Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2023 | Jul. 31, 2023 | |
Document And Entity Information | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2023 | |
Document Transition Report | false | |
Entity File Number | 001-37852 | |
Entity Registrant Name | PROTAGONIST THERAPEUTICS, INC. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 98-0505495 | |
Entity Address, Address Line One | 7707 Gateway Boulevard, Suite 140 | |
Entity Address, City or Town | Newark | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 94560-1160 | |
City Area Code | 510 | |
Local Phone Number | 474-0170 | |
Title of 12(b) Security | Common Stock | |
Trading Symbol | PTGX | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 57,530,242 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q2 | |
Entity Central Index Key | 0001377121 | |
Amendment Flag | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 235,382 | $ 125,744 |
Marketable securities | 78,019 | 111,611 |
Receivable from collaboration partner | 39 | 10 |
Prepaid expenses and other current assets | 3,501 | 5,712 |
Total current assets | 316,941 | 243,077 |
Property and equipment, net | 1,263 | 1,565 |
Restricted cash - noncurrent | 225 | 225 |
Operating lease right-of-use asset | 2,037 | 3,061 |
Total assets | 320,466 | 247,928 |
Current liabilities: | ||
Accounts payable | 4,573 | 3,640 |
Payable to collaboration partner | 10 | 69 |
Accrued expenses and other payables | 19,369 | 24,955 |
Operating lease liability - current | 2,446 | 2,515 |
Total current liabilities | 26,398 | 31,179 |
Operating lease liability - noncurrent | 1,141 | |
Total liabilities | 26,398 | 32,320 |
Commitments and contingencies | ||
Stockholders' equity: | ||
Preferred stock, $0.00001 par value, 10,000,000 shares authorized; no shares issued and outstanding | ||
Common stock, $0.00001 par value, 90,000,000 shares authorized; 57,494,185 and 49,339,252 shares issued and outstanding as of June 30, 2023 and December 31, 2022, respectively | 1 | |
Additional paid-in capital | 903,205 | 752,722 |
Accumulated other comprehensive loss | (198) | (359) |
Accumulated deficit | (608,940) | (536,755) |
Total stockholders' equity | 294,068 | 215,608 |
Total liabilities and stockholders' equity | $ 320,466 | $ 247,928 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2023 | Dec. 31, 2022 |
Condensed Consolidated Balance Sheets | ||
Preferred stock, par value | $ 0.00001 | $ 0.00001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.00001 | $ 0.00001 |
Common stock, shares authorized | 90,000,000 | 90,000,000 |
Common stock, shares issued | 57,494,185 | 49,339,252 |
Common stock, shares outstanding | 57,494,185 | 49,339,252 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Condensed Consolidated Statements of Operations | ||||
License and collaboration revenue | $ 0 | $ 859 | $ 0 | $ 26,581 |
Revenue from Contract with Customer, Product and Service [Extensible List] | License and Collaboration Agreement | License and Collaboration Agreement | License and Collaboration Agreement | License and Collaboration Agreement |
Operating expenses: | ||||
Research and development | $ 33,182 | $ 34,611 | $ 60,598 | $ 70,929 |
General and administrative | 9,172 | 7,691 | 17,777 | 18,206 |
Total operating expenses | 42,354 | 42,302 | 78,375 | 89,135 |
Loss from operations | (42,354) | (41,443) | (78,375) | (62,554) |
Interest income | 3,913 | 484 | 6,404 | 652 |
Other expense, net | (19) | (78) | (214) | (65) |
Net loss | $ (38,460) | $ (41,037) | $ (72,185) | $ (61,967) |
Net loss per share, basic | $ (0.68) | $ (0.84) | $ (1.34) | $ (1.27) |
Net loss per share, diluted | $ (0.68) | $ (0.84) | $ (1.34) | $ (1.27) |
Weighted-average shares used to compute net loss per share, basic | 56,775,742 | 49,049,902 | 53,691,965 | 48,902,047 |
Weighted-average shares used to compute net loss per share, diluted | 56,775,742 | 49,049,902 | 53,691,965 | 48,902,047 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Condensed Consolidated Statements of Comprehensive Loss | ||||
Net loss | $ (38,460) | $ (41,037) | $ (72,185) | $ (61,967) |
Other comprehensive loss: | ||||
(Loss) gain on translation of foreign operations | (209) | 194 | (114) | |
Unrealized loss on marketable securities | (76) | (39) | (33) | (307) |
Comprehensive loss | $ (38,536) | $ (41,285) | $ (72,024) | $ (62,388) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholder's Equity - USD ($) $ in Thousands | Common Stock At-the-market offering | Common Stock Public offerings | Common Stock | Additional Paid-In Capital At-the-market offering | Additional Paid-In Capital Public offerings | Additional Paid-In Capital | Accumulated Other Comprehensive (Loss) Gain | Accumulated Deficit | At-the-market offering | Public offerings | Total |
Balance, Beginning at Dec. 31, 2021 | $ 709,682 | $ (299) | $ (409,362) | $ 300,021 | |||||||
Balance, Beginning (in shares) at Dec. 31, 2021 | 47,838,330 | ||||||||||
Increase (Decrease) in Stockholders' Equity | |||||||||||
Issuance of common stock, net of issuance costs | $ 14,553 | $ 14,553 | |||||||||
Issuance of common stock, net of issuance costs (in shares) | 422,367 | ||||||||||
Issuance of common stock under equity incentive and employee stock purchase plans | 3,213 | 3,213 | |||||||||
Issuance of common stock under equity incentive and employee stock purchase plans (in shares) | 430,960 | ||||||||||
Shares withheld for net settlement of tax withholding upon vesting of restricted stock units | (186) | (186) | |||||||||
Shares withheld for net settlement of tax withholding upon vesting of restricted stock units (in shares) | (7,726) | ||||||||||
Stock-based compensation expense | 12,740 | 12,740 | |||||||||
Issuance costs related to prior period common stock offering | 25 | 25 | |||||||||
Other comprehensive gain (loss) | (421) | (421) | |||||||||
Net loss | (61,967) | (61,967) | |||||||||
Balance, Ending at Jun. 30, 2022 | 740,027 | (720) | (471,329) | 267,978 | |||||||
Balance, Ending (in shares) at Jun. 30, 2022 | 48,683,931 | ||||||||||
Balance, Beginning at Dec. 31, 2021 | 709,682 | (299) | (409,362) | 300,021 | |||||||
Balance, Beginning (in shares) at Dec. 31, 2021 | 47,838,330 | ||||||||||
Balance, Ending at Dec. 31, 2022 | 752,722 | (359) | (536,755) | $ 215,608 | |||||||
Balance, Ending (in shares) at Dec. 31, 2022 | 49,339,252 | 49,339,252 | |||||||||
Balance, Beginning at Mar. 31, 2022 | 732,542 | (472) | (430,292) | $ 301,778 | |||||||
Balance, Beginning (in shares) at Mar. 31, 2022 | 48,552,102 | ||||||||||
Increase (Decrease) in Stockholders' Equity | |||||||||||
Issuance of common stock under equity incentive and employee stock purchase plans | 655 | 655 | |||||||||
Issuance of common stock under equity incentive and employee stock purchase plans (in shares) | 131,829 | ||||||||||
Stock-based compensation expense | 6,805 | 6,805 | |||||||||
Issuance costs related to prior period common stock offering | 25 | 25 | |||||||||
Other comprehensive gain (loss) | (248) | (248) | |||||||||
Net loss | (41,037) | (41,037) | |||||||||
Balance, Ending at Jun. 30, 2022 | 740,027 | (720) | (471,329) | 267,978 | |||||||
Balance, Ending (in shares) at Jun. 30, 2022 | 48,683,931 | ||||||||||
Balance, Beginning at Dec. 31, 2022 | 752,722 | (359) | (536,755) | $ 215,608 | |||||||
Balance, Beginning (in shares) at Dec. 31, 2022 | 49,339,252 | 49,339,252 | |||||||||
Balance, Ending at Mar. 31, 2023 | $ 1 | 786,768 | (122) | (570,480) | $ 216,167 | ||||||
Balance, Ending (in shares) at Mar. 31, 2023 | 51,440,503 | ||||||||||
Balance, Beginning at Dec. 31, 2022 | 752,722 | (359) | (536,755) | $ 215,608 | |||||||
Balance, Beginning (in shares) at Dec. 31, 2022 | 49,339,252 | 49,339,252 | |||||||||
Increase (Decrease) in Stockholders' Equity | |||||||||||
Issuance of common stock, net of issuance costs | $ 1 | $ 24,301 | $ 107,790 | $ 24,302 | $ 107,790 | ||||||
Issuance of common stock, net of issuance costs (in shares) | 1,749,199 | 5,750,000 | |||||||||
Issuance of common stock under equity incentive and employee stock purchase plans | 3,234 | $ 3,234 | |||||||||
Issuance of common stock under equity incentive and employee stock purchase plans (in shares) | 687,697 | ||||||||||
Shares withheld for net settlement of tax withholding upon vesting of restricted stock units | (769) | (769) | |||||||||
Shares withheld for net settlement of tax withholding upon vesting of restricted stock units (in shares) | (31,963) | ||||||||||
Stock-based compensation expense | 15,927 | 15,927 | |||||||||
Other comprehensive gain (loss) | 161 | 161 | |||||||||
Net loss | (72,185) | (72,185) | |||||||||
Balance, Ending at Jun. 30, 2023 | $ 1 | 903,205 | (198) | (608,940) | $ 294,068 | ||||||
Balance, Ending (in shares) at Jun. 30, 2023 | 57,494,185 | 57,494,185 | |||||||||
Balance, Beginning at Mar. 31, 2023 | $ 1 | 786,768 | (122) | (570,480) | $ 216,167 | ||||||
Balance, Beginning (in shares) at Mar. 31, 2023 | 51,440,503 | ||||||||||
Increase (Decrease) in Stockholders' Equity | |||||||||||
Issuance of common stock, net of issuance costs | $ 107,790 | $ 107,790 | |||||||||
Issuance of common stock, net of issuance costs (in shares) | 5,750,000 | ||||||||||
Issuance of common stock under equity incentive and employee stock purchase plans | 973 | 973 | |||||||||
Issuance of common stock under equity incentive and employee stock purchase plans (in shares) | 329,486 | ||||||||||
Shares withheld for net settlement of tax withholding upon vesting of restricted stock units | (669) | (669) | |||||||||
Shares withheld for net settlement of tax withholding upon vesting of restricted stock units (in shares) | (25,804) | ||||||||||
Stock-based compensation expense | 8,343 | 8,343 | |||||||||
Other comprehensive gain (loss) | (76) | (76) | |||||||||
Net loss | (38,460) | (38,460) | |||||||||
Balance, Ending at Jun. 30, 2023 | $ 1 | $ 903,205 | $ (198) | $ (608,940) | $ 294,068 | ||||||
Balance, Ending (in shares) at Jun. 30, 2023 | 57,494,185 | 57,494,185 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Cash Flows from Operating Activities | ||
Net loss | $ (72,185) | $ (61,967) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation | 15,927 | 12,740 |
Operating lease right-of-use asset amortization | 1,168 | 1,168 |
(Accretion) amortization of discount/premium on marketable securities | (2,215) | 454 |
Depreciation | 485 | 508 |
Other | 194 | |
Changes in operating assets and liabilities: | ||
Receivable from collaboration partner | (29) | 1,523 |
Prepaid expenses and other assets | 2,211 | (255) |
Accounts payable | 933 | (184) |
Payable to collaboration partner | (59) | (819) |
Accrued expenses and other payables | (5,661) | (1,553) |
Deferred revenue | (1,601) | |
Operating lease liability | (1,354) | (1,315) |
Net cash used in operating activities | (60,585) | (51,301) |
Cash Flows from Investing Activities | ||
Purchase of marketable securities | (34,122) | (102,121) |
Proceeds from maturities of marketable securities | 69,896 | 132,942 |
Purchases of property and equipment | (186) | (563) |
Net cash provided by investing activities | 35,588 | 30,258 |
Cash Flows from Financing Activities | ||
Proceeds from public offering of common stock, net of issuance costs | 107,868 | |
Proceeds from at-the-market offering, net of issuance costs | 24,302 | 14,553 |
Proceeds from issuance of common stock upon exercise of stock options and purchases under employee stock purchase plan | 3,234 | 3,213 |
Tax withholding payments related to net settlement of restricted stock units | (769) | (186) |
Issuance costs related to prior period common stock offering | 25 | |
Net cash provided by financing activities | 134,635 | 17,605 |
Effect of exchange rate changes on cash, cash equivalents and restricted cash | 10 | |
Net increase (decrease) in cash, cash equivalents and restricted cash | 109,638 | (3,428) |
Cash, cash equivalents and restricted cash, beginning of period | 125,969 | 123,890 |
Cash, cash equivalents and restricted cash, end of period | 235,607 | 120,462 |
Supplemental Disclosure of Non-Cash Financing and Investing Information: | ||
Purchases of property and equipment in accounts payable and accrued liabilities | 61 | $ 122 |
Issuance costs related to common stock offering included in accrued liabilities and other payables | $ 78 |
Organization and Description of
Organization and Description of Business | 6 Months Ended |
Jun. 30, 2023 | |
Organization and Description of Business | |
Organization and Description of Business | PROTAGONIST THERAPEUTICS, INC. Notes to Unaudited Condensed Consolidated Financial Statements Note 1. Protagonist Therapeutics, Inc. (the “Company”) is headquartered in Newark, California. The Company is a biopharmaceutical company with peptide-based new chemical entities rusfertide and JNJ-2113 (formerly PN-235) in different stages of clinical development, both derived from the Company’s proprietary technology platform. The Company’s Operating segments are components of an enterprise for which separate financial information is available and is evaluated regularly by the Chief Executive Officer, the Company’s chief operating decision maker, in deciding how to allocate resources and assessing performance. Liquidity As of June 30, 2023, the Company had cash, cash equivalents and marketable securities of $313.4 million. The Company has incurred net losses from operations since inception and had an accumulated deficit of $608.9 million as of June 30, 2023. The Company’s ultimate success depends upon the outcome of its research and development and collaboration activities. The Company expects to incur additional losses in the future and anticipates the need to raise additional capital to continue to execute its long-range business plan. Since the Company’s initial public offering in August 2016, it has financed its operations primarily through proceeds from offerings of common stock and payments received under license and collaboration agreements. Risks and Uncertainties The Company is currently operating in a period of economic uncertainty and capital markets disruption, which has been impacted by the COVID-19 pandemic, domestic and global monetary and fiscal policy, geopolitical instability, including the ongoing military conflict between Russia and Ukraine and rising tensions between China and Taiwan, a recessionary environment, historically high domestic and global inflation and of failures of banking and other financial institutions. The Company has experienced delays in its existing and planned clinical trials due to worldwide impacts related to the COVID-19 pandemic, and its future results of operations and liquidity could be adversely impacted by outbreaks of disease, epidemics and pandemics, including further delays in existing and planned clinical trials, difficulty in recruiting patients for these clinical trials, delays in manufacturing and collaboration activities and supply chain disruptions. The conflict in Ukraine has exacerbated market disruptions, including significant volatility in commodity prices as well as supply chain interruptions, and has contributed to record inflation globally. The U.S. Federal Reserve and other central banks may be unable to contain inflation through more restrictive monetary policy and inflation may increase or continue for a prolonged period of time. Inflationary factors, such as increases in the cost of clinical supplies, interest rates, overhead costs and transportation costs may adversely affect the Company’s operating results. In addition, the failure of Silicon Valley Bank and other regional banks in the United States during the first half of 2023 has given rise to uncertainty in the security of amounts in deposit accounts uninsured by the Federal Deposit Insurance Corporation. The Company continues to monitor these events and the potential impact on its business. Although the Company does not believe that inflation has had a material impact on its financial position or results of operations to date, it may be adversely affected in the future due to global monetary and fiscal policy, macroeconomic factors, supply chain constraints, the ongoing conflict between Russia and Ukraine and other factors, and such factors may lead to increases in the cost of manufacturing for and initiation of studies in the Company’s product candidates. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2023 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | Note 2. Basis of Presentation and Consolidation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States (“GAAP”) and applicable rules and regulations of the SEC regarding interim financial reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by GAAP have been condensed or omitted, and accordingly the condensed consolidated balance sheet as of June 30, 2023 has been derived from the Company’s unaudited consolidated financial statements at that date but does not include all of the information required by GAAP for complete consolidated financial statements. These unaudited interim condensed consolidated financial statements have been prepared on the same basis as the Company’s annual consolidated financial statements and, in the opinion of management, reflect all adjustments (consisting of normal recurring adjustments) that are necessary for a fair presentation of the Company’s condensed consolidated financial statements. The results of operations for the three and six months ended June 30, 2023 are not necessarily indicative of the results to be expected for the year ending December 31, 2023 or for any future period. Effective January 1, 2023, the financial statements of Protagonist Australia use the U.S. dollar as the functional currency due to the expected nature of the ongoing operations of this subsidiary. The cumulative translation adjustment as of January 1, 2023 related to this subsidiary was not material. Prior to January 1, 2023, the financial statements of Protagonist Australia used the Australian dollar as the functional currency since the majority of expense transactions occurred in such currency. Foreign currency translation gains and losses are reported as a component of stockholders’ equity in accumulated other comprehensive loss on the condensed consolidated balance sheets. The accompanying unaudited condensed consolidated financial statements and related financial information should be read in conjunction with the audited consolidated financial statements and the related notes thereto for the year ended December 31, 2022 included in the Company’s Annual Report on Form 10-K, filed with the SEC on March 15, 2023. Principles of Consolidation The accompanying unaudited interim condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiary. All intercompany transactions and balances have been eliminated upon consolidation. Use of Estimates The preparation of the condensed consolidated financial statements in conformity with GAAP requires management to make estimates, assumptions and judgments that affect the reported amounts of assets and liabilities and disclosure of contingent liabilities as of the date of the condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. On an ongoing basis, management evaluates its estimates, including those related to revenue recognition, accruals for research and development activities, stock-based compensation, income taxes, marketable securities and leases. Estimates related to revenue recognition include actual costs incurred versus total estimated costs of the Company’s deliverables to determine percentage of completion in addition to the application and estimates of potential revenue constraints in the determination of the transaction price under its license and collaboration agreements. Management bases these estimates on historical and anticipated results, trends, and various other assumptions that the Company believes are reasonable under the circumstances, including assumptions as to forecasted amounts and future events. Actual results could differ materially from these estimates. There has been uncertainty and disruption in the global economy and financial markets due to a number of factors, including the COVID-19 pandemic, geopolitical instability, inflationary pressures and domestic and global monetary and fiscal policy. The Company has taken into consideration any known impacts in its accounting estimates to date and is not aware of any additional specific events or circumstances that would require any additional updates to its estimates or judgments or a revision of the carrying value of its assets or liabilities as of the issuance of this report. These estimates may change as new events occur and additional information is obtained. Actual results could differ materially from these estimates under different assumptions or conditions. Cash as Reported in Condensed Consolidated Statements of Cash Flows Cash as reported in the condensed consolidated statements of cash flows includes the aggregate amounts of cash and cash equivalents and the restricted cash as presented on the condensed consolidated balance sheets. Cash as reported in the condensed consolidated statements of cash flows consists of (in thousands): June 30, 2023 2022 Cash and cash equivalents $ 235,382 $ 120,237 Restricted cash - noncurrent 225 225 Total cash reported on condensed consolidated statements of cash flows $ 235,607 $ 120,462 Investment Impairment As of each reporting date, the Company assesses each of its investments in available-for-sale debt securities whose fair value is below its cost basis to determine if the investment’s impairment is due to credit-related factors or noncredit-related factors. Factors considered in determining whether an impairment is credit-related include the extent to which the investment’s fair value is less than its cost basis, declines in published credit ratings, issuer default on interest or principal payments, and declines in the financial condition and near-term prospects of the issuer. Credit-related impairments on available-for-sale debt securities are recognized as an allowance for credit losses with a corresponding adjustment to other income (expense), net. The portion of the impairment that is not credit-related is recorded as a reduction of other comprehensive income (loss), net of applicable taxes. The Company has elected to exclude accrued interest from both the fair value and the amortized cost basis of the available-for-sale debt securities for the purposes of identifying and measuring an impairment. The Company writes off accrued interest as a reduction of interest income when an issuer has defaulted on interest payments due on a security. Significant Accounting Policies Other than the change in Protagonist Australia functional currency from the Australian dollar to the U.S. dollar effective January 1, 2023 and the investment impairment policy, as discussed above, there have been no material changes to the Company’s significant accounting policies during the three and six months ended June 30, 2023 as compared to those disclosed in Note 2. Summary of Significant Accounting Policies included in our Annual Report on Form 10-K for the year ended December 31, 2022. Recently Adopted Accounting Pronouncement In June 2016, the Financial Accounting Standard Board (“FASB”) issued Accounting Standard Update (“ASU”) 2016-13, Financial Instruments - Credit Losses (Topic 326) Financial Instruments – Credit Losses (Topic 326): Effective Dates |
License and Collaboration Agree
License and Collaboration Agreement | 6 Months Ended |
Jun. 30, 2023 | |
License and Collaboration Agreement.. | |
License and Collaboration Agreement | |
License and Collaboration Agreement | Note 3. License and Collaboration Agreement Agreement Terms On July 27, 2021, the Company entered into an Amended and Restated License and Collaboration Agreement (the “Restated Agreement”) with Janssen Biotech, Inc., a Pennsylvania corporation (“Janssen”), which amended and restated the License and Collaboration Agreement, effective July 13, 2017, by and between the Company and Janssen (the “Original Agreement”), as amended by the first amendment, effective May 7, 2019 (the “First Amendment”). Prior to January 1, 2023, Janssen was a related party to the Company as Johnson & Johnson Innovation - JJDC, Inc. was a significant (greater than 5%) stockholder of the Company, and both companies are subsidiaries of Johnson & Johnson. Upon the effectiveness of the Original Agreement, the Company received a non-refundable, upfront cash payment of $50.0 million from Janssen. Upon the effectiveness of the First Amendment, the Company received a $25.0 million payment from Janssen in 2019. The Company received a $5.0 million payment triggered by the successful nomination of a second-generation oral Interleukin (“IL”)-23 receptor antagonist development compound (“second-generation compound”) during the first quarter of 2020 and received a $7.5 million payment triggered by the completion of data collection activities for the first Phase 1 clinical trial of a second-generation compound during the fourth quarter of 2021. The Company received a $25.0 million milestone payment in connection with the dosing of the third patient in the first Phase 2 clinical trial for a second-generation compound during the second quarter of 2022. The Restated Agreement relates to the development, manufacture and commercialization of oral IL-23 receptor antagonist drug candidates. The candidates nominated for initial development pursuant to the Restated Agreement included PTG-200 (JNJ-67864238), PN-232 (JNJ-75105186) and JNJ-2113 (JNJ-77242113) (formerly PN-235). PTG-200 is an oral IL-23 receptor antagonist that was in Phase 2a development for the treatment of Crohn’s disease (“CD”). During the fourth quarter of 2021, following a pre-specified interim analysis criteria, a portfolio decision was made by Janssen to stop further development of both PTG-200 and PN-232 in favor of advancing JNJ-2113, based on its superior potency and overall pharmacokinetic and pharmacodynamic profile. Janssen is primarily responsible for the conduct of all future trials, including anticipated Phase 2 and Phase 3 trials, and the Company is primarily responsible for the conduct of the second-generation Phase 1 trials. The Restated Agreement enables Janssen to develop collaboration compounds for multiple indications. Under the Restated Agreement, Janssen is required to use commercially reasonable efforts to develop at least one collaboration compound for at least two indications. Upcoming potential development milestones for second-generation compounds include: ● $50.0 million upon the dosing of the third patient in a Phase 3 clinical trial for a second-generation compound for any indication; ● $115.0 million upon a Phase 3 clinical trial for a second-generation compound for any indication meeting its primary clinical endpoint; ● $35.0 million upon the filing of a New Drug Application (“NDA”) for a second-generation compound with the U.S. Food and Drug Administration (the “FDA”); ● $50.0 million upon FDA approval of an NDA for a second-generation compound; ● $10.0 million upon the dosing of the third patient in the first Phase 2 clinical trial for any second-generation compound for a second indication (i.e., an indication different than the indication which triggered the $25.0 million milestone received during the second quarter of 2022 described above); and ● $15.0 million upon the dosing of the third patient in a Phase 3 clinical trial for a second-generation compound for a second indication. Pursuant to the Restated Agreement, the Company remains eligible to receive tiered royalties on net product sales at percentages ranging from six percent to ten percent. The sales milestone payments in the Original Agreement also remain the same in the Restated Agreement. Pursuant to both the Original and Restated Agreements, payments to the Company for research and development services are generally billed and collected as services are performed or assets are delivered, including research activities and Phase 1 and Phase 2 development activities. Janssen bills the Company for its share of the PTG-200 Phase 2a development costs as expenses are incurred by Janssen. Milestone payments are received after the related milestones are achieved. Janssen retains exclusive, worldwide rights to develop and commercialize IL-23 receptor antagonist compounds derived from the research collaboration conducted under the Original Agreement, or Janssen’s further research under the Restated Agreement. Any further research and development will be conducted by Janssen. The Company will have the right to co-detail (for CD and ulcerative colitis indications) up to two of the IL-23 receptor antagonist compounds under the collaboration in the U.S. market. The Restated Agreement remains in effect until the royalty obligations cease following patent and regulatory expiry, unless terminated earlier. Upon a termination of the Restated Agreement, all rights revert back to the Company, and in certain circumstances, if such termination occurs during ongoing clinical trials, Janssen would, if requested, provide certain financial and operational support to the Company for the completion of such trials. Revenue Recognition The Restated Agreement contains a single performance obligation for the development license; Phase 1 development services for PTG-200, PN-232 and JNJ-2113 (formerly PN-235); the Company’s services associated with Phase 2a development for PTG-200 in CD; the initial year of second-generation compound research services; and all other such services that the Company may perform at the request of Janssen to support the development of PTG-200 through Phase 2a and PN-232 and JNJ-2113 through Phase 1. Under the Restated Agreement, development services performed by the Company for PTG-200 beyond Phase 2a and PN-232 and JNJ-2113 beyond Phase 1 are no longer required. The contract duration is defined as the period in which parties to the contract have present enforceable rights and obligations. For revenue recognition purposes, the duration of the Restated Agreement for the identified single initial performance obligation began on the Original Agreement’s effective date of July 13, 2017 and ended upon the completion of Phase 1 clinical trials for PN-232 and JNJ-2113. Final activities related to these trials were completed as of June 30, 2022. The transaction price of the initial performance obligation under the Restated Agreement was $131.7 million as of June 30, 2022, an increase of $0.2 million from the transaction price of $131.5 million as of March 31, 2022. In order to determine the transaction price, the Company evaluated all payments to be received during the duration of the contract, net of development costs reimbursement expected to be payable to Janssen. The transaction price as of June 30, 2022 included $112.5 million of nonrefundable payments received to date, $17.9 million of reimbursement from Janssen for services performed for IL-23 receptor antagonist compound research costs and other services, and variable consideration consisting of $8.2 million of development cost reimbursement from Janssen, partially offset by $6.9 million of net cost reimbursement due to Janssen for services performed. The Company concluded that the variable consideration constraint was appropriately reflected in the estimated transaction price as of June 30, 2022, and that the achievement of future milestones was subject to additional development and/or regulatory uncertainty and therefore it was not probable at June 30, 2022 that a material reversal of such revenues would not occur. Janssen also opted in for certain additional services to be performed by the Company that were outside the initial performance obligation. Revenue for these additional services was recognized as these services were performed. No license and collaboration revenue was recognized for the three and six months ended June 30, 2023 because the Company completed its performance obligation under the collaboration as of June 30, 2022. For the three and six months ended June 30, 2022, the Company recognized license and collaboration revenue of $0.9 million and $26.6 million, respectively. License and collaboration revenue for the three and six months ended June 30, 2022 was primarily related to the transaction price recognized under the Restated Agreement based on proportional performance. The following tables present changes in the Company’s contract assets and liabilities during the periods presented (in thousands): Balance at Balance at Beginning of End of Six Months Ended June 30, 2023 Period Additions Deductions Period Contract assets: Receivable from collaboration partner $ 10 $ 41 (12) $ 39 Contract liabilities: Payable to collaboration partner $ 69 $ 11 (70) $ 10 Balance at Balance at Beginning of End of Six Months Ended June 30, 2022 Period Additions Deductions Period Contract assets: Receivable from collaboration partner $ 1,566 $ 25,165 $ (26,688) $ 43 Contract liabilities: Deferred revenue $ 1,601 $ 25,757 $ (27,358) $ — Payable to collaboration partner $ 899 $ 30 $ (849) $ 80 During the three and six months ended June 30, 2022, the Company recognized revenue of $0.9 million from amounts included in the deferred revenue contract liability balance at the beginning of each period. None of the costs to obtain or fulfill the contract were capitalized. |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2023 | |
Fair Value Measurements | |
Fair Value Measurements | Note 4. Fair Value Measurements Financial assets and liabilities are recorded at fair value. The accounting guidance for fair value provides a framework for measuring fair value, clarifies the definition of fair value and expands disclosures regarding fair value measurements. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants at the reporting date. The accounting guidance establishes a three-tiered hierarchy, which prioritizes the inputs used in the valuation methodologies in measuring fair value as follows: Level 1 Level 2— Level 3 In determining fair value, the Company utilizes quoted market prices, broker or dealer quotations, or valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible and considers counterparty credit risk in its assessment of fair value. The following tables present the fair value of the Company’s financial assets determined using the inputs defined above (in thousands): June 30, 2023 Level 1 Level 2 Level 3 Total Assets: Money market funds $ 64,578 $ — $ — $ 64,578 Commercial paper — 132,955 — 132,955 Corporate debt securities — 6,408 — 6,408 U.S. Treasury and agency securities — 101,851 — 101,851 Total financial assets $ 64,578 $ 241,214 $ — $ 305,792 December 31, 2022 Level 1 Level 2 Level 3 Total Assets: Money market funds $ 54,292 $ — $ — $ 54,292 Commercial paper — 110,227 — 110,227 Corporate debt securities — 10,741 — 10,741 U.S. Treasury and agency securities 57,242 — 57,242 Total financial assets $ 54,292 $ 178,210 $ — $ 232,502 The Company’s commercial paper, corporate debt securities, and U.S. Treasury and agency securities, including U.S. Treasury bills, are classified as Level 2 as they were valued based upon quoted market prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets that are not active and model-based valuation techniques, for which all significant inputs are observable in the market or can be corroborated by observable market data for substantially the full term of the assets. The carrying amount of the Company’s remaining financial assets and liabilities, including cash, receivables and payables, approximates their fair value due to their short-term nature. |
Cash Equivalents and Marketable
Cash Equivalents and Marketable Securities | 6 Months Ended |
Jun. 30, 2023 | |
Cash Equivalents and Marketable Securities | |
Cash Equivalents and Marketable Securities | Note 5. Cash Equivalents and Marketable Securities Cash equivalents and marketable securities consisted of the following (in thousands): June 30, 2023 Amortized Gross Unrealized Cost Gains Losses Fair Value Money market funds $ 64,578 $ — $ — $ 64,578 Commercial paper 133,007 — (52) 132,955 Corporate debt securities 6,422 — (14) 6,408 U.S. Treasury and agency securities 101,872 22 (43) 101,851 Total cash equivalents and marketable securities $ 305,879 $ 22 $ (109) $ 305,792 Classified as: Cash equivalents $ 227,773 Marketable securities 78,019 Total cash equivalents and marketable securities $ 305,792 December 31, 2022 Amortized Gross Unrealized Cost Gains Losses Fair Value Money market funds $ 54,292 $ — $ — $ 54,292 Commercial paper 110,257 — (30) 110,227 Corporate debt securities 10,756 — (15) 10,741 U.S. Treasury and agency securities 57,251 27 (36) 57,242 Total cash equivalents and marketable securities $ 232,556 $ 27 $ (81) $ 232,502 Classified as: Cash equivalents $ 120,891 Marketable securities 111,611 Total cash equivalents and marketable securities $ 232,502 Marketable securities of $78.0 million and $111.6 million held at June 30, 2023 and December 31, 2022, respectively, had contractual maturities of less than one year. The Company does not intend to sell its securities that are in an unrealized loss position, and it is not more likely than not that the Company will be required to sell its securities before recovery of their amortized cost basis, which may be at maturity. There were no material realized gains or realized losses on marketable securities for the periods presented. The Company evaluated securities with unrealized losses to determine whether such losses, if any, are due to credit-related factors and determined that there were no credit-related losses to be recognized as of June 30, 2023. |
Balance Sheet Components
Balance Sheet Components | 6 Months Ended |
Jun. 30, 2023 | |
Balance Sheet Components | |
Balance Sheet Components | Note 6. Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consisted of the following (in thousands): June 30, December 31, 2023 2022 Prepaid clinical and research related expenses $ 796 $ 2,746 Prepaid insurance 827 1,417 Prepaid license 607 489 Other prepaid expenses 1,260 1,018 Other receivable 11 42 Prepaid expenses and other current assets $ 3,501 $ 5,712 Property and Equipment, Net Property and equipment, net consisted of the following (in thousands): June 30, December 31, 2023 2022 Laboratory equipment $ 4,982 $ 4,817 Furniture and computer equipment 1,089 1,089 Leasehold improvements 913 913 Total property and equipment 6,984 6,819 Accumulated depreciation (5,721) (5,254) Property and equipment, net $ 1,263 $ 1,565 Accrued Expenses and Other Payables Accrued expenses and other payables consisted of the following (in thousands): June 30, December 31, 2023 2022 Accrued clinical and research related expenses $ 14,703 $ 19,109 Accrued employee related expenses 3,633 4,967 Accrued professional service fees 868 464 Other 165 415 Total accrued expenses and other payables $ 19,369 $ 24,955 |
Stockholders' Equity
Stockholders' Equity | 6 Months Ended |
Jun. 30, 2023 | |
Stockholders' Equity | |
Stockholders' Equity | Note 7. Stockholders’ Equity In April 2023, the Company completed an underwritten public offering of 5,000,000 shares of its common stock at a public offering price of $20.00 per share and issued an additional 750,000 shares of common stock at a price of $20.00 per share following the underwriters’ exercise of their option to purchase additional shares. Net proceeds, after deducting underwriting commissions and offering costs paid by the Company, were approximately $107.8 million. In August 2022, the Company entered into an Open Market Sale Agreement SM (the “Sales Agreement”), pursuant to which the Company may offer and sell up to $100.0 million of shares of common stock from time to time in “at-the-market” offerings (the “2022 ATM Facility”). There were no sales of the Company’s common stock under the 2022 ATM Facility during the year ended December 31, 2022. During the three months ended March 31, 2023, the Company sold 1,749,199 shares of its common stock under the 2022 ATM Facility for net proceeds of $24.3 million, after deducting issuance costs. There were no sales of the Company’s common stock under the 2022 ATM Facility during the three months ended June 30, 2023. In November 2019, the Company entered into an Open Market Sale Agreement SM (the “Prior Sales Agreement”), pursuant to which the Company could offer and sell up to $75.0 million of shares of common stock from time to time in “at-the-market” offerings (the “2019 ATM Facility”). During the year ended December 31, 2022, the Company sold 422,367 shares of its common stock under the 2019 ATM Facility for net proceeds of $14.6 million, after deducting issuance costs. The Prior Sales Agreement was terminated in connection with and replaced by the Sales Agreement in August 2022. In August 2018, the Company entered into a Securities Purchase Agreement with certain accredited investors (each, an “Investor” and, collectively, the “Investors”), pursuant to which the Company sold an aggregate of 2,750,000 shares of its common stock at a price of $8.00 per share, for aggregate net proceeds of $21.7 million, after deducting offering expenses payable by the Company. In a concurrent private placement, the Company issued the Investors warrants to purchase an aggregate of 2,750,000 shares of its common stock (each, a “Warrant” and, collectively, the “Warrants”). Each Warrant is exercisable from August 8, 2018 through August 8, 2023. Warrants to purchase 1,375,000 shares of the Company’s common stock have an exercise price of $10.00 per share and Warrants to purchase 1,375,000 shares of the Company’s common stock have an exercise price of $15.00 per share. The exercise price and number of shares of common stock issuable upon the exercise of the Warrants (the “Warrant Shares”) are subject to adjustment in the event of any stock dividends and splits, reverse stock split, recapitalization, reorganization or similar transaction, as described in the Warrants. Under certain circumstances, the Warrants may be exercisable on a “cashless” basis. In connection with the issuance and sale of the common stock and Warrants, the Company granted the Investors certain registration rights with respect to the Warrants and the Warrant Shares. The common stock and warrants are classified as equity in accordance with Accounting Standards Codification Topic 480 , Distinguishing Liabilities from Equity (“ASC 480”) |
Equity Plans
Equity Plans | 6 Months Ended |
Jun. 30, 2023 | |
Equity Plans | |
Equity Plans | Note 8. Equity Plans Equity Incentive Plan In July 2016, the Company’s Board of Directors (“the Board”) and stockholders approved the Company’s 2016 Equity Incentive Plan (the “2016 Plan”) to replace the 2007 Stock Option Plan. The 2016 Plan is administered by the Board, or a committee appointed by the Board, which determines the types of awards to be granted, including the number of shares subject to the awards, the exercise price and the vesting schedule. Awards granted under the 2016 Plan expire no later than ten years from the date of grant. As of June 30, 2023, 841,577 shares of common stock were available for issuance under the 2016 Plan. Inducement Plan In May 2018, the Board approved the Company’s 2018 Inducement Plan (as subsequently amended, the “2018 Inducement Plan”), a non-stockholder approved stock plan, under which the Company awards options and restricted stock unit awards to persons that were not previously employees or directors of the Company, or following a bona fide period of non-employment, as an inducement material to such persons entering into employment with the Company, within the meaning of Rule 5635(c)(4) of the Nasdaq Listing Rules. The 2018 Inducement Plan is administered by the Board or the Compensation Committee of the Board (the “Compensation Committee”), which determines the types of awards to be granted, including the number of shares subject to the awards, the exercise price and the vesting schedule. Awards granted under the 2018 Inducement Plan expire no later than ten years from the date of grant. As of June 30, 2023, 575,961 shares of common stock were available for issuance under the 2018 Inducement Plan. Stock Options Stock option activity under the Company’s equity incentive and inducement plans is set forth below: Weighted- Weighted- Average Average Exercise Remaining Aggregate Options Price Per Contractual Intrinsic Outstanding Share Life Value (1) (years) (in millions) Balances at December 31, 2022 6,240,509 $ 19.03 Options granted 2,262,750 12.61 Options exercised (220,771) 12.27 Options forfeited (157,679) 26.14 Balances at June 30, 2023 8,124,809 $ 17.29 7.53 $ 92.2 Options exercisable – June 30, 2023 4,410,899 $ 16.81 6.33 51.9 Options vested and expected to vest – June 30, 2023 8,124,809 $ 17.29 7.53 $ 92.2 (1) The aggregate intrinsic values were calculated as the difference between the exercise price of the options and the closing price of the Company’s common stock on June 30, 2023. The calculation excludes options with an exercise price higher than the closing price of the Company’s common stock on June 30, 2023. The estimated weighted-average grant-date fair value of common stock underlying options granted to employees during the six months ended June 30, 2023 was $10.40 per share. Stock Options Valuation Assumptions The fair value of employee stock option awards was estimated at the date of grant using a Black-Scholes option-pricing model with the following assumptions: Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 Expected term (in years) 6.08 - 6.08 5.50 - 6.08 5.27 - 6.08 5.27- 6.08 Expected volatility 106.2% - 107.5% 96.3% - 99.9% 106.2% - 107.5% 96.3% - 99.9% Risk-free interest rate 3.71% - 4.04% 2.71% - 2.93% 3.57% - 4.04% 1.64% - 2.93% Dividend yield — — — — In determining the fair value of the options granted, the Company uses the Black-Scholes option-pricing model and assumptions discussed below. Each of these inputs is subjective and generally requires judgment to determine. Expected Term Expected Volatility Risk-Free Interest Rate Expected Dividend Restricted Stock Units Restricted stock unit (“RSU”) activity under the Company’s equity incentive plans is set forth below: Weighted Average Number of Grant Date Shares Fair Value Unvested RSUs at December 31, 2022 637,436 $ 19.29 Granted 396,775 12.17 Vested (284,321) 14.20 Forfeited (12,901) 16.28 Unvested RSUs at June 30, 2023 736,989 $ 18.37 Performance Stock Units Performance stock unit (“PSU”) activity under the Company’s equity incentive plans is set forth below: Weighted Average Number of Grant Date Shares Fair Value Unvested PSUs at December 31, 2022 199,500 $ 14.59 Granted — — Vested (114,000) 8.76 Forfeited — — Unvested PSUs at June 30, 2023 85,500 $ 23.57 The terms of the PSUs provide for 100% of shares to be earned based on the achievement of certain pre-determined performance objectives, subject to the participant’s continued employment. The PSUs will vest, if at all, upon certification by the Compensation Committee of the actual achievement of the related performance objectives, subject to specified change of control exceptions. Stock-based compensation expense associated with PSUs is based on the fair value of the Company’s common stock on the grant date, which equals the closing price of the Company’s common stock on the grant date. The Company recognizes compensation expense over the vesting period of the awards that are ultimately expected to vest when the achievement of the related performance objectives becomes probable. During the three and six months ended June 30, 2023, the Compensation Committee certified the actual achievement of performance objectives related to certain PSUs. As a result, recipients earned a total of 114,000 shares of common stock. The total fair market value of PSUs on vest date during the three and six months ended June 30, 2023 was $3.0 million. The total grant date fair value of unvested PSUs outstanding as of June 30, 2023 was $2.0 million. As of June 30, 2023, the achievement of the related performance objectives was deemed not probable and, accordingly, no stock-based compensation for unvested PSUs has been recognized as expense as of June 30, 2023. Employee Stock Purchase Plan The Company’s 2016 Employee Stock Purchase Plan (“2016 ESPP”) allows eligible employees to purchase shares of the Company’s common stock at a discount through payroll deductions of up to 15% of their eligible compensation. At the end of each offering period, eligible employees are able to purchase shares at 85% of the lower of the fair market value of the Company’s common stock at the beginning of the offering period or at the end of each applicable purchase period. During the six months ended June 30, 2023, a total of 68,605 shares of common stock were issued under the 2016 ESPP, and 1,486,685 shares of common stock remained available for issuance as of June 30, 2023. Stock-Based Compensation Total stock-based compensation expense was as follows (in thousands): Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 Research and development $ 4,809 $ 4,106 $ 9,391 $ 7,432 General and administrative 3,534 2,699 6,536 5,308 Total stock-based compensation expense $ 8,343 $ 6,805 $ 15,927 $ 12,740 As of June 30, 2023, total unrecognized stock-based compensation expense was approximately $60.7 million, which the Company expects to recognize over a weighted-average period of approximately 2.7 years. |
Net Loss per Share
Net Loss per Share | 6 Months Ended |
Jun. 30, 2023 | |
Net Loss per Share | |
Net Loss per Share | Note 9. Net Loss per Share As the Company had net losses for the three and six months ended June 30, 2023 and 2022, all potential weighted average dilutive common shares were determined to be anti-dilutive. The following table sets forth the computation of basic and diluted net loss per share (in thousands, except share and per share data): Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 Numerator: Net loss $ (38,460) $ (41,037) $ (72,185) $ (61,967) Denominator: Weighted-average shares used to compute net loss per common share, basic and diluted 56,775,742 49,049,902 53,691,965 48,902,047 Net loss per share, basic and diluted $ (0.68) $ (0.84) $ (1.34) $ (1.27) The following outstanding shares of potentially dilutive securities have been excluded from diluted net loss per share computations for the periods presented because their inclusion would be anti-dilutive: June 30, 2023 2022 Options to purchase common stock 8,124,809 6,825,121 Common stock warrants 2,750,000 2,750,000 Restricted stock units 736,989 766,090 Performance stock units 85,500 219,000 ESPP shares 24,998 19,103 Total 11,722,296 10,579,314 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2023 | |
Summary of Significant Accounting Policies | |
Basis of Presentation and Consolidation | Basis of Presentation and Consolidation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States (“GAAP”) and applicable rules and regulations of the SEC regarding interim financial reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by GAAP have been condensed or omitted, and accordingly the condensed consolidated balance sheet as of June 30, 2023 has been derived from the Company’s unaudited consolidated financial statements at that date but does not include all of the information required by GAAP for complete consolidated financial statements. These unaudited interim condensed consolidated financial statements have been prepared on the same basis as the Company’s annual consolidated financial statements and, in the opinion of management, reflect all adjustments (consisting of normal recurring adjustments) that are necessary for a fair presentation of the Company’s condensed consolidated financial statements. The results of operations for the three and six months ended June 30, 2023 are not necessarily indicative of the results to be expected for the year ending December 31, 2023 or for any future period. Effective January 1, 2023, the financial statements of Protagonist Australia use the U.S. dollar as the functional currency due to the expected nature of the ongoing operations of this subsidiary. The cumulative translation adjustment as of January 1, 2023 related to this subsidiary was not material. Prior to January 1, 2023, the financial statements of Protagonist Australia used the Australian dollar as the functional currency since the majority of expense transactions occurred in such currency. Foreign currency translation gains and losses are reported as a component of stockholders’ equity in accumulated other comprehensive loss on the condensed consolidated balance sheets. The accompanying unaudited condensed consolidated financial statements and related financial information should be read in conjunction with the audited consolidated financial statements and the related notes thereto for the year ended December 31, 2022 included in the Company’s Annual Report on Form 10-K, filed with the SEC on March 15, 2023. |
Principles of Consolidation | Principles of Consolidation The accompanying unaudited interim condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiary. All intercompany transactions and balances have been eliminated upon consolidation. |
Use of Estimates | Use of Estimates The preparation of the condensed consolidated financial statements in conformity with GAAP requires management to make estimates, assumptions and judgments that affect the reported amounts of assets and liabilities and disclosure of contingent liabilities as of the date of the condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. On an ongoing basis, management evaluates its estimates, including those related to revenue recognition, accruals for research and development activities, stock-based compensation, income taxes, marketable securities and leases. Estimates related to revenue recognition include actual costs incurred versus total estimated costs of the Company’s deliverables to determine percentage of completion in addition to the application and estimates of potential revenue constraints in the determination of the transaction price under its license and collaboration agreements. Management bases these estimates on historical and anticipated results, trends, and various other assumptions that the Company believes are reasonable under the circumstances, including assumptions as to forecasted amounts and future events. Actual results could differ materially from these estimates. There has been uncertainty and disruption in the global economy and financial markets due to a number of factors, including the COVID-19 pandemic, geopolitical instability, inflationary pressures and domestic and global monetary and fiscal policy. The Company has taken into consideration any known impacts in its accounting estimates to date and is not aware of any additional specific events or circumstances that would require any additional updates to its estimates or judgments or a revision of the carrying value of its assets or liabilities as of the issuance of this report. These estimates may change as new events occur and additional information is obtained. Actual results could differ materially from these estimates under different assumptions or conditions. |
Cash as Reported in Consolidated Statements of Cash Flows | Cash as Reported in Condensed Consolidated Statements of Cash Flows Cash as reported in the condensed consolidated statements of cash flows includes the aggregate amounts of cash and cash equivalents and the restricted cash as presented on the condensed consolidated balance sheets. Cash as reported in the condensed consolidated statements of cash flows consists of (in thousands): June 30, 2023 2022 Cash and cash equivalents $ 235,382 $ 120,237 Restricted cash - noncurrent 225 225 Total cash reported on condensed consolidated statements of cash flows $ 235,607 $ 120,462 |
Investment Impairment | Investment Impairment As of each reporting date, the Company assesses each of its investments in available-for-sale debt securities whose fair value is below its cost basis to determine if the investment’s impairment is due to credit-related factors or noncredit-related factors. Factors considered in determining whether an impairment is credit-related include the extent to which the investment’s fair value is less than its cost basis, declines in published credit ratings, issuer default on interest or principal payments, and declines in the financial condition and near-term prospects of the issuer. Credit-related impairments on available-for-sale debt securities are recognized as an allowance for credit losses with a corresponding adjustment to other income (expense), net. The portion of the impairment that is not credit-related is recorded as a reduction of other comprehensive income (loss), net of applicable taxes. The Company has elected to exclude accrued interest from both the fair value and the amortized cost basis of the available-for-sale debt securities for the purposes of identifying and measuring an impairment. The Company writes off accrued interest as a reduction of interest income when an issuer has defaulted on interest payments due on a security. |
Recently Adopted Accounting Pronouncement | Recently Adopted Accounting Pronouncement In June 2016, the Financial Accounting Standard Board (“FASB”) issued Accounting Standard Update (“ASU”) 2016-13, Financial Instruments - Credit Losses (Topic 326) Financial Instruments – Credit Losses (Topic 326): Effective Dates |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Summary of Significant Accounting Policies | |
Schedule of cash as reported in the consolidated statements of cash flows | Cash as reported in the condensed consolidated statements of cash flows consists of (in thousands): June 30, 2023 2022 Cash and cash equivalents $ 235,382 $ 120,237 Restricted cash - noncurrent 225 225 Total cash reported on condensed consolidated statements of cash flows $ 235,607 $ 120,462 |
License and Collaboration Agr_2
License and Collaboration Agreement (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
License and Collaboration Agreement. | |
Schedule of changes in contract assets and liabilities | Balance at Balance at Beginning of End of Six Months Ended June 30, 2023 Period Additions Deductions Period Contract assets: Receivable from collaboration partner $ 10 $ 41 (12) $ 39 Contract liabilities: Payable to collaboration partner $ 69 $ 11 (70) $ 10 Balance at Balance at Beginning of End of Six Months Ended June 30, 2022 Period Additions Deductions Period Contract assets: Receivable from collaboration partner $ 1,566 $ 25,165 $ (26,688) $ 43 Contract liabilities: Deferred revenue $ 1,601 $ 25,757 $ (27,358) $ — Payable to collaboration partner $ 899 $ 30 $ (849) $ 80 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Fair Value Measurements | |
Schedule of fair value of financial assets | June 30, 2023 Level 1 Level 2 Level 3 Total Assets: Money market funds $ 64,578 $ — $ — $ 64,578 Commercial paper — 132,955 — 132,955 Corporate debt securities — 6,408 — 6,408 U.S. Treasury and agency securities — 101,851 — 101,851 Total financial assets $ 64,578 $ 241,214 $ — $ 305,792 December 31, 2022 Level 1 Level 2 Level 3 Total Assets: Money market funds $ 54,292 $ — $ — $ 54,292 Commercial paper — 110,227 — 110,227 Corporate debt securities — 10,741 — 10,741 U.S. Treasury and agency securities 57,242 — 57,242 Total financial assets $ 54,292 $ 178,210 $ — $ 232,502 |
Cash Equivalents and Marketab_2
Cash Equivalents and Marketable Securities (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Cash Equivalents and Marketable Securities | |
Schedule of cash equivalents and marketable securities | Cash equivalents and marketable securities consisted of the following (in thousands): June 30, 2023 Amortized Gross Unrealized Cost Gains Losses Fair Value Money market funds $ 64,578 $ — $ — $ 64,578 Commercial paper 133,007 — (52) 132,955 Corporate debt securities 6,422 — (14) 6,408 U.S. Treasury and agency securities 101,872 22 (43) 101,851 Total cash equivalents and marketable securities $ 305,879 $ 22 $ (109) $ 305,792 Classified as: Cash equivalents $ 227,773 Marketable securities 78,019 Total cash equivalents and marketable securities $ 305,792 December 31, 2022 Amortized Gross Unrealized Cost Gains Losses Fair Value Money market funds $ 54,292 $ — $ — $ 54,292 Commercial paper 110,257 — (30) 110,227 Corporate debt securities 10,756 — (15) 10,741 U.S. Treasury and agency securities 57,251 27 (36) 57,242 Total cash equivalents and marketable securities $ 232,556 $ 27 $ (81) $ 232,502 Classified as: Cash equivalents $ 120,891 Marketable securities 111,611 Total cash equivalents and marketable securities $ 232,502 |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Balance Sheet Components | |
Summary of Prepaid Expenses and Other Current Assets | Prepaid expenses and other current assets consisted of the following (in thousands): June 30, December 31, 2023 2022 Prepaid clinical and research related expenses $ 796 $ 2,746 Prepaid insurance 827 1,417 Prepaid license 607 489 Other prepaid expenses 1,260 1,018 Other receivable 11 42 Prepaid expenses and other current assets $ 3,501 $ 5,712 |
Summary of Property and Equipment Net | Property and equipment, net consisted of the following (in thousands): June 30, December 31, 2023 2022 Laboratory equipment $ 4,982 $ 4,817 Furniture and computer equipment 1,089 1,089 Leasehold improvements 913 913 Total property and equipment 6,984 6,819 Accumulated depreciation (5,721) (5,254) Property and equipment, net $ 1,263 $ 1,565 |
Schedule of Accrued Expenses and Other Payables | Accrued expenses and other payables consisted of the following (in thousands): June 30, December 31, 2023 2022 Accrued clinical and research related expenses $ 14,703 $ 19,109 Accrued employee related expenses 3,633 4,967 Accrued professional service fees 868 464 Other 165 415 Total accrued expenses and other payables $ 19,369 $ 24,955 |
Equity Plans (Tables)
Equity Plans (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Schedule of activity under equity incentive plans | Weighted- Weighted- Average Average Exercise Remaining Aggregate Options Price Per Contractual Intrinsic Outstanding Share Life Value (1) (years) (in millions) Balances at December 31, 2022 6,240,509 $ 19.03 Options granted 2,262,750 12.61 Options exercised (220,771) 12.27 Options forfeited (157,679) 26.14 Balances at June 30, 2023 8,124,809 $ 17.29 7.53 $ 92.2 Options exercisable – June 30, 2023 4,410,899 $ 16.81 6.33 51.9 Options vested and expected to vest – June 30, 2023 8,124,809 $ 17.29 7.53 $ 92.2 (1) The aggregate intrinsic values were calculated as the difference between the exercise price of the options and the closing price of the Company’s common stock on June 30, 2023. The calculation excludes options with an exercise price higher than the closing price of the Company’s common stock on June 30, 2023. |
Schedule of stock-based compensation expense | Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 Research and development $ 4,809 $ 4,106 $ 9,391 $ 7,432 General and administrative 3,534 2,699 6,536 5,308 Total stock-based compensation expense $ 8,343 $ 6,805 $ 15,927 $ 12,740 |
Options to Purchase Common Stock | |
Black-Scholes option-pricing model assumptions | Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 Expected term (in years) 6.08 - 6.08 5.50 - 6.08 5.27 - 6.08 5.27- 6.08 Expected volatility 106.2% - 107.5% 96.3% - 99.9% 106.2% - 107.5% 96.3% - 99.9% Risk-free interest rate 3.71% - 4.04% 2.71% - 2.93% 3.57% - 4.04% 1.64% - 2.93% Dividend yield — — — — |
Restricted stock units | |
Schedule of activity under equity incentive plans | Weighted Average Number of Grant Date Shares Fair Value Unvested RSUs at December 31, 2022 637,436 $ 19.29 Granted 396,775 12.17 Vested (284,321) 14.20 Forfeited (12,901) 16.28 Unvested RSUs at June 30, 2023 736,989 $ 18.37 |
Performance Stock Units | |
Schedule of performance stock unit activity | Weighted Average Number of Grant Date Shares Fair Value Unvested PSUs at December 31, 2022 199,500 $ 14.59 Granted — — Vested (114,000) 8.76 Forfeited — — Unvested PSUs at June 30, 2023 85,500 $ 23.57 |
Net Loss per Share (Tables)
Net Loss per Share (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Net Loss per Share | |
Schedule of computation of the basic and diluted net loss per share attributable to common stockholders | Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 Numerator: Net loss $ (38,460) $ (41,037) $ (72,185) $ (61,967) Denominator: Weighted-average shares used to compute net loss per common share, basic and diluted 56,775,742 49,049,902 53,691,965 48,902,047 Net loss per share, basic and diluted $ (0.68) $ (0.84) $ (1.34) $ (1.27) |
Schedule of potentially dilutive securities excluded from diluted net loss per share calculations | June 30, 2023 2022 Options to purchase common stock 8,124,809 6,825,121 Common stock warrants 2,750,000 2,750,000 Restricted stock units 736,989 766,090 Performance stock units 85,500 219,000 ESPP shares 24,998 19,103 Total 11,722,296 10,579,314 |
Organization and Description _2
Organization and Description of Business - Liquidity (Details) $ in Thousands | 6 Months Ended | |
Jun. 30, 2023 USD ($) segment | Dec. 31, 2022 USD ($) | |
Organization and Description of Business | ||
Number of operating segments | segment | 1 | |
Net losses from operations since inception | ||
Cash, cash equivalents and marketable securities | $ 313,400 | |
Accumulated deficit | $ (608,940) | $ (536,755) |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Cash and Cash Equivalents and Restricted Cash (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 | Jun. 30, 2022 | Dec. 31, 2021 |
Aggregate amounts of cash and cash equivalents and the restricted cash | ||||
Cash and cash equivalents | $ 235,382 | $ 125,744 | $ 120,237 | |
Restricted cash - noncurrent | 225 | 225 | 225 | |
Total cash reported on condensed consolidated statements of cash flows | $ 235,607 | $ 125,969 | $ 120,462 | $ 123,890 |
License and Collaboration Agr_3
License and Collaboration Agreement - Narrative (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||||||||
Jul. 27, 2021 | Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Mar. 31, 2022 | Dec. 31, 2021 | Mar. 31, 2020 | May 07, 2019 | Jul. 13, 2017 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||
License and collaboration revenue | $ 0 | $ 859 | $ 0 | $ 26,581 | ||||||
Revenue recognized | 900 | 900 | ||||||||
Janssen | Services performed for IL-23 receptor antagonist compound research costs and other services | ||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||
Reimbursement for services performed | 17,900 | 17,900 | ||||||||
Janssen | License and Collaboration Agreement | Three phase 1 studies of second-generation compounds | ||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||
Eligible amount received | $ 7,500 | |||||||||
Janssen | License and Collaboration Agreement | 3rd patient in the first Phase 2 clinical trial for any second-generation compound for a second indication | ||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||
Eligible amount received | 25,000 | 25,000 | ||||||||
Janssen | Original Agreement | Upfront cash payment | ||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||
Upfront payment | $ 50,000 | |||||||||
Janssen | Restated Agreement | ||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||
Contract modification, increase (decrease) in adjustment to revenue | 200 | |||||||||
Upfront payment | 112,500 | 112,500 | ||||||||
Development cost payable | 6,900 | 6,900 | ||||||||
Reimbursement for services performed | 8,200 | 8,200 | ||||||||
Final transaction price | $ 131,700 | $ 131,700 | $ 131,500 | |||||||
Janssen | Restated Agreement | Second-generation Oral Interleukin ("IL")-23 Receptor Antagonist Development Compound | ||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||
Eligible amount received | $ 5,000 | |||||||||
Janssen | Restated Agreement | Minimum | ||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||
Percentage of royalties on net product sales | 6% | |||||||||
Janssen | Restated Agreement | Maximum | ||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||
Percentage of royalties on net product sales | 10% | |||||||||
Janssen | Restated Agreement | License and Collaboration Agreement | ||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||
Eligible amount received | $ 25,000 | |||||||||
Janssen | Restated Agreement | License and Collaboration Agreement | Dosing of the 3rd patient in a Phase 3 clinical trial for a second-generation compound for any indication | ||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||
Upcoming potential development milestones | 50,000 | 50,000 | ||||||||
Janssen | Restated Agreement | License and Collaboration Agreement | Phase 3 clinical trial for a second-generation compound for any indication | ||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||
Upcoming potential development milestones | 115,000 | 115,000 | ||||||||
Janssen | Restated Agreement | License and Collaboration Agreement | Filing of New Drug Application ("NDA") for second-generation compound with the U.S. Food and Drug Administration | ||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||
Upcoming potential development milestones | 35,000 | 35,000 | ||||||||
Janssen | Restated Agreement | License and Collaboration Agreement | FDA approval of NDA for second-generation compound | ||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||
Upcoming potential development milestones | 50,000 | 50,000 | ||||||||
Janssen | Restated Agreement | License and Collaboration Agreement | Phase 2 studies for second-generation products | ||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||
Upcoming potential development milestones | 25,000 | 25,000 | ||||||||
Janssen | Restated Agreement | License and Collaboration Agreement | 3rd patient in the first Phase 2 clinical trial for any second-generation compound for a second indication | ||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||
Upcoming potential development milestones | 10,000 | 10,000 | ||||||||
Janssen | Restated Agreement | License and Collaboration Agreement | Dosing Of Third Patient In Phase 3 Clinical Trial For Second Generation Compound For A Second Indication [Member] | ||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||
Upcoming potential development milestones | $ 15,000 | $ 15,000 |
License and Collaboration Agr_4
License and Collaboration Agreement - Contract Assets and Liabilities (Details) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Payable to collaboration partner - related party | ||
Balance at Beginning of Period | $ 69 | |
Balance at End of Period | 10 | |
License and Collaboration Agreement | ||
Receivable from collaboration partner - related party | ||
Balance at Beginning of Period | 10 | $ 1,566 |
Additions | 41 | 25,165 |
Deductions | (12) | (26,688) |
Balance at End of Period | 39 | 43 |
Deferred revenue - related party | ||
Balance at Beginning of Period | 1,601 | |
Additions | 25,757 | |
Deductions | (27,358) | |
Payable to collaboration partner - related party | ||
Balance at Beginning of Period | 69 | 899 |
Additions | 11 | 30 |
Deductions | (70) | (849) |
Balance at End of Period | $ 10 | $ 80 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - Recurring - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | $ 305,792 | $ 232,502 |
Money Market Funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 64,578 | 54,292 |
Commercial Paper | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 132,955 | 110,227 |
Corporate debt securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 6,408 | 10,741 |
U.S. Treasury and agency securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 101,851 | 57,242 |
Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 64,578 | 54,292 |
Level 1 [Member] | Money Market Funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 64,578 | 54,292 |
Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 241,214 | 178,210 |
Level 2 [Member] | Commercial Paper | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 132,955 | 110,227 |
Level 2 [Member] | Corporate debt securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 6,408 | 10,741 |
Level 2 [Member] | U.S. Treasury and agency securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | $ 101,851 | $ 57,242 |
Cash Equivalents and Marketab_3
Cash Equivalents and Marketable Securities - Cash Equivalents and Marketable Securities (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Cash Equivalents and Marketable Securities | ||
Total cash equivalents and marketable securities, Amortized Cost | $ 305,879 | $ 232,556 |
Total cash equivalents and marketable securities, Gross Unrealized Gains | 22 | 27 |
Total cash equivalents and marketable securities, Gross Unrealized Losses | (109) | (81) |
Total cash equivalents and marketable securities, Fair Value | 305,792 | 232,502 |
Corporate debt securities | ||
Cash Equivalents and Marketable Securities | ||
Total cash equivalents and marketable securities, Amortized Cost | 6,422 | 10,756 |
Total cash equivalents and marketable securities, Gross Unrealized Losses | (14) | (15) |
Total cash equivalents and marketable securities, Fair Value | 6,408 | 10,741 |
U.S. Treasury and agency securities | ||
Cash Equivalents and Marketable Securities | ||
Total cash equivalents and marketable securities, Amortized Cost | 101,872 | 57,251 |
Total cash equivalents and marketable securities, Gross Unrealized Gains | 22 | 27 |
Total cash equivalents and marketable securities, Gross Unrealized Losses | (43) | (36) |
Total cash equivalents and marketable securities, Fair Value | 101,851 | 57,242 |
Money Market Funds | ||
Cash Equivalents and Marketable Securities | ||
Total cash equivalents and marketable securities, Amortized Cost | 64,578 | 54,292 |
Total cash equivalents and marketable securities, Fair Value | 64,578 | 54,292 |
Commercial Paper | ||
Cash Equivalents and Marketable Securities | ||
Total cash equivalents and marketable securities, Amortized Cost | 133,007 | 110,257 |
Total cash equivalents and marketable securities, Gross Unrealized Losses | (52) | (30) |
Total cash equivalents and marketable securities, Fair Value | $ 132,955 | $ 110,227 |
Cash Equivalents and Marketab_4
Cash Equivalents and Marketable Securities - Classification of Cash Equivalents and Marketable Securities (Details) - USD ($) | 6 Months Ended | 12 Months Ended |
Jun. 30, 2023 | Dec. 31, 2022 | |
Classified as: | ||
Cash equivalents | $ 227,773,000 | $ 120,891,000 |
Marketable securities - current | 78,019,000 | 111,611,000 |
Total cash equivalents and marketable securities | $ 305,792,000 | $ 232,502,000 |
Contractual maturities | ||
Maximum period of current contractual maturities | 1 year | 1 year |
Realized Gain (loss) | $ 0 | $ 0 |
Credit-related losses to be recognized | $ 0 |
Balance Sheet Components - Prep
Balance Sheet Components - Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Prepaid Expense and Other Assets, Current [Abstract] | ||
Prepaid clinical and research related expenses | $ 796 | $ 2,746 |
Prepaid insurance | 827 | 1,417 |
Prepaid licenses | 607 | 489 |
Other prepaid expenses | 1,260 | 1,018 |
Other receivable | 11 | 42 |
Prepaid expenses and other current assets | $ 3,501 | $ 5,712 |
Balance Sheet Components - Prop
Balance Sheet Components - Property and Equipment, Net (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Property and Equipment | ||
Total property and equipment | $ 6,984 | $ 6,819 |
Accumulated depreciation | (5,721) | (5,254) |
Property and equipment, net | 1,263 | 1,565 |
Laboratory equipment | ||
Property and Equipment | ||
Total property and equipment | 4,982 | 4,817 |
Furniture and computer equipment | ||
Property and Equipment | ||
Total property and equipment | 1,089 | 1,089 |
Leasehold improvements | ||
Property and Equipment | ||
Total property and equipment | $ 913 | $ 913 |
Balance Sheet Components - Accr
Balance Sheet Components - Accrued Expenses and Other Payables (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Accrued Expenses and Other Payables | ||
Accrued clinical and research related expenses | $ 14,703 | $ 19,109 |
Accrued employee related expenses | 3,633 | 4,967 |
Accrued professional service fees | 868 | 464 |
Other | 165 | 415 |
Total accrued expenses and other payables | $ 19,369 | $ 24,955 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||||||
Aug. 08, 2018 | Apr. 30, 2023 | Aug. 31, 2022 | Jan. 31, 2022 | Nov. 30, 2019 | Aug. 31, 2018 | Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2023 | Dec. 31, 2022 | |
Stock transactions | ||||||||||
Common stock sold, price per share | $ 20 | |||||||||
Common stock issued (in shares) | 5,000,000 | |||||||||
Proceeds from public offering of common stock, net of issuance costs | $ 107,800 | $ 107,868 | ||||||||
2019 Sales Agreement | ||||||||||
Stock transactions | ||||||||||
Common stock issued (in shares) | 422,367 | |||||||||
Maximum aggregate offering price | $ 75,000 | |||||||||
Proceeds from public offering of common stock, net of issuance costs | $ 14,600 | |||||||||
2022 Sales Agreement | ||||||||||
Stock transactions | ||||||||||
Common stock issued (in shares) | 0 | 1,749,199 | 0 | |||||||
Maximum aggregate offering price | $ 100,000 | |||||||||
Aggregate net proceeds | $ 24,300 | |||||||||
Over-Allotment Option | ||||||||||
Stock transactions | ||||||||||
Common stock sold, price per share | $ 20 | |||||||||
Common stock issued (in shares) | 750,000 | |||||||||
Common Stock | Private Placement | ||||||||||
Stock transactions | ||||||||||
Number of warrants exercised | 0 | 0 | ||||||||
Investors | Private Placement | ||||||||||
Stock transactions | ||||||||||
Aggregate shares of common stock sold | 2,750,000 | |||||||||
Common stock sold, price per share | $ 8 | |||||||||
Net proceeds from sale of common stock | $ 21,700 | |||||||||
Warrants issued to purchase common stock, number of shares | 2,750,000 | |||||||||
Warrants exercisable date | Aug. 08, 2023 | |||||||||
$10.00 per share | Investors | Private Placement | ||||||||||
Stock transactions | ||||||||||
Warrants to purchase common stock (in shares) | 1,375,000 | |||||||||
Exercise Price (per share) | $ 10 | |||||||||
$15.00 per share | Investors | Private Placement | ||||||||||
Stock transactions | ||||||||||
Warrants to purchase common stock (in shares) | 1,375,000 | |||||||||
Exercise Price (per share) | $ 15 |
Equity Plans - Narrative (Detai
Equity Plans - Narrative (Details) - shares | 1 Months Ended | 6 Months Ended | |
May 31, 2018 | Jul. 31, 2016 | Jun. 30, 2023 | |
Equity Plans | |||
Dividend yield | 0% | ||
2016 Equity Incentive Plan | |||
Equity Plans | |||
Expiration period | 10 years | ||
Number of shares available for issuance | 841,577 | ||
2018 Inducement Plan | |||
Equity Plans | |||
Expiration period | 10 years | ||
Number of shares available for issuance | 575,961 |
Equity Plans - Stock Option Act
Equity Plans - Stock Option Activity (Details) $ / shares in Units, $ in Millions | 6 Months Ended |
Jun. 30, 2023 USD ($) $ / shares shares | |
Options Outstanding | |
Options Outstanding, Beginning balance | shares | 6,240,509 |
Options Outstanding, Options granted | shares | 2,262,750 |
Options Outstanding, Options exercised | shares | (220,771) |
Options Outstanding, Options forfeited | shares | (157,679) |
Options Outstanding, Ending balance | shares | 8,124,809 |
Options Outstanding, Options exercisable | shares | 4,410,899 |
Options Outstanding, Options vested and expected to vest | shares | 8,124,809 |
Weighted-Average Exercise Price Per Share | |
Weighted-Average Exercise Price Per Share, Beginning balance | $ 19.03 |
Weighted-Average Exercise Price Per Share, Options granted | 12.61 |
Weighted-Average Exercise Price Per Share, Options exercised | 12.27 |
Weighted-Average Exercise Price Per Share, Options forfeited | 26.14 |
Weighted-Average Exercise Price Per Share, Ending balance | 17.29 |
Weighted-Average Exercise Price Per Share, Options exercisable | 16.81 |
Weighted-Average Exercise Price Per Share, Options vested and expected to vest | $ 17.29 |
Weighted-Average Remaining Contractual Life (years) | |
Weighted-Average Remaining Contractual Life (years) | 7 years 6 months 10 days |
Weighted-Average Remaining Contractual Life (years), Options exercisable | 6 years 3 months 29 days |
Weighted-Average Remaining Contractual Life (years), Options vested and expected to vest | 7 years 6 months 10 days |
Aggregate Intrinsic Value | |
Aggregate Intrinsic Value, Options Outstanding | $ | $ 92.2 |
Aggregate Intrinsic Value, Options exercisable | $ | 51.9 |
Aggregate Intrinsic Value, Options vested and expected to vest | $ | $ 92.2 |
Options, weighted-average grant-date fair value | $ 10.40 |
Equity Plans - Stock Options Va
Equity Plans - Stock Options Valuation Assumptions (Details) | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | |
Equity Plans | |||||
Dividend yield | 0% | ||||
Options to Purchase Common Stock | |||||
Equity Plans | |||||
Expected volatility, Minimum | 106.20% | 96.30% | 106.20% | 96.30% | |
Expected volatility, Maximum | 107.50% | 99.90% | 107.50% | 99.90% | |
Risk-free interest rate, Minimum | 3.71% | 2.71% | 3.57% | 1.64% | |
Risk-free interest rate, Maximum | 4.04% | 2.93% | 4.04% | 2.93% | |
Expected Volatility, Percentage Of Mix Allocated To Peer Companies | 25% | ||||
Expected Volatility, Percentage Of Mix Allocated To Entity Stock Price | 75% | ||||
Options to Purchase Common Stock | Minimum | |||||
Equity Plans | |||||
Expected term (in years) | 6 years 29 days | 5 years 6 months | 5 years 3 months 7 days | 5 years 3 months 7 days | |
Options to Purchase Common Stock | Maximum | |||||
Equity Plans | |||||
Expected term (in years) | 6 years 29 days | 6 years 29 days | 6 years 29 days | 6 years 29 days |
Equity Plans - Restricted and P
Equity Plans - Restricted and Performance Stock Units - (Details) $ / shares in Units, $ in Millions | 6 Months Ended |
Jun. 30, 2023 USD ($) $ / shares shares | |
Restricted stock units | |
Number of Shares | |
Number of shares, Unvested, Beginning balance | shares | 637,436 |
Number of shares, Granted | shares | 396,775 |
Number of shares, Vested | shares | (284,321) |
Number of Shares, Forfeited | shares | (12,901) |
Number of shares, Unvested, Ending balance | shares | 736,989 |
Weighted-Average Grant Date Fair Value | |
Weighted-Average Grant Date Fair Value, Unvested, Beginning balance | $ / shares | $ 19.29 |
Weighted-Average Grant Date Fair Value, Granted | $ / shares | 12.17 |
Weighted-Average Grant Date Fair Value, Vested | $ / shares | 14.20 |
Weighted-Average Grant Date Fair Value, Forfeited | $ / shares | 16.28 |
Weighted-Average Grant Date Fair Value, Unvested, Ending balance | $ / shares | $ 18.37 |
Performance Stock Units | |
Number of Shares | |
Number of shares, Unvested, Beginning balance | shares | 199,500 |
Number of shares, Vested | shares | (114,000) |
Number of shares, Unvested, Ending balance | shares | 85,500 |
Weighted-Average Grant Date Fair Value | |
Weighted-Average Grant Date Fair Value, Unvested, Beginning balance | $ / shares | $ 14.59 |
Weighted-Average Grant Date Fair Value, Vested | $ / shares | 8.76 |
Weighted-Average Grant Date Fair Value, Unvested, Ending balance | $ / shares | $ 23.57 |
Aggregate fair value of restricted stock units that vested | $ | $ 2 |
Equity Plans - Performance Stoc
Equity Plans - Performance Stock Units (Details) - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | |
Equity Plans | |||||
Stock-based compensation | $ 15,927,000 | $ 12,740,000 | |||
Common Stock | |||||
Equity Plans | |||||
Number of shares issued | 329,486 | 131,829 | 687,697 | 430,960 | |
Performance Stock Units | |||||
Equity Plans | |||||
Vesting percentage of requisite service period | 100% | 100% | |||
Stock-based compensation | $ 0 | ||||
Fair value of units vested | 2,000,000 | ||||
Performance Stock Units | Common Stock | |||||
Equity Plans | |||||
Fair value of units vested | $ 3,000,000 | $ 3,000,000 | |||
Number of shares issued | 114,000 |
Equity Plans - Employee Stock P
Equity Plans - Employee Stock Purchase Plan 2016 ESPP (Details) | 6 Months Ended |
Jun. 30, 2023 shares | |
Equity Plans | |
Dividend yield | 0% |
2016 Employee Stock Purchase Plan | |
Equity Plans | |
Maximum payroll deduction for share purchases (as a percent) | 15% |
Purchase price of stock (as a percent) | 85% |
Shares issued in period | 68,605 |
Number of shares available for issuance | 1,486,685 |
Equity Plans - Stock-based Comp
Equity Plans - Stock-based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total stock-based compensation expense | $ 8,343 | $ 6,805 | $ 15,927 | $ 12,740 |
Total unrecognized stock-based compensation costs related to stock options | 60,700 | $ 60,700 | ||
Period of unrecognized stock-based compensation costs to be recognized | 2 years 8 months 12 days | |||
Research and Development | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total stock-based compensation expense | 4,809 | 4,106 | $ 9,391 | 7,432 |
General and Administrative | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total stock-based compensation expense | $ 3,534 | $ 2,699 | $ 6,536 | $ 5,308 |
Net Loss per Share - Computatio
Net Loss per Share - Computation (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Numerator: | ||||
Net loss | $ (38,460) | $ (41,037) | $ (72,185) | $ (61,967) |
Denominator: | ||||
Weighted-average shares used to compute net loss per common share, Basic | 56,775,742 | 49,049,902 | 53,691,965 | 48,902,047 |
Weighted-average shares used to compute net loss per common share, Diluted | 56,775,742 | 49,049,902 | 53,691,965 | 48,902,047 |
Net loss per share, basic | $ (0.68) | $ (0.84) | $ (1.34) | $ (1.27) |
Net loss per share, diluted | $ (0.68) | $ (0.84) | $ (1.34) | $ (1.27) |
Net Loss per Share - Antidiluti
Net Loss per Share - Antidilutive Securities (Details) - shares | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Potentially dilutive securities have been excluded from diluted net loss per share calculations | ||
Anti-dilutive securities (in shares) | 11,722,296 | 10,579,314 |
Options to Purchase Common Stock | ||
Potentially dilutive securities have been excluded from diluted net loss per share calculations | ||
Anti-dilutive securities (in shares) | 8,124,809 | 6,825,121 |
Common stock warrants | ||
Potentially dilutive securities have been excluded from diluted net loss per share calculations | ||
Anti-dilutive securities (in shares) | 2,750,000 | 2,750,000 |
Restricted stock units | ||
Potentially dilutive securities have been excluded from diluted net loss per share calculations | ||
Anti-dilutive securities (in shares) | 736,989 | 766,090 |
Performance Stock Units | ||
Potentially dilutive securities have been excluded from diluted net loss per share calculations | ||
Anti-dilutive securities (in shares) | 85,500 | 219,000 |
ESPP shares | ||
Potentially dilutive securities have been excluded from diluted net loss per share calculations | ||
Anti-dilutive securities (in shares) | 24,998 | 19,103 |