0000950170-23-006588 | 10-K | XBRL Viewer

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Document and Entity Information - USD ($) $ in Millions	12 Months Ended
Document and Entity Information - USD ($) $ in Millions	Dec. 31, 2022	Mar. 04, 2023	Jun. 30, 2022
Cover [Abstract]
Document Type	10-K
Amendment Flag	false
Document Period End Date	Dec. 31, 2022
Document Fiscal Year Focus	2022
Entity Registrant Name	Galera Therapeutics, Inc.
Entity Central Index Key	0001563577
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Current Fiscal Year End Date	--12-31
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	true
Title of 12(b) Security	Common Stock,$0.001 par value per share
Trading Symbol	GRTX
Security Exchange Name	NASDAQ
Entity Shell Company	false
Entity Common Stock Shares Outstanding		42,830,066
Entity File Number	001-39114
Entity Incorporation State Country Code	DE
Entity Tax Identification Number	46-1454898
Entity Address, Address Line One	P.O. Box 134
Entity Address, City or Town	Malvern
Entity Address, State or Province	PA
Entity Address, Postal Zip Code	19355
City Area Code	610
Local Phone Number	725-1500
Document Annual Report	true
Document Transition Report	false
Entity Voluntary Filers	No
Document Fiscal Period Focus	FY
Entity Ex Transition Period	true
ICFR Auditor Attestation Flag	false
Entity Public Float			$ 32.2
Entity Well-known Seasoned Issuer	No
Documents Incorporated by Reference	Portions of the registrant’s definitive Proxy Statement, relating to its 2023 Annual Meeting of Stockholders to be filed with the Securities and Exchange Commission are incorporated by reference into Part III of this Annual Report on Form 10-K.
Auditor Name	KPMG LLP
Auditor Firm ID	185
Auditor Location	Philadelphia, Pennsylvania

Consolidated Balance Sheets - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021
Current Assets:
Cash and cash equivalents	$ 4,266	$ 19,859
Short-Term Investments	27,331	51,358
Restricted cash	50	0
Refundable PDUFA fee	3,242	0
Prepaid expenses and other current assets	3,646	6,175
Total current assets	38,535	77,392
Property and equipment, net	438	527
Acquired intangible asset	2,258	2,258
Goodwill	881	881
Right-of-use lease assets	43	296
Other assets	1,881	1,957
Total Assets	44,036	83,311
Current Liabilities:
Accounts payable	3,581	5,044
Accrued expenses	9,754	7,633
Lease liabilities	44	258
Total current liabilities	13,379	12,935
Royalty purchase liability	139,635	128,063
Lease liabilities, net of current portion	0	44
Deferred tax liability	203	273
Total liabilities	153,217	141,315
Commitments (Note 8)
Stockholders’ Equity:
Preferred stock, $0.001 par value: 10,000,000 shares authorized; no shares issued and outstanding.	0	0
Common stock, $0.001 par value: 200,000,000 shares authorized; 28,510,066 and 26,458,767 shares issued and outstanding at December 31, 2022 and December 31, 2021, respectively	28	26
Additional paid-in capital	269,137	258,086
Accumulated other comprehensive income	(22)	(14)
Accumulated deficit	(378,324)	(316,102)
Total stockholders’ equity	(109,181)	(58,004)
Total liabilities and stockholders' equity	$ 44,036	$ 83,311

Consolidated Balance Sheets (Parenthetical) - $ / shares	Dec. 31, 2022	Dec. 31, 2021
Statement of Financial Position [Abstract]
Preferred stock, par value	$ 0.001	$ 0.001
Preferred stock, shares authorized (shares)	10,000,000	10,000,000
Preferred stock, shares issued (shares)	0	0
Preferred stock, shares outstanding (shares)	0	0
Common stock, par value	$ 0.001	$ 0.001
Common stock, shares authorized	200,000,000	200,000,000
Shares issued for common stock	28,510,066	26,458,767
Common stock, shares outstanding	28,510,066	26,458,767

CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Operating expenses:
Research and development	$ 31,012	$ 52,417
General and administrative	20,214	20,951
Loss from operations	(51,226)	(73,368)
Other income (expenses):
Interest income	506	32
Interest expense	(11,571)	(7,194)
Foreign currency gain (loss)	(1)	(4)
Loss before income tax benefit	(62,292)	(80,534)
Income tax benefit	70	0
Net loss	$ (62,222)	$ (80,534)
Income (Loss) from Continuing Operations, Per Diluted Share	$ (2.30)	$ (3.12)
Income (Loss) from Continuing Operations, Per Basic Share	$ (2.30)	$ (3.12)
Weighted Average Limited Partnership Units Outstanding, Basic	27,086,664	25,789,458
Weighted Average Limited Partnership Units Outstanding, Diluted	27,086,664	25,789,458

CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Statement of Comprehensive Income [Abstract]
Net loss	$ (62,222)	$ (80,534)
Unrealized gain (loss) on short-term investments	(8)	(26)
Comprehensive loss	$ (62,230)	$ (80,560)

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

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CONSOLIDATED STATEMENTS OF CHANGES IN REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT) - USD ($) $ in Thousands	Total	Common Stock	Additional Paid-in Capital	Accumulated Other Comprehensive Income (loss)	Accumulated Deficit
Balance at Dec. 31, 2020	$ 6,118	$ 25	$ 241,649	$ 12	$ (235,568)
Balance (in shares) at Dec. 31, 2020		24,976,142
Share-based compensation expense	7,231		7,231
Exercise of stock options	1,266		1,266
Exercise of stock options, shares		591,257
Sale of shares under Open Market sale agreement, shares		891,368
Sale of shares under Open Market Sale Agreement , net	7,941	$ 1	7,940
Unrealized gain (loss) on short-term investments	(26)			(26)
Net loss	(80,534)				(80,534)
Balance at Dec. 31, 2021	$ (58,004)	$ 26	258,086	14	(316,102)
Balance (in shares) at Dec. 31, 2021	26,458,767	26,458,767
Share-based compensation expense	$ 7,164		7,164
Exercise of stock options	$ 81		81
Exercise of stock options, shares	68,526	68,526
Sale of shares under Open Market sale agreement, shares		1,982,773
Sale of shares under Open Market Sale Agreement , net	$ 3,808	$ 2	3,806
Unrealized gain (loss) on short-term investments	(8)			(8)
Net loss	(62,222)				(62,222)
Balance at Dec. 31, 2022	$ (109,181)	$ 28	$ 269,137	$ (22)	$ (378,324)
Balance (in shares) at Dec. 31, 2022	28,510,066	28,510,066

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

+ References

+ Details

- Definition

Total of all stockholders' equity (deficit) items, net of receivables from officers, directors, owners, and affiliates of the entity which are attributable to the parent. The amount of the economic entity's stockholders' equity attributable to the parent excludes the amount of stockholders' equity which is allocable to that ownership interest in subsidiary equity which is not attributable to the parent (noncontrolling interest, minority interest). This excludes temporary equity and is sometimes called permanent equity.

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CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Operating activities:
Net loss	$ (62,222)	$ (80,534)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization	114	778
Noncash interest expense	11,571	7,194
Share-based compensation expense	7,164	7,231
Deferred tax liability	(70)	0
Changes in operating assets and liabilities:
Refundable PDUFA fee	(3,242)	0
Prepaid expenses and other current assets	2,529	(1,022)
Other assets	330	(246)
Accounts payable	(1,463)	(101)
Accrued expense	2,121	(951)
Other liabilities	(258)	(307)
Cash used in operating activities	(43,426)	(67,958)
Investing activities:
Purchases of short-term investments	(59,891)	(71,979)
Proceeds from sales of short-term investments	83,910	77,500
Purchase of property and equipment	(25)	(283)
Cash provided by investing activities	23,994	5,238
Financing activities:
Proceeds from royalty purchase agreement	0	57,500
Proceeds from the sale of common stock , net of issuance costs	3,808	7,941
Proceeds from exercise of stock options	81	1,266
Cash provided by financing activities	3,889	66,707
Net increase (decrease) in cash, cash equivalents and restricted cash	(15,543)	3,987
Cash, cash equivalents and restricted cash at beginning of year	19,859	15,872
Cash, cash equivalents and restricted cash at end of year	4,316	19,859
Supplemental schedule of non-cash financing activities:
Purchase of property and equipment included in accounts payable and accrued expenses	$ 0	$ 9

Organization and description of business

12 Months Ended

Dec. 31, 2022

Organization, Consolidation and Presentation of Financial Statements [Abstract]

Organization and description of business

1. Organization and description of business

Galera Therapeutics, Inc. was incorporated as a Delaware corporation on November 19, 2012 (inception) and together with its subsidiaries (the Company, or Galera) is a clinical stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer. Galera's technology consists of selective small molecule dismutase mimetics that are in late-stage development in patients with cancer. Avasopasem manganese (avasopasem, or GC4419) is in development for radiotherapy-induced toxicities, including severe oral mucositis (SOM) in patients with locally advanced head and neck cancer (HNC) and esophagitis in patients with lung cancer. The Company is also exploring the potential for avasopasem to reduce cisplatin-induced kidney damage. In February 2018, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to avasopasem for the reduction of SOM induced by radiotherapy. In February 2023, the FDA accepted and granted Priority Review designation to the Company's New Drug Application (NDA) for avasopasem for this indication. Galera’s second dismutase mimetic product candidate, rucosopasem manganese (rucosopasem, or GC4711), is in clinical-stage development to augment the anti-cancer efficacy of stereotactic body radiation therapy (SBRT) in patients with non-small cell lung cancer (NSCLC) and locally advanced pancreatic cancer (LAPC).

In December 2021, the Company announced corrected topline efficacy results from a Phase 3 trial (referred to as the ROMAN trial) evaluating avasopasem for the reduction of radiotherapy-induced SOM in patients with locally advanced HNC. The results demonstrated efficacy across multiple SOM endpoints with a statistically significant reduction on the primary endpoint of reduction in the incidence of SOM and a statistically significant reduction on the secondary endpoint of number of days of SOM, with a median of 18 days in the placebo arm versus 8 days in the avasopasem arm. The Company had previously announced topline results from the ROMAN trial in October 2021 that incorrectly stated the reduction on the primary endpoint was not statistically significant. Upon further analysis following the October topline data announcement, an error by the contract research organization was identified in the statistical program. Correction of this error yielded the correct, statistically significant p-values for the primary and a key secondary endpoint. The ROMAN trial is the Company’s second randomized trial conducted in patients with HNC to achieve statistical significance and demonstrate improved clinical benefit in reducing SOM. In December 2022, the Company submitted an NDA to the FDA for avasopasem for radiotherapy-induced SOM in patients with HNC undergoing standard-of-care treatment. The NDA is supported by the data from the two randomized, double-blinded, placebo-controlled trials (ROMAN and Phase 2b GT-201), as well as data from other clinical trials of avasopasem in the proposed indication. In February 2023, the FDA accepted the NDA and granted priority review with a Prescription Drug User Fee Act (PDUFA) target date of August 9, 2023. The FDA indicated in its acceptance of filing letter that it is not planning to hold an advisory committee meeting on the application.

In addition to developing avasopasem for the reduction of normal tissue toxicity from radiotherapy, the Company is developing its second dismutase mimetic product candidate, rucosopasem, to increase the anti-cancer efficacy of higher daily doses of radiotherapy, or SBRT. In September 2021, in support of rucosopasem, the Company announced final results from its Phase 1/2 pilot trial of avasopasem in combination with SBRT in patients with unresectable or borderline resectable LAPC. In this proof-of-concept trial, survival and tumor outcome benefits were observed. The Company used its observations from this pilot trial to inform the design of rucosopasem clinical trials in combination with SBRT. The Company has successfully completed Phase 1 trials of intravenous rucosopasem in healthy volunteers and is currently evaluating rucosopasem in combination with SBRT in a Phase 1/2 safety and anti-cancer efficacy trial in NSCLC and a Phase 2b trial of rucosopasem in combination with SBRT in patients with LAPC.

Liquidity

The Company has incurred recurring losses and negative cash flows from operations since inception and has an accumulated deficit of $378.3 million as of December 31, 2022. The Company anticipates incurring additional losses until such time, if ever, that it can generate significant sales of its product candidates currently in development. The Company follows the provisions of Financial Accounting Standards Board, or FASB, Accounting Standards Codification, or ASC, Topic 205-40, Presentation of Financial Statements—Going Concern, which

requires management to assess the Company’s ability to continue as a going concern for one year after the date the financial statements are issued. The Company expects its existing cash, cash equivalents and short-term investments as of December 31, 2022, together with the net proceeds from its February 2023 registered direct offering, will enable the Company to fund its operating expenses and capital expenditure requirements into the fourth quarter of 2023, but not for more than one year after the date these consolidated financial statements were issued, and therefore management has concluded that substantial doubt exists about the Company’s ability to continue as a going concern. Management’s plans to mitigate this risk include raising additional capital through equity or debt financings, or through strategic transactions. Management’s plans may also include the deferral of certain operating expenses unless and until additional capital is received. However, there can be no assurance that the Company will be successful in raising additional capital or that such capital, if available, will be on terms that are acceptable to the Company, or that the Company will be successful in deferring certain operating expenses. If the Company is unable to raise sufficient additional capital or defer sufficient operating expenses, the Company may be compelled to reduce the scope of its operations and planned capital expenditures. In the future, if the Company is not able to continue to raise sufficient capital to fund its operations, the Company may decide to delay or discontinue certain activities, including planned research and development activities, hiring plans, manufacturing activities and commercial preparation efforts. The consolidated financial statements have been prepared assuming the Company will continue as a going concern, which contemplates the continuity of operations, the realization of assets and the satisfaction of liabilities and commitments in the normal course of business.

In December 2020, the Company filed a registration statement with the Securities and Exchange Commission (SEC) which covers the offering, issuance and sale of up to $200.0 million in Company securities, which includes an Open Market Sale Agreement with Jefferies LLC (the Sales Agreement) covering the offering, issuance and sale of up to a maximum aggregate offering price of $50.0 million of the Company’s common stock, which could be utilized to raise funding for future operating expenses and capital expenditure requirements. During the year ended December 31, 2022, the Company sold approximately 2.0 million shares of common stock and received net proceeds of $3.8 million pursuant to the Sales Agreement. As of December 31, 2022, there remained $37.8 million available under the Sales Agreement.

On February 17, 2023, the Company completed a registered direct offering, which resulted in the issuance and sale of 14,320,000 shares of its common stock and warrants to purchase up to 14,320,000 shares of common stock at a combined offering price of $2.095 per share and accompanying warrant, generating gross proceeds of $30.0 million. The warrants have an exercise price of $1.97 per share of common stock, are exercisable immediately following their issuance and will expire five years from the date of issuance. The Company received net proceeds of approximately $27.7 million from this offering, after deducting placement agent fees and offering expenses.

Basis of Presentation and Significant Accounting Policies

12 Months Ended

Dec. 31, 2022

Accounting Policies [Abstract]

Basis of Presentation and Significant Accounting Policies

2. Basis of presentation and significant accounting policies

Basis of presentation and consolidation

The accompanying consolidated financial statements have been prepared in conformity with U.S. generally accepted accounting principles (U.S. GAAP). Any reference in these notes to applicable guidance is meant to refer to U.S. GAAP as found in the Accounting Standards Codification (ASC) and Accounting Standards Updates (ASU) of the Financial Accounting Standards Board (FASB).

The consolidated financial statements include the accounts of Galera Therapeutics, Inc. and its wholly owned subsidiaries, Galera Therapeutics Australia Pty Ltd (Galera Australia) and Galera Labs, LLC. All intercompany accounts and transactions have been eliminated in consolidation.

The Company has determined the functional currency of Galera Australia to be the U.S. dollar. The Company records remeasurement gains and losses on monetary assets and liabilities, such as accounts payable, which are not denominated in U.S. dollars in the statements of operations.

The Company manages its operations as a single reportable segment for the purposes of assessing performance and making operating decisions.

Use of estimates

The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities as of the date of the consolidated financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates.

Estimates and assumptions are periodically reviewed and the effects of revisions are reflected in the consolidated financial statements in the period they are determined to be necessary. Significant areas that require management’s estimates include the share-based compensation assumptions, royalty purchase liability assumptions and accrued research and development expenses.

Fair value of financial instruments

Management believes that the carrying amounts of the Company’s financial instruments, including accounts payable and accrued expenses, approximate fair value due to the short-term nature of those instruments. Short-term investments are recorded at their estimated fair value. The royalty purchase liability is accounted for as debt and interest is accreted over the expected repayment period which approximates fair value.

Concentration of credit risk

Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash and cash equivalents and short-term investments. The Company maintains deposits in federally insured financial institutions in excess of federally insured limits. The Company has not experienced any losses in such accounts and believes it is not exposed to significant risk on its cash and cash equivalents.

Cash and cash equivalents

The Company considers all highly liquid investments that have maturities of three months or less when acquired to be cash equivalents. Cash and cash equivalents as of December 31, 2022 and 2021 consisted of bank deposits, U.S. Treasury obligations and a money market mutual fund invested in U.S. Treasury obligations.

Restricted cash

Restricted cash represents collateral provided under a commercial credit card agreement entered into with TD Bank, N.A. during July 2022. Restricted cash was $50,000 as of December 31, 2022. The Company has recorded this deposit and accumulated interest thereon as restricted cash on its consolidated balance sheet.

Refundable PDUFA fee

In December 2022, the Company paid a $3.2 million PDUFA fee to the FDA in conjunction with the filing of its NDA for avasopasem. The Company requested and has been granted a small business waiver of this PDUFA fee from the FDA, and the amount has been recorded as a Refundable PDUFA fee on the Company’s consolidated balance sheet, as a refund is expected in 2023.

Short-term investments

Short-term investments consist of debt securities with a maturity of greater than three months when acquired. The Company classifies its short-term investments at the time of purchase as available-for-sale securities, which are net of unrealized losses of $8,000 and $26,000 during the years ended December 31, 2022 and 2021, respectively. Available-for-sale securities are carried at fair value. Unrealized gains and losses on available-for-sale securities are reported in accumulated other comprehensive income (loss), a component of stockholders’ equity (deficit), until realized.

Property and equipment

Property and equipment are recorded at cost and depreciated using the straight-line method over their estimated useful lives ranging from three to five years. Leasehold improvements are amortized over the shorter of their economic lives or the remaining lease term. The costs of maintenance and repairs are expensed as incurred. Improvements and betterments that add new functionality or extend the useful life of the asset are capitalized.

Impairment of long-lived assets

Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to estimated undiscounted future cash flows expected to be generated by the asset. If the carrying amount of an asset exceeds its estimated undiscounted future cash flows, then an impairment charge is recognized for the amount by which the carrying value of the asset exceeds the estimated fair value of the asset. As of December 31, 2022, the Company believes that no revision of the remaining useful lives or write-down of long-lived assets is required.

Goodwill and acquired intangible asset

In November 2012, the Company completed a Series A redeemable convertible preferred stock (Series A) financing with venture capital investors and simultaneously acquired Galera Therapeutics, LLC (LLC), a limited liability company incorporated in Missouri in 2009. LLC was renamed Galera Labs, LLC in January 2013 and operates as a wholly-owned subsidiary of the Company. The Company applied the purchase method of accounting under which the consideration given to the LLC members and noteholders was allocated to the fair value of the net assets assumed from the LLC at the date of the acquisition. The sole intangible asset acquired represented the fair value of in-process research and development (IPR&D) which has been recorded on the accompanying consolidated balance sheets as an indefinite life intangible asset. A deferred tax liability was recorded for the difference between the fair value of the acquired IPR&D and its tax basis of zero which was recognized as goodwill in applying the purchase method of accounting.

Intangible assets related to IPR&D are considered indefinite-lived intangible assets and, along with goodwill, are not amortized, but are assessed for impairment annually or more frequently if impairment indicators exist. For those compounds that reach commercialization, the IPR&D assets will be amortized over their estimated useful lives. If the associated research and development effort related to IPR&D is abandoned, the related assets will be written-off and the Company will record a noncash impairment loss on its consolidated statements of operations. For the years ended December 31, 2022 and 2021, the Company determined that there was no impairment to goodwill or IPR&D.

Royalty purchase liability

In November 2018, the Company entered into an Amended and Restated Purchase and Sale Agreement (the Royalty Agreement), with Clarus IV Galera Royalty AIV, L.P., Clarus IV-A, L.P., Clarus IV-B, L.P., Clarus IV-C, L.P. and Clarus IV-D, L.P. (collectively, Blackstone or Blackstone Life Sciences). Pursuant to the Royalty Agreement, Blackstone agreed to pay up to $80.0 million (the Royalty Purchase Price) in four tranches of $20.0 million each upon the achievement of specific Phase 3 clinical trial patient enrollment milestones. The Company received the first tranche of the Royalty Purchase Price in November 2018, the second tranche of the Royalty Purchase Price in April 2019, and the third tranche of the Royalty Purchase Price in February 2020, in each case in connection with the achievement of the first three milestones, respectively. The proceeds received have been recorded as long-term debt obligations. Interest expense on such obligation is imputed by estimating risk adjusted future royalty payments over the term of the Royalty Agreement which takes into consideration the probability of obtaining FDA approval. Other significant assumptions include adjustments to estimated gross revenues to arrive at net product sales from which a royalty payment can be estimated. The non-cash interest expense recorded increases the balance of the royalty obligation. The royalty obligation will be reduced when royalty payments are made, if any.

In May 2020, the Company entered into Amendment No. 1 to the Royalty Agreement (the Amendment) with Clarus IV Galera Royalty AIV, L.P. (the Blackstone Purchaser). The Blackstone Purchaser is affiliated with Blackstone Life Sciences, the successor in interest to Clarus Ventures. The Amendment increased the Royalty Purchase Price by $37.5 million to $117.5 million, by increasing the fourth tranche from $20.0 million to $37.5 million, which was received in July 2021, and adding a new $20.0 million tranche upon the achievement of an additional clinical enrollment milestone, which was received in June 2021. The Company accounted for the Amendment as a debt modification and is amortizing fees paid to the Blackstone Purchaser related to the Amendment over the estimated term of the royalty purchase liability utilizing the effective-interest method.

Actual royalty payments are highly uncertain and may change depending on a number of factors, including the Company’s ability to obtain FDA approval, successfully commercialize the Company’s product candidates and the timing of future royalty payments. The Company imputes interest expense on the royalty purchase obligations based on such factors at each reporting period. As these factors change, the Company will adjust its estimate of the imputed interest expense accordingly.

Leases

At lease commencement, the Company records a lease liability based on the present value of lease payments over the expected lease term including any options to extend the lease that the Company is reasonably certain to exercise. The Company calculates the present value of lease payments using an incremental borrowing rate as the Company’s leases do not provide an implicit interest rate. The Company’s incremental borrowing rate for a lease is the rate of interest it would have to pay on a collateralized basis to borrow an amount equal to the lease payments under similar terms. At the lease commencement date, the Company records a corresponding right-of-use lease asset based on the lease liability, adjusted for any lease incentives received and any initial direct costs paid to the lessor prior to the lease commencement date. The Company may enter into leases with an initial term of 12 months or less (short-term leases). For short-term leases, the Company records the rent expense on a straight-line basis and does not record the leases on the balance sheet. The Company had no short-term leases as of December 31, 2022 and 2021.

After lease commencement, the Company measures its leases as follows: (i) the lease liability based on the present value of the remaining lease payments using the discount rate determined at lease commencement, and (ii) the right-of-use lease asset based on the remeasured lease liability, adjusted for any unamortized lease incentives received, any unamortized initial direct costs and the cumulative difference between rent expense and amounts paid under the lease agreement. Any lease incentives received and any initial direct costs are amortized on a straight-line basis over the expected lease term. Rent expense is recorded on a straight-line basis over the expected lease term.

Research and development expenses

Research and development costs are expensed as incurred and consist primarily of funds paid to third parties for the provision of services for product candidate development, clinical and preclinical development and related supply and manufacturing costs, and regulatory compliance costs. The Company accrues and expenses preclinical studies and clinical trial activities performed by third parties based upon estimates of the proportion of work completed over the term of the individual trial and patient enrollment rates in accordance with agreements with clinical research organizations and clinical trial sites. The Company determines the estimates by reviewing contracts, vendor agreements and purchase orders, and through discussions with internal clinical personnel and external service providers as to the progress or stage of completion of trials or services and the agreed-upon fee to be paid for such services. However, actual costs and timing of clinical trials are highly uncertain, subject to risks and may change depending upon a number of factors, including the Company’s clinical development plan.

Management makes estimates of the Company’s accrued expenses as of each balance sheet date in the Company’s consolidated financial statements based on facts and circumstances known to the Company at that time. If the actual timing of the performance of services or the level of effort varies from the estimate, the Company will adjust the accrual accordingly. Nonrefundable advance payments for goods and services, including fees for process development or manufacturing and distribution of clinical supplies that will be used in future research and development activities, are deferred and recognized as expense in the period that the related goods are consumed or services are performed.

In September 2020, the Company was awarded a Small Business Innovation Research grant from the National Cancer Institute of the National Institutes of Health, which will partially fund its Phase 1/2 safety and anti-cancer efficacy trial in NSCLC (the Grant). Costs entitled to reimbursement under the Grant are accounted for as a reduction to research and development expenses. During the year ended December 31, 2021, the Company recorded a reduction to research and development expense of $0.4 million for expenses for which it has been reimbursed under the Grant. The Company has fully utilized the $1.1 million of available funding under the Grant and did not receive any reimbursement during the year ended December 31, 2022.

Share-based compensation

The Company measures share-based awards at their grant-date fair value and records compensation expense on a straight-line basis over the vesting period of the awards.

Estimating the fair value of share-based awards requires the input of subjective assumptions, including the expected life of the options and stock price volatility. The Company accounts for forfeitures of stock option awards as they occur. The Company uses the Black-Scholes option pricing model to value its stock option awards. The assumptions used in estimating the fair value of share-based awards represent management’s estimate and involve inherent uncertainties and the application of management’s judgment. As a result, if factors change and management uses different assumptions, share-based compensation expense could be materially different for future awards.

The expected life of the stock options is estimated using the “simplified method,” as the Company has limited historical information from which to develop reasonable expectations about future exercise patterns and post-vesting employment termination behavior for its stock option grants. The simplified method is the midpoint between the vesting period and the contractual term of the option. For stock price volatility, the Company uses comparable public companies as a basis for its expected volatility to calculate the fair value of option grants. The risk-free rate is based on the U.S. Treasury yield curve commensurate with the expected life of the option.

Employee Benefit Plan

The Company sponsors a 401(k) defined contribution plan for its employees. Employee contributions are voluntary. The Company matches employee contributions in an amount equal to 100% of the first 4% of eligible compensation, and such employer contributions are immediately vested. During the year ended December 31, 2022 and 2021, the Company provided matching contributions of $0.3 million and $0.3 million, respectively.

Income taxes

The Company uses the asset and liability method of accounting for income taxes. Deferred tax assets and liabilities are recognized for the estimated future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases, and operating loss and 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. A valuation allowance is provided when it is more likely than not that some portion or all of a deferred tax asset will not be realized. The Company recognizes the benefit of an uncertain tax position that it has taken or expects to take on its income tax return if such a position is more likely than not to be sustained.

Net loss per share

Basic loss per share of common stock is computed by dividing net loss by the weighted-average number of shares of common stock outstanding during each period. Diluted loss per share of common stock includes the effect, if any, from the potential exercise or conversion of securities, such as stock options and common stock warrants, which would result in the issuance of incremental shares of common stock. For diluted net loss per share, the weighted-average number of shares of common stock is the same for basic net loss per share due to the fact that when a net loss exists, dilutive securities are not included in the calculation as the impact is anti-dilutive.

The following potentially dilutive securities have been excluded from the computation of diluted weighted-average shares of common stock outstanding, as they would be anti-dilutive:


	December 31,
	2022		2021
Stock options		5,783,185		4,970,975
Common stock warrants		550,661		550,661
		6,333,846		5,521,636

Fair Value Measurements

12 Months Ended

Dec. 31, 2022

Fair Value Disclosures [Abstract]

Fair Value Measurements

3. Fair value measurements

The Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible. The Company determines fair value based on assumptions that market participants would use in pricing an asset or liability in the principal or most advantageous market. When considering market participant assumptions in fair value measurements, the following fair value hierarchy distinguishes between observable and unobservable inputs, which are categorized in one of the following levels:

•

Level 1 Inputs: Unadjusted quoted prices in active markets for identical assets or liabilities accessible to the reporting entity at the measurement date.

•

Level 2 Inputs: Other than quoted prices included in Level 1 inputs that are observable for the asset or liability, either directly or indirectly, for substantially the full term of the asset or liability.

•

Level 3 Inputs: Unobservable inputs for the asset or liability used to measure fair value to the extent that observable inputs are not available, thereby allowing for situations in which there is little, if any, market activity for the asset or liability at measurement date.

The following table presents the Company’s assets and liabilities that are measured at fair value on a recurring basis (amounts in thousands):


	December 31, 2022
	(Level 1)		(Level 2)		(Level 3)
Assets
Money market funds and U.S. Treasury obligations (included in cash equivalents)	$	3,467	$	—	$	—

Short-term investments
U.S. government agency securities	$	—	$	8,172	$	—
U.S. Treasury obligations		19,159		—		—
Total short-term investments	$	19,159	$	8,172	$	—


	December 31, 2021
	(Level 1)		(Level 2)		(Level 3)
Assets
Money market funds and U.S. Treasury obligations (included in cash equivalents)	$	12,346	$	—	$	—

Short-term investments
U.S. government agency securities	$	—	$	5,413	$	—
U.S. Treasury obligations		45,945		—		—
Total short-term investments	$	45,945	$	5,413	$	—

There were no changes in valuation techniques during the years ended December 31, 2022 and 2021. The Company’s short-term investment instruments classified using Level 1 inputs within the fair value hierarchy are classified as such because they are valued using quoted market prices, broker or dealer quotations, or alternative pricing sources with reasonable levels of price transparency. The fair value of Level 2 securities is estimated based on observable inputs other than quoted prices in active markets for identical assets and liabilities, quoted prices for identical or similar assets or liabilities in inactive markets, or other inputs that are observable or can be corroborated by observable market data for substantially the full term on the assets or liabilities.

- 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

Property and Equipment

12 Months Ended

Dec. 31, 2022

Property, Plant and Equipment [Abstract]

Property and Equipment

4. Property and equipment

Property and equipment consist of (amounts in thousands):


	December 31,			December 31,
	2022			2021
Laboratory equipment	$	1,398		$	1,379
Computer hardware and software		292			292
Leasehold improvements		270			264
Furniture and fixtures		179			179
Property and equipment, gross		2,139			2,114
Less: Accumulated depreciation and amortization		(1,701	)		(1,587	)
Property and equipment, net	$	438		$	527

Depreciation and amortization expense was $0.1 million and $0.8 million for the years ended December 31, 2022 and 2021, respectively.

Accrued Expenses

12 Months Ended

Dec. 31, 2022

Payables and Accruals [Abstract]

Accrued Expenses

5. Accrued expenses

Accrued expenses consist of (amounts in thousands):


	December 31,		December 31,
	2022		2021
Compensation and related benefits	$	2,655	$	2,038
Research and development expenses		6,764		5,360
Professional fees and other expenses		335		235
	$	9,754	$	7,633

Royalty Purchase Liability

12 Months Ended

Dec. 31, 2022

Royalty Purchase Liability [Abstract]

Royalty Purchase Liability

6. Royalty purchase liability

Pursuant to the Royalty Agreement, Blackstone agreed to pay up to $80.0 million (the Royalty Purchase Price) in four tranches of $20.0 million each upon the achievement of specific Phase 3 clinical trial patient enrollment milestones. The Company received the first tranche of the Royalty Purchase Price in November 2018, the second tranche of the Royalty Purchase Price in April 2019, and the third tranche of the Royalty Purchase Price in February 2020, in each case in connection with the achievement of the first three milestones, respectively.

In May 2020, the Company entered into Amendment No. 1 to the Royalty Agreement (the Amendment) with Clarus IV Galera Royalty AIV, L.P. (the Blackstone Purchaser). The Blackstone Purchaser is affiliated with Blackstone Life Sciences, the successor in interest to Clarus Ventures. The Amendment increased the Royalty Purchase Price by $37.5 million, to $117.5 million by increasing the fourth tranche from $20.0 million to $37.5 million and adding a new $20.0 million tranche upon the achievement of an additional clinical enrollment milestone. The Company accounted for the Amendment as a debt modification and is amortizing fees paid to the Blackstone Purchaser related to the Amendment over the estimated term of the royalty purchase liability utilizing the effective-interest method. In June 2021, the Company received the new tranche ($20.0 million) under the Amendment in connection with the enrollment of the first patient in a Phase 2b trial of rucosopasem in combination with SBRT in patients with locally advanced pancreatic cancer, which the Company refers to as the GRECO-2 trial. Also in June

2021, the Company completed enrollment in the ROMAN trial, thereby achieving the milestone associated with the fourth tranche ($37.5 million) under the Amendment, which was received in July 2021.

The Company accounts for the Royalty Agreement as a debt instrument. The $117.5 million in proceeds received as of December 31, 2022 have been recorded as a liability on the accompanying consolidated balance sheets. Interest expense is imputed based on the estimated royalty repayment period described below, which takes into consideration the probability and timing of obtaining FDA approval and the potential future revenue from commercializing its product candidates, and which results in a corresponding increase in the liability balance. As a result of the NDA submission and market research conducted in 2022 to estimate the potential opportunity for avasopasem for radiation-induced SOM among key stakeholders, the Company updated the assumptions underlying the calculation of interest expense on the royalty purchase liability. The Company recognized $11.6 million and $7.2 million in noncash interest expense during the years ended December 31, 2022 and 2021, respectively. As of December 31, 2022, the effective interest rate was 9.6%.

Pursuant to the Royalty Agreement and the Amendment, in connection with the payment of each tranche of the Royalty Purchase Price, the Company has agreed to sell, convey, transfer and assign to Blackstone all of its right, title and interest in a high single-digit percentage of (i) worldwide net sales of avasopasem and rucosopasem (collectively, the Products) and (ii) all amounts received by the Company or its affiliates, licensees and sublicensees with respect to Product-related damages (collectively, the Product Payments) during the Royalty Period. The Royalty Period means, on a Product-by-Product and country-by-country basis, the period of time commencing on the commercial launch of such Product in such country and ending on the latest to occur of (i) the 12th anniversary of such commercial launch, (ii) the expiration of all valid claims of the Company’s patents covering such Product in such country, and (iii) the expiration of regulatory data protection or market exclusivity or similar regulatory protection afforded by the health authorities in such country, to the extent such protection or exclusivity effectively prevents generic versions of such Product from entering the market in such country.

The Royalty Agreement and the Amendment will remain in effect until the date on which the aggregate amount of the Product Payments paid to Blackstone exceeds a fixed single-digit multiple of the actual amount of the Royalty Purchase Price received by the Company, unless earlier terminated pursuant to the mutual written agreement of the Company and Blackstone. If no Products are commercialized, the Company would not have an obligation to make Product Payments to Blackstone, which is the sole mechanism for repaying the liability.

Upon execution of the Amendment, the Company issued common stock warrants to the Blackstone Purchaser, each of which became exercisable upon the receipt by the Company of the applicable specified milestone payment. The issued warrants expire six years after the initial exercise dates, as follows:

Shares

Exercise Price

Initial Exercise Date

Expiration Date

New Milestone Warrant

293,686

13.62

6/7/2021

6/6/2027

Fourth Milestone Warrant

256,975

13.62

7/19/2021

7/18/2027

The warrants are equity-classified and were valued at $4.7 million at the time of issuance using the Black-Scholes option pricing model. The warrants were recorded as a discount to the royalty purchase liability. The Company amortizes the debt discount to interest expense over the estimated term of the royalty purchase liability utilizing the effective-interest method.

Income Taxes

12 Months Ended

Dec. 31, 2022

Income Tax Disclosure [Abstract]

Income Taxes

10. Income Taxes

The Company’s loss before income taxes for the years ended December 31, 2022 and 2021 is as follows (in thousands):


	Year ended December 31,
	2022			2021
Domestic	$	(62,281	)	$	(80,587	)
Foreign		(11	)		53
	$	(62,292	)	$	(80,534	)

The Company’s tax benefit for the years ended December 31, 2022 and 2021 is summarized as follows (in thousands):


	Year ended December 31,
	2022			2021
Current
Federal	$	—		$	—
State		—			—
Foreign		—			—
		—			—
Deferred:
Federal		—			—
State		(70	)		—
Foreign		—			—
		(70	)		—
Total income tax benefit	$	(70	)	$	—

A reconciliation of the federal income tax rate to the Company’s effective tax rate is as follows:


	Year ended December 31,
	2022				2021
Rate reconciliation:
Federal tax benefit at statutory rate		21.0		%		21.0		%
State tax, net of federal benefit		3.1				1.5
Net operating loss carryforwards		0.1				—
Change in tax rate		(9.6	)			—
Sale of royalty interest		(3.9	)			(16.9	)
Research and development		(0.8	)			0.4
Change in valuation allowance		(9.1	)			(5.6	)
Share-based compensation		(0.6	)			(0.3	)
Other		(0.1	)			(0.1	)
Total provision		0.1		%		—		%

The tax effects of temporary differences that give rise to significant portions of the deferred tax assets and liabilities were as follows (in thousands):


	December 31,
	2022			2021
Deferred tax assets
Net operating loss carryforwards	$	41,697		$	43,111
Share-based compensation		3,731			2,874
Research and development credits		7,287			7,827
Capitalized research and development expenses		6,354			—
Accrued expenses and other		82			77
Gross deferred tax assets		59,151			53,889
Valuation allowance		(58,424	)		(52,787	)
Net deferred tax asset		727			1,102
Deferred tax liabilities
Accrued expenses and other		(348	)		(722	)
Acquired in-process research and development		(582	)		(653	)
Net deferred tax liabilities	$	(203	)	$	(273	)

In assessing the need for a valuation allowance, the Company may utilize indefinite-lived deferred tax liabilities from an intangible asset as a future source of income. The Company’s acquired IPR&D intangible asset can be utilized as a source of income arising from the future reversal of temporary difference that can be offset against post 2017 indefinite-lived net operating losses (NOLs). Therefore, the Company is permitted to offset the indefinite-lived deferred tax liability up to the 80 percent limitation for NOLs generated subsequent to January 1, 2018.

Beginning in 2022, the 2017 Tax Cuts and Jobs Act requires taxpayers to capitalize research and development expenses with amortization periods over five and fifteen years, depending on where the research is conducted. The Company has $28.3 million of research and development costs being capitalized in 2022. However, given the Company has a valuation allowance against its deferred tax assets, including the capitalized research and development costs, the enacted provision does not have a material impact on the consolidated financial statements.

The valuation allowance increased by $5.6 million and $4.5 million for the years ended December 31, 2022 and 2021, respectively.

The following table summarizes carryforwards of federal, state and foreign NOLs as of December 31, 2022 and 2021, respectively (in thousands):


	December 31,
	2022		2021
Combined NOL Carryforwards:
Federal	$	162,335	$	145,265
State		184,382		167,252
Foreign		1,716		1,516

The NOL carryforwards begin expiring in 2032 for both federal and state income tax purposes. As of December 31, 2022, the Company also has federal, state and foreign research and development tax credit carryforwards of $7.3 million that will begin to expire in 2032, unless previously utilized.

The NOL and tax credit carryforwards are subject to review and possible adjustment by the Internal Revenue Service and state tax authorities. In general, under Section 382 of the Code, a corporation that undergoes an “ownership change,” generally defined as a greater than 50% change by value in its equity ownership over a three-year period, is subject to limitations on its ability to utilize its pre change tax credits as well as its NOLs to offset future taxable income. During 2021, the Company conducted a Section 382 study and determined that approximately $63.7 million in NOLs and $2.7 million in research and development tax credits were limited by Section 382 as of December 31, 2021. As a result of the Section 382 analysis, approximately $1.4 million of research and development tax credits are scheduled to expire unused due to the annual Section 382 limitation and therefore were written off in 2021.

The Company will recognize interest and penalties related to uncertain tax positions as income tax expense. As of December 31, 2022, the Company had no accrued interest and penalties related to uncertain tax positions and no amounts have been recognized in the Company’s statements of operations. Due to NOL and tax credit carryforwards that remain unutilized, income tax returns from 2019 through 2021 remain subject to examination by the taxing jurisdictions. The NOLs remain subject to review until utilized.

- 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
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section 50
-Paragraph 21
-URI https://asc.fasb.org/extlink&oid=121826272&loc=d3e32857-109319

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
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-Paragraph 2
-Subparagraph (SAB Topic 11.C)
-URI https://asc.fasb.org/extlink&oid=122134291&loc=d3e330215-122817

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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-URI https://asc.fasb.org/extlink&oid=122134291&loc=d3e330036-122817

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-Publisher FASB
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Reference 7: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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Reference 8: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
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-Subparagraph (SX 210.4-08(h)(2))
-URI https://asc.fasb.org/extlink&oid=120395691&loc=d3e23780-122690

+ Details

Commitments and Contingencies

12 Months Ended

Dec. 31, 2022

Commitments and Contingencies Disclosure [Abstract]

Commitments

8. Commitments

Executive employment agreements

The Company has entered into employment agreements with certain key executives, providing for compensation and severance in certain circumstances, as described in the respective agreements.

Legal matters

The Company is subject from time to time to various claims and legal actions arising during the ordinary course of its business. Management believes that there are currently no claims or legal actions that would reasonably be expected to have a material adverse effect on the Company’s results of operations, financial condition or cash flows.

Leases

12 Months Ended

Dec. 31, 2022

Leases [Abstract]

Leases

7. Leases

The Company had a non-cancelable operating lease for office and laboratory space in Malvern, Pennsylvania which ended in February 2023. The discount rate used to account for the Company’s operating lease is the Company’s estimated incremental borrowing rate of 5.3%.

Supplemental balance sheet information related to leases was as follows:


	December 31,		December 31,
	2022		2021
Operating Leases
Right-of-use lease assets	$	43	$	296

Lease liabilities, current		44		258
Lease liabilities, net of current portion		—		44
Total operating lease liabilities	$	44	$	302

The components of lease expense were as follows:


	Year ended December 31,
	2022		2021
Operating lease costs
Operating lease rental expense	$	259	$	303
Interest on lease liabilities		8		22
Total operating lease expense	$	267	$	325

Supplemental cash flow information related to leases was as follows:


	Year ended December 31,
	2022		2021
Cash paid for amounts included in the measurement of lease liabilities
Operating cash flows for operating leases	$	266	$	325
Right-of-use assets obtained in exchange for lease obligation
Operating leases		—		70

Our operating lease liabilities as of December 31, 2022 will mature, as follows (amounts in thousands):


2023		44
Total		44
Less: imputed interest		0
	$	44

Additionally, in October 2022 the Company entered into a new operating lease agreement for office space in Malvern, Pennsylvania. The lease commencement date is expected to occur in May 2023. The lease expiration date will be 7.4 years after the lease commencement date. Total rental payments are approximately $1.6 million from the commencement date through the expiration date. The Company is also required to pay the increase in certain operating expenses over a base year, in accordance with the terms of the lease agreement.

Stockholders' Equity (Deficit)

12 Months Ended

Dec. 31, 2022

Equity [Abstract]

Stockholders’ Equity

9. Stockholders' Equity (Deficit)

Equity offerings

In December 2020, the Company entered into the Sales Agreement with Jefferies LLC (Jefferies) as sales agent, pursuant to which it may, from time to time, issue and sell common stock with an aggregate value of up to $50.0 million in “at-the-market” (ATM) offerings under the Company’s Registration Statement on Form S-3 (File No. 333-251061) filed with the SEC on December 1, 2020. Sales of common stock, if any, pursuant to the Sales Agreement, may be made in sales deemed to be an “at the market offering” as defined in Rule 415(a) of the Securities Act, including sales made directly through the Nasdaq Global Market or on any other existing trading market for the Company’s common stock. The Company is required to pay Jefferies a commission equal to three percent of the gross sales proceeds and has provided Jefferies with customary indemnification rights. During the year ended December 31, 2022, 1,982,773 shares were sold under the Sales Agreement at a weighted average price per share of $2.00. Net proceeds to the Company after deducting fees, commissions and other expenses related to the offering were $3.8 million for the year ended December 31, 2022. As of December 31, 2022, there was $37.8 million of available capacity under the Sales Agreement.

Share-based compensation

In connection with the Company’s Initial Public Offering, or IPO, in November 2019, the Company’s board of directors adopted and the Company’s stockholders approved the Galera Therapeutics, Inc. 2019 Incentive Award Plan (the 2019 Plan), which became effective upon the effectiveness of the registration statement on Form S-1 for the IPO. Upon effectiveness of the 2019 Plan, the Company ceased granting new awards under the Prior Plan (as defined herein).

The 2019 Plan provides for the grant of incentive stock options, nonstatutory stock options, restricted stock awards, restricted stock units, stock appreciation rights and other stock-based awards. The number of shares of common stock initially available for issuance under the 2019 Plan was 1,948,970 shares of common stock plus the number of shares subject to awards outstanding under the Prior Plan that expire, terminate or are otherwise surrendered, cancelled, forfeited or repurchased by the Company on or after the effective date of the 2019 Plan. In addition, the number of shares of common stock available for issuance under the 2019 Plan is subject to an annual increase on the first day of each calendar year beginning on January 1, 2020 and ending on and including January 1, 2029 equal to the lesser of (i) 4% of the Company’s outstanding shares of common stock on the final day of the immediately preceding calendar year, and (ii) such smaller number of shares of common stock as determined by the Company’s board of directors. As of December 31, 2022, there were 1,429,544 shares available for future issuance under the 2019 Plan, including 1,058,350 shares added pursuant to this provision effective January 1, 2022. Pursuant to this provision, the Company added an additional 1,140,402 shares to the total shares available for issuance under the 2019 Plan effective January 1, 2023. The maximum number of shares of common stock that may be issued under the 2019 Plan upon the exercise of incentive stock options is 14,130,029.

In November 2019, the Company’s board of directors adopted and the Company’s stockholders approved the Galera Therapeutics, Inc. 2019 Employee Stock Purchase Plan (the ESPP). The ESPP allows employees to buy Company stock through after-tax payroll deductions at a discount from market value. The number of shares of common stock initially available for issuance under the ESPP was 243,621 shares of common stock. In addition, the number of shares of common stock available for issuance under the ESPP is subject to an annual increase on the first day of each calendar year beginning on January 1, 2020 and ending on and including January 1, 2029 equal to the lesser of (i) 1% of the Company’s outstanding shares of common stock on the final day of the immediately preceding calendar year and (ii) such smaller number of shares of common stock as determined by the Company’s board of directors, provided that not more than 3,288,886 shares of common stock may be issued under the ESPP. As of December 31, 2022, there were 1,006,084 shares available for issuance under the ESPP, including 264,587 shares added pursuant to this provision effective January 1, 2022. Pursuant to this provision, the Company added an additional 285,100 shares to the total shares available for issuance under the ESPP effective January 1, 2023.

In November 2012, the Company adopted the Equity Incentive Plan (the Prior Plan). The total number of shares subject to outstanding awards under the Prior Plan as of December 31, 2022 was 1,888,574. No shares

remain available for issuance under the Prior Plan and no further grants will be made under the Prior Plan; however, the Prior Plan continues to govern awards that are outstanding under it.

The Company's stock option awards vest based on the terms in the governing agreements and generally vest over four years and have a term of 10 years.

Share-based compensation expense was as follows for the years ended December 31, 2022 and 2021 (in thousands):


	Year ended December 31,
	2022		2021
Research and development	$	2,596	$	2,919
General and administrative		4,568		4,312
	$	7,164	$	7,231

The following table summarizes the activity related to stock option grants for the year ended December 31, 2022:


	Shares			Weighted average exercise price per share		Weighted- average remaining contractual life (years)
Outstanding at January 1, 2022		4,970,975		$	8.45	7.1
Granted		1,608,646			2.05
Exercised		(68,526	)		1.20
Forfeited		(727,910	)		7.63
Outstanding at December 31, 2022		5,783,185		$	6.86		6.8
Vested and exercisable at December 31, 2022		3,593,449		$	7.41		5.7
Vested and expected to vest at December 31, 2022		5,783,185		$	6.86		6.8

As of December 31, 2022, the unrecognized compensation cost was $9.5 million and will be recognized over an estimated weighted-average remaining amortization period of 2.1 years. The aggregate intrinsic value of options outstanding and options exercisable as of December 31, 2022 was $83,000 and $34,000, respectively. Options granted during the years ended December 31, 2022 and 2021 had weighted-average grant-date fair values of $1.57 and $7.73 per share, respectively.

The fair value of options is estimated using the Black-Scholes option pricing model, which takes into account inputs such as the exercise price, the estimated fair value of the underlying common stock at the grant date, expected term, expected stock price volatility, risk-free interest rate and dividend yield. The fair value of stock options granted during the years ended December 31, 2022 and 2021 was determined using the methods and assumptions discussed below.

•

The expected term of employee stock options with service-based vesting is determined using the “simplified” method, as prescribed in SEC’s Staff Accounting Bulletin (SAB) No. 107, whereby the expected life equals the arithmetic average of the vesting term and the original contractual term of the option due to the Company’s lack of sufficient historical data. The expected term of nonemployee options is equal to the contractual term.

•

The expected stock price volatility is based on historical volatilities of comparable public entities within the Company’s industry which were commensurate with the expected term assumption as described in SAB No. 107.

•

The risk-free interest rate is based on the interest rate payable on U.S. Treasury securities in effect at the time of grant for a period that is commensurate with the expected term.

•

The expected dividend yield is 0% because the Company has not historically paid, and does not expect for the foreseeable future to pay, a dividend on its common stock.

•

The Company’s board of directors has determined the per share value of the Company’s common stock based on the closing price as reported by the NASDAQ Global Market on the date of the grant.

The grant date fair value of each option grant was estimated throughout the year using the Black-Scholes option-pricing model using the following weighted-average assumptions:


	Year ended December 31,
	2022			2021
Expected term (in years)		6.2			6.2
Expected stock price volatility		92.7	%		89.5	%
Risk-free interest rate		2.07	%		0.79	%
Expected dividend yield		0	%		0	%

- Definition

The entire disclosure for shareholders' equity comprised of portions attributable to the parent entity and noncontrolling interest, including other comprehensive income. Includes, but is not limited to, balances of common stock, preferred stock, additional paid-in capital, other capital and retained earnings, accumulated balance for each classification of other comprehensive income and amount of comprehensive income.

+ References

Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-URI https://asc.fasb.org/topic&trid=2208762

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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-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496171-112644

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+ Details

Related Party Transactions

12 Months Ended

Dec. 31, 2022

Related Party Transactions

11. Related Party Transactions

IntellectMap provides IT-advisory services to the Company. The chief executive officer of IntellectMap is the brother of the Company’s chief executive officer. Fees incurred by the Company with respect to IntellectMap during each of the years ended December 31, 2022 and 2021 were $0.2 million.

Subsequent Events

12 Months Ended

Dec. 31, 2022

Subsequent Events [Abstract]

Subsequent events

12. Subsequent Events

In February 2023, the FDA accepted for filing and granted priority review to the NDA for avasopasem for radiotherapy-induced SOM in patients with HNC, with a PDUFA target date of August 9, 2023. This may have an impact on the amounts the Company records for interest on the royalty purchase liability, and such impact may be material.

On February 17, 2023, the Company completed a registered direct offering, which resulted in the issuance and sale of 14,320,000 shares of its common stock and warrants to purchase up to 14,320,000 shares of common stock at a combined offering price of $2.095 per share and accompanying warrant, generating gross proceeds of $30 million. The warrants have an exercise price of $1.97 per share of common stock, are exercisable immediately following their issuance and will expire five years from the date of issuance. The Company received net proceeds of approximately $27.7 million from this offering, after deducting placement agent fees and offering expenses.

Basis of Presentation and Significant Accounting Policies (Policies)

12 Months Ended

Dec. 31, 2022

Accounting Policies [Abstract]

Basis of Presentation and Consolidation

Basis of presentation and consolidation

The Company manages its operations as a single reportable segment for the purposes of assessing performance and making operating decisions.

Use of Estimates

Use of estimates

Fair Value of Financial Instruments

Fair value of financial instruments

Concentrations of Credit Risk

Concentration of credit risk

Cash and Cash Equivalents

Cash and cash equivalents

Restricted cash

Refundable PDUFA fee

Restricted Cash

Restricted cash

Refundable PDUFA Fee

Refundable PDUFA fee

Short-Term Investments

Short-term investments

Property and Equipment

Property and equipment

Impairment of Long-Lived Assets

Impairment of long-lived assets

Goodwill and Acquired Intangible Asset

Goodwill and acquired intangible asset

Royalty Purchase Liability

Royalty purchase liability

Leases

Research and Development Expenses

Research and development expenses

Share-Based Compensation

Share-based compensation

The Company measures share-based awards at their grant-date fair value and records compensation expense on a straight-line basis over the vesting period of the awards.

Employee Benefit Plan

Income Taxes

Income taxes

Net Loss Per Share

Net loss per share

The following potentially dilutive securities have been excluded from the computation of diluted weighted-average shares of common stock outstanding, as they would be anti-dilutive:


	December 31,
	2022		2021
Stock options		5,783,185		4,970,975
Common stock warrants		550,661		550,661
		6,333,846		5,521,636

Basis of Presentation and Significant Accounting Policies (Tables)

12 Months Ended

Dec. 31, 2022

Accounting Policies [Abstract]

Dilutive Securities Excluded from Computation of Diluted Weighted Average Shares of Common Stock Outstanding

The following potentially dilutive securities have been excluded from the computation of diluted weighted-average shares of common stock outstanding, as they would be anti-dilutive:


	December 31,
	2022		2021
Stock options		5,783,185		4,970,975
Common stock warrants		550,661		550,661
		6,333,846		5,521,636

Fair Value Measurements (Tables)

12 Months Ended

Dec. 31, 2022

Fair Value Disclosures [Abstract]

Summary of Assets and Liabilities Measured at Fair Value on Recurring Basis

The following table presents the Company’s assets and liabilities that are measured at fair value on a recurring basis (amounts in thousands):


	December 31, 2022
	(Level 1)		(Level 2)		(Level 3)
Assets
Money market funds and U.S. Treasury obligations (included in cash equivalents)	$	3,467	$	—	$	—

Short-term investments
U.S. government agency securities	$	—	$	8,172	$	—
U.S. Treasury obligations		19,159		—		—
Total short-term investments	$	19,159	$	8,172	$	—


	December 31, 2021
	(Level 1)		(Level 2)		(Level 3)
Assets
Money market funds and U.S. Treasury obligations (included in cash equivalents)	$	12,346	$	—	$	—

Short-term investments
U.S. government agency securities	$	—	$	5,413	$	—
U.S. Treasury obligations		45,945		—		—
Total short-term investments	$	45,945	$	5,413	$	—

Property and Equipment (Tables)

12 Months Ended

Dec. 31, 2022

Property, Plant and Equipment [Abstract]

Schedule of Property and Equipment

Property and equipment consist of (amounts in thousands):


	December 31,			December 31,
	2022			2021
Laboratory equipment	$	1,398		$	1,379
Computer hardware and software		292			292
Leasehold improvements		270			264
Furniture and fixtures		179			179
Property and equipment, gross		2,139			2,114
Less: Accumulated depreciation and amortization		(1,701	)		(1,587	)
Property and equipment, net	$	438		$	527

Accrued Expenses (Tables)

12 Months Ended

Dec. 31, 2022

Payables and Accruals [Abstract]

Schedule of Accrued Expenses

Accrued expenses consist of (amounts in thousands):


	December 31,		December 31,
	2022		2021
Compensation and related benefits	$	2,655	$	2,038
Research and development expenses		6,764		5,360
Professional fees and other expenses		335		235
	$	9,754	$	7,633

Income Taxes (Tables)

12 Months Ended

Dec. 31, 2022

Income Tax Disclosure [Abstract]

Summary of Company's Loss Before Income Taxes

The Company’s loss before income taxes for the years ended December 31, 2022 and 2021 is as follows (in thousands):


	Year ended December 31,
	2022			2021
Domestic	$	(62,281	)	$	(80,587	)
Foreign		(11	)		53
	$	(62,292	)	$	(80,534	)

Summary of Company's Tax Provision (Benefit)

The Company’s tax benefit for the years ended December 31, 2022 and 2021 is summarized as follows (in thousands):


	Year ended December 31,
	2022			2021
Current
Federal	$	—		$	—
State		—			—
Foreign		—			—
		—			—
Deferred:
Federal		—			—
State		(70	)		—
Foreign		—			—
		(70	)		—
Total income tax benefit	$	(70	)	$	—

Summary of Effective Tax Rate of Reconciliation of Federal Income Tax Rate

A reconciliation of the federal income tax rate to the Company’s effective tax rate is as follows:


	Year ended December 31,
	2022				2021
Rate reconciliation:
Federal tax benefit at statutory rate		21.0		%		21.0		%
State tax, net of federal benefit		3.1				1.5
Net operating loss carryforwards		0.1				—
Change in tax rate		(9.6	)			—
Sale of royalty interest		(3.9	)			(16.9	)
Research and development		(0.8	)			0.4
Change in valuation allowance		(9.1	)			(5.6	)
Share-based compensation		(0.6	)			(0.3	)
Other		(0.1	)			(0.1	)
Total provision		0.1		%		—		%

Schedule of Significant Portions of Deferred Tax Assets and Liabilities

The tax effects of temporary differences that give rise to significant portions of the deferred tax assets and liabilities were as follows (in thousands):


	December 31,
	2022			2021
Deferred tax assets
Net operating loss carryforwards	$	41,697		$	43,111
Share-based compensation		3,731			2,874
Research and development credits		7,287			7,827
Capitalized research and development expenses		6,354			—
Accrued expenses and other		82			77
Gross deferred tax assets		59,151			53,889
Valuation allowance		(58,424	)		(52,787	)
Net deferred tax asset		727			1,102
Deferred tax liabilities
Accrued expenses and other		(348	)		(722	)
Acquired in-process research and development		(582	)		(653	)
Net deferred tax liabilities	$	(203	)	$	(273	)

Summary of Carryforwards of Federal, State and Foreign NOLs and Tax Credits

The following table summarizes carryforwards of federal, state and foreign NOLs as of December 31, 2022 and 2021, respectively (in thousands):


	December 31,
	2022		2021
Combined NOL Carryforwards:
Federal	$	162,335	$	145,265
State		184,382		167,252
Foreign		1,716		1,516

Royalty purchase liability (Tables)

12 Months Ended

Dec. 31, 2022

Royalty Purchase Liability [Abstract]

Schedule of Common Stock Warrants

Shares

Exercise Price

Initial Exercise Date

Expiration Date

New Milestone Warrant

293,686

13.62

6/7/2021

6/6/2027

Fourth Milestone Warrant

256,975

13.62

7/19/2021

7/18/2027

Leases (Tables)

12 Months Ended

Dec. 31, 2022

Leases [Abstract]

Summary of Supplemental Balance Sheet Information Related to Leases

Supplemental balance sheet information related to leases was as follows:


	December 31,		December 31,
	2022		2021
Operating Leases
Right-of-use lease assets	$	43	$	296

Lease liabilities, current		44		258
Lease liabilities, net of current portion		—		44
Total operating lease liabilities	$	44	$	302

Summary of Lease Costs and Other Information

The components of lease expense were as follows:


	Year ended December 31,
	2022		2021
Operating lease costs
Operating lease rental expense	$	259	$	303
Interest on lease liabilities		8		22
Total operating lease expense	$	267	$	325

Summary of Supplemental Cash Flow Information Related to Leases

Supplemental cash flow information related to leases was as follows:


	Year ended December 31,
	2022		2021
Cash paid for amounts included in the measurement of lease liabilities
Operating cash flows for operating leases	$	266	$	325
Right-of-use assets obtained in exchange for lease obligation
Operating leases		—		70

Lessee Operating Lease Liability Maturity

Our operating lease liabilities as of December 31, 2022 will mature, as follows (amounts in thousands):


2023		44
Total		44
Less: imputed interest		0
	$	44

Stockholders' Equity (Deficit) (Tables)

12 Months Ended

Dec. 31, 2022

Equity [Abstract]

Summary of Share-based Compensation Expense

Share-based compensation expense was as follows for the years ended December 31, 2022 and 2021 (in thousands):


	Year ended December 31,
	2022		2021
Research and development	$	2,596	$	2,919
General and administrative		4,568		4,312
	$	7,164	$	7,231

Summary of Activity Related to Stock Option Grants

The following table summarizes the activity related to stock option grants for the year ended December 31, 2022:


	Shares			Weighted average exercise price per share		Weighted- average remaining contractual life (years)
Outstanding at January 1, 2022		4,970,975		$	8.45	7.1
Granted		1,608,646			2.05
Exercised		(68,526	)		1.20
Forfeited		(727,910	)		7.63
Outstanding at December 31, 2022		5,783,185		$	6.86		6.8
Vested and exercisable at December 31, 2022		3,593,449		$	7.41		5.7
Vested and expected to vest at December 31, 2022		5,783,185		$	6.86		6.8

Summary of Fair Value of Each Option Grant Estimated Throughout Year Using Black-Scholes Option-pricing Model

The grant date fair value of each option grant was estimated throughout the year using the Black-Scholes option-pricing model using the following weighted-average assumptions:


	Year ended December 31,
	2022			2021
Expected term (in years)		6.2			6.2
Expected stock price volatility		92.7	%		89.5	%
Risk-free interest rate		2.07	%		0.79	%
Expected dividend yield		0	%		0	%

Loss Per Share (Tables)

12 Months Ended

Dec. 31, 2022

Earnings Per Share [Abstract]

Dilutive Securities Excluded from Computation of Diluted Weighted Average Shares of Common Stock Outstanding

The following potentially dilutive securities have been excluded from the computation of diluted weighted-average shares of common stock outstanding, as they would be anti-dilutive:


	December 31,
	2022		2021
Stock options		5,783,185		4,970,975
Common stock warrants		550,661		550,661
		6,333,846		5,521,636

Organization and description of business - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands		12 Months Ended
	Feb. 17, 2023	Dec. 31, 2022	Dec. 31, 2021
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items]
Retained Earnings (Accumulated Deficit)		$ (378,324)	$ (316,102)
Subsequent Event [Member]
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items]
Proceeds from common stock offering	$ 30,000
Common stock offering price	2.095%
Exercise price	$ 1.97
Net Proceeds from Common Stock and Warrants	$ 27,700
Sale of common stock in initial public offering, net of issuance costs, shares	14,320,000
Open Market Sale Agreement [Member]
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items]
Proceeds from common stock offering		$ 3,800
Sale of common stock in initial public offering, net of issuance costs, shares		2.0
Proceeds from issuance of remaining common stock		$ 37,800
Open Market Sale Agreement [Member] \| Jefferies L L C [Member]
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items]
Maximum Offering Issuance And Sale Expense Covered In Company Securities		200,000
Registration Payment Arrangement, Maximum Potential Consideration		$ 50,000

Basis of Presentation and Significant Accounting Policies - Additional Information (Detail) - USD ($)	1 Months Ended	12 Months Ended
	Nov. 30, 2018	Dec. 31, 2022	Dec. 31, 2021	Jun. 30, 2021	May 31, 2020
Summary Of Significant Accounting Policies [Line Items]
Restricted cash		$ 50,000
Refundable PDUFA Fee		$ 3,242,000	$ 0
Property, plant and equipment, depreciation methods		straight-line method
Impairment to goodwill		$ 0	0
Total agreed amount of royalty purchase price		139,635,000	128,063,000
Royalty purchase price		0	57,500,000
Reduction to research and development expense			400,000
Funding available under the grant		$ 1,100,000
Defined Contribution Plan, Employer Matching Contribution, Percent		100.00%
Percentage Of Employee Eligible For Compensation And Employer Contribution		4.00%
Defined Contribution Plan, Employer Discretionary Contribution Amount		$ 300,000	300,000
Royalty Agreements [Member]
Summary Of Significant Accounting Policies [Line Items]
Total agreed amount of royalty purchase price	$ 80,000,000.0
Royalty purchase price		$ 117,500,000
Outstanding amount of royalty agreement					$ 20,000,000.0
Amended Royalty Agreements
Summary Of Significant Accounting Policies [Line Items]
Total agreed amount of royalty purchase price					117,500,000
Outstanding amount of royalty agreement					37,500,000
Minimum [Member]
Summary Of Significant Accounting Policies [Line Items]
Property, plant and equipment, estimated useful lives		3 years
Maximum [Member]
Summary Of Significant Accounting Policies [Line Items]
Property, plant and equipment, estimated useful lives		5 years
U.S. Treasury Securities [Member]
Summary Of Significant Accounting Policies [Line Items]
Debt Securities, Available-for-Sale, Unrealized Loss		$ 8,000	$ 26,000
Fifth Tranche \| Royalty Agreements [Member]
Summary Of Significant Accounting Policies [Line Items]
Outstanding amount of royalty agreement				$ 20,000,000.0
Fifth Tranche \| Amended Royalty Agreements
Summary Of Significant Accounting Policies [Line Items]
Outstanding amount of royalty agreement					$ 20,000,000.0
First Tranche \| Royalty Agreements [Member]
Summary Of Significant Accounting Policies [Line Items]
Royalty purchase price	$ 20,000,000.0

Basis of Presentation and Significant Accounting Policies - Dilutive Securities Excluded from Computation of Diluted Weighted Average Shares of Common Stock (Details) - shares	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive Securities excluded from computation of earnings per share	6,333,846	5,521,636
Stock Options
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive Securities excluded from computation of earnings per share	5,783,185	4,970,975
Common Stock Warrants
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive Securities excluded from computation of earnings per share	550,661	550,661

Fair Value Measurements - Summary of Assets and Liabilities Measured at Fair Value on Recurring Basis (Detail) - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021
Level 1 [Member] \| Money Market Funds and U.S. Treasury Obligations
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Cash equivalents and restricted cash equivalents	$ 3,467	$ 12,346
Level 1 [Member] \| US Government Corporations and Agencies Securities [Member]
Marketable securities:
Marketable securities	0	0
Level 1 [Member] \| U.S. Treasury Securities [Member]
Marketable securities:
Marketable securities	19,159	45,945
Level 2 [Member] \| Money Market Funds and U.S. Treasury Obligations
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Cash equivalents and restricted cash equivalents	0	0
Level 2 [Member] \| US Government Corporations and Agencies Securities [Member]
Marketable securities:
Marketable securities	8,172	5,413
Level 2 [Member] \| U.S. Treasury Securities [Member]
Marketable securities:
Marketable securities	0	0
Level 3 [Member] \| Money Market Funds and U.S. Treasury Obligations
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Cash equivalents and restricted cash equivalents	0	0
Level 3 [Member] \| US Government Corporations and Agencies Securities [Member]
Marketable securities:
Marketable securities	0	0
Level 3 [Member] \| U.S. Treasury Securities [Member]
Marketable securities:
Marketable securities	0	0
Short-Term Investments [Member] \| Level 1 [Member]
Marketable securities:
Total	19,159	45,945
Short-Term Investments [Member] \| Level 2 [Member]
Marketable securities:
Total	8,172	5,413
Short-Term Investments [Member] \| Level 3 [Member]
Marketable securities:
Total	$ 0	$ 0

Fair Value Measurements - Additional Information (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Fair Value Disclosures [Abstract]
Changes in valuation techniques	$ 0	$ 0

Property and Equipment - Schedule of Property and Equipment (Detail) - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021
Property, Plant and Equipment [Line Items]
Total property and equipment	$ 2,139	$ 2,114
Less: accumulated depreciation and amortization	(1,701)	(1,587)
Property and equipment, net	438	527
Laboratory Equipment [Member]
Property, Plant and Equipment [Line Items]
Total property and equipment	1,398	1,379
Computer Equipment [Member]
Property, Plant and Equipment [Line Items]
Total property and equipment	292	292
Leasehold Improvements [Member]
Property, Plant and Equipment [Line Items]
Total property and equipment	270	264
Furniture and Fixtures [Member]
Property, Plant and Equipment [Line Items]
Total property and equipment	$ 179	$ 179

Property and Equipment, Net - Additional Information (Detail) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Property, Plant and Equipment [Abstract]
Depreciation and amortization expense	$ 114	$ 778

Accrued Expenses - Schedule of Accrued Expenses (Detail) - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021
Payables and Accruals [Abstract]
Compensation and related benefits	$ 2,655	$ 2,038
Research and development expenses	6,764	5,360
Professional fees and other expenses	335	235
Total accrued expenses	$ 9,754	$ 7,633

Royalty Purchase Liability - Additional Information (Details) - USD ($) $ in Thousands	1 Months Ended	12 Months Ended
	Nov. 30, 2018	Dec. 31, 2022	Dec. 31, 2021	Jul. 31, 2021	Jun. 30, 2021	May 31, 2020
Royalty Purchase Liability [Line Items]
Royalty purchase liability		$ 139,635	$ 128,063
Royalty purchase price		0	57,500
Noncash interest expense		11,571	7,194
Total agreed amount of royalty purchase price		$ 139,635	128,063
Warrant expiration term		6 years
Fair value of equity classified warrants		$ 4,700
Royalty Agreements
Royalty Purchase Liability [Line Items]
Royalty purchase liability	$ 80,000
Royalty purchase price		117,500
Noncash interest expense		$ 11,600	$ 7,200
Effective interest rate		9.60%
Outstanding amount of royalty agreement						$ 20,000
Total agreed amount of royalty purchase price	80,000
Royalty Agreements \| First Tranche
Royalty Purchase Liability [Line Items]
Royalty purchase price	$ 20,000
Royalty Agreements \| Fourth Tranche
Royalty Purchase Liability [Line Items]
Outstanding amount of royalty agreement				$ 37,500
Royalty Agreements \| Fifth Tranche
Royalty Purchase Liability [Line Items]
Outstanding amount of royalty agreement					$ 20,000
Amended Royalty Agreements
Royalty Purchase Liability [Line Items]
Royalty purchase liability						117,500
Outstanding amount of royalty agreement						37,500
Total agreed amount of royalty purchase price						117,500
Amended Royalty Agreements \| Fifth Tranche
Royalty Purchase Liability [Line Items]
Outstanding amount of royalty agreement						$ 20,000

Royalty purchase liability - Schedule of Common Stock Warrants (Details)	12 Months Ended
	Dec. 31, 2022 $ / shares shares
New Milestone Warrant
Class of Warrant or Right [Line Items]
Class of warrant, shares issued \| shares	293,686
Exercise price \| $ / shares	$ 13.62
Initial Exercise Date	Jun. 07, 2021
Expiration Date	Jun. 06, 2027
Fourth Milestone Warrant
Class of Warrant or Right [Line Items]
Class of warrant, shares issued \| shares	256,975
Exercise price \| $ / shares	$ 13.62
Initial Exercise Date	Jul. 19, 2021
Expiration Date	Jul. 18, 2027

Income Taxes - Summary of Company's Loss Before Income Taxes (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Income Tax Disclosure [Abstract]
Domestic	$ (62,281)	$ (80,587)
Foreign	(11)	53
Loss before income tax benefit	$ (62,292)	$ (80,534)

- Definition

Amount of income (loss) from continuing operations, including income (loss) from equity method investments, before deduction of income tax expense (benefit), and income (loss) attributable to noncontrolling interest.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 32
-Subparagraph (c)
-URI https://asc.fasb.org/extlink&oid=126901519&loc=d3e8933-108599

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 30
-Subparagraph (b)
-URI https://asc.fasb.org/extlink&oid=126901519&loc=d3e8906-108599

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 32
-Subparagraph (f)
-URI https://asc.fasb.org/extlink&oid=126901519&loc=d3e8933-108599

Reference 4: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 940
-SubTopic 20
-Section 25
-Paragraph 1
-URI https://asc.fasb.org/extlink&oid=126941158&loc=d3e41242-110953

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 22
-URI https://asc.fasb.org/extlink&oid=126901519&loc=d3e8736-108599

Reference 6: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 220
-SubTopic 10
-Section S99
-Paragraph 2
-Subparagraph (SX 210.5-03(10))
-URI https://asc.fasb.org/extlink&oid=126953954&loc=SL114868664-224227

Reference 7: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 944
-SubTopic 220
-Section S99
-Paragraph 1
-Subparagraph (SX 210.7-04(8))
-URI https://asc.fasb.org/extlink&oid=120400993&loc=SL114874131-224263

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 942
-SubTopic 235
-Section S99
-Paragraph 1
-Subparagraph (SX 210.9-05(b)(2))
-URI https://asc.fasb.org/extlink&oid=120399901&loc=d3e537907-122884

Reference 9: http://www.xbrl.org/2003/role/exampleRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 31
-URI https://asc.fasb.org/extlink&oid=126901519&loc=d3e8924-108599

Reference 10: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 942
-SubTopic 220
-Section S99
-Paragraph 1
-Subparagraph (SX 210.9-04(15))
-URI https://asc.fasb.org/extlink&oid=120399700&loc=SL114874048-224260

+ Details

Income Taxes - Summary of Company's Tax Provision (Benefit) (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Income Tax Disclosure [Abstract]
Current - Federal	$ 0	$ 0
Current - State	0	0
Current - Foreign	0	0
Current - Total	0	0
Deferred - Federal	0	0
Deferred - State	(70)	0
Deferred - Foreign	0	0
Deferred - Total	(70)	0
Total income tax benefit	$ 70	$ 0

Income Taxes - Summary of Effective Tax Rate of Reconciliation of Federal Income Tax Rate (Details)	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Income Tax Disclosure [Abstract]
Federal tax benefit at statutory rate	21.00%	21.00%
State tax, net of federal benefit	3.10%	1.50%
Net operating loss carryforwards	0.10%	0.00%
Change in tax rate	(9.60%)	0.00%
Sale of royalty interest	(3.90%)	(16.90%)
Research and development	(0.80%)	0.40%
Change in valuation allowance	(9.10%)	(5.60%)
Share-based compensation	(0.60%)	(0.30%)
Other	(0.10%)	(0.10%)
Total provision	0.10%	0.00%

Income Taxes - Schedule of Significant Portions of Deferred Tax Assets and Liabilities (Details) - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021
Deferred tax assets
Net operating loss carryforwards	$ 41,697	$ 43,111
Share-based compensation	3,731	2,874
Research & development credits	7,287	7,827
Capitalized research and development expenses	6,354	0
Accrued expenses and other	82	77
Gross deferred tax assets	59,151	53,889
Valuation allowance	(58,424)	(52,787)
Net deferred tax asset	727	1,102
Deferred tax liabilities
Accrued expenses and other	(348)	(722)
Acquired in-process research and development	(582)	(653)
Net deferred tax liabilities	$ (203)	$ (273)

Income Taxes - Additional Information (Details) - USD ($) $ in Millions	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Operating Loss Carryforwards [Line Items]
Percentage of maximum offset indefinite lived deferred tax liability for net operating loss	80.00%
Research and development costs	$ 28.3
Tax credit carryforward, amount		$ 63.7
Increase in valuation allowance	$ 5.6	4.5
Tax credit carryforward, amount	50.00%
Accrued interest and penalties	$ 0.0
Minimum [Member]
Operating Loss Carryforwards [Line Items]
Amortization periods, capitalized research and development expenses	5 years
Maximum [Member]
Operating Loss Carryforwards [Line Items]
Amortization periods, capitalized research and development expenses	15 years
Research and Development
Operating Loss Carryforwards [Line Items]
Tax credit carryforward, amount		1.4
Research and Development \| State
Operating Loss Carryforwards [Line Items]
Tax credit carryforward, amount	$ 7.3
Research and Development \| Foreign
Operating Loss Carryforwards [Line Items]
Tax credit carryforward, amount		$ 2.7

Income Taxes - Summary of Carryforwards of Federal, State and Foreign NOLs and Tax Credits (Details) - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021
Federal
Operating Loss Carryforwards [Line Items]
Combined NOL Carryforwards	$ 162,335	$ 145,265
State
Operating Loss Carryforwards [Line Items]
Combined NOL Carryforwards	184,382	167,252
Foreign
Operating Loss Carryforwards [Line Items]
Combined NOL Carryforwards	$ 1,716	$ 1,516

Collaborations - Additional Information (Detail) - $ / shares	Dec. 31, 2022	Dec. 31, 2021
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items]
Common stock, par value	$ 0.001	$ 0.001

Leases - Additional Information (Detail) - USD ($) $ in Thousands	1 Months Ended
	Oct. 31, 2022	Dec. 31, 2022	Oct. 30, 2022	Dec. 31, 2021
Lessee Lease Description [Line Items]
Operating lease expiration	2004-07
Operating Lease, Liability, Noncurrent		$ 0		$ 44
Lessee, Operating Lease, Discount Rate		5.30%
Right-of-use lease assets		$ 43		296
Operating lease, liability		$ 44	$ 1,600	$ 302

Leases - Summary of Balance Sheet Information Related to Leases (Details) - USD ($) $ in Thousands	Dec. 31, 2022	Oct. 30, 2022	Dec. 31, 2021
Leases [Abstract]
Right-of-use lease assets	$ 43		$ 296
Lease liabilities	44		258
Lease liabilities, net of current portion	0		44
Total operating lease liabilities	$ 44	$ 1,600	$ 302

Leases - Summary of Components of Lease Expense (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Leases [Abstract]
Operating lease rental expense	$ 259	$ 303
Interest on lease liabilities	8	22
Total operating lease expense	$ 267	$ 325

Leases - Summary of Supplemental Cash Flow Information Related to Lease (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Leases [Abstract]
Operating cash flows from operating leases	$ 266	$ 325
Right Of Use Assets Obtained In Exchange For Lease Obligations [Abstract]
Operating leases	$ 0	$ 70

Leases - Summary of Operating Leases Liabilities Maturities (Details) - USD ($) $ in Thousands	Dec. 31, 2022	Oct. 30, 2022	Dec. 31, 2021
Leases [Abstract]
2023	$ 44
Total	44
Less: imputed interest	0
Operating lease, liability	$ 44	$ 1,600	$ 302

Commitments (Additional Information) (Details)	Dec. 31, 2022 Claim
Commitments and Contingencies Disclosure [Abstract]
Number of pending claims or legal actions	0

Stockholders' Equity (Deficit) - Additional Information (Details) - USD ($)	1 Months Ended		12 Months Ended
	Dec. 31, 2020	Nov. 30, 2019	Dec. 31, 2022	Dec. 31, 2021
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Aggregate value of common stock sale under ATM offering			$ 37,800,000
Expected dividend yield			0.00%	0.00%
Unrecognized equity-based compensation expense related to restricted stock			$ 9,500,000
Acceleration resulted in additional expense			$ 7,164,000	$ 7,231,000
Weighted average period of unrecognized compensation costs			2 years 1 month 6 days
Weighted average grant date fair value per share			$ 1.57	$ 7.73
Stock options outstanding			5,783,185	4,970,975
Potential dilutive securities excluded from computation of diluted net loss per common share			6,333,846	5,521,636
Performance-based options forfeited			727,910
Aggregate Intrinsic Value, Outstanding			$ 83,000,000
Aggregate Intrinsic Value, Exercisable			$ 34,000,000
At-the-market Offering [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Aggregate value of common stock sale under ATM offering	$ 50,000,000.0
Commission to agent as percentage of ATM offering proceeds			3.00%
Shares available for issuance			1,982,773
Weighted Average Price Of Shares Purchase			$ 2.00
Proceeds from issuance of common stock			$ 3,800,000
Common Stock [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Shares available for issuance			1,429,544
2019 Incentive Award Plan \| Common Stock [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Shares available for future issuance		1,948,970
Percentage of cumulative increase in number of shares for future issuance		4.00%
Shares available for issuance		1,140,402	1,058,350
2019 Employee Stock Purchase Plan
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Shares available for issuance			285,100
2019 Employee Stock Purchase Plan \| Common Stock [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Percentage of cumulative increase in number of shares for future issuance		1.00%
Shares available for issuance		264,587	1,006,084
Shares of Common stock initially available for issuance under the ESPP		243,621
2012 Equity Incentive Plan
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Remaining vesting period			4 years
Share-Based Compensation Arrangement by Share-Based Payment Award, Terms of Award			10 years
Shares of Common stock initially available for issuance under the ESPP			0
Aggregate Intrinsic Value, Outstanding			$ 1,888,574
Maximum [Member] \| 2019 Incentive Award Plan \| Common Stock [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Share Based Payment Award Terms Of Award		14,130,029
Maximum [Member] \| 2019 Employee Stock Purchase Plan \| Common Stock [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Share Based Payment Award Terms Of Award		3,288,886

Stockholders' Equity (Deficit) - Schedule of Equity-based Compensation Expense (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]
Equity-based compensation expense	$ 7,164	$ 7,231
Research and Development [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]
Equity-based compensation expense	2,596	2,919
General and Administrative [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]
Equity-based compensation expense	$ 4,568	$ 4,312

Stockholders' Equity (Deficit) - Summary of Stock Option Activity (Details) - $ / shares	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Share-Based Payment Arrangement [Abstract]
Number of Options, Outstanding, Beginning Balance	4,970,975
Number of options, Granted	1,608,646
Number of options, Exercised	(68,526)
Number of options, Forfeited	(727,910)
Number of Options, Outstanding, Ending Balance	5,783,185	4,970,975
Number of Options, Exercisable	3,593,449
Number of Options, expected to vest	5,783,185
Weighted Average Exercise Price per Share, Outstanding, Beginning Balance	$ 8.45
Weighted Average Exercise Price per Share, Granted	2.05
Weighted Average Exercise Price per Share, Exercised	1.20
Weighted Average Exercise Price per Share, Forfeited	7.63
Weighted Average Exercise Price per Share, Outstanding, Ending Balance	6.86	$ 8.45
Weighted Average Exercise Price per Share, Exercisable	7.41
Weighted Average Exercise Price per Share, expected to vest	$ 6.86
Weighted Average Remaining Contractual Term, Outstanding	6 years 9 months 18 days	7 years 1 month 6 days
Weighted Average Remaining Contractual Term, Exercisable	5 years 8 months 12 days
Weighted Average Remaining Contractual Term, Expected to vest	6 years 9 months 18 days

Stockholders' Equity (Deficit) - Summary of Fair Value of Each Option Grant Estimated Throughout Year Using Black-Scholes Option-pricing Model (Details)	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Share-Based Payment Arrangement [Abstract]
Expected life of options	6 years 2 months 12 days	6 years 2 months 12 days
Expected volatility of underlying stock	92.70%	89.50%
Risk-free interest rate	2.07%	0.79%
Expected dividend yield	0.00%	0.00%

Loss Per Share - Schedule of Basic and Diluted Net Loss Per Share (Detail) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Earnings Per Share [Abstract]
Net loss	$ (62,222)	$ (80,534)

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

+ References

+ Details

Loss Per Share - Potential Dilutive Securities Excluded from Computation of Diluted Net Loss Per Common Share (Detail) - shares	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Potential dilutive securities excluded from computation of diluted net loss per common share	6,333,846	5,521,636

Stockholders' Equity - Additional Information (Detail) - $ / shares	Dec. 31, 2022	Dec. 31, 2021
Class Of Stock [Line Items]
Common stock, par value	$ 0.001	$ 0.001

401(k) Plan - Additional Information (Detail) - USD ($) $ in Millions	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Defined Contribution Plan Disclosure [Line Items]
Employer matching contribution of employee contribution, percent	100.00%
Employer discretionary contribution amount	$ 0.3	$ 0.3

Related Party Transactions - Additional Information (Details) - USD ($) $ in Millions	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
IntellectMap
Related Party Transaction [Line Items]
Advisory services fees	$ 0.2	$ 0.2

Subsequent Events (Additional Information) (Details) - USD ($) $ / shares in Units, $ in Millions	Feb. 17, 2023	Dec. 31, 2022	Dec. 31, 2021
Subsequent Event [Line Items]
Common Stock, Shares, Issued		28,510,066	26,458,767
Warrant expiration term		6 years
Subsequent Event [Member]
Subsequent Event [Line Items]
Offering price	$ 2.095
Gross proceeds	$ 30.0
Exercise price	$ 1.97
Warrant expiration term	5 years
Net proceeds	$ 27.7
Subsequent Event [Member] \| Common Stock [Member]
Subsequent Event [Line Items]
Common Stock, Shares, Issued	14,320,000
Shares available for future issuance	14,320,000