G1 Therapeutics (GTHX) 10-Q 2 Nov 22 2022 Q3 Quarterly report Financial data

Cover Page

Cover Page - shares	9 Months Ended
	Sep. 30, 2022	Oct. 28, 2022
Cover [Abstract]
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Sep. 30, 2022
Document Transition Report	false
Entity File Number	001-38096
Entity Registrant Name	G1 THERAPEUTICS, INC.
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	26-3648180
Entity Address, Address Line One	700 Park Offices Drive
Entity Address, Address Line Two	Suite 200
Entity Address, City or Town	Research Triangle Park
Entity Address, State or Province	NC
Entity Address, Postal Zip Code	27709
City Area Code	(919)
Local Phone Number	213-9835
Title of 12(b) Security	Common Stock, par value $0.0001 per share
Trading Symbol	GTHX
Security Exchange Name	NASDAQ
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Large Accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		42,912,081
Entity Central Index Key	0001560241
Amendment Flag	false
Document Fiscal Year Focus	2022
Document Fiscal Period Focus	Q3
Current Fiscal Year End Date	--12-31

Condensed Balance Sheets (unaud

Condensed Balance Sheets (unaudited) - USD ($)	Sep. 30, 2022	Dec. 31, 2021
Current assets
Cash and cash equivalents	$ 93,238,000	$ 221,186,000
Restricted cash	63,000	63,000
Marketable securities	29,744,000	0
Accounts Receivable	10,521,000	5,688,000
Inventories	13,950,000	3,471,000
Prepaid expenses and other current assets	9,949,000	13,157,000
Total current assets	157,465,000	243,565,000
Property and equipment, net	2,126,000	2,013,000
Restricted cash	250,000	312,000
Operating lease assets	6,239,000	7,035,000
Other assets	493,000	1,169,000
Total assets	166,573,000	254,094,000
Current liabilities
Accounts payable	8,442,000	2,897,000
Accrued expenses	27,251,000	23,180,000
Deferred revenue	9,000	31,000
Other current liabilities	1,432,000	1,505,000
Total current liabilities	37,134,000	27,613,000
Loan payable	76,558,000	75,190,000
Deferred revenue	1,000,000	1,000,000
Operating lease liabilities	5,916,000	6,750,000
Total liabilities	120,608,000	110,553,000
Stockholders’ equity
Common Stock, Value, Issued	4,000	4,000
Treasury Stock, Value	(8,000)	(8,000)
Additional paid-in capital	744,338,000	728,004,000
Accumulated deficit	(698,369,000)	(584,459,000)
Total stockholders’ equity	45,965,000	143,541,000
Total liabilities and stockholders' equity	$ 166,573,000	$ 254,094,000

Condensed Balance Sheets (Paren

Condensed Balance Sheets (Parenthetical) (unaudited) - $ / shares	Sep. 30, 2022	Dec. 31, 2021
Statement of Financial Position [Abstract]
Common stock, par value (in dollars per share)	$ 0.0001	$ 0.0001
Common stock, shares authorized (in shares)	120,000,000	120,000,000
Common stock, shares, issued (in shares)	42,923,747	42,588,814
Common stock, shares, outstanding (in shares)	42,897,081	42,562,148
Treasury stock, shares (in 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, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Revenues
Total revenues	$ 23,576	$ 4,858	$ 41,051	$ 25,680
Operating expenses
Cost of goods sold	1,111	591	2,756	1,642
Research and development	19,581	21,143	66,729	56,435
Selling, general and administrative	24,432	24,268	76,857	72,474
Total operating expenses	45,124	46,002	146,342	130,551
Loss from operations	(21,548)	(41,144)	(105,291)	(104,871)
Other income (expense)
Interest income	211	7	270	35
Interest expense	(2,764)	(934)	(7,436)	(2,609)
Other income (expense)	48	(76)	(234)	(208)
Total other income (expense), net	(2,505)	(1,003)	(7,400)	(2,782)
Loss before income taxes	(24,053)	(42,147)	(112,691)	(107,653)
Income tax expense	1,219	321	1,219	679
Net loss	$ (25,272)	$ (42,468)	$ (113,910)	$ (108,332)
Net loss per share, diluted (in US dollars per share)	$ (0.59)	$ (1)	$ (2.67)	$ (2.60)
Net loss per share, basic (in US dollars per share)	$ (0.59)	$ (1)	$ (2.67)	$ (2.60)
Weighted average common shares outstanding, diluted (in shares)	42,799,342	42,383,573	42,731,826	41,740,911
Weighted average common shares outstanding, basic (in shares)	42,799,342	42,383,573	42,731,826	41,740,911
Product sales, net
Revenues
Total revenues	$ 8,269	$ 3,576	$ 22,467	$ 6,717
License revenue
Revenues
Total revenues	$ 15,307	$ 1,282	$ 18,584	$ 18,963

Condensed Statements of Stockho

Condensed Statements of Stockholders' Equity (unaudited) - USD ($) $ in Thousands	Total	Common stock	Treasury stock	Additional paid-in capital	Accumulated deficit
Beginning balance common stock, shares, outstanding, (in shares) at Dec. 31, 2020		38,140,756
Balance at Dec. 31, 2020	$ 177,351	$ 4	$ (8)	$ 613,462	$ (436,107)
Beginning balance treasury stock, shares (in shares) at Dec. 31, 2020			(26,666)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Public offering (ATM), (in shares)		3,513,027
Public offering (ATM)	86,378			86,378
Exercise of common stock options (in shares)		388,857
Exercise of common stock options	2,264			2,264
Stock-based compensation	5,892			5,892
Net loss during quarter	(26,442)				(26,442)
Ending balance, common stock, shares, outstanding (in shares) at Mar. 31, 2021		42,042,640
Balance at Mar. 31, 2021	245,443	$ 4	$ (8)	707,996	(462,549)
Ending balance treasury stock, shares (in shares) at Mar. 31, 2021			(26,666)
Beginning balance common stock, shares, outstanding, (in shares) at Dec. 31, 2020		38,140,756
Balance at Dec. 31, 2020	177,351	$ 4	$ (8)	613,462	(436,107)
Beginning balance treasury stock, shares (in shares) at Dec. 31, 2020			(26,666)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Net loss during quarter	(108,332)
Ending balance, common stock, shares, outstanding (in shares) at Sep. 30, 2021		42,548,814
Balance at Sep. 30, 2021	178,339	$ 4	$ (8)	722,782	(544,439)
Ending balance treasury stock, shares (in shares) at Sep. 30, 2021			(26,666)
Beginning balance common stock, shares, outstanding, (in shares) at Mar. 31, 2021		42,042,640
Balance at Mar. 31, 2021	$ 245,443	$ 4	$ (8)	707,996	(462,549)
Beginning balance treasury stock, shares (in shares) at Mar. 31, 2021			(26,666)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Exercise of common stock options (in shares)	230,347
Exercise of common stock options	$ 1,481			1,481
Stock-based compensation	5,694			5,694
Net loss during quarter	(39,422)				(39,422)
Ending balance, common stock, shares, outstanding (in shares) at Jun. 30, 2021		42,272,987
Balance at Jun. 30, 2021	$ 213,196	$ 4	$ (8)	715,171	(501,971)
Ending balance treasury stock, shares (in shares) at Jun. 30, 2021			(26,666)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Exercise of common stock options (in shares)	275,827
Exercise of common stock options	$ 2,083			2,083
Stock-based compensation	5,528			5,528
Net loss during quarter	(42,468)				(42,468)
Ending balance, common stock, shares, outstanding (in shares) at Sep. 30, 2021		42,548,814
Balance at Sep. 30, 2021	$ 178,339	$ 4	$ (8)	722,782	(544,439)
Ending balance treasury stock, shares (in shares) at Sep. 30, 2021			(26,666)
Beginning balance common stock, shares, outstanding, (in shares) at Dec. 31, 2021	42,562,148	42,588,814
Balance at Dec. 31, 2021	$ 143,541	$ 4	$ (8)	728,004	(584,459)
Beginning balance treasury stock, shares (in shares) at Dec. 31, 2021	(26,666)		(26,666)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Exercise of common stock options (in shares)		27,333
Exercise of common stock options	$ 18			18
Restricted stock units vested (in shares)		116,051
Restricted stock units vested	0
Stock-based compensation	5,765			5,765
Net loss during quarter	(49,192)				(49,192)
Ending balance, common stock, shares, outstanding (in shares) at Mar. 31, 2022		42,732,198
Balance at Mar. 31, 2022	$ 100,132	$ 4	$ (8)	733,787	(633,651)
Ending balance treasury stock, shares (in shares) at Mar. 31, 2022			(26,666)
Beginning balance common stock, shares, outstanding, (in shares) at Dec. 31, 2021	42,562,148	42,588,814
Balance at Dec. 31, 2021	$ 143,541	$ 4	$ (8)	728,004	(584,459)
Beginning balance treasury stock, shares (in shares) at Dec. 31, 2021	(26,666)		(26,666)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Exercise of common stock options (in shares)	177,608
Net loss during quarter	$ (113,910)
Ending balance, common stock, shares, outstanding (in shares) at Sep. 30, 2022	42,897,081	42,923,747
Balance at Sep. 30, 2022	$ 45,965	$ 4	$ (8)	744,338	(698,369)
Ending balance treasury stock, shares (in shares) at Sep. 30, 2022	(26,666)		(26,666)
Beginning balance common stock, shares, outstanding, (in shares) at Mar. 31, 2022		42,732,198
Balance at Mar. 31, 2022	$ 100,132	$ 4	$ (8)	733,787	(633,651)
Beginning balance treasury stock, shares (in shares) at Mar. 31, 2022			(26,666)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Exercise of common stock options (in shares)		0
Exercise of common stock options	0			0
Restricted stock units vested (in shares)		21,945
Restricted stock units vested	0
Stock-based compensation	5,639			5,639
Net loss during quarter	(39,446)				(39,446)
Ending balance, common stock, shares, outstanding (in shares) at Jun. 30, 2022		42,754,143
Balance at Jun. 30, 2022	66,325	$ 4	$ (8)	739,426	(673,097)
Ending balance treasury stock, shares (in shares) at Jun. 30, 2022			(26,666)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Exercise of common stock options (in shares)		150,275
Exercise of common stock options	127			127
Restricted stock units vested (in shares)		19,329
Restricted stock units vested	0
Stock-based compensation	4,785			4,785
Net loss during quarter	$ (25,272)				(25,272)
Ending balance, common stock, shares, outstanding (in shares) at Sep. 30, 2022	42,897,081	42,923,747
Balance at Sep. 30, 2022	$ 45,965	$ 4	$ (8)	$ 744,338	$ (698,369)
Ending balance treasury stock, shares (in shares) at Sep. 30, 2022	(26,666)		(26,666)

Condensed Statements of Cash Fl

Condensed Statements of Cash Flows (unaudited) - USD ($)	9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021
Cash flows from operating activities
Net loss	$ (113,910,000)	$ (108,332,000)
Adjustments to reconcile net loss to net cash used in operating activities
Stock-based compensation	16,189,000	17,114,000
Accretion of discount on available for sale securities	(83,000)	0
Depreciation and amortization	393,000	355,000
Amortization of debt issuance costs	1,690,000	682,000
Non-cash interest expense	726,000	236,000
Non-cash equity interest, net	354,000	228,000
Change in operating assets and liabilities
Accounts receivable	(4,833,000)	(5,003,000)
Inventories	(10,479,000)	(1,375,000)
Prepaid expenses and other assets	5,730,000	(4,580,000)
Accounts payable	3,819,000	(109,000)
Accrued expenses and other liabilities	2,438,000	2,547,000
Deferred revenue	(22,000)	789,000
Net cash used in operating activities	(97,988,000)	(97,448,000)
Cash flows from investing activities
Purchases of marketable securities	(29,661,000)	0
Purchases of property and equipment	(506,000)	0
Net cash provided/used in investing activities	(30,167,000)	0
Cash flows from financing activities
Proceeds from stock options exercised	145,000	5,828,000
Proceeds from loan agreement	0	10,000,000
Payments of debt issuance costs	0	(100,000)
Proceeds from public offering, net of underwriting fees and commissions	0	86,429,000
Payment of public offering costs	0	(51,000)
Net cash provided by financing activities	145,000	102,106,000
Net change in cash, cash equivalents and restricted cash	(128,010,000)	4,658,000
Cash, cash equivalents and restricted cash
Beginning of period	221,561,000	207,806,000
End of period	93,551,000	212,464,000
Supplemental disclosure of cash flow information
Cash paid for interest	5,610,000	1,856,000
Non-cash operating, investing and financing activities
Upfront project costs and other current assets in accounts payable and accrued expenses	$ 1,726,000	$ 114,000

Business Description

Business Description	9 Months Ended
	Sep. 30, 2022
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Business Description	50%) the rates of adverse events associated with sacituzumab govitecan-hziy, including myelosuppression, diarrhea, and potentially alopecia, due to the presence of CDK4/6-expressing cells in the intestinal crypt and hair follicles, compared to the previously published sacituzumab govitecan-hziy single agent safety profile. The Company expects to release a more comprehensive data set including safety and initial efficacy results at a medical meeting in the first half of 2023. Trilaciclib Product Portfolio Candidate Indication Current Status Timing of Endpoints Development & trilaciclib 1L metastatic Colorectal cancer (CRC) Registrational Phase 3 trial (enrollment completed in June 2022) 1Q 2023 Primary: myeloprotection* G1 Therapeutics owns all global development and commercial rights across all indications, with the exception of Greater China (Simcere) 1L metastatic Triple negative breast cancer (mTNBC) Registrational Phase 3 trial (enrollment completed in October 2022) 2H 2023 Primary: OS* 1L Bladder cancer (mUC) Phase 2 trial 4Q 2022 Primary: PFS Antibody-drug conjugate (ADC) combination trial in mTNBC Phase 2 trial (enrolling) 4Q 2022 - milestone achieved Primary: PFS Mechanism of action trial in early stage neoadjuvant TNBC Phase 2 trial (enrollment completed in August 2022) 4Q 2022 Primary: Immune-based MOA* PFS=progression-free survival; OS=overall survival; PRO=patient reported outcome; ORR=overall response rate; pCR=pathological complete response; MOA=mechanism of action. *Additional initial results expected: (i) Phase 3 colorectal cancer trial: myeloprotection and ORR endpoints; (ii) Phase 3 1L mTNBC trial: interim OS analysis; if the trial meets the interim analysis stopping rule, it will terminate and we will report the topline results. If it does not, the trial will continue to the final analysis; (iii) Phase 2 bladder cancer trial: ORR and preliminary safety data; (iv) Phase 2 trial to confirm the immune-based mechanism of action (MOA) of trilaciclib in early-stage neoadjuvant TNBC: immune endpoints (e.g., CD8+ / Treg ratio) The Company also has an active investigator Initiated Studies (“ISS”) program. An ISS is a study that is developed and conducted by a qualified physician external to the Company who assumes full responsibility for the conduct of the study. The Company supports investigator sponsored studies that align with its areas of scientific interest. In October of 2022, the Company announced that it is supporting a recently-initiated Phase 2 ISS of trilaciclib and lurbinectedin in patients with ES-SCLC. The primary endpoint is the rate of grade 4 neutropenia in any cycle when trilaciclib is administered prior to lurbinectedin in enrolled subjects. The Company has partnered with Nanjing Simcere Dongyuan Pharmaceutical Co., Ltd (“Simcere”) to develop trilaciclib in all indications in Greater China (mainland China, Hong Kong, Macau and Taiwan) since August 2020. On July 13, 2022, the NMPA conditionally approved COSELA (trilaciclib hydrochloride for injection) for marketing in China. COSELA is currently indicated in China to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen for ES-SCLC. As a result of receiving approval in China, Simcere paid the Company a $13.0 million milestone payment in the third quarter of 2022. In total, G1 may receive up to $156.0 million in milestone payments. G1 will also receive double-digit royalties on annual net sales of COSELA in China. The Company out-licensed global rights to lerociclib in 2020, an internally discovered and differentiated oral CDK4/6 inhibitor designed to enable more effective combination treatment strategies across multiple oncology indications. In addition, the company out-licensed global rights to an internally discovered cyclin-dependent kinase 2 (“CDK2”) inhibitor for all human and veterinary uses. After completing the evaluation of the Company’s rintodestrant partnering options and recent data in the highly competitive oral SERD space, the Company made the strategic decision to discontinue the program. The Company reverted the rights back to the originator (University of Illinois Chicago) during the third quarter of 2022; there are no additional financial obligations due to the originator resulting from the reversion. The Company also has intellectual property focused on cyclin-dependent kinase targets." id="sjs-B4">Business Description G1 Therapeutics, Inc. (the “Company” or “G1”) is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel small molecule therapeutics for the treatment of patients with cancer. The Company’s first U.S. Food and Drug Administration (“FDA”)-approved product, COSELA® (trilaciclib), is the first and only therapy indicated to proactively help protect bone marrow from the damage of chemotherapy (myeloprotection) and is the first innovation in managing myelosuppression in decades. In July 2022, COSELA (trilaciclib hydrochloride for injection) was conditionally approved by the China National Medical Products Administration (NMPA) for marketing in China. Trilaciclib was developed from a technology platform that targets key cellular pathways, including transient arrest of the cell cycle at the G1 phase, prior to the beginning of DNA replication. G1 is currently pursuing trilaciclib across key growth platforms. Controlled administration and clean G1 arrest from transient cyclin-dependent kinase 4/6 (“CDK4/6") inhibition can protect the bone marrow and reduce hematologic adverse events (“AEs”) caused by cytotoxic therapy and may increase the ability to receive longer treatment durations. Transient CDK4/6 inhibition also may improve survival in combination with leading and emerging treatments through (1) myeloprotection, enabling increased cytotoxic exposure while protecting the immune system, and/or (2) immunomodulation, while also allowing beneficial T cell proliferation, which may improve patients’ overall anti-tumor immune responses. The Company is exploring the use of trilaciclib in a variety of trials across multiple tumor types and treatment combinations to optimize these potential benefits of myeloprotection and improved survival in combination with leading and emerging treatments for patients globally. The Company was incorporated on May 19, 2008 in the State of Delaware. The Company uses “COSELA” when referring to its FDA approved drug and “trilaciclib” when referring to the development of COSELA for additional indications. Product Portfolio The Company’s lead compound, trilaciclib, is a first-in-class therapy initially designed to help protect against chemotherapy-induced myelosuppression. Trilaciclib helps protect hematopoietic stem and progenitor cells (“HSPCs”) in the bone marrow by transiently inhibiting CDK4/6 leading to a temporary arrest of susceptible host cells during chemotherapy in patients. This reduces the duration and severity of neutropenia and other myelosuppressive consequences of chemotherapy. In addition, trilaciclib may improve survival outcomes when administered as combination with leading and emerging treatments in patients by increasing their ability to receive more cytotoxic therapy, protecting their immune systems from damage caused by cytotoxic therapy (myeloprotection), and improving their immune response by modulating multiple immune functions while also allowing beneficial T cell proliferation (immunomodulation). On February 12, 2021, trilaciclib (COSELA) was approved by the 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 extensive small cell lung cancer (“ES-SCLC”). On July 13, 2022, COSELA (trilaciclib hydrochloride for injection) was conditionally approved in China by the NMPA to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen for ES-SCLC. The Company continues to explore these potential benefits across multiple clinical trials. The Company is also executing on its tumor-agnostic strategy to evaluate the potential benefits of trilaciclib to patients with other tumors and to generate new data for trilaciclib in a variety of cytotoxic settings and treatment combinations to maximize its potential for patients in existing and future treatment paradigms. The Company currently has five on-going clinical trials: a Phase 3 pivotal trial in 1L colorectal cancer (“CRC”), a Phase 3 pivotal trial in 1L metastatic triple negative breast cancer (“mTNBC”), a Phase 2 trial in 1L bladder cancer with chemotherapy induction and checkpoint inhibitor maintenance, a Phase 2 trial in combination with an antibody-drug conjugate (“ADC”) in 2L/3L mTNBC, and a Phase 2 trial in neoadjuvant TNBC designed to validate trilaciclib’s immune-based mechanism of action (“MOA”). These studies will evaluate trilaciclib’s benefits of proactive multi-lineage myeloprotection and anti-tumor efficacy/survival in combination with leading and emerging treatments by myeloprotection and/or immunomodulation. In addition, the MOA and ADC Phase 2 trials will inform the design of future additional pivotal studies across multiple tumor types and treatment combinations . The Company is also conducting extensive preclinical work to assess the additive/synergistic potential of trilaciclib with a variety of new and emerging therapeutic agents that may be pursued as combination treatments in future clinical trials. New non-clinical data presented in September 2022 showed consistent synergistic potential of trilaciclib to enhance the cancer immune cycle by enhancing T cell activation, favorably altering the tumor microenvironment, and improving long-term surveillance. In November 2022, the Company provided encouraging initial data from its ongoing Phase 2 trial of trilaciclib in combination with the ADC, sacituzumab govitecan-hziy. Initial data demonstrate the potential for an on-target effect of trilaciclib to reduce (>50%) the rates of adverse events associated with sacituzumab govitecan-hziy, including myelosuppression, diarrhea, and potentially alopecia, due to the presence of CDK4/6-expressing cells in the intestinal crypt and hair follicles, compared to the previously published sacituzumab govitecan-hziy single agent safety profile. The Company expects to release a more comprehensive data set including safety and initial efficacy results at a medical meeting in the first half of 2023. Trilaciclib Product Portfolio Candidate Indication Current Status Timing of Endpoints Development & trilaciclib 1L metastatic Colorectal cancer (CRC) Registrational Phase 3 trial (enrollment completed in June 2022) 1Q 2023 Primary: myeloprotection* G1 Therapeutics owns all global development and commercial rights across all indications, with the exception of Greater China (Simcere) 1L metastatic Triple negative breast cancer (mTNBC) Registrational Phase 3 trial (enrollment completed in October 2022) 2H 2023 Primary: OS* 1L Bladder cancer (mUC) Phase 2 trial 4Q 2022 Primary: PFS Antibody-drug conjugate (ADC) combination trial in mTNBC Phase 2 trial (enrolling) 4Q 2022 - milestone achieved Primary: PFS Mechanism of action trial in early stage neoadjuvant TNBC Phase 2 trial (enrollment completed in August 2022) 4Q 2022 Primary: Immune-based MOA* PFS=progression-free survival; OS=overall survival; PRO=patient reported outcome; ORR=overall response rate; pCR=pathological complete response; MOA=mechanism of action. *Additional initial results expected: (i) Phase 3 colorectal cancer trial: myeloprotection and ORR endpoints; (ii) Phase 3 1L mTNBC trial: interim OS analysis; if the trial meets the interim analysis stopping rule, it will terminate and we will report the topline results. If it does not, the trial will continue to the final analysis; (iii) Phase 2 bladder cancer trial: ORR and preliminary safety data; (iv) Phase 2 trial to confirm the immune-based mechanism of action (MOA) of trilaciclib in early-stage neoadjuvant TNBC: immune endpoints (e.g., CD8+ / Treg ratio) The Company also has an active investigator Initiated Studies (“ISS”) program. An ISS is a study that is developed and conducted by a qualified physician external to the Company who assumes full responsibility for the conduct of the study. The Company supports investigator sponsored studies that align with its areas of scientific interest. In October of 2022, the Company announced that it is supporting a recently-initiated Phase 2 ISS of trilaciclib and lurbinectedin in patients with ES-SCLC. The primary endpoint is the rate of grade 4 neutropenia in any cycle when trilaciclib is administered prior to lurbinectedin in enrolled subjects. The Company has partnered with Nanjing Simcere Dongyuan Pharmaceutical Co., Ltd (“Simcere”) to develop trilaciclib in all indications in Greater China (mainland China, Hong Kong, Macau and Taiwan) since August 2020. On July 13, 2022, the NMPA conditionally approved COSELA (trilaciclib hydrochloride for injection) for marketing in China. COSELA is currently indicated in China to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen for ES-SCLC. As a result of receiving approval in China, Simcere paid the Company a $13.0 million milestone payment in the third quarter of 2022. In total, G1 may receive up to $156.0 million in milestone payments. G1 will also receive double-digit royalties on annual net sales of COSELA in China. The Company out-licensed global rights to lerociclib in 2020, an internally discovered and differentiated oral CDK4/6 inhibitor designed to enable more effective combination treatment strategies across multiple oncology indications. In addition, the company out-licensed global rights to an internally discovered cyclin-dependent kinase 2 (“CDK2”) inhibitor for all human and veterinary uses. After completing the evaluation of the Company’s rintodestrant partnering options and recent data in the highly competitive oral SERD space, the Company made the strategic decision to discontinue the program. The Company reverted the rights back to the originator (University of Illinois Chicago) during the third quarter of 2022; there are no additional financial obligations due to the originator resulting from the reversion. The Company also has intellectual property focused on cyclin-dependent kinase targets.

Basis of Presentation and Summa

Basis of Presentation and Summary of Significant Accounting Policies	9 Months Ended
	Sep. 30, 2022
Accounting Policies [Abstract]
Basis of Presentation and Summary of Significant Accounting Policies	Basis of Presentation and Summary of Significant Accounting Policies Basis of Presentation The accompanying condensed financial statements of the Company have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”). In the opinion of management, the Company has made all necessary adjustments, which include normal recurring adjustments necessary for a fair statement of the Company’s financial position and results of operations for the interim periods presented. The information presented in the condensed financial statements and related notes as of September 30, 2022, and for the three and nine months ended September 30, 2022, and 2021, is unaudited. The results for the three and nine months ended September 30, 2022, 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, 2021 filed with the SEC on February 23, 2022, (the “2021 Form 10-K”). The December 31, 2021 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. Certain amounts have been reclassified to conform to current presentation. The Company has experienced net losses since its inception and has an accumulated deficit of $698.4 million and $584.5 million as of September 30, 2022 and December 31, 2021, respectively. The Company expects to incur losses and have negative net cash flows from operating activities as it executes on its strategy including engaging in further research and development activities, particularly conducting non-clinical studies and clinical trials. The success of the Company depends on the ability to successfully commercialize its technologies to support its operations and strategic plan. As of the date of issuance of these financial statements, the Company expects that its cash and cash equivalents and marketable securities as of September 30, 2022 will not be sufficient to fund the Company’s planned operations and remain in compliance with its financial covenants for the next 12 months from the date of issuance of these financial statements. Based on the foregoing, the Company has concluded that substantial doubt exists about the Company’s ability to continue as a going concern for a period of at least 12 months from the date of issuance of these condensed financial statements. Until such time, if ever, as we can generate substantial revenues, we expect to finance our cash needs through a combination of equity offerings, debt financings, other third-party funding, marketing and distribution arrangements and other collaborations, strategic alliances and licensing arrangements. There can be no assurances that the Company will be able to secure such additional financing if at all, or on terms that are satisfactory to the Company, and that it will be sufficient to meet its needs. In the event the Company is not successful in obtaining sufficient funding, this could force it to delay, limit, or reduce its product development, commercialization efforts or other operations, and could result in the default on our loan payable. The Company’s financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business. The financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of the uncertainties described above. In connection with the Loan Payable described in Note 8, the Company is required to remain in compliance with a minimum cash covenant and a minimum monthly net product revenue covenant (determined in accordance with U.S. GAAP), measured on a trailing six-month basis. The lender also has the ability to call debt based on a material adverse change clause, which is subjectively defined. If the Company is not in compliance with the monthly net revenue covenants, the minimum cash covenant, or the subjective acceleration clauses are triggered under the agreement, then the lender may call the debt resulting in the Company immediately needing additional funds. As of September 30, 2022, the Company was in compliance with all covenants. Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and the accompanying notes. On an ongoing basis, the Company’s management evaluates its estimates which include, but are not limited to, estimates related to accrued expenses, accrued external clinical costs, net product sales, common stock valuation, stock-based compensation expense and deferred tax asset valuation allowance. Actual results could differ from those estimates. Cash and Cash Equivalents The Company considers all highly liquid investments purchased with original maturities of 90 days or less at acquisition to be cash equivalents. Cash and cash equivalents include cash held in banks and amounts held primarily in interest-bearing money market accounts. Cash equivalents are carried at cost, which approximates their fair market value. Marketable Securities The Company determines the appropriate classification of marketable securities at the time of purchase and reevaluates such designation at each condensed balance sheet date. The Company classified all of its marketable securities at September 30, 2022 as “available-for-sale” pursuant to ASC Topic 320, Investments – Debt and Equity Securities. Investments not classified as cash equivalents are presented as either short-term or long-term investments based on both their maturities as well as the time period the Company intends to hold such securities. Available-for-sale securities are maintained by an investment manager and primarily consist of fixed income securities. Available-for-sale securities are carried at fair value. Any premium or discount arising at purchase is amortized or accreted to interest income over the life of the instrument. Realized gains and losses are determined using the specific identification method and are included in other (income) expense, net. Accounts Receivable 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 its 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. The Company began capitalizing inventory upon receiving FDA approval for COSELA on February 12, 2021. Prior to FDA approval of COSELA, expenses associated with the manufacturing of the Company's products were recorded as research and development expense. Inventory valuation reserves are 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 reserves 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 reserves have been recorded for any periods presented. Debt The Company classifies its loan payable in current or long-term liabilities based on the timing of scheduled principal payments. The loan and security agreement (the "Loan Agreement") with Hercules Capital contains events of default, including a material adverse change, which is subjectively defined, in the Company’s business, payment defaults, and breaches of covenants following any applicable cure period. In the event of default by the Company under the Loan Agreement, the Company may be required to repay all amounts then outstanding under the Loan Agreement. The Company has determined that subjective acceleration under the material adverse events clause included in the Loan Agreement is not probable and, therefore, has classified the outstanding principal amount in long-term liabilities based on the timing of scheduled principal payments. Revenue Recognition For elements of those arrangements that the Company determines should be accounted for under ASC 606, Revenue from Contracts with Customers (“ASC 606”), the Company assesses which activities in its license or collaboration agreements are performance obligations that should be accounted for separately and determines the transaction price of the arrangement, which includes the assessment of the probability of achievement of future milestones and other potential consideration. For arrangements that include multiple performance obligations, such as granting a license or performing manufacturing or research and development activities, the Company allocates the transaction price based on the relative standalone selling price and recognizes revenue that is allocated to the respective performance obligation when (or as) control is transferred to the customer and the performance obligation is satisfied. Accordingly, the Company develops assumptions that require judgment to determine the standalone selling price for each performance obligation identified in the contract. These key assumptions may include revenue forecasts, clinical development timelines and costs, discount rates and probabilities of clinical and regulatory success. License Revenue Licenses of Intellectual Property If a license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenue allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue associated with the bundled performance obligation. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of progress and related revenue recognition. Milestone Payments At the inception of each arrangement that includes developmental and regulatory milestone payments, the Company evaluates whether the achievement of each milestone specifically relates to the Company’s efforts to satisfy a performance obligation or transfer a distinct good or service within a performance obligation. The Company evaluates each milestone to determine when and how much of the milestone to include in the transaction price. The Company first estimates the amount of the milestone payment that the Company could receive using either the expected value or the most likely amount approach. The Company primarily uses the most likely amount approach as that approach is generally most predictive for milestone payments with a binary outcome. Then, the Company considers whether any portion of that estimated amount is subject to the variable consideration constraint (that is, whether it is probable that a significant reversal of cumulative revenue would not occur upon resolution of the uncertainty). The Company updates the estimate of variable consideration included in the transaction price at each reporting date which includes updating the assessment of the likely amount of consideration and the application of the constraint to reflect current facts and circumstances. For regulatory milestones, the Company recognizes revenue at a point in time upon approval, as that is when achievement of the milestone is considered probable. The Company assesses milestones as they are achieved to determine whether they are tied to any other performance obligations in the respective license agreements. Royalties For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company will recognize revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). To date, the Company has 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) GPO fees. 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 : The Company estimates reductions to product sales for Public Health Service Institutions, such as Medicaid, Medicare and Veterans’ Administration (“VA”) programs, as well as certain other qualifying federal and state government programs, and other group purchasing organizations. The Company estimates these reductions based upon the Company’s contracts with government agencies and other organizations, statutorily defined discounts and estimated payor mix. These organizations purchase directly from the Company’s specialty distributors at a discount and the specialty distributors charge the Company back the difference between the wholesaler price and the discounted price. The Company’s liability for Medicaid rebates consists of estimates for claims that a state will make. The Company’s reserve for this discounted pricing is based on expected sales to qualified healthcare providers and the chargebacks that customers have already claimed. Co-pay assistance: Eligible patients who have commercial insurance may receive assistance from the Company to reduce the patient’s out of pocket costs. Liabilities for co-pay assistance are calculated by actual program participation from third-party administrators. Distribution Fees: The Company has written contracts with its customers that include terms for distribution fees and costs for inventory management. The Company estimates and records distribution fees due to its customers based on gross sales. Product Returns: The Company generally offers a right of return based on the product’s expiration date and certain spoilage and damaged instances. The Company estimates the amount of product sales that may be returned and records the estimate as a reduction of product sales in the period the related product sales are recognized. The Company’s estimates for expected returns are based primarily on an ongoing analysis of sales information and visibility into the inventory remaining in the distribution channel. 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 , the Company reflects in the financial statements the benefit of positions taken in a previously filed tax return or expected to be taken in a future tax return only when it is considered ‘more-likely-than-not’ that the position taken will be sustained by a taxing authority. As of September 30, 2022, and December 31, 2021, the Company had no unrecognized income tax benefits and correspondingly there is no impact on the Company’s effective income tax rate associated with these items. The Company’s policy for recording interest and penalties relating to uncertain income tax positions is to record them as a component of income tax expense in the accompanying statements of operations. As of September 30, 2022, and December 31, 2021, the Company had no such accruals. There was $1.2 million of income tax expense recognized during the three and nine months ended September 30, 2022. There was $0.3 million and $0.7 million of income tax expense recognized during the three and nine months ended September 30, 2021, respectively. The income tax expense related to the foreign withholding taxes incurred as a result of the Simcere milestone payments received during the respective periods. 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 , the Company presents debt issuance costs on the condensed balance sheet as a direct deduction from the associated debt.

Fair Value Measurements

Fair Value Measurements	9 Months Ended
	Sep. 30, 2022
Fair Value Disclosures [Abstract]
Fair Value Measurements	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, 2022, and December 31, 2021, these financial instruments and respective fair values have been classified as follows (in thousands): Quoted prices Significant Significant Balance at September 30, Assets: Cash and cash equivalents $ 51,675 $ — $ — $ 51,675 Marketable securities: U.S. Treasury Bills $ 29,744 $ — $ — $ 29,744 Total assets at fair value $ 81,419 $ — $ — $ 81,419 Quoted prices Significant Significant Balance at December 31, Assets Cash and cash equivalents $ 110,443 $ — $ — $ 110,443 Marketable securities: U.S. Treasury Bills $ — $ — $ — $ — Total assets at fair value $ 110,443 $ — $ — $ 110,443 During the three and nine months ended September 30, 2022, and the year ended December 31, 2021, there were no changes in valuation methodology. The Loan Payable (discussed in Note 8), which was recorded using Level 3 inputs, has a variable interest rate and the carrying value approximates its fair value. As of September 30, 2022, the carrying value was $76.6 million.

Inventories

Inventories	9 Months Ended
	Sep. 30, 2022
Inventory Disclosure [Abstract]
Inventories	Inventories Inventories as of September 30, 2022, and December 31, 2021 consist of the following (in thousands): September 30, 2022 December 31, 2021 Raw materials $ 7,516 $ 2,105 Work in process 2,845 1,342 Finished goods 3,589 24 Inventories $ 13,950 $ 3,471 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, 2022
Property, Plant and Equipment [Abstract]
Property and Equipment	Property and Equipment Property and equipment consists of the following (in thousands): September 30, 2022 December 31, 2021 Computer equipment $ 327 $ 327 Laboratory equipment 334 334 Furniture and fixtures 866 866 Leasehold improvements 1,782 1,782 Manufacturing equipment 506 — Accumulated depreciation (1,689) (1,296) Property and equipment, net $ 2,126 $ 2,013

Patent License Agreement

Patent License Agreement	9 Months Ended
	Sep. 30, 2022
Patent License Agreement [Abstract]
Patent License Agreement	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. In May 2022, the Company notified the University that it was terminating the license agreement.

Accrued Expenses

Accrued Expenses	9 Months Ended
	Sep. 30, 2022
Payables and Accruals [Abstract]
Accrued Expenses	Accrued Expenses Accrued expenses are comprised as follows (in thousands): September 30, 2022 December 31, 2021 Accrued external research $ 367 $ 773 Accrued professional fees and other 5,321 8,058 Accrued external clinical study costs 17,162 9,579 Accrued compensation expense 4,401 4,770 Accrued expenses $ 27,251 $ 23,180

Loan Payable

Loan Payable	9 Months Ended
	Sep. 30, 2022
Debt Disclosure [Abstract]
Loan Payable	Loan Payable On May 29, 2020, the Company entered into a loan and security agreement (the “Loan Agreement”) with Hercules Capital, Inc. (“Hercules”), under which Hercules agreed to lend the Company up to $100.0 million, to be made available in a series of tranches, subject to certain terms and conditions. The first tranche totals $30.0 million, of which the Company received $20.0 million at closing. Upon initiation of the Phase 3 trial of COSELA for metastatic colorectal cancer and receiving FDA approval for COSELA for small cell lung cancer (“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 a First Amendment to Loan and Security Agreement (the “First Amendment”) with Hercules whereby the Company drew the remaining $10.0 million of the first tranche and the interest rate and financial covenants were amended. Unless loan advances exceeded $40.0 million, no financial covenants were required. Amounts initially borrowed under the Loan Agreement bore an interest rate equal to the greater of either (i) (a) the prime rate as reported in The Wall Street Journal, plus (b) 6.40%, and (ii) 9.65%. Based on original terms of the Loan Agreement, the Company agreed to make interest only payments through June 1, 2022 and following the interest only period, the Company agreed to repay the principal balance and interest of the advances in equal monthly installments through June 1, 2024. Based on the original terms of the Loan Agreement, upon satisfaction of the Performance Milestone, the interest only period was extended through January 1, 2023 and the maturity date was extended to June 1, 2025. Upon entering into the First Amendment on March 31, 2021, the interest rate was amended to the greater of either (i) (a) the prime rate as reported in The Wall Street Journal, plus (b) 6.20%, and (ii) 9.45%. The Company may prepay advances under the Loan Agreement, in whole or in part, at any time subject to a prepayment charge equal to (a) 3.0% of the prepayment amount in the first year; (b) 2.0% of the prepayment amount in the second year; and (c) 1.0% of the prepayment amount in the third year. Upon prepayment or repayment of all or any of the advances under the Loan Agreement, the Company 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 have been accrued over the term of the loan using effective-interest method. On November 1, 2021, the Company entered into a Second Amendment to Loan and Security Agreement (the “Second Amendment”) under which Hercules agreed to lend the Company up to $150.0 million, to be made available in a series of tranches, subject to certain terms and conditions. The first tranche was increased to $100.0 million. At close of the Second Amendment, the Company borrowed an additional $45.0 million from the first tranche. The Company had the right to request that Hercules make the remaining $25.0 million term loan advances under the first tranche to the Company by September 15, 2022, which the Company did not exercise. The second tranche of $20.0 million will become available to the Company upon achievement of $50.0 million trailing six-month net product revenue of COSELA no later than June 30, 2023 and will be available through December 15, 2023. The third tranche of $15.0 million will become available upon achievement of certain development performance milestones and available through December 15, 2023. The fourth tranche of $15.0 million will be available at Hercules’ approval through June 30, 2024. Amounts borrowed under the Second Amendment bore an interest rate equal to the greater of either (i) (a) the prime rate as reported in The Wall Street Journal, plus (b) 5.90%, and (ii) 9.15%. The Company will make interest only payments through December 1, 2024 and may be extended through December 1, 2025, in quarterly increments, subject to compliance with covenants of the Second Amendment. Following the interest only period, the Company will repay the principal balance and interest of the advances in equal monthly installments through November 1, 2026. The Company may prepay advances under the Second Amendment, in whole or in part, at any time subject to a prepayment charge equal to (a) 3.0% of the prepayment amount in the first year from the closing of the Second Amendment; (b) 2.0% of the prepayment amount in the second year from the closing of the Second Amendment; and (c) 1.0% of the prepayment amount in the third year from the closing of the Second Amendment. Upon prepayment or repayment of all or any of the advances under the Second Amendment, the Company will pay (in addition to the prepayment charge) an end of term charge of 6.75% of the aggregate amount funded. The Company will be required to make a final payment to Hercules in the amount of 6.75% of the amounts funded, less any amount previously paid. In addition, the Company will be required to make a payment to Hercules for $2.1 million on the earliest occurrence of (i) June 1, 2025, (ii) the date the Company repays the outstanding principal amount in full, or (iii) the date that the principal amount becomes due and payable in full. The Second Amendment is secured by substantially all of the Company’s assets, including intellectual property, subject to certain exemptions. The Company out-licensed lerociclib as permitted in the Loan Agreement and the Company may out-license rintodestrant upon approval of the licensing terms by Hercules. The Second Amendment contains a minimum revenue covenant. Beginning August 15, 2022, with the reporting of the financial results for the second fiscal quarter ended June 30, 2022, and tested monthly, the Company must have achieved net product revenue of COSELA of at least 65% of the amounts projected in the Company’s forecast. Testing of the minimum revenue covenant shall be waived at any time in which either (a) the Company’s market capitalization exceeds $750.0 million and the Company maintains unrestricted cash equal to at least 50% of the total amounts funded, or (b) the Company maintains unrestricted cash equal to at least 100% of the total amounts funded. The Company evaluated the Second Amendment under the guidance found in ASC 470-50 Modification and Extinguishment . The Company concluded that the previous debt under the Loan Agreement was extinguished based on the difference in present value of the cash flows of the Loan Agreement and the Second Amendment. Accordingly, the difference between the carrying value of the Loan Agreement as of November 1, 2021, including the unamortized debt issuance costs, and the fair value of the Second Amendment was recorded as a $0.2 million loss on extinguishment of debt for the twelve months ended December 31, 2021. Fees paid to third parties directly related to the funded portion of the Second Amendment have been capitalized as debt issuance costs and will be amortized to interest expense over the life of the Second Amendment using the effective interest method. Fees paid that were directly related to the unfunded portion is accounted for as a deferred financing charge and amortized to interest expense over the period the unfunded portions are available. The end of term charges associated with the Second Amendment are being accreted through interest expense using the effective interest method over the related term of the debt. On June 24, 2022, the Company entered into a Third Amendment to Loan and Security Agreement (the “Third Amendment”) with Hercules which extended the time for drawing the remainder of the first tranche advance of up to $25.0 million from September 15, 2022 to December 31, 2022. The Third Amendment also added a minimum cash covenant whereby the Company must maintain unrestricted cash equal to at least 50% of the outstanding debt, and such percentage shall decrease upon the Company achieving specified net product revenue of COSELA. It further provides for a minimum revenue covenant that, beginning August 15, 2022 with the reporting of the financial results for the second fiscal quarter ended June 30, 2022, and tested monthly, the Company must have achieved net product revenue of COSELA of at least 80% of the amounts projected in the Company’s forecast. Testing of the minimum revenue covenant shall be waived at any time in which either (a) the Company’s market capitalization exceeds $750.0 million and the Company maintains unrestricted cash equal to at least 50% of the total amounts funded, or (b) the Company maintains unrestricted cash equal to at least 100% of the total amounts funded. The Company evaluated the Third Amendment under the guidance found in ASC 470-50 Modification and Extinguishment. The Company concluded that the Third Amendment was a modification and there was no impact to the financial statements. The Loan Agreement contains events of default, including a material adverse change, which is subjectively defined, in the Company’s business, payment defaults, and breaches of covenants following any applicable cure period. In the event of default by the Company under the Loan Agreement, the Company may be required to repay all amounts then outstanding under the Loan Agreement. The Company has determined that subjective acceleration under the material adverse events clause included in the Loan Agreement is not probable and, therefore, has classified the outstanding principal amount in long-term liabilities based on the timing of scheduled principal payments. As of September 30, 2022 and as of the date of the issuance of these financial statements, the Company was in compliance with all covenants and has not been notified of an event of default by the lender under the Loan Agreement. During the nine months ended September 30, 2022, the Company recognized $7.4 million of interest expense related to the debt, which is reflected in other income (expense), net on the statement of operations. As of September 30, 2022, the future principal payments due under the Loan Agreement, excluding interest, is as follows (in thousands): Amount 2022 $ — 2023 — 2024 2,776 2025 35,495 2026 36,729 Total principal outstanding 75,000 End of term charge 2,313 Unamortized debt issuance costs (755) Total $ 76,558

Stockholders' Equity

Stockholders' Equity	9 Months Ended
	Sep. 30, 2022
Equity [Abstract]
Stockholders' Equity	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 used the entirety of the remaining availability under the 2018 sales agreement with Cowen. On July 2, 2021, the Company filed an automatic shelf registration statement on Form S-3 with the Securities and Exchange Commission (the “SEC”), which became effective upon filing, pursuant to which the Company registered for sale an unlimited amount of any combination of its common stock, preferred stock, debt securities, warrants, rights and/or units from time to time and at prices and on terms that the Company may determine, so long as the Company continued to satisfy the requirements of a “well-known seasoned issuer” under SEC rules (the “2021 Form S-3”). In connection with the 2021 Form S-3, on July 2, 2021, the Company entered into a sales agreement for “at the market offerings” with Cowen, which allowed the Company to issue and sell shares of common stock pursuant to the 2021 Form S-3 for total gross sales proceeds of up to $150.0 million from time to time through Cowen, acting as its agent (the “2021 Sales Agreement”). The Company did not sell any shares of common stock under the 2021 Sales Agreement. Since the Company no longer qualified as a “well-known seasoned issuer” as such term is defined in Rule 405 under the Securities Act of 1933, as amended, at the time of the filing of the Company’s 2021 Form 10-K in February 2022, the Company filed an automatic post-effective amendment to the 2021 Form S-3 on Form POSASR prior to filing of the Company’s 2021 Form 10-K, which became effective upon filing, to register for sale up to $300.0 million of any combination of its common stock, preferred stock, debt securities, warrants, rights and/or units from time to time and at prices and on terms that the Company may determine and, as required by SEC rules, and another post-effective amendment to the 2021 Form S-3 on Form POS AM after the filing of the Company’s 2021 Form 10-K. The post-effective amendment to the 2021 Form S-3 on Form POS AM was declared effective by the SEC on May 3, 2022 and the 2021 Form S-3 will remain in effect for up to three years from the date it originally became effective, which was July 2, 2021. The 2021 Form S-3 also includes a prospectus covering up to an aggregate of $100.0 million in common stock that the Company may issue and sell from time to time, through Cowen acting as its sales agent, pursuant to that certain sales agreement that the Company entered into with Cowen on February 23, 2022 (the “2022 Sales Agreement”). In connection with the Company entering into the 2022 Sales Agreement with Cowen, the Company terminated the 2021 Sales Agreement. As of the date hereof, the Company has not sold any shares of common stock or other securities under the 2022 Sales Agreement for “at the market offerings.” 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, 2022, 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, 2022, and December 31, 2021 as follows: September 30, 2022 December 31, 2021 Common stock options outstanding 7,484,758 6,701,727 RSUs outstanding 633,206 414,991 Options and RSUs available for grant under Equity Incentive Plans 2,282,009 1,771,635 10,399,973 8,888,353

Stock-Based Compensation

Stock-Based Compensation	9 Months Ended
	Sep. 30, 2022
Share-Based Payment Arrangement [Abstract]
Stock-Based Compensation	Stock-Based Compensation 2011 Equity Incentive Plan In March 2011, the Company adopted the 2011 Equity Incentive Plan (the “2011 Plan”). The 2011 Plan provided for the direct award or sale of the Company’s common stock and for the grant of stock options to employees, directors, officers, consultants and advisors of the Company. The 2011 Plan was subsequently amended in August 2012, October 2013, February 2015, December 2015, April 2016 and November 2016 to allow for the issuance of additional shares of common stock. In connection with the adoption of the 2017 Plan (as defined below), the 2011 Plan was terminated and no further awards will be made under the 2011 Plan. 2017 Equity Incentive Plan In May 2017, the Company adopted the 2017 Equity Incentive Plan (the “2017 Plan”). The 2017 Plan provided for the direct award or sale of the Company’s common stock and for the grant of up to 1,932,000 stock options to employees, directors, officers, consultants and advisors of the Company. The 2017 Plan provides for the grant of incentive stock options, non-statutory stock options or restricted stock. Effective January 1, 2022, and in accordance with the “evergreen” provision of the 2017 Plan, an additional 1,096,553 shares were made available for issuance. Under both the 2011 Plan and the 2017 Plan, options to purchase the Company’s common stock may be granted at a price no less than the fair market value of a share of common stock on the date of grant. The fair value shall be the closing sales price for a share as quoted on any established securities exchange for such grant date or the last preceding date for which such quotation exists. Vesting terms of options issued are determined by the Board of Directors or Compensation Committee of the Board. The Company’s stock options vest based on terms in the stock option agreements. Stock options have a maximum term of ten years. 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, 2022, there were a total of 1,630,159 shares of common stock available for future issuance under the 2017 Plan. Amended and Restated 2021 Inducement Equity Incentive Plan In February 2021, the Company adopted the 2021 Inducement Equity Incentive Plan (the “2021 Inducement Plan”). The 2021 Inducement Plan provides for the grant of up to 500,000 non-qualified options, stock grants, and stock-based awards to employees and directors of the Company. The 2021 Inducement Plan does not include an evergreen provision. In September 2021, the Company adopted the 2021 Sales Force Inducement Equity Incentive Plan (the “2021 Sales Force Inducement Plan”). The 2021 Sales Force Inducement Plan provides for the grant of up to 500,000 non-qualified options, stock grants, and stock-based awards to sales force individuals and support staff that were not previously employees or directors of the Company. The 2021 Sales Force Inducement Plan does not include an evergreen provision. In March 2022, the Company merged the 2021 Sales Force Inducement Plan into the 2021 Inducement Plan and amended and restated the 2021 Inducement Plan to create the Amended and Restated 2021 Inducement Equity Incentive Plan (the “Amended and Restated 2021 Plan”). In addition, the number of shares reserved for issuance under the Amended and Restated 2021 Plan was increased by 750,000 shares of the Company’s common stock, for an aggregate of 1,750,000 shares of the Company’s common stock authorized to issue under the Amended and Restated 2021 Plan. The Amended and Restated 2021 Plan does not include an evergreen provision. As of September 30, 2022, there was a total of 651,850 shares of common stock available for future issuance under the Amended and Restated 2021 Plan. Stock-Based Compensation The Company recognizes compensation costs related to stock options granted to employees based on the estimated fair value of the awards on the date of grant, net of estimated forfeitures. The grant date fair value of the stock-based awards is generally recognized on a straight-line basis over the requisite service period, which is generally the vesting period of the respective awards. Share-based awards granted to non-employee directors as compensation for serving on the Company’s Board of Directors are accounted for in the same manner as employee share-based compensation awards. The Company calculates the fair value of stock options using the Black-Scholes option pricing model. The Black-Scholes option-pricing model requires the use of subjective assumptions, including the expected volatility of the Company’s common stock, the assumed dividend yield, the expected term of the Company’s stock options and the fair value of the underlying common stock on the date of grant. The Company also incurs stock-based compensation expense related to RSUs. 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, 2022 2021 2022 2021 Cost of goods sold $ 52 $ 68 $ 155 $ 237 Research and development 980 1,142 3,149 3,775 Selling, general and administrative 3,753 4,318 12,885 13,102 Total stock-based compensation expense $ 4,785 $ 5,528 $ 16,189 $ 17,114 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, 2022, and September 30, 2021: Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Expected volatility 79.1% - 80.1% 77.7% - 78.4% 76.7% - 80.1% 77.7% - 79.6% Weighted-average risk free rate 2.6% - 3.3% 0.9% - 1.1% 1.4% - 3.3% 0.4% - 1.2% Dividend yield —% —% —% —% Expected term (in years) 5.91 6.05 6.00 6.00 Stock Option Activity The following table is a summary of the Stock option activity for the nine months ended September 30, 2022: Weighted average Options Weighted Remaining Aggregate (in thousands) Balance as of December 31, 2021 6,701,727 $ 17.88 7.2 $ 10,427 Granted 1,695,639 9.58 Cancelled (735,000) 20.09 Exercised (177,608) 0.82 Balance as of September 30, 2022 7,484,758 $ 16.19 7.1 $ 15,909 Exercisable at December 31, 2021 3,660,578 $ 16.72 5.9 $ 10,422 Vested at December 31, 2021 and expected to vest 6,701,727 $ 17.88 7.2 $ 10,427 Exercisable at September 30, 2022 4,377,489 $ 17.82 5.9 $ 11,419 Vested at September 30, 2022 and expected to vest 7,484,758 $ 16.19 7.1 $ 15,909 As of September 30, 2022, unrecognized compensation expense related to unvested stock options totaled $25.7 million, which the Company expects to be recognized over a weighted-average period of approximately 2.3 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 nine months ended September 30, 2022: Number of Weighted – Average Balance as of December 31, 2021 414,991 $ 18.24 Granted 468,631 9.30 Cancelled (93,091) 12.34 Vested (157,325) 18.58 Balance as of September 30, 2022 633,206 $ 12.40 As of September 30, 2022, 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 2.5 years.

License Revenue

License Revenue	9 Months Ended
	Sep. 30, 2022
Revenue Recognition [Abstract]
License Revenue	License Revenue Incyclix License Agreement On May 22, 2020, the Company entered into an exclusive license agreement with Incyclix Bio, LLC (“Incyclix”), formerly ARC Therapeutics, LLC, a company primarily owned by a former board member, whereby the Company granted to Incyclix an exclusive, worldwide, royalty-bearing license, with the right to sublicense, solely to make, have made, use, sell, offer for sale, import, export, and commercialize products related to its CDK2 inhibitor compounds. At close, the Company received consideration in the form of an upfront payment of $1.0 million and an equity interest in Incyclix equal to 10% of its issued and outstanding units valued at $1.1 million. In addition, the Company may receive a future development milestone payment totaling $2.0 million and royalty payments in the mid-single digits based on net sales of the licensed compound after commercialization. The Company has right of first negotiation to re-acquire these assets. The Company assessed the license agreement in accordance with ASC 606 and identified one performance obligation in the contract, which is the transfer of the license, as Incyclix can benefit from the license using its own resources. The Company recognized $2.1 million in license revenue consisting of the upfront payment and the 10% equity interest in Incyclix upon the effective date as the Company determined the license was a right to use the intellectual property and the Company had provided all necessary information to Incyclix to benefit from the license. The Company considers the future potential development milestones and sales-based royalties to be variable consideration. The development milestone is excluded from the transaction price because it determined the payment to be fully constrained under ASC 606 due to the inherent uncertainty in the achievement of such milestone due to factors outside of the Company’s control. As sales-based royalties are all related to the license of the intellectual property, the Company will recognize revenue in the period when subsequent sales are made pursuant to the sales-based royalty exception. The Company will re-evaluate the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur. There was no revenue recognized during the nine months ended September 30, 2022. 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. Through December 31, 2021, the Company recognized an additional $3.0 million in revenue for the achievement of development and commercial milestones as defined by the license agreement. There was no milestone revenue recognized during the nine months ended September 30, 2022. 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 agreed to 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 each quarter, and EQRx will pay within 30 days after its receipt of such invoice. For the nine months ended September 30, 2022, the Company recognized revenue of $1.9 million for the reimbursement of clinical trial costs. No development and commercial milestones, as defined by the license agreement, have been achieved through September 30, 2022. Simcere License Agreement On August 3, 2020, the Company entered into an exclusive license agreement with Simcere for the development and commercialization of trilaciclib in all indications in Greater China (mainland China, Hong Kong, Macau, and Taiwan) (the “Simcere Territory”). Under the license agreement, the Company granted to Simcere an exclusive, royalty-bearing, non-transferable license, with the right to grant sublicenses, to develop, obtain, hold and maintain regulatory approvals for, and commercialize trilaciclib in the Simcere Territory. Under the license agreement, Simcere agreed to pay the Company a non-refundable, upfront cash payment of $14.0 million with the potential to pay an additional $156.0 million upon reaching certain development and commercial milestones. In addition, Simcere will pay the Company tiered low double-digit royalties on annual net sales of trilaciclib in the Simcere Territory. In 2020, the Company transferred the license and related technology and know-how to Simcere, which resulted in the recognition of $14.0 million in revenue in accordance with ASC 606. Through December 31, 2021, the Company recognized an additional $8.0 million in revenue for the achievement of development and commercial milestones as defined by the license agreement. For the nine months ended September 30, 2022, the Company recognized $1.9 million for reimbursement of clinical trial costs and $0.4 million for drug supply sold to Simcere. There was $14.0 million of milestone revenue recognized during the nine months ended September 30, 2022.

Net Loss Per Common Share

Net Loss Per Common Share	9 Months Ended
	Sep. 30, 2022
Earnings Per Share [Abstract]
Net Loss Per Common Share	Net Loss per Common Share Basic net loss per common share is computed using the weighted average number of common shares outstanding during the period including nominal issuances of common stock warrants. Diluted net loss per common share is computed using the sum of the weighted average number of common shares outstanding during the period and, if dilutive, the weighted average number of potential shares of common stock, including the assumed exercise of stock options, stock warrants and unvested restricted common stock. For the three and nine months ended September 30, 2022, and 2021, the following potentially dilutive securities have been excluded from the computations of diluted weighted-average shares outstanding because the effect would be anti-dilutive: Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Stock options issued and outstanding 7,800,293 6,892,488 7,766,062 7,162,589 Unvested RSUs 649,883 476,735 626,889 461,337 Total potential dilutive shares 8,450,176 7,369,223 8,392,951 7,623,926 Amounts in the table above reflect the common stock equivalents of the noted instrument.

Income Taxes

Income Taxes	9 Months Ended
	Sep. 30, 2022
Income Tax Disclosure [Abstract]
Income Taxes	Income TaxesThe Company’s effective income tax rate was (5.1%) and (0.8%) for the three months ended September 30, 2022 and 2021 and (1.1%) and (0.6%) for the nine months ended September 30, 2022, and 2021, 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, 2022
Related Party Transactions [Abstract]
Related Party Transactions	Related Party TransactionsThe Company entered into a senior advisor agreement on September 29, 2020 with Mark A. Velleca, M.D., Ph.D., a member of the Board of Directors, with an effective date of January 1, 2021. Pursuant to the terms of the agreement, Dr. Velleca will receive $200,000 annually, paid in equal quarterly installments, for his services. The senior advisor agreement will expire on December 31, 2023.

Subsequent Events

Subsequent Events	9 Months Ended
	Sep. 30, 2022
Subsequent Events [Abstract]
Subsequent Events	Subsequent Event On November 1, 2022, the Company and Hercules Capital, Inc. entered into a fourth amendment (the “Fourth Amendment”) to amend the loan and security agreement (the "Loan and Security Agreement"), dated as of May 29, 2020. As of September 30, 2022, the total loan amount outstanding is $75.0 million. The Fourth Amendment extended the time for drawing the Tranche 1D Advance (as defined in the Loan and Security Agreement) of up to $25.0 million from December 31, 2022 to June 30, 2023. The Fourth Amendment also amended the minimum cash covenant such that if the outstanding debt is less than or equal to $75.0 million, the Company must maintain unrestricted cash equal to at least 65% of the outstanding debt. In addition, if the outstanding debt is greater than $75.0 million, the Company must maintain unrestricted cash equal to at least 70% of the outstanding debt. If the Company achieves specified net revenue of COSELA, the cash percentage decreases to 45% of the outstanding debt. The Fourth Amendment also re-set the prepayment premiums associated with any prepayment of the loans under the Loan and Security Agreement. This description is only a summary of the Fourth Amendment and is qualified in its entirety by reference to the Fourth Amendment, a copy of which is filed as an Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q for the quarter ending September 30, 2022 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, 2022
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, 2022, and for the three and nine months ended September 30, 2022, and 2021, is unaudited. The results for the three and nine months ended September 30, 2022, 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, 2021 filed with the SEC on February 23, 2022, (the “2021 Form 10-K”). The December 31, 2021 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. Certain amounts have been reclassified to conform to current presentation. The Company has experienced net losses since its inception and has an accumulated deficit of $698.4 million and $584.5 million as of September 30, 2022 and December 31, 2021, respectively. The Company expects to incur losses and have negative net cash flows from operating activities as it executes on its strategy including engaging in further research and development activities, particularly conducting non-clinical studies and clinical trials. The success of the Company depends on the ability to successfully commercialize its technologies to support its operations and strategic plan. As of the date of issuance of these financial statements, the Company expects that its cash and cash equivalents and marketable securities as of September 30, 2022 will not be sufficient to fund the Company’s planned operations and remain in compliance with its financial covenants for the next 12 months from the date of issuance of these financial statements. Based on the foregoing, the Company has concluded that substantial doubt exists about the Company’s ability to continue as a going concern for a period of at least 12 months from the date of issuance of these condensed financial statements. Until such time, if ever, as we can generate substantial revenues, we expect to finance our cash needs through a combination of equity offerings, debt financings, other third-party funding, marketing and distribution arrangements and other collaborations, strategic alliances and licensing arrangements. There can be no assurances that the Company will be able to secure such additional financing if at all, or on terms that are satisfactory to the Company, and that it will be sufficient to meet its needs. In the event the Company is not successful in obtaining sufficient funding, this could force it to delay, limit, or reduce its product development, commercialization efforts or other operations, and could result in the default on our loan payable. The Company’s financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business. The financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of the uncertainties described above. In connection with the Loan Payable described in Note 8, the Company is required to remain in compliance with a minimum cash covenant and a minimum monthly net product revenue covenant (determined in accordance with U.S. GAAP), measured on a trailing six-month basis. The lender also has the ability to call debt based on a material adverse change clause, which is subjectively defined. If the Company is not in compliance with the monthly net revenue covenants, the minimum cash covenant, or the subjective acceleration clauses are triggered under the agreement, then the lender may call the debt resulting in the Company immediately needing additional funds. As of September 30, 2022, the Company was in compliance with all covenants.
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, common stock valuation, stock-based compensation expense and deferred tax asset valuation allowance. Actual results could differ from those estimates.
Cash and Cash Equivalents	Cash and Cash Equivalents The Company considers all highly liquid investments purchased with original maturities of 90 days or less at acquisition to be cash equivalents. Cash and cash equivalents include cash held in banks and amounts held primarily in interest-bearing money market accounts. Cash equivalents are carried at cost, which approximates their fair market value.
Marketable Securities	Marketable SecuritiesThe Company determines the appropriate classification of marketable securities at the time of purchase and reevaluates such designation at each condensed balance sheet date. The Company classified all of its marketable securities at September 30, 2022 as “available-for-sale” pursuant to ASC Topic 320, Investments – Debt and Equity Securities. Investments not classified as cash equivalents are presented as either short-term or long-term investments based on both their maturities as well as the time period the Company intends to hold such securities. Available-for-sale securities are maintained by an investment manager and primarily consist of fixed income securities. Available-for-sale securities are carried at fair value. Any premium or discount arising at purchase is amortized or accreted to interest income over the life of the instrument. Realized gains and losses are determined using the specific identification method and are included in other (income) expense, net.
Accounts Receivable	Accounts Receivable The Company’s accounts receivable consists of amounts due from specialty distributors in the U.S. (collectively, its “Customers”) related to sales of COSELA and have standard payment terms. Trade receivables are recorded net of the estimated variable consideration for chargebacks based on contractual terms and the Company’s expectation regarding the utilization and earnings of the chargebacks and discounts as well as the net amount expected to be collected from its customers. Estimates of the Company’s credit losses are determined based on existing contractual payment terms, individual customer circumstances, and any changes to the economic environment.
Inventories	Inventories Inventories are stated at the lower of cost or net realizable value and recognized on a weighted-average cost method. The Company uses actual cost to determine the cost basis for inventory. Inventory is capitalized based on when future economic benefit is expected to be realized. Due to the nature of the Company’s supply chain process, inventory that is owned by the Company, is physically stored at third-party warehouses, logistics providers, and contract manufacturers. The Company began capitalizing inventory upon receiving FDA approval for COSELA on February 12, 2021. Prior to FDA approval of COSELA, expenses associated with the manufacturing of the Company's products were recorded as research and development expense. Inventory valuation reserves are 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 reserves 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 reserves have been recorded for any periods presented.
Debt, Debt Issuance Costs	Debt The Company classifies its loan payable in current or long-term liabilities based on the timing of scheduled principal payments. The loan and security agreement (the "Loan Agreement") with Hercules Capital contains events of default, including a material adverse change, which is subjectively defined, in the Company’s business, payment defaults, and breaches of covenants following any applicable cure period. In the event of default by the Company under the Loan Agreement, the Company may be required to repay all amounts then outstanding under the Loan Agreement. The Company has determined that subjective acceleration under the material adverse events clause included in the Loan Agreement is not probable and, therefore, has classified the outstanding principal amount in long-term liabilities based on the timing of scheduled principal payments. Debt Issuance Costs Debt issuance costs are amortized to interest expense over the estimated life of the related debt based on the effective interest method. In accordance with ASC 835, Interest , the Company presents debt issuance costs on the condensed balance sheet as a direct deduction from the associated debt.
Revenue Recognition	Revenue Recognition For elements of those arrangements that the Company determines should be accounted for under ASC 606, Revenue from Contracts with Customers (“ASC 606”), the Company assesses which activities in its license or collaboration agreements are performance obligations that should be accounted for separately and determines the transaction price of the arrangement, which includes the assessment of the probability of achievement of future milestones and other potential consideration. For arrangements that include multiple performance obligations, such as granting a license or performing manufacturing or research and development activities, the Company allocates the transaction price based on the relative standalone selling price and recognizes revenue that is allocated to the respective performance obligation when (or as) control is transferred to the customer and the performance obligation is satisfied. Accordingly, the Company develops assumptions that require judgment to determine the standalone selling price for each performance obligation identified in the contract. These key assumptions may include revenue forecasts, clinical development timelines and costs, discount rates and probabilities of clinical and regulatory success. License Revenue Licenses of Intellectual Property If a license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenue allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue associated with the bundled performance obligation. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of progress and related revenue recognition. Milestone Payments At the inception of each arrangement that includes developmental and regulatory milestone payments, the Company evaluates whether the achievement of each milestone specifically relates to the Company’s efforts to satisfy a performance obligation or transfer a distinct good or service within a performance obligation. The Company evaluates each milestone to determine when and how much of the milestone to include in the transaction price. The Company first estimates the amount of the milestone payment that the Company could receive using either the expected value or the most likely amount approach. The Company primarily uses the most likely amount approach as that approach is generally most predictive for milestone payments with a binary outcome. Then, the Company considers whether any portion of that estimated amount is subject to the variable consideration constraint (that is, whether it is probable that a significant reversal of cumulative revenue would not occur upon resolution of the uncertainty). The Company updates the estimate of variable consideration included in the transaction price at each reporting date which includes updating the assessment of the likely amount of consideration and the application of the constraint to reflect current facts and circumstances. For regulatory milestones, the Company recognizes revenue at a point in time upon approval, as that is when achievement of the milestone is considered probable. The Company assesses milestones as they are achieved to determine whether they are tied to any other performance obligations in the respective license agreements. Royalties For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company will recognize revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). To date, the Company has 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) GPO fees. 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 : The Company estimates reductions to product sales for Public Health Service Institutions, such as Medicaid, Medicare and Veterans’ Administration (“VA”) programs, as well as certain other qualifying federal and state government programs, and other group purchasing organizations. The Company estimates these reductions based upon the Company’s contracts with government agencies and other organizations, statutorily defined discounts and estimated payor mix. These organizations purchase directly from the Company’s specialty distributors at a discount and the specialty distributors charge the Company back the difference between the wholesaler price and the discounted price. The Company’s liability for Medicaid rebates consists of estimates for claims that a state will make. The Company’s reserve for this discounted pricing is based on expected sales to qualified healthcare providers and the chargebacks that customers have already claimed. Co-pay assistance: Eligible patients who have commercial insurance may receive assistance from the Company to reduce the patient’s out of pocket costs. Liabilities for co-pay assistance are calculated by actual program participation from third-party administrators. Distribution Fees: The Company has written contracts with its customers that include terms for distribution fees and costs for inventory management. The Company estimates and records distribution fees due to its customers based on gross sales. Product Returns: The Company generally offers a right of return based on the product’s expiration date and certain spoilage and damaged instances. The Company estimates the amount of product sales that may be returned and records the estimate as a reduction of product sales in the period the related product sales are recognized. The Company’s estimates for expected returns are based primarily on an ongoing analysis of sales information and visibility into the inventory remaining in the distribution channel.
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
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.

Business Description (Tables)

Business Description (Tables)	9 Months Ended
	Sep. 30, 2022
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Schedule of Product Information	Candidate Indication Current Status Timing of Endpoints Development & trilaciclib 1L metastatic Colorectal cancer (CRC) Registrational Phase 3 trial (enrollment completed in June 2022) 1Q 2023 Primary: myeloprotection* G1 Therapeutics owns all global development and commercial rights across all indications, with the exception of Greater China (Simcere) 1L metastatic Triple negative breast cancer (mTNBC) Registrational Phase 3 trial (enrollment completed in October 2022) 2H 2023 Primary: OS* 1L Bladder cancer (mUC) Phase 2 trial 4Q 2022 Primary: PFS Antibody-drug conjugate (ADC) combination trial in mTNBC Phase 2 trial (enrolling) 4Q 2022 - milestone achieved Primary: PFS Mechanism of action trial in early stage neoadjuvant TNBC Phase 2 trial (enrollment completed in August 2022) 4Q 2022 Primary: Immune-based MOA*

Fair Value Measurements (Tables

Fair Value Measurements (Tables)	9 Months Ended
	Sep. 30, 2022
Fair Value Disclosures [Abstract]
Summary of Financial Instruments and Respective Fair Values	At September 30, 2022, and December 31, 2021, these financial instruments and respective fair values have been classified as follows (in thousands): Quoted prices Significant Significant Balance at September 30, Assets: Cash and cash equivalents $ 51,675 $ — $ — $ 51,675 Marketable securities: U.S. Treasury Bills $ 29,744 $ — $ — $ 29,744 Total assets at fair value $ 81,419 $ — $ — $ 81,419 Quoted prices Significant Significant Balance at December 31, Assets Cash and cash equivalents $ 110,443 $ — $ — $ 110,443 Marketable securities: U.S. Treasury Bills $ — $ — $ — $ — Total assets at fair value $ 110,443 $ — $ — $ 110,443

Inventories (Tables)

Inventories (Tables)	9 Months Ended
	Sep. 30, 2022
Inventory Disclosure [Abstract]
Schedule of Inventories	Inventories as of September 30, 2022, and December 31, 2021 consist of the following (in thousands): September 30, 2022 December 31, 2021 Raw materials $ 7,516 $ 2,105 Work in process 2,845 1,342 Finished goods 3,589 24 Inventories $ 13,950 $ 3,471

Property and Equipment (Tables)

Property and Equipment (Tables)	9 Months Ended
	Sep. 30, 2022
Property, Plant and Equipment [Abstract]
Schedule of Property and Equipment	Property and equipment consists of the following (in thousands): September 30, 2022 December 31, 2021 Computer equipment $ 327 $ 327 Laboratory equipment 334 334 Furniture and fixtures 866 866 Leasehold improvements 1,782 1,782 Manufacturing equipment 506 — Accumulated depreciation (1,689) (1,296) Property and equipment, net $ 2,126 $ 2,013

Accrued Expenses (Tables)

Accrued Expenses (Tables)	9 Months Ended
	Sep. 30, 2022
Payables and Accruals [Abstract]
Schedule of Accrued Expenses	Accrued expenses are comprised as follows (in thousands): September 30, 2022 December 31, 2021 Accrued external research $ 367 $ 773 Accrued professional fees and other 5,321 8,058 Accrued external clinical study costs 17,162 9,579 Accrued compensation expense 4,401 4,770 Accrued expenses $ 27,251 $ 23,180

Loan Payable (Tables)

Loan Payable (Tables)	9 Months Ended
	Sep. 30, 2022
Debt Disclosure [Abstract]
Schedule of Outstanding Debt Obligations	As of September 30, 2022, the future principal payments due under the Loan Agreement, excluding interest, is as follows (in thousands): Amount 2022 $ — 2023 — 2024 2,776 2025 35,495 2026 36,729 Total principal outstanding 75,000 End of term charge 2,313 Unamortized debt issuance costs (755) Total $ 76,558

Stockholders' Equity (Tables)

Stockholders' Equity (Tables)	9 Months Ended
	Sep. 30, 2022
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, 2022, and December 31, 2021 as follows: September 30, 2022 December 31, 2021 Common stock options outstanding 7,484,758 6,701,727 RSUs outstanding 633,206 414,991 Options and RSUs available for grant under Equity Incentive Plans 2,282,009 1,771,635 10,399,973 8,888,353

Stock-Based Compensation (Table

Stock-Based Compensation (Tables)	9 Months Ended
	Sep. 30, 2022
Share-Based Payment Arrangement [Abstract]
Summary of Share-Based Compensation Expense Included in Statement of Operations	The table below summarizes the stock-based compensation expense recognized in the Company’s statement of operations by classification (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Cost of goods sold $ 52 $ 68 $ 155 $ 237 Research and development 980 1,142 3,149 3,775 Selling, general and administrative 3,753 4,318 12,885 13,102 Total stock-based compensation expense $ 4,785 $ 5,528 $ 16,189 $ 17,114
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, 2022, and September 30, 2021: Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Expected volatility 79.1% - 80.1% 77.7% - 78.4% 76.7% - 80.1% 77.7% - 79.6% Weighted-average risk free rate 2.6% - 3.3% 0.9% - 1.1% 1.4% - 3.3% 0.4% - 1.2% Dividend yield —% —% —% —% Expected term (in years) 5.91 6.05 6.00 6.00
Summary of Stock Option Activity	The following table is a summary of the Stock option activity for the nine months ended September 30, 2022: Weighted average Options Weighted Remaining Aggregate (in thousands) Balance as of December 31, 2021 6,701,727 $ 17.88 7.2 $ 10,427 Granted 1,695,639 9.58 Cancelled (735,000) 20.09 Exercised (177,608) 0.82 Balance as of September 30, 2022 7,484,758 $ 16.19 7.1 $ 15,909 Exercisable at December 31, 2021 3,660,578 $ 16.72 5.9 $ 10,422 Vested at December 31, 2021 and expected to vest 6,701,727 $ 17.88 7.2 $ 10,427 Exercisable at September 30, 2022 4,377,489 $ 17.82 5.9 $ 11,419 Vested at September 30, 2022 and expected to vest 7,484,758 $ 16.19 7.1 $ 15,909
Summary of Restricted Stock Units Activity	The following table is a summary of the RSU activity for nine months ended September 30, 2022: Number of Weighted – Average Balance as of December 31, 2021 414,991 $ 18.24 Granted 468,631 9.30 Cancelled (93,091) 12.34 Vested (157,325) 18.58 Balance as of September 30, 2022 633,206 $ 12.40

Net Loss Per Common Share (Tabl

Net Loss Per Common Share (Tables)	9 Months Ended
	Sep. 30, 2022
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, 2022, and 2021, the following potentially dilutive securities have been excluded from the computations of diluted weighted-average shares outstanding because the effect would be anti-dilutive: Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Stock options issued and outstanding 7,800,293 6,892,488 7,766,062 7,162,589 Unvested RSUs 649,883 476,735 626,889 461,337 Total potential dilutive shares 8,450,176 7,369,223 8,392,951 7,623,926

Business Description (Details)

Business Description (Details) - Nanjing Simcere Dongyuan Pharmaceutical Co., Ltd - Collaborative arrangement, transaction with party to collaborative arrangement $ in Millions	Jul. 13, 2022 USD ($)
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Collaborative arrangement, rights and obligations, maximum aggregate milestone payments	$ 13
Revenue, remaining performance obligation, variable consideration amount	$ 156

Basis of Presentation and Sum_3

Basis of Presentation and Summary of Significant Accounting Policies - Additional Information (Details) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021	Dec. 31, 2021
Accounting Policies [Abstract]
Accumulated deficit	$ 698,369,000		$ 698,369,000		$ 584,459,000
Unrecognized income tax benefits	0		0		0
Accrued income taxes	0		0		$ 0
Income tax expense	$ 1,219,000	$ 321,000	$ 1,219,000	$ 679,000

Fair Value Measurements - Summa

Fair Value Measurements - Summary of Financial Instruments and Respective Fair Values (Details) - USD ($)	Sep. 30, 2022	Dec. 31, 2021
Assets
Cash and Cash Equivalents, Fair Value Disclosure	$ 51,675,000	$ 110,443,000
Debt Securities, Available-for-Sale	29,744,000	0
Assets at fair value	81,419,000	110,443,000
Quoted prices in active markets for identical assets (Level 1)
Assets
Cash and Cash Equivalents, Fair Value Disclosure	51,675,000	110,443,000
Debt Securities, Available-for-Sale	29,744,000	0
Assets at fair value	81,419,000	110,443,000
Significant other observable inputs (Level 2)
Assets
Cash and Cash Equivalents, Fair Value Disclosure	0	0
Debt Securities, Available-for-Sale	0	0
Assets at fair value	0	0
Significant other unobservable inputs (Level 3)
Assets
Cash and Cash Equivalents, Fair Value Disclosure	0	0
Debt Securities, Available-for-Sale	0	0
Assets at fair value	$ 0	$ 0

Fair Value Measurements - Addit

Fair Value Measurements - Additional Information (Details) - USD ($)	3 Months Ended	9 Months Ended	12 Months Ended
	Sep. 30, 2022	Sep. 30, 2022	Dec. 31, 2021
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items]
Changes in valuation methodology	$ 0	$ 0	$ 0
Loan payable	76,558,000	76,558,000	$ 75,190,000
Significant other unobservable inputs (Level 3)
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items]
Loan payable	$ 76,600,000	$ 76,600,000

Inventories - Schedule of Inven

Inventories - Schedule of Inventories (Details) - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
Inventory Disclosure [Abstract]
Raw materials	$ 7,516	$ 2,105
Work in process	2,845	1,342
Finished goods	3,589	24
Inventories	$ 13,950	$ 3,471

Property and Equipment - Schedu

Property and Equipment - Schedule of Property and Equipment (Details) - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
Property Plant And Equipment [Line Items]
Accumulated depreciation	$ (1,689)	$ (1,296)
Property and equipment, net	2,126	2,013
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
Manufacturing equipment
Property Plant And Equipment [Line Items]
Property and equipment, gross	$ 506	$ 0

Property and Equipment - Additi

Property and Equipment - Additional Information (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Property, Plant and Equipment [Abstract]
Depreciation expenses relating to property and equipment	$ 139	$ 117	$ 393	$ 355

Accrued Expenses - Schedule of

Accrued Expenses - Schedule of Accrued Expenses (Details) - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
Payables and Accruals [Abstract]
Accrued external research	$ 367	$ 773
Accrued professional fees and other	5,321	8,058
Accrued external clinical study costs	17,162	9,579
Accrued compensation expense	4,401	4,770
Accrued expenses	$ 27,251	$ 23,180

Loan Payable - Additional Infor

Loan Payable - Additional Information (Details) - USD ($)			3 Months Ended	9 Months Ended
	Jun. 24, 2022	Nov. 01, 2021	Mar. 31, 2021	Sep. 30, 2022	May 29, 2020
Debt Instrument [Line Items]
Interest expense, loan agreement				$ 7,400,000
Loan Agreement | Hercules Capital, Inc.
Debt Instrument [Line Items]
Loan agreement, basis spread on variable rate				6.40%
Loan agreement, interest rate, stated percentage				9.65%
Percentage of prepayment of loan amount for year first				3%
Percentage of prepayment of loan amount for year second				2%
Percentage of prepayment of loan amount for year third				1%
Percentage of loan amount prepayment charge				6.95%
Extinguishment of debt, amount				$ 200,000
Loan Agreement | Hercules Capital, Inc. | First Amendment to Loan and Security Agreement
Debt Instrument [Line Items]
Loan agreement, basis spread on variable rate			6.20%
Loan agreement, interest rate, stated percentage			9.45%
Loan Agreement | Hercules Capital, Inc. | First Tranche
Debt Instrument [Line Items]
Loan amount					$ 30,000,000
Remaining loan amount					20,000,000
Percentage of aggregate amount of all loan advances payment				6.95%
End of term fee				$ 2,100,000
Loan Agreement | Hercules Capital, Inc. | First Tranche | First Amendment to Loan and Security Agreement
Debt Instrument [Line Items]
Remaining loan amount			$ 10,000,000
Loan Agreement | Hercules Capital, Inc. | Second Tranche
Debt Instrument [Line Items]
Loan amount					20,000,000
Loan Agreement | Hercules Capital, Inc. | Third Tranche
Debt Instrument [Line Items]
Loan amount					30,000,000
Loan Agreement | Hercules Capital, Inc. | Fourth Tranche
Debt Instrument [Line Items]
Loan amount					20,000,000
Loan Agreement | Hercules Capital, Inc. | Maximum
Debt Instrument [Line Items]
Loan amount					$ 100,000,000
Loan Agreement | Hercules Capital, Inc. | Minimum | First Amendment to Loan and Security Agreement
Debt Instrument [Line Items]
Loan amount			$ 40,000,000
Second Amendment
Debt Instrument [Line Items]
Percentage of net product revenue				65%
Debt instrument minimum revenue of covenant market capitalization amount				$ 750,000,000
Debt instrument, covenant, unrestricted cash balance, percenatge				50%
Debt instrument percentage of unrestricted cash				100%
Second Amendment | Hercules Capital, Inc.
Debt Instrument [Line Items]
Loan agreement, basis spread on variable rate		5.90%
Loan agreement, interest rate, stated percentage		9.15%
Percentage of prepayment of loan amount for year first		3%
Percentage of prepayment of loan amount for year second		2%
Percentage of prepayment of loan amount for year third		1%
Percentage of loan amount prepayment charge		6.75%
Second Amendment | Hercules Capital, Inc. | First Tranche
Debt Instrument [Line Items]
Loan amount		$ 100,000,000
Remaining loan amount		$ 25,000,000
Percentage of aggregate amount of all loan advances payment		6.75%
End of term fee		$ 2,100,000
Debt instrument additional borrowing amount		45,000,000
Second Amendment | Hercules Capital, Inc. | Second Tranche
Debt Instrument [Line Items]
Loan amount		20,000,000
Debt instrument available upon achievement of net product revenue		$ 50,000,000
Debt instrument trailing net product revenue		6 months
Second Amendment | Hercules Capital, Inc. | Third Tranche
Debt Instrument [Line Items]
Loan amount		$ 15,000,000
Second Amendment | Hercules Capital, Inc. | Fourth Tranche
Debt Instrument [Line Items]
Loan amount		15,000,000
Second Amendment | Hercules Capital, Inc. | Maximum
Debt Instrument [Line Items]
Loan amount		$ 150,000,000
Third Amendment
Debt Instrument [Line Items]
Loan amount	$ 25,000,000
Percentage of net product revenue	80%
Debt instrument minimum revenue of covenant market capitalization amount	$ 750,000,000
Debt instrument, covenant, unrestricted cash balance, percenatge	50%
Debt instrument percentage of unrestricted cash	100%

Loan Payable - Schedule Future

Loan Payable - Schedule Future Principal Payments Due Under Loan Agreement Excluding Interest (Details)	9 Months Ended
	Sep. 30, 2022 USD ($)
Debt Disclosure [Abstract]
2022	$ 0
2023	0
2024	2,776,000
2025	35,495,000
2026	36,729,000
Total principal outstanding	75,000,000
End of term charge	2,313,000
Unamortized debt issuance costs	(755,000)
Total	$ 76,558,000

Stockholders' Equity - Addition

Stockholders' Equity - Additional Information (Details)				1 Months Ended
	Feb. 23, 2022 USD ($)	Jul. 02, 2021 USD ($)	Jun. 15, 2018 USD ($)	Feb. 09, 2021 USD ($) shares	Sep. 30, 2022 vote shares	Dec. 31, 2021 shares
Class Of Stock [Line Items]
Common stock, shares authorized (in shares)					120,000,000	120,000,000
Common stock, number of votes per share | vote					1
Undesignated preferred stock, shares authorized to issue					5,000,000
Preferred stock, shares issued (in shares)					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 | $		$ 150,000,000	$ 125,000,000
Proceeds from issuance of common stock | $				$ 86,400,000
Cowen And Company L L C | 2022 sales agreement
Class Of Stock [Line Items]
Maximum gross proceeds of common stock allowed from issuance and sell | $	$ 300,000,000
Cowen And Company L L C | Common stock | At the market offerings
Class Of Stock [Line Items]
Common stock, shares issued (in shares)				3,513,027
Cowen And Company L L C | Common stock | 2022 sales agreement
Class Of Stock [Line Items]
Proceeds from issuance of common stock | $	$ 100,000,000

Stockholders' Equity - Summary

Stockholders' Equity - Summary of Common Stock Shares Reserved for Future Issuance (Details) - shares	Sep. 30, 2022	Dec. 31, 2021
Class Of Stock [Line Items]
Common stock, shares reserved for future issuance (in shares)	10,399,973	8,888,353
Common stock options outstanding
Class Of Stock [Line Items]
Common stock, shares reserved for future issuance (in shares)	7,484,758	6,701,727
RSUs outstanding
Class Of Stock [Line Items]
Common stock, shares reserved for future issuance (in shares)	633,206	414,991
Options and RSUs available for grant under Equity Incentive Plans
Class Of Stock [Line Items]
Common stock, shares reserved for future issuance (in shares)	2,282,009	1,771,635

Stock-Based Compensation - Addi

Stock-Based Compensation - Additional Information (Details) - USD ($) $ in Millions		9 Months Ended
	Jan. 01, 2022	Sep. 30, 2022	Mar. 31, 2022	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		$ 25.7
Weighted-average recognition period		2 years 3 months 18 days
Restricted Stock Units (RSUs)
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Weighted-average recognition period		2 years 6 months
Number of common shares received upon vesting (in shares)		1
Unrecognized compensation cost		$ 6.1
2011 Equity Incentive Plan
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Number of shares available for grant under equity incentive plan (in shares)		0
2017 Equity Incentive Plan (in shares)
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Number of shares available for grant under equity incentive plan (in shares)		1,630,159
Number of shares approved for grant under equity incentive plan (in shares)				1,932,000
Number of additional shares approved for grant under equity incentive plan (in shares)	1,096,553
2021 Inducement Equity Incentive Plan (in shares) | Maximum
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Number of shares approved for grant under equity incentive plan (in shares)		500,000
2021 Sales Force Inducement Plan (in shares) | Maximum
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Number of shares approved for grant under equity incentive plan (in shares)		500,000
Amended and restated 2021 inducement equity incentive plan
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Number of shares available for grant under equity incentive plan (in shares)		651,850
Amended and restated 2021 inducement equity incentive plan | Maximum
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Number of shares approved for grant under equity incentive plan (in shares)			1,750,000
Additional number of shares reserved for future issuance under equity incentive plan (in shares)			750,000

Stock-Based Compensation - Summ

Stock-Based Compensation - Summary of Share-Based Compensation Expense Included in Statements of Operations (Details) - Employee and Non-employee Stock Options - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Total stock-based compensation expense	$ 4,785	$ 5,528	$ 16,189	$ 17,114
Cost of Goods Sold
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Total stock-based compensation expense	52	68	155	237
Research and Development
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Total stock-based compensation expense	980	1,142	3,149	3,775
Selling, General and Administrative
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Total stock-based compensation expense	$ 3,753	$ 4,318	$ 12,885	$ 13,102

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, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Expected volatility, minimum	79.10%	77.70%	76.70%	77.70%
Expected volatility, maximum	80.10%	78.40%	80.10%	79.60%
Weighted-average risk free rate, minimum	2.60%	0.90%	1.40%	0.40%
Weighted-average risk free rate, maximum	3.30%	1.10%	3.30%	1.20%
Dividend yield	0%	0%	0%	0%
Expected term (in years)	5 years 10 months 28 days	6 years 18 days	6 years	6 years

Stock-Based Compensation - Su_2

Stock-Based Compensation - Summary of Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended		9 Months Ended	12 Months Ended
	Sep. 30, 2021	Jun. 30, 2021	Sep. 30, 2022	Dec. 31, 2021
Options outstanding
Beginning balance (in shares)			6,701,727
Granted (in shares)			1,695,639
Cancelled (in shares)			(735,000)
Exercised (in shares)	(275,827)	(230,347)	(177,608)
Ending balance (in shares)			7,484,758	6,701,727
Exercisable (in shares)			4,377,489	3,660,578
Vested and expected to vest (in shares)			7,484,758	6,701,727
Weighted average exercise price
Beginning balance (in US dollars per share)			$ 17.88
Granted (in US dollars per share)			9.58
Cancelled (in US dollars per share)			20.09
Exercised (in US dollars per share)			0.82
Ending balance (in US dollars per share)			16.19	$ 17.88
Exercisable (in US dollars per share)			17.82	16.72
Vested and expected to vest (in US dollars per share)			$ 16.19	$ 17.88
Weighted average, Remaining contractual for life (Years)
Beginning, end of period			7 years 1 month 6 days	7 years 2 months 12 days
Exercisable			5 years 10 months 24 days	5 years 10 months 24 days
Vested and expected to vest			7 years 1 month 6 days	7 years 2 months 12 days
Weighted average, Aggregate intrinsic value
Balance			$ 15,909	$ 10,427
Exercisable			11,419	10,422
Vested and expected to vest			$ 15,909	$ 10,427

Stock-Based Compensation - Su_3

Stock-Based Compensation - Summary of Restricted Stock Units Activity (Details) - Restricted Stock Units (RSUs)	9 Months Ended
	Sep. 30, 2022 $ / shares shares
Number of RSUs
Beginning balance (in shares) | shares	414,991
Granted (in shares) | shares	468,631
Cancelled (in shares) | shares	(93,091)
Vested (in shares) | shares	(157,325)
Ending balance (in shares) | shares	633,206
Weighted-Average Fair Value per Share
Beginning balance (in US dollars per share) | $ / shares	$ 18.24
Granted (in US dollars per share) | $ / shares	9.30
Cancelled (in US dollars per share) | $ / shares	12.34
Vested (in US dollars per share) | $ / shares	18.58
Ending balance (in US dollars per share) | $ / shares	$ 12.40

License Revenue - Additional In

License Revenue - Additional Information (Details) - USD ($)					9 Months Ended	12 Months Ended
	Aug. 03, 2020	Jul. 22, 2020	Jun. 15, 2020	May 22, 2020	Sep. 30, 2022	Dec. 31, 2021	Dec. 31, 2020
Incyclix Bio, LLC
Revenue Recognition Multiple Deliverable Arrangements [Line Items]
Upfront payment received				$ 1,000,000
Percentage of equity interest received as consideration				10%
Value of equity interest received				$ 1,100,000
Milestone payments receivable				2,000,000
License revenue recognized				$ 2,100,000	$ 0
Equity interest				10%
Genor Biopharma Co. Inc.
Revenue Recognition Multiple Deliverable Arrangements [Line Items]
Milestone payments receivable			$ 40,000,000
License revenue recognized			6,000,000			$ 3,000,000
Non-refundable, upfront payment			$ 6,000,000
Milestone revenue recognized					0
EQRx Inc.
Revenue Recognition Multiple Deliverable Arrangements [Line Items]
Upfront payment received		$ 20,000,000
Milestone payments receivable		290,000,000
License revenue recognized		$ 20,000,000
Typical payment terms on invoice payment		30 days
Number of days due from invoice date		30 days
Revenue recognized for reimbursement of clinical trials costs					1,900,000
Nanjing Simcere Dongyuan Pharmaceutical Co., Ltd
Revenue Recognition Multiple Deliverable Arrangements [Line Items]
Upfront payment received	$ 14,000,000						$ 14,000,000
Milestone payments receivable	$ 156,000,000
License revenue recognized						$ 8,000,000
Milestone revenue recognized					14,000,000
Revenue recognized for reimbursement of clinical trials costs					1,900,000
Revenue recognized for reimbursement of license revenue supply					$ 400,000

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, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items]
Total potential dilutive shares	8,450,176	7,369,223	8,392,951	7,623,926
Stock Options Issued and Outstanding
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items]
Total potential dilutive shares	7,800,293	6,892,488	7,766,062	7,162,589
Restricted Stock Units (RSUs)
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items]
Total potential dilutive shares	649,883	476,735	626,889	461,337

Income Taxes - Additional Infor

Income Taxes - Additional Information (Details) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Income Tax Contingency [Line Items]
Effective tax rate	(5.10%)	(0.80%)	(1.10%)	(0.60%)
Income tax expense (benefit)	$ 1,219,000	$ 321,000	$ 1,219,000	$ 679,000
U.S.
Income Tax Contingency [Line Items]
Income tax expense (benefit)			$ 0

Related Party Transactions - Ad

Related Party Transactions - Additional Information (Details) $ in Millions	9 Months Ended
	Sep. 30, 2022 USD ($)
Senior Advisor Agreement | Member of Board of Directors
Related Party Transaction [Line Items]
Service payment	$ 0.2

Subsequent Events (Details)

Subsequent Events (Details) - Fourth Amendment - Subsequent Event $ in Millions	Nov. 01, 2022 USD ($)
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Loan amount	$ 75
Debt instrument additional borrowing amount	25
Outstanding Debt Less Than Or Equal To 75.0 Million
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Debt instrument, covenant, outstanding debt threshold	$ 75
Debt instrument, covenant, unrestricted cash balance, percenatge	65%
Outstanding Debt Greater Than 75.0 Million
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Debt instrument, covenant, outstanding debt threshold	$ 75
Debt instrument, covenant, unrestricted cash balance, percenatge	70%
Achievement Of Net Revenue Milestones
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Debt instrument, covenant, unrestricted cash balance, percenatge	45%