Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2023 | Nov. 10, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2023 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q3 | |
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 | |
Entity Ex Transition Period | true | |
Title of 12(b) Security | Common Stock,$0.001 par value per share | |
Trading Symbol | GRTX | |
Security Exchange Name | NASDAQ | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 54,392,170 | |
Entity File Number | 001-39114 | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 46-1454898 | |
Entity Address, Address Line One | 45 Liberty Blvd, Suite 230 | |
Entity Address, City or Town | Malvern | |
Entity Address, State or Province | PA | |
Entity Address, Postal Zip Code | 19355 | |
City Area Code | 610 | |
Local Phone Number | 725-1500 | |
Document Quarterly Report | true | |
Document Transition Report | false |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 24,379,000 | $ 4,266,000 |
Short-term investments | 3,985,000 | 27,331,000 |
Restricted cash | 50,000 | 50,000 |
Refundable PDUFA Fee | 0 | 3,242,000 |
Prepaid expenses and other current assets | 2,831,000 | 3,646,000 |
Total current assets | 31,245,000 | 38,535,000 |
Property and equipment, net | 198,000 | 438,000 |
Acquired intangible asset | 2,258,000 | 2,258,000 |
Goodwill | 881,000 | 881,000 |
Right-of-use lease assets | 1,249,000 | 43,000 |
Other assets | 1,948,000 | 1,881,000 |
Total assets | 37,779,000 | 44,036,000 |
Current liabilities: | ||
Accounts payable | 3,715,000 | 3,581,000 |
Accrued expenses | 8,784,000 | 9,754,000 |
Lease liabilities | 131,000 | 44,000 |
Total current liabilities | 12,630,000 | 13,379,000 |
Royalty purchase liability | 150,344,000 | 139,635,000 |
Lease liabilities, net of current portion | 1,155,000 | 0 |
Deferred tax liability | 203,000 | 203,000 |
Total liabilities | 164,332,000 | 153,217,000 |
Stockholders' deficit: | ||
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; 53,734,123 and 28,510,066 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively | 54,000 | 28,000 |
Additional paid-in capital | 305,212,000 | 269,137,000 |
Accumulated other comprehensive loss | 0 | (22,000) |
Accumulated deficit | (431,819,000) | (378,324,000) |
Total stockholders' deficit | (126,553,000) | (109,181,000) |
Total liabilities and stockholders' deficit | $ 37,779,000 | $ 44,036,000 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Sep. 30, 2023 | Dec. 31, 2022 |
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 (shares) | 200,000,000 | 200,000,000 |
Common stock, shares issued (shares) | 53,734,123 | 28,510,066 |
Common stock, shares outstanding (shares) | 53,734,123 | 28,510,066 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Operating expenses: | ||||
Research and development | $ 6,093 | $ 8,105 | $ 20,926 | $ 22,848 |
General and administrative | 4,994 | 4,853 | 20,849 | 15,193 |
Restructuring costs | 2,309 | 0 | 2,309 | 0 |
Loss from operations | (13,396) | (12,958) | (44,084) | (38,041) |
Other income (expenses): | ||||
Interest income | 411 | 171 | 1,300 | 256 |
Interest expense | 2,087 | (3,245) | (10,709) | (8,247) |
Foreign currency loss | (1) | (1) | (2) | (2) |
Net loss | $ (15,073) | $ (16,033) | $ (53,495) | $ (46,034) |
Net loss per share of common stock, basic | $ (0.33) | $ (0.6) | $ (1.3) | $ (1.72) |
Net loss per share of common stock, diluted | $ (0.33) | $ (0.6) | $ (1.3) | $ (1.72) |
Weighted-average shares of common stock outstanding, basic | 45,477,952 | 26,823,546 | 41,234,679 | 26,798,348 |
Weighted-average shares of common stock outstanding, diluted | 45,477,952 | 26,823,546 | 41,234,679 | 26,798,348 |
CONSOLIDATED STATEMENTS OF COMP
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Statement of Comprehensive Income [Abstract] | ||||
Net loss | $ (15,073) | $ (16,033) | $ (53,495) | $ (46,034) |
Unrealized gain (loss) on short-term investments | (5) | 17 | 22 | (79) |
Comprehensive loss | $ (15,078) | $ (16,016) | $ (53,473) | $ (46,113) |
CONSOLIDATED STATEMENTS OF CHAN
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' DEFICIT - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Accumulated Other Comprehensive income (loss) | Accumulated Deficit |
Balance at Dec. 31, 2021 | $ (58,004) | $ 26 | $ 258,086 | $ (14) | $ (316,102) |
Balance (in shares) at Dec. 31, 2021 | 26,458,767 | ||||
Share-based compensation expense | 1,848 | 1,848 | |||
Exercise of stock options | 58 | 58 | |||
Exercise of stock options, shares | 46,358 | ||||
Sale of common stock and common stock warrants in registered direct offering, net of issuance costs | (1,117) | $ 1 | 1,116 | ||
Sale of common stock and common stock warrants in registered direct offering, net of issuance costs, shares | 314,296 | ||||
Unrealized gain (loss) on short-term investments | (47) | (47) | |||
Net loss | (15,443) | (15,443) | |||
Balance at Mar. 31, 2022 | (70,471) | $ 27 | 261,108 | (61) | (331,545) |
Balance (in shares) at Mar. 31, 2022 | 26,819,421 | ||||
Balance at Dec. 31, 2021 | (58,004) | $ 26 | 258,086 | (14) | (316,102) |
Balance (in shares) at Dec. 31, 2021 | 26,458,767 | ||||
Unrealized gain (loss) on short-term investments | (79) | ||||
Net loss | (46,034) | ||||
Balance at Sep. 30, 2022 | (97,502) | $ 27 | 264,700 | (93) | (362,136) |
Balance (in shares) at Sep. 30, 2022 | 26,831,589 | ||||
Balance at Mar. 31, 2022 | (70,471) | $ 27 | 261,108 | (61) | (331,545) |
Balance (in shares) at Mar. 31, 2022 | 26,819,421 | ||||
Share-based compensation expense | 1,830 | 1,830 | |||
Exercise of stock options | 2 | 2 | |||
Exercise of stock options, shares | 2,168 | ||||
Unrealized gain (loss) on short-term investments | (49) | (49) | |||
Net loss | (14,558) | (14,558) | |||
Balance at Jun. 30, 2022 | (83,246) | $ 27 | 262,940 | (110) | (346,103) |
Balance (in shares) at Jun. 30, 2022 | 26,821,589 | ||||
Share-based compensation expense | 1,750 | 1,750 | |||
Exercise of stock options | 10 | 10 | |||
Exercise of stock options, shares | 10,000 | ||||
Unrealized gain (loss) on short-term investments | 17 | ||||
Net loss | (16,033) | (16,033) | |||
Balance at Sep. 30, 2022 | (97,502) | $ 27 | 264,700 | (93) | (362,136) |
Balance (in shares) at Sep. 30, 2022 | 26,831,589 | ||||
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 | |||
Share-based compensation expense | $ 1,458 | 1,458 | |||
Exercise of stock options | 184 | $ 1 | 183 | ||
Exercise of stock options, shares | 76,767 | ||||
Sale of common stock and common stock warrants in registered direct offering, net of issuance costs | (27,598) | $ (14) | (27,584) | ||
Sale of common stock and common stock warrants in registered direct offering, net of issuance costs, shares | (14,320,000) | ||||
Unrealized gain (loss) on short-term investments | 38 | 38 | |||
Net loss | (17,710) | (17,710) | |||
Balance at Mar. 31, 2023 | (97,613) | $ 43 | 298,362 | 16 | (396,034) |
Balance (in shares) at Mar. 31, 2023 | 42,906,833 | ||||
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 | |||
Exercise of stock options, shares | 78,600 | ||||
Unrealized gain (loss) on short-term investments | $ 22 | ||||
Net loss | (53,495) | ||||
Balance at Sep. 30, 2023 | $ (126,553) | $ 54 | 305,212 | (431,819) | |
Balance (in shares) at Sep. 30, 2023 | 53,734,123 | 53,734,123 | |||
Balance at Mar. 31, 2023 | $ (97,613) | $ 43 | 298,362 | 16 | (396,034) |
Balance (in shares) at Mar. 31, 2023 | 42,906,833 | ||||
Share-based compensation expense | 1,525 | 1,525 | |||
Exercise of common stock warrants (Shares) | 920,000 | ||||
Exercise of common stock warrants | 1,812 | $ 1 | 1,811 | ||
Unrealized gain (loss) on short-term investments | (11) | (11) | |||
Net loss | (20,712) | (20,712) | |||
Balance at Jun. 30, 2023 | (114,999) | $ 44 | 301,698 | 5 | (416,746) |
Balance (in shares) at Jun. 30, 2023 | 43,826,833 | ||||
Share-based compensation expense | 1,390 | 1,390 | |||
Exercise of stock options | 4 | 4 | |||
Exercise of stock options, shares | 1,833 | ||||
Sale of common stock and common stock warrants in registered direct offering, net of issuance costs | 1,933 | $ 10 | 1,923 | ||
Sale of common stock and common stock warrants in registered direct offering, net of issuance costs, shares | 9,805,457 | ||||
Exercise of common stock warrants (Shares) | 100,000 | ||||
Exercise of common stock warrants | 197 | 197 | |||
Unrealized gain (loss) on short-term investments | (5) | $ (5) | |||
Net loss | (15,073) | (15,073) | |||
Balance at Sep. 30, 2023 | $ (126,553) | $ 54 | $ 305,212 | $ (431,819) | |
Balance (in shares) at Sep. 30, 2023 | 53,734,123 | 53,734,123 |
CONSOLIDATED STATEMENTS OF CH_2
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY (DEFICIT) (Parenthetical) $ in Millions | 3 Months Ended |
Mar. 31, 2023 USD ($) | |
Statement of Stockholders' Equity [Abstract] | |
Sale of common stock in registered direct offering, issuance costs | $ 2,403 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Operating activities: | ||
Net loss | $ (53,495,000) | $ (46,034,000) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 44,000 | 88,000 |
Noncash interest expense | 10,709,000 | 8,247,000 |
Share-based compensation expense | 4,373,000 | 5,428,000 |
Gain on disposal of property and equipment | (72,000) | 0 |
Changes in operating assets and liabilities: | ||
Refundable PDUFA fee | 3,242,000 | 0 |
Prepaid expenses and other current assets | 1,133,000 | 4,077,000 |
Other assets | 37,000 | 60,000 |
Accounts payable | 134,000 | (1,453,000) |
Accrued expense | (970,000) | 299,000 |
Other liabilities | (68,000) | (193,000) |
Cash used in operating activities | (34,933,000) | (29,481,000) |
Investing activities: | ||
Purchases of short-term investments | (22,627,000) | (46,920,000) |
Proceeds from sales of short-term investments | 45,995,000 | 68,160,000 |
Purchase of property and equipment | (50,000) | (25,000) |
Cash provided by (used in) investing activities | 23,318,000 | 21,215,000 |
Financing activities: | ||
Proceeds From sale of common stock and common stock warrants in registered direct offering | 27,598,000 | 0 |
Proceeds from the sale of common stock under the Open Market Sale Agreement | 1,933,000 | 1,117,000 |
Proceeds from the exercise of common stock warrants | 2,009,000 | 0 |
Proceeds from exercise of stock options | 188,000 | 70,000 |
Cash provided by financing activities | 31,728,000 | 1,187,000 |
Net increase (decrease) in cash, cash equivalents and restricted cash | 20,113,000 | (7,079,000) |
Cash, cash equivalents and restricted cash at beginning of period | 4,316,000 | 19,859,000 |
Cash, cash equivalents and restricted cash at end of period | 24,429,000 | 12,780,000 |
Supplemental schedule of non-cash investing and financing activities: | ||
Right-of-use asset obtained in exchange for lease obligation | 1,310,000 | 0 |
Sale of property and equipment in exchange for prepaid future services | $ 319,000 | $ 0 |
Organization and description of
Organization and description of business | 9 Months Ended |
Sep. 30, 2023 | |
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 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, and cisplatin-induced kidney damage in patients with cancer. The U.S. Food and Drug Administration (FDA) has granted Fast Track and Breakthrough Therapy designations to avasopasem for the reduction of SOM induced by radiotherapy. 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). The FDA and European Medicines Agency (EMA) have granted orphan drug designation and orphan medicinal product designation, respectively, to rucosopasem for the treatment of pancreatic cancer. On August 9, 2023, the Company announced that it had received a Complete Response Letter (CRL) from the FDA regarding the Company’s New Drug Application (NDA) for avasopasem for radiotherapy-induced SOM in patients with HNC undergoing standard-of-care treatment. In the CRL, the FDA communicated that the results from the Phase 3 ROMAN trial together with the supporting data from the Phase 2b GT-201 trial were not sufficiently persuasive to establish substantial evidence of avasopasem’s effectiveness and safety for reducing SOM in patients with HNC. FDA stated that results from an additional clinical trial will be required for resubmission. The Company requested a Type A meeting with the FDA to understand the FDA’s rationale for its decision and discuss next steps to support an NDA resubmission seeking approval of avasopasem. In the Type A meeting held on September 28, 2023, and in the subsequently received meeting minutes, the FDA reiterated the need for an additional Phase 3 trial to support resubmission of the NDA. The Company is exploring potential strategic alternatives, as it is not feasible to conduct an additional trial with the Company’s current resources. In connection with the CRL announcement, on August 9, 2023, the Company further announced that it would focus resources on exploring a potential approval path for avasopasem in radiotherapy-induced SOM, progressing its ongoing clinical trials for rucosopasem, and concurrently evaluating strategic alternatives, including partnering, for the continued development of avasopasem and rucosopasem. As a result, the Company wound down its commercial readiness efforts for avasopasem and reduced headcount across several departments. This reduction in force, which was approved by the Company’s Board of Directors, reduced the Company’s workforce by 22 employees, or approximately 70 %, as of August 9, 2023 (the Workforce Reduction). The decision was based on cost-reduction initiatives intended to reduce operating expenses. In addition to developing avasopasem for the reduction of normal tissue toxicity from radiotherapy, the Company has been 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 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 (GRECO-1) and a Phase 2b trial of rucosopasem in combination with SBRT in patients with LAPC (GRECO-2). On October 31, 2023, the Company announced the decision to halt the GRECO-1 and GRECO-2 trials, following a futility analysis of the GRECO-2 trial. The analysis indicated that the trial was unlikely to succeed as designed. The Company believes this decision will enable the Company to conserve cash while it continues to explore potential strategic alternatives with the goal of maximizing shareholder value. The Company has engaged Stifel, Nicolaus & Company, Inc. (Stifel), as its financial advisor, to assist in reviewing strategic alternatives. Such alternatives may include a merger, sale, divestiture of assets, licensing, or other strategic transaction. Liquidity The Company has incurred recurring losses and negative cash flows from operations since inception and has an accumulated deficit of $ 431.8 million as of September 30, 2023. The Company expects its existing cash, cash equivalents and short-term investments as of September 30, 2023, taking into account the discontinuation of the GRECO-1 and GRECO-2 trials, will enable the Company to fund its operating expenses and capital expenditure requirements into 2025. The Company has engaged Stifel, as its financial advisor, to assist in reviewing strategic alternatives with the goal of maximizing value for its shareholders. Such alte rnatives may include a merger, sale, divestiture of assets, licensing, or other strategic transaction. If the Company is unable to undertake any strategic alternative, it may be required to cease operations altogether. |
Basis of Presentation and Signi
Basis of Presentation and Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Significant Accounting Policies | 2. Basis of presentation and significant accounting policies The summary of significant accounting policies disclosed in the Company’s annual consolidated financial statements for the years ended December 31, 2022 and 2021 included in the Company’s annual report on Form 10-K filed with the SEC on March 8, 2023 have not materially changed, except as set forth below. Basis of presentation and consolidation The accompanying unaudited interim consolidated financial statements have been prepared in conformity with U.S. generally accepted accounting principles (U.S. GAAP) for interim financial information. 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). In the opinion of management, the accompanying interim consolidated financial statements include all normal and recurring adjustments (which consist primarily of accruals, estimates and assumptions that impact the financial statements) considered necessary to present fairly the Company’s financial position as of September 30, 2023 and its results of operations for the three and nine months ended September 30, 2023 and 2022, and statements of changes in stockholders’ deficit and cash flows for the nine months ended September 30, 2023 and 2022. Operating results for the three and nine months ended September 30, 2023 are not necessarily indicative of the results that may be expected for the year ending December 31, 2023, or for any future period. The interim consolidated financial statements, presented herein, do not contain the required disclosures under U.S. GAAP for annual financial statements. Therefore, these interim consolidated financial statements should be read in conjunction with the annual audited consolidated financial statements and related notes as of and for the year ended December 31, 2022 , included in the Company’s annual report on Form 10-K and filed with the SEC on March 8, 2023. Use of estimates The preparation of unaudited interim 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 unaudited interim 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 unaudited interim consolidated financial statements in the period they are determined to be necessary. Significant areas that require management’s estimates include share-based compensation assumptions, royalty purchase liability assumptions and accrued research and development expenses. 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 September 30, 2023 and December 31, 2022 consisted of bank deposits, U.S. Treasury obligations, U.S. government agency securities, and a money market mutual fund invested in U.S. Treasury obligations. We maintain a portion of our cash and cash equivalents in accounts with major financial institutions, and our deposits at these institutions exceed insured limits. 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 September 30, 2023. The Company has recorded this deposit and accumulated interest thereon as restricted cash on its consolidated balance sheet. In October 2023, the commercial credit card agreement was terminated by the Company and the bank removed the restriction on the cash. 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 was granted a small business waiver of this PDUFA fee from the FDA. The Company received the refund of the PDUFA fee from the FDA in May 2023. 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. Restructuring Costs As a result of the Workforce Reduction, the Company incurred total restructuring-related charges of $ 2.3 million during the three months ended September 30, 2023. See Note 10. As of September 30, 2023, $ 1.6 million of the total restructuring-related charges remain unpaid and are included in accrued expenses in the accompanying consolidated balance sheet. See Note 5. Net loss per share The Company uses the two-class method to compute net income per common share during periods the Company realizes net income and has securities that entitle the holder to participate in dividends and earnings of the Company. The two-class method is not applicable during periods with a net loss, as the participating securities are not obligated to fund losses. 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: September 30, 2023 2022 Stock options 6,387,121 6,006,957 Common stock warrants 13,850,661 550,661 20,237,782 6,557,618 Recent Accounting Pronouncements In August 2020, FASB issued ASU 2020-06, “Debt-Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging-Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity,” which simplifies accounting for convertible instruments by removing major separation models required under current GAAP. The ASU removes certain settlement conditions that are required for equity contracts to qualify for the derivative scope exception, and it also simplifies the diluted earnings per share calculation in certain areas. This guidance is effective for fiscal years beginning after December 15, 2023, including interim periods therein. Early adoption is permitted. The Company adopted this ASU on January 1, 2023. There was no impact to the Company's consolidated financial statements. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2023 | |
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): September 30, 2023 (Level 1) (Level 2) (Level 3) Assets Money market funds and U.S. Treasury obligations $ 23,511 $ — $ — Short-term investments U.S. government agency securities $ — $ 1,993 $ — U.S. Treasury obligations 1,992 — — Total short-term investments $ 1,992 $ 1,993 $ — December 31, 2022 (Level 1) (Level 2) (Level 3) Assets Money market funds and U.S. Treasury obligations $ 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 $ — There were no changes in valuation techniques during the nine months ended September 30, 2023 . 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. |
Property and Equipment
Property and Equipment | 9 Months Ended |
Sep. 30, 2023 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | 4. Property and equipment Property and equipment consist of (amounts in thousands): September 30, December 31, 2023 2022 Laboratory equipment $ 571 $ 1,398 Computer hardware and software 305 292 Leasehold improvements 36 270 Furniture and fixtures 179 179 Property and equipment, gross 1,091 2,139 Less: Accumulated depreciation and amortization ( 893 ) ( 1,701 ) Property and equipment, net $ 198 $ 438 Depreciation and amortization expense was $ 44,000 and $ 0.1 million for the nine months ended September 30, 2023 and 2022 , respectively. |
Accrued Expenses
Accrued Expenses | 9 Months Ended |
Sep. 30, 2023 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | 5. Accrued expenses Accrued expenses consist of (amounts in thousands): September 30, December 31, 2023 2022 Compensation and related benefits $ 1,262 $ 2,655 Restructuring costs 1,584 — Research and development expenses 5,609 6,764 Professional fees and other expenses 329 335 $ 8,784 $ 9,754 |
Royalty Purchase Liability
Royalty Purchase Liability | 9 Months Ended |
Sep. 30, 2023 | |
Royalty Purchase Liability [Abstract] | |
Royalty Purchase Liability | 6. Royalty purchase liability Pursuant to our 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), 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 September 30, 2023 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. The Company updated the assumptions underlying the calculation of interest expense on the royalty purchase liability based on the CRL received from the FDA in August 2023 on the Company's NDA for avasopasem for radiotherapy-induced SOM. The Company recogni zed $ 10.7 million and $ 8.2 million in noncash interest expense during the nine months ended September 30, 2023 and 2022, respectively. As of September 30, 2023 , the effective interest rate was 5.6 %. 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 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. |
Leases
Leases | 9 Months Ended |
Sep. 30, 2023 | |
Leases [Abstract] | |
Leases | 7. Leases The Company has a non-cancelable operating lease for office space in Malvern, Pennsylvania which, as of September 30, 2023, has a remaining lease term of approximately 7.0 years. The discount rate used to account for the Company’s operating leases under FASB ASU No. 2018-11, Leases (Topic 842) , was the Company’s estimated incremental borrowing rate of 5.4 %. Supplemental balance sheet information related to leases was as follows: September 30, December 31, 2023 2022 Operating Leases Right-of-use lease assets $ 1,249 $ 43 Lease liabilities, current 131 44 Lease liabilities, net of current portion 1,155 — Total operating lease liabilities $ 1,286 $ 44 Lease cost, as presented below, includes costs associated with leases for which right-of-use (ROU) assets have been recognized as well as short-term leases. The components of lease expense were as follows: Three months ended Nine months ended 2023 2022 2023 2022 Operating lease costs Operating lease rental expense $ 54 $ 65 $ 138 $ 201 Total operating lease expense $ 54 $ 65 $ 138 $ 201 Supplemental cash flow information related to leases was as follows: Nine months ended 2023 2022 Cash paid for amounts included in the measurement of lease liabilities Operating cash flows for operating leases $ 97 $ 200 Right-of-use assets obtained in exchange for lease obligation Operating leases 1,310 — Future minimum rental payments under the Company’s non-cancelable operating lease liabilities as of September 30, 2023 (amounts in thousands): Remainder of 2023 53 2024 195 2025 217 2026 220 2027 and after 857 Total 1,542 Less: imputed interest ( 256 ) $ 1,286 |
Equity
Equity | 9 Months Ended |
Sep. 30, 2023 | |
Equity [Abstract] | |
Equity | 8. Equity Equity offerings In February 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, and received net proceeds of $ 27.6 million after deducting placement agent fees and offering expenses. The warrants are equity-classified, 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. During the nine months ended September 30, 2023 , warrants were exercised in exchange for 1,020,000 shares of common stock resulting in proceeds of $ 2.0 million. In December 2020, the Company entered into an Open Market Sale Agreement (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 nine months ended September 30, 2023 , 9,805,457 shares were sold under the Sales Agreement at a weighted average price per share of $0.21, resulting in net proceeds to the Company after deducting fees, commissions and other expenses related to the offering of approximately $ 1.9 million. There is approximately $ 35.6 million of available capacity under the Sales Agreement as of the date of this Quarterly Report on Form 10-Q. Share-based compensation Equity Incentive Plan In November 2012, the Company adopted the Galera Therapeutics, Inc. Equity Incentive Plan (the Prior Plan). The Prior Plan provided for the grant of incentive stock options, nonstatutory stock options, restricted stock awards, and stock appreciation rights. In connection with the adoption of the 2019 Plan (as defined below), the Company ceased issuing awards under the Prior Plan. As a result, no shares remain available for issuance under the Prior Plan; however, the Prior Plan continues to govern awards that are outstanding under it. The total number of shares subject to outstanding awards under the Prior Plan as of September 30, 2023 wa s 1,714,906 . 2019 Incentive Award Plan 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. 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 September 30, 2023 , there were 1,562,083 shares available for future issuance under the 2019 Plan, including 1,140,402 shares added pursuant to this provision 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 September 30, 2023 , there were 1,291,184 shares available for issuance under the ESPP, including 285,100 shares added pursuant to this provision effective January 1, 2023. 2023 Employment Inducement Award Plan On April 28, 2023, the Board of Directors adopted the Galera Therapeutics, Inc. 2023 Employment Inducement Award Plan (Inducement Plan), which became effective on such date without stockholder approval pursuant to Rule 5635(c)(4) of The Nasdaq Stock Market LLC listing rules (“Rule 5635(c)(4)”). The Inducement Plan provides for the grant of nonstatutory stock options, stock appreciation rights, restricted stock, restricted stock units, and other stock-based awards. In accordance with Rule 5635(c)(4), awards under the Inducement Plan may only be granted to persons who (a) were not previously an employee or director of the Company, or (b) are commencing employment with the Company following a bona fide period of non-employment, in either case as an inducement material to the individual’s entering into employment with the Company. A total of 1,500,000 shares of common stock was reserved for issuance under the Inducement Plan. Any shares subject to awards previously granted under the Inducement Plan that expire, terminate or are otherwise surrendered, canceled, or forfeited, in a manner that results in the Company (i) acquiring the shares covered by the award at a price not greater than the price (as adjusted to reflect any equity restructuring) paid by the participant for such shares or (ii) not issuing any shares covered by the award, the unused shares covered by such awards will again be available for award grants under the Inducement Plan. As of September 30, 2023, there were 1,500,000 shares available for issuance under the Inducement Plan. Share-based Compensation Share-based compensation expense was as follows for the three and nine months ended September 30, 2023 and 2022 (in thousands): Three months ended Nine months ended 2023 2022 2023 2022 Research and development $ 415 $ 644 $ 1,315 $ 1,951 General and administrative 975 1,106 3,058 3,477 $ 1,390 $ 1,750 $ 4,373 $ 5,428 The following table summarizes the activity related to stock option grants for the nine months ended September 30, 2023: Shares Weighted Weighted- Outstanding at January 1, 2023 5,783,185 $ 6.86 6.8 Granted 2,378,700 2.11 Exercised ( 78,600 ) 2.39 Forfeited ( 1,696,164 ) 3.92 Outstanding at September 30, 2023 6,387,121 $ 5.93 6.2 Vested and exercisable at September 30, 2023 4,315,554 $ 7.03 4.9 Vested and expected to vest at September 30, 2023 6,387,121 $ 5.93 6.2 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 . As of September 30, 2023, the unrecognized compensation cos t was $ 5.5 million and will be recognized over an estimated weighted-average amortization period of 1.9 years. The aggregate intrinsic value of options outstanding and of options exercisable as of September 30, 2023 were zero. Options granted during the nine months ended September 30, 2023 and 2022 had weighted-average grant-date fair values of $ 1.66 and $ 1.57 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 during the nine months ended September 30, 2023 and 2022 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 nine months ended September 30, 2023 and 2022 using the Black-Scholes option-pricing model using the following weighted-average assumptions: Nine months ended 2023 2022 Expected term (in years) 6.2 6.2 Expected stock price volatility 95.3 % 92.7 % Risk-free interest rate 4.05 % 2.06 % Expected dividend yield 0 % 0 % |
Related Party Transactions
Related Party Transactions | 9 Months Ended |
Sep. 30, 2023 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 9. Related party transactions IntellectMap provides information technology 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 both of the nine months ended September 30, 2023 and 2022 were $ 0.2 million . |
Restructuring charges
Restructuring charges | 9 Months Ended |
Sep. 30, 2023 | |
Restructuring Charges [Abstract] | |
Restructuring charges | 10. Restructuring charges On August 9, 2023, the Company announced a plan to reduce expenses and extend its cash runway. In connection with this plan, the Board of Directors of the Company approved the Workforce Reduction. The decision was based on cost-reduction initiatives intended to reduce operating expenses. The Company incurred a $ 2.3 million charge in the third quarter of 2023 in connection with the Workforce Reduction, primarily consisting of severance payments, employee benefits and related costs. The following table summarizes the restructuring balances at September 30, 2023 (in thousands): 2023 Balance, January 1 $ — Current year restructuring costs 2,309 Payment of employee severance and related costs ( 725 ) Balance, September 30 $ 1,584 |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2023 | |
Subsequent Events [Abstract] | |
Subsequent Events | 11. Subsequent events On October 31, 2023, the Company announced the decision to halt the GRECO-1 and GRECO-2 trials, following a futility analysis of the GRECO-2 trial. The analysis indicated that the trial was unlikely to succeed as designed. The Company believes this decision will enable the Company to conserve cash while it continues to explore potential strategic alternatives with the goal of maximizing shareholder value. The discontinuation of the GRECO trials is expected to have an impact on the amounts the Company records for interest expense on the royalty purchase liability under the Royalty Agreement and may impact the carrying value of the royalty purchase liability, and such impacts may be material. In addition, the Company may perform impairment testing on the carrying value of the acquired intangible asset and goodwill on the balance sheet during the fourth quarter of 2023. |
Basis of Presentation and Sig_2
Basis of Presentation and Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Liquidity | Liquidity The Company has incurred recurring losses and negative cash flows from operations since inception and has an accumulated deficit of $ 431.8 million as of September 30, 2023. The Company expects its existing cash, cash equivalents and short-term investments as of September 30, 2023, taking into account the discontinuation of the GRECO-1 and GRECO-2 trials, will enable the Company to fund its operating expenses and capital expenditure requirements into 2025. The Company has engaged Stifel, as its financial advisor, to assist in reviewing strategic alternatives with the goal of maximizing value for its shareholders. Such alte rnatives may include a merger, sale, divestiture of assets, licensing, or other strategic transaction. If the Company is unable to undertake any strategic alternative, it may be required to cease operations altogether. |
Basis of Presentation and Consolidation | Basis of presentation and consolidation The accompanying unaudited interim consolidated financial statements have been prepared in conformity with U.S. generally accepted accounting principles (U.S. GAAP) for interim financial information. 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). In the opinion of management, the accompanying interim consolidated financial statements include all normal and recurring adjustments (which consist primarily of accruals, estimates and assumptions that impact the financial statements) considered necessary to present fairly the Company’s financial position as of September 30, 2023 and its results of operations for the three and nine months ended September 30, 2023 and 2022, and statements of changes in stockholders’ deficit and cash flows for the nine months ended September 30, 2023 and 2022. Operating results for the three and nine months ended September 30, 2023 are not necessarily indicative of the results that may be expected for the year ending December 31, 2023, or for any future period. The interim consolidated financial statements, presented herein, do not contain the required disclosures under U.S. GAAP for annual financial statements. Therefore, these interim consolidated financial statements should be read in conjunction with the annual audited consolidated financial statements and related notes as of and for the year ended December 31, 2022 , included in the Company’s annual report on Form 10-K and filed with the SEC on March 8, 2023. |
Use of Estimates | Use of estimates The preparation of unaudited interim 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 unaudited interim 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 unaudited interim consolidated financial statements in the period they are determined to be necessary. Significant areas that require management’s estimates include share-based compensation assumptions, royalty purchase liability assumptions and accrued research and development expenses. |
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 September 30, 2023 and December 31, 2022 consisted of bank deposits, U.S. Treasury obligations, U.S. government agency securities, and a money market mutual fund invested in U.S. Treasury obligations. We maintain a portion of our cash and cash equivalents in accounts with major financial institutions, and our deposits at these institutions exceed insured limits. |
Restricted cash | 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 September 30, 2023. The Company has recorded this deposit and accumulated interest thereon as restricted cash on its consolidated balance sheet. In October 2023, the commercial credit card agreement was terminated by the Company and the bank removed the restriction on the cash. 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 was granted a small business waiver of this PDUFA fee from the FDA. The Company received the refund of the PDUFA fee from the FDA in May 2023. |
Research and Development Expenses | 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. Restructuring Costs As a result of the Workforce Reduction, the Company incurred total restructuring-related charges of $ 2.3 million during the three months ended September 30, 2023. See Note 10. As of September 30, 2023, $ 1.6 million of the total restructuring-related charges remain unpaid and are included in accrued expenses in the accompanying consolidated balance sheet. See Note 5. |
Net Loss Per Share | Net loss per share The Company uses the two-class method to compute net income per common share during periods the Company realizes net income and has securities that entitle the holder to participate in dividends and earnings of the Company. The two-class method is not applicable during periods with a net loss, as the participating securities are not obligated to fund losses. 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: September 30, 2023 2022 Stock options 6,387,121 6,006,957 Common stock warrants 13,850,661 550,661 20,237,782 6,557,618 |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In August 2020, FASB issued ASU 2020-06, “Debt-Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging-Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity,” which simplifies accounting for convertible instruments by removing major separation models required under current GAAP. The ASU removes certain settlement conditions that are required for equity contracts to qualify for the derivative scope exception, and it also simplifies the diluted earnings per share calculation in certain areas. This guidance is effective for fiscal years beginning after December 15, 2023, including interim periods therein. Early adoption is permitted. The Company adopted this ASU on January 1, 2023. There was no impact to the Company's consolidated financial statements. |
Basis of Presentation and Sig_3
Basis of Presentation and Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
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: September 30, 2023 2022 Stock options 6,387,121 6,006,957 Common stock warrants 13,850,661 550,661 20,237,782 6,557,618 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
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): September 30, 2023 (Level 1) (Level 2) (Level 3) Assets Money market funds and U.S. Treasury obligations $ 23,511 $ — $ — Short-term investments U.S. government agency securities $ — $ 1,993 $ — U.S. Treasury obligations 1,992 — — Total short-term investments $ 1,992 $ 1,993 $ — December 31, 2022 (Level 1) (Level 2) (Level 3) Assets Money market funds and U.S. Treasury obligations $ 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 $ — |
Property and Equipment (Tables)
Property and Equipment (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property Plant and Equipment | Property and equipment consist of (amounts in thousands): September 30, December 31, 2023 2022 Laboratory equipment $ 571 $ 1,398 Computer hardware and software 305 292 Leasehold improvements 36 270 Furniture and fixtures 179 179 Property and equipment, gross 1,091 2,139 Less: Accumulated depreciation and amortization ( 893 ) ( 1,701 ) Property and equipment, net $ 198 $ 438 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses consist of (amounts in thousands): September 30, December 31, 2023 2022 Compensation and related benefits $ 1,262 $ 2,655 Restructuring costs 1,584 — Research and development expenses 5,609 6,764 Professional fees and other expenses 329 335 $ 8,784 $ 9,754 |
Royalty purchase liability (Tab
Royalty purchase liability (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Royalty Purchase Liability [Abstract] | |
Schedule of Common Stock Warrants | 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 |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Leases [Abstract] | |
Summary of Supplemental Balance Sheet Information Related to Leases | Supplemental balance sheet information related to leases was as follows: September 30, December 31, 2023 2022 Operating Leases Right-of-use lease assets $ 1,249 $ 43 Lease liabilities, current 131 44 Lease liabilities, net of current portion 1,155 — Total operating lease liabilities $ 1,286 $ 44 |
Summary of Components of Lease Expense | The components of lease expense were as follows: Three months ended Nine months ended 2023 2022 2023 2022 Operating lease costs Operating lease rental expense $ 54 $ 65 $ 138 $ 201 Total operating lease expense $ 54 $ 65 $ 138 $ 201 |
Summary of Supplemental Cash Flow Information Related to Leases | Supplemental cash flow information related to leases was as follows: Nine months ended 2023 2022 Cash paid for amounts included in the measurement of lease liabilities Operating cash flows for operating leases $ 97 $ 200 Right-of-use assets obtained in exchange for lease obligation Operating leases 1,310 — |
Summary of Future Minimum Rental Payments Under Non Cancelable Operating Leases | Future minimum rental payments under the Company’s non-cancelable operating lease liabilities as of September 30, 2023 (amounts in thousands): Remainder of 2023 53 2024 195 2025 217 2026 220 2027 and after 857 Total 1,542 Less: imputed interest ( 256 ) $ 1,286 |
Equity (Tables)
Equity (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Equity [Abstract] | |
Summary of Share-based Compensation Expense | Share-based compensation expense was as follows for the three and nine months ended September 30, 2023 and 2022 (in thousands): Three months ended Nine months ended 2023 2022 2023 2022 Research and development $ 415 $ 644 $ 1,315 $ 1,951 General and administrative 975 1,106 3,058 3,477 $ 1,390 $ 1,750 $ 4,373 $ 5,428 |
Summary of Activity Related to Stock Option Grants | The following table summarizes the activity related to stock option grants for the nine months ended September 30, 2023: Shares Weighted Weighted- Outstanding at January 1, 2023 5,783,185 $ 6.86 6.8 Granted 2,378,700 2.11 Exercised ( 78,600 ) 2.39 Forfeited ( 1,696,164 ) 3.92 Outstanding at September 30, 2023 6,387,121 $ 5.93 6.2 Vested and exercisable at September 30, 2023 4,315,554 $ 7.03 4.9 Vested and expected to vest at September 30, 2023 6,387,121 $ 5.93 6.2 |
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 nine months ended September 30, 2023 and 2022 using the Black-Scholes option-pricing model using the following weighted-average assumptions: Nine months ended 2023 2022 Expected term (in years) 6.2 6.2 Expected stock price volatility 95.3 % 92.7 % Risk-free interest rate 4.05 % 2.06 % Expected dividend yield 0 % 0 % |
Restructuring charges (Tables)
Restructuring charges (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Restructuring Charges [Abstract] | |
Summary of Restructuring balances | The following table summarizes the restructuring balances at September 30, 2023 (in thousands): 2023 Balance, January 1 $ — Current year restructuring costs 2,309 Payment of employee severance and related costs ( 725 ) Balance, September 30 $ 1,584 |
Organization and description _2
Organization and description of business - Additional Information (Details) $ in Thousands | Feb. 17, 2023 shares | Sep. 30, 2023 USD ($) | Aug. 09, 2023 Employees | Dec. 31, 2022 USD ($) |
Organization And Description Of Business [Line Items] | ||||
Number of reduction in company's current workforce employees | Employees | 22 | |||
Workforce Reduction Rate | 70% | |||
Accumulated deficit | $ | $ (431,819) | $ (378,324) | ||
Issuance and sale of common stock and warrants to purchase shares of common stock | shares | 14,320,000 |
Basis of Presentation and Sig_4
Basis of Presentation and Significant Accounting Policies - Additional Information (Details) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 USD ($) | Sep. 30, 2023 USD ($) | Aug. 09, 2023 Employees | Dec. 31, 2022 USD ($) | |
Accounting Policies [Abstract] | ||||
Restricted Cash | $ 50,000 | $ 50,000 | $ 50,000 | |
Number of reduction in company's current workforce employees | Employees | 22 | |||
Workforce Reduction Rate | 70% | |||
Restructuring-Related Charge | 2,300,000 | 2,300,000 | ||
Restructuring-Related Charges Remain Unpaid ed In Accrued Expenses | 1,600,000 | 1,600,000 | ||
Refundable PDUFA Fee | $ 0 | $ 0 | $ 3,242,000 |
Basis of Presentation and Sig_5
Basis of Presentation and Significant Accounting Policies - Dilutive Securities Excluded from Computation of Diluted Weighted Average Shares of Common Stock Outstanding (Details) - shares | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive Securities excluded from computation of earnings per share | 20,237,782 | 6,557,618 |
Stock Options | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive Securities excluded from computation of earnings per share | 6,387,121 | 6,006,957 |
Common Stock Warrants | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive Securities excluded from computation of earnings per share | 13,850,661 | 550,661 |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Assets and Liabilities Measured at Fair Value on Recurring Basis (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Level 1 | U.S. Treasury obligations | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets fair value | $ 1,992 | $ 19,159 |
Level 1 | Short- Term Investments | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total short-term investments | 1,992 | 19,159 |
Level 1 | Money Market Funds and U.S. Treasury Obligations | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash equivalents, at fair value | 23,511 | 3,467 |
Level 1 | U.S. government agency securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets fair value | 0 | 0 |
Level 2 | U.S. Treasury obligations | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets fair value | 0 | 0 |
Level 2 | Short- Term Investments | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total short-term investments | 1,993 | 8,172 |
Level 2 | Money Market Funds and U.S. Treasury Obligations | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash equivalents, at fair value | 0 | 0 |
Level 2 | U.S. government agency securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets fair value | 1,993 | 8,172 |
Level 3 | U.S. Treasury obligations | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets fair value | 0 | 0 |
Level 3 | Short- Term Investments | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total short-term investments | 0 | 0 |
Level 3 | Money Market Funds and U.S. Treasury Obligations | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash equivalents, at fair value | 0 | 0 |
Level 3 | U.S. government agency securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets fair value | $ 0 | $ 0 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) | 9 Months Ended |
Sep. 30, 2023 USD ($) | |
Fair Value Disclosures [Abstract] | |
Changes in valuation techniques | $ 0 |
Property and Equipment - Schedu
Property and Equipment - Schedule of Property and Equipment (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 1,091 | $ 2,139 |
Less: Accumulated depreciation and amortization | (893) | (1,701) |
Property and equipment, net | 198 | 438 |
Laboratory Equipment | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 571 | 1,398 |
Computer Hardware and Software | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 305 | 292 |
Leasehold Improvements | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 36 | 270 |
Furniture and Fixtures | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 179 | $ 179 |
Property and Equipment - Additi
Property and Equipment - Additional Information (Details) - USD ($) | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation and amortization | $ 44,000 | $ 88,000 |
Accrued Expenses - Schedule of
Accrued Expenses - Schedule of Accrued Expenses (Details) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Payables and Accruals [Abstract] | ||
Compensation and related benefits | $ 1,262 | $ 2,655 |
Restructuring Costs | 1,584 | 0 |
Research and development expenses | 5,609 | 6,764 |
Professional fees and other expenses | 329 | 335 |
Accrued expenses | $ 8,784 | $ 9,754 |
Royalty Purchase Liability - Ad
Royalty Purchase Liability - Additional Information (Details) - USD ($) $ in Thousands | 1 Months Ended | 9 Months Ended | |||||
Nov. 30, 2018 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Jul. 31, 2021 | Jun. 30, 2021 | May 31, 2020 | |
Royalty Purchase Liability [Line Items] | |||||||
Total agreed amount of royalty purchase price | $ 150,344 | $ 139,635 | |||||
Noncash interest expense | $ 10,709 | $ 8,247 | |||||
Warrant expiration term | 6 years | ||||||
Fair value of equity classified warrants | $ 4,700 | ||||||
Royalty Agreements | |||||||
Royalty Purchase Liability [Line Items] | |||||||
Total agreed amount of royalty purchase price | $ 80,000 | ||||||
Royalty purchase price | 117,500 | ||||||
Outstanding amount of royalty agreement | $ 20,000 | ||||||
Noncash interest expense | $ 10,700 | $ 8,200 | |||||
Effective interest rate | 5.60% | ||||||
Royalty Agreements | First Tranche | |||||||
Royalty Purchase Liability [Line Items] | |||||||
Royalty purchase price | $ 20,000 | ||||||
Royalty Agreements | Fifth Tranche | |||||||
Royalty Purchase Liability [Line Items] | |||||||
Outstanding amount of royalty agreement | $ 20,000 | ||||||
Royalty Agreements | Fourth Tranche | |||||||
Royalty Purchase Liability [Line Items] | |||||||
Outstanding amount of royalty agreement | $ 37,500 | ||||||
Amended Royalty Agreements | |||||||
Royalty Purchase Liability [Line Items] | |||||||
Total agreed amount of royalty purchase price | 117,500 | ||||||
Outstanding amount of royalty agreement | 37,500 | ||||||
Amended Royalty Agreements | Fifth Tranche | |||||||
Royalty Purchase Liability [Line Items] | |||||||
Outstanding amount of royalty agreement | $ 20,000 |
Royalty Purchase Liability - Sc
Royalty Purchase Liability - Schedule of Common Stock Warrants (Details) | 9 Months Ended |
Sep. 30, 2023 $ / 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 |
Leases - Additional Information
Leases - Additional Information (Details) $ in Thousands | Sep. 30, 2023 USD ($) |
Lessee Lease Description [Line Items] | |
Lease Rental payments | $ 1,542 |
Operating lease, discount rate | 5.40% |
Leases - Summary of Balance She
Leases - Summary of Balance Sheet Information Related to Leases (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Leases [Abstract] | ||
Right-of-use lease assets | $ 1,249 | $ 43 |
Lease liabilities, current | 131 | 44 |
Lease liabilities, net of current portion | 1,155 | 0 |
Total operating lease liabilities | $ 1,286 | $ 44 |
Leases - Summary of Components
Leases - Summary of Components of Lease Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Leases [Abstract] | ||||
Operating lease rental expense | $ 54 | $ 65 | $ 138 | $ 201 |
Total operating lease expense | $ 54 | $ 65 | $ 138 | $ 201 |
Leases - Summary of Supplementa
Leases - Summary of Supplemental Cash Flow Information Related to Lease (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Leases [Abstract] | ||
Operating cash flows for operating leases | $ 97 | $ 200 |
Right-of-use assets obtained in exchange for lease obligation | ||
Operating leases | $ 1,310 | $ 0 |
Leases - Summary of Future Mini
Leases - Summary of Future Minimum Rental Payments Under Non Cancelable Operating Leases (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Leases [Abstract] | ||
Remainder of 2023 | $ 53 | |
2024 | 195 | |
2025 | 217 | |
2026 | 220 | |
2027 And After | 857 | |
Total | 1,542 | |
Less: imputed interest | (256) | |
Operating lease liabilities | $ 1,286 | $ 44 |
Equity - Additional Information
Equity - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||||||
Feb. 23, 2023 | Feb. 17, 2023 | Jan. 01, 2023 | Dec. 31, 2020 | Nov. 30, 2019 | Sep. 30, 2023 | Mar. 31, 2023 | Mar. 31, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Oct. 31, 2023 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Weighted average price per share | $ 2.095 | ||||||||||
Shares, Granted | 2,378,700 | ||||||||||
Warrant exercise price | $ 1.97 | ||||||||||
Net proceeds from common stock | $ 27,600 | ||||||||||
Issuance and sale of common stock and warrants to purchase shares of common stock | 14,320,000 | ||||||||||
Exercisable and expire period | 5 years | ||||||||||
Stock Issued During Period Shares of Common Stock Warrants Exercised | 1,020,000 | 1,020,000 | |||||||||
Stock Issued During Period Value Common Stock Warrants Exercised | $ 2,000 | $ 2,000 | |||||||||
Unrecognized compensation cost | $ 5,500 | $ 5,500 | |||||||||
Estimated recognition weighted-average amortization period | 1 year 10 months 24 days | ||||||||||
Weighted-average grant-date fair values of options granted | $ 1.66 | $ 1.57 | |||||||||
Expected dividend yield | 0% | 0% | |||||||||
Common Stock | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Sale of shares under ATM, Shares | 1,562,083 | ||||||||||
Sale Of Shares Under Open Market Sale Agrrement Shares | (9,805,457) | 14,320,000 | (314,296) | ||||||||
Shares available for issuance | 1,562,083 | ||||||||||
2019 Incentive Award Plan | Common Stock | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Sale of shares under ATM, Shares | 1,140,402 | 1,291,184 | |||||||||
Common stock reserved for future issuance | 1,948,970 | ||||||||||
Number of shares of common stock initially available for issuance | 1,948,970 | ||||||||||
Percentage of shares of common stock outstanding | 4% | ||||||||||
Shares available for issuance | 1,140,402 | 1,291,184 | |||||||||
2019 Incentive Award Plan | Common Stock | Maximum Member | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Number of shares issued under the plan | 14,130,029 | ||||||||||
2019 Employee Stock Purchase Plan | Common Stock | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Sale of shares under ATM, Shares | 285,100 | ||||||||||
Percentage of shares of common stock outstanding | 1% | ||||||||||
Number of shares available for issuance | 243,621 | ||||||||||
Shares available for issuance | 285,100 | ||||||||||
2019 Employee Stock Purchase Plan | Common Stock | Maximum Member | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Number of shares issued under the plan | 3,288,886 | ||||||||||
2012 Equity Incentive Plan | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Number of shares available for issuance | 1,500,000 | 1,500,000 | |||||||||
Aggregate intrinsic value of options outstanding | $ 1,714,906 | $ 1,714,906 | |||||||||
2023 Employment Inducement Award Plan [Member] | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Vesting period | 4 years | ||||||||||
Term of award | 10 years | ||||||||||
2023 Employment Inducement Award Plan [Member] | April 28, 2023 [Member] | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Common stock reserved for future issuance | 1,500,000 | 1,500,000 | |||||||||
Number of shares of common stock initially available for issuance | 1,500,000 | 1,500,000 | |||||||||
Subsequent Event [Member] | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Available capacity under the Sales Agreement | $ 35,600 | ||||||||||
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 | ||||||||||
Commission to agent as percentage of ATM offering proceeds | 3% | ||||||||||
Sale Of Shares Under Open Market Sale Agrrement Shares | 9,805,457 | ||||||||||
Net proceeds to the Company after deducting fees, commissions and other expenses | $ 1,900 |
Equity - Summary of Share-based
Equity - Summary of Share-based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total share-based compensation expense | $ 1,390 | $ 1,750 | $ 4,373 | $ 5,428 |
Research and Development | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total share-based compensation expense | 415 | 644 | 1,315 | 1,951 |
General and Administrative | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total share-based compensation expense | $ 975 | $ 1,106 | $ 3,058 | $ 3,477 |
Equity - Summary of Activity Re
Equity - Summary of Activity Related to Stock Option Grants (Details) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 $ / shares shares | Dec. 31, 2022 $ / shares shares | |
Share-Based Payment Arrangement [Abstract] | ||
Shares, Outstanding beginning balance | shares | 5,783,185 | |
Shares, Granted | shares | 2,378,700 | |
Shares, Exercised | shares | (78,600) | |
Shares, Forfeited | shares | (1,696,164) | |
Shares, Outstanding ending balance | shares | 6,387,121 | 5,783,185 |
Shares, Vested and exercisable | shares | 4,315,554 | |
Shares, Vested and expected to vest | shares | 6,387,121 | |
Weighted average exercise price per share, Outstanding beginning balance | $ / shares | $ 6.86 | |
Weighted average exercise price per share, Granted | $ / shares | 2.11 | |
Weighted average exercise price per share, Exercised | $ / shares | 2.39 | |
Weighted average exercise price per share, Forfeited | $ / shares | 3.92 | |
Weighted average exercise price per share, Outstanding ending balance | $ / shares | 5.93 | $ 6.86 |
Weighted average exercise price per share, Vested and exercisable | $ / shares | 7.03 | |
Weighted average exercise price per share, Vested and expected to vest | $ / shares | $ 5.93 | |
Weighted average remaining contractual life, Outstanding | 6 years 9 months 18 days | |
Weighted average remaining contractual life, Vested and exercisable | 4 years 10 months 24 days | |
Weighted average remaining contractual life, Vested and expected to vest | 6 years 2 months 12 days |
Equity - Summary of Fair Value
Equity - Summary of Fair Value of Each Option Grant Estimated Throughout Year Using Black-Scholes Option-pricing Model (Details) | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Fair Value Assumptions and Methodology [Abstract] | ||
Expected term (in years) | 6 years 2 months 12 days | 6 years 2 months 12 days |
Expected stock price volatility | 95.30% | 92.70% |
Risk-free interest rate | 4.05% | 2.06% |
Expected dividend yield | 0% | 0% |
Related Party Transactions (Det
Related Party Transactions (Details) - USD ($) $ in Millions | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
IntellectMap | ||
Related Party Transaction [Line Items] | ||
Advisory services fees | $ 0.2 | $ 0.2 |
Restructuring charges (Addition
Restructuring charges (Additional Information) (Details) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended |
Sep. 30, 2023 | Sep. 30, 2023 | |
Restructuring Charges [Abstract] | ||
Incured Restructuring Charges | $ 2.3 | $ 2.3 |
Restructuring charges - Summary
Restructuring charges - Summary of Restructuring balances (Details) $ in Thousands | 9 Months Ended |
Sep. 30, 2023 USD ($) | |
Restructuring Charges [Abstract] | |
Balance, January 1 | $ 0 |
Current year restructuring costs | 2,309 |
Payment of employee severance and related costs | (725) |
Balance, September 30 | $ 1,584 |
Subsequent events (Additional I
Subsequent events (Additional Information) (Details) | Aug. 09, 2023 Employees |
Subsequent Event [Line Items] | |
Number of reduction in company's current workforce employees | 22 |
Workforce Reduction Rate | 70% |