Items] | ||||||
Milestone payments | $ 2,600,000 | |||||
University | License Revenue | ||||||
Patent License Agreement [Line Items] | ||||||
Non-refundable license issue fee | $ 500,000 |
Accrued Expenses - Schedule of
Accrued Expenses - Schedule of Accrued Expenses (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Payables And Accruals [Abstract] | ||
Accrued external research | $ 2,205 | $ 3,219 |
Accrued professional fees and other | 7,337 | 3,920 |
Accrued external clinical study costs | 8,992 | 5,683 |
Accrued compensation expense | 3,479 | 3,664 |
Accrued expenses | $ 22,013 | $ 16,486 |
Loan Payable - Additional Infor
Loan Payable - Additional Information (Details) - USD ($) $ in Thousands | May 29, 2020 | Sep. 30, 2021 | Sep. 30, 2021 |
Debt Instrument [Line Items] | |||
Loan amount | $ 30,273 | $ 30,273 | |
Milestone payments | 600 | ||
Loan net carrying amount | $ 30,000 | $ 30,000 | |
Loan Agreement | Hercules Capital, Inc. | |||
Debt Instrument [Line Items] | |||
Loan amount | $ 20,000 | ||
Earliest maturity date | Jun. 1, 2022 | ||
Latest maturity date | Jan. 1, 2023 | ||
Debt instrument, maturity date | Jun. 1, 2025 | ||
Debt instrument maturity date description | following the interest only period, the Company will repay the principal balance and interest of the advances in equal monthly installments through June 1, 2024 | ||
Interest rate description | greater of either (i) (a) the prime rate as reported in The Wall Street Journal, plus (b) 6.40%, and (ii) 9.65% | ||
Loan agreement, basis spread on variable rate | 6.40% | ||
Loan agreement, interest rate, stated percentage | 9.65% | 9.65% | |
Prepayment fee description | (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. | ||
Percentage of prepayment of loan amount for year first | 3.00% | ||
Percentage of prepayment of loan amount for year second | 2.00% | ||
Percentage of prepayment of loan amount for year third | 1.00% | ||
Percentage of loan amount prepayment charge | 6.95% | ||
Loan agreement, issuance costs | $ 400 | $ 400 | |
Line of credit facility upfront fee | $ 200 | ||
Loan Agreement | Hercules Capital, Inc. | First Amendment to Loan and Security Agreement | |||
Debt Instrument [Line Items] | |||
Interest rate description | greater of either (i) (a) the prime rate as reported in The Wall Street Journal, plus (b) 6.20%, and (ii) 9.45% | ||
Loan agreement, basis spread on variable rate | 6.20% | ||
Loan agreement, interest rate, stated percentage | 9.45% | 9.45% | |
Loan agreement, issuance costs | $ 100 | $ 100 | |
Line of credit facility upfront fee | 100 | ||
Loan Agreement | Hercules Capital, Inc. | First Tranche | |||
Debt Instrument [Line Items] | |||
Loan amount | 30,000 | ||
Milestone payments | 20,000 | ||
End of term fee | $ 2,100 | 2,100 | |
Percentage of aggregate amount of all loan advances payment | 6.95% | ||
Loan net carrying amount | $ 19,400 | 19,400 | |
Loan Agreement | Hercules Capital, Inc. | First Tranche | Other Income (Expense) | |||
Debt Instrument [Line Items] | |||
Interest expense, loan agreement | 2,600 | ||
Loan Agreement | Hercules Capital, Inc. | First Tranche | First Amendment to Loan and Security Agreement | |||
Debt Instrument [Line Items] | |||
Remaining loan amount | 10,000 | 10,000 | |
Increase in net carrying amount of loan | 9,800 | 9,800 | |
Loan Agreement | Hercules Capital, Inc. | Second Tranche | |||
Debt Instrument [Line Items] | |||
Loan amount | 20,000 | ||
Loan Agreement | Hercules Capital, Inc. | Third Tranche | |||
Debt Instrument [Line Items] | |||
Loan amount | 30,000 | ||
Loan Agreement | Hercules Capital, Inc. | Fourth Tranche | |||
Debt Instrument [Line Items] | |||
Loan amount | $ 20,000 | ||
Loan Agreement | Hercules Capital, Inc. | Maximum | |||
Debt Instrument [Line Items] | |||
Loan amount | 100,000 | 100,000 | |
Loan Agreement | Hercules Capital, Inc. | Minimum | First Amendment to Loan and Security Agreement | |||
Debt Instrument [Line Items] | |||
Loan amount | $ 40,000 | $ 40,000 |
Loan Payable - Schedule of Carr
Loan Payable - Schedule of Carrying Value and Repayment Maturities Due Under Loan Agreement Excluding Interest (Details) $ in Thousands | 9 Months Ended |
Sep. 30, 2021USD ($) | |
Debt Disclosure [Abstract] | |
2023 | $ 11,127 |
2024 | 12,236 |
2025 | 6,637 |
Total principal outstanding | 30,000 |
End of term charge | 817 |
Unamortized debt issuance costs | (544) |
Loan amount | $ 30,273 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Details) - USD ($) $ in Millions | Jul. 02, 2021 | Jun. 15, 2018 | Feb. 09, 2021 | Sep. 30, 2021 | Dec. 31, 2020 |
Class Of Stock [Line Items] | |||||
Common stock, shares authorized | 120,000,000 | 120,000,000 | |||
Common stock, voting rights | Holders of common stock are entitled to one vote per share. | ||||
Undesignated preferred stock, shares authorized to issue | 5,000,000 | ||||
Preferred stock, shares issued | 0 | ||||
Preferred stock, shares outstanding | 0 | ||||
Cowen And Company L L C | At The Market Offerings | |||||
Class Of Stock [Line Items] | |||||
Maximum gross proceeds of common stock allowed from issuance and sell | $ 150 | $ 125 | |||
Proceeds from Issuance of Common Stock | $ 86.4 | ||||
Cowen And Company L L C | Common Stock | At The Market Offerings | |||||
Class Of Stock [Line Items] | |||||
Common stock, shares issued | 3,513,027 |
Stockholders' Equity - Summary
Stockholders' Equity - Summary of Common Stock Shares Reserved for Future Issuance (Details) - shares | Sep. 30, 2021 | Dec. 31, 2020 |
Class Of Stock [Line Items] | ||
Common stock, shares reserved for future issuance | 8,928,353 | 7,576,831 |
RSUs Outstanding | ||
Class Of Stock [Line Items] | ||
Common stock, shares reserved for future issuance | 432,591 | |
Options and RSUs available for grant under Equity Incentive Plans | ||
Class Of Stock [Line Items] | ||
Common stock, shares reserved for future issuance | 1,812,608 | 932,051 |
Common Stock Options Outstanding | ||
Class Of Stock [Line Items] | ||
Common stock, shares reserved for future issuance | 6,683,154 | 6,644,780 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Details) - USD ($) $ in Millions | Jan. 01, 2021 | Sep. 30, 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 | $ 37.4 | ||
Weighted-average recognition period | 2 years 4 months 24 days | ||
Restricted Stock Units (RSUs) | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Weighted-average recognition period | 2 years 7 months 6 days | ||
Unrecognized compensation cost | $ 6.1 | ||
2017 Equity Incentive Plan | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Number of shares approved for grant under equity incentive plan | 1,932,000 | ||
Number of additional shares approved for grant under equity incentive plan | 1,096,553 | ||
Number of shares available for grant under equity incentive plan | 1,081,208 | ||
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 | 0 | ||
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 | 231,400 | ||
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 | 500,000 | ||
2021 Sales Force Inducement Plan | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Number of shares available for grant under equity incentive plan | 500,000 | ||
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 | 500,000 |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Share-Based Compensation Expense Included in Statements of Operations (Details) - Employee and Non-employee Stock Options - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total stock-based compensation expense | $ 5,528 | $ 4,922 | $ 17,114 | $ 14,016 |
Cost of Goods Sold | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total stock-based compensation expense | 68 | 237 | ||
Research and Development | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total stock-based compensation expense | 1,142 | 1,733 | 3,775 | 5,367 |
Selling, General and Administrative | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total stock-based compensation expense | $ 4,318 | $ 3,189 | $ 13,102 | $ 8,649 |
Stock-Based Compensation - Fair
Stock-Based Compensation - Fair Value of Stock Options Granted Using Black-Scholes Options Pricing Model (Details) - Employee and Non-employee Stock Options | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Expected volatility, minimum | 77.70% | 79.00% | 77.70% | 74.80% |
Expected volatility, maximum | 78.40% | 80.20% | 79.60% | 80.20% |
Weighted-average risk free rate, minimum | 0.90% | 0.30% | 0.40% | 0.30% |
Weighted-average risk free rate, maximum | 1.10% | 0.40% | 1.20% | 1.70% |
Expected term (in years) | 6 years 18 days | 6 years 21 days | 6 years | 6 years 7 days |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary of Stock Option Activity (Details) $ / shares in Units, $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021USD ($)$ / sharesshares | Dec. 31, 2020USD ($)$ / sharesshares | |
Options outstanding | ||
Beginning balance | shares | 6,644,780 | |
Granted | shares | 1,886,253 | |
Cancelled | shares | (952,848) | |
Exercised | shares | (895,031) | |
Ending balance | shares | 6,683,154 | 6,644,780 |
Exercisable | shares | 3,594,284 | 3,542,190 |
Vested and expected to vest | shares | 6,683,154 | 6,644,780 |
Weighted average exercise price | ||
Beginning balance | $ / shares | $ 16.91 | |
Granted | $ / shares | 18.43 | |
Cancelled | $ / shares | 20.65 | |
Exercised | $ / shares | 6.51 | |
Ending balance | $ / shares | 18.20 | $ 16.91 |
Exercisable | $ / shares | 16.46 | 12.94 |
Vested and expected to vest | $ / shares | $ 18.20 | $ 16.91 |
Weighted average, Remaining contractual for life (Years) | ||
Balance | 7 years 4 months 24 days | 7 years 3 months 18 days |
Exercisable | 6 years 1 month 6 days | 6 years |
Vested and expected to vest | 7 years 4 months 24 days | 7 years 3 months 18 days |
Weighted average, Aggregate intrinsic value | ||
Balance | $ | $ 15,424 | $ 35,464 |
Exercisable | $ | 15,235 | 31,686 |
Vested and expected to vest | $ | $ 15,424 | $ 35,464 |
Stock-Based Compensation - Su_3
Stock-Based Compensation - Summary of Restricted Stock Units Activity (Details) - Restricted Stock Units (RSUs) | 9 Months Ended |
Sep. 30, 2021$ / sharesshares | |
Number of RSUs | |
Granted | shares | 507,906 |
Cancelled | shares | (75,315) |
Ending balance | shares | 432,591 |
Weighted-Average Fair Value per Share | |
Granted | $ / shares | $ 18.20 |
Cancelled | $ / shares | 18.07 |
Ending balance | $ / shares | $ 18.23 |
License Revenue - Additional In
License Revenue - Additional Information (Details) - USD ($) $ in Millions | Aug. 03, 2020 | Jul. 22, 2020 | Jun. 15, 2020 | Sep. 30, 2021 | Mar. 31, 2021 | Sep. 30, 2021 |
Genor Biopharma Co. Inc. | ||||||
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | ||||||
Non-refundable, upfront payment | $ 6 | |||||
Milestone payments receivable | 40 | |||||
License revenue recognized | $ 6 | $ 3 | ||||
EQRx Inc. | ||||||
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | ||||||
Milestone payments receivable | $ 290 | |||||
License revenue recognized | 20 | $ 4.8 | $ 4.8 | |||
Upfront payment received | $ 20 | |||||
Typical payment terms on invoice payment | 30 days | |||||
Number of days due from invoice date | 30 days | |||||
Manufacturing costs | $ 2 | 2 | ||||
Nanjing Simcere Dongyuan Pharmaceutical Co., Ltd | ||||||
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | ||||||
Milestone payments receivable | $ 156 | |||||
License revenue recognized | 8 | |||||
Upfront payment received | 14 | 14 | ||||
Withholding taxes | $ 1.4 | $ 0.8 |
Net Loss Per Common Share - Sch
Net Loss Per Common Share - Schedule of Potentially Dilutive Securities Excluded from Computations of Diluted Weighted-average Shares Outstanding (Details) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Total potential dilutive shares | 7,369,223 | 6,648,285 | 7,623,926 | 6,525,810 |
Stock Options Issued and Outstanding | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Total potential dilutive shares | 6,892,488 | 6,648,285 | 7,162,589 | 6,525,810 |
Restricted Stock Units (RSUs) | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Total potential dilutive shares | 476,735 | 461,337 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Income Tax Contingency [Line Items] | ||||
Effective tax rate | (0.80%) | (8.40%) | (0.60%) | (1.30%) |
Income tax benefit | $ (321) | $ (931) | $ (679) | $ (931) |
U.S. | ||||
Income Tax Contingency [Line Items] | ||||
Income tax benefit | $ 0 |
Related Party Transactions - Ad
Related Party Transactions - Additional Information (Details) | 9 Months Ended |
Sep. 30, 2021USD ($) | |
Scientific Advisory | Chairman of the Board of Directors | |
Related Party Transaction [Line Items] | |
Consulting agreement expiration date | Jun. 30, 2021 |
Scientific Clinical and Regulatory Advisory | Chairman of the Board of Directors | |
Related Party Transaction [Line Items] | |
Consulting agreement expiration date | Jun. 30, 2022 |
Senior Advisor Agreement | |
Related Party Transaction [Line Items] | |
Service Payment | $ 200,000 |
Senior Advisor Agreement | Chairman of the Board of Directors | |
Related Party Transaction [Line Items] | |
Senior advisor agreement expiration date | Dec. 31, 2023 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Detail) - USD ($) $ in Thousands | Nov. 01, 2021 | Sep. 30, 2021 | May 29, 2020 |
Subsequent Event [Line Items] | |||
Loan amount | $ 30,273 | ||
Loan Agreement | Hercules Capital, Inc. | |||
Subsequent Event [Line Items] | |||
Loan amount | $ 20,000 | ||
Loan Agreement | First Tranche | Hercules Capital, Inc. | |||
Subsequent Event [Line Items] | |||
Loan amount | $ 30,000 | ||
Maximum | Loan Agreement | Hercules Capital, Inc. | |||
Subsequent Event [Line Items] | |||
Loan amount | $ 100,000 | ||
Subsequent Event | Loan Agreement | |||
Subsequent Event [Line Items] | |||
Loan amount | $ 45,000 | ||
Subsequent Event | Loan Agreement | First Tranche | |||
Subsequent Event [Line Items] | |||
Loan amount | 75,000 | ||
Subsequent Event | Loan Agreement | First Tranche | Hercules Capital, Inc. | |||
Subsequent Event [Line Items] | |||
Loan amount | 100,000 | ||
Subsequent Event | Maximum | Loan Agreement | Hercules Capital, Inc. | |||
Subsequent Event [Line Items] | |||
Loan amount | $ 150,000 |