Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2022 | Apr. 29, 2022 | |
Document And Entity Information | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Mar. 31, 2022 | |
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 | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 48,656,189 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q1 | |
Entity Central Index Key | 0001377121 | |
Amendment Flag | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 98,477 | $ 123,665 |
Marketable securities | 206,812 | 203,235 |
Receivable from collaboration partner and contract asset - related party | 25,150 | 1,566 |
Research and development tax incentive receivable | 2,878 | 2,792 |
Prepaid expenses and other current assets | 8,205 | 9,478 |
Total current assets | 341,522 | 340,736 |
Property and equipment, net | 2,064 | 1,798 |
Restricted cash - noncurrent | 225 | 225 |
Operating lease right-of-use asset | 4,485 | 4,936 |
Total assets | 348,296 | 347,695 |
Current liabilities: | ||
Accounts payable | 7,159 | 1,600 |
Payable to collaboration partner - related party | 380 | 899 |
Accrued expenses and other payables | 32,874 | 37,716 |
Deferred revenue - related party | 768 | 1,601 |
Operating lease liability - current | 2,275 | 2,200 |
Total current liabilities | 43,456 | 44,016 |
Operating lease liability - noncurrent | 3,062 | 3,658 |
Total liabilities | 46,518 | 47,674 |
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 48,552,102 and 47,838,330 shares issued and outstanding as of March 31, 2022 and December 31, 2021, respectively | ||
Additional paid-in capital | 732,542 | 709,682 |
Accumulated other comprehensive loss | (472) | (299) |
Accumulated deficit | (430,292) | (409,362) |
Total stockholders' equity | 301,778 | 300,021 |
Total liabilities and stockholders' equity | $ 348,296 | $ 347,695 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2022 | Dec. 31, 2021 |
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 | 48,552,102 | 47,838,330 |
Common stock, shares outstanding | 48,552,102 | 47,838,330 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Condensed Consolidated Statements of Operations | ||
License and collaboration revenue - related party | $ 25,722 | $ 6,189 |
Revenue from Contract with Customer, Product and Service [Extensible List] | License and Collaboration Agreement | License and Collaboration Agreement |
Operating expenses: | ||
Research and development | $ 36,318 | $ 24,245 |
General and administrative | 10,515 | 5,965 |
Total operating expenses | 46,833 | 30,210 |
Loss from operations | (21,111) | (24,021) |
Interest income | 168 | 102 |
Other income (expense), net | 13 | (79) |
Net loss | $ (20,930) | $ (23,998) |
Net loss per share, basic | $ (0.43) | $ (0.54) |
Net loss per share diluted | $ (0.43) | $ (0.54) |
Weighted-average shares used to compute net loss per share, basic | 48,752,548 | 44,224,169 |
Weighted Average Number of Shares Outstanding, Diluted | 48,752,548 | 44,224,169 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Condensed Consolidated Statements of Comprehensive Loss | ||
Net loss | $ (20,930) | $ (23,998) |
Other comprehensive loss: | ||
Gain (loss) on translation of foreign operations | 95 | (33) |
Unrealized loss on marketable securities | (268) | (28) |
Comprehensive loss | $ (21,103) | $ (24,059) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholder's Equity - USD ($) $ in Thousands | Common Stock | Additional Paid-In Capital | Accumulated Other Comprehensive (Loss) Gain | Accumulated Deficit | Total |
Balance, Beginning at Dec. 31, 2020 | $ 563,389 | $ 28 | $ (283,811) | $ 279,606 | |
Balance, Beginning (in shares) at Dec. 31, 2020 | 43,745,465 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Issuance of common stock under equity incentive and employee stock purchase plans | 1,316 | 1,316 | |||
Issuance of common stock under equity incentive and employee stock purchase plans (in shares) | 200,841 | ||||
Shares withheld for net settlement of tax withholding upon vesting of restricted stock units | (189) | (189) | |||
Shares withheld for net settlement of tax withholding upon vesting of restricted stock units (in shares) | (7,060) | ||||
Stock-based compensation expense | 2,660 | 2,660 | |||
Other comprehensive loss | (61) | (61) | |||
Net loss | (23,998) | (23,998) | |||
Balance, Ending at Mar. 31, 2021 | 567,176 | (33) | (307,809) | 259,334 | |
Balance, Ending (in shares) at Mar. 31, 2021 | 43,939,246 | ||||
Balance, Beginning at Dec. 31, 2021 | 709,682 | (299) | (409,362) | $ 300,021 | |
Balance, Beginning (in shares) at Dec. 31, 2021 | 47,838,330 | 47,838,330 | |||
Increase (Decrease) in Stockholders' Equity | |||||
Issuance of common stock pursuant to at-the-market offering, net of issuance costs | 14,553 | $ 14,553 | |||
Issuance of common stock pursuant to at-the-market offering, net of issuance costs (in shares) | 422,367 | ||||
Issuance of common stock under equity incentive and employee stock purchase plans | 2,558 | 2,558 | |||
Issuance of common stock under equity incentive and employee stock purchase plans (in shares) | 299,131 | ||||
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 | 5,935 | 5,935 | |||
Other comprehensive loss | (173) | (173) | |||
Net loss | (20,930) | (20,930) | |||
Balance, Ending at Mar. 31, 2022 | $ 732,542 | $ (472) | $ (430,292) | $ 301,778 | |
Balance, Ending (in shares) at Mar. 31, 2022 | 48,552,102 | 48,552,102 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | Dec. 31, 2020 | |
Cash Flows from Operating Activities | |||
Net loss | $ (20,930) | $ (23,998) | |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Stock-based compensation | 5,935 | 2,660 | |
Operating lease right-of-use asset amortization | 584 | 444 | |
Net amortization of premium on marketable securities | 358 | 348 | |
Depreciation | 249 | 180 | |
Changes in operating assets and liabilities: | |||
Research and development tax incentive receivable | (751) | ||
Receivable from collaboration partner - related party | (23,584) | (1,570) | |
Prepaid expenses and other assets | 1,279 | 57 | |
Accounts payable | 5,559 | (344) | |
Payable to collaboration partner - related party | (519) | 4,091 | |
Accrued expenses and other payables | (5,110) | (673) | |
Deferred revenue - related party | (833) | (8,709) | |
Operating lease liability | (654) | (491) | |
Net cash used in operating activities | (37,666) | (28,756) | |
Cash Flows from Investing Activities | |||
Purchase of marketable securities | (55,832) | (87,205) | |
Proceeds from maturities of marketable securities | 51,629 | 80,552 | |
Purchases of property and equipment | (273) | (140) | |
Net cash used in investing activities | (4,476) | (6,793) | |
Cash Flows from Financing Activities | |||
Proceeds from at-the-market offering, net of issuance costs | 14,553 | ||
Proceeds from issuance of common stock upon exercise of stock options and purchases under employee stock purchase plan | 2,558 | 1,316 | |
Tax withholding payments related to net settlement of restricted stock units | (186) | (189) | |
Issuance costs related to common stock offering | (148) | ||
Net cash provided by financing activities | 16,925 | 979 | |
Effect of exchange rate changes on cash, cash equivalents and restricted cash | 29 | (23) | |
Net decrease in cash, cash equivalents and restricted cash | (25,188) | (34,593) | |
Cash, cash equivalents and restricted cash, beginning of period | 123,890 | 117,818 | |
Cash, cash equivalents and restricted cash, end of period | 98,702 | 83,225 | $ 117,818 |
Supplemental Disclosure of Non-Cash Financing and Investing Information: | |||
Purchases of property and equipment in accounts payable and accrued liabilities | 235 | 97 | |
Public Offering | Accrued liabilities and other payables | |||
Supplemental Disclosure of Non-Cash Financing and Investing Information: | |||
Issuance costs related to common stock offering | $ 25 | $ 58 | $ 205 |
Organization and Description of
Organization and Description of Business | 3 Months Ended |
Mar. 31, 2022 | |
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 multiple peptide-based new chemical entities in different stages of clinical development, all derived from the Company's proprietary technology platform. Operating segments are components of an enterprise for which separate financial information is available and is evaluated regularly by the Company’s chief operating decision maker in deciding how to allocate resources and assessing performance. Liquidity As of March 31, 2022, the Company had cash, cash equivalents and marketable securities of $305.3 million. The Company has incurred net losses from operations since inception and had an accumulated deficit of $430.3 million as of March 31, 2022. 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 subject to risks and uncertainties as a result of the ongoing COVID-19 pandemic. The impact of the COVID-19 pandemic on the Company's activities depends on a number of factors, including, but not limited to, the duration and severity of the pandemic, including the severity of any additional periods of increases or spikes in the number of cases in the areas the Company and its suppliers operate and areas where the Company’s clinical trial sites are located; the development and spread of COVID-19 variants, the timing, extent, effectiveness and durability of COVID-19 vaccine programs or other treatments; and new or continuing travel and other restrictions and public health measures. The Company has experienced delays in its existing and planned clinical trials due to the worldwide impacts of the pandemic. The Company's future results of operations and liquidity could be adversely impacted by further delays in existing and planned clinical trials, continued difficulty in recruiting patients for these clinical trials, delays in manufacturing and collaboration activities, supply chain disruptions, and the ongoing impact on its operating activities and employees. The extent of the impact of the COVID-19 pandemic remains difficult to predict as this event is ongoing and information continues to evolve. Capital markets and economies worldwide have been negatively impacted and may be further impacted in the future. Such economic disruption could have a material adverse effect on the Company’s business. As of the date of issuance of these condensed consolidated financial statements, the extent to which the COVID-19 pandemic may materially impact the Company's future financial condition, liquidity or results of operations remains uncertain. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2022 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | Note 2. Basis of Presentation 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 March 31, 2022 has been derived from the Company’s audited 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 months ended March 31, 2022 are not necessarily indicative of the results to be expected for the year ending December 31, 2022 or for any other interim period or for any other future year. The accompanying 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, 2021 included in the Company’s Annual Report on Form 10-K, filed with the SEC on February 28, 2022. 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. Due to the ongoing COVID-19 pandemic and military conflict between Ukraine and Russia, there has been uncertainty and disruption in the global economy and financial markets. 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 date of 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): March 31, 2022 2021 Cash and cash equivalents $ 98,477 $ 83,000 Restricted cash - noncurrent 225 225 Total cash reported on condensed consolidated statements of cash flows $ 98,702 $ 83,225 Significant Accounting Policies There have been no material changes to the Company’s significant accounting policies during the three months ended March 31, 2022 as compared to those disclosed in Note 2. Significant Accounting Policies included in our Annual Report on Form 10-K for the year ended December 31, 2021. Recently Issued Accounting Pronouncements Not Yet Adopted as of March 31, 2022 In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses (Topic 326) Financial Instruments – Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic 842): Effective Dates |
License and Collaboration Agree
License and Collaboration Agreement | 3 Months Ended |
Mar. 31, 2022 | |
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 (“Restated Agreement”) with Janssen Biotech, Inc., a Pennsylvania corporation (“Janssen”). The Restated Agreement amends and restates the License and Collaboration Agreement, dated May 26, 2017, by and between the Company and Janssen (as amended by the First Amendment thereto, effective May 7, 2019, the “Original Agreement”). Janssen is a related party to the Company as Johnson & Johnson Innovation - JJDC, Inc., a significant stockholder of the Company, and Janssen are both subsidiaries of Johnson & Johnson. The Original Agreement became effective on July 13, 2017. 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 also 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 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. In March 2022, the Company became eligible to receive 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. 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 include PTG-200 (JN-67864238), PN-232 (JNJ-75105186) and PN-235 (JNJ-77242113). 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 PN-235, based on its superior potency and overall pharmacokinetic and pharmacodynamic profile. Janssen is primarily responsible for the conduct of all future trials, including these anticipated Phase 2 trials, and the Company is primarily responsible for the conduct of the second-generation Phase 1 trials. Pursuant to the Restated Agreement, the parties have: ● amended development milestones to reflect Janssen’s expected development of collaboration compounds for multiple indications in the IL-23 pathway; ● limited the Company’s further development and related expense obligations under the Restated Agreement to the PTG-200 Phase 2a trial and the ongoing Phase 1 trials in PN-232 and PN-235; Janssen is responsible for all other future development and related expenses under the Restated Agreement; and ● concluded the parties’ two-year research collaboration, while enabling Janssen to continue conducting additional research through July 2024 on compounds developed pursuant to the Original Agreement. 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. The Company’s development cost obligations in the Original Agreement for the period following the effective date of the Original Agreement were as follows: (a) up to $20.0 million of costs related to up to three Phase 1 trials of second-generation compounds; (b) up to $20.0 million of costs related to Phase 2a and 2b costs for PTG-200 (i.e., 20% of the first $100.0 million in costs); and (c) up to $25.0 million in costs related to up to two Phase 2 trials evaluating second-generation compounds. The Company’s continuing development expense obligations under the Restated Agreement are as follows: (a) the Company funded 20% of the costs related to the Phase 2a trial evaluating PTG-200 for the treatment of CD (subject to a $20.0 million cap); (b) the Company was responsible for 50% of agreed-upon costs related to the ongoing Phase 1 trial evaluating PN-235 incurred through January 4, 2021; and (c) the Company was responsible for 100% of agreed-upon costs related to the Phase 1 trial evaluating PN-232. Certain of the Company’s previous development expense obligations under the Original Agreement were limited or eliminated as follows: (a) the Company’s previous $25.0 million obligation for 20% of costs related to Phase 2 trials for second-generation products was eliminated; (b) the Company’s previous $5.0 million obligation for 50% of the costs of a potential third Phase 1 trial evaluating a second-generation compound was eliminated; and (c) the Company had no obligation to fund any portion of any Phase 2b or other trial evaluating PTG-200 beyond the Phase 2a trial in CD. One milestone for second-generation Phase 2 development was reduced from $50.0 million to $25.0 million in the Restated Agreement; otherwise, the various milestone payment amounts in the Restated Agreement remain substantially the same as in the Original Agreement. To reflect parallel development of multiple indications in the IL-23 pathway, milestone payments under the Restated Agreement generally now correspond to the achievement of specified milestones in: (a) any initial indication (rather than CD, as in the Original Agreement); (b) any second indication (rather than ulcerative colitis (“UC”), as in the Original Agreement); and (c) any third indication. With respect to second-generation compounds, milestone payments for second and third indications may be triggered by any second-generation compound (i.e., not necessarily the second-generation compound that triggered the initial payment for any indication, or the payment for a second indication). In addition, the opt-in payments contemplated by the Original Agreement related to the scope of Janssen’s license rights have been converted into development milestones in the Restated Agreement. Upcoming potential development milestones for second-generation compounds include: ● $10.0 million for 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 described above); ● $50.0 million for dosing of the third patient in a Phase 3 clinical trial for a second-generation compound for any indication; ● $15.0 million for dosing of the third patient in a Phase 3 clinical trial for a second-generation compound for a second indication; and ● $115.0 million for a Phase 3 clinical trial for a second-generation compound for any indication meeting its primary clinical endpoint. Development milestones for PTG-200 were unchanged under the Restated Amendment, except that milestone achievement is generally no longer indication-specific. Pursuant to the Restated Agreement, the Company remains eligible to receive tiered royalties on net product sales at percentages ranging from mid-single digits 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 UC 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 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 PN-235 through Phase 1. Under the Restated Agreement, development services performed by the Company for PTG-200 beyond Phase 2a and PN-232 and PN-235 beyond Phase 1 are no longer required. The Company determined that the license was not distinct from the revised development services within the context of the agreement because the revised development services did not change the utility of the intellectual property. The Company also concluded that the remaining development services are not distinct from the partially delivered combined promise comprised under the agreement prior to the Restated Agreement of the development license and PTG-200, PN-232 and PN-235 services, including compound supply and other services. Therefore, the Restated Agreement is treated as if it were part of the Original Agreement. The Restated Agreement was accounted for as if it were a modification of services under the Original Agreement by applying a cumulative catch-up adjustment to revenue. As of the effective date of the Restated Agreement, the Company calculated the adjusted cumulative revenue under the Restated Agreement with primary updates to the transaction price, including the release of and update of prior constraints and fewer remaining services to be provided, resulting in a cumulative adjustment that increased revenue by $8.0 million for the year ended December 31, 2021. 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 obligations began on the Original Agreement effective date of July 13, 2017 and will end upon the later of the end of Phase 2a for PTG-200 in CD or the completion of a Phase 1 clinical trial for either PN-232 or PN-235. Final activities related to these trials are expected to be completed in 2022. The Company uses the most likely amount method to estimate variable consideration included in the transaction price. Variable consideration after the effective date of the Restated Agreement consists of future milestone payments and cost sharing payments for agreed upon services offset by development costs reimbursable to Janssen. Cost sharing payments from Janssen relate to the agreed upon services for development activities that the Company performs within the duration of the contract are included in the transaction price at the Company’s share of the estimated budgeted costs for these activities, including primarily internal full-time equivalent effort and third-party contract costs. Cost sharing payments to Janssen related to agreed-upon services for activities that Janssen performs within the duration of the contract are not a distinct service that Janssen transfers to the Company. Therefore, the consideration payable to Janssen is accounted for as a reduction in the transaction price. The transaction price of the initial performance obligation under the Restated Agreement was $131.5 million as of March 31, 2022, an increase of $25.0 million from the transaction price of $106.5 million as of December 31, 2021. 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 March 31, 2022 includes $87.5 million of nonrefundable payments received to date, the $25.0 million milestone payment receivable following dosing of the third patient in the Phase 2b clinical trial of PN-235, $17.9 million of reimbursement from Janssen for services performed for IL-23 receptor antagonist compound research costs and other services, and estimated variable consideration consisting of $8.2 million of development cost reimbursement receivable from Janssen, partially offset by $7.1 million of net cost reimbursement due to Janssen for services performed. The Company concluded that the variable consideration constraint is appropriately reflected in the estimated transaction as of March 31, 2022, and that the achievement of future milestones is subject to additional development and/or regulatory uncertainty and therefore it is not probable at March 31, 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 are outside the initial performance obligation. Revenue for these additional services is recognized as these services are performed. The Company re-evaluates the transaction price, including variable consideration, at the end of each reporting period and as uncertain events are resolved or other changes in circumstances occur. The Company and Janssen make quarterly cost sharing payments to one another in amounts necessary to ensure that each party bears its contractual share of the overall shared costs incurred. The Company utilizes a cost-based input method to measure proportional performance and to calculate the corresponding amount of revenue to recognize. In applying the cost-based input methods of revenue recognition, the Company uses actual costs incurred relative to expected costs to fulfill the combined performance obligation. These costs consist primarily of internal full-time equivalent effort and third-party contract costs. Revenue will be recognized based on actual costs incurred as a percentage of total estimated costs as the Company completes its performance obligations. A cost-based input method of revenue recognition requires management to make estimates of costs to complete the Company’s performance obligations. The Company believes this is the best measure of progress because other measures do not reflect how the Company transfers its performance obligation to Janssen. In making such estimates, significant judgment is required to evaluate assumptions related to cost estimates. The cumulative effect of revisions to estimated costs to complete the Company’s performance obligations will be recorded in the period in which changes are identified and amounts can be reasonably estimated. A significant change in these assumptions and estimates could have a material impact on the timing and amount of revenue recognized in future periods. For the three months ended March 31, 2022 and 2021, the Company recognized license and collaboration revenue of $25.7 million and $5.6 million, respectively, which was primarily related to the transaction price under the Restated Agreement recognized based on proportional performance. In addition, the Company recognized $0.6 million in revenue for the three months ended March 31, 2021 related to additional services provided by the Company under the agreement. No such revenue related to additional services provided by the Company was recognized for the three months ended March 31, 2022. 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 Three Months Ended March 31, 2022 Period Additions Deductions Period Contract assets: Receivable from collaboration partner - related party $ 1,566 $ 25,150 $ (1,566) $ 25,150 Contract liabilities: Deferred revenue - related party $ 1,601 $ 25,658 $ (26,491) $ 768 Payable to collaboration partner - related party $ 899 $ 330 $ (849) $ 380 Balance at Balance at Beginning of End of Three Months Ended March 31, 2021 Period Additions Deductions Period Contract assets: Receivable from collaboration partner - related party $ 2,426 $ 1,570 $ — $ 3,996 Contract liabilities: Deferred revenue - related party $ 14,477 $ 1,017 $ (9,726) $ 5,768 Payable to collaboration partner - related party $ 2,732 $ 4,091 $ — $ 6,823 During the three months ended March 31, 2022 and 2021, the Company recognized revenue of $13,000 and $1.1 million, respectively, from amounts included in the deferred revenue contract liability balance at the beginning of each period. |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2022 | |
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 table presents the fair value of the Company’s financial assets determined using the inputs defined above (in thousands). March 31, 2022 Level 1 Level 2 Level 3 Total Assets: Money market funds $ 35,422 $ — $ — $ 35,422 Commercial paper — 138,084 — 138,084 Corporate debt securities — 45,350 — 45,350 U.S. Treasury and agency securities — 77,648 — 77,648 Supranational and sovereign government securities — 3,000 — 3,000 Total financial assets carried at fair value $ 35,422 $ 264,082 $ — $ 299,504 December 31, 2021 Level 1 Level 2 Level 3 Total Assets: Money market funds $ 39,854 $ — $ — $ 39,854 Commercial paper — 157,141 — 157,141 Corporate debt securities — 75,548 — 75,548 U.S. Treasury and agency securities 40,017 — 40,017 Supranational and sovereign government securities — 6,010 — 6,010 Total financial assets carried at fair value $ 39,854 $ 278,716 $ — $ 318,570 The Company’s commercial paper, corporate debt securities, U.S. Treasury and agency securities, including U.S. Treasury bills, and supranational and sovereign government securities 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 our 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 | 3 Months Ended |
Mar. 31, 2022 | |
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): March 31, 2022 Amortized Gross Unrealized Cost Gains Losses Fair Value Money market funds $ 35,422 $ — $ — $ 35,422 Commercial paper 138,123 1 (40) 138,084 Corporate debt securities 45,455 — (105) 45,350 U.S. Treasury and agency securities 77,915 1 (268) 77,648 Supranational and sovereign government securities 3,000 — — 3,000 Total cash equivalents and marketable securities $ 299,915 $ 2 $ (413) $ 299,504 Classified as: Cash equivalents $ 92,692 Marketable securities - current 206,812 Total cash equivalents and marketable securities $ 299,504 December 31, 2021 Amortized Gross Unrealized Cost Gains Losses Fair Value Money market funds $ 39,854 $ — $ — $ 39,854 Commercial paper 157,157 — (16) 157,141 Corporate debt securities 75,598 — (50) 75,548 U.S. Treasury and agency securities 40,093 — (76) 40,017 Supranational and sovereign government securities 6,011 — (1) 6,010 Total cash equivalents and marketable securities $ 318,713 $ — $ (143) $ 318,570 Classified as: Cash equivalents $ 115,335 Marketable securities - current 203,235 Total cash equivalents and marketable securities $ 318,570 Marketable securities – current of $206.8 million and $203.2 million held at March 31, 2022 and December 31, 2021, 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 |
Balance Sheet Components
Balance Sheet Components | 3 Months Ended |
Mar. 31, 2022 | |
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): March 31, December 31, 2022 2021 Prepaid clinical and research related expenses $ 4,579 $ 5,242 Prepaid insurance 1,429 1,746 Other prepaid expenses 1,721 1,515 Other receivable 476 975 Prepaid expenses and other current assets $ 8,205 $ 9,478 Property and Equipment, Net Property and equipment, net consisted of the following (in thousands): March 31, December 31, 2022 2021 Laboratory equipment $ 4,619 $ 4,156 Furniture and computer equipment 1,072 1,023 Leasehold improvements 898 877 Total property and equipment 6,589 6,056 Less: accumulated depreciation (4,525) (4,258) Property and equipment, net $ 2,064 $ 1,798 Accrued Expenses and Other Payables Accrued expenses and other payables consisted of the following (in thousands): March 31, December 31, 2022 2021 Accrued clinical and research related expenses $ 27,514 $ 27,950 Accrued employee related expenses 2,643 7,125 Accrued professional service fees 1,063 734 Accrued collaboration payments 1,500 1,500 Other 154 407 Total accrued expenses and other payables $ 32,874 $ 37,716 |
Research Collaboration and Lice
Research Collaboration and License Agreement | 3 Months Ended |
Mar. 31, 2022 | |
Research Collaboration and License Agreement | |
Research Collaboration and License Agreement | |
Research Collaboration and License Agreement | Note 7. Research Collaboration and License Agreement The Company and Zealand Pharma A/S (“Zealand”) entered into a collaboration agreement in June 2012. In October 2013, Zealand abandoned the collaboration, and the collaboration agreement was terminated in 2014. The agreement provides for certain post-termination payment obligations to Zealand with respect to compounds related to the collaboration that meet specified conditions set forth in the collaboration agreement and which the Company elects to further develop following Zealand’s abandonment of the collaboration. The Company has the right, but not the obligation, to further develop and commercialize such compounds. The agreement provides for payments to Zealand for the achievement of certain development, regulatory and sales milestone events that occur prior to a partnering arrangement related to such compounds between the Company and a third party. The Company previously determined that rusfertide is a compound for which the post-termination payments described above are required under the collaboration agreement and has made three development milestone payments for an aggregate amount of $1.0 million under the agreement. However, upon reevaluation, the Company concluded in 2019 that rusfertide is not a compound requiring post-termination payments under the agreement and initiated an arbitration proceeding in January 2020. On August 4, 2021, the Company and Zealand agreed to resolve the dispute and entered into an Arbitration Resolution Agreement. See Note 9. Commitments and Contingencies – Legal Proceedings for additional information on the results of arbitration proceedings related to this research and collaboration agreement Milestone payments to collaboration partners are recorded as research and development expense in the period that the expense is incurred. No research and development expense was recorded under the Zealand collaboration agreement for the three months ended March 31, 2022 or March 31, 2021. |
Research and Development Tax In
Research and Development Tax Incentive | 3 Months Ended |
Mar. 31, 2022 | |
Research and Development Tax Incentive [Abstract] | |
Research and Development Tax Incentive | Note 8. Research and Development Tax Incentive The Company did not recognize |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2022 | |
Commitments and Contingencies | |
Commitments and Contingencies | Note 9. Commitments and Contingencies Legal Proceedings The Company recognizes accruals for legal actions to the extent that it concludes that a loss is both probable and reasonably estimable. The Company accrues for the best estimate of a loss within a range; however, if no estimate in the range is better than any other, it accrues the minimum amount in the range. If the Company determines that a loss is reasonably possible and the loss or range of loss can be estimated, it discloses the possible loss. On January 23, 2020, the Company initiated arbitration proceedings with the International Court of Arbitration of the International Chamber of Commerce against Zealand related to a collaboration agreement the Company and Zealand entered into in 2012 and terminated in 2014. The agreement provides for certain post-termination payment obligations to Zealand with respect to compounds related to the collaboration that the Company elects to further develop and meet specified conditions. On August 4, 2021, the Company and Zealand agreed to resolve the dispute and reached an Arbitration Resolution Agreement. Under the Arbitration Resolution Agreement, (1) the Company is required to make an additional payment of $1.5 million to Zealand in August 2022 with respect to rusfertide, (2) all development milestones with respect of rusfertide were reduced by 50%, except that the Company agreed to pay in full within two (2) business days after the effective date of the Agreement (and timely paid): (i) a $1.0 million milestone for initiation of a Phase 2b clinical trial; and (ii) a $1.5 million milestone for initiation of a Phase 3 clinical trial; (3) the royalty rates payable by the Company on net sales of rusfertide were reduced by 50%; (4) all sales milestone payments on net sales of rusfertide were reduced by 50%; (5) the parties agreed that each party will retain all payments previously made by the other party in connection with the original collaboration agreement; and (6) the parties released claims related to the original collaboration agreement, the abandonment agreement and the arbitration. In addition to the payments specified in items (1) and (2) above, the Company may also be required to pay Zealand up to $2.75 million in future development milestone payments relating to rusfertide. Those payments include up to $1.0 million in the aggregate for registrational proposals and up to $1.75 million in the aggregate for commercial launch in the three geographic territories specified in the original collaboration agreement. The Company considered the outcome of these arbitration proceedings as being related to its research and development project; therefore, payments or milestone payments were recorded as research and development expenses. As a result, no related legal accruals were recognized as of March 31, 2022. |
Stockholders' Equity
Stockholders' Equity | 3 Months Ended |
Mar. 31, 2022 | |
Stockholders' Equity | |
Stockholders' Equity | Note 10. Stockholders’ Equity 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 , In December 2018, the Company entered into an exchange agreement (the “Exchange Agreement”) with an Investor and its affiliates (the “Exchanging Stockholders”), pursuant to which the Company exchanged an aggregate of 1,000,000 shares of the Company’s common stock, par value $0.00001 per share, owned by the Exchanging Stockholders for pre-funded warrants (the “Exchange Warrants”) to purchase an aggregate of 1,000,000 shares of common stock (subject to adjustment in the event of any stock dividends and splits, reverse stock split, recapitalization, reorganization or similar transaction, as described in the Exchange Warrants), with an exercise price of $0.00001 per share. The Exchange Warrants will expire ten years from the date of issuance. The Exchange Warrants are exercisable at any time prior to expiration except that the Exchange Warrants cannot be exercised by the Exchanging Stockholders if, after giving effect thereto, the Exchanging Stockholders would beneficially own more than 9.99% of the Company’s common stock, subject to certain exceptions. In accordance with Accounting Standards Codification Topic 505, Equity , In October 2019, the Company filed a registration statement on Form S-3 (File No. 333-234414) that was declared effective as of November 22, 2019 and permits the offering, issuance, and sale by the Company of up to a maximum aggregate offering price of $250.0 million of its common stock, preferred stock, debt securities and warrants (the “2019 Form S-3”). Up to a maximum of $75.0 million of the maximum aggregate offering price of $250.0 million may be issued and sold pursuant to an at-the market (“ATM”) financing facility under a sales agreement entered into by the Company on November 27, 2019 (the “2019 Sales Agreement”). In January 2022, the Company sold 422,367 shares of its common stock under its ATM financing facility pursuant to the 2019 Sales Agreement for net proceeds of $14.6 million, after deducting issuance costs. As of March 31, 2022, a total of $79.3 million of securities remained available for sale under the 2019 Form S-3, $17.0 million of which remained available for sale under the ATM financing facility. The 2019 Form S-3 expires in October 2022. In December 2020, the Company filed an automatic registration statement on Form S-3ASR and an accompanying prospectus (File No. 333-251254). In June 2021, pursuant to this Form S-3ASR, the Company completed an underwritten public offering of 3,046,358 shares of its common stock at a public offering price of $37.75 per share and issued an additional 456,953 shares of common stock at a price of $37.75 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 $123.8 million. The Form S-3ASR expires in December 2023. |
Equity Plans
Equity Plans | 3 Months Ended |
Mar. 31, 2022 | |
Equity Plans | |
Equity Plans | Note 11. Equity Plans Equity Incentive Plan In July 2016, the Company’s board of directors 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 of directors, or a committee appointed by the board of directors, 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 March 31, 2022, 1,095,340 shares were available for issuance under the 2016 Plan. Inducement Plan In May 2018, the Company’s board of directors approved the 2018 Inducement Plan, as subsequently amended. The 2018 Inducement Plan is 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 of directors or the Compensation Committee of 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 2018 Inducement Plan expire no later than ten years from the date of grant. As of March 31, 2022, 743,125 shares were available for issuance under the Amended and Restated 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 (years) Value (1) (in millions) Balances at December 31, 2021 5,890,540 $ 17.66 7.47 $ 102.7 Options granted 1,122,100 28.85 Options exercised (165,488) 11.68 Options forfeited (37,542) 39.04 Balances at March 31, 2022 6,809,610 $ 19.53 7.37 $ 46.0 Options exercisable – March 31, 2022 3,349,241 $ 13.59 6.05 $ 34.5 Options vested and expected to vest – March 31, 2022 6,809,610 $ 19.53 7.37 $ 46.0 (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 March 31, 2022. The calculation excludes options with an exercise price higher than the closing price of the Company’s common stock on March 31, 2022. The estimated weighted-average grant-date fair value of common stock underlying options granted to employees during the three months ended March 31, 2022 was $22.56 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 March 31, 2022 2021 Expected term (in years) 5.27- 6.08 5.27- 6.08 Expected volatility 97.1% - 98.2% 89.8% - 90.2% Risk-free interest rate 1.64% - 2.13% 0.11% - 0.97% 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 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, 2021 405,972 $ 20.13 Granted 312,550 28.73 Vested (104,712) 14.73 Forfeited (7,000) 28.73 Unvested RSUs at March 31, 2022 606,810 $ 24.61 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, 2021 105,500 $ 23.57 Granted — — Vested — — Forfeited — — Unvested PSUs at March 31, 2022 105,500 $ 23.57 The terms of the unvested 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 expire on February 28, 2026 if the performance objectives are not achieved. The PSUs will vest, if at all, upon certification by the Compensation Committee of the Company’s Board of Directors of the actual achievement of the 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 objective becomes probable. The total fair value of outstanding PSUs as of March 31, 2022 was $2.5 million. As of March 31, 2022, the achievement of the related performance objective was deemed not probable and, accordingly, no stock-based compensation for the PSUs has been recognized as expense as of March 31, 2022. Employee Stock Purchase Plan The 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 three months ended March 31, 2022, a total of 28,931 shares of common stock were issued under the 2016 ESPP, and 1,285,068 shares remain available for issuance as of March 31, 2022. Stock-Based Compensation Total stock-based compensation expense was as follows (in thousands): Three Months Ended March 31, 2022 2021 Research and development $ 3,326 $ 1,475 General and administrative 2,609 1,185 Total stock-based compensation expense $ 5,935 $ 2,660 As of March 31, 2022, total unrecognized stock-based compensation expense was approximately $73.6 million, which the Company expects to recognize over a weighted-average period of approximately 2.9 years. |
Net Loss per Share
Net Loss per Share | 3 Months Ended |
Mar. 31, 2022 | |
Net Loss per Share | |
Net Loss per Share | Note 12. Net Loss per Share As the Company had net losses for the three months ended March 31, 2022 and 2021, 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 March 31, 2022 2021 Numerator: Net loss $ (20,930) $ (23,998) Denominator: Weighted-average shares used to compute net loss per common share, basic and diluted 48,752,548 44,224,169 Net loss per share, basic and diluted $ (0.43) $ (0.54) 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: March 31, 2022 2021 Options to purchase common stock 6,809,610 5,698,164 Common stock warrants 2,750,000 2,750,000 Restricted stock units 606,810 448,380 Performance stock units 105,500 110,500 ESPP shares 19,762 16,778 Total 10,291,682 9,023,822 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2022 | |
Summary of Significant Accounting Policies | |
Basis of Presentation | Basis of Presentation 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 March 31, 2022 has been derived from the Company’s audited 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 months ended March 31, 2022 are not necessarily indicative of the results to be expected for the year ending December 31, 2022 or for any other interim period or for any other future year. The accompanying 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, 2021 included in the Company’s Annual Report on Form 10-K, filed with the SEC on February 28, 2022. |
Basis of Presentation and 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. Due to the ongoing COVID-19 pandemic and military conflict between Ukraine and Russia, there has been uncertainty and disruption in the global economy and financial markets. 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 date of 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 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): March 31, 2022 2021 Cash and cash equivalents $ 98,477 $ 83,000 Restricted cash - noncurrent 225 225 Total cash reported on condensed consolidated statements of cash flows $ 98,702 $ 83,225 |
Recently Issued Accounting Pronouncements Adopted and Recently Issued Accounting Pronouncements Not Yet Adopted | Recently Issued Accounting Pronouncements Not Yet Adopted as of March 31, 2022 In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses (Topic 326) Financial Instruments – Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic 842): Effective Dates |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
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): March 31, 2022 2021 Cash and cash equivalents $ 98,477 $ 83,000 Restricted cash - noncurrent 225 225 Total cash reported on condensed consolidated statements of cash flows $ 98,702 $ 83,225 |
License and Collaboration Agr_2
License and Collaboration Agreement (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
License and Collaboration Agreement. | |
Schedule of changes in contract assets and liabilities | 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 Three Months Ended March 31, 2022 Period Additions Deductions Period Contract assets: Receivable from collaboration partner - related party $ 1,566 $ 25,150 $ (1,566) $ 25,150 Contract liabilities: Deferred revenue - related party $ 1,601 $ 25,658 $ (26,491) $ 768 Payable to collaboration partner - related party $ 899 $ 330 $ (849) $ 380 Balance at Balance at Beginning of End of Three Months Ended March 31, 2021 Period Additions Deductions Period Contract assets: Receivable from collaboration partner - related party $ 2,426 $ 1,570 $ — $ 3,996 Contract liabilities: Deferred revenue - related party $ 14,477 $ 1,017 $ (9,726) $ 5,768 Payable to collaboration partner - related party $ 2,732 $ 4,091 $ — $ 6,823 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Fair Value Measurements | |
Schedule of fair value of financial assets | The following table presents the fair value of the Company’s financial assets determined using the inputs defined above (in thousands). March 31, 2022 Level 1 Level 2 Level 3 Total Assets: Money market funds $ 35,422 $ — $ — $ 35,422 Commercial paper — 138,084 — 138,084 Corporate debt securities — 45,350 — 45,350 U.S. Treasury and agency securities — 77,648 — 77,648 Supranational and sovereign government securities — 3,000 — 3,000 Total financial assets carried at fair value $ 35,422 $ 264,082 $ — $ 299,504 December 31, 2021 Level 1 Level 2 Level 3 Total Assets: Money market funds $ 39,854 $ — $ — $ 39,854 Commercial paper — 157,141 — 157,141 Corporate debt securities — 75,548 — 75,548 U.S. Treasury and agency securities 40,017 — 40,017 Supranational and sovereign government securities — 6,010 — 6,010 Total financial assets carried at fair value $ 39,854 $ 278,716 $ — $ 318,570 |
Cash Equivalents and Marketab_2
Cash Equivalents and Marketable Securities (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Cash Equivalents and Marketable Securities | |
Schedule of cash equivalents and marketable securities | Cash equivalents and marketable securities consisted of the following (in thousands): March 31, 2022 Amortized Gross Unrealized Cost Gains Losses Fair Value Money market funds $ 35,422 $ — $ — $ 35,422 Commercial paper 138,123 1 (40) 138,084 Corporate debt securities 45,455 — (105) 45,350 U.S. Treasury and agency securities 77,915 1 (268) 77,648 Supranational and sovereign government securities 3,000 — — 3,000 Total cash equivalents and marketable securities $ 299,915 $ 2 $ (413) $ 299,504 Classified as: Cash equivalents $ 92,692 Marketable securities - current 206,812 Total cash equivalents and marketable securities $ 299,504 December 31, 2021 Amortized Gross Unrealized Cost Gains Losses Fair Value Money market funds $ 39,854 $ — $ — $ 39,854 Commercial paper 157,157 — (16) 157,141 Corporate debt securities 75,598 — (50) 75,548 U.S. Treasury and agency securities 40,093 — (76) 40,017 Supranational and sovereign government securities 6,011 — (1) 6,010 Total cash equivalents and marketable securities $ 318,713 $ — $ (143) $ 318,570 Classified as: Cash equivalents $ 115,335 Marketable securities - current 203,235 Total cash equivalents and marketable securities $ 318,570 |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Balance Sheet Components | |
Summary of Prepaid Expenses and Other Current Assets | March 31, December 31, 2022 2021 Prepaid clinical and research related expenses $ 4,579 $ 5,242 Prepaid insurance 1,429 1,746 Other prepaid expenses 1,721 1,515 Other receivable 476 975 Prepaid expenses and other current assets $ 8,205 $ 9,478 |
Summary of Property and Equipment Net | March 31, December 31, 2022 2021 Laboratory equipment $ 4,619 $ 4,156 Furniture and computer equipment 1,072 1,023 Leasehold improvements 898 877 Total property and equipment 6,589 6,056 Less: accumulated depreciation (4,525) (4,258) Property and equipment, net $ 2,064 $ 1,798 |
Schedule of Accrued Expenses and Other Payables | March 31, December 31, 2022 2021 Accrued clinical and research related expenses $ 27,514 $ 27,950 Accrued employee related expenses 2,643 7,125 Accrued professional service fees 1,063 734 Accrued collaboration payments 1,500 1,500 Other 154 407 Total accrued expenses and other payables $ 32,874 $ 37,716 |
Equity Plans (Tables)
Equity Plans (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Schedule of activity under equity incentive plans | Weighted- Weighted- Average Average Exercise Remaining Aggregate Options Price Per Contractual Intrinsic Outstanding Share Life (years) Value (1) (in millions) Balances at December 31, 2021 5,890,540 $ 17.66 7.47 $ 102.7 Options granted 1,122,100 28.85 Options exercised (165,488) 11.68 Options forfeited (37,542) 39.04 Balances at March 31, 2022 6,809,610 $ 19.53 7.37 $ 46.0 Options exercisable – March 31, 2022 3,349,241 $ 13.59 6.05 $ 34.5 Options vested and expected to vest – March 31, 2022 6,809,610 $ 19.53 7.37 $ 46.0 (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 March 31, 2022. The calculation excludes options with an exercise price higher than the closing price of the Company’s common stock on March 31, 2022. |
Schedule of stock-based compensation expense | Total stock-based compensation expense was as follows (in thousands): Three Months Ended March 31, 2022 2021 Research and development $ 3,326 $ 1,475 General and administrative 2,609 1,185 Total stock-based compensation expense $ 5,935 $ 2,660 |
Options to Purchase Common Stock | |
Black-Scholes option-pricing model assumptions | Three Months Ended March 31, 2022 2021 Expected term (in years) 5.27- 6.08 5.27- 6.08 Expected volatility 97.1% - 98.2% 89.8% - 90.2% Risk-free interest rate 1.64% - 2.13% 0.11% - 0.97% 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, 2021 405,972 $ 20.13 Granted 312,550 28.73 Vested (104,712) 14.73 Forfeited (7,000) 28.73 Unvested RSUs at March 31, 2022 606,810 $ 24.61 |
Performance Stock Units | |
Schedule of performance stock unit activity | Weighted Average Number of Grant Date Shares Fair Value Unvested PSUs at December 31, 2021 105,500 $ 23.57 Granted — — Vested — — Forfeited — — Unvested PSUs at March 31, 2022 105,500 $ 23.57 |
Net Loss per Share (Tables)
Net Loss per Share (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Net Loss per Share | |
Schedule of computation of the basic and diluted net loss per share attributable to common stockholders | Three Months Ended March 31, 2022 2021 Numerator: Net loss $ (20,930) $ (23,998) Denominator: Weighted-average shares used to compute net loss per common share, basic and diluted 48,752,548 44,224,169 Net loss per share, basic and diluted $ (0.43) $ (0.54) |
Schedule of potentially dilutive securities excluded from diluted net loss per share calculations | March 31, 2022 2021 Options to purchase common stock 6,809,610 5,698,164 Common stock warrants 2,750,000 2,750,000 Restricted stock units 606,810 448,380 Performance stock units 105,500 110,500 ESPP shares 19,762 16,778 Total 10,291,682 9,023,822 |
Organization and Description _2
Organization and Description of Business - Liquidity (Details) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022USD ($)segment | Dec. 31, 2021USD ($) | |
Organization and Description of Business | ||
Number of operating segments | segment | 1 | |
Net losses from operations since inception | ||
Cash, cash equivalents and marketable securities | $ 305,300 | |
Accumulated deficit | $ (430,292) | $ (409,362) |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Cash and Cash Equivalents and Restricted Cash (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 | Mar. 31, 2021 | Dec. 31, 2020 |
Aggregate amounts of cash and cash equivalents and the restricted cash | ||||
Cash and cash equivalents | $ 98,477 | $ 123,665 | $ 83,000 | |
Restricted cash - noncurrent | 225 | 225 | 225 | |
Total cash reported on condensed consolidated statements of cash flows | $ 98,702 | $ 123,890 | $ 83,225 | $ 117,818 |
License and Collaboration Agr_3
License and Collaboration Agreement - Narrative (Details) - USD ($) | Jul. 27, 2021 | Mar. 31, 2022 | Mar. 31, 2021 | Dec. 31, 2021 | Mar. 31, 2020 | May 07, 2019 | Jul. 13, 2017 |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Recognized revenue from deferred revenue contract liability | $ 13,000 | $ 1,100,000 | |||||
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 | 17,900,000 | ||||||
Janssen | License and Collaboration Agreement | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Collaboration revenue recorded following the contract modification | 25,700,000 | 5,600,000 | |||||
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 | $ 7,500,000 | ||||||
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 | 25,000,000 | ||||||
Janssen | 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 | 115,000,000 | ||||||
Janssen | License and Collaboration Agreement | Completion of clinical data collection for Phase 1 activities for the first of either PN-232 or PN-235 | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Upcoming potential development milestones | 25,000,000 | ||||||
Janssen | Original Agreement | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Transaction price | 106,500,000 | ||||||
Janssen | Original Agreement | License and Collaboration Agreement | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Duration of the parties' research collaboration agreement | 2 years | ||||||
Janssen | Original Agreement | License and Collaboration Agreement | Three phase 1 studies of second-generation compounds | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Expense obligations eliminated | $ 5,000,000 | ||||||
Percentage of development cost eliminated | 50.00% | ||||||
Janssen | Original Agreement | License and Collaboration Agreement | Phase 2a and 2b costs for PTG-200 | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Development cost payable | $ 100,000,000 | ||||||
Development cost incurred, percentage | 20.00% | ||||||
Janssen | Original Agreement | License and Collaboration Agreement | Phase 2 studies for second-generation products | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Percentage of development cost eliminated | 20.00% | ||||||
Milestone payment | $ 50,000,000 | ||||||
Janssen | Original Agreement | License and Collaboration Agreement | Maximum | Three phase 1 studies of second-generation compounds | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Development cost payable | 20,000,000 | ||||||
Janssen | Original Agreement | License and Collaboration Agreement | Maximum | Phase 2a and 2b costs for PTG-200 | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Development cost payable | 20,000,000 | ||||||
Janssen | Original Agreement | License and Collaboration Agreement | Maximum | Phase 2 studies for second-generation products | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Development cost payable | $ 25,000,000 | ||||||
Expense obligations eliminated | $ 25,000,000 | ||||||
Janssen | Original Agreement | Upfront cash payment | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Upfront payment | $ 50,000,000 | ||||||
Janssen | Restated Agreement | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Upfront payment | 87,500,000 | ||||||
Development cost payable | 7,100,000 | ||||||
Reimbursement for services performed | 8,200,000 | ||||||
Maximum percentages royalties on net product sales | 10.00% | ||||||
Increase (decrease) in transaction price | 25,000,000 | $ 8,000,000 | |||||
Transaction price | $ 131,500,000 | ||||||
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 | $ 5,000,000 | ||||||
Janssen | Restated Agreement | Phase 2a study evaluating PTG-200 for the treatment of CD | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Development cost incurred, percentage | 50.00% | ||||||
Janssen | Restated Agreement | Additional services | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Revenue recognized | $ 0 | $ 600,000 | |||||
Janssen | Restated Agreement | License and Collaboration Agreement | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Eligible amount received | $ 25,000,000 | ||||||
Janssen | Restated Agreement | License and Collaboration Agreement | Phase 1 studies of second-generation compounds | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Percentage of development cost eliminated | 100.00% | ||||||
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 | $ 25,000,000 | ||||||
Milestone payment | $ 25,000,000 | ||||||
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 | $ 10,000,000 | ||||||
Janssen | Restated Agreement | License and Collaboration Agreement | Phase 2a study evaluating PTG-200 for the treatment of CD | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Development cost incurred, percentage | 20.00% | ||||||
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 | $ 50,000,000 | ||||||
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 | 15,000,000 | ||||||
Janssen | Restated Agreement | License and Collaboration Agreement | Maximum | Phase 2a study evaluating PTG-200 for the treatment of CD | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Development cost payable | $ 20,000,000 |
License and Collaboration Agr_4
License and Collaboration Agreement - Contract Assets and Liabilities (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Deferred revenue - related party | ||
Balance at Beginning of Period | $ 1,601 | |
Balance at End of Period | 768 | |
Payable to collaboration partner - related party | ||
Balance at Beginning of Period | 899 | |
Balance at End of Period | 380 | |
Janssen | License and Collaboration Agreement | ||
Receivable from collaboration partner - related party | ||
Balance at Beginning of Period | 1,566 | $ 2,426 |
Additions | 25,150 | 1,570 |
Deductions | (1,566) | |
Balance at End of Period | 25,150 | 3,996 |
Deferred revenue - related party | ||
Balance at Beginning of Period | 1,601 | 14,477 |
Additions | 25,658 | 1,017 |
Deductions | (26,491) | (9,726) |
Balance at End of Period | 768 | 5,768 |
Payable to collaboration partner - related party | ||
Balance at Beginning of Period | 899 | 2,732 |
Additions | 330 | 4,091 |
Deductions | (849) | |
Balance at End of Period | $ 380 | $ 6,823 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - Recurring - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | $ 299,504 | $ 318,570 |
Money Market Funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 35,422 | 39,854 |
Commercial Paper | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 138,084 | 157,141 |
U.S. Treasury and agency securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 77,648 | 40,017 |
Corporate debt securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 45,350 | 75,548 |
Supranational and sovereign government securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 3,000 | 6,010 |
Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 35,422 | 39,854 |
Level 1 [Member] | Money Market Funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 35,422 | 39,854 |
Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 264,082 | 278,716 |
Level 2 [Member] | Commercial Paper | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 138,084 | 157,141 |
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 | 77,648 | 40,017 |
Level 2 [Member] | Corporate debt securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 45,350 | 75,548 |
Level 2 [Member] | Supranational and sovereign government securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | $ 3,000 | $ 6,010 |
Cash Equivalents and Marketab_3
Cash Equivalents and Marketable Securities - Cash Equivalents and Marketable Securities (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Cash Equivalents and Marketable Securities | ||
Total cash equivalents and marketable securities, Amortized Cost | $ 299,915 | $ 318,713 |
Total cash equivalents and marketable securities, Gross Unrealized Gains | 2 | |
Total cash equivalents and marketable securities, Gross Unrealized Losses | (413) | (143) |
Total cash equivalents and marketable securities, Fair Value | 299,504 | 318,570 |
U.S. Treasury and agency securities | ||
Cash Equivalents and Marketable Securities | ||
Total cash equivalents and marketable securities, Amortized Cost | 77,915 | 40,093 |
Total cash equivalents and marketable securities, Gross Unrealized Gains | 1 | |
Total cash equivalents and marketable securities, Gross Unrealized Losses | (268) | (76) |
Total cash equivalents and marketable securities, Fair Value | 77,648 | 40,017 |
Corporate debt securities | ||
Cash Equivalents and Marketable Securities | ||
Total cash equivalents and marketable securities, Amortized Cost | 45,455 | 75,598 |
Total cash equivalents and marketable securities, Gross Unrealized Losses | (105) | (50) |
Total cash equivalents and marketable securities, Fair Value | 45,350 | 75,548 |
Supranational and sovereign government securities | ||
Cash Equivalents and Marketable Securities | ||
Total cash equivalents and marketable securities, Amortized Cost | 3,000 | 6,011 |
Total cash equivalents and marketable securities, Gross Unrealized Losses | (1) | |
Total cash equivalents and marketable securities, Fair Value | 3,000 | 6,010 |
Money Market Funds | ||
Cash Equivalents and Marketable Securities | ||
Total cash equivalents and marketable securities, Amortized Cost | 35,422 | 39,854 |
Total cash equivalents and marketable securities, Fair Value | 35,422 | 39,854 |
Commercial Paper | ||
Cash Equivalents and Marketable Securities | ||
Total cash equivalents and marketable securities, Amortized Cost | 138,123 | 157,157 |
Total cash equivalents and marketable securities, Gross Unrealized Gains | 1 | |
Total cash equivalents and marketable securities, Gross Unrealized Losses | (40) | (16) |
Total cash equivalents and marketable securities, Fair Value | $ 138,084 | $ 157,141 |
Cash Equivalents and Marketab_4
Cash Equivalents and Marketable Securities - Classification of Cash Equivalents and Marketable Securities (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2022 | Dec. 31, 2021 | |
Classified as: | ||
Cash equivalents | $ 92,692 | $ 115,335 |
Marketable securities - current | 206,812 | 203,235 |
Total cash equivalents and marketable securities | $ 299,504 | $ 318,570 |
Contractual maturities | ||
Maximum period of current contractual maturities | 1 year | 1 year |
Realized Gain (loss) | $ 0 | $ 0 |
Balance Sheet Components - Prep
Balance Sheet Components - Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Prepaid Expense and Other Assets, Current [Abstract] | ||
Prepaid clinical and research related expenses | $ 4,579 | $ 5,242 |
Prepaid insurance | 1,429 | 1,746 |
Other prepaid expenses | 1,721 | 1,515 |
Other receivable | 476 | 975 |
Prepaid expenses and other current assets | $ 8,205 | $ 9,478 |
Balance Sheet Components - Prop
Balance Sheet Components - Property and Equipment, Net (Details) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2022 | Mar. 31, 2021 | Dec. 31, 2021 | |
Property and Equipment | |||
Total property and equipment | $ 6,589 | $ 6,056 | |
Less: accumulated depreciation and amortization | (4,525) | (4,258) | |
Property and equipment, net | 2,064 | 1,798 | |
Property and equipment income statement disclosure | |||
Depreciation expense | 249 | $ 180 | |
Laboratory Equipment | |||
Property and Equipment | |||
Total property and equipment | 4,619 | 4,156 | |
Furniture and Computer Equipment | |||
Property and Equipment | |||
Total property and equipment | 1,072 | 1,023 | |
Leasehold Improvements | |||
Property and Equipment | |||
Total property and equipment | $ 898 | $ 877 |
Balance Sheet Components - Accr
Balance Sheet Components - Accrued Expenses and Other Payables (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Accrued Expenses and Other Payables | ||
Accrued clinical and research related expenses | $ 27,514 | $ 27,950 |
Accrued employee related expenses | 2,643 | 7,125 |
Accrued professional service fees | 1,063 | 734 |
Accrued collaboration payments | 1,500 | 1,500 |
Other | 154 | 407 |
Total accrued expenses and other payables | $ 32,874 | $ 37,716 |
Research Collaboration and Li_2
Research Collaboration and License Agreement (Details) | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2022USD ($) | Mar. 31, 2021USD ($) | Dec. 31, 2014USD ($)payment | |
Research Collaboration and License Agreement | |||
Research and development | $ 36,318,000 | $ 24,245,000 | |
Research Collaboration and License Agreement | Zealand Pharma | |||
Research Collaboration and License Agreement | |||
Aggregate milestone payment | $ 1,000,000 | ||
Number of development milestone payments | payment | 3 | ||
Research and development | $ 0 | $ 0 |
Research and Development Tax _2
Research and Development Tax Incentive (Details) - Australian Taxation Office $ in Millions, $ in Millions | 3 Months Ended | ||||||
Mar. 31, 2022USD ($) | Mar. 31, 2022AUD ($) | Mar. 31, 2021USD ($) | Mar. 31, 2021AUD ($) | Mar. 31, 2022AUD ($) | Dec. 31, 2021USD ($) | Dec. 31, 2021AUD ($) | |
Reduction to research and development expenses | $ 0 | $ 0 | $ 0.8 | $ 1 | |||
Research And Development Cash Tax Incentive Receivable | $ 2.9 | $ 3.8 | $ 2.8 | $ 3.8 |
Commitments and Contingencies (
Commitments and Contingencies (Details) - Zealand Pharma | Aug. 04, 2021USD ($)item | Mar. 31, 2022USD ($) |
Loss Contingencies [Line Items] | ||
Loss contingency accrual | $ 0 | |
Arbitration Resolution Agreement | ||
Loss Contingencies [Line Items] | ||
Additional milestone payment | $ 1,500,000 | |
Litigation Settlement, Collaborative Arrangement Milestone Payment Reduction Percentage | 50.00% | |
Number Of Business Days | 2 | |
Percentage of reduction in royalty payable | 50.00% | |
Percentage of sales milestone reductions | 50.00% | |
Future development milestone payable | $ 2,750,000 | |
Registration proposal payable | 1,000,000 | |
Commercial launch expenses | $ 1,750,000 | |
Number of geographic territories | item | 3 | |
Arbitration Resolution Agreement | Phase 2 clinical trial | ||
Loss Contingencies [Line Items] | ||
Milestone payment | $ 1,000,000 | |
Arbitration Resolution Agreement | Phase 3 clinical trial | ||
Loss Contingencies [Line Items] | ||
Milestone payment | $ 1,500,000 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - USD ($) $ / shares in Units, $ in Millions | Nov. 27, 2019 | Jan. 31, 2022 | Jun. 30, 2021 | Oct. 31, 2019 | Dec. 31, 2018 | Aug. 31, 2018 | Mar. 31, 2022 | Dec. 31, 2021 | Aug. 06, 2018 |
Stock transactions | |||||||||
Par value (per share) | $ 0.00001 | $ 0.00001 | |||||||
2019 Form S-3 | |||||||||
Stock transactions | |||||||||
Common stock available for sale | $ 79.3 | ||||||||
Maximum aggregate offering price | $ 250 | ||||||||
2019 Sales Agreement | |||||||||
Stock transactions | |||||||||
Common stock issued (in shares) | 422,367 | ||||||||
Common stock available for sale | $ 17 | ||||||||
Maximum aggregate offering price | $ 250 | $ 75 | |||||||
Proceeds from public offering of common stock, net of issuance costs | $ 14.6 | ||||||||
Underwritten public offering | |||||||||
Stock transactions | |||||||||
Net proceeds from sale of common stock | $ 123.8 | ||||||||
Common stock issued (in shares) | 3,046,358 | ||||||||
Common stock issued, price per share | $ 37.75 | ||||||||
underwritten public offering, Additional offering | |||||||||
Stock transactions | |||||||||
Common stock issued (in shares) | 456,953 | ||||||||
Common stock issued, price per share | $ 37.75 | ||||||||
Common Stock | |||||||||
Stock transactions | |||||||||
Common stock issued (in shares) | 422,367 | ||||||||
Common Stock | Private Placement | |||||||||
Stock transactions | |||||||||
Number of warrants exercised | 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 | $ 21.7 | ||||||||
Warrants issued to purchase common stock, number of shares | 2,750,000 | ||||||||
Warrants exercisable date | Aug. 8, 2023 | ||||||||
Exchange Agreement | Exchanging Stockholders | |||||||||
Stock transactions | |||||||||
Warrants issued to purchase common stock, number of shares | 1,000,000 | ||||||||
Exercise Price (per share) | $ 0.00001 | ||||||||
Common stock exchanged for pre-funded warrants | 1,000,000 | ||||||||
Par value (per share) | $ 0.00001 | ||||||||
Duration of warrants from date of issuance (in years) | 10 years | ||||||||
Equity method investment, ownership percentage | 9.99% | ||||||||
Exchange Agreement | Exchanging Stockholders | Common Stock | |||||||||
Stock transactions | |||||||||
Remaining number of Exchange Warrants unexercised | 400,000 | ||||||||
$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 | Jan. 01, 2021 | May 31, 2018 | Jul. 31, 2016 | Mar. 31, 2022 | Mar. 31, 2021 | Dec. 31, 2021 |
Equity Plans | ||||||
Average volatility | 25.00% | 50.00% | ||||
Percentage of volatility of stock options since IPO | 75.00% | 50.00% | ||||
2016 Equity Incentive Plan | ||||||
Equity Plans | ||||||
Expiration period | 10 years | |||||
Number of shares available for issuance | 1,095,340 | |||||
2018 Inducement Plan | ||||||
Equity Plans | ||||||
Expiration period | 10 years | |||||
Number of shares available for issuance | 743,125 | |||||
Options to Purchase Common Stock | ||||||
Equity Plans | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Dividend Rate | 0.00% | 0.00% |
Equity Plans - Stock Option Act
Equity Plans - Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Millions | 3 Months Ended | 12 Months Ended |
Mar. 31, 2022 | Dec. 31, 2021 | |
Options Outstanding | ||
Options Outstanding, Beginning balance | 5,890,540 | |
Options Outstanding, Options granted | 1,122,100 | |
Options Outstanding, Options exercised | (165,488) | |
Options Outstanding, Options forfeited | (37,542) | |
Options Outstanding, Ending balance | 6,809,610 | 5,890,540 |
Options Outstanding, Options exercisable | 3,349,241 | |
Options Outstanding, Options vested and expected to vest | 6,809,610 | |
Weighted-Average Exercise Price Per Share | ||
Weighted-Average Exercise Price Per Share, Beginning balance | $ 17.66 | |
Weighted-Average Exercise Price Per Share, Options granted | 28.85 | |
Weighted-Average Exercise Price Per Share, Options exercised | 11.68 | |
Weighted-Average Exercise Price Per Share, Options forfeited | 39.04 | |
Weighted-Average Exercise Price Per Share, Ending balance | 19.53 | $ 17.66 |
Weighted-Average Exercise Price Per Share, Options exercisable | 13.59 | |
Weighted-Average Exercise Price Per Share, Options vested and expected to vest | $ 19.53 | |
Weighted-Average Remaining Contractual Life (years) | ||
Weighted-Average Remaining Contractual Life (years) | 7 years 4 months 13 days | |
Weighted-Average Remaining Contractual Life (years), Options exercisable | 6 years 18 days | |
Weighted-Average Remaining Contractual Life (years), Options vested and expected to vest | 7 years 4 months 13 days | 7 years 5 months 19 days |
Aggregate Intrinsic Value | ||
Aggregate Intrinsic Value, Options Outstanding | $ 46 | $ 102.7 |
Aggregate Intrinsic Value, Options exercisable | 34.5 | |
Aggregate Intrinsic Value, Options vested and expected to vest | $ 46 | |
Options, weighted-average grant-date fair value | $ 22.56 |
Equity Plans - Stock Options Va
Equity Plans - Stock Options Valuation Assumptions (Details) - Options to Purchase Common Stock | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Equity Plans | ||
Expected volatility, Minimum | 97.10% | 89.80% |
Expected volatility, Maximum | 98.20% | 90.20% |
Risk-free interest rate, Minimum | 1.64% | 0.11% |
Risk-free interest rate, Maximum | 2.13% | 0.97% |
Dividend yield | 0.00% | 0.00% |
Minimum | ||
Equity Plans | ||
Expected term (in year) | 5 years 3 months 7 days | 5 years 3 months 7 days |
Maximum | ||
Equity Plans | ||
Expected term (in year) | 6 years 29 days | 6 years 29 days |
Equity Plans - Restricted Stock
Equity Plans - Restricted Stock Units - (Details) $ / shares in Units, $ in Millions | 3 Months Ended |
Mar. 31, 2022USD ($)$ / sharesshares | |
Restricted stock units | |
Number of Shares | |
Number of shares, Unvested, Beginning balance | shares | 405,972 |
Number of shares, Granted | shares | 312,550 |
Number of shares, Vested | shares | (104,712) |
Number of Shares, Forfeited | shares | (7,000) |
Number of shares, Unvested, Ending balance | shares | 606,810 |
Weighted-Average Grant Date Fair Value | |
Weighted-Average Grant Date Fair Value, Unvested, Beginning balance | $ / shares | $ 20.13 |
Weighted-Average Grant Date Fair Value, Granted | $ / shares | 28.73 |
Weighted-Average Grant Date Fair Value, Vested | $ / shares | 14.73 |
Weighted-Average Grant Date Fair Value, Forfeited | $ / shares | 28.73 |
Weighted-Average Grant Date Fair Value, Unvested, Ending balance | $ / shares | $ 24.61 |
Performance Stock Units | |
Number of Shares | |
Number of shares, Unvested, Beginning balance | shares | 105,500 |
Number of shares, Unvested, Ending balance | shares | 105,500 |
Weighted-Average Grant Date Fair Value | |
Weighted-Average Grant Date Fair Value, Unvested, Beginning balance | $ / shares | $ 23.57 |
Weighted-Average Grant Date Fair Value, Unvested, Ending balance | $ / shares | $ 23.57 |
Aggregate fair value of restricted stock units that vested | $ | $ 2.5 |
Equity Plans - Performance Stoc
Equity Plans - Performance Stock Units (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Equity Plans | ||
Stock-based compensation | $ 5,935,000 | $ 2,660,000 |
Performance Stock Units | ||
Equity Plans | ||
Vesting percentage of requisite service period | 100.00% | |
Fair value of stock units | 2,500,000 | |
Stock-based compensation | $ 0 |
Equity Plans - Employee Stock P
Equity Plans - Employee Stock Purchase Plan (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Equity Plans | ||
Stock-based compensation | $ 5,935 | $ 2,660 |
2016 Employee Stock Purchase Plan | ||
Equity Plans | ||
Maximum payroll deduction for share purchases (as a percent) | 15.00% | |
Purchase price of stock (as a percent) | 85.00% | |
Shares issued in period | 28,931 | |
Number of shares available for issuance | 1,285,068 |
Equity Plans - Stock-based Comp
Equity Plans - Stock-based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Total stock-based compensation expense | $ 5,935 | $ 2,660 |
Total unrecognized stock-based compensation costs related to stock options | $ 73,600 | |
Period of unrecognized stock-based compensation costs to be recognized | 2 years 10 months 24 days | |
Research and Development | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Total stock-based compensation expense | $ 3,326 | 1,475 |
General and Administrative | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Total stock-based compensation expense | $ 2,609 | $ 1,185 |
Net Loss per Share - Computatio
Net Loss per Share - Computation (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Numerator: | ||
Net loss | $ (20,930) | $ (23,998) |
Denominator: | ||
Weighted-average shares used to compute net loss per common share, basic and diluted | 48,752,548 | 44,224,169 |
Net loss per shares, basic and diluted | $ (0.43) | $ (0.54) |
Net Loss per Share - Antidiluti
Net Loss per Share - Antidilutive Securities (Details) - shares | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Potentially dilutive securities have been excluded from diluted net loss per share calculations | ||
Anti-dilutive securities (in shares) | 10,291,682 | 9,023,822 |
Options to Purchase Common Stock | ||
Potentially dilutive securities have been excluded from diluted net loss per share calculations | ||
Anti-dilutive securities (in shares) | 6,809,610 | 5,698,164 |
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) | 606,810 | 448,380 |
Performance Stock Units | ||
Potentially dilutive securities have been excluded from diluted net loss per share calculations | ||
Anti-dilutive securities (in shares) | 105,500 | 110,500 |
ESPP shares | ||
Potentially dilutive securities have been excluded from diluted net loss per share calculations | ||
Anti-dilutive securities (in shares) | 19,762 | 16,778 |