gthx-20230930

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

______________________________________________

FORM 10-Q

______________________________________________

(Mark One)


x			QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2023


o			TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

FOR THE TRANSITION PERIOD FROM TO

Commission File Number 001-38096

______________________________________________

G1 THERAPEUTICS, INC.

(Exact name of Registrant as specified in its Charter)

______________________________________________


Delaware			26-3648180
(State or other jurisdiction of incorporation or organization)			(I.R.S. Employer Identification No.)

700 Park Offices Drive, Suite 200 Research Triangle Park, NC 27709
(Address of principal executive offices including zip code)

Registrant’s telephone number, including area code: (919) 213-9835

______________________________________________

Securities registered pursuant to Section 12(b) of the Act:

______________________________________________


Title of each class	Trading Symbol	Name of each exchange on which registered
Common Stock $.0001 par value	GTHX	The Nasdaq Stock Market

Indicate by check mark whether the Registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No o

Indicate by check mark whether the Registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the Registrant was required to submit such files). Yes x No o

Indicate by check mark whether the Registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer

Accelerated filer

Non-accelerated filer

Smaller reporting company

Emerging growth company

If an emerging growth company, indicate by check mark if the Registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o

Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes o No x

As of October 27, 2023 the registrant had 51,843,669 shares of common stock, $0.0001 par value per share, outstanding.

Table of Contents


		Page
PART I	FINANCIAL INFORMATION	1
Item 1.	Financial Statements (Unaudited)	1
	Condensed Balance Sheets	1
	Condensed Statements of Operations	2
	Condensed Statements of Stockholders’ Equity	3
	Condensed Statements of Cash Flows	4
	Notes to Unaudited Condensed Financial Statements	5
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	23
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	42
Item 4.	Controls and Procedures	43

PART II	OTHER INFORMATION	44
Item 1A.	Risk Factors	44

Item 6.	Exhibits	44
	Signatures	46

PART I—FINANCIAL INFORMATION

Item 1. Financial Statements.

G1 Therapeutics, Inc.

Condensed Balance Sheets (unaudited)

(in thousands, except share and per share amounts)


	September 30, 2023		December 31, 2022

Assets
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
Liabilities and Stockholders’ Equity
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

The accompanying notes are an integral part of these condensed financial statements.

G1 Therapeutics, Inc.

Condensed Statements of Operations (unaudited)

(in thousands, except share and per share amounts)


	Three Months Ended September 30,				Nine Months Ended September 30,
	2023		2022		2023		2022
Revenues
Product sales, net	$	10,839	$	8,269	$	32,422	$	22,467
License revenue	1,461		15,307		35,216		18,584
Total revenues	12,300		23,576		67,638		41,051
Operating expenses
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)
Net loss per share, basic and diluted	$	(0.35)	$	(0.59)	$	(0.72)	$	(2.67)
Weighted average common shares outstanding, basic and diluted	51,777,731		42,799,342		51,697,989		42,731,826

The accompanying notes are an integral part of these condensed financial statements.

G1 Therapeutics, Inc.

Condensed Statements of Stockholders’ Equity (unaudited)

(in thousands, except share and per share amounts)


	Common stock			Treasury stock			Additional paid-in capital		Accumulated deficit		Total stock- holders' equity
	Shares	Amount		Shares	Amount
Balance at December 31, 2022	51,526,100	$	5	(26,666)	$	(8)	$	800,768	$	(732,018)	$	68,747
Public offering	—	—		—	—		(1)		—		(1)
Exercise of common stock options	3,008	—		—	—		1		—		1
Restricted stock units vested	156,855	—		—	—		—		—		—
Stock-based compensation	—	—		—	—		3,836		—		3,836
Net loss during quarter	—	—		—	—		—		(27,595)		(27,595)
Balance at March 31, 2023	51,685,963	$	5	(26,666)	$	(8)	$	804,604	$	(759,613)	$	44,988
Public Offering	—	—		—	—		40		—		40
Exercise of common stock options	—	—		—	—		—		—		—
Restricted stock units vested	49,150	—		—	—		—		—		—
Stock-based compensation	—	—		—	—		3,810		—		3,810
Net income during quarter	—	—		—	—		—		8,710		8,710
Balance at June 30, 2023	51,735,113	$	5	(26,666)	$	(8)	$	808,454	$	(750,903)	$	57,548
Public Offering	—	—		—	—		—		—		—
Exercise of common stock options	60,000	—		—	—		23		—		23
Restricted stock units vested	41,431	—		—	—		—		—		—
Stock-based compensation	—	—		—	—		3,655		—		3,655
Net loss during quarter	—	—		—	—		—		(18,204)		(18,204)
Balance at September 30, 2023	51,836,544	$	5	(26,666)	$	(8)	$	812,132	$	(769,107)	$	43,022

	Common stock			Treasury stock			Additional paid-in capital		Accumulated deficit		Total stock- holders' equity
	Shares	Amount		Shares	Amount
Balance at December 31, 2021	42,588,814	$	4	(26,666)	$	(8)	$	728,004	$	(584,459)	$	143,541
Exercise of common stock options	27,333	—		—	—		18		—		18
Restricted stock units vested	116,051	—		—	—		—		—		—
Stock-based compensation	—	—		—	—		5,765		—		5,765
Net loss during quarter	—	—		—	—		—		(49,192)		(49,192)
Balance at March 31, 2022	42,732,198	$	4	(26,666)	$	(8)	$	733,787	$	(633,651)	$	100,132
Exercise of common stock options	—	—		—	—		—		—		—
Restricted stock units vested	21,945	—		—	—		—		—		—
Stock-based compensation	—	—		—	—		5,639		—		5,639
Net loss during quarter	—	—		—	—		—		(39,446)		(39,446)
Balance at June 30, 2022	42,754,143	$	4	(26,666)	$	(8)	$	739,426	$	(673,097)	$	66,325
Exercise of common stock options	150,275	—		—	—		127		—		127
Restricted stock units vested	19,329	—		—	—		—		—		—
Stock-based compensation	—	—		—	—		4,785		—		4,785
Net loss during quarter	—	—		—	—		—		(25,272)		(25,272)
Balance at September 30, 2022	42,923,747	4		(26,666)	(8)		744,338		(698,369)		45,965

The accompanying notes are an integral part of these condensed financial statements.

G1 Therapeutics, Inc.

Condensed Statements of Cash Flows (unaudited)

(amounts in thousands)


	Nine Months Ended September 30,
	2023		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	—		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		—

Purchases of property and equipment	—		(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)		—
Payment of public offering costs	(281)		—
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

The accompanying notes are an integral part of these condensed financial statements.

G1 Therapeutics, Inc.

Notes to Financial Statements

(unaudited)

1. Description of Business

G1 Therapeutics, Inc. (the “Company”) is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel small molecule therapeutics for the treatment of patients with cancer. The Company's first product approved by the U.S. Food and Drug Administration (“FDA”), COSELA® (trilaciclib), is the first and only therapy indicated to proactively help protect bone marrow from the damage of chemotherapy (myeloprotection) 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.

2. Basis of Presentation and Summary of Significant Accounting Policies

Basis of Presentation

The accompanying condensed financial statements of the Company have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”). In the opinion of management, the Company has made all necessary adjustments, which include normal recurring adjustments necessary for a fair statement of the Company’s financial position and results of operations for the interim periods presented.

The information presented in the condensed financial statements and related notes as of September 30, 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

SEC Form 10-Q filed by G1 Therapeutics Inc.