0001628280-23-035947 | 10-Q | XBRL Viewer

Inventories

9 Months Ended

Sep. 30, 2023

Inventories consist of the following (in thousands):


	September 30, 2023		December 31, 2022
Raw materials	$	2,891	$	2,790
Work in process	9,541		10,153
Finished goods	1,059		3,236
Inventories, net	$	13,491	$	16,179

The Company uses third party contract manufacturing organizations for the production of its raw materials, active pharmaceutical ingredients, and finished drug product which the Company owns. The Company evaluates the risk of excess inventory and product expiry by evaluating current and future product demand relative to product shelf life. Inventory balances above are presented net of inventory reserves totaling $1.9 million and $0.1 million as of September 30, 2023 and December 31, 2022, respectively.

Net Loss Per Common Share (Details) - shares	3 Months Ended		9 Months Ended
Net Loss Per Common Share (Details) - shares	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Total potential dilutive shares	9,325,522	8,450,176	9,315,172	8,392,951
Stock options issued and outstanding
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Total potential dilutive shares	7,287,279	7,800,293	7,685,855	7,766,062
Restricted Stock Units (RSUs)
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Total potential dilutive shares	1,769,793	649,883	1,393,671	626,889
Performance Shares
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Total potential dilutive shares	218,450	0	216,049	0
Deferred Shares
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Total potential dilutive shares	50,000	0	19,597	0

Stockholders' Equity - Narrative (Details) $ / shares in Units, $ in Millions	Dec. 20, 2022 USD ($) shares	Nov. 17, 2022 USD ($) $ / shares shares	Feb. 23, 2022 USD ($)	Jul. 02, 2021 USD ($)	Sep. 30, 2023 vote shares	Dec. 31, 2022 shares
Class of Stock [Line Items]
Common stock, shares authorized (in shares)					120,000,000	120,000,000
Common stock, number of votes per share \| vote					1
Undesignated preferred stock, shares authorized to issue					5,000,000
Preferred stock, shares outstanding (in shares)					0
Preferred stock, shares issued (in shares)					0
2021 Sales Agreement
Class of Stock [Line Items]
Maximum gross proceeds of common stock allowed from issuance and sell \| $				$ 150.0
Common stock
Class of Stock [Line Items]
Common stock, shares authorized (in shares)					120,000,000
Cowen And Company L L C \| 2022 Sales Agreement
Class of Stock [Line Items]
Maximum gross proceeds of common stock allowed from issuance and sell \| $			$ 300.0
Proceeds from issuance of common stock \| $	$ 55.7	$ 50.1	$ 100.0
Sale of stock, number of shares issued in transaction	8,573,353	7,700,000
Sale of stock, price per share \| $ / shares		$ 6.50
Consideration received on transaction \| $	$ 52.0
Cowen And Company L L C \| Over-Allotment Option
Class of Stock [Line Items]
Sale of stock, number of shares issued in transaction		873,353

Accrued Expenses

9 Months Ended

Sep. 30, 2023

Payables and Accruals [Abstract]

Accrued Expenses

Accrued ExpensesAccrued expenses are comprised as follows (in thousands):


	September 30, 2023		December 31, 2022
Accrued external research	$	110	$	268
Accrued professional fees and other	5,692		4,304
Accrued external clinical study costs	14,702		15,566
Accrued compensation expense	3,677		5,419
Accrued expenses	$	24,181	$	25,557

Fair Value of Financial Instruments

9 Months Ended

Sep. 30, 2023

Fair Value Disclosures [Abstract]

Fair Value of Financial Instruments

The Company provides disclosure of financial assets and financial liabilities that are carried at fair value based on the price that would be received upon sale of an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. Fair value measurements may be classified based on the amount of subjectivity associated with the inputs to fair valuation of these assets and liabilities using the following three levels:


Level 1						Inputs are unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date.

Level 2						Inputs include quoted prices for similar assets and liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, inputs other than quoted prices that are observable for the asset or liability and inputs that are derived principally from or corroborated by observable market data by correlation or other means.

Level 3						Unobservable inputs that reflect the Company’s estimates of the assumptions that market participants would use in pricing the asset or liability. The Company develops these inputs based on the best information available, including its own data.

The carrying amounts of cash, cash equivalents, accounts payable and accrued liabilities approximate fair value because of their short-term nature.

At September 30, 2023 and December 31, 2022, these financial instruments and respective fair values have been classified as follows (in thousands):


	Quoted prices in active markets for identical assets (Level 1)		Significant other observable inputs (Level 2)		Significant other unobservable inputs (Level 3)		Balance at September 30, 2023
Assets:
Money market funds	$	52,314	$	—	$	—	$	52,314
Marketable securities:
U.S. Treasury Bills	41,729		—		—		41,729
Total assets at fair value	$	94,043	$	—	$	—	$	94,043


	Quoted prices in active markets for identical assets (Level 1)		Significant other observable inputs (Level 2)		Significant other unobservable inputs (Level 3)		Balance at December 31, 2022
Assets:
Money market funds	$	84,167	$	—	$	—	$	84,167
Marketable securities:
U.S. Treasury Bills	50,476		—		—		50,476
Total assets at fair value	$	134,643	$	—	$	—	$	134,643

During the three and nine months ended September 30, 2023, and the year ended December 31, 2022, there were no changes in valuation methodology.

The Loan Payable (discussed in Note 7) has a variable interest rate and is carried at amortized cost, which approximates its fair value that is determined using Level 3 inputs. As of September 30, 2023, the carrying value was $51.2 million.

- Definition

The entire disclosure for the fair value of financial instruments (as defined), including financial assets and financial liabilities (collectively, as defined), and the measurements of those instruments as well as disclosures related to the fair value of non-financial assets and liabilities. Such disclosures about the financial instruments, assets, and liabilities would include: (1) the fair value of the required items together with their carrying amounts (as appropriate); (2) for items for which it is not practicable to estimate fair value, disclosure would include: (a) information pertinent to estimating fair value (including, carrying amount, effective interest rate, and maturity, and (b) the reasons why it is not practicable to estimate fair value; (3) significant concentrations of credit risk including: (a) information about the activity, region, or economic characteristics identifying a concentration, (b) the maximum amount of loss the entity is exposed to based on the gross fair value of the related item, (c) policy for requiring collateral or other security and information as to accessing such collateral or security, and (d) the nature and brief description of such collateral or security; (4) quantitative information about market risks and how such risks are managed; (5) for items measured on both a recurring and nonrecurring basis information regarding the inputs used to develop the fair value measurement; and (6) for items presented in the financial statement for which fair value measurement is elected: (a) information necessary to understand the reasons for the election, (b) discussion of the effect of fair value changes on earnings, (c) a description of [similar groups] items for which the election is made and the relation thereof to the balance sheet, the aggregate carrying value of items included in the balance sheet that are not eligible for the election; (7) all other required (as defined) and desired information.

+ References + Details

Stock-Based Compensation - Narrative (Details) - USD ($) $ in Thousands		9 Months Ended
	Jan. 01, 2023	Sep. 30, 2023	Mar. 31, 2022	Sep. 30, 2021	Feb. 28, 2021	May 31, 2017
Employee Stock Options
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Stock options, maximum term		10 years
Unrecognized stock-based compensation costs		$ 12,500
Weighted-average recognition period		2 years
Restricted Stock Units (RSUs)
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Weighted-average recognition period		2 years 3 months 18 days
Number of common shares received upon vesting (in shares)		1
Unrecognized compensation cost		$ 6,700
Performance Shares
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Weighted-average recognition period		2 years 3 months 18 days
Number of common shares received upon vesting (in shares)		1
Unrecognized compensation cost		$ 1,300
Deferred Shares
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Weighted-average recognition period		8 months 12 days
Number of common shares received upon vesting (in shares)		1
Unrecognized compensation cost		$ 100
2011 Equity Incentive Plan
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Number of shares available for grant under equity incentive plan (in shares)		0
2017 Equity Incentive Plan
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Number of shares available for grant under equity incentive plan (in shares)		1,278,194
Number of shares approved for grant under equity incentive plan (in shares)						1,932,000
Number of additional shares approved for grant under equity incentive plan (in shares)	1,096,553
2021 Sales Force Inducement Plan \| Maximum
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Number of shares approved for grant under equity incentive plan (in shares)				500,000	500,000
Amended And Restated 2021 Inducement Equity Incentive Plan
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Number of shares available for grant under equity incentive plan (in shares)		832,669
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

Condensed Balance Sheets (unaudited) (Parenthetical) - $ / shares	Sep. 30, 2023	Dec. 31, 2022
Statement of Financial Position [Abstract]
Common stock, par value (in US dollars per share)	$ 0.0001	$ 0.0001
Common stock, shares authorized (in shares)	120,000,000	120,000,000
Common stock, shares issued (in shares)	51,836,544	51,526,100
Common stock, shares outstanding (in shares)	51,809,878	51,499,434
Treasury stock, common, shares (in shares)	26,666	26,666

Property and Equipment

9 Months Ended

Sep. 30, 2023

Property, Plant and Equipment [Abstract]

Property and Equipment

Property and equipment consists of the following (in thousands):


	September 30, 2023		December 31, 2022
Computer equipment	$	327	$	327
Laboratory equipment	334		334
Furniture and fixtures	866		866
Leasehold improvements	1,782		1,782
Manufacturing equipment	506		506
Accumulated depreciation	(2,215)		(1,826)
Property and equipment, net	$	1,600	$	1,989

Depreciation expenses relating to property and equipment were $127 thousand and $389 thousand for the three and nine months ended September 30, 2023, respectively, and $139 thousand and $393 thousand for the three and nine months ended September 30, 2022, respectively.

Loan Payable

9 Months Ended

Sep. 30, 2023

Debt Disclosure [Abstract]

Loan Payable

On May 29, 2020, the Company entered into a loan and security agreement (the “Loan Agreement”) with Hercules Capital, Inc. (“Hercules”), under which Hercules agreed to lend the Company up to $100.0 million, to be made available in a series of tranches, subject to certain terms and conditions. The first tranche totals $30.0 million, of which the Company received $20.0 million at closing. Upon initiation of the Phase 3 trial of COSELA for metastatic colorectal cancer and receiving FDA approval for COSELA for small cell lung cancer (the "Performance Milestone”), the second tranche of $20.0 million became available to the Company for drawdown through December 15, 2021. The third tranche of $30.0 million was available through December 31, 2022. The fourth tranche of $20.0 million was available at Hercules’ approval through December 31, 2022. On March 31, 2021, the Company entered into the First Amendment to Loan and Security Agreement (the “First Amendment”) with Hercules whereby the Company drew the remaining $10.0 million of the first tranche and the interest rate and financial covenants were amended. Unless loan advances exceeded $40.0 million, no financial covenants were required.

Amounts initially borrowed under the original terms of the Loan Agreement bore an interest rate equal to the greater of either (i) (a) the prime rate as reported in The Wall Street Journal, plus (b) 6.40%, and (ii) 9.65%. Based on original terms of the Loan Agreement, the Company agreed to make interest only payments through June 1, 2022 and following the interest only period, the Company agreed to repay the principal balance and interest of the advances in equal monthly installments through June 1, 2024. Based on the original terms of the Loan Agreement, upon satisfaction of the Performance Milestone, the interest only period was extended through January 1, 2023 and the maturity date was extended to June 1, 2025. Upon entering into the First Amendment on March 31, 2021, the interest rate was amended to the greater of either (i) (a) the prime rate as reported in The Wall Street Journal, plus (b) 6.20%, and (ii) 9.45%.

The Company may prepay advances under the Loan Agreement, in whole or in part, at any time subject to a prepayment charge equal to (a) 3.0% of the prepayment amount in the first year; (b) 2.0% of the prepayment amount in the second year; and (c) 1.0% of the prepayment amount in the third year.

Upon prepayment or repayment of all or any of the advances under the Loan Agreement, the Company agreed to pay (in addition to the prepayment charge) an end of term charge of 6.95% of the aggregate funded amount. With respect to the first tranche, the end of term charge of $2.1 million would be payable upon any prepayment or repayment. To the extent that the Company was provided additional advances under the Loan Agreement, the 6.95% end of term charge would be applied to such additional amounts. These amounts have been accrued over the term of the loan using effective-interest method.

On November 1, 2021, the Company entered into a Second Amendment to Loan and Security Agreement (the “Second Amendment”) under which Hercules agreed to lend the Company up to $150.0 million, to be made available in a series of tranches, subject to certain terms and conditions. The first tranche was increased to $100.0 million. At close of the Second Amendment, the Company borrowed an additional $45.0 million from the first tranche. The Company had the right to request that Hercules make the remaining $25.0 million term loan advances under the first tranche to the Company by September 15, 2022, which the Company did not exercise. The second tranche of $20.0 million will become available to the Company upon achievement of $50.0 million trailing six-month net product revenue of COSELA no later than June 30, 2023 and will be available through December 15, 2023. The third tranche of $15.0 million will become available upon achievement of certain development performance milestones and available through December 15, 2023. The fourth tranche of $15.0 million will be available at Hercules’ approval through June 30, 2024.

Amounts borrowed under the Second Amendment bore an interest rate equal to the greater of either (i) (a) the prime rate as reported in The Wall Street Journal, plus (b) 5.90%, and (ii) 9.15%. The Company will make interest only payments through December 1, 2024 and may be extended through December 1, 2025, in quarterly increments, subject to compliance with covenants of the Second Amendment. Following the interest only period, the Company will repay the principal balance and interest of the advances in equal monthly installments through November 1, 2026.

The Company may prepay advances under the Second Amendment, in whole or in part, at any time subject to a prepayment charge equal to (a) 3.0% of the prepayment amount in the first year from the closing of the Second Amendment; (b) 2.0% of the prepayment amount in the second year from the closing of the Second Amendment; and (c) 1.0% of the prepayment amount in the third year from the closing of the Second Amendment.

Upon prepayment or repayment of all or any of the advances under the Second Amendment, the Company will pay (in addition to the prepayment charge) an end of term charge of 6.75% of the aggregate amount funded. The Company will be required to make a final payment to Hercules in the amount of 6.75% of the amounts funded, less any amount previously paid. In addition, the Company will be required to make a payment to Hercules for $2.1 million on the earliest occurrence of (i) June 1, 2025, (ii) the date the Company repays the outstanding principal amount in full, or (iii) the date that the principal amount becomes due and payable in full.

The Second Amendment is secured by substantially all of the Company’s assets, including intellectual property, subject to certain exemptions. The Company out-licensed lerociclib as permitted in the Loan Agreement.

The Second Amendment contains a minimum revenue covenant. Beginning August 15, 2022, with the reporting of the financial results for the second fiscal quarter ended June 30, 2022, and tested monthly, the Company must have achieved net product revenue of COSELA of at least 65% of the amounts projected in the Company’s forecast. Testing of the minimum revenue covenant shall be waived at any time in which either (a) the Company’s market capitalization exceeds $750.0 million and the Company maintains unrestricted cash equal to at least 50% of the total amounts funded, or (b) the Company maintains unrestricted cash equal to at least 100% of the total amounts funded.

The Company evaluated the Second Amendment under the guidance found in ASC 470-50 Modification and Extinguishment. The Company concluded that the previous debt under the Loan Agreement was extinguished based on the difference in present value of the cash flows of the Loan Agreement and the Second Amendment. Accordingly, the difference between the carrying value of the Loan Agreement as of November 1, 2021, including the unamortized debt issuance costs, and the fair value of the Second Amendment was recorded as a $0.2 million loss on extinguishment of debt for the twelve months ended December 31, 2021. Fees paid to third parties directly related to the funded portion of the Second Amendment have been capitalized as debt issuance costs and will be amortized to interest expense over the life of the Second Amendment using the effective interest method. Fees paid that were directly related to the unfunded portion is accounted for as a deferred financing charge and amortized to interest expense over the period the unfunded portions are available. The end of term charges associated with the Second Amendment are being accreted through interest expense using the effective interest method over the related term of the debt.

On June 24, 2022, the Company entered into a Third Amendment to Loan and Security Agreement (the “Third Amendment”) with Hercules, which extended the time for drawing the remainder of the first tranche advance of up to $25.0 million from September 15, 2022 to December 31, 2022, which the Company did not exercise. The Third Amendment also added a minimum cash covenant whereby the Company must maintain unrestricted cash equal to at least 50% of the outstanding debt, and such percentage shall decrease upon the Company achieving specified net product revenue of COSELA. It further provided for a minimum revenue covenant that, beginning August 15, 2022 with the reporting of the financial results for the second fiscal quarter ended June 30, 2022, and tested monthly, the Company must have achieved net product revenue of COSELA of at least 80% of the amounts projected in the Company’s forecast. Testing of the minimum revenue covenant shall be waived at any time in which either (a) the Company’s market capitalization exceeds $750.0 million and the Company maintains unrestricted cash equal to at least 50% of the total amounts funded, or (b) the Company maintains unrestricted cash equal to at least 100% of the total amounts funded. The Company evaluated the Third Amendment under the guidance found in ASC 470-50 Modification and Extinguishment. The Company concluded that the Third Amendment was a modification and there was no impact to the financial statements.

On November 1, 2022, the Company entered into a Fourth Amendment to Loan and Security Agreement (the “Fourth Amendment”) with Hercules, which extended the time for drawing the remainder of the first tranche advance of up to $25.0 million from December 31, 2022 to June 30, 2023. The Fourth Amendment continued to provide for a minimum revenue covenant, tested monthly, where the Company must achieve net product revenue of COSELA of at least 80% of the amounts projected in the Company's forecast. The Fourth Amendment also amended the minimum cash covenant such that if the outstanding debt is less than or equal to $75.0 million, the Company must maintain unrestricted cash equal to at least 65% of the outstanding debt in addition to meeting the required revenue covenant. In addition, if the outstanding debt is greater than $75.0 million, the Company must maintain unrestricted cash equal to at least 70% of the outstanding debt while meeting the revenue covenant. If the Company achieves the specified net revenue of COSELA, the cash percentage will decrease to 45% of the outstanding debt. Testing of the minimum revenue covenant shall be waived at any time in which either (a) the Company's market capitalization exceeds $750.0 million and the Company maintains unrestricted cash equal to at least 50% of the total amounts funded, or (b) the Company maintains unrestricted cash equal to at least 100% of the total amounts funded. The Fourth Amendment also re-set the prepayment premiums associated with any prepayment of the loans under the Loan Agreement. The Company evaluated the Fourth Amendment under the guidance found in ASC 470-50 Modification and Extinguishment. The Company concluded that the Fourth Amendment was a modification and there was no impact to the financial statements.

On June 6, 2023, the Company entered into a Fifth Amendment to Loan and Security Agreement (the “Fifth Amendment”) with Hercules, under which Hercules agreed to lend the Company up to $75.0 million, subject to specified conditions. In conjunction with the closing of the Fifth Amendment, the Company repaid $25.0 million of the outstanding debt such that the total loan amount outstanding upon closing of the Fifth Amendment is $50.0 million. In addition to the $25.0 million principal prepayment, upon closing of the Fifth Amendment, the Company made a $1.7 million pro-rata payment of the end-of-term charge. The Company continues to be required to make a payment to Hercules for $2.1 million on the earliest occurrence of (i) June 1, 2025, (ii) the date the Company repays the outstanding principal amount in full, or (iii) the date that the principal amount becomes due and payable in full.

The Fifth Amendment eliminated advances under Tranches 2 and 3 and increased the advance available under Tranche 4 from $15.0 million to $25.0 million and extended the time for drawing the Tranche 4 Advance (as defined in the Loan and Security Agreement) from June 30, 2024 to December 15, 2024.

Amounts borrowed under the Fifth Amendment will bear an interest rate equal to the greater of either (i) (a) the prime rate as reported in The Wall Street Journal, plus (b) 5.65%, and (ii) 9.15% The Company will make interest only payments through December 1, 2024 and may be extended through December 1, 2025, in quarterly increments, subject to conditional borrowing base compliance. Following the interest only period, the Company will repay the principal balance and interest of the advances in equal monthly installments through November 1, 2026.

The Company may prepay advances under the Fifth Amendment, in whole or in part, at any time subject to a prepayment charge equal to (a) 3.0% of the prepayment amount in the first year from the effective date of the Fourth Amendment; (b) 2.0% of the prepayment amount in the second year from the effective date of the Fourth Amendment; and (c) 1.0% of the prepayment amount in the third year from the effective date of the Fourth Amendment. For the avoidance of doubt, no prepayment charge shall be applicable when repayments are required to maintain compliance with the conditional borrowing base limit as discussed below.

The Fifth Amendment amended the minimum cash covenant such that the Company must maintain unrestricted cash equal to at least 35% of the outstanding debt at all times. The minimum cash covenant shall be eliminated upon the Company's achievement of quarterly net product revenue of $45.0 million or trailing six months net product revenue of $85.0 million.

The Fifth Amendment removed the existing minimum revenue covenant and provided for a conditional borrowing base limit, beginning with the financial reporting for the period ended June 30, 2023, and tested monthly thereafter. The Fifth Amendment also provides that the Company’s debt outstanding shall not exceed certain thresholds of trailing three month net product revenue of COSELA.

The Company evaluated the Fifth Amendment under the guidance found in ASC 470-50 Modification and Extinguishment. The Company concluded that the Fifth Amendment was a modification; accordingly, no gain or loss was recorded. A new effective interest rate was established based on the carrying value of the debt and the revised cash flows. The remaining end of term charges will be accreted through interest expense through the maturity date using the updated effective interest rate. The borrowing capacity of the new arrangement is less than the old arrangement. As such, the existing unamortized deferred financing costs of the new arrangement were written off in proportion to the decrease in the borrowing capacity of the unfunded portion of the arrangement. The remaining unamortized deferred financing costs will be amortized to interest expense and deferred over the commitment term of the new arrangement.

The Loan Agreement contains events of default, including a material adverse change, which is subjectively defined, in the Company’s business, payment defaults, and breaches of covenants following any applicable cure period. In the event of default by the Company under the Loan Agreement, the Company may be required to repay all amounts then outstanding under the Loan Agreement. The Company has determined that subjective acceleration under the material adverse events clause included in the Loan Agreement is not probable and, therefore, has classified the outstanding principal amount in long-term liabilities based on the timing of scheduled principal payments.

As of September 30, 2023, the outstanding debt of $50.0 million does not exceed the required threshold of trailing three month revenue for the period ended September 30, 2023. Additionally, as of September 30, 2023 the Company maintained unrestricted cash equal to more than 35% of the total outstanding debt and has not been notified of an event of default by the lender under the Loan Agreement.

The Company recognized $2.1 million and $7.9 million of interest expense related to the debt for the three and nine months ended September 30, 2023, respectively, and $2.8 million and $7.4 million for the three and nine months ended September 30, 2022, respectively. Interest expense is reflected in other income (expense), net on the statement of operations.

As of September 30, 2023, the future principal payments due under the Loan Agreement, excluding interest, are as follows (in thousands):


	Amount
2023	$	—
2024	1,819
2025	23,469
2026	24,712
Total principal outstanding	50,000
End of term charge	1,759
Unamortized debt issuance costs	(513)
Total	$	51,246

- Definition

The entire disclosure for information about short-term and long-term debt arrangements, which includes amounts of borrowings under each line of credit, note payable, commercial paper issue, bonds indenture, debenture issue, own-share lending arrangements and any other contractual agreement to repay funds, and about the underlying arrangements, rationale for a classification as long-term, including repayment terms, interest rates, collateral provided, restrictions on use of assets and activities, whether or not in compliance with debt covenants, and other matters important to users of the financial statements, such as the effects of refinancing and noncompliance with debt covenants.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1B
-Subparagraph (h)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481139/470-20-50-1B

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 235
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(c))
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480678/235-10-S99-1

Reference 3: http://fasb.org/us-gaap/role/ref/legacyRef
-Topic 470
-Name Accounting Standards Codification
-Publisher FASB
-URI https://asc.fasb.org//470/tableOfContent

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1B
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481139/470-20-50-1B

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1B
-Subparagraph (g)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481139/470-20-50-1B

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1B
-Subparagraph (i)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481139/470-20-50-1B

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1C
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481139/470-20-50-1C

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1C
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481139/470-20-50-1C

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1C
-Subparagraph (c)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481139/470-20-50-1C

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1E
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481139/470-20-50-1E

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1I
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481139/470-20-50-1I

Reference 12: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1I
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481139/470-20-50-1I

Reference 13: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1I
-Subparagraph (d)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481139/470-20-50-1I

+ Details

Condensed Statements of Operations (unaudited) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Revenues [Abstract]
Total revenues	$ 12,300	$ 23,576	$ 67,638	$ 41,051
Operating Expenses [Abstract]
Cost of goods sold	3,076	1,111	5,939	2,756
Research and development	8,811	19,581	36,331	66,729
Selling, general and administrative	16,781	24,432	55,966	76,857
Total operating expenses	28,668	45,124	98,236	146,342
Loss from operations	(16,368)	(21,548)	(30,598)	(105,291)
Other income (expense)
Interest income	585	211	1,944	270
Interest expense	(2,115)	(2,764)	(7,914)	(7,436)
Other income (expense)	599	48	1,692	(234)
Total other income (expense), net	(931)	(2,505)	(4,278)	(7,400)
Loss before income taxes	(17,299)	(24,053)	(34,876)	(112,691)
Income tax expense	905	1,219	2,213	1,219
Net loss	$ (18,204)	$ (25,272)	$ (37,089)	$ (113,910)
Earnings Per Share [Abstract]
Basic (in usd per share)	$ (0.35)	$ (0.59)	$ (0.72)	$ (2.67)
Diluted (in usd per share)	$ (0.35)	$ (0.59)	$ (0.72)	$ (2.67)
Weighted Average Common Shares Outstanding [Abstract]
Basic (in shares)	51,777,731	42,799,342	51,697,989	42,731,826
Diluted (in shares)	51,777,731	42,799,342	51,697,989	42,731,826
Product sales, net
Revenues [Abstract]
Total revenues	$ 10,839	$ 8,269	$ 32,422	$ 22,467
License revenue
Revenues [Abstract]
Total revenues	$ 1,461	$ 15,307	$ 35,216	$ 18,584

Fair Value of Financial Instruments (Details) - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]
U.S. Treasury Bills	$ 41,729	$ 50,476
Total assets at fair value	94,043	134,643
Loan payable	51,246	77,015
Quoted prices in active markets for identical assets (Level 1)
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]
U.S. Treasury Bills	41,729	50,476
Total assets at fair value	94,043	134,643
Significant other observable inputs (Level 2)
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]
U.S. Treasury Bills	0	0
Total assets at fair value	0	0
Significant other unobservable inputs (Level 3)
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]
U.S. Treasury Bills	0	0
Total assets at fair value	0	0
Loan payable	51,200
Money Market Funds
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]
Money market funds	52,314	84,167
Money Market Funds \| Quoted prices in active markets for identical assets (Level 1)
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]
Money market funds	52,314	84,167
Money Market Funds \| Significant other observable inputs (Level 2)
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]
Money market funds	0	0
Money Market Funds \| Significant other unobservable inputs (Level 3)
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]
Money market funds	$ 0	$ 0

Property, Plant, and Equipment - Narrative (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Property, Plant and Equipment [Abstract]
Depreciation expenses relating to property and equipment	$ 127	$ 139	$ 389	$ 393

Description of Business	9 Months Ended
Description of Business	Sep. 30, 2023
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Description of Business	Description of BusinessG1 Therapeutics, Inc. (the “Company”) is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel small molecule therapeutics for the treatment of patients with cancer. The Company's first product approved by the U.S. Food and Drug Administration (“FDA”), COSELA® (trilaciclib), is the first and only therapy indicated to proactively help protect bone marrow from the damage of chemotherapy (myeloprotection) in patients with extensive-stage small cell lung cancer (“ES-SCLC”), and is the first innovation in managing myeloprotection in decades. In July 2022, COSELA (trilaciclib hydrochloride for injection) was conditionally approved by the China National Medical Products Administration (NMPA) for marketing in mainland China. The Company is also exploring the potential use of trilaciclib in certain cancers, focused in the core areas of metastatic triple negative breast cancer (“mTNBC”) and treatment combinations with targeted chemotherapy medicines called antibody-drug conjugates (“ADCs”) including other indications.

License Revenue	9 Months Ended
License Revenue	Sep. 30, 2023
Revenue Recognition and Deferred Revenue [Abstract]
License Revenue	License Revenue Incyclix License Agreement On May 22, 2020, the Company entered into an exclusive license agreement with Incyclix Bio, LLC (“Incyclix”), formerly ARC Therapeutics, LLC, a company primarily owned by a former board member, whereby the Company granted to Incyclix an exclusive, worldwide, royalty-bearing license, with the right to sublicense, solely to make, have made, use, sell, offer for sale, import, export, and commercialize products related to its cyclin dependent kinase 2 (“CDK2”) inhibitor compounds. At close, the Company received consideration in the form of an upfront payment of $1.0 million and an equity interest in Incyclix equal to 10% of its issued and outstanding units valued at $1.1 million. In addition, the Company may receive a future development milestone payment totaling $2.0 million and royalty payments in the mid-single digits based on net sales of the licensed compound after commercialization. The Company has right of first negotiation to re-acquire these assets. In the first quarter of 2022, Incyclix announced a new round of financing which the Company did not participate. Following the financing, the Company's equity interest is now approximately 6.5%. The Company assessed the license agreement in accordance with ASC 606 and identified one performance obligation in the contract, which is the transfer of the license, as Incyclix can benefit from the license using its own resources. The Company recognized $2.1 million in license revenue consisting of the upfront payment and the 10% equity interest in Incyclix upon the effective date as the Company determined the license was a right to use the intellectual property and the Company had provided all necessary information to Incyclix to benefit from the license. The Company considers the future potential development milestone and sales-based royalties to be variable consideration. The development milestone is excluded from the transaction price because it determined the payment to be fully constrained under ASC 606 due to the inherent uncertainty in the achievement of such milestone due to factors outside of the Company’s control. As sales-based royalties are all related to the license of the intellectual property, the Company will recognize revenue in the period when subsequent sales are made pursuant to the sales-based royalty exception. The Company will re-evaluate the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur. There was no revenue recognized during the nine months ended September 30, 2023. Genor License Agreement On June 15, 2020, the Company entered into an exclusive license agreement with Genor Biopharma Co. Inc. (“Genor”) for the development and commercialization of lerociclib in the Asia-Pacific region, excluding Japan (the “Genor Territory”). Under the license agreement, the Company granted to Genor an exclusive, royalty-bearing, non-transferable license, with the right to grant sublicenses, to develop, obtain, hold and maintain regulatory approvals for, and commercialize lerociclib, in the Genor Territory. Under the license agreement, Genor agreed to pay the Company a non-refundable, upfront cash payment of $6.0 million with the potential to pay an additional $40.0 million upon reaching certain development and commercial milestones. In addition, Genor will pay the Company tiered royalties ranging from high single to low double-digits based on annual net sales of lerociclib in the Genor Territory. In September 2020, the Company transferred to Genor the related technology and know-how that is necessary to develop, seek regulatory approval for, and commercialize lerociclib in the Genor Territory, which resulted in the recognition of $6.0 million in revenue in accordance with ASC 606. Since then, through December 31, 2022, the Company had recognized an additional $3.0 million in revenue for the achievement of development and commercial milestones as defined by the license agreement. There was no milestone revenue recognized during the nine months ended September 30, 2023. EQRx License Agreement On July 22, 2020, the Company entered into an exclusive license agreement with EQRx, Inc. (“EQRx”) for the development and commercialization of lerociclib in the U.S., Europe, Japan and all other global markets, excluding the Asia-Pacific region (except Japan) (the “EQRx Territory”). Under the license agreement, the Company granted to EQRx an exclusive, royalty-bearing, non-transferable license, with the right to grant sublicenses, to develop, obtain, hold and maintain regulatory approvals for, and commercialize lerociclib in the EQRx Territory. Under the license agreement, EQRx agreed to pay the Company a non-refundable, upfront cash payment of $20.0 million with the potential to pay an additional $290.0 million upon reaching certain development and commercial milestones. In addition, EQRx would pay the Company tiered royalties ranging from mid-single digits to mid-teens based on annual net sales of lerociclib in the EQRx Territory. In September 2020, the Company transferred to EQRx the related technology and know-how that was necessary to develop, seek regulatory approval for, and commercialize lerociclib in the EQRx Territory which resulted in the recognition of $20.0 million in revenue in accordance with ASC 606. EQRx was responsible for the development of the product in the EQRx Territory. The Company agreed to continue until completion, as the clinical trial sponsor, its two primary clinical trials and EQRx agreed to reimburse the Company for all related out-of-pocket costs incurred after the effective date of the license agreement. On August 1, 2023, the Company received from EQRx formal notice of termination of the lerociclib license agreement in connection with the acquisition of EQRx by Revolution Medicines, Inc. The notice stated the intention to revert the lerociclib product rights back to the Company. Under the terms of the license agreement, EQRx is responsible for winding down its development activities. On September 13, 2023, the parties entered into a letter agreement whereby EQRx would pay the Company $1.6 million to reimburse anticipated wind down costs. The payment was received during the quarter ended September 30, 2023. No milestones were achieved through September 30, 2023, and as a result of the termination, the Company will not receive any further milestone payments or future royalties from EQRx. During the nine months ended September 30, 2023, the Company recognized revenue of $1.3 million for the reimbursement of patent and clinical trial costs. Of the $1.6 million payment received during the current quarter, $0.6 million is held as short-term deferred revenue on the condensed balance sheet as of September 30, 2023, and will be recognized as revenue when clinical trial costs associated with the wind down are incurred. Simcere License Agreement On August 3, 2020, the Company entered into an exclusive license agreement with Simcere for the development and commercialization of trilaciclib in all indications in Greater China (mainland China, Hong Kong, Macau, and Taiwan) (the “Simcere Territory”). Under the license agreement, the Company granted to Simcere an exclusive, royalty-bearing, non-transferable license, with the right to grant sublicenses, to develop, obtain, hold and maintain regulatory approvals for, and commercialize trilaciclib in the Simcere Territory. Since entering into the license agreement, the Company had received an upfront payment of $14.0 million and an additional $22.0 million for the achievement of development milestones through December 31, 2022. On April 28, 2023, the Company amended the license agreement with Simcere, whereby the Company received a one-time, non-refundable payment of $30.0 million in exchange for the relief of future royalty payments from the sale of COSELA in Greater China. In addition, the milestone payments under the license agreement were adjusted such that the Company will be eligible to receive a $5.0 million payment upon Simcere’s filing an NDA of TNBC in mainland China and a $13.0 million payment upon Simcere receiving regulatory approval of TNBC in mainland China. Under the amended license agreement, Simcere is not responsible for any sales milestone payments or any royalties accrued after April 28, 2023. Following the amendment, the Company continues to own all the global development and commercial rights to trilaciclib, excluding Greater China. During the nine months ended September 30, 2023, the Company recognized $30.0 million in revenue from the one-time payment for the relief of future royalty payments, $2.7 million in supply and manufacturing services, $0.6 million in royalty revenue, and $0.5 million in patent and clinical trial reimbursable costs.

- Definition

The entire disclosure of revenue from contract with customer to transfer good or service and to transfer nonfinancial asset. Includes, but is not limited to, disaggregation of revenue, credit loss recognized from contract with customer, judgment and change in judgment related to contract with customer, and asset recognized from cost incurred to obtain or fulfill contract with customer. Excludes insurance and lease contracts.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 9
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-URI https://asc.fasb.org//1943274/2147479806/606-10-50-9

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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Reference 3: http://www.xbrl.org/2003/role/disclosureRef
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Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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Reference 5: http://www.xbrl.org/2003/role/disclosureRef
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Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Name Accounting Standards Codification
-Topic 606
-Publisher FASB
-URI https://asc.fasb.org//606/tableOfContent

+ Details

Inventories (Details) - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022
Inventory Disclosure [Abstract]
Raw materials	$ 2,891	$ 2,790
Work in process	9,541	10,153
Finished goods	1,059	3,236
Inventories, net	13,491	16,179
Inventory reserves	$ 1,900	$ 100

Accrued Expenses (Details) - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022
Payables and Accruals [Abstract]
Accrued external research	$ 110	$ 268
Accrued professional fees and other	5,692	4,304
Accrued external clinical study costs	14,702	15,566
Accrued compensation expense	3,677	5,419
Accrued expenses	$ 24,181	$ 25,557

Cover - shares	9 Months Ended
Cover - shares	Sep. 30, 2023	Oct. 27, 2023
Cover [Abstract]
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Sep. 30, 2023
Current Fiscal Year End Date	--12-31
Document Transition Report	false
Entity File Number	001-38096
Entity Registrant Name	G1 THERAPEUTICS, INC.
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	26-3648180
Entity Address, Address Line One	700 Park Offices Drive
Entity Address, Address Line Two	Suite 200
Entity Address, City or Town	Research Triangle Park
Entity Address, State or Province	NC
Entity Address, Postal Zip Code	27709
City Area Code	919
Local Phone Number	213-9835
Title of 12(b) Security	Common Stock $.0001 par value
Trading Symbol	GTHX
Security Exchange Name	NASDAQ
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		51,843,669
Entity Central Index Key	0001560241
Amendment Flag	false
Document Fiscal Period Focus	Q3
Document Fiscal Year Focus	2023

Property and Equipment (Tables)

9 Months Ended

Sep. 30, 2023

Property, Plant and Equipment [Abstract]

Schedule of Property and Equipment

Property and equipment consists of the following (in thousands):


	September 30, 2023		December 31, 2022
Computer equipment	$	327	$	327
Laboratory equipment	334		334
Furniture and fixtures	866		866
Leasehold improvements	1,782		1,782
Manufacturing equipment	506		506
Accumulated depreciation	(2,215)		(1,826)
Property and equipment, net	$	1,600	$	1,989

Stockholders' Equity - Summary of Shares Reserved for Future Issuance (Details) - shares	Sep. 30, 2023	Dec. 31, 2022
Class of Stock [Line Items]
Common stock, shares reserved for future issuance (in shares)	11,157,082	10,370,973
Common stock options outstanding
Class of Stock [Line Items]
Common stock, shares reserved for future issuance (in shares)	7,073,702	7,372,028
Restricted Stock Unit Outstanding
Class of Stock [Line Items]
Common stock, shares reserved for future issuance (in shares)	1,704,067	675,406
Performance Share Unit Outstanding
Class of Stock [Line Items]
Common stock, shares reserved for future issuance (in shares)	218,450	0
Options, RSUs and PSUs Available For Grant Under Equity Incentive Plan
Class of Stock [Line Items]
Common stock, shares reserved for future issuance (in shares)	2,110,863	2,323,539
Deferred Shares
Class of Stock [Line Items]
Common stock, shares reserved for future issuance (in shares)	50,000	0

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

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Reference 1: http://www.xbrl.org/2003/role/exampleRef
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+ Details

Net Loss Per Common Share

9 Months Ended

Sep. 30, 2023

Earnings Per Share [Abstract]

Net Loss Per Common Share

Net Loss per Common Share

Basic net loss per common share is computed using the weighted average number of common shares outstanding during the period including nominal issuances of common stock warrants. Diluted net loss per common share is computed using the sum of the weighted average number of common shares outstanding during the period and, if dilutive, the weighted average number of potential shares of common stock, including the assumed exercise of stock options, stock warrants and unvested restricted common stock. For the three and nine months ended September 30, 2023 and 2022, 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,
	2023	2022	2023	2022
Stock options issued and outstanding	7,287,279	7,800,293	7,685,855	7,766,062
Unvested RSUs	1,769,793	649,883	1,393,671	626,889
Unvested PSUs	218,450	—	216,049	—
Unvested DSUs	50,000	—	19,597	—
Total potential dilutive shares	9,325,522	8,450,176	9,315,172	8,392,951

Amounts in the table above reflect the common stock equivalents of the noted instruments.

Related Party Transactions	9 Months Ended
Related Party Transactions	Sep. 30, 2023
Related Party Transactions [Abstract]
Related Party Transactions	Related Party Transactions On September 19, 2023, Mark A. Velleca, M.D., Ph.D., notified the Company of his decision to resign from the Company's Board of Directors, effective as of September 30, 2023. Dr. Velleca was a member of the Board since May 2014. Dr. Velleca’s decision to resign was not due to any disagreement with the Company on any matter relating to the Company’s operations, policies or practices. Dr. Velleca will continue to serve as a senior advisor to the Company pursuant to the terms of a Senior Advisor Agreement dated September 29, 2020 (the “Agreement”), as amended by that certain First Amendment to Senior Advisor Agreement, dated as of September 20, 2023 (the “Amendment”). Pursuant to the terms of the Agreement, Dr. Velleca was paid in equal quarterly installments, for his services, of which one final installment of $50,000 has not been paid as of September 30, 2023. Pursuant to the Amendment, the term of the Agreement has been extended from December 31, 2023 to December 31, 2024. Dr. Velleca will not receive any cash or equity compensation for his services during the period from January 1, 2024 through December 31, 2024 (the “Extended Term”), however any stock options held by Dr. Velleca will continue to vest in accordance with their terms during the Extended Term.

- Definition

The entire disclosure for related party transactions. Examples of related party transactions include transactions between (a) a parent company and its subsidiary; (b) subsidiaries of a common parent; (c) and entity and its principal owners; and (d) affiliates.

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+ Details

Property and Equipment - Schedule of Property and Equipment (Details) - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022
Property, Plant and Equipment [Line Items]
Accumulated depreciation	$ (2,215)	$ (1,826)
Property and equipment, net	1,600	1,989
Computer equipment
Property, Plant and Equipment [Line Items]
Property, plant and equipment, gross	327	327
Laboratory equipment
Property, Plant and Equipment [Line Items]
Property, plant and equipment, gross	334	334
Furniture and fixtures
Property, Plant and Equipment [Line Items]
Property, plant and equipment, gross	866	866
Leasehold improvements
Property, Plant and Equipment [Line Items]
Property, plant and equipment, gross	1,782	1,782
Manufacturing equipment
Property, Plant and Equipment [Line Items]
Property, plant and equipment, gross	$ 506	$ 506

Loan Payable (Tables)

9 Months Ended

Sep. 30, 2023

Debt Disclosure [Abstract]

Schedule of Outstanding Debt Obligations

As of September 30, 2023, the future principal payments due under the Loan Agreement, excluding interest, are as follows (in thousands):


	Amount
2023	$	—
2024	1,819
2025	23,469
2026	24,712
Total principal outstanding	50,000
End of term charge	1,759
Unamortized debt issuance costs	(513)
Total	$	51,246

Stockholders' Equity (Tables)

9 Months Ended

Sep. 30, 2023

Equity [Abstract]

Summary of Common Stock Shares Reserved for Future Issuance

The Company has reserved authorized shares of common stock for future issuance as follows:


	September 30, 2023	December 31, 2022
Common stock options outstanding	7,073,702	7,372,028
RSUs outstanding (1)	1,704,067	675,406
PSUs outstanding (1)	218,450	—
DSUs outstanding (1)	50,000	—
Options, RSUs, PSUs and DSUs available for grant under Equity Incentive Plans (1)	2,110,863	2,323,539
	11,157,082	10,370,973

(1) RSUs, PSUs, and DSUs are further defined in Note 9.

- Definition

Tabular disclosure of an entity's stock, including par or stated value per share, number and dollar amount of share subscriptions, shares authorized, shares issued, shares outstanding, number and dollar amount of shares held in an employee trust, dividend per share, total dividends, share conversion features, par value plus additional paid in capital, the value of treasury stock and other information necessary to a fair presentation, and EPS information. Stock by class includes common, convertible, and preferred stocks which are not redeemable or redeemable solely at the option of the issuer. Includes preferred stock with redemption features that are solely within the control of the issuer and mandatorily redeemable stock if redemption is required to occur only upon liquidation or termination of the reporting entity. If more than one issue is outstanding, state the title of each issue and the corresponding dollar amount; dollar amount of any shares subscribed but unissued and the deduction of subscriptions receivable there from; number of shares authorized, issued, and outstanding.

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+ Details

Stock-Based Compensation

9 Months Ended

Sep. 30, 2023

Share-Based Payment Arrangement [Abstract]

Stock-Based Compensation

2011 Equity Incentive Plan

In March 2011, the Company adopted the 2011 Equity Incentive Plan (the “2011 Plan”). The 2011 Plan provided for the direct award or sale of the Company’s common stock and for the grant of stock options to employees, directors, officers, consultants and advisors of the Company. The 2011 Plan was subsequently amended in August 2012, October 2013, February 2015, December 2015, April 2016 and November 2016 to allow for the issuance of additional shares of common stock. In connection with the adoption of the 2017 Plan (as defined below), the 2011 Plan was terminated and no further awards will be made under the 2011 Plan.

2017 Equity Incentive Plan

In May 2017, the Company adopted the 2017 Equity Incentive Plan (the “2017 Plan”). The 2017 Plan provided for the direct award or sale of the Company’s common stock and for the grant of up to 1,932,000 stock options to employees, directors, officers, consultants and advisors of the Company. The 2017 Plan provides for the grant of incentive stock options, non-statutory stock options or restricted stock. Effective January 1, 2023, and in accordance with the “evergreen” provision of the 2017 Plan, an additional 1,096,553 shares were made available for issuance.

Under both the 2011 Plan and the 2017 Plan, options to purchase the Company’s common stock may be granted at a price no less than the fair market value of a share of common stock on the date of grant. The fair value shall be the closing sales price for a share as quoted on any established securities exchange for such grant date or the last preceding date for which such quotation exists. Vesting terms of options issued are determined by the Board of Directors or Compensation Committee of the Board. The Company’s stock options vest based on terms in the stock option agreements. Stock options have a maximum term of ten years.

In January 2021, the Company began granting RSUs under the 2017 Plan. RSUs are granted at the fair market value of a share of common stock on the date of grant.

In January 2023, the Company began granting PSUs, which are subject to non-market performance and service conditions, to Company executives under the 2017 Plan. PSUs are granted at the fair market value of a share of common stock on the date of grant.

2023 Deferred Compensation Plan (a sub-plan to the 2017 Plan)

In May 2023, the Company adopted the G1 Therapeutics, Inc. Deferred Compensation Plan for Non-Employee Directors to enable non-employee directors of the Company (each a “Non-Employee Director”) to elect to defer annually the receipt of shares that vest in accordance with the terms of RSUs granted under the 2017 Plan (the “Vested RSUs”) for service as a Non-Employee Director (the “Deferred Compensation Plan”). The Deferred Compensation Plan is intended to comply with the requirements of Section 409A of the Internal Revenue Code of 1986, as amended. Under the Deferred Compensation Plan, the Non-Employee Directors shall be entitled to file with the Compensation Committee of the Board prior to December 31 of each Plan Year (as defined therein) an election form so as to make an election under the Deferred Compensation Plan effective for the following Plan Year, pursuant to which a Non-Employee Director may elect to defer receipt of shares underlying Vested RSUs with respect to RSUs granted in the following Plan Year. The Deferred Compensation Plan is unfunded and unsecured.

As of September 30, 2023, there were a total of 1,278,194 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, 2023, there was a total of 832,669 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, PSUs, and DSUs. The fair value of RSUs, PSUs, and DSUs is determined by the closing market price of the Company’s common stock on the date of grant and then recognized over the requisite service period of the award. As the PSUs have non-market performance and service conditions, compensation expense will be recognized over the requisite service periods if and when the achievement of such performance condition(s) is determined to be probable by the Company. If a performance condition is not determined to be probable or is not met, no stock-based compensation expense is recognized. The Company reassesses the probability of achieving the performance condition(s) at each reporting period. As of September 30, 2023, the Company did not deem the achievement of any performance condition(s) to be probable and no compensation expense related to PSUs was recognized.

The table below summarizes the stock-based compensation expense recognized in the Company’s statement of operations by classification (in thousands):


	Three Months Ended September 30,				Nine Months Ended September 30,
	2023		2022		2023		2022
Cost of goods sold	$	45	$	52	$	203	$	155
Research and development	516		980		1,704		3,149
Selling, general and administrative	3,094		3,753		9,394		12,885
Total stock-based compensation expense	$	3,655	$	4,785	$	11,301	$	16,189

Stock options – Black-Scholes inputs

The fair value of each option grant is estimated on the grant date using the Black-Scholes option-pricing model, using the following weighted average assumptions for the three and nine months ended September 30, 2023 and September 30, 2022:


	Three Months Ended September 30,		Nine Months Ended September 30,
	2023	2022	2023	2022
Expected volatility	86.0% - 86.2%	79.1% - 80.1%	81.4% - 88.4%	76.7% - 80.1%
Weighted-average risk free rate	4.1% - 4.2%	2.6% - 3.3%	3.4% - 4.2%	1.4% - 3.3%
Dividend yield	—%	—%	—%	—%
Expected term (in years)	6.06	5.91	6.00	6.00

Stock Option Activity

The following table is a summary of stock option activity for the nine months ended September 30, 2023:


				Weighted average
	Options outstanding	Weighted average exercise price		Remaining contractual for life (Years)	Aggregate intrinsic value
					(in thousands)
Balance as of December 31, 2022	7,372,028	$	16.15	6.9	$	3,281
Granted	1,364,630	4.80
Cancelled	(1,599,948)	19.15
Exercised	(63,008)	0.38
Balance as of September 30, 2023	7,073,702	$	13.43	6.6	$	470
Exercisable at December 31, 2022	4,562,674	$	17.85	5.8	$	3,248
Vested at December 31, 2022 and expected to vest	7,372,028	$	16.15	6.9	$	3,281
Exercisable at September 30, 2023	4,818,167	$	15.55	5.6	$	470
Vested at September 30, 2023 and expected to vest	7,073,702	$	13.43	6.6	$	470

As of September 30, 2023, unrecognized compensation expense related to unvested stock options totaled $12.5 million, which is expected to be recognized over a weighted-average period of approximately 2.0 years.

Restricted Stock Units

The Company’s restricted stock units (“RSUs”) are considered nonvested share awards and require no payment from the employee. For each RSU, employees receive one common share at the end of the vesting period. Compensation cost is recorded based on the market price of the Company’s common stock on the grant date and is recognized on a straight-line basis over the requisite service period.

The following table is a summary of the RSU activity for the nine months ended September 30, 2023:


	Number of RSUs	Weighted – Average Fair Value per Share
Balance as of December 31, 2022	675,406	$	12.31
Granted	1,614,750	3.76
Cancelled	(338,653)	6.97
Vested	(247,436)	12.56
Balance as of September 30, 2023	1,704,067	$	5.23

As of September 30, 2023, there was $6.7 million of total unrecognized compensation cost related to the Company's RSUs that are expected to vest. These costs are expected to be recognized over a weighted-average period of approximately 2.3 years.

Performance Based Restricted Stock Units

The Company's performance based restricted stock units (“PSUs”) are considered nonvested share awards and require no payment from the employee. For each PSU, employees receive one common share at the end of the vesting period, subject to non-market performance and service conditions. Compensation cost is recorded based on the market price of the Company's common stock on the grant date and is recognized over the requisite service if and when the achievement of such performance condition(s) is determined to be probable by the Company. The Company reassesses the probability of achieving the performance condition(s) at each reporting period. As of September 30, 2023, the Company did not deem the achievement of any performance condition(s) to be probable and compensation expense related to PSUs was not recognized.

The following table is a summary of the PSU activity for the nine months ended September 30, 2023:


	Number of PSUs	Weighted – Average Fair Value per Share
Balance as of December 31, 2022	—	$	—
Granted	218,450	5.73
Cancelled	—	—
Vested	—	—
Balance as of September 30, 2023	218,450	$	5.73

As of September 30, 2023, there was $1.3 million of total unrecognized compensation cost related to the Company's PSUs that are expected to vest. These costs are expected to be recognized over a weighted-average period of approximately 2.3 years.

Deferred Share Units

The Company's DSUs are considered nonvested share awards and require no payment from the holders. For each DSU, holders receive one common share on a future date, generally upon “Separation from Service” (within the meaning of Section 409A of the Code) as a Non-Employee Director of the Company for any reason. Upon settlement, holders will receive one fully paid and non-assessable common share in respect of each vested DSU. Compensation cost is recorded based on the market price of the Company’s common stock on the grant date and is recognized on a straight-line basis over the requisite service period.

The following table is a summary of the DSU activity for the nine months ended September 30, 2023:


	Number of DSUs	Weighted – Average Fair Value per Share
Balance as of December 31, 2022	—	$	—
Granted	50,000	2.83
Cancelled	—	—
Vested	—	—
Balance as of September 30, 2023	50,000	$	2.83

As of September 30, 2023, there was $0.1 million of total unrecognized compensation cost related to the Company's DSUs that are expected to vest. These costs are expected to be recognized over a weighted-average period of approximately 0.7 years.

Basis of Presentation and Summary of Significant Accounting Policies	9 Months Ended
	Sep. 30, 2023
Accounting Policies [Abstract]
Basis of Presentation and Significant Accounting Policies	Basis of Presentation and Summary of Significant Accounting Policies Basis of Presentation The accompanying condensed financial statements of the Company have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”). In the opinion of management, the Company has made all necessary adjustments, which include normal recurring adjustments necessary for a fair statement of the Company’s financial position and results of operations for the interim periods presented. The information presented in the condensed financial statements and related notes as of September 30, 2023, and for the three and nine months ended September 30, 2023, and 2022, is unaudited. The results for the three and nine months ended September 30, 2023, are not necessarily indicative of the results expected for the full fiscal year or any future period. These interim financial statements should be read in conjunction with the financial statements and notes set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 filed with the SEC on March 1, 2023 (the “2022 Form 10-K”). The December 31, 2022 condensed balance sheet included herein was derived from the audited financial statements as of that date, but does not include all disclosures, including notes, required by U.S. GAAP for complete financial statements. The Company has experienced net losses since its inception and has an accumulated deficit of $769.1 million and $732.0 million as of September 30, 2023 and December 31, 2022, respectively. The Company expects to incur losses and have negative net cash flows from operating activities as it executes on its strategy including engaging in further research and development activities, particularly conducting non-clinical studies and clinical trials. The success of the Company depends on the ability to successfully commercialize its technologies to support its operations and strategic plan. Management has evaluated actions already taken, the significance of anticipated continued losses, future cash flow projections, and the ability of the Company to remain in compliance with the financial covenants and requirements as defined within the Loan Agreement (as defined below). Based on the foregoing, as of the date of issuance of these condensed financial statements, the Company expects that its cash and cash equivalents and marketable securities as of September 30, 2023 will be sufficient to fund the Company’s planned operations and remain in compliance with its objective financial covenants for at least the next 12 months from the date of issuance of these condensed financial statements. Until such time, if ever, as the Company can generate substantial revenues, the Company expects to finance its cash needs through a combination of equity offerings, debt financings, other third-party funding, marketing and distribution arrangements and other collaborations, strategic alliances and licensing arrangements. There can be no assurances that the Company will be able to secure such additional financing if at all, or on terms that are satisfactory to the Company, and that it will be sufficient to meet its needs. In the event the Company is not successful in obtaining sufficient funding, this could force it to delay, limit, or reduce its product development, commercialization efforts or other operations. The Company’s condensed financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business. The condensed financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of the uncertainties described above. In connection with the Loan Payable described in Note 7, the Company is required to be in compliance with a minimum cash covenant and is subject to a conditional borrowing base measured on a trailing three-month net revenue basis, which began with the financial reporting for the period ended June 30, 2023, and has been tested monthly thereafter. The lender also has the ability to call debt based on a material adverse change clause, which is subjectively defined. If the Company is not in compliance with the minimum cash covenant, conditional borrowing base requirements, or the subjective acceleration clauses are triggered under the agreement, then the lender may call the debt resulting in the Company immediately needing additional funds. As of September 30, 2023, the Company is in compliance with the minimum cash covenant and the conditional borrowing base requirements as set forth in the Loan Agreement. Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and the accompanying notes. On an ongoing basis, the Company’s management evaluates its estimates which include, but are not limited to, estimates related to accrued expenses, accrued external clinical costs, net product sales, common stock valuation, stock-based compensation expense and deferred tax asset valuation allowance. Actual results could differ from those estimates. Cash and Cash Equivalents The Company considers all highly liquid investments purchased with an original maturity of three months or less at the date of purchase to be cash equivalents. Cash and cash equivalents at September 30, 2023 consist of amounts on deposit in banks, including checking accounts and money market accounts. Cash deposits are all in financial institutions in the United States. As part of the lease for the office space which commenced on September 2, 2019, the Company obtained a standby letter of credit in the amount of $0.5 million related to the security deposit. This letter of credit is secured by money market funds at the financial institution. Therefore, these funds are classified as restricted cash on the balance sheet. The letter of credit will be reduced ratably on each anniversary of the commencement of the lease until the end of the lease term. As of September 30, 2023, restricted cash totaled $0.3 million. Marketable Securities The Company determines the appropriate classification of marketable securities at the time of purchase and reevaluates such designation at each balance sheet date. The Company classified all of its marketable securities at September 30, 2023 as “available-for-sale” pursuant to ASC Topic 320, Investments – Debt and Equity Securities. Investments not classified as cash equivalents are presented as either short-term or long-term investments based on both their maturities as well as the time period the Company intends to hold such securities. Available-for-sale securities are maintained by an investment manager and primarily consist of fixed income securities. Available-for-sale securities are carried at fair value. Any premium or discount arising at purchase is amortized or accreted to interest income over the life of the instrument. Realized gains and losses are determined using the specific identification method and are included in other (income) expense, net. As of September 30, 2023 the unrealized gains and losses are not considered to be material. Accounts Receivable The Company’s accounts receivable consists of amounts due from specialty distributors in the U.S. (collectively, its “customers”) related to sales of COSELA and have standard payment terms. Trade receivables are recorded net of the estimated variable consideration for chargebacks based on contractual terms and the Company’s expectation regarding the utilization and earnings of the chargebacks and discounts as well as the net amount expected to be collected from the Company’s customers. Estimates of the Company’s credit losses are determined based on existing contractual payment terms, individual customer circumstances, and any changes to the economic environment. In addition, the Company’s accounts receivable consists of open invoices issued to its license partners for services rendered by the Company or receivables with its license partners for invoices related to milestones that were completed and recognized as revenue. The Company also has unbilled accounts receivable related to clinical trial reimbursements where the Company has the right to invoice the license partner and accordingly has recognized revenue. Invoicing to the license partner will occur once the Company has been invoiced by the service provider. As of September 30, 2023, unbilled accounts receivable totaled $0.2 million. Inventories Inventories are stated at the lower of cost or net realizable value and recognized on a weighted-average cost method. The Company uses actual cost to determine the cost basis for inventory. Inventory is capitalized based on when future economic benefit is expected to be realized. Due to the nature of the Company’s supply chain process, inventory that is owned by the Company, is physically stored at third-party warehouses, logistics providers, and contract manufacturers. Inventory valuation is established based on a number of factors including, but not limited to, finished goods not meeting product specifications, product excess and obsolescence, or application of the lower of cost or net realizable value concepts. The determination of events requiring the establishment of inventory valuation, together with the calculation of the amount of such adjustments may require judgment. The Company analyzes its inventory levels on a periodic basis to determine if any inventory is at risk for expiration prior to sale or has a cost basis that is greater than its estimated future net realizable value. Any adjustments are recognized through cost of sales in the period in which they are incurred. Inventories presented in the condensed balance sheets are net of reserves for excess and obsolete inventory, which were $1.9 million as of September 30, 2023. Debt The Company classifies its loan payable in current or long-term liabilities based on the timing of scheduled principal payments. The loan and security agreement with Hercules Capital, Inc. (as amended, the “Loan Agreement”) contains events of default, including a material adverse change, which is subjectively defined, in the Company’s business, payment defaults, and breaches of covenants following any applicable cure period. In the event of default by the Company under the Loan Agreement, the Company may be required to repay all amounts then outstanding under the Loan Agreement. The Company has determined that subjective acceleration under the material adverse events clause included in the Loan Agreement is not probable and, therefore, has classified the outstanding principal amount in long-term liabilities based on the timing of scheduled principal payments. Revenue Recognition For elements of those arrangements that the Company determines should be accounted for under ASC 606, Revenue from Contracts with Customers (“ASC 606”), the Company assesses which activities in its license or collaboration agreements are performance obligations that should be accounted for separately and determines the transaction price of the arrangement, which includes the assessment of the probability of achievement of future milestones and other potential consideration. For arrangements that include multiple performance obligations, such as granting a license or performing manufacturing or research and development activities, the Company allocates the transaction price based on the relative standalone selling price and recognizes revenue that is allocated to the respective performance obligation when (or as) control is transferred to the customer and the performance obligation is satisfied. Accordingly, the Company develops assumptions that require judgment to determine the standalone selling price for each performance obligation identified in the contract. These key assumptions may include revenue forecasts, clinical development timelines and costs, discount rates and probabilities of clinical and regulatory success. License Revenue Licenses of Intellectual Property If a license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenue allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue associated with the bundled performance obligation. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of progress and related revenue recognition. Milestone Payments At the inception of each arrangement that includes developmental and regulatory milestone payments, the Company evaluates whether the achievement of each milestone specifically relates to the Company’s efforts to satisfy a performance obligation or transfer a distinct good or service within a performance obligation. The Company evaluates each milestone to determine when and how much of the milestone to include in the transaction price. The Company first estimates the amount of the milestone payment that the Company could receive using either the expected value or the most likely amount approach. The Company primarily uses the most likely amount approach as that approach is generally most predictive for milestone payments with a binary outcome. Then, the Company considers whether any portion of that estimated amount is subject to the variable consideration constraint (that is, whether it is probable that a significant reversal of cumulative revenue would not occur upon resolution of the uncertainty). The Company updates the estimate of variable consideration included in the transaction price at each reporting date which includes updating the assessment of the likely amount of consideration and the application of the constraint to reflect current facts and circumstances. For regulatory milestones, the Company recognizes revenue at a point in time upon approval, as that is when achievement of the milestone is considered probable. The Company assesses milestones as they are achieved to determine whether they are tied to any other performance obligations in the respective license agreements. Royalties For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company will recognize revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). During the nine months ended September 30, 2023, the Company recognized $0.6 million in revenue related to sales-based royalties. Product Sales, Net The Company sells COSELA to specialty distributors in the U.S. and, in accordance with ASC 606, recognizes revenue at the point in time when the customer is deemed to have obtained control of the product. The customer is deemed to have obtained control of the product at the time of physical receipt of the product at the customers’ distribution facilities, or Free on Board (“FOB”) destination, the terms of which are designated in the contract. Product sales are recorded at the net selling price, which includes estimates of variable consideration for which reserves are established for (a) rebates and chargebacks, (b) co-pay assistance programs, (c) distribution fees, (d) product returns, and (e) other discounts. Where appropriate, these estimates take into consideration a range of possible outcomes for relevant factors such as current contractual and statutory requirements, and forecasted customer buying and payment patterns. Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the applicable contract. The amount of variable consideration may be constrained and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. Actual amounts of consideration ultimately received may differ from the Company's estimates. If actual results in the future vary from estimates, the Company adjusts these estimates, which would affect net product revenue and earnings in the period such variances become known. Liabilities related to co-pay assistance, rebates, returns, and GPO fees are classified as “Accrued Expenses” in the Condensed Balance Sheets. Discounts such as chargebacks and specialty distributor fees are recorded as a reduction to trade accounts receivable, which is included in “Accounts Receivable” in the Condensed Balance Sheets. Concentration of Credit Risk Financial instruments that potentially subject the Company to credit risk consist of cash and cash equivalents. Deposits with financial institutions are insured, up to certain limits, by the Federal Deposit Insurance Corporation (“FDIC”). The Company’s cash deposits often exceed the FDIC insurance limit; however, all deposits are maintained with high credit quality institutions and the Company has not experienced any losses in such accounts. The financial condition of financial institutions is periodically reassessed, and the Company believes the risk of any loss is minimal. The Company believes the risk of any loss on cash due to credit risk is minimal. Cost of Goods Sold Cost of goods sold includes direct and indirect costs related to the manufacturing and distribution of COSELA, including third-party manufacturing costs, packaging services, freight-in, third-party logistics costs associated with COSELA, and Company personnel costs. Cost of goods sold may also include period costs related to certain inventory manufacturing services and inventory adjustment charges, including reserves for excess and obsolete inventory. Research and Development Research and development expenses consist of costs incurred to further the Company’s research and development activities and include salaries and related employee benefits, manufacturing of pharmaceutical active ingredients and drug products, costs associated with clinical trials, nonclinical activities, regulatory activities, research-related overhead expenses and fees paid to expert consultants, external service providers and contract research organizations which conduct certain research and development activities on behalf of the Company. Costs incurred in the research and development of products are charged to research and development expense as incurred. Each reporting period, management estimated and accrued research and development expenses, including external clinical study costs associated with clinical trial activities. The process of estimating and accruing expenses involved reviewing contracts and purchase orders, identifying services that have been provided on the Company’s behalf, and estimating the level of service performed and the associated cost incurred for the service when the Company has not yet been invoiced or otherwise notified of the actual costs. Costs for clinical trial activities were estimated based on an evaluation of vendors’ progress towards completion of specific tasks, using data such as patient enrollment, clinical site activations or information provided by vendors regarding their actual costs incurred. Payments for these activities are based on the terms of individual contracts and payment timing may differ significantly from the period in which the services were performed. The Company determines accrual estimates through reports from and discussions with applicable personnel and outside service providers as to the progress or state of completion of trials, or the services completed. The estimates of accrued external clinical study costs as of each balance sheet date are based on the facts and circumstances known at the time. Income Taxes Income taxes are accounted for using the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to temporary differences between the financial statements carrying amounts of assets and liabilities and their respective tax bases, operating loss carryforwards, and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. In accordance with Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) 740, Accounting for Income Taxes, the Company reflects in the financial statements the benefit of positions taken in a previously filed tax return or expected to be taken in a future tax return only when it is considered ‘more-likely-than-not’ that the position taken will be sustained by a taxing authority. As of September 30, 2023 and December 31, 2022, the Company had no unrecognized income tax benefits and correspondingly there is no impact on the Company’s effective income tax rate associated with these items. The Company’s policy for recording interest and penalties relating to uncertain income tax positions is to record them as a component of income tax expense in the accompanying statements of operations. As of September 30, 2023 and December 31, 2022, the Company had no such accruals. Stock-Based Compensation The primary type of stock-based payments utilized by the Company are stock options. The Company accounts for stock-based employee compensation arrangements by measuring the cost of employee services received in exchange for all equity awards granted based on the fair value of the award on the grant date. The fair value of each employee stock option is estimated on the date of grant using an options pricing model. The Company currently uses the Black-Scholes valuation model to estimate the fair value of its share-based payments. The model requires management to make a number of assumptions including expected volatility, expected life, risk-free interest rate and expected dividends. The Company also incurs stock-based compensation expense related to restricted stock units (“RSUs”), performance based restricted stock units (“PSUs”), and deferred share units (“DSUs”). The fair value of RSUs, PSUs, and DSUs is determined by the closing market price of the Company’s common stock on the date of grant and then recognized over the requisite service period of the award. As the PSUs have non-market performance and service conditions, compensation expense will be recognized over the requisite service periods if and when the achievement of such performance condition(s) is determined to be probable by the Company. If a performance condition is not determined to be probable or is not met, no stock-based compensation expense is recognized. The Company reassesses the probability of achieving the performance condition(s) at each reporting period. As of September 30, 2023, the Company did not deem the achievement of any performance condition(s) to be probable and no compensation expense related to PSUs was recognized. Debt Issuance Costs Debt issuance costs are amortized to interest expense over the estimated life of the related debt based on the effective interest method. In accordance with ASC 835, Interest, the Company presents debt issuance costs on the balance sheet as a direct deduction from the associated debt.

Stock-Based Compensation - Summary of Restricted Stock Units Activity (Details) - Restricted Stock Units (RSUs)	9 Months Ended
	Sep. 30, 2023 $ / shares shares
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward]
Beginning balance (in shares) \| shares	675,406
Granted (in shares) \| shares	1,614,750
Cancelled (in shares) \| shares	(338,653)
Vested (in shares) \| shares	(247,436)
Ending balance (in shares) \| shares	1,704,067
Weighted-Average Fair Value per Share
Beginning balance (in US dollars per share) \| $ / shares	$ 12.31
Granted (in US dollars per share) \| $ / shares	3.76
Cancelled (in US dollars per share) \| $ / shares	6.97
Vested (in US dollars per share) \| $ / shares	12.56
Ending balance (in US dollars per share) \| $ / shares	$ 5.23

Stock-Based Compensation - Summary of Share-Based Compensation Expense Included in Statements of Operations (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Total stock-based compensation expense	$ 3,655	$ 4,785	$ 11,301	$ 16,189
Cost of goods sold
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Total stock-based compensation expense	45	52	203	155
Research and development
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Total stock-based compensation expense	516	980	1,704	3,149
Selling, general and administrative
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Total stock-based compensation expense	$ 3,094	$ 3,753	$ 9,394	$ 12,885

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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Reference 2: http://www.xbrl.org/2003/role/disclosureRef
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Reference 3: http://www.xbrl.org/2003/role/disclosureRef
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Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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Reference 5: http://www.xbrl.org/2003/role/disclosureRef
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Reference 6: http://www.xbrl.org/2003/role/disclosureRef
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Reference 13: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

Income Taxes - Narrative (Details)	3 Months Ended		9 Months Ended
Income Taxes - Narrative (Details)	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Income Tax Disclosure [Abstract]
Effective income tax rate reconciliation, percent	(5.20%)	(5.10%)	(6.30%)	(1.10%)

Related Party Transactions (Details) $ in Thousands	9 Months Ended
Related Party Transactions (Details) $ in Thousands	Sep. 30, 2023 USD ($)
Senior Advisor Agreement \| Board of Directors Chairman
Related Party Transaction [Line Items]
Related party payments	$ 50

Condensed Balance Sheets (unaudited) - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022
Current assets
Cash and cash equivalents	$ 52,623	$ 94,594
Restricted cash	63	63
Marketable securities	41,729	50,476
Accounts receivable and unbilled receivables, net	9,265	11,094
Inventories, net	13,491	16,179
Prepaid expenses and other current assets	8,932	7,094
Total current assets	126,103	179,500
Property and equipment, net	1,600	1,989
Restricted cash	187	250
Operating lease assets	5,180	5,962
Other assets	27	264
Total assets	133,097	187,965
Current liabilities
Accounts payable	7,335	7,431
Accrued expenses	24,181	25,557
Deferred revenue	686	7
Other current liabilities	1,451	2,593
Total current liabilities	33,653	35,588
Loan payable	51,246	77,015
Deferred revenue	500	1,000
Operating lease liabilities	4,676	5,615
Total liabilities	90,075	119,218
Stockholders’ equity
Common stock, $0.0001 par value, 120,000,000 shares authorized as of September 30, 2023, and December 31, 2022; 51,836,544 and 51,526,100 shares issued as of September 30, 2023, and December 31, 2022, respectively; 51,809,878 and 51,499,434 shares outstanding as of September 30, 2023, and December 31, 2022, respectively	5	5
Treasury stock, 26,666 shares as of September 30, 2023, and December 31, 2022	(8)	(8)
Additional paid-in capital	812,132	800,768
Accumulated deficit	(769,107)	(732,018)
Total stockholders’ equity	43,022	68,747
Total liabilities and stockholders' equity	$ 133,097	$ 187,965

Stock-Based Compensation - Summary of Stock Option Activity (Details) $ / shares in Units, $ in Thousands	9 Months Ended	12 Months Ended
	Sep. 30, 2023 USD ($) $ / shares shares	Dec. 31, 2022 USD ($) $ / shares shares
Options outstanding
Beginning balance (in shares) \| shares	7,372,028
Granted (in shares) \| shares	1,364,630
Cancelled (in shares) \| shares	(1,599,948)
Exercised (in shares) \| shares	(63,008)
Ending balance (in shares) \| shares	7,073,702	7,372,028
Exercisable (in shares) \| shares	4,818,167	4,562,674
Vested and expected to vest (in shares) \| shares	7,073,702	7,372,028
Weighted average exercise price
Beginning balance (in US dollars per share) \| $ / shares	$ 16.15
Granted (in US dollars per share) \| $ / shares	4.80
Cancelled (in US dollars per share) \| $ / shares	19.15
Exercised (in US dollars per share) \| $ / shares	0.38
Ending balance (in US dollars per share) \| $ / shares	13.43	$ 16.15
Exercisable (in US dollars per share) \| $ / shares	15.55	17.85
Vested and expected to vest (in US dollars per share) \| $ / shares	$ 13.43	$ 16.15
Weighted average, remaining contractual for life (years)
Beginning, end of period	6 years 7 months 6 days	6 years 10 months 24 days
Exercisable	5 years 7 months 6 days	5 years 9 months 18 days
Vested and expected to vest	6 years 7 months 6 days	6 years 10 months 24 days
Weighted average, aggregate intrinsic value
Balance \| $	$ 470	$ 3,281
Exercisable \| $	470	3,248
Vested and expected to vest \| $	$ 470	$ 3,281

Fair Value of Financial Instruments (Tables)

9 Months Ended

Sep. 30, 2023

Fair Value Disclosures [Abstract]

Summary of Financial Instruments and Respective Fair Values

At September 30, 2023 and December 31, 2022, these financial instruments and respective fair values have been classified as follows (in thousands):


	Quoted prices in active markets for identical assets (Level 1)		Significant other observable inputs (Level 2)		Significant other unobservable inputs (Level 3)		Balance at September 30, 2023
Assets:
Money market funds	$	52,314	$	—	$	—	$	52,314
Marketable securities:
U.S. Treasury Bills	41,729		—		—		41,729
Total assets at fair value	$	94,043	$	—	$	—	$	94,043


	Quoted prices in active markets for identical assets (Level 1)		Significant other observable inputs (Level 2)		Significant other unobservable inputs (Level 3)		Balance at December 31, 2022
Assets:
Money market funds	$	84,167	$	—	$	—	$	84,167
Marketable securities:
U.S. Treasury Bills	50,476		—		—		50,476
Total assets at fair value	$	134,643	$	—	$	—	$	134,643

Condensed Statements of Cash Flows (unaudited) - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022
Cash flows from operating activities
Net loss	$ (37,089)	$ (113,910)
Adjustments to reconcile net loss to net cash used in operating activities
Stock-based compensation	11,301	16,189
Accretion of discount on available for sale securities	(1,710)	(83)
Depreciation and amortization	389	393
Amortization of debt issuance costs	1,157	1,690
Non-cash interest expense	590	726
Non-cash equity interest, net	0	354
Change in operating assets and liabilities
Accounts receivable	1,829	(4,833)
Inventories	2,688	(10,479)
Prepaid expenses and other assets	(35)	5,730
Accounts payable	(1,050)	3,819
Accrued expenses and other liabilities	(3,794)	2,438
Deferred revenue	179	(22)
Net cash used in operating activities	(25,545)	(97,988)
Cash flows from investing activities
Purchases of marketable securities	(77,543)	(29,661)
Maturities of marketable securities	88,000	0
Purchases of property and equipment	0	(506)
Net cash provided by/(used in) investing activities	10,457	(30,167)
Cash flows from financing activities
Proceeds from stock options exercised	24	145
Repayment of debt	(26,689)	0
Payment of public offering costs	(281)	0
Net cash (used in)/provided by financing activities	(26,946)	145
Net change in cash, cash equivalents and restricted cash	(42,034)	(128,010)
Cash, cash equivalents and restricted cash
Beginning of period	94,907	221,561
End of period	52,873	93,551
Supplemental disclosure of cash flow information
Cash paid for interest	7,019	5,610
Non-cash operating, investing and financing activities
Upfront project costs and other current assets in accounts payable and accrued expenses	$ 1,021	$ 1,726

Basis of Presentation and Summary of Significant Accounting Policies (Policies)

9 Months Ended

Sep. 30, 2023

Accounting Policies [Abstract]

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, 2023, and for the three and nine months ended September 30, 2023, and 2022, is unaudited. The results for the three and nine months ended September 30, 2023, are not necessarily indicative of the results expected for the full fiscal year or any future period. These interim financial statements should be read in conjunction with the financial statements and notes set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 filed with the SEC on March 1, 2023 (the “2022 Form 10-K”). The December 31, 2022 condensed balance sheet included herein was derived from the audited financial statements as of that date, but does not include all disclosures, including notes, required by U.S. GAAP for complete financial statements.

The Company has experienced net losses since its inception and has an accumulated deficit of $769.1 million and $732.0 million as of September 30, 2023 and December 31, 2022, respectively. The Company expects to incur losses and have negative net cash flows from operating activities as it executes on its strategy including engaging in further research and development activities, particularly conducting non-clinical studies and clinical trials. The success of the Company depends on the ability to successfully commercialize its technologies to support its operations and strategic plan. Management has evaluated actions already taken, the significance of anticipated continued losses, future cash flow projections, and the ability of the Company to remain in compliance with the financial covenants and requirements as defined within the Loan Agreement (as defined below). Based on the foregoing, as of the date of issuance of these condensed financial statements, the Company expects that its cash and cash equivalents and marketable securities as of September 30, 2023 will be sufficient to fund the Company’s planned operations and remain in compliance with its objective financial covenants for at least the next 12 months from the date of issuance of these condensed financial statements. Until such time, if ever, as the Company can generate substantial revenues, the Company expects to finance its cash needs through a combination of equity offerings, debt financings, other third-party funding, marketing and distribution arrangements and other collaborations, strategic alliances and licensing arrangements. There can be no assurances that the Company will be able to secure such additional financing if at all, or on terms that are satisfactory to the Company, and that it will be sufficient to meet its needs. In the event the Company is not successful in obtaining sufficient funding, this could force it to delay, limit, or reduce its product development, commercialization efforts or other operations. The Company’s condensed financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business. The condensed financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of the uncertainties described above.

In connection with the Loan Payable described in Note 7, the Company is required to be in compliance with a minimum cash covenant and is subject to a conditional borrowing base measured on a trailing three-month net revenue basis, which began with the financial reporting for the period ended June 30, 2023, and has been tested monthly thereafter. The lender also has the ability to call debt based on a material adverse change clause, which is subjectively defined. If the Company is not in compliance with the minimum cash covenant, conditional borrowing base requirements, or the subjective acceleration clauses are triggered under the agreement, then the lender may call the debt resulting in the Company immediately needing additional funds. As of September 30, 2023, the Company is in compliance with the minimum cash covenant and the conditional borrowing base requirements as set forth in the Loan Agreement.

Use of Estimates

Use of EstimatesThe preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and the accompanying notes. On an ongoing basis, the Company’s management evaluates its estimates which include, but are not limited to, estimates related to accrued expenses, accrued external clinical costs, net product sales, common stock valuation, stock-based compensation expense and deferred tax asset valuation allowance. Actual results could differ from those estimates.

Cash and Cash Equivalents

The Company considers all highly liquid investments purchased with an original maturity of three months or less at the date of purchase to be cash equivalents. Cash and cash equivalents at September 30, 2023 consist of amounts on deposit in banks, including checking accounts and money market accounts. Cash deposits are all in financial institutions in the United States. As part of the lease for the office space which commenced on September 2, 2019, the Company obtained a standby letter of credit in the amount of $0.5 million related to the security deposit. This letter of credit is secured by money market funds at the financial institution. Therefore, these funds are classified as restricted cash on the balance sheet. The letter of credit will be reduced ratably on each anniversary of the commencement of the lease until the end of the lease term. As of September 30, 2023, restricted cash totaled $0.3 million.

Marketable Securities

Marketable SecuritiesThe Company determines the appropriate classification of marketable securities at the time of purchase and reevaluates such designation at each balance sheet date. The Company classified all of its marketable securities at September 30, 2023 as “available-for-sale” pursuant to ASC Topic 320, Investments – Debt and Equity Securities. Investments not classified as cash equivalents are presented as either short-term or long-term investments based on both their maturities as well as the time period the Company intends to hold such securities. Available-for-sale securities are maintained by an investment manager and primarily consist of fixed income securities. Available-for-sale securities are carried at fair value. Any premium or discount arising at purchase is amortized or accreted to interest income over the life of the instrument. Realized gains and losses are determined using the specific identification method and are included in other (income) expense, net.

Accounts Receivable

The Company’s accounts receivable consists of amounts due from specialty distributors in the U.S. (collectively, its “customers”) related to sales of COSELA and have standard payment terms. Trade receivables are recorded net of the estimated variable consideration for chargebacks based on contractual terms and the Company’s expectation regarding the utilization and earnings of the chargebacks and discounts as well as the net amount expected to be collected from the Company’s customers. Estimates of the Company’s credit losses are determined based on existing contractual payment terms, individual customer circumstances, and any changes to the economic environment.

In addition, the Company’s accounts receivable consists of open invoices issued to its license partners for services rendered by the Company or receivables with its license partners for invoices related to milestones that were completed and recognized as revenue. The Company also has unbilled accounts receivable related to clinical trial reimbursements where the Company has the right to invoice the license partner and accordingly has recognized revenue. Invoicing to the license partner will occur once the Company has been invoiced by the service provider.

Inventories

Inventories are stated at the lower of cost or net realizable value and recognized on a weighted-average cost method. The Company uses actual cost to determine the cost basis for inventory. Inventory is capitalized based on when future economic benefit is expected to be realized. Due to the nature of the Company’s supply chain process, inventory that is owned by the Company, is physically stored at third-party warehouses, logistics providers, and contract manufacturers.

Inventory valuation is established based on a number of factors including, but not limited to, finished goods not meeting product specifications, product excess and obsolescence, or application of the lower of cost or net realizable value concepts. The determination of events requiring the establishment of inventory valuation, together with the calculation of the amount of such adjustments may require judgment. The Company analyzes its inventory levels on a periodic basis to determine if any inventory is at risk for expiration prior to sale or has a cost basis that is greater than its estimated future net realizable value. Any adjustments are recognized through cost of sales in the period in which they are incurred.

Debt, Debt Issuance Costs

Debt

The Company classifies its loan payable in current or long-term liabilities based on the timing of scheduled principal payments. The loan and security agreement with Hercules Capital, Inc. (as amended, the “Loan Agreement”) contains events of default, including a material adverse change, which is subjectively defined, in the Company’s business, payment defaults, and breaches of covenants following any applicable cure period. In the event of default by the Company under the Loan Agreement, the Company may be required to repay all amounts then outstanding under the Loan Agreement. The Company has determined that subjective acceleration under the material adverse events clause included in the Loan Agreement is not probable and, therefore, has classified the outstanding principal amount in long-term liabilities based on the timing of scheduled principal payments.

Debt Issuance Costs

Debt issuance costs are amortized to interest expense over the estimated life of the related debt based on the effective interest method. In accordance with ASC 835, Interest, the Company presents debt issuance costs on the balance sheet as a direct deduction from the associated debt.

Revenue Recognition

For elements of those arrangements that the Company determines should be accounted for under ASC 606, Revenue from Contracts with Customers (“ASC 606”), the Company assesses which activities in its license or collaboration agreements are performance obligations that should be accounted for separately and determines the transaction price of the arrangement, which includes the assessment of the probability of achievement of future milestones and other potential consideration. For arrangements that include multiple performance obligations, such as granting a license or performing manufacturing or research and development activities, the Company allocates the transaction price based on the relative standalone selling price and recognizes revenue that is allocated to the respective performance obligation when (or as) control is transferred to the customer and the performance obligation is satisfied. Accordingly, the Company develops assumptions that require judgment to determine the standalone selling price for each performance obligation identified in the contract. These key assumptions may include revenue forecasts, clinical development timelines and costs, discount rates and probabilities of clinical and regulatory success.

License Revenue

Licenses of Intellectual Property

If a license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenue allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue associated with the bundled performance obligation. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of progress and related revenue recognition.

Milestone Payments

At the inception of each arrangement that includes developmental and regulatory milestone payments, the Company evaluates whether the achievement of each milestone specifically relates to the Company’s efforts to satisfy a performance obligation or transfer a distinct good or service within a performance obligation. The Company evaluates each milestone to determine when and how much of the milestone to include in the transaction price. The Company first estimates the amount of the milestone payment that the Company could receive using either the expected value or the most likely amount approach. The Company primarily uses the most likely amount approach as that approach is generally most predictive for milestone payments with a binary outcome. Then, the Company considers whether any portion of that estimated amount is subject to the variable consideration constraint (that is, whether it is probable that a significant reversal of cumulative revenue would not occur upon resolution of the uncertainty). The Company updates the estimate of variable consideration included in the transaction price at each reporting date which includes updating the assessment of the likely amount of consideration and the application of the constraint to reflect current facts and circumstances. For regulatory milestones, the Company recognizes revenue at a point in time upon approval, as that is when achievement of the milestone is considered probable. The Company assesses milestones as they are achieved to determine whether they are tied to any other performance obligations in the respective license agreements.

Royalties

For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company will recognize revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). During the nine months ended September 30, 2023, the Company recognized $0.6 million in revenue related to sales-based royalties.

Product Sales, Net

The Company sells COSELA to specialty distributors in the U.S. and, in accordance with ASC 606, recognizes revenue at the point in time when the customer is deemed to have obtained control of the product. The customer is deemed to have obtained control of the product at the time of physical receipt of the product at the customers’ distribution facilities, or Free on Board (“FOB”) destination, the terms of which are designated in the contract.

Product sales are recorded at the net selling price, which includes estimates of variable consideration for which reserves are established for (a) rebates and chargebacks, (b) co-pay assistance programs, (c) distribution fees, (d) product returns, and (e) other discounts. Where appropriate, these estimates take into consideration a range of possible outcomes for relevant factors such as current contractual and statutory requirements, and forecasted customer buying and payment patterns. Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the applicable contract. The amount of variable consideration may be constrained and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. Actual amounts of consideration ultimately received may differ from the Company's estimates. If actual results in the future vary from estimates, the Company adjusts these estimates, which would affect net product revenue and earnings in the period such variances become known.

Liabilities related to co-pay assistance, rebates, returns, and GPO fees are classified as “Accrued Expenses” in the Condensed Balance Sheets. Discounts such as chargebacks and specialty distributor fees are recorded as a reduction to trade accounts receivable, which is included in “Accounts Receivable” in the Condensed Balance Sheets.

Concentration of Credit Risk

Financial instruments that potentially subject the Company to credit risk consist of cash and cash equivalents. Deposits with financial institutions are insured, up to certain limits, by the Federal Deposit Insurance Corporation (“FDIC”). The Company’s cash deposits often exceed the FDIC insurance limit; however, all deposits are maintained with high credit quality institutions and the Company has not experienced any losses in such accounts. The financial condition of financial institutions is periodically reassessed, and the Company believes the risk of any loss is minimal. The Company believes the risk of any loss on cash due to credit risk is minimal.

Cost of Goods Sold

Cost of goods sold includes direct and indirect costs related to the manufacturing and distribution of COSELA, including third-party manufacturing costs, packaging services, freight-in, third-party logistics costs associated with COSELA, and Company personnel costs. Cost of goods sold may also include period costs related to certain inventory manufacturing services and inventory adjustment charges, including reserves for excess and obsolete inventory.

Research and Development

Research and development expenses consist of costs incurred to further the Company’s research and development activities and include salaries and related employee benefits, manufacturing of pharmaceutical active ingredients and drug products, costs associated with clinical trials, nonclinical activities, regulatory activities, research-related overhead expenses and fees paid to expert consultants, external service providers and contract research organizations which conduct certain research and development activities on behalf of the Company. Costs incurred in the research and development of products are charged to research and development expense as incurred.

Each reporting period, management estimated and accrued research and development expenses, including external clinical study costs associated with clinical trial activities. The process of estimating and accruing expenses involved reviewing contracts and purchase orders, identifying services that have been provided on the Company’s behalf, and estimating the level of service performed and the associated cost incurred for the service when the Company has not yet been invoiced or otherwise notified of the actual costs.

Costs for clinical trial activities were estimated based on an evaluation of vendors’ progress towards completion of specific tasks, using data such as patient enrollment, clinical site activations or information provided by vendors regarding their actual costs incurred. Payments for these activities are based on the terms of individual contracts and payment timing may differ significantly from the period in which the services were performed. The Company determines accrual estimates through reports from and discussions with applicable personnel and outside service providers as to the progress or state of completion of trials, or the services completed. The estimates of accrued external clinical study costs as of each balance sheet date are based on the facts and circumstances known at the time.

Income Taxes

Income taxes are accounted for using the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to temporary differences between the financial statements carrying amounts of assets and liabilities and their respective tax bases, operating loss carryforwards, and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date.

In accordance with Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) 740, Accounting for Income Taxes, the Company reflects in the financial statements the benefit of positions taken in a previously filed tax return or expected to be taken in a future tax return only when it is considered ‘more-likely-than-not’ that the position taken will be sustained by a taxing authority. As of September 30, 2023 and December 31, 2022, the Company had no unrecognized income tax benefits and correspondingly there is no impact on the Company’s effective income tax rate associated with these items. The Company’s policy for recording interest and penalties relating to uncertain income tax positions is to record them as a component of income tax expense in the accompanying statements of operations.

Stock-Based Compensation

The primary type of stock-based payments utilized by the Company are stock options. The Company accounts for stock-based employee compensation arrangements by measuring the cost of employee services received in exchange for all equity awards granted based on the fair value of the award on the grant date. The fair value of each employee stock option is estimated on the date of grant using an options pricing model. The Company currently uses the Black-Scholes valuation model to estimate the fair value of its share-based payments. The model requires management to make a number of assumptions including expected volatility, expected life, risk-free interest rate and expected dividends.

The Company also incurs stock-based compensation expense related to restricted stock units (“RSUs”), performance based restricted stock units (“PSUs”), and deferred share units (“DSUs”). The fair value of RSUs, PSUs, and DSUs is determined by the closing market price of the Company’s common stock on the date of grant and then recognized over the requisite service period of the award. As the PSUs have non-market performance and service conditions, compensation expense will be recognized over the requisite service periods if and when the achievement of such performance condition(s) is determined to be probable by the Company. If a performance condition is not determined to be probable or is not met, no stock-based compensation expense is recognized. The Company reassesses the probability of achieving the performance condition(s) at each reporting period.

Fair Value of Financial Instruments


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.

Inventories (Tables)

9 Months Ended

Sep. 30, 2023

Inventory Disclosure [Abstract]

Schedule of Inventories

Inventories consist of the following (in thousands):


	September 30, 2023		December 31, 2022
Raw materials	$	2,891	$	2,790
Work in process	9,541		10,153
Finished goods	1,059		3,236
Inventories, net	$	13,491	$	16,179

Basis of Presentation and Summary of Significant Accounting Policies - Narrative (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022	Dec. 31, 2022	Sep. 02, 2019
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]
Accumulated deficit	$ 769,107		$ 769,107		$ 732,018
Restricted cash	300		300
Unbilled receivables, current	200		200
Inventory reserves	1,900		1,900		100
Total revenues	12,300	$ 23,576	67,638	$ 41,051
Unrecognized tax benefits	0		0		0
Accrued income taxes	$ 0		0		$ 0
Nanjing Simcere Dongyuan Pharmaceutical Co Ltd \| Royalty
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]
Total revenues			$ 600
Restricted Cash \| Standby Letters of Credit
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]
Security deposit						$ 500

Income Taxes	9 Months Ended
Income Taxes	Sep. 30, 2023
Income Tax Disclosure [Abstract]
Income Taxes	Income TaxesThe Company’s effective income tax rate was (5.2)% and (5.1)% for the three months ended September 30, 2023 and 2022, respectively, and (6.3)% and (1.1)% for the nine months ended September 30, 2023 and 2022, respectively.

- Definition

The entire disclosure for income taxes. Disclosures may include net deferred tax liability or asset recognized in an enterprise's statement of financial position, net change during the year in the total valuation allowance, approximate tax effect of each type of temporary difference and carryforward that gives rise to a significant portion of deferred tax liabilities and deferred tax assets, utilization of a tax carryback, and tax uncertainties information.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480990/946-20-50-13

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 235
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(h)(2))
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480678/235-10-S99-1

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-Name Accounting Standards Codification
-Publisher FASB
-URI https://asc.fasb.org//740/tableOfContent

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 14
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482685/740-10-50-14

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 21
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482685/740-10-50-21

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 270
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482526/740-270-50-1

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 17
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482685/740-10-50-17

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SAB TOPIC 6.I.5.Q1)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147479360/740-10-S99-1

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 2
-Subparagraph (SAB Topic 11.C)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147479360/740-10-S99-2

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 30
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482603/740-30-50-2

+ Details

Stock-Based Compensation (Tables)

9 Months Ended

Sep. 30, 2023

Share-Based Payment Arrangement [Abstract]

Summary of Share-Based Compensation Expense Included in Statement of Operations

The table below summarizes the stock-based compensation expense recognized in the Company’s statement of operations by classification (in thousands):


	Three Months Ended September 30,				Nine Months Ended September 30,
	2023		2022		2023		2022
Cost of goods sold	$	45	$	52	$	203	$	155
Research and development	516		980		1,704		3,149
Selling, general and administrative	3,094		3,753		9,394		12,885
Total stock-based compensation expense	$	3,655	$	4,785	$	11,301	$	16,189

Summary of Fair Value of Stock Options Granted Using Black-Scholes Options Pricing Model


	Three Months Ended September 30,		Nine Months Ended September 30,
	2023	2022	2023	2022
Expected volatility	86.0% - 86.2%	79.1% - 80.1%	81.4% - 88.4%	76.7% - 80.1%
Weighted-average risk free rate	4.1% - 4.2%	2.6% - 3.3%	3.4% - 4.2%	1.4% - 3.3%
Dividend yield	—%	—%	—%	—%
Expected term (in years)	6.06	5.91	6.00	6.00

Summary of Stock Option Activity

The following table is a summary of stock option activity for the nine months ended September 30, 2023:


				Weighted average
	Options outstanding	Weighted average exercise price		Remaining contractual for life (Years)	Aggregate intrinsic value
					(in thousands)
Balance as of December 31, 2022	7,372,028	$	16.15	6.9	$	3,281
Granted	1,364,630	4.80
Cancelled	(1,599,948)	19.15
Exercised	(63,008)	0.38
Balance as of September 30, 2023	7,073,702	$	13.43	6.6	$	470
Exercisable at December 31, 2022	4,562,674	$	17.85	5.8	$	3,248
Vested at December 31, 2022 and expected to vest	7,372,028	$	16.15	6.9	$	3,281
Exercisable at September 30, 2023	4,818,167	$	15.55	5.6	$	470
Vested at September 30, 2023 and expected to vest	7,073,702	$	13.43	6.6	$	470

Summary of Restricted Stock Units Activity

The following table is a summary of the RSU activity for the nine months ended September 30, 2023:


	Number of RSUs	Weighted – Average Fair Value per Share
Balance as of December 31, 2022	675,406	$	12.31
Granted	1,614,750	3.76
Cancelled	(338,653)	6.97
Vested	(247,436)	12.56
Balance as of September 30, 2023	1,704,067	$	5.23

Summary of Performance Stock Units Activity

The following table is a summary of the PSU activity for the nine months ended September 30, 2023:


	Number of PSUs	Weighted – Average Fair Value per Share
Balance as of December 31, 2022	—	$	—
Granted	218,450	5.73
Cancelled	—	—
Vested	—	—
Balance as of September 30, 2023	218,450	$	5.73

Share-Based Payment Arrangement, Deferred Shares, Activity

The following table is a summary of the DSU activity for the nine months ended September 30, 2023:


	Number of DSUs	Weighted – Average Fair Value per Share
Balance as of December 31, 2022	—	$	—
Granted	50,000	2.83
Cancelled	—	—
Vested	—	—
Balance as of September 30, 2023	50,000	$	2.83

Stock-Based Compensation - Summary of Deferred Share Units Activity (Details) - Deferred Shares	9 Months Ended
	Sep. 30, 2023 $ / shares shares
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward]
Beginning balance (in shares) \| shares	0
Granted (in shares) \| shares	50,000
Cancelled (in shares) \| shares	0
Vested (in shares) \| shares	0
Ending balance (in shares) \| shares	50,000
Weighted-Average Fair Value per Share
Beginning balance (in US dollars per share) \| $ / shares	$ 0
Granted (in US dollars per share) \| $ / shares	2.83
Cancelled (in US dollars per share) \| $ / shares	0
Vested (in US dollars per share) \| $ / shares	0
Ending balance (in US dollars per share) \| $ / shares	$ 2.83

Net Loss Per Common Share (Tables)

9 Months Ended

Sep. 30, 2023

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, 2023 and 2022, 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,
	2023	2022	2023	2022
Stock options issued and outstanding	7,287,279	7,800,293	7,685,855	7,766,062
Unvested RSUs	1,769,793	649,883	1,393,671	626,889
Unvested PSUs	218,450	—	216,049	—
Unvested DSUs	50,000	—	19,597	—
Total potential dilutive shares	9,325,522	8,450,176	9,315,172	8,392,951

Loan Payable - Schedule of Outstanding Debt Obligations (Details) $ in Thousands	9 Months Ended
	Sep. 30, 2023 USD ($)
Debt Disclosure [Abstract]
2023	$ 0
2023	1,819
2024	23,469
2025	24,712
Total principal outstanding	50,000
End of term charge	1,759
Unamortized debt issuance costs	(513)
Total	$ 51,246

- Definition

Amount, after deduction of unamortized premium (discount) and debt issuance cost, of long-term debt. Excludes lease obligation.

+ References + Details

Stock-Based Compensation - Summary of Performance Stock Units Activity (Details) - Performance Shares	9 Months Ended
	Sep. 30, 2023 $ / shares shares
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward]
Beginning balance (in shares) \| shares	0
Granted (in shares) \| shares	218,450
Cancelled (in shares) \| shares	0
Vested (in shares) \| shares	0
Ending balance (in shares) \| shares	218,450
Weighted-Average Fair Value per Share
Beginning balance (in US dollars per share) \| $ / shares	$ 0
Granted (in US dollars per share) \| $ / shares	5.73
Cancelled (in US dollars per share) \| $ / shares	0
Vested (in US dollars per share) \| $ / shares	0
Ending balance (in US dollars per share) \| $ / shares	$ 5.73

Accrued Expenses (Tables)

9 Months Ended

Sep. 30, 2023

Payables and Accruals [Abstract]

Schedule of Accrued Expenses

Accrued expenses are comprised as follows (in thousands):


	September 30, 2023		December 31, 2022
Accrued external research	$	110	$	268
Accrued professional fees and other	5,692		4,304
Accrued external clinical study costs	14,702		15,566
Accrued compensation expense	3,677		5,419
Accrued expenses	$	24,181	$	25,557

License Revenue (Details)					1 Months Ended	3 Months Ended			9 Months Ended		12 Months Ended
License Revenue (Details)	Sep. 13, 2023 USD ($)	Aug. 03, 2020 USD ($)	Jul. 22, 2020 USD ($)	May 22, 2020 USD ($) performance_obligation	Sep. 30, 2020 USD ($)	Sep. 30, 2023 USD ($)	Mar. 31, 2023 USD ($)	Sep. 30, 2022 USD ($)	Sep. 30, 2023 USD ($)	Sep. 30, 2022 USD ($)	Dec. 31, 2022 USD ($)	Apr. 28, 2023 USD ($)	Jun. 15, 2020 USD ($)
Revenue Recognition, Multiple-deliverable Arrangements [Line Items]
Total revenues						$ 12,300,000		$ 23,576,000	$ 67,638,000	$ 41,051,000
A R C Therapeutics L L C
Revenue Recognition, Multiple-deliverable Arrangements [Line Items]
Upfront payment received				$ 1,000,000
Percentage of equity interest received				10.00%
Value of equity interest received				$ 1,100,000
Milestone payments receivable				$ 2,000,000
Percentage of equity interest				10.00%		6.50%			6.50%
Number of performance obligations \| performance_obligation				1
Total revenues				$ 2,100,000					$ 0
Genor Biopharma Co Inc
Revenue Recognition, Multiple-deliverable Arrangements [Line Items]
Milestone payments receivable													$ 40,000,000
Total revenues					$ 6,000,000				0		$ 3,000,000
Upfront cash payment receivable under agreement													$ 6,000,000
E Q Rx Inc
Revenue Recognition, Multiple-deliverable Arrangements [Line Items]
Upfront payment received	$ 1,600,000		$ 20,000,000
Milestone payments receivable			$ 290,000,000
Total revenues					$ 20,000,000
Revenue recognized for reimbursement of clinical trials costs									1,300,000
Deferred revenue						$ 600,000			600,000
Nanjing Simcere Dongyuan Pharmaceutical Co Ltd
Revenue Recognition, Multiple-deliverable Arrangements [Line Items]
Upfront payment received		$ 14,000,000
Revenue recognized for reimbursement of clinical trials costs									500,000
Revenue recognized for reimbursement of supply, manufacturing services and patent costs									2,700,000
Nanjing Simcere Dongyuan Pharmaceutical Co Ltd \| Royalty
Revenue Recognition, Multiple-deliverable Arrangements [Line Items]
Upfront payment received									30,000,000
Total revenues									$ 600,000
Nanjing Simcere Dongyuan Pharmaceutical Co Ltd \| Collaborative Arrangement, Transaction with Party to Collaborative Arrangement
Revenue Recognition, Multiple-deliverable Arrangements [Line Items]
Total revenues							$ 22,000,000
Upfront cash payment receivable under agreement												$ 30,000,000
Nanjing Simcere Dongyuan Pharmaceutical Co Ltd \| Collaborative Arrangement, Transaction with Party to Collaborative Arrangement \| Filing of NDA of TNBC
Revenue Recognition, Multiple-deliverable Arrangements [Line Items]
Revenue, remaining performance obligation, variable consideration amount												5,000,000
Nanjing Simcere Dongyuan Pharmaceutical Co Ltd \| Collaborative Arrangement, Transaction with Party to Collaborative Arrangement \| Regulatory Approval of TNBC
Revenue Recognition, Multiple-deliverable Arrangements [Line Items]
Revenue, remaining performance obligation, variable consideration amount												$ 13,000,000

Condensed Statements of Stockholders' Equity (unaudited) - USD ($) $ in Thousands	Total	Common stock	Treasury stock	Additional paid-in capital	Accumulated deficit
Beginning balance common stock, shares, outstanding (in shares) at Dec. 31, 2021		42,588,814
Beginning balance at Dec. 31, 2021	$ 143,541	$ 4	$ (8)	$ 728,004	$ (584,459)
Beginning balance treasury stock, shares (in shares) at Dec. 31, 2021			(26,666)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Exercise of common stock options (in shares)		27,333
Exercise of common stock options	18			18
Restricted stock units vested (in shares)		116,051
Restricted stock units vested	0
Stock-based compensation	5,765			5,765
Net loss	(49,192)				(49,192)
Ending balance common stock, shares, outstanding (in shares) at Mar. 31, 2022		42,732,198
Ending balance at Mar. 31, 2022	100,132	$ 4	$ (8)	733,787	(633,651)
Ending balance treasury stock, shares (in shares) at Mar. 31, 2022			(26,666)
Beginning balance common stock, shares, outstanding (in shares) at Dec. 31, 2021		42,588,814
Beginning balance at Dec. 31, 2021	143,541	$ 4	$ (8)	728,004	(584,459)
Beginning balance treasury stock, shares (in shares) at Dec. 31, 2021			(26,666)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Net loss	(113,910)
Ending balance common stock, shares, outstanding (in shares) at Sep. 30, 2022		42,923,747
Ending 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)
Beginning balance common stock, shares, outstanding (in shares) at Mar. 31, 2022		42,732,198
Beginning 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	0
Restricted stock units vested (in shares)		21,945
Restricted stock units vested	0
Stock-based compensation	5,639			5,639
Net loss	(39,446)				(39,446)
Ending balance common stock, shares, outstanding (in shares) at Jun. 30, 2022		42,754,143
Ending 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	(25,272)				(25,272)
Ending balance common stock, shares, outstanding (in shares) at Sep. 30, 2022		42,923,747
Ending 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)
Beginning balance common stock, shares, outstanding (in shares) at Dec. 31, 2022	51,499,434	51,526,100
Beginning balance at Dec. 31, 2022	$ 68,747	$ 5	$ (8)	800,768	(732,018)
Beginning balance treasury stock, shares (in shares) at Dec. 31, 2022	(26,666)		(26,666)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Public offering	$ (1)			(1)
Exercise of common stock options (in shares)		3,008
Exercise of common stock options	1			1
Restricted stock units vested (in shares)		156,855
Restricted stock units vested	0
Stock-based compensation	3,836			3,836
Net loss	(27,595)				(27,595)
Ending balance common stock, shares, outstanding (in shares) at Mar. 31, 2023		51,685,963
Ending balance at Mar. 31, 2023	$ 44,988	$ 5	$ (8)	804,604	(759,613)
Ending balance treasury stock, shares (in shares) at Mar. 31, 2023			(26,666)
Beginning balance common stock, shares, outstanding (in shares) at Dec. 31, 2022	51,499,434	51,526,100
Beginning balance at Dec. 31, 2022	$ 68,747	$ 5	$ (8)	800,768	(732,018)
Beginning balance treasury stock, shares (in shares) at Dec. 31, 2022	(26,666)		(26,666)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Exercise of common stock options (in shares)	63,008
Net loss	$ (37,089)
Ending balance common stock, shares, outstanding (in shares) at Sep. 30, 2023	51,809,878	51,836,544
Ending balance at Sep. 30, 2023	$ 43,022	$ 5	$ (8)	812,132	(769,107)
Ending balance treasury stock, shares (in shares) at Sep. 30, 2023	(26,666)		(26,666)
Beginning balance common stock, shares, outstanding (in shares) at Mar. 31, 2023		51,685,963
Beginning balance at Mar. 31, 2023	$ 44,988	$ 5	$ (8)	804,604	(759,613)
Beginning balance treasury stock, shares (in shares) at Mar. 31, 2023			(26,666)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Public offering	40			40
Exercise of common stock options	0
Restricted stock units vested (in shares)		49,150
Restricted stock units vested	0
Stock-based compensation	3,810			3,810
Net loss	8,710				8,710
Ending balance common stock, shares, outstanding (in shares) at Jun. 30, 2023		51,735,113
Ending balance at Jun. 30, 2023	57,548	$ 5	$ (8)	808,454	(750,903)
Ending balance treasury stock, shares (in shares) at Jun. 30, 2023			(26,666)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Public offering	0
Exercise of common stock options (in shares)		60,000
Exercise of common stock options	23			23
Restricted stock units vested (in shares)		41,431
Restricted stock units vested	0
Stock-based compensation	3,655			3,655
Net loss	$ (18,204)				(18,204)
Ending balance common stock, shares, outstanding (in shares) at Sep. 30, 2023	51,809,878	51,836,544
Ending balance at Sep. 30, 2023	$ 43,022	$ 5	$ (8)	$ 812,132	$ (769,107)
Ending balance treasury stock, shares (in shares) at Sep. 30, 2023	(26,666)		(26,666)

Stock-Based Compensation - Fair Value of Stock Options Granted Using Black-Scholes Options Pricing Model (Details) - Stock options issued and outstanding	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Expected volatility, minimum	86.00%	79.10%	81.40%	76.70%
Expected volatility, maximum	86.20%	80.10%	88.40%	80.10%
Weighted-average risk free rate, minimum	4.10%	2.60%	3.40%	1.40%
Weighted-average risk free rate, maximum	4.20%	3.30%	4.20%	3.30%
Dividend yield	0.00%	0.00%	0.00%	0.00%
Expected term (in years)	6 years 21 days	5 years 10 months 28 days	6 years	6 years

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References

+ Details

Stockholders' Equity

9 Months Ended

Sep. 30, 2023

Equity [Abstract]

Stockholders' Equity

Stockholders’ Equity

Common stock

The Company is authorized to issue 120,000,000 shares of common stock. Holders of common stock are entitled to one vote per share and are entitled to receive dividends, as if and when declared by the Company’s Board of Directors.

On July 2, 2021, the Company filed an automatic shelf registration statement on Form S-3ASR with the Securities and Exchange Commission (the “SEC”), which became effective upon filing, pursuant to which the Company registered for sale an unlimited amount of any combination of its common stock, preferred stock, debt securities, warrants, rights and/or units from time to time and at prices and on terms that the Company may determine, so long as the Company continued to satisfy the requirements of a “well-known seasoned issuer” under SEC rules (the “2021 Form S-3”). The 2021 Form S-3 also included a prospectus covering up to an aggregate of $150.0 million in shares of common stock that the Company may issue and sell from time to time through Cowen and Company, LLC (“Cowen”), acting as its agent, pursuant to a sales agreement for “at the market offerings” the Company entered into with Cowen in July 2021 (the “2021 Sales Agreement”). The Company did not sell any shares of common stock under the 2021 Sales Agreement.

At the time of the filing of the Company's Annual Report on Form 10-K for the year ended December 31, 2021 filed with the SEC on February 23, 2022, the Company no longer qualified as a “well-known seasoned issuer” as such term is defined in Rule 405 under the Securities Act of 1933, as amended. As a result, in February 2022, the Company amended the 2021 Form S-3 to register for sale up to $300.0 million of any combination of its common stock, preferred stock, debt securities, warrants, rights and/or units from time to time and at prices and on terms that the Company may determine. The 2021 Form S-3, as amended, will remain in effect for up to three years from the date it originally became effective, which was July 2, 2021. The amended 2021 Form S-3 also includes a prospectus covering up to an aggregate of $100.0 million in common stock that the Company may issue and sell from time to time, through Cowen acting as its sales agent, pursuant to that certain sales agreement that the Company entered into with Cowen on February 23, 2022 (the “2022 Sales Agreement”). In connection with the Company entering into the 2022 Sales Agreement with Cowen, the Company terminated the 2021 Sales Agreement. As of the date hereof, the Company has not sold any shares of common stock or other securities under the 2022 Sales Agreement for “at the market offerings.”

On November 17, 2022, the Company entered into an underwriting agreement related to a public offering of 7,700,000 shares of common stock at a public offering price of $6.50 per share less the underwriting discounts and commissions, pursuant to the shelf registration statement on Form S-3. The Company received approximately $50.1 million in gross proceeds from this offering, before deducting underwriting discounts and commissions and offering expenses. The offering closed on November 22, 2022. In addition, 873,353 shares of common stock were issued upon exercise by the underwriters of their option to purchase additional shares at the same offering price, which closed on December 20, 2022. The gross proceeds from the offering of the aggregate of 8,573,353 shares of the Company's common stock were $55.7 million and net proceeds of $52.0 million, after deducting underwriting discounts and commissions and other offering expenses payable by the Company.

Preferred stock

The Company is authorized to issue 5,000,000 shares of undesignated preferred stock in one or more series. As of September 30, 2023, no shares of preferred stock were issued or outstanding.

Shares Reserved for Future Issuance

The Company has reserved authorized shares of common stock for future issuance as follows:


	September 30, 2023	December 31, 2022
Common stock options outstanding	7,073,702	7,372,028
RSUs outstanding (1)	1,704,067	675,406
PSUs outstanding (1)	218,450	—
DSUs outstanding (1)	50,000	—
Options, RSUs, PSUs and DSUs available for grant under Equity Incentive Plans (1)	2,110,863	2,323,539
	11,157,082	10,370,973

(1) RSUs, PSUs, and DSUs are further defined in Note 9.

- Definition

The entire disclosure for equity.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
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-Name Accounting Standards Codification
-Section 50
-Paragraph 13
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Reference 2: http://www.xbrl.org/2003/role/disclosureRef
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Reference 3: http://www.xbrl.org/2003/role/disclosureRef
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Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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Reference 6: http://www.xbrl.org/2003/role/disclosureRef
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Reference 9: http://www.xbrl.org/2003/role/disclosureRef
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Reference 10: http://fasb.org/us-gaap/role/ref/legacyRef
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Reference 11: http://www.xbrl.org/2003/role/disclosureRef
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Reference 13: http://www.xbrl.org/2003/role/disclosureRef
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Reference 14: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

Loan Payable - Narrative (Details) - USD ($) $ in Thousands					3 Months Ended		9 Months Ended		12 Months Ended
Loan Payable - Narrative (Details) - USD ($) $ in Thousands	Jun. 06, 2023	Nov. 01, 2022	Jun. 24, 2022	Nov. 01, 2021	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022	Dec. 31, 2021	Jun. 30, 2023	Jun. 05, 2023	Dec. 31, 2022	Mar. 31, 2021	May 29, 2020
Debt Instrument [Line Items]
Repayments of debt							$ 26,689	$ 0
Loan payable					$ 51,246		51,246					$ 77,015
Interest expense					$ (2,115)	$ (2,764)	$ (7,914)	$ (7,436)
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%		9.65%
Percentage of prepayment loan amount for first year							3.00%
Percentage of prepayment loan amount for second year							2.00%
Percentage of prepayment loan amount for third year							1.00%
Extinguishment of debt, amount									$ 200
Loan Agreement \| Hercules Capital Inc \| First Amendment To Loan And Security Agreement
Debt Instrument [Line Items]
Loan agreement, basis spread on variable rate							6.20%
Loan agreement, interest rate, stated percentage					9.45%		9.45%
Loan Agreement \| Hercules Capital Inc \| Tranche One
Debt Instrument [Line Items]
Loan amount														$ 30,000
Percentage of aggregate amount of all loan advances payment							6.95%
End of term fee					$ 2,100		$ 2,100
Loan Agreement \| Hercules Capital Inc \| Tranche One \| First Amendment To Loan And Security Agreement
Debt Instrument [Line Items]
Remaining loan amount													$ 10,000
Loan Agreement \| Hercules Capital Inc \| Tranche Two
Debt Instrument [Line Items]
Loan amount														20,000
Loan Agreement \| Hercules Capital Inc \| Tranche Three
Debt Instrument [Line Items]
Loan amount														30,000
Loan Agreement \| Hercules Capital Inc \| Tranche Four
Debt Instrument [Line Items]
Loan amount														20,000
Loan Agreement \| Hercules Capital Inc \| Maximum
Debt Instrument [Line Items]
Loan amount														$ 100,000
Loan Agreement \| Hercules Capital Inc \| Minimum \| First Amendment To Loan And Security Agreement
Debt Instrument [Line Items]
Borrowing capacity without financial covenants										$ 40,000
Third Amendment
Debt Instrument [Line Items]
Loan amount			$ 25,000
Debt instrument percentage of net product revenue			80.00%
Debt instrument minimum revenue of covenant market capitalization amount			$ 750,000
Debt instrument percentage of unrestricted cash			100.00%
Debt instrument, covenant, unrestricted cash balance, percentage			50.00%
Loan And Security Agreement
Debt Instrument [Line Items]
Debt instrument percentage of net product revenue				65.00%
Debt instrument percentage of minimum revenue of covenant unrestricted cash				50.00%
Debt instrument percentage of unrestricted cash				100.00%
Loan And Security Agreement \| Hercules Capital Inc
Debt Instrument [Line Items]
Loan agreement, basis spread on variable rate				5.90%
Loan agreement, interest rate, stated percentage				9.15%
Percentage of prepayment loan amount for first year				3.00%
Percentage of prepayment loan amount for second year				2.00%
Percentage of prepayment loan amount for third year				1.00%
Loan And Security Agreement \| Hercules Capital Inc \| Tranche One
Debt Instrument [Line Items]
Loan amount				$ 100,000
Remaining loan amount				$ 25,000
Percentage of aggregate amount of all loan advances payment				6.75%
End of term fee				$ 2,100
Debt instrument additional borrowing amount				45,000
Loan And Security Agreement \| Hercules Capital Inc \| Tranche Two
Debt Instrument [Line Items]
Loan amount				20,000
Debt instrument available upon achievement of net product revenue				$ 50,000
Debt instrument trailing net product revenue				6 months
Loan And Security Agreement \| Hercules Capital Inc \| Tranche Three
Debt Instrument [Line Items]
Loan amount				$ 15,000
Loan And Security Agreement \| Hercules Capital Inc \| Tranche Four
Debt Instrument [Line Items]
Loan amount				15,000
Loan And Security Agreement \| Hercules Capital Inc \| Maximum
Debt Instrument [Line Items]
Loan amount				$ 150,000
Fourth Amendment
Debt Instrument [Line Items]
Debt instrument additional borrowing amount		$ 25,000
Debt instrument percentage of net product revenue		80.00%
Debt instrument minimum revenue of covenant market capitalization amount		$ 750,000
Debt instrument percentage of unrestricted cash		100.00%
Debt instrument, covenant, unrestricted cash balance, percentage		50.00%
Debt instrument, covenant, outstanding debt threshold		$ 75,000
Fourth Amendment \| Outstanding Debt Less Than Or Equal To 75.0 Million
Debt Instrument [Line Items]
Debt instrument, covenant, unrestricted cash balance, percentage		65.00%
Fourth Amendment \| Outstanding Debt Greater Than 75.0 Million
Debt Instrument [Line Items]
Debt instrument, covenant, unrestricted cash balance, percentage		70.00%
Fourth Amendment \| Achievement Of Net Revenue Milestones
Debt Instrument [Line Items]
Debt instrument, covenant, unrestricted cash balance, percentage		45.00%
Fifth Amendment
Debt Instrument [Line Items]
Debt instrument, covenant, outstanding debt threshold							$ 50,000
End of term fee, pro-rata payment	$ 1,700
Fifth Amendment \| Hercules Capital Inc
Debt Instrument [Line Items]
Loan amount	$ 75,000
Loan agreement, interest rate, stated percentage	9.15%
Percentage of prepayment loan amount for first year	3.00%
Percentage of prepayment loan amount for second year	2.00%
Percentage of prepayment loan amount for third year	1.00%
Debt instrument trailing net product revenue	6 months
Debt instrument, covenant, unrestricted cash balance, percentage	35.00%
Repayments of debt	$ 25,000
Loan payable	50,000
Minimum quarterly net product revenue covenant	45,000
Trailing six month product revenue covenant	$ 85,000
Fifth Amendment \| Hercules Capital Inc \| Prime Rate
Debt Instrument [Line Items]
Loan agreement, basis spread on variable rate	5.65%
Fifth Amendment \| Hercules Capital Inc \| Tranche Four
Debt Instrument [Line Items]
Loan amount	$ 25,000										$ 15,000