Cover
Cover - shares | 6 Months Ended | |
Jun. 30, 2021 | Jul. 30, 2021 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2021 | |
Document Transition Report | false | |
Entity File Number | 001-39112 | |
Entity Registrant Name | OYSTER POINT PHARMA, INC. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 81-1030955 | |
Entity Address, Address Line One | 202 Carnegie Center, Suite 109 | |
Entity Address, City or Town | Princeton | |
Entity Address, State or Province | NJ | |
Entity Address, Postal Zip Code | 08540 | |
City Area Code | 609 | |
Local Phone Number | 382-9032 | |
Title of 12(b) Security | Common stock, par value $0.001 | |
Trading Symbol | OYST | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | true | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 26,014,621 | |
Amendment Flag | false | |
Entity Central Index Key | 0001720725 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Period Focus | Q2 | |
Document Fiscal Year Focus | 2021 |
Condensed Balance Sheets
Condensed Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Current Assets | ||
Cash and cash equivalents | $ 154,805 | $ 192,585 |
Prepaid expenses and other current assets | 4,081 | 3,782 |
Total current assets | 158,886 | 196,367 |
Property and equipment, net | 1,743 | 804 |
Restricted cash | 61 | 61 |
Other assets | 30 | 0 |
Right-of-use assets, net | 783 | 678 |
Total Assets | 161,503 | 197,910 |
Current Liabilities | ||
Accounts payable | 2,332 | 2,279 |
Accrued expenses and other current liabilities | 6,594 | 8,285 |
Lease liabilities | 545 | 418 |
Total current liabilities | 9,471 | 10,982 |
Lease liabilities, non-current | 248 | 269 |
Total Liabilities | 9,719 | 11,251 |
Commitments and Contingencies (Note 7) | ||
Stockholders’ Equity | ||
Preferred stock, $0.001 par value per share; 5,000,000 shares authorized; none outstanding | 0 | 0 |
Common stock, $0.001 par value per share; 1,000,000,000 shares authorized, 26,006,437 and 25,890,490 shares issued and outstanding at June 30, 2021 and December 31, 2020, respectively | 26 | 26 |
Additional paid-in capital | 347,434 | 341,384 |
Accumulated deficit | (195,676) | (154,751) |
Total Stockholders’ Equity | 151,784 | 186,659 |
Total Liabilities and Stockholders’ Equity | $ 161,503 | $ 197,910 |
Condensed Balance Sheets (Paren
Condensed Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2021 | Dec. 31, 2020 |
Statement of Financial Position [Abstract] | ||
Par value of preferred stock (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock authorized (in shares) | 5,000,000 | 5,000,000 |
Preferred stock outstanding (in shares) | 0 | 0 |
Common stock par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock authorized (in shares) | 1,000,000,000 | 1,000,000,000 |
Common stock shares issued (in shares) | 26,006,437 | 25,890,490 |
Common stock shares outstanding (in shares) | 26,006,437 | 25,890,490 |
Condensed Statements of Operati
Condensed Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Operating expenses: | ||||
Research and development | $ 6,730 | $ 8,554 | $ 12,558 | $ 19,894 |
Selling, general and administrative | 15,296 | 6,940 | 28,388 | 12,529 |
Total operating expenses | 22,026 | 15,494 | 40,946 | 32,423 |
Loss from operations | (22,026) | (15,494) | (40,946) | (32,423) |
Other income, net | 10 | 30 | 21 | 440 |
Net loss and comprehensive loss | $ (22,016) | $ (15,464) | $ (40,925) | $ (31,983) |
Net loss per share, diluted (in dollars per share) | $ (0.85) | $ (0.66) | $ (1.58) | $ (1.43) |
Net loss per share, basic (in dollars per share) | $ (0.85) | $ (0.66) | $ (1.58) | $ (1.43) |
Weighted average shares outstanding, basic (in shares) | 25,989,913 | 23,442,530 | 25,957,186 | 22,405,031 |
Weighted average shares outstanding, diluted (in shares) | 25,989,913 | 23,442,530 | 25,957,186 | 22,405,031 |
Condensed Statements of Stockho
Condensed Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Common Stock | Common StockUnvested restricted stock units | Additional Paid-In Capital | Accumulated Deficit |
Beginning balance, common stock (in shares) at Dec. 31, 2019 | 21,366,950 | ||||
Beginning balance at Dec. 31, 2019 | $ 137,298 | $ 21 | $ 221,508 | $ (84,231) | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (16,519) | (16,519) | |||
Issuance of common stock upon exercise of stock options (in shares) | 3,530 | ||||
Issuance of common stock upon exercise of stock options | 4 | 4 | |||
Stock-based compensation expense | 1,180 | 1,180 | |||
Ending balance, common stock (in shares) at Mar. 31, 2020 | 21,370,480 | ||||
Ending balance at Mar. 31, 2020 | 121,963 | $ 21 | 222,692 | (100,750) | |
Beginning balance, common stock (in shares) at Dec. 31, 2019 | 21,366,950 | ||||
Beginning balance at Dec. 31, 2019 | 137,298 | $ 21 | 221,508 | (84,231) | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (31,983) | ||||
Ending balance, common stock (in shares) at Jun. 30, 2020 | 25,743,405 | ||||
Ending balance at Jun. 30, 2020 | 220,815 | $ 26 | 337,003 | (116,214) | |
Beginning balance, common stock (in shares) at Mar. 31, 2020 | 21,370,480 | ||||
Beginning balance at Mar. 31, 2020 | 121,963 | $ 21 | 222,692 | (100,750) | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | $ (15,464) | (15,464) | |||
Issuance of common stock upon exercise of stock options (in shares) | 60,425 | ||||
Issuance of common stock upon exercise of stock options | $ 82 | 82 | |||
Issuance of common stock upon secondary equity offering, net of issuance costs of $8,125 (in shares) | 4,312,500 | ||||
Issuance of common stock upon exercise of stock options | 112,625 | $ 5 | 112,620 | ||
Stock-based compensation expense | 1,609 | 1,609 | |||
Ending balance, common stock (in shares) at Jun. 30, 2020 | 25,743,405 | ||||
Ending balance at Jun. 30, 2020 | $ 220,815 | $ 26 | 337,003 | (116,214) | |
Beginning balance, common stock (in shares) at Dec. 31, 2020 | 25,890,490 | 25,890,490 | |||
Beginning balance at Dec. 31, 2020 | $ 186,659 | $ 26 | 341,384 | (154,751) | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (18,909) | (18,909) | |||
Issuance of common stock upon exercise of stock options (in shares) | 55,046 | 15,252 | |||
Issuance of common stock upon exercise of stock options | 218 | 218 | |||
Stock-based compensation expense | 2,680 | 2,680 | |||
Ending balance, common stock (in shares) at Mar. 31, 2021 | 25,960,788 | ||||
Ending balance at Mar. 31, 2021 | $ 170,648 | $ 26 | 344,282 | (173,660) | |
Beginning balance, common stock (in shares) at Dec. 31, 2020 | 25,890,490 | 25,890,490 | |||
Beginning balance at Dec. 31, 2020 | $ 186,659 | $ 26 | 341,384 | (154,751) | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | $ (40,925) | ||||
Issuance of common stock upon exercise of stock options (in shares) | 83,794 | ||||
Ending balance, common stock (in shares) at Jun. 30, 2021 | 26,006,437 | 26,006,437 | |||
Ending balance at Jun. 30, 2021 | $ 151,784 | $ 26 | 347,434 | (195,676) | |
Beginning balance, common stock (in shares) at Mar. 31, 2021 | 25,960,788 | ||||
Beginning balance at Mar. 31, 2021 | 170,648 | $ 26 | 344,282 | (173,660) | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (22,016) | (22,016) | |||
Issuance of common stock upon exercise of stock options (in shares) | 28,748 | 16,901 | |||
Issuance of common stock upon exercise of stock options | 104 | 104 | |||
Stock-based compensation expense | $ 3,048 | 3,048 | |||
Ending balance, common stock (in shares) at Jun. 30, 2021 | 26,006,437 | 26,006,437 | |||
Ending balance at Jun. 30, 2021 | $ 151,784 | $ 26 | $ 347,434 | $ (195,676) |
Condensed Statement of Cash Flo
Condensed Statement of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Cash flows from operating activities | ||
Net loss | $ (40,925) | $ (31,983) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation expense | 5,728 | 2,789 |
Depreciation | 55 | 40 |
Reduction in the carrying amount of the right-of-use assets | 239 | 188 |
Changes in assets and liabilities: | ||
Prepaid expenses and other current assets | (290) | 1,217 |
Accounts payable | 53 | 3,252 |
Change in lease liabilities | (239) | (207) |
Accrued expenses and other current liabilities | (1,676) | (394) |
Other assets | (30) | 0 |
Net cash used in operating activities | (37,085) | (25,098) |
Cash flows from investing activities | ||
Purchase of property and equipment | (994) | (342) |
Net cash used in investing activities | (994) | (342) |
Cash flows from financing activities | ||
Payment of deferred offering costs | (23) | 0 |
Proceeds from follow-on equity offering, net of issuance costs | 0 | 112,965 |
Proceeds from the exercise of stock options | 322 | 86 |
Net cash provided by financing activities | 299 | 113,051 |
Net (decrease) increase in cash, cash equivalents and restricted cash | (37,780) | 87,611 |
Cash, cash equivalents and restricted cash at the beginning of the period | 192,646 | 139,198 |
Cash, cash equivalents and restricted cash at the end of the period | 154,866 | 226,809 |
Reconciliation of cash, cash equivalents and restricted cash | ||
Cash and cash equivalents | 154,805 | 226,748 |
Restricted cash | 61 | 61 |
Cash, cash equivalents and restricted cash | 154,866 | 226,809 |
Supplemental cash flow information | ||
Right-of-use for office space and office equipment acquired through leases | 344 | 320 |
Supplemental non-cash flow information | ||
Unpaid offering costs | $ 0 | $ 340 |
Condensed Statements of Stock_2
Condensed Statements of Stockholders' Equity (Parenthetical) $ in Thousands | 3 Months Ended |
Jun. 30, 2020USD ($) | |
Statement of Stockholders' Equity [Abstract] | |
Stock issuance costs | $ 8,125 |
Nature of Business, Basis of Pr
Nature of Business, Basis of Presentation and Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2020 | |
Accounting Policies [Abstract] | |
Nature of Business, Basis of Presentation and Significant Accounting Policies | Nature of Business, Basis of Presentation and Significant Accounting Policies Description of the Business Oyster Point Pharma, Inc. (the Company) is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of pharmaceutical therapies to treat ophthalmic diseases. The Company’s principal office is located in Princeton, New Jersey. From inception through June 30, 2021, the Company has been engaged in business planning, research, clinical development of its therapeutic product candidates, recruiting and raising capital, as well as preparation for the commercialization of its lead product candidate, OC-01. In December of 2020, t he Company submitted a 505(b)(2) New Drug Application (NDA) for OC-01 (varenicline) nasal spray for the treatment of signs and symptoms of dry eye disease. The U.S. Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) target action date of October 17, 2021 as the goal to complete its review of the NDA. Liquidity The Company incurred net losses of $40.9 million and $32.0 million for the six months ended June 30, 2021 and 2020, respectively, and had an accumulated deficit of $195.7 million as of June 30, 2021. The Company has been incurring higher expenses due to the Company's preparation for the commercialization of its lead product candidate, OC-01 (varenicline) nasal spray, if approved by the FDA, including to establish commercial scale manufacturing arrangements and to provide for the marketing, commercial operations and distribution of the product. The Company expended and will continue to expend additional funds to complete the research, development and clinical testing of its product candidates. The Company will require additional funds to commercialize its products. The Company is unable to entirely fund these efforts with its current financial resources and there can be no assurance that it will be able to secure such additional financing on a timely basis, if at all, that will be sufficient to meet these needs. If adequate funds are unavailable on a timely basis from operations or additional sources of financing, the Company may have to delay, reduce and or eliminate certain commercial related expenses, included in selling, general and administrative expenses, as well as delay, reduce or eliminate the scope of one or more of its research or development programs, which would materially and adversely affect its business, financial condition and operations. The Company continues to be subject to risks and uncertainties as a result of the SARS-CoV-2 virus pandemic. The pandemic and related public health developments, have adversely affected workforces, economies, and financial markets globally, potentially leading to an economic downturn. As of June 30, 2021, the Company has not been materially affected by the adverse results of the pandemic, however, it is not possible to predict the duration or magnitude of the adverse results of the pandemic or the full extent of its effects on the Company's financial condition, liquidity or results of operations. The Company had cash and cash equivalents of $154.8 million as of June 30, 2021. Management believes that the Company’s current cash and cash equivalents will be sufficient to fund its planned operations for at least 12 months from the date of issuance of these financial statements. Basis of Presentation The unaudited interim condensed financial statements and accompanying notes have been prepared in accordance with U.S. generally accepted accounting principles (U.S. GAAP). Accordingly, certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to such rules and regulations. In the opinion of management, the accompanying unaudited condensed financial statements contain all adjustments, which are of a normal recurring nature, necessary to state fairly the Company’s financial position as of June 30, 2021 and as of December 31, 2020, the results of operations for the six months ended June 30, 2021 and 2020, and cash flows for the six months ended June 30, 2021 and 2020. While management believes that the disclosures presented are adequate to mitigate the risk of the information being misleading, these unaudited condensed financial statements should be read in conjunction with the audited financial statements and the related notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020. The results of the Company’s operations for any interim period are not necessarily indicative of the results of operations for any other interim period or for the full year. Research Collaboration Agreement In May 2021, the Company entered into a research collaboration agreement with Adaptive Phage Therapeutics (APT) for the development of potential biological treatments for multiple ophthalmic diseases. Under the terms of the collaboration agreement, the Company has the option and certain rights to obtain an exclusive license to develop and commercialize APT’s technology for ophthalmic diseases and disorders. Under the license terms, if such option is exercised, the Company would pay for potential development and regulatory milestones, as well as the potential for sales-related milestones and tiered royalties of net sales, if a licensed phage therapy is approved by the FDA or certain other regulatory authorities. Pursuant to the terms of the agreement, the Company paid a one-time, non-refundable, upfront payment of $0.5 million for the collaboration and option agreement which was included in research and development expense for the three and six months ended June 30, 2021. Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts of assets and liabilities, disclosure of contingent assets and liabilities and the reported amounts of expenses in the condensed financial statements and accompanying notes. Significant items subject to such estimates and assumptions include stock-based compensation and certain research and development accruals. Actual results could differ from these estimates, and such differences could be material to the Company’s financial position and results of operations. Summary of Significant Accounting Policies The Company’s significant accounting policies are disclosed in Note 1 . Nature of Business, Basis of Presentation and Significant Accounting Policies in the Annual Report on Form 10-K for the year ended December 31, 2020. There have been no material changes in the Company's accounting policies from those disclosed in the financial statements and the related notes included in the Annual Report on Form 10-K for the year ended December 31, 2020. Recent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (the FASB) under its accounting standard codifications (ASC) or other standard setting bodies and are adopted by the Company as of the specified effective date, unless otherwise discussed below. ASU 2020-10 — In October 2020, the FASB issued ASU 2020-10, Codification Improvements, which updated various codification topics by clarifying or improving disclosure requirements to align with the SEC’s regulations. The amendments in ASU 2020-10 are effective for annual periods beginning after December 15, 2020, for public business entities. The Company adopted ASU 2020-10 on January 1, 2021 and its adoption did not have a material effect on the Company’s financial statements and related disclosures. |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2021 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Fair Value Measurements The Company assesses the fair value of financial instruments as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, a three-tier fair value hierarchy has been established, which prioritizes the inputs used in measuring fair value as follows: Level 1 Quoted prices in active markets for identical assets or liabilities. Level 2 Observable inputs other than Level 1 prices such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Level 3 Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. As of June 30, 2021, financial assets measured and recognized at fair value on a recurring basis were as follows (in thousands): Fair Value Measurements at June 30, 2021 Quoted Price in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Total Assets Money market funds $ 153,805 $ — $ — $ 153,805 Total fair value of assets $ 153,805 $ — $ — $ 153,805 As of December 31, 2020, financial assets measured and recognized at fair value on a recurring basis were as follows (in thousands): Fair Value Measurements at December 31, 2020 Quoted Price in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Total Assets Money market funds $ 191,585 $ — $ — $ 191,585 Total fair value of assets $ 191,585 $ — $ — $ 191,585 Money market funds are included in cash and cash equivalents on the Company's condensed balance sheets and are classified within Level 1 of the fair value hierarchy as they are valued using quoted market prices. The carrying amounts reflected in the Company's condensed balance sheets for cash equivalents, prepaid expenses and other current assets, restricted cash, accounts payable and accrued expenses and other liabilities approximate their fair values, due to their short-term nature. Concentration of Credit Risk |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 6 Months Ended |
Jun. 30, 2021 | |
Payables and Accruals [Abstract] | |
Accrued Expenses and Other Current Liabilities | Accrued Expenses and Other Current LiabilitiesAccrued expenses and other current liabilities consisted of the following (in thousands): June 30, 2021 December 31, 2020 Accrued compensation $ 3,776 $ 3,500 Accrued professional services 2,222 1,244 Accrued research and development expense 596 3,541 Total accrued expenses and other current liabilities $ 6,594 $ 8,285 |
Stockholders' Equity
Stockholders' Equity | 6 Months Ended |
Jun. 30, 2021 | |
Equity [Abstract] | |
Stockholders' Equity | Stockholders' Equity Common Stock The Company is authorized to issue 1,000,000,000 shares of common stock, at a par value of $0.001 per share. Each share of common stock is entitled to one vote. The Company reserved common stock for future issuance as follows: June 30, 2021 December 31, 2020 Outstanding options under the 2016 Equity Incentive Plan 2,458,812 2,567,566 Outstanding options under the 2019 Equity Incentive Plan 1,676,659 918,145 Equity awards available for grant under the 2019 Plan (1) 1,948,226 1,790,106 Unvested restricted stock units (RSUs) 173,007 61,215 Shares reserved for purchase under the Employee Stock Purchase Plan (ESPP) 270,000 270,000 Total 6,526,704 5,607,032 (1) — Effective January 1, 2021, in connection with the evergreen provision under the 2019 Equity Incentive Plan (the 2019 Plan) 1,035,619 shares were added to the 2019 Plan. Stock Options The following table summarizes stock option activity under the 2016 Equity Incentive Plan and the 2019 Plan during the six months ended June 30, 2021 (in thousands, except share, contractual term and per share data): Outstanding Options Number of Shares Underlying Outstanding Options Weighted Average Exercise Price Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic Value Balance, January 1, 2021 3,485,711 $ 10.74 8.2 $ 36,506 Options granted 810,986 18.98 Options exercised (83,794) 3.84 1,369 Options forfeited (77,432) 16.99 335 Balance, June 30, 2021 4,135,471 12.38 8.1 30,931 Shares vested and exercisable as of June 30, 2021 1,950,464 6.55 7.2 23,731 Vested and expected to vest as of June 30, 2021 4,135,471 $ 12.38 8.1 $ 30,931 The weighted average fair value of options granted during the six months ended June 30, 2021 was $11.84 per share. As of June 30, 2021, the total unrecognized stock-based compensation expense for stock options was $25.8 million, which is expected to be recognized over a weighted average period of 2.8 years. Restricted Stock Units Restricted stock units (RSUs) are granted to the Company's directors and employees. The value of an RSU award is based on the Company's stock price on the date of the grant. The shares underlying the RSUs are not issued until the RSUs vest. Upon vesting, each RSU converts into one share of the Company's common stock. Activity with respect to the Company's restricted stock units during the six months ended June 30, 2021 was as follows (in thousands, except share, contractual term, and per share data): Outstanding RSUs Number of Shares Underlying Outstanding Awards Weighted Average Grant Date Fair Value per Share Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic Value Outstanding at January 1, 2021 61,215 $ 23.83 1.4 $ 1,152 Restricted stock units granted 144,317 18.54 2,676 Restricted stock units vested (32,153) 27.15 648 Restricted units forfeited (372) 18.77 8 Balance, June 30, 2021 173,007 18.81 6.0 2,974 Unvested and expected to vest as of June 30, 2021 173,007 $ 18.81 6.0 $ 2,974 As of June 30, 2021, the total unrecognized stock-based compensation expense for RSUs was $2.8 million, which is expected to be recognized over a weighted average period of 2.8 years. 2019 Employee Stock Purchase Plan In October 2019, the Company adopted the 2019 Employee Stock Purchase Plan (ESPP), which became effective on October 29, 2019. Effective April 1, 2021, the Company established its first offering period under the ESPP, which began on April 16, 2021 and will end on November 15, 2021. After the first offering period, the ESPP provides for automatic six-month offering periods. The ESPP allows eligible employees to purchase shares of the Company's common stock at a 15% discount through payroll deductions, subject to plan limitations. At the end of each offering period, employees are able to purchase shares at 85% of the lower of the fair market fair value of the Company's common stock on the first trading day of the offering period or on the last day of the offering period. Stock-Based Compensation Expense Total stock-based compensation expense recorded related to the Company's equity incentive plans was as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Research and development $ 460 $ 239 $ 826 $ 456 Selling, general and administrative 2,588 1,370 4,902 2,333 Total stock-based compensation expense $ 3,048 $ 1,609 $ 5,728 $ 2,789 |
Net Loss Per Share
Net Loss Per Share | 6 Months Ended |
Jun. 30, 2021 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | Net Loss Per Share 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 June 30, Six Months Ended June 30, 2021 2020 2021 2020 Numerator: Net loss $ (22,016) $ (15,464) $ (40,925) $ (31,983) Denominator: Weighted average shares outstanding, basic and diluted 25,989,913 23,442,530 25,957,186 22,405,031 Net loss per share, basic and diluted $ (0.85) $ (0.66) $ (1.58) $ (1.43) The following outstanding shares of potentially dilutive securities were excluded from the computation of diluted net loss per share for the periods presented because including them would have been antidilutive: As of June 30, 2021 2020 Options to purchase common stock 4,135,471 3,281,886 Unvested restricted stock units 173,007 77,530 Shares committed under the ESPP 14,069 — Total 4,322,547 3,359,416 |
Leases
Leases | 6 Months Ended |
Jun. 30, 2021 | |
Leases [Abstract] | |
Leases | Leases The Company is party to several operating and finance lease agreements related to office and laboratory space and office equipment. In February 2021, the Company entered into a lease agreement for laboratory and office space in New Jersey for a three-year term beginning on March 1, 2021 and ending on February 29, 2024. Total future minimum lease payments under the Company's operating lease agreements are $0.8 million as of June 30, 2021. Total lease payments required over the life of the Company's operating leases are $1.6 million. Rent expense was $0.3 million and $0.2 million for the six months ended June 30, 2021 and June 30, 2020, respectively. The remaining lease terms were between 1.1 and 2.7 years as of June 30, 2021. Supplemental balance sheet information for the Company's leases is as follows (in thousands): June 30, 2021 December 31, 2020 Operating lease right-of-use asset $ 757 $ 644 Finance lease right-of-use asset 26 34 Total right-of-use asset $ 783 $ 678 Operating lease liabilities $ 527 $ 400 Finance lease liabilities 18 18 Total lease liabilities $ 545 $ 418 Operating lease liabilities, non-current $ 237 $ 250 Finance lease liabilities, non-current 11 19 Total lease liabilities, non-current $ 248 $ 269 The maturities of the lease liabilities under non-cancelable operating and finance leases are as follows (in thousands): As of June 30, 2021 Finance Leases Operating Leases Total 2021 (remainder) $ 9 $ 277 $ 286 2022 16 376 392 2023 5 126 131 2024 — 21 21 Total undiscounted cash flows 30 800 830 Less: imputed interest (1) (36) (37) Total lease liability 29 764 793 Less: current portion (18) (527) (545) Lease liability $ 11 $ 237 $ 248 |
Leases | Leases The Company is party to several operating and finance lease agreements related to office and laboratory space and office equipment. In February 2021, the Company entered into a lease agreement for laboratory and office space in New Jersey for a three-year term beginning on March 1, 2021 and ending on February 29, 2024. Total future minimum lease payments under the Company's operating lease agreements are $0.8 million as of June 30, 2021. Total lease payments required over the life of the Company's operating leases are $1.6 million. Rent expense was $0.3 million and $0.2 million for the six months ended June 30, 2021 and June 30, 2020, respectively. The remaining lease terms were between 1.1 and 2.7 years as of June 30, 2021. Supplemental balance sheet information for the Company's leases is as follows (in thousands): June 30, 2021 December 31, 2020 Operating lease right-of-use asset $ 757 $ 644 Finance lease right-of-use asset 26 34 Total right-of-use asset $ 783 $ 678 Operating lease liabilities $ 527 $ 400 Finance lease liabilities 18 18 Total lease liabilities $ 545 $ 418 Operating lease liabilities, non-current $ 237 $ 250 Finance lease liabilities, non-current 11 19 Total lease liabilities, non-current $ 248 $ 269 The maturities of the lease liabilities under non-cancelable operating and finance leases are as follows (in thousands): As of June 30, 2021 Finance Leases Operating Leases Total 2021 (remainder) $ 9 $ 277 $ 286 2022 16 376 392 2023 5 126 131 2024 — 21 21 Total undiscounted cash flows 30 800 830 Less: imputed interest (1) (36) (37) Total lease liability 29 764 793 Less: current portion (18) (527) (545) Lease liability $ 11 $ 237 $ 248 |
Commitment and Contingencies
Commitment and Contingencies | 6 Months Ended |
Jun. 30, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies License Agreement The Company is party to a non-exclusive patent license agreement with Pfizer, which granted the Company non-exclusive rights under Pfizer’s patent rights covering varenicline tartrate to develop, manufacture, and commercialize the OC-01 (varenicline) nasal spray product. If the Company commercializes OC-01 (varenicline) nasal spray, it may be required to pay a single milestone payment in low double-digit millions and tiered royalties on net sales of OC-01 (varenicline) nasal spray at percentages ranging from the mid-single digits to the mid-teens. The royalty obligation to Pfizer would commence upon the first commercial sale of OC-01 (varenicline) nasal spray and expire upon the later of (a) the expiration of all regulatory or data exclusivity granted to Pfizer in connection with varenicline in the United States; and (b) the expiration or abandonment of the last valid claims of the licensed patents. No milestone was achieved or probable to be achieved or royalties payable accrued as of June 30, 2021 and December 31, 2020. Contingencies |
Subsequent Events
Subsequent Events | 6 Months Ended |
Jun. 30, 2021 | |
Subsequent Events [Abstract] | |
Subsequent Events | Subsequent Events Credit Facility with OrbiMed On August 5, 2021, the Company entered into a $125 million term loan credit facility (the Credit Agreement) with OrbiMed Royalty & Credit Opportunities III, LP, as administrative agent and initial lender (OrbiMed). The Credit Agreement provides for loans to be funded in three separate tranches, the first $45 million tranche to be funded no later than August 13, 2021, the second $50 million tranche to be funded, at the option of the Company, upon FDA approval of OC-01 (varenicline) nasal spray and the third $30 million tranche to be funded, at the option of the Company, upon the Company receiving $40 million in net recurring revenue from the sale and/or licensing of OC-01. The Company’s obligations under the Credit Agreement are secured by all or substantially all of its assets and property, subject to customary exceptions. Any material subsidiaries that the Company (other than certain immaterial subsidiaries) forms or acquires after closing are required to provide a guarantee of the Company’s obligations under the Credit Agreement and provide a pledge of their assets. The Credit Agreement matures on August 5, 2027 and the loan is structured for full principal repayment at maturity. The term loans bear interest at a rate per annum equal to the sum of (x) the daily secured overnight financing rate as administered by the Federal Reserve Bank of New York, subject to a 0.40% floor, plus (y) a margin of 8.10% . Commencing with the first full fiscal quarter after the closing date, the Company is required to make quarterly revenue interest payments to OrbiMed in an amount equal to 3% of all net revenue from annual sales and licenses of OC-01 up to $300 million and 1% of all revenue from annual sales and licenses of OC-01 between $300 million and $500 million, subject to caps on such quarterly payments. These caps increase both on an annual basis and upon funding of the second and third term loan tranches. If the Company does not obtain OC-01 approval by June 30, 2022, the Credit Agreement requires monthly repayments of principal starting on August 5, 2024. Additionally, commencing with the fourth full fiscal quarter after OC-01 approval, if the Company does not meet certain minimum recurring revenue thresholds from the sale and/or licensing of OC-01 in the last four quarters, the Credit Agreement requires a $5 million repayment of principal on the interest payment date following such fiscal quarter. This test is applied each quarter following commencement. The Company is permitted to prepay, in whole or in part, the term loans, subject to the payment of a prepayment fee, an exit fee and a buyout amount (calculated as the revenue interest cap set forth above less the amount of royalty payments made to OrbiMed). The term loans are also required to be mandatorily prepaid with the proceeds of certain asset sales and casualty events (subject to payment of the prepayment fee and exit fee) and the issuance of convertible debt. The Credit Agreement contains customary affirmative and negative covenants. The affirmative covenants include, among others, administrative and reporting requirements subject to certain exceptions and materiality thresholds. The negative covenants include, among others, limitations on the Company’s ability to, in each case, subject to certain exceptions, (i) incur additional debt, (ii) incur liens, (iii) make investments, acquisitions, loans or advances, (iv) sell assets, (v) make restricted payments, including dividends and distributions on, and redemptions, repurchases or retirement of, the Company’s capital stock, (vi) enter into fundamental changes, including mergers and consolidations, (vii) enter into transactions with affiliates, (viii) change the nature of the Company’s business, (ix) make prepayments of certain debt, (x) modify or terminate material agreements and (xi) enter into certain outbound licenses of material intellectual property. The Credit Agreement also requires compliance with a minimum liquidity covenant of $20 million prior to OC-01 approval and $5 million after OC-01 approval. The Credit Agreement includes customary events of default, including failure to pay principal, interest or certain other amounts when due; material inaccuracy of representations and warranties; breach of covenants; specified cross-default to other material indebtedness; certain bankruptcy and insolvency events; certain ERISA events; certain undischarged judgments; material impairment of security interests; material adverse change and material regulatory events, in certain cases subject to certain thresholds and grace periods. Ji Xing License and Collaboration Agreement On August 5, 2021, the Company entered into a license and collaboration agreement (License Agreement) with Ji Xing Pharmaceuticals Limited (Ji Xing), which is an entity affiliated with RTW Investments, LP. Pursuant to the License Agreement, the Company will grant Ji Xing an exclusive license to develop and commercialize OC-01 (varenicline) nasal spray and OC-02 (simpinicline) nasal spray pharmaceutical products , for all prophylactic uses for, and treatment of, ophthalmology diseases or disorders (the Field) in the greater China region, including mainland China, Hong Kong Special Administrative Region, Macau Special Administrative Region, and Taiwan (the Territory). Ji Xing will be responsible for development, regulatory, manufacturing and commercialization activities in the Territory, and the Company will be responsible for supplying the drug substance and finished products of OC-01 (varenicline) and OC-02 (simpinicline) for Ji Xing’s clinical development at quantities to be agreed by the parties, subject to one or more separate supply agreements as contemplated by the License Agreement. Ji Xing is prohibited from engaging in certain competitive activities during the term of the License Agreement. Subject to certain limitations, the Company may not commercialize any nAChR agonist in the Field in the Territory, without first offering Ji Xing a right of first negotiation for such product in the Territory. The Company has also granted Ji Xing a right of first negotiation to expand indications or uses of OC-01 (varenicline) or OC-02 (simpinicline) in the Territory. The Company will receive an upfront cash payment of $17.5 million and up to 0.75% of shares in Ji Xing, half of which will be subject to a pre-specified vesting condition. In addition, the Company is eligible to receive up to $204.8 million in aggregate development and sales-based milestone payments and tiered low teens to low twenties royalties based on future net sales of OC-01 and OC-02 in the Territory. The License Agreement will remain in effect, unless terminated earlier, until the expiration of all royalty terms for all licensed products in the Territory under the License Agreement. Ji Xing may terminate the License Agreement for convenience by providing at least one hundred eighty (180) days written notice. Each party has the right to terminate the License Agreement for the other party’s uncured material breach or insolvency. The Company may also terminate the License Agreement if Ji Xing, its affiliates or sublicensees challenges the enforceability, validity or scope of certain patents owned by the Company, subject to customary exceptions set forth in the License Agreement. Upon termination, any license granted by the Company to Ji Xing will terminate, and all sublicenses granted by Ji Xing shall also terminate. As of March 31, 2021, entities affiliated with RTW Investments, LP, beneficially owned greater than 5% of the Company’s outstanding shares of common stock. As a result, the License Agreement is considered a related party transaction and was approved by the audit committee of the board of directors of the Company. 2021 Inducement Plan In July 2021, the Company's Board of Directors approved the adoption of the 2021 Inducement Plan (Inducement Plan), which is to be used exclusively for grants of awards to individuals who were not previously employees or directors of the Company (or following a bona fide period of non-employment) as a material inducement to such individuals’ entry into employment with the Company, pursuant to Nasdaq Listing Rule 5635(c)(4). The Company has reserved 650,000 shares of its common stock that may be issued under the Inducement Plan. The terms and conditions of the Inducement Plan are substantially similar to those of the 2019 Plan. |
Nature of Business, Basis of _2
Nature of Business, Basis of Presentation and Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2021 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The unaudited interim condensed financial statements and accompanying notes have been prepared in accordance with U.S. generally accepted accounting principles (U.S. GAAP). Accordingly, certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to such rules and regulations. In the opinion of management, the accompanying unaudited condensed financial statements contain all adjustments, which are of a normal recurring nature, necessary to state fairly the Company’s financial position as of June 30, 2021 and as of December 31, 2020, the results of operations for the six months ended June 30, 2021 and 2020, and cash flows for the six months ended June 30, 2021 and 2020. While management believes that the disclosures presented are adequate to mitigate the risk of the information being misleading, these unaudited condensed financial statements should be read in conjunction with the audited financial statements and the related notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020. The results of the Company’s operations for any interim period are not necessarily indicative of the results of operations for any other interim period or for the full year. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts of assets and liabilities, disclosure of contingent assets and liabilities and the reported amounts of expenses in the condensed financial statements and accompanying notes. Significant items subject to such estimates and assumptions include stock-based compensation and certain research and development accruals. Actual results could differ from these estimates, and such differences could be material to the Company’s financial position and results of operations. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (the FASB) under its accounting standard codifications (ASC) or other standard setting bodies and are adopted by the Company as of the specified effective date, unless otherwise discussed below. ASU 2020-10 — In October 2020, the FASB issued ASU 2020-10, Codification Improvements, which updated various codification topics by clarifying or improving disclosure requirements to align with the SEC’s regulations. The amendments in ASU 2020-10 are effective for annual periods beginning after December 15, 2020, for public business entities. The Company adopted ASU 2020-10 on January 1, 2021 and its adoption did not have a material effect on the Company’s financial statements and related disclosures. |
Fair Value Measurements | The Company assesses the fair value of financial instruments as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, a three-tier fair value hierarchy has been established, which prioritizes the inputs used in measuring fair value as follows: Level 1 Quoted prices in active markets for identical assets or liabilities. Level 2 Observable inputs other than Level 1 prices such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Level 3 Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Fair Value Disclosures [Abstract] | |
Schedule of financial assets measured and recognized at fair value | As of June 30, 2021, financial assets measured and recognized at fair value on a recurring basis were as follows (in thousands): Fair Value Measurements at June 30, 2021 Quoted Price in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Total Assets Money market funds $ 153,805 $ — $ — $ 153,805 Total fair value of assets $ 153,805 $ — $ — $ 153,805 As of December 31, 2020, financial assets measured and recognized at fair value on a recurring basis were as follows (in thousands): Fair Value Measurements at December 31, 2020 Quoted Price in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Total Assets Money market funds $ 191,585 $ — $ — $ 191,585 Total fair value of assets $ 191,585 $ — $ — $ 191,585 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Payables and Accruals [Abstract] | |
Schedule of accrued expenses | Accrued expenses and other current liabilities consisted of the following (in thousands): June 30, 2021 December 31, 2020 Accrued compensation $ 3,776 $ 3,500 Accrued professional services 2,222 1,244 Accrued research and development expense 596 3,541 Total accrued expenses and other current liabilities $ 6,594 $ 8,285 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Equity [Abstract] | |
Schedule of Conversions of Stock | The Company reserved common stock for future issuance as follows: June 30, 2021 December 31, 2020 Outstanding options under the 2016 Equity Incentive Plan 2,458,812 2,567,566 Outstanding options under the 2019 Equity Incentive Plan 1,676,659 918,145 Equity awards available for grant under the 2019 Plan (1) 1,948,226 1,790,106 Unvested restricted stock units (RSUs) 173,007 61,215 Shares reserved for purchase under the Employee Stock Purchase Plan (ESPP) 270,000 270,000 Total 6,526,704 5,607,032 (1) — Effective January 1, 2021, in connection with the evergreen provision under the 2019 Equity Incentive Plan (the 2019 Plan) 1,035,619 shares were added to the 2019 Plan. |
Schedule of stock options activity | The following table summarizes stock option activity under the 2016 Equity Incentive Plan and the 2019 Plan during the six months ended June 30, 2021 (in thousands, except share, contractual term and per share data): Outstanding Options Number of Shares Underlying Outstanding Options Weighted Average Exercise Price Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic Value Balance, January 1, 2021 3,485,711 $ 10.74 8.2 $ 36,506 Options granted 810,986 18.98 Options exercised (83,794) 3.84 1,369 Options forfeited (77,432) 16.99 335 Balance, June 30, 2021 4,135,471 12.38 8.1 30,931 Shares vested and exercisable as of June 30, 2021 1,950,464 6.55 7.2 23,731 Vested and expected to vest as of June 30, 2021 4,135,471 $ 12.38 8.1 $ 30,931 |
Schedule of activity for restricted stock units | Activity with respect to the Company's restricted stock units during the six months ended June 30, 2021 was as follows (in thousands, except share, contractual term, and per share data): Outstanding RSUs Number of Shares Underlying Outstanding Awards Weighted Average Grant Date Fair Value per Share Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic Value Outstanding at January 1, 2021 61,215 $ 23.83 1.4 $ 1,152 Restricted stock units granted 144,317 18.54 2,676 Restricted stock units vested (32,153) 27.15 648 Restricted units forfeited (372) 18.77 8 Balance, June 30, 2021 173,007 18.81 6.0 2,974 Unvested and expected to vest as of June 30, 2021 173,007 $ 18.81 6.0 $ 2,974 |
Schedule of stock-based compensation expense | Total stock-based compensation expense recorded related to the Company's equity incentive plans was as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Research and development $ 460 $ 239 $ 826 $ 456 Selling, general and administrative 2,588 1,370 4,902 2,333 Total stock-based compensation expense $ 3,048 $ 1,609 $ 5,728 $ 2,789 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Earnings Per Share [Abstract] | |
Schedule of earnings per share, basic and diluted | 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 June 30, Six Months Ended June 30, 2021 2020 2021 2020 Numerator: Net loss $ (22,016) $ (15,464) $ (40,925) $ (31,983) Denominator: Weighted average shares outstanding, basic and diluted 25,989,913 23,442,530 25,957,186 22,405,031 Net loss per share, basic and diluted $ (0.85) $ (0.66) $ (1.58) $ (1.43) |
Schedule of antidilutive securities excluded from computation of earnings per share | The following outstanding shares of potentially dilutive securities were excluded from the computation of diluted net loss per share for the periods presented because including them would have been antidilutive: As of June 30, 2021 2020 Options to purchase common stock 4,135,471 3,281,886 Unvested restricted stock units 173,007 77,530 Shares committed under the ESPP 14,069 — Total 4,322,547 3,359,416 |
Leases (Tables)
Leases (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Leases [Abstract] | |
Supplemental balance sheet information for lessee | Supplemental balance sheet information for the Company's leases is as follows (in thousands): June 30, 2021 December 31, 2020 Operating lease right-of-use asset $ 757 $ 644 Finance lease right-of-use asset 26 34 Total right-of-use asset $ 783 $ 678 Operating lease liabilities $ 527 $ 400 Finance lease liabilities 18 18 Total lease liabilities $ 545 $ 418 Operating lease liabilities, non-current $ 237 $ 250 Finance lease liabilities, non-current 11 19 Total lease liabilities, non-current $ 248 $ 269 |
Schedule of maturities of lease liabilities | The maturities of the lease liabilities under non-cancelable operating and finance leases are as follows (in thousands): As of June 30, 2021 Finance Leases Operating Leases Total 2021 (remainder) $ 9 $ 277 $ 286 2022 16 376 392 2023 5 126 131 2024 — 21 21 Total undiscounted cash flows 30 800 830 Less: imputed interest (1) (36) (37) Total lease liability 29 764 793 Less: current portion (18) (527) (545) Lease liability $ 11 $ 237 $ 248 |
Nature of Business, Basis of _3
Nature of Business, Basis of Presentation and Significant Accounting Policies (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||
May 31, 2021 | Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Comprehensive loss | $ (22,016) | $ (15,464) | $ (40,925) | $ (31,983) | ||
Accumulated deficit | (195,676) | (195,676) | $ (154,751) | |||
Cash and cash equivalents | 154,805 | 226,748 | 154,805 | 226,748 | $ 192,585 | |
Research and development | $ 6,730 | $ 8,554 | $ 12,558 | $ 19,894 | ||
Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Research and development | $ 500 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - Fair Value, Recurring - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total fair value of assets | $ 153,805 | $ 191,585 |
Money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Money market funds | 153,805 | 191,585 |
Quoted Price in Active Markets for Identical Assets (Level 1) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total fair value of assets | 153,805 | 191,585 |
Quoted Price in Active Markets for Identical Assets (Level 1) | Money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Money market funds | 153,805 | 191,585 |
Significant Other Observable Inputs (Level 2) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total fair value of assets | 0 | 0 |
Significant Other Observable Inputs (Level 2) | Money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Money market funds | 0 | 0 |
Significant Unobservable Inputs (Level 3) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total fair value of assets | 0 | 0 |
Significant Unobservable Inputs (Level 3) | Money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Money market funds | $ 0 | $ 0 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Payables and Accruals [Abstract] | ||
Accrued compensation | $ 3,776 | $ 3,500 |
Accrued professional services | 2,222 | 1,244 |
Accrued research and development expense | 596 | 3,541 |
Total accrued expenses and other current liabilities | $ 6,594 | $ 8,285 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) $ / shares in Units, $ in Millions | Apr. 01, 2021 | Jun. 30, 2021USD ($)shares$ / shares | Dec. 31, 2020$ / sharesshares |
Class of Stock [Line Items] | |||
Common stock authorized (in shares) | shares | 1,000,000,000 | 1,000,000,000 | |
Common stock par value (in dollars per share) | $ / shares | $ 0.001 | $ 0.001 | |
Number of votes per share | shares | 1 | ||
Weighted-average grant-date fair value of options (in dollars per share) | $ / shares | $ 11.84 | ||
Unrecognized stock-based compensation expense | $ | $ 25.8 | ||
Weighted-average recognition period of unrecognized stock-based compensation expense (in years) | 2 years 9 months 18 days | ||
2019 ESPP | |||
Class of Stock [Line Items] | |||
ESPP percent discount | 15.00% | ||
ESPP percent of market fair value | 85.00% | ||
Unvested restricted stock units | |||
Class of Stock [Line Items] | |||
Unrecognized stock-based compensation expense | $ | $ 2.8 | ||
Weighted-average recognition period of unrecognized stock-based compensation expense (in years) | 2 years 9 months 18 days |
Stockholders' Equity - Reserved
Stockholders' Equity - Reserved Common Stock (Details) - shares | Jan. 01, 2021 | Jun. 30, 2021 | Dec. 31, 2020 |
Class of Stock [Line Items] | |||
Outstanding options (in shares) | 4,135,471 | 3,485,711 | |
Unvested RSUs and shares reserved for purchase under the ESPP | 173,007 | 61,215 | |
Total (in shares) | 6,526,704 | 5,607,032 | |
2016 Plan | |||
Class of Stock [Line Items] | |||
Outstanding options (in shares) | 2,458,812 | 2,567,566 | |
2019 Plan | |||
Class of Stock [Line Items] | |||
Outstanding options (in shares) | 1,676,659 | 918,145 | |
Unvested RSUs and shares reserved for purchase under the ESPP | 173,007 | 61,215 | |
Additional shares authorized (in shares) | 1,035,619 | ||
2019 Plan | Unvested restricted stock units | |||
Class of Stock [Line Items] | |||
Equity awards available to grant (in shares) | 1,948,226 | 1,790,106 | |
2019 ESPP | |||
Class of Stock [Line Items] | |||
Unvested RSUs and shares reserved for purchase under the ESPP | 270,000 | 270,000 |
Stockholders' Equity - Option A
Stockholders' Equity - Option Activity During The Period (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | 12 Months Ended |
Jun. 30, 2020 | Jun. 30, 2021 | Dec. 31, 2020 | |
Number of Shares Underlying Outstanding Options | |||
Beginning balance (in shares) | 3,485,711 | ||
Options granted (in shares) | 810,986 | ||
Options exercised (in shares) | (60,425) | (83,794) | |
Options forfeited (in shares) | (77,432) | ||
Ending balance (in shares) | 4,135,471 | 3,485,711 | |
Shares vested at end of period (in shares) | 1,950,464 | ||
Shares exercisable at end of period (in shares) | 1,950,464 | ||
Shares vested and expected to vest at end of period (in shares) | 4,135,471 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price [Abstract] | |||
Beginning balance (in dollars per share) | $ 10.74 | ||
Options granted (in dollars per share) | 18.98 | ||
Options exercise price (in dollars per share) | 3.84 | ||
Options forfeited (in dollars per share) | 16.99 | ||
Ending balance (in dollars per share) | 12.38 | $ 10.74 | |
Shares vested and exercisable at end of period (in dollars per share) | 6,550 | ||
Shares vested and expected to vest at end of period (in dollars per share) | $ 12,380 | ||
Weighted-Average Remaining Contractual Term (Years) | |||
Weighted average contractual term (in years) | 8 years 1 month 6 days | 8 years 2 months 12 days | |
Shares vested and exercisable at end of period, weighted average remaining contractual term (in years) | 7 years 2 months 12 days | ||
Shares vested and expected to vest at end of period, weighted average remaining contractual term (in years) | 8 years 1 month 6 days | ||
Aggregate Intrinsic Value | |||
Aggregate intrinsic value, outstanding ending balance | $ 36,506 | ||
Aggregate intrinsic value, options exercised | 1,369 | ||
Aggregate intrinsic value, options forfeited | 335 | ||
Aggregate intrinsic value, outstanding ending balance | 30,931 | $ 36,506 | |
Shares vested and exercisable at end of period, aggregate intrinsic value | 23,731 | ||
Shares vested and expected to vest at end of period, aggregate intrinsic value | $ 30,931 |
Stockholders' Equity - RSU Acti
Stockholders' Equity - RSU Activity During The Period (Details) - USD ($) $ / shares in Units, $ in Thousands | 6 Months Ended | 12 Months Ended |
Jun. 30, 2021 | Dec. 31, 2020 | |
Number of Shares Underlying Outstanding Units | ||
Outstanding at beginning of period (in shares) | 61,215 | |
Restricted stock units granted (in shares) | 144,317 | |
Shares vested in period (in shares) | (32,153) | |
Restricted units forfeited (in shares) | (372) | |
Outstanding at end of period (in shares) | 173,007 | 61,215 |
Unvested and expected to vest (in shares) | 173,007 | |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Weighted Average Grant Date Fair Value [Abstract] | ||
Beginning outstanding balance (in dollars per share) | $ 23.83 | |
Restricted stock units granted, weighted average grant date fair value (in dollars per share) | 18.54 | |
Restricted stock units vested, weighted average grant date fair value (in dollars per share) | 27.15 | |
Restricted units forfeited, weighted average grant date fair value (in dollars per share) | 18.77 | |
Ending outstanding balance (in dollars per share) | 18.81 | $ 23.83 |
Unvested and expected to vest (in dollars per share) | $ 18.81 | |
Weighted Average Remaining Contractual Term (Years) | ||
Weighted average remaining contractual term, restricted stock units (in years) | 6 years | 1 year 4 months 24 days |
Vested and expected to vest, weighted average remaining contractual term (in years) | 6 years | |
Shave-Based Compensation Arrangement By share-Based Payment Award, Equity Instruments Other Than Options, Aggregate Intrinsic Value [Roll Forward] | ||
Restricted stock units outstanding, aggregate intrinsic value, beginning of period | $ 1,152 | |
Restricted stock units granted, aggregate intrinsic value | 2,676 | |
Restricted stock units vested, aggregate intrinsic value | 648 | |
Restricted stock units outstanding, aggregate intrinsic value, end of period | 8 | |
Restricted stock units outstanding, aggregate intrinsic value, end of period | 2,974 | $ 1,152 |
Vested and expected to vest, aggregate intrinsic value | $ 2,974 |
Stockholders' Equity - Stock Ba
Stockholders' Equity - Stock Based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total stock-based compensation expense | $ 3,048 | $ 1,609 | $ 5,728 | $ 2,789 |
Research and development | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total stock-based compensation expense | 460 | 239 | 826 | 456 |
Selling, general and administrative | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total stock-based compensation expense | $ 2,588 | $ 1,370 | $ 4,902 | $ 2,333 |
Net Loss Per Share (Details)
Net Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2021 | Mar. 31, 2021 | Jun. 30, 2020 | Mar. 31, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Numerator: | ||||||
Net loss | $ (22,016) | $ (18,909) | $ (15,464) | $ (16,519) | $ (40,925) | $ (31,983) |
Denominator: | ||||||
Weighted average shares outstanding, diluted (in shares) | 25,989,913 | 23,442,530 | 25,957,186 | 22,405,031 | ||
Weighted average shares outstanding, basic (in shares) | 25,989,913 | 23,442,530 | 25,957,186 | 22,405,031 | ||
Net loss per share, basic (in dollars per share) | $ (0.85) | $ (0.66) | $ (1.58) | $ (1.43) | ||
Net loss per share, diluted (in dollars per share) | $ (0.85) | $ (0.66) | $ (1.58) | $ (1.43) |
Net Loss Per Share - Antidiluti
Net Loss Per Share - Antidilutive Securities (Details) - shares | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potentially dilutive securities excluded from the computation of diluted net loss per share (in shares) | 4,322,547 | 3,359,416 |
Options to purchase common stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potentially dilutive securities excluded from the computation of diluted net loss per share (in shares) | 4,135,471 | 3,281,886 |
Unvested restricted stock units | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potentially dilutive securities excluded from the computation of diluted net loss per share (in shares) | 173,007 | 77,530 |
Shares committed under the ESPP | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potentially dilutive securities excluded from the computation of diluted net loss per share (in shares) | 14,069 | 0 |
Leases - Narrative (Details)
Leases - Narrative (Details) - USD ($) $ in Thousands | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Feb. 28, 2021 | |
Operating Leased Assets [Line Items] | |||
Term of lease contract | 3 years | ||
Future minimum lease payments | $ 764 | ||
Lease payments required over life of lease | 800 | $ 1,600 | |
Lease expense | $ 300 | $ 200 | |
Princeton New Jersey Office Space, lease ending in 2022 | Minimum | |||
Operating Leased Assets [Line Items] | |||
Remaining term of operating lease | 1 year 1 month 6 days | ||
Princeton New Jersey Office Space, lease ending in 2022 | Maximum | |||
Operating Leased Assets [Line Items] | |||
Remaining term of operating lease | 2 years 8 months 12 days |
Leases - Supplemental Balance S
Leases - Supplemental Balance Sheet Information (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Leases [Abstract] | ||
Operating lease right-of-use asset | $ 757 | $ 644 |
Finance lease right-of-use asset | 26 | 34 |
Total right-of-use asset | 783 | 678 |
Operating lease liabilities | 527 | 400 |
Finance lease liabilities | 18 | 18 |
Total lease liabilities | 545 | 418 |
Operating lease liabilities, non-current | 237 | 250 |
Finance lease liabilities, non-current | 11 | 19 |
Total lease liabilities, non-current | $ 248 | $ 269 |
Leases - Lease Maturity Schedul
Leases - Lease Maturity Schedules (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Feb. 28, 2021 | Dec. 31, 2020 |
Finance Leases | |||
2021 (remainder) | $ 9 | ||
2022 | 16 | ||
2023 | 5 | ||
2024 | 0 | ||
Total undiscounted cash flows | 30 | ||
Less: imputed interest | (1) | ||
Total lease liability | 29 | ||
Less: current portion | (18) | $ (18) | |
Lease liability | 11 | 19 | |
Operating Leases | |||
2021 (remainder) | 277 | ||
2022 | 376 | ||
2023 | 126 | ||
2024 | 21 | ||
Total undiscounted cash flows | 800 | $ 1,600 | |
Less: imputed interest | (36) | ||
Total lease liability | 764 | ||
Less: current portion | (527) | (400) | |
Lease liabilities, non-current | 237 | 250 | |
Total | |||
2021 (remainder) | 286 | ||
2022 | 392 | ||
2022 | 131 | ||
2023 | 21 | ||
Total undiscounted cash flows | 830 | ||
Less: imputed interest | (37) | ||
Total lease liability | 793 | ||
Less: current portion | (545) | (418) | |
Total lease liabilities, non-current | $ 248 | $ 269 |
Subsequent Events (Details)
Subsequent Events (Details) - Subsequent Event - USD ($) $ in Millions | Aug. 05, 2021 | Aug. 04, 2021 | Jul. 30, 2021 |
Revolving Credit Facility | OrbiMed Credit Facility | |||
Subsequent Event [Line Items] | |||
OrbiMed credit facility | $ 125 | ||
Quarterly revenue interest payments, percentage of net recurring revenue up to specified amount | 3.00% | ||
Quarterly revenue interest payments, percentage of net recurring revenue over specified amount to aggregate cap | 1.00% | ||
Required principal payment if FDA approval not obtained before specified date | $ 5 | ||
Minimum liquidity covenant prior to FDA approval | 20 | ||
Minimum liquidity covenant after FDA approval | 5 | ||
Amount provided at signing | Revolving Credit Facility | OrbiMed Credit Facility | |||
Subsequent Event [Line Items] | |||
Initial borrowing capacity of OrbiMed credit facility | 45 | ||
Amount provided upon FDA approval | Revolving Credit Facility | OrbiMed Credit Facility | |||
Subsequent Event [Line Items] | |||
Contingent increase in credit facility | 50 | ||
Amount provided contingent upon certain net sales performance | Revolving Credit Facility | OrbiMed Credit Facility | |||
Subsequent Event [Line Items] | |||
Contingent increase in credit facility | 30 | ||
Required recurring revenue for funding | $ 40 | ||
Secured Overnight Financing Rate (SOFR) Overnight Index Swap Rate | Revolving Credit Facility | OrbiMed Credit Facility | |||
Subsequent Event [Line Items] | |||
Interest rate (as a percentage) | 8.10% | ||
Maximum | Revolving Credit Facility | OrbiMed Credit Facility | |||
Subsequent Event [Line Items] | |||
Net recurring revenue from annual sales and licenses up to specified amount | $ 300 | ||
Net recurring revenue from annual sales and licenses over specified amount to aggregate cap | 500 | ||
Minimum | Revolving Credit Facility | OrbiMed Credit Facility | |||
Subsequent Event [Line Items] | |||
Net recurring revenue from annual sales and licenses over specified amount to aggregate cap | $ 300 | ||
Forecast | Beneficial Owner | |||
Subsequent Event [Line Items] | |||
Equity interest percentage (up to) | 0.75% | ||
Ji Xing Pharmaceuticals Limited | License | Forecast | Beneficial Owner | |||
Subsequent Event [Line Items] | |||
Upfront payment on license agreement | $ 17.5 | ||
Period for written notice of termination | 180 days | ||
Ji Xing Pharmaceuticals Limited | License | Forecast | Maximum | Beneficial Owner | |||
Subsequent Event [Line Items] | |||
Aggregate development and net sales-based milestone payments (up to) | $ 204.8 | ||
Inducement Stock Incentive Plan | Common Stock | |||
Subsequent Event [Line Items] | |||
Shares authorized for Inducement Stock Incentive Plan (in shares) | 650,000 |