Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2022 | Aug. 05, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2022 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q2 | |
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,$0.001 par value per share | |
Trading Symbol | GRTX | |
Security Exchange Name | NASDAQ | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 26,821,589 | |
Entity File Number | 001-39114 | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 46-1454898 | |
Entity Address, Address Line One | 2 W. Liberty Blvd #100 | |
Entity Address, City or Town | Malvern | |
Entity Address, State or Province | PA | |
Entity Address, Postal Zip Code | 19355 | |
City Area Code | 610 | |
Local Phone Number | 725-1500 | |
Document Quarterly Report | true | |
Document Transition Report | false |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 17,376 | $ 19,859 |
Short-term investments | 34,631 | 51,358 |
Prepaid expenses and other current assets | 3,181 | 6,175 |
Total current assets | 55,188 | 77,392 |
Property and equipment, net | 486 | 527 |
Acquired intangible asset | 2,258 | 2,258 |
Goodwill | 881 | 881 |
Right-of-use lease assets | 168 | 296 |
Other assets | 2,097 | 1,957 |
Total assets | 61,078 | 83,311 |
Current liabilities: | ||
Accounts payable | 3,588 | 5,044 |
Accrued expenses | 7,226 | 7,633 |
Lease liabilities | 172 | 258 |
Total current liabilities | 10,986 | 12,935 |
Royalty purchase liability | 133,065 | 128,063 |
Lease liabilities, net of current portion | 44 | |
Deferred tax liability | 273 | 273 |
Total liabilities | 144,324 | 141,315 |
Stockholders' deficit: | ||
Preferred stock, $0.001 par value: 10,000,000 shares authorized; no shares issued and outstanding | ||
Common stock, $0.001 par value: 200,000,000 shares authorized; 26,821,589 and 26,458,767 shares issued and outstanding at June 30, 2022 and December 31, 2021, respectively | 27 | 26 |
Additional paid-in capital | 262,940 | 258,086 |
Accumulated other comprehensive loss | (110) | (14) |
Accumulated deficit | (346,103) | (316,102) |
Total stockholders' deficit | (83,246) | (58,004) |
Total liabilities and stockholders' deficit | $ 61,078 | $ 83,311 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Jun. 30, 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 (shares) | 200,000,000 | 200,000,000 |
Common stock, shares issued (shares) | 26,821,589 | 26,458,767 |
Common stock, shares outstanding (shares) | 26,821,589 | 26,458,767 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Operating expenses: | ||||
Research and development | $ 6,662 | $ 15,966 | $ 14,769 | $ 28,389 |
General and administrative | 5,293 | 5,122 | 10,340 | 10,180 |
Loss from operations | (11,955) | (21,088) | (25,109) | (38,569) |
Other income (expenses): | ||||
Interest income | 71 | 6 | 85 | 25 |
Interest expense | (2,699) | (1,302) | (5,002) | (2,555) |
Gain on disposal of assets | 26 | 0 | 26 | 0 |
Foreign currency loss | (1) | (2) | (1) | (2) |
Net loss | $ (14,558) | $ (22,386) | $ (30,001) | $ (41,101) |
Net loss per share of common stock, basic | $ (0.54) | $ (0.88) | $ (1.12) | $ (1.63) |
Net loss per share of common stock, diluted | $ (0.54) | $ (0.88) | $ (1.12) | $ (1.63) |
Weighted-average shares of common stock outstanding, basic | 26,821,303 | 25,401,046 | 26,785,540 | 25,195,763 |
Weighted-average shares of common stock outstanding, diluted | 26,821,303 | 25,401,046 | 26,785,540 | 25,195,763 |
CONSOLIDATED STATEMENTS OF COMP
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Statement of Comprehensive Income [Abstract] | ||||
Net loss | $ (14,558) | $ (22,386) | $ (30,001) | $ (41,101) |
Unrealized loss on short-term investments | (49) | (7) | (96) | (9) |
Comprehensive loss | $ (14,607) | $ (22,393) | $ (30,097) | $ (41,110) |
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, 2020 | $ 6,118 | $ 25 | $ 241,649 | $ 12 | $ (235,568) |
Balance (in shares) at Dec. 31, 2020 | 24,976,142 | ||||
Share-based compensation expense | 1,791 | 1,791 | |||
Exercise of stock options | 235 | 235 | |||
Exercise of stock options, shares | 217,015 | ||||
Unrealized loss on short-term investments | (2) | (2) | |||
Net loss | (18,715) | (18,715) | |||
Balance at Mar. 31, 2021 | (10,573) | $ 25 | 243,675 | 10 | (254,283) |
Balance (in shares) at Mar. 31, 2021 | 25,193,157 | ||||
Balance at Dec. 31, 2020 | 6,118 | $ 25 | 241,649 | 12 | (235,568) |
Balance (in shares) at Dec. 31, 2020 | 24,976,142 | ||||
Unrealized loss on short-term investments | (9) | ||||
Net loss | (41,101) | ||||
Balance at Jun. 30, 2021 | (25,517) | $ 26 | 251,123 | 3 | (276,669) |
Balance (in shares) at Jun. 30, 2021 | 25,919,411 | ||||
Balance at Mar. 31, 2021 | (10,573) | $ 25 | 243,675 | 10 | (254,283) |
Balance (in shares) at Mar. 31, 2021 | 25,193,157 | ||||
Share-based compensation expense | 1,611 | 1,611 | |||
Exercise of stock options | 120 | 120 | |||
Exercise of stock options, shares | 60,975 | ||||
Sale of shares under Open Market Sale Agreement, net | 5,718 | $ 1 | 5,717 | ||
Sale of shares under open market sale agreement, shares | 665,279 | ||||
Unrealized loss on short-term investments | (7) | (7) | |||
Net loss | (22,386) | (22,386) | |||
Balance at Jun. 30, 2021 | (25,517) | $ 26 | 251,123 | 3 | (276,669) |
Balance (in shares) at Jun. 30, 2021 | 25,919,411 | ||||
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 | $ 1,848 | 1,848 | |||
Exercise of stock options | 58 | 58 | |||
Exercise of stock options, shares | 46,358 | ||||
Sale of shares under Open Market Sale Agreement, net | 1,117 | $ 1 | 1,116 | ||
Sale of shares under open market sale agreement, shares | 314,296 | ||||
Unrealized 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 | 26,458,767 | |||
Exercise of stock options, shares | 48,526 | ||||
Unrealized loss on short-term investments | $ (96) | ||||
Net loss | (30,001) | ||||
Balance at Jun. 30, 2022 | $ (83,246) | $ 27 | 262,940 | (110) | (346,103) |
Balance (in shares) at Jun. 30, 2022 | 26,821,589 | 26,821,589 | |||
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 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 | 26,821,589 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Operating activities: | ||
Net loss | $ (30,001) | $ (41,101) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 61 | 208 |
Noncash interest expense | 5,002 | 2,555 |
Share-based compensation expense | 3,678 | 3,402 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | 2,994 | 316 |
Other assets | (12) | (240) |
Accounts payable | (1,456) | 3,126 |
Accrued expense | (407) | (374) |
Other liabilities | (130) | 0 |
Cash used in operating activities | (20,271) | (32,108) |
Investing activities: | ||
Purchases of short-term investments | (34,529) | (7,167) |
Proceeds from sales of short-term investments | 51,160 | 36,000 |
Purchase of property and equipment | (20) | (205) |
Cash provided by investing activities | 16,611 | 28,628 |
Financing activities: | ||
Proceeds from royalty purchase agreement | 0 | 20,000 |
Proceeds from the sale of common stock, net of issuance costs | 1,117 | 5,718 |
Proceeds from exercise of stock options | 60 | 355 |
Cash provided by financing activities | 1,177 | 26,073 |
Net decrease in cash and cash equivalents | (2,483) | 22,593 |
Cash and cash equivalents at beginning of period | 19,859 | 15,872 |
Cash and cash equivalents at end of period | 17,376 | 38,465 |
Supplemental schedule of non-cash investing and financing activities: | ||
Deferred offering costs included in accounts payable and accrued expenses | 0 | 98 |
Purchase of property and equipment included in accounts payable and accrued expenses | $ 0 | $ 5 |
Organization and description of
Organization and description of business | 6 Months Ended |
Jun. 30, 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 (GC4419, also referred to as avasopasem) 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. 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 with or without systemic therapy. Galera’s second dismutase mimetic product candidate, rucosopasem manganese (GC4711, also referred to as rucosopasem), 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 Company had previously announced topline results from the ROMAN trial in October 2021. 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 resulted in improved p-values for the primary and secondary endpoints. The corrected 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. 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. Based on these data and interactions with the FDA, the Company plans to submit to the FDA a New Drug Application, or NDA, of avasopasem for radiotherapy-induced SOM by the end of 2022. 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 (referred to as the GRECO-1 trial), and a Phase 2b trial of rucosopasem in combination with SBRT in patients with LAPC (referred to as the GRECO-2 trial). Liquidity The Company has incurred recurring losses and negative cash flows from operations since inception and has an accumulated deficit of $ 346.1 million as of June 30, 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 expects its existing cash, cash equivalents and short-term investments as of June 30, 2022 will enable the Company to fund its operating expenses and capital expenditure requirements for at least the next twelve months from the issuance of these financial statements. 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. 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 six months ended June 30, 2022, the Company sold approximately 0.3 million shares of common stock and received net proceeds of $ 1.1 million pursuant to the Sales Agreement. As of June 30, 2022 , there remained approximately $ 40.6 million available under the Sales Agreement. |
Basis of Presentation and Signi
Basis of Presentation and Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2022 | |
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, 2021 and 2020 included in the Company’s annual report on Form 10-K filed with the SEC on March 10, 2022 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 June 30, 2022 and its results of operations for the three and six months ended June 30, 2022 and 2021, and statements of changes in stockholder’s equity (deficit) and cash flows for the six months ended June 30, 2022 and 2021. Operating results for the three and six months ended June 30, 2022 are not necessarily indicative of the results that may be expected for the year ending December 31, 2022, 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, 2021 , included in the Company’s annual report on Form 10-K and filed with the SEC on March 10, 2022. 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. 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 six months ended June 30, 2021 , the Company recorded a reduction to research and development expense of $ 0.3 million for expenses for which it has been reimbursed, or is entitled to reimbursement, 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 six months ended June 30, 2022 . Net loss per share Basic loss per share of common stock is computed by dividing net loss attributable to common stockholders 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: June 30, 2022 2021 Stock options 5,814,022 5,009,997 Common stock warrants 550,661 550,661 6,364,683 5,560,658 Recent Accounting Pronouncements There were no new accounting pronouncements that were issued or became effective since the issuance of the Company’s Annual Report on Form 10-K for the year ended December 31, 2021 that had, or are expected to have, a material impact on its consolidated financial position, results of operations or cash flows. |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 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): June 30, 2022 (Level 1) (Level 2) (Level 3) Assets Money market funds and U.S. Treasury obligations $ 14,140 $ — $ — Short-term investments U.S. Treasury obligations $ 34,631 — — December 31, 2021 (Level 1) (Level 2) (Level 3) Assets Money market funds and U.S. Treasury obligations $ 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 six months ended June 30, 2022 . 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 | 6 Months Ended |
Jun. 30, 2022 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | 4. Property and equipment Property and equipment consist of (amounts in thousands): June 30, December 31, 2022 2021 Laboratory equipment $ 1,393 $ 1,379 Computer hardware and software 292 292 Leasehold improvements 270 264 Furniture and fixtures 179 179 Property and equipment, gross 2,134 2,114 Less: Accumulated depreciation and amortization ( 1,648 ) ( 1,587 ) Property and equipment, net $ 486 $ 527 Depreciation and amortization expense was $ 0.1 million and $ 0.2 million for the six months ended June 30, 2022 and 2021 , respectively. |
Royalty Purchase Liability
Royalty Purchase Liability | 6 Months Ended |
Jun. 30, 2022 | |
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 June 30, 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. In May 2022, the Company, after interactions with the FDA, announced that it intends to submit an NDA of avasopasem for radiotherapy-induced SOM by the end of 2022. As a result, the Company updated the assumptions underlying the calculation of interest expense on the royalty purchase liability accordingly. The Company recogni zed $ 5.0 million and $ 2.6 million in noncash interest expense during the six months ended June 30, 2022 and 2021, respectively. As of June 30, 2022 , the effective interest rate was 8.2 %. 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 | 6 Months Ended |
Jun. 30, 2022 | |
Leases [Abstract] | |
Leases | 7. Leases The Company has a non-cancelable operating lease for office space in Malvern, Pennsylvania which, as of June 30, 2022 , has a remaining lease term of approximately 0.7 years. The discount rate used to account for the Company’s operating leases under FASB ASU No. 2018-11, Leases (Topic 842), is the Company’s estimated incremental borrowing rate of 5.3 %. Supplemental balance sheet information related to leases was as follows: June 30, December 31, 2022 2021 Operating Leases Right-of-use lease assets $ 168 $ 296 Lease liabilities, current 172 258 Lease liabilities, net of current portion — 44 Total operating lease liabilities $ 172 $ 302 The components of lease expense were as follows: Three months ended Six months ended 2022 2021 2022 2021 Operating lease costs Operating lease rental expense $ 62 $ 75 $ 130 $ 149 Interest on lease liabilities 3 6 6 13 Total operating lease expense $ 65 $ 81 $ 136 $ 162 Supplemental cash flow information related to leases was as follows: Six months ended 2022 2021 Cash paid for amounts included in the measurement of lease liabilities Operating cash flows for operating leases $ 135 $ 162 Right-of-use assets obtained in exchange for lease obligation Operating leases — 70 Future minimum rental payments under the Company’s non-cancelable operating lease liabilities as of June 30, 2022 (amounts in thousands): Remainder of 2022 $ 131 2023 44 Total 175 Less: imputed interest ( 3 ) $ 172 |
Related Party Transactions
Related Party Transactions | 6 Months Ended |
Jun. 30, 2022 | |
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 the six months ended June 30, 2022 and 2021 were $ 0.1 million . |
Basis of Presentation and Sig_2
Basis of Presentation and Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2022 | |
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 $ 346.1 million as of June 30, 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 expects its existing cash, cash equivalents and short-term investments as of June 30, 2022 will enable the Company to fund its operating expenses and capital expenditure requirements for at least the next twelve months from the issuance of these financial statements. 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. 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 six months ended June 30, 2022, the Company sold approximately 0.3 million shares of common stock and received net proceeds of $ 1.1 million pursuant to the Sales Agreement. As of June 30, 2022 , there remained approximately $ 40.6 million available under the Sales Agreement. |
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 June 30, 2022 and its results of operations for the three and six months ended June 30, 2022 and 2021, and statements of changes in stockholder’s equity (deficit) and cash flows for the six months ended June 30, 2022 and 2021. Operating results for the three and six months ended June 30, 2022 are not necessarily indicative of the results that may be expected for the year ending December 31, 2022, 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, 2021 , included in the Company’s annual report on Form 10-K and filed with the SEC on March 10, 2022. |
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. |
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. 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 six months ended June 30, 2021 , the Company recorded a reduction to research and development expense of $ 0.3 million for expenses for which it has been reimbursed, or is entitled to reimbursement, 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 six months ended June 30, 2022 . |
Net Loss Per Share | Net loss per share Basic loss per share of common stock is computed by dividing net loss attributable to common stockholders 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: June 30, 2022 2021 Stock options 5,814,022 5,009,997 Common stock warrants 550,661 550,661 6,364,683 5,560,658 Recent Accounting Pronouncements There were no new accounting pronouncements that were issued or became effective since the issuance of the Company’s Annual Report on Form 10-K for the year ended December 31, 2021 that had, or are expected to have, a material impact on its consolidated financial position, results of operations or cash flows. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements There were no new accounting pronouncements that were issued or became effective since the issuance of the Company’s Annual Report on Form 10-K for the year ended December 31, 2021 that had, or are expected to have, a material impact on its consolidated financial position, results of operations or cash flows. |
Basis of Presentation and Sig_3
Basis of Presentation and Significant Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 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: June 30, 2022 2021 Stock options 5,814,022 5,009,997 Common stock warrants 550,661 550,661 6,364,683 5,560,658 Recent Accounting Pronouncements There were no new accounting pronouncements that were issued or became effective since the issuance of the Company’s Annual Report on Form 10-K for the year ended December 31, 2021 that had, or are expected to have, a material impact on its consolidated financial position, results of operations or cash flows. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 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): June 30, 2022 (Level 1) (Level 2) (Level 3) Assets Money market funds and U.S. Treasury obligations $ 14,140 $ — $ — Short-term investments U.S. Treasury obligations $ 34,631 — — December 31, 2021 (Level 1) (Level 2) (Level 3) Assets Money market funds and U.S. Treasury obligations $ 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)
Property and Equipment (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property Plant and Equipment | Property and equipment consist of (amounts in thousands): June 30, December 31, 2022 2021 Laboratory equipment $ 1,393 $ 1,379 Computer hardware and software 292 292 Leasehold improvements 270 264 Furniture and fixtures 179 179 Property and equipment, gross 2,134 2,114 Less: Accumulated depreciation and amortization ( 1,648 ) ( 1,587 ) Property and equipment, net $ 486 $ 527 |
Royalty purchase liability (Tab
Royalty purchase liability (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
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) | 6 Months Ended |
Jun. 30, 2022 | |
Leases [Abstract] | |
Summary of Supplemental Balance Sheet Information Related to Leases | Supplemental balance sheet information related to leases was as follows: June 30, December 31, 2022 2021 Operating Leases Right-of-use lease assets $ 168 $ 296 Lease liabilities, current 172 258 Lease liabilities, net of current portion — 44 Total operating lease liabilities $ 172 $ 302 |
Summary of Components of Lease Expense | The components of lease expense were as follows: Three months ended Six months ended 2022 2021 2022 2021 Operating lease costs Operating lease rental expense $ 62 $ 75 $ 130 $ 149 Interest on lease liabilities 3 6 6 13 Total operating lease expense $ 65 $ 81 $ 136 $ 162 |
Summary of Supplemental Cash Flow Information Related to Leases | Supplemental cash flow information related to leases was as follows: Six months ended 2022 2021 Cash paid for amounts included in the measurement of lease liabilities Operating cash flows for operating leases $ 135 $ 162 Right-of-use assets obtained in exchange for lease obligation Operating leases — 70 |
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 June 30, 2022 (amounts in thousands): Remainder of 2022 $ 131 2023 44 Total 175 Less: imputed interest ( 3 ) $ 172 |
Equity (Tables)
Equity (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Equity [Abstract] | |
Summary of Share-based Compensation Expense | Share-based compensation expense was as follows for the three and six months ended June 30, 2022 and 2021 (in thousands): Three months ended Six months ended 2022 2021 2022 2021 Research and development $ 646 $ 567 $ 1,307 $ 1,351 General and administrative 1,184 1,044 2,371 2,051 $ 1,830 $ 1,611 $ 3,678 $ 3,402 |
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 six months ended June 30, 2022 and 2021 using the Black-Scholes option-pricing model using the following weighted-average assumptions: Six months ended 2022 2021 Expected term (in years) 6.2 6.2 Expected stock price volatility 91.4 % 91.0 % Risk-free interest rate 1.86 % 0.67 % Expected dividend yield 0 % 0 % |
Organization and description _2
Organization and description of business - Additional Information (Details) - USD ($) $ in Thousands | 1 Months Ended | 6 Months Ended | |
Dec. 31, 2020 | Jun. 30, 2022 | Dec. 31, 2021 | |
Organization And Description Of Business [Line Items] | |||
Date of incorporation | Nov. 19, 2012 | ||
Accumulated deficit | $ (346,103) | $ (316,102) | |
Open Market Sale Agreement | |||
Organization And Description Of Business [Line Items] | |||
Number of shares sold | 300,000 | ||
Net proceeds from common stock | $ 1,100 | ||
Proceeds from issuance of remaining common stock | $ 40,600 | ||
Open Market Sale Agreement | Jefferies LLC | |||
Organization And Description Of Business [Line Items] | |||
Maximum Offering Issuance And Sale Expense Covered In Company Securities | $ 200,000 | ||
Maximum Aggregate Offering Price | $ 50,000 |
Basis of Presentation and Sig_4
Basis of Presentation and Significant Accounting Policies - Additional Information (Details) $ in Millions | 6 Months Ended |
Jun. 30, 2022 USD ($) | |
Accounting Policies [Abstract] | |
Reduction to research and development expense | $ 0.3 |
Funding available under the grant | $ 1.1 |
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 | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive Securities excluded from computation of earnings per share | 6,364,683 | 5,560,658 |
Stock Options | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive Securities excluded from computation of earnings per share | 5,814,022 | 5,009,997 |
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 - Summa
Fair Value Measurements - Summary of Assets and Liabilities Measured at Fair Value on Recurring Basis (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
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 | $ 14,140 | $ 12,346 |
Level 1 | U.S. government agency securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets fair value | ||
Level 1 | U.S. Treasury obligations | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets fair value | 34,631 | 45,945 |
Level 1 | Short- Term Investments | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total short-term investments | 45,945 | |
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 | ||
Level 2 | U.S. government agency securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets fair value | 5,413 | |
Level 2 | U.S. Treasury obligations | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets fair value | ||
Level 2 | Short- Term Investments | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total short-term investments | 5,413 | |
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 | ||
Level 3 | U.S. government agency securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets fair value | ||
Level 3 | U.S. Treasury obligations | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets fair value | ||
Level 3 | Short- Term Investments | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total short-term investments |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) | 6 Months Ended |
Jun. 30, 2022 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 | Jun. 30, 2022 | Dec. 31, 2021 |
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 2,134 | $ 2,114 |
Less: Accumulated depreciation and amortization | (1,648) | (1,587) |
Property and equipment, net | 486 | 527 |
Laboratory Equipment | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 1,393 | 1,379 |
Computer Hardware and Software | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 292 | 292 |
Leasehold Improvements | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 270 | 264 |
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 ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation and amortization | $ 61 | $ 208 |
Accrued Expenses - Schedule of
Accrued Expenses - Schedule of Accrued Expenses (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Payables and Accruals [Abstract] | ||
Compensation and related benefits | $ 1,498 | $ 2,038 |
Research and development expenses | 5,264 | 5,360 |
Professional fees and other expenses | 464 | 235 |
Accrued expenses | $ 7,226 | $ 7,633 |
Royalty Purchase Liability - Ad
Royalty Purchase Liability - Additional Information (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||||
Nov. 30, 2018 | Mar. 31, 2022 | Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2021 | Jul. 31, 2021 | May 31, 2020 | |
Royalty Purchase Liability [Line Items] | |||||||
Total agreed amount of royalty purchase price | $ 133,065 | $ 128,063 | |||||
Royalty purchase price | 0 | $ 20,000 | |||||
Noncash interest expense | $ 5,002 | 2,555 | |||||
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 | $ 5,000 | 2,600 | |||||
Effective interest rate | 8.20% | ||||||
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) | 6 Months Ended |
Jun. 30, 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 |
Leases - Additional Information
Leases - Additional Information (Details) | Jun. 30, 2022 |
Laboratory Space | |
Lessee Lease Description [Line Items] | |
Non-cancelable operating lease, term | 8 months 12 days |
ASC 842 | |
Lessee Lease Description [Line Items] | |
Operating lease, discount rate | 5.30% |
Leases - Summary of Balance She
Leases - Summary of Balance Sheet Information Related to Leases (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Leases [Abstract] | ||
Right-of-use lease assets | $ 168 | $ 296 |
Lease liabilities, current | 172 | 258 |
Lease liabilities, net of current portion | 44 | |
Total operating lease liabilities | $ 172 | $ 302 |
Leases - Summary of Components
Leases - Summary of Components of Lease Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Leases [Abstract] | ||||
Operating lease rental expense | $ 62 | $ 75 | $ 130 | $ 149 |
Interest on lease liabilities | 3 | 6 | 6 | 13 |
Total operating lease expense | $ 65 | $ 81 | $ 136 | $ 162 |
Leases - Summary of Supplementa
Leases - Summary of Supplemental Cash Flow Information Related to Lease (Details) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Leases [Abstract] | ||
Operating cash flows from operating leases | $ 135 | $ 162 |
Right-of-use assets obtained in exchange for lease obligation | ||
Operating leases | $ 70 |
Leases - Summary of Future Mini
Leases - Summary of Future Minimum Rental Payments Under Non Cancelable Operating Leases (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Leases [Abstract] | ||
Remainder of 2022 | $ 131 | |
2023 | 44 | |
Total | 175 | |
Less: imputed interest | (3) | |
Operating lease liabilities | $ 172 | $ 302 |
Equity - Additional Information
Equity - Additional Information (Details) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 6 Months Ended | ||
Dec. 31, 2020 | Nov. 30, 2019 | Jun. 30, 2022 | Jun. 30, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Unrecognized compensation cost | $ 13.4 | |||
Estimated recognition weighted-average amortization period | 2 years 4 months 24 days | |||
Aggregate intrinsic value of options outstanding | $ 0.1 | |||
Weighted-average grant-date fair values of options granted | $ 1.67 | $ 8.50 | ||
Expected dividend yield | 0% | 0% | ||
Common Stock | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Sale of shares under ATM, Shares | 1,418,707 | |||
2019 Incentive Award Plan | Common Stock | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Sale of shares under ATM, Shares | 1,058,350 | |||
Number of shares of common stock initially available for issuance | 1,948,970 | |||
Percentage of shares of common stock outstanding | 4% | |||
2019 Incentive Award Plan | Common Stock | Maximum | ||||
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 | 264,587 | 1,006,084 | ||
Percentage of shares of common stock outstanding | 1% | |||
Number of shares available for issuance | 243,621 | |||
2019 Employee Stock Purchase Plan | Common Stock | Maximum | ||||
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 | 0 | |||
Number of shares authorized | 2,007,776 | |||
Vesting period | 4 years | |||
Term of award | 10 years | |||
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 | $ 40.6 | ||
Commission to agent as percentage of ATM offering proceeds | 3% | |||
Sale of shares under ATM, Shares | 314,296 | |||
Weighted average price per share | $ 3.70 | |||
Net proceeds from common stock | $ 1.1 |
Equity - Summary of Share-based
Equity - Summary of Share-based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total share-based compensation expense | $ 1,830 | $ 1,611 | $ 3,678 | $ 3,402 |
Research and Development | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total share-based compensation expense | 646 | 567 | 1,307 | 1,351 |
General and Administrative | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total share-based compensation expense | $ 1,184 | $ 1,044 | $ 2,371 | $ 2,051 |
Equity - Summary of Activity Re
Equity - Summary of Activity Related to Stock Option Grants (Details) - $ / shares | 6 Months Ended |
Jun. 30, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Shares, Outstanding beginning balance | 4,970,975 |
Shares, Granted | 1,356,400 |
Shares, Exercised | (48,526) |
Shares, Forfeited | (464,827) |
Shares, Outstanding ending balance | 5,814,022 |
Shares, Vested and exercisable | 3,113,199 |
Shares, Vested and expected to vest | 5,814,022 |
Weighted average exercise price per share, Outstanding beginning balance | $ 8.45 |
Weighted average exercise price per share, Granted | 2.19 |
Weighted average exercise price per share, Exercised | 1.25 |
Weighted average exercise price per share, Forfeited | 8.96 |
Weighted average exercise price per share, Outstanding ending balance | 7.01 |
Weighted average exercise price per share, Vested and exercisable | 7.05 |
Weighted average exercise price per share, Vested and expected to vest | $ 7.01 |
Weighted average remaining contractual life, Outstanding | 7 years 3 months 18 days |
Weighted average remaining contractual life, Vested and exercisable | 5 years 10 months 24 days |
Weighted average remaining contractual life, Vested and expected to vest | 7 years 3 months 18 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) | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
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 | 91.40% | 91% |
Risk-free interest rate | 1.86% | 0.67% |
Expected dividend yield | 0% | 0% |
Related Party Transactions (Det
Related Party Transactions (Details) - USD ($) | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
IntellectMap | ||
Related Party Transaction [Line Items] | ||
Advisory services fees | $ 100 | $ 100 |