Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2020 | Apr. 30, 2020 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2020 | |
Document Fiscal Year Focus | 2020 | |
Document Fiscal Period Focus | Q1 | |
Trading Symbol | GTHX | |
Entity Registrant Name | G1 THERAPEUTICS, INC. | |
Entity Central Index Key | 0001560241 | |
Current Fiscal Year End Date | --12-31 | |
Title of 12(b) Security | Common Stock, par value $0.0001 per share | |
Security Exchange Name | NASDAQ | |
Entity Incorporation, State or Country Code | DE | |
Entity Filer Category | Large Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 37,737,260 | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Current Reporting Status | Yes | |
Entity Shell Company | false | |
Entity File Number | 001-38096 | |
Entity Address, Address Line One | 700 Park Offices Drive | |
Entity Address, Address Line Two | Suite 200 | |
Entity Address, City or Town | Research Triangle Park | |
Entity Address, State or Province | NC | |
Entity Address, Postal Zip Code | 27709 | |
City Area Code | 919 | |
Local Phone Number | 213-9835 | |
Entity Tax Identification Number | 26-3648180 | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity Interactive Data Current | Yes |
Condensed Balance Sheets (unaud
Condensed Balance Sheets (unaudited) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Current assets | ||
Cash and cash equivalents | $ 242,402 | $ 269,208 |
Restricted cash | 63 | 63 |
Prepaid expenses and other current assets | 1,124 | 1,732 |
Total current assets | 243,589 | 271,003 |
Property and equipment, net | 3,371 | 3,538 |
Restricted cash | 437 | 437 |
Operating lease assets | 9,117 | 9,853 |
Total assets | 256,514 | 284,831 |
Current liabilities | ||
Accounts payable | 4,703 | 3,684 |
Accrued expenses | 12,682 | 15,403 |
Other current liabilities | 1,063 | 682 |
Total current liabilities | 18,448 | 19,769 |
Operating lease liabilities | 8,616 | 9,535 |
Total liabilities | 27,064 | 29,304 |
Stockholders’ equity | ||
Common stock, $0.0001 par value, 120,000,000 shares authorized as of March 31, 2020 and December 31, 2019, respectively; 37,763,926 and 37,638,260 shares issued as of March 31, 2020 and December 31, 2019, respectively; 37,737,260 and 37,611,594 shares outstanding as of March 31, 2020 and December 31, 2019, respectively | 4 | 4 |
Treasury stock, 26,666 shares | (8) | (8) |
Additional paid-in capital | 597,330 | 592,384 |
Accumulated deficit | (367,876) | (336,853) |
Total stockholders’ equity | 229,450 | 255,527 |
Total liabilities and stockholders' equity | $ 256,514 | $ 284,831 |
Condensed Balance Sheets (Paren
Condensed Balance Sheets (Parenthetical) (unaudited) - $ / shares | Mar. 31, 2020 | Dec. 31, 2019 |
Statement Of Financial Position [Abstract] | ||
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 120,000,000 | 120,000,000 |
Common stock, shares, issued | 37,763,926 | 37,638,260 |
Common stock, shares, outstanding | 37,737,260 | 37,611,594 |
Treasury stock, shares | 26,666 | 26,666 |
Condensed Statements of Operati
Condensed Statements of Operations (unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Operating expenses | ||
Research and development | $ 20,434 | $ 18,080 |
General and administrative | 11,387 | 7,801 |
Total operating expenses | 31,821 | 25,881 |
Operating loss | (31,821) | (25,881) |
Other income (expense) | ||
Other income | 798 | 1,929 |
Total other income, net | 798 | 1,929 |
Net loss | (31,023) | (23,952) |
Net loss attributable to common stockholders | $ (31,023) | $ (23,952) |
Net loss per share attributable to common stockholders, basic and diluted | $ (0.82) | $ (0.64) |
Weighted average common shares outstanding, basic and diluted | 37,659,722 | 37,396,980 |
Condensed Statements of Stockho
Condensed Statements of Stockholders' Equity (unaudited) - USD ($) $ in Thousands | Total | Common Stock | Treasury Stock | Additional Paid-in Capital | Accumulated Deficit |
Balance at Dec. 31, 2018 | $ 358,820 | $ 4 | $ (8) | $ 573,230 | $ (214,406) |
Balance (in shares) at Dec. 31, 2018 | 37,268,792 | (26,666) | |||
Exercise of common stock options | 269 | 269 | |||
Exercise of common stock options (in shares) | 218,890 | ||||
Stock-based compensation | 3,804 | 3,804 | |||
Net loss during quarter | (23,952) | (23,952) | |||
Balance at Mar. 31, 2019 | 338,941 | $ 4 | $ (8) | 577,303 | (238,358) |
Balance (in shares) at Mar. 31, 2019 | 37,487,682 | (26,666) | |||
Balance at Dec. 31, 2019 | 255,527 | $ 4 | $ (8) | 592,384 | (336,853) |
Balance (in shares) at Dec. 31, 2019 | 37,638,260 | (26,666) | |||
Exercise of common stock options | $ 219 | 219 | |||
Exercise of common stock options (in shares) | 125,666 | 125,666 | |||
Stock-based compensation | $ 4,727 | 4,727 | |||
Net loss during quarter | (31,023) | (31,023) | |||
Balance at Mar. 31, 2020 | $ 229,450 | $ 4 | $ (8) | $ 597,330 | $ (367,876) |
Balance (in shares) at Mar. 31, 2020 | 37,763,926 | (26,666) |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows (unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Cash flows from operating activities | ||
Net loss | $ (31,023) | $ (23,952) |
Adjustments to reconcile net loss to net cash used in operating activities | ||
Depreciation and amortization | 159 | 64 |
Stock-based compensation | 4,727 | 3,804 |
Loss on disposal of fixed assets | 8 | |
Change in operating assets and liabilities | ||
Prepaid expenses and other assets | 1,371 | 156 |
Accounts payable | 992 | (631) |
Accrued expenses and other liabilities | (3,259) | (987) |
Net cash used in operating activities | (27,025) | (21,546) |
Cash flows from investing activities | ||
Purchases of property and equipment | (216) | |
Net cash used in investing activities | (216) | |
Cash flows from financing activities | ||
Proceeds from stock options and warrants exercised | 219 | 269 |
Net cash provided by financing activities | 219 | 269 |
Net change in cash and cash equivalents | (26,806) | (21,493) |
Cash and cash equivalents and restricted cash | ||
Beginning of period | 269,708 | 369,290 |
End of period | 242,902 | 347,797 |
Non-cash investing and financing activities | ||
Upfront project costs and other current assets in accounts payable | $ 27 | 315 |
Purchases of equipment in accounts payable and accrued expenses | $ 54 |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2020 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 3. Fair Value Measurements The Company provides disclosure of financial assets and financial liabilities that are carried at fair value based on the price that would be received upon sale of an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. Fair value measurements may be classified based on the amount of subjectivity associated with the inputs to fair valuation of these assets and liabilities using the following three levels: Level 1 Inputs are unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date. Level 2 Inputs include quoted prices for similar assets and liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, inputs other than quoted prices that are observable for the asset or liability and inputs that are derived principally from or corroborated by observable market data by correlation or other means. Level 3 Unobservable inputs that reflect the Company’s estimates of the assumptions that market participants would use in pricing the asset or liability. The Company develops these inputs based on the best information available, including its own data. The carrying amounts of cash, cash equivalents, accounts payable and accrued liabilities approximate fair value because of their short-term nature. At March 31, 2020 and December 31, 2019 these financial instruments and respective fair values have been classified as follows (in thousands): Quoted prices in active markets for identical assets (Level 1) Significant other observable inputs (Level 2) Significant other unobservable inputs (Level 3) Balance at March 31, 2020 Assets Money market funds $ 225,886 $ — $ — $ 225,886 Certificates of Deposit 15,942 — — 15,942 Total assets at fair value: $ 241,828 $ — $ — $ 241,828 Quoted prices in active markets for identical assets (Level 1) Significant other observable inputs (Level 2) Significant other unobservable inputs (Level 3) Balance at December 31, 2019 Assets Money market funds $ 252,563 $ — $ — $ 252,563 Certificates of Deposit 15,873 — — 15,873 Total assets at fair value: $ 268,436 $ — $ — $ 268,436 During the three months ended March 31, 2020 and the year ended December 31, 2019, there were no changes in valuation methodology. |
Property and Equipment
Property and Equipment | 3 Months Ended |
Mar. 31, 2020 | |
Property Plant And Equipment [Abstract] | |
Property and Equipment | 4. Property and equipment Property and equipment consists of the following (in thousands): March 31, 2020 December 31, 2019 Computer equipment $ 330 $ 332 Laboratory equipment 865 871 Furniture and fixtures 1,071 1,071 Leasehold improvements 1,941 1,941 Accumulated depreciation (836 ) (677 ) Property and equipment, net $ 3,371 $ 3,538 Depreciation expense relating to property and equipment was $159 thousand for the three months ended March 31, 2020 and $64 thousand for the three months ended March 31, 2019. |
Patent License Agreement
Patent License Agreement | 3 Months Ended |
Mar. 31, 2020 | |
Patent License Agreement [Abstract] | |
Patent License Agreement | 5. Patent license agreement On November 23, 2016, the Company entered into a license agreement with the Board of Trustees of the University of Illinois (“the University”), which was amended on March 24, 2017. Pursuant to the license agreement, as amended, the University licensed patent rights to the Company, with rights of sublicense, to make, have made, use, import, sell and offer for sale products covered by certain patent rights owned by the University. The rights licensed to the Company are exclusive, worldwide, non-transferable rights, for all fields of use. Under the terms of the agreement the Company paid a one-time only, non-refundable license issue fee in the amount of $0.5 million which was charged to research and development expense in the fourth quarter of 2016. The Company is also obligated to pay annual maintenance fees to the University. All annual minimum payments are fully creditable against any royalty payments made by the Company. Under the terms of the agreement, the Company must pay the University royalty percentage on all net sales of products and a share of sublicensing revenues. In addition, the University is eligible to receive milestone payments of up to $2.6 million related to the initiation and execution of clinical trials and the first commercial sale of a product in another country. To date, the Company has made milestone payments totaling $0.6 million, of which $0 was incurred during the first quarter of 2020. The Company will be responsible for any future patent prosecution costs that may arise. The term of the license agreement will continue until the later of (i) the expiration of the last valid claim within the patent rights covering the product in such country, (ii) the expiration of market exclusivity in such country and (iii) the 10th anniversary of the first commercial sale in such country. The University may terminate the agreement in the event (i) the Company fails to pay any amount or make any report when required to be made and fails to cure such failure within thirty (30) days after receipt of notice from the University, (ii) is in breach of any provision of the agreement and fails to remedy within forty-five (45) days after receipt of notice, (iii) makes a report to the University under the agreement that is determined to be materially false, (iv) declares insolvency or bankruptcy or (v) takes an action that causes patent rights or technical information to be subject to lien or encumbrance and fails to remedy any such breach within forty-five (45) days of receipt of notice from the University. The Company may terminate the agreement at any time on written notice to the University at least ninety (90) days prior to the termination date specified in the notice. Upon expiration or termination of the agreement, all rights revert to the University. |
Accrued Expenses
Accrued Expenses | 3 Months Ended |
Mar. 31, 2020 | |
Payables And Accruals [Abstract] | |
Accrued Expenses | 6. Accrued expenses Accrued expenses are comprised as follows (in thousands): March 31, 2020 December 31, 2019 Accrued external research $ 2,216 $ 2,737 Accrued professional fees and other 1,914 1,487 Accrued external clinical study costs 7,596 7,996 Accrued compensation expense 956 3,183 Accrued expenses $ 12,682 $ 15,403 |
Stockholders' Equity
Stockholders' Equity | 3 Months Ended |
Mar. 31, 2020 | |
Equity [Abstract] | |
Stockholders' Equity | 7. Stockholders’ Equity Common Stock The Company is authorized to issue 120.0 million shares of common stock. Holders of common stock are entitled to one vote per share. Holders of common stock are entitled to receive dividends, if and when, declared by the Company’s Board of Directors. Preferred Stock The Company is authorized to issue 5.0 million shares of undesignated preferred stock in one or more series. As of March 31, 2020, no shares of preferred stock were issued or outstanding. Shares Reserved for Future Issuance The Company has reserved for future issuance the following number of shares of common stock: March 31, 2020 December 31, 2019 (unaudited) Common stock options outstanding 6,766,589 5,744,036 Options available for grant under Equity Incentive Plans 1,187,072 938,738 7,953,661 6,682,774 |
Stock-based Compensation
Stock-based Compensation | 3 Months Ended |
Mar. 31, 2020 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock-based Compensation | 8. Stock-based Compensation 2011 Equity Incentive Plan In March 2011, the Company adopted the 2011 Equity Incentive Plan (the “2011 Plan”). The 2011 Plan provided for the direct award or sale of the Company’s common stock and for the grant of stock options to employees, directors, officers, consultants and advisors of the Company. The 2011 Plan was subsequently amended in August 2012, October 2013, February 2015, December 2015, April 2016 and November 2016 to allow for the issuance of additional shares of common stock. In connection with the adoption of the 2017 Plan (as defined below), the 2011 Plan was terminated and no further awards will be made under the 2011 Plan. 2017 Equity Incentive Plan In May 2017, the Company adopted the 2017 Equity Incentive Plan (the “2017 Plan”). The 2017 Plan provided for the direct award or sale of the Company’s common stock and for the grant of up to 1,932,000 stock options to employees, directors, officers, consultants and advisors of the Company. The 2017 Plan provides for the grant of incentive stock options, non-statutory stock options or restricted stock. Effective January 1, 2020, and in accordance with the “evergreen” provision of the 2017 plan, an additional 1,096,553 shares were made available for issuance. Under both the 2011 Plan and the 2017 Plan, options to purchase the Company’s common stock may be granted at a price no less than the fair market value of a share of common stock on the date of grant. The fair value shall be the closing sales price for a share as quoted on any established securities exchange for such grant date or the last preceding date for which such quotation exists. Vesting terms of options issued are determined by the Board of Directors or Compensation Committee of the Board. The Company’s stock options vest based on terms in the stock option agreements. Stock options have a maximum term of ten years. As of March 31, 2020, there were a total of 1,187,072 shares of common stock available for future issuance under the 2017 Plan. Stock Option Expense The Company recognizes compensation costs related to stock options granted to employees based on the estimated fair value of the awards on the date of grant, net of estimated forfeitures. The grant date fair value of the stock-based awards is generally recognized on a straight-line basis over the requisite service period, which is generally the vesting period of the respective awards. Share-based awards granted to non-employee directors as compensation for serving on the Company’s Board of Directors are accounted for in the same manner as employee share-based compensation awards. During the three months ended March 31, 2020, the Company recorded employee share-based compensation expense of $4.7 million. During the three months ended March 31, 2019, the Company recorded employee share-based compensation expense of $3.7 million. The Company recognizes compensation costs related to stock options granted to non-employees based on the estimated fair value of the awards on the date of grant in the same manner as employees. During the three months ended March 31, 2020, the Company did not have any non-employee share-based compensation expense. During the three months ended March 31, 2019, the Company recorded non-employee share-based compensation expense of $0.1 million. The Company calculates the fair value of stock options using the Black-Scholes option pricing model. The Black-Scholes option-pricing model requires the use of subjective assumptions, including the expected volatility of the Company’s common stock, the assumed dividend yield, the expected term of the Company’s stock options and the fair value of the underlying common stock on the date of grant. Stock options— Black-Scholes inputs The fair value of stock options was estimated using the following weighted-average assumptions for the three months ended March 31, 2020 and March 31, 2019: Three Months Ended March 31, 2020 2019 (unaudited) Expected volatility 74.8 - 78.3% 77.8 - 82.1% Weighted-average risk free rate 0.4 - 1.7% 2.5 - 2.6% Dividend yield —% —% Expected term (in years) 6.06 6.08 The table below summarizes the stock-based compensation expense recognized in the Company’s statement of operations by classification (in thousands): Three Months Ended March 31, 2020 2019 (unaudited) Research and development $ 1,800 $ 1,494 General and administrative 2,927 2,310 Total stock-based compensation expense $ 4,727 $ 3,804 Stock Option Activity Stock option activity for the three months ended March 31, 2020 is as follows: Weighted average Weighted average Remaining Aggregate Options exercise contractual intrinsic outstanding price life (Years) value (in thousands) Balance as of December 31, 2019 5,744,036 $ 16.88 7.5 $ 72,251 Cancelled (247,818 ) $ 33.67 Granted 1,396,037 18.67 Exercised (125,666 ) 1.74 Balance as of March 31, 2020 6,766,589 $ 16.92 7.8 $ 19,809 Exercisable at December 31, 2019 3,001,179 8.93 6.1 $ 58,797 Vested at December 31, 2019 and expected to vest 5,744,036 16.88 7.5 $ 72,251 Exercisable at March 31, 2020 3,260,268 10.60 6.2 $ 19,545 Vested at March 31, 2020 and expected to vest 6,766,589 16.92 7.8 $ 19,809 |
Net Loss Per Common Share
Net Loss Per Common Share | 3 Months Ended |
Mar. 31, 2020 | |
Earnings Per Share [Abstract] | |
Net Loss Per Common Share | 9. Net loss per common share Basic net loss per common share is computed using the weighted average number of common shares outstanding during the period including nominal issuances of common stock warrants. Diluted net loss per common share is computed using the sum of the weighted average number of common shares outstanding during the period and, if dilutive, the weighted average number of potential shares of common stock, including the assumed exercise of stock options, stock warrants and unvested restricted common stock. For the three months ended March 31, 2020 and 2019, the following potentially dilutive securities have been excluded from the computations of diluted weighted-average shares outstanding because the effect would be anti-dilutive: Three Months Ended March 31, 2020 2019 (unaudited) Stock options issued and outstanding 6,276,155 5,156,076 6,276,155 5,156,076 Amounts in the table above reflect the common stock equivalents of the noted instruments. |
Related Party Transactions
Related Party Transactions | 3 Months Ended |
Mar. 31, 2020 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 10. Related party transactions The Company maintains a consulting agreement with a member of the Board of Directors for scientific advisory services outside of his role on the Board of Directors that expires on June 30, 2020. |
Basis of Presentation and Summa
Basis of Presentation and Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2020 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying condensed financial statements of the Company have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”). In the opinion of management, the Company has made all necessary adjustments, which include normal recurring adjustments necessary for a fair statement of the Company’s financial position and results of operations for the interim periods presented. The information presented in the condensed financial statements and related notes as of March 31, 2020, and for the three months ended March 31, 2020 and 2019, is unaudited. The results for the three months ended March 31, 2020 are not necessarily indicative of the results expected for the full fiscal year or any future period. These interim financial statements should be read in conjunction with the financial statements and notes set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019 filed with the SEC on February 26, 2020 (collectively, “2019 Form 10-K”). The December 31, 2019 condensed balance sheet included herein was derived from the audited financial statements as of that date, but does not include all disclosures, including notes, required by U.S. GAAP for complete financial statements. |
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 reported in the financial statements and the accompanying notes. On an ongoing basis, the Company’s management evaluates its estimates which include, but are not limited to, estimates related to accrued expenses, accrued external clinical costs, stock-based compensation expense and deferred tax asset valuation allowance. The Company bases its estimates on historical experience and other market specific or other relevant assumptions it believes to be reasonable under the circumstances. Actual results could differ from those estimates. |
Research and Development | Research and Development Research and development expenses consist of costs incurred to further the Company’s research and development activities and include salaries and related employee benefits, manufacturing of pharmaceutical active ingredients and drug products, costs associated with clinical trials, nonclinical activities, regulatory activities, research-related overhead expenses and fees paid to expert consultants, external service providers and contract research organizations which conduct certain research and development activities on behalf of the Company. Costs incurred in the research and development of products are charged to research and development expense as incurred. Each reporting period, management estimated and accrued research and development expenses, including external clinical study costs associated with clinical trial activities. The process of estimating and accruing expenses involves reviewing contracts and purchase orders, identifying services that have been provided on the Company’s behalf, and estimating the level of service performed and the associated cost incurred for the service when the Company has not yet been invoiced or otherwise notified of the actual costs. Costs for clinical trial activities were estimated based on an evaluation of vendors’ progress towards completion of specific tasks, using data such as patient enrollment, clinical site activations or information provided by vendors regarding their actual costs incurred. Payments for these activities are based on the terms of individual contracts and payment timing may differ significantly from the period in which the services were performed. The Company determines accrual estimates through reports from and discussions with applicable personnel and outside service providers as to the progress or state of completion of trials, or the services completed. The estimates of accrued external clinical study costs as of each balance sheet date are based on the facts and circumstances known at the time. |
Income Taxes | Income taxes The Company did not record a federal or state income tax benefit for the three months ended March 31, 2020 due to its conclusion that a full valuation allowance is required against the Company’s deferred tax assets. Income taxes are accounted for using the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to temporary differences between the financial statements carrying amounts of assets and liabilities and their respective tax bases, operating loss carryforwards, and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. In accordance with Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) 740, Accounting for Income Taxes |
Stock-Based Compensation | Stock-Based Compensation The primary type of stock-based payments utilized by the Company are stock options. The Company accounts for stock-based employee compensation arrangements by measuring the cost of employee services received in exchange for all equity awards granted based on the fair value of the award on the grant date. The fair value of each employee stock option is estimated on the date of grant using an options pricing model. The Company currently uses the Black-Scholes valuation model to estimate the fair value of its share-based payments. The model requires management to make a number of assumptions including expected volatility, expected life, risk-free interest rate and expected dividends. |
Coronoavirus (COVID-19) Impact on Operations | Coronavirus (COVID-19) impact on operations The Company has implemented business continuity plans to address the COVID-19 pandemic and minimize disruptions to ongoing operations. The timeline for filing the trilaciclib NDA has not been impacted by COVID-19, and the Company expects to complete the NDA filing in the second quarter of 2020. Initiation of two clinical trials, the rintodestrant/palbociclib combination trial and the I-SPY 2 trial, is on track to begin in the second quarter of 2020. Initial enrollment of these trials is likely to be impacted by COVID-19. The Company does not anticipate significant supply chain delays or shortages as a result of the COVID-19 pandemic. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements Recently Adopted Accounting Standards In August 2018, the FASB issued ASU No. 2018-15, Goodwill and Other—Internal-Use Software |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Fair Value Disclosures [Abstract] | |
Summary of Financial Instruments and Respective Fair Values | At March 31, 2020 and December 31, 2019 these financial instruments and respective fair values have been classified as follows (in thousands): Quoted prices in active markets for identical assets (Level 1) Significant other observable inputs (Level 2) Significant other unobservable inputs (Level 3) Balance at March 31, 2020 Assets Money market funds $ 225,886 $ — $ — $ 225,886 Certificates of Deposit 15,942 — — 15,942 Total assets at fair value: $ 241,828 $ — $ — $ 241,828 Quoted prices in active markets for identical assets (Level 1) Significant other observable inputs (Level 2) Significant other unobservable inputs (Level 3) Balance at December 31, 2019 Assets Money market funds $ 252,563 $ — $ — $ 252,563 Certificates of Deposit 15,873 — — 15,873 Total assets at fair value: $ 268,436 $ — $ — $ 268,436 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Property Plant And Equipment [Abstract] | |
Schedule of Property and Equipment | Property and equipment consists of the following (in thousands): March 31, 2020 December 31, 2019 Computer equipment $ 330 $ 332 Laboratory equipment 865 871 Furniture and fixtures 1,071 1,071 Leasehold improvements 1,941 1,941 Accumulated depreciation (836 ) (677 ) Property and equipment, net $ 3,371 $ 3,538 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Payables And Accruals [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses are comprised as follows (in thousands): March 31, 2020 December 31, 2019 Accrued external research $ 2,216 $ 2,737 Accrued professional fees and other 1,914 1,487 Accrued external clinical study costs 7,596 7,996 Accrued compensation expense 956 3,183 Accrued expenses $ 12,682 $ 15,403 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Equity [Abstract] | |
Summary of Common Stock Shares Reserved for Future Issuance | The Company has reserved for future issuance the following number of shares of common stock: March 31, 2020 December 31, 2019 (unaudited) Common stock options outstanding 6,766,589 5,744,036 Options available for grant under Equity Incentive Plans 1,187,072 938,738 7,953,661 6,682,774 |
Stock-based Compensation (Table
Stock-based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Summary of Stock Option Activity | Stock option activity for the three months ended March 31, 2020 is as follows: Weighted average Weighted average Remaining Aggregate Options exercise contractual intrinsic outstanding price life (Years) value (in thousands) Balance as of December 31, 2019 5,744,036 $ 16.88 7.5 $ 72,251 Cancelled (247,818 ) $ 33.67 Granted 1,396,037 18.67 Exercised (125,666 ) 1.74 Balance as of March 31, 2020 6,766,589 $ 16.92 7.8 $ 19,809 Exercisable at December 31, 2019 3,001,179 8.93 6.1 $ 58,797 Vested at December 31, 2019 and expected to vest 5,744,036 16.88 7.5 $ 72,251 Exercisable at March 31, 2020 3,260,268 10.60 6.2 $ 19,545 Vested at March 31, 2020 and expected to vest 6,766,589 16.92 7.8 $ 19,809 |
Employee and Non-employee Stock Options | |
Summary of Fair Value of Stock Options Granted Using Black-Scholes Options Pricing Model | The fair value of stock options was estimated using the following weighted-average assumptions for the three months ended March 31, 2020 and March 31, 2019: Three Months Ended March 31, 2020 2019 (unaudited) Expected volatility 74.8 - 78.3% 77.8 - 82.1% Weighted-average risk free rate 0.4 - 1.7% 2.5 - 2.6% Dividend yield —% —% Expected term (in years) 6.06 6.08 |
Summary of Stock-Based Compensation Expense Recognized in Statement of Operations by Classification | The table below summarizes the stock-based compensation expense recognized in the Company’s statement of operations by classification (in thousands): Three Months Ended March 31, 2020 2019 (unaudited) Research and development $ 1,800 $ 1,494 General and administrative 2,927 2,310 Total stock-based compensation expense $ 4,727 $ 3,804 |
Net Loss Per Common Share (Tabl
Net Loss Per Common Share (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Earnings Per Share [Abstract] | |
Schedule of Potentially Dilutive Securities Excluded from Computations of Diluted Weighted-average Shares Outstanding | For the three months ended March 31, 2020 and 2019, the following potentially dilutive securities have been excluded from the computations of diluted weighted-average shares outstanding because the effect would be anti-dilutive: Three Months Ended March 31, 2020 2019 (unaudited) Stock options issued and outstanding 6,276,155 5,156,076 6,276,155 5,156,076 |
Business Description - Addition
Business Description - Additional Information (Details) | 3 Months Ended |
Mar. 31, 2020Product | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Number of clinical-stage product candidates from pipeline | 3 |
Basis of Presentation and Sum_2
Basis of Presentation and Summary of Significant Accounting Policies - Additional Information (Details) | 3 Months Ended | |
Mar. 31, 2020USD ($)Trial | Dec. 31, 2019USD ($) | |
Accounting Policies [Abstract] | ||
Federal, state income tax benefit | $ 0 | |
Unrecognized income tax benefits | 0 | $ 0 |
Accrued income taxes | $ 0 | $ 0 |
Number of clinical trials initiated related to COVID-19 | Trial | 2 |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Financial Instruments and Respective Fair Values (Details) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Assets | ||
Assets at fair value | $ 241,828 | $ 268,436 |
Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Assets | ||
Assets at fair value | 241,828 | 268,436 |
Money Market Funds | ||
Assets | ||
Assets at fair value | 225,886 | 252,563 |
Money Market Funds | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Assets | ||
Assets at fair value | 225,886 | 252,563 |
Certificates of Deposit | ||
Assets | ||
Assets at fair value | 15,942 | 15,873 |
Certificates of Deposit | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Assets | ||
Assets at fair value | $ 15,942 | $ 15,873 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) - USD ($) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2020 | Dec. 31, 2019 | |
Fair Value Disclosures [Abstract] | ||
Changes in valuation methodology | $ 0 | $ 0 |
Property and Equipment - Schedu
Property and Equipment - Schedule of Property and Equipment (Details) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Property Plant And Equipment [Line Items] | ||
Accumulated depreciation | $ (836) | $ (677) |
Property and equipment, net | 3,371 | 3,538 |
Computer Equipment | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 330 | 332 |
Laboratory Equipment | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 865 | 871 |
Furniture and Fixtures | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 1,071 | 1,071 |
Leasehold Improvements | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 1,941 | $ 1,941 |
Property and Equipment - Additi
Property and Equipment - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Property Plant And Equipment [Abstract] | ||
Depreciation expenses relating to property and equipment | $ 159 | $ 64 |
Patent License Agreement - Addi
Patent License Agreement - Additional Information (Details) - USD ($) | 3 Months Ended | 40 Months Ended | ||
Mar. 31, 2020 | Mar. 31, 2019 | Dec. 31, 2016 | Mar. 31, 2020 | |
Patent License Agreement [Line Items] | ||||
Non-refundable license issue fee | $ 20,434,000 | $ 18,080,000 | ||
University | ||||
Patent License Agreement [Line Items] | ||||
License agreement date | Nov. 23, 2016 | |||
License agreement amendment date | Mar. 24, 2017 | |||
Milestone payments | $ 0 | $ 600,000 | ||
Term of license agreement description | The term of the license agreement will continue until the later of (i) the expiration of the last valid claim within the patent rights covering the product in such country, (ii) the expiration of market exclusivity in such country and (iii) the 10th anniversary of the first commercial sale in such country. The University may terminate the agreement in the event (i) the Company fails to pay any amount or make any report when required to be made and fails to cure such failure within thirty (30) days after receipt of notice from the University, (ii) is in breach of any provision of the agreement and fails to remedy within forty-five (45) days after receipt of notice, (iii) makes a report to the University under the agreement that is determined to be materially false, (iv) declares insolvency or bankruptcy or (v) takes an action that causes patent rights or technical information to be subject to lien or encumbrance and fails to remedy any such breach within forty-five (45) days of receipt of notice from the University. The Company may terminate the agreement at any time on written notice to the University at least ninety (90) days prior to the termination date specified in the notice. Upon expiration or termination of the agreement, all rights revert to the University. | |||
License agreement termination notice period | 90 days | |||
University | Maximum | ||||
Patent License Agreement [Line Items] | ||||
Milestone payments | $ 2,600,000 | |||
University | License | ||||
Patent License Agreement [Line Items] | ||||
Non-refundable license issue fee | $ 500,000 |
Accrued Expenses - Schedule of
Accrued Expenses - Schedule of Accrued Expenses (Details) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Payables And Accruals [Abstract] | ||
Accrued external research | $ 2,216 | $ 2,737 |
Accrued professional fees and other | 1,914 | 1,487 |
Accrued external clinical study costs | 7,596 | 7,996 |
Accrued compensation expense | 956 | 3,183 |
Accrued expenses | $ 12,682 | $ 15,403 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Details) - shares | 3 Months Ended | |
Mar. 31, 2020 | Dec. 31, 2019 | |
Equity [Abstract] | ||
Common stock, shares authorized | 120,000,000 | 120,000,000 |
Common stock, voting rights | Holders of common stock are entitled to one vote per share. | |
Undesignated preferred stock, shares authorized to issue | 5,000,000 | |
Preferred stock, shares issued | 0 | |
Preferred stock, shares outstanding | 0 |
Stockholders' Equity - Summary
Stockholders' Equity - Summary of Common Stock Shares Reserved for Future Issuance (Details) - shares | Mar. 31, 2020 | Dec. 31, 2019 |
Class Of Stock [Line Items] | ||
Common stock, shares reserved for future issuance | 7,953,661 | 6,682,774 |
Common Stock Options Outstanding | ||
Class Of Stock [Line Items] | ||
Common stock, shares reserved for future issuance | 6,766,589 | 5,744,036 |
Options Available For Grant Under Equity Incentive Plan | ||
Class Of Stock [Line Items] | ||
Common stock, shares reserved for future issuance | 1,187,072 | 938,738 |
Stock-based Compensation - Addi
Stock-based Compensation - Additional Information (Details) - USD ($) | Jan. 01, 2020 | Mar. 31, 2020 | Mar. 31, 2019 | May 31, 2017 |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Share-based compensation expense | $ 4,727,000 | $ 3,804,000 | ||
Employee Stock Options | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Stock options, maximum term | 10 years | |||
Share-based compensation expense | $ 4,700,000 | 3,700,000 | ||
Non-employee Stock Options | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Share-based compensation expense | $ 0 | $ 100,000 | ||
2011 Equity Incentive Plan | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Number of shares available for grant under equity incentive plan | 0 | |||
2017 Equity Incentive Plan | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Number of shares available for grant under equity incentive plan | 1,187,072 | |||
Number of shares approved for grant under equity incentive plan | 1,932,000 | |||
Number of additional shares approved for grant under equity incentive plan | 1,096,553 |
Stock-based Compensation - Fair
Stock-based Compensation - Fair Value of Stock Options Granted Using Black-Scholes Options Pricing Model (Details) - Employee and Non-employee Stock Options | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected volatility, minimum | 74.80% | 77.80% |
Expected volatility, maximum | 78.30% | 82.10% |
Weighted-average risk free rate, minimum | 0.40% | 2.50% |
Weighted-average risk free rate, maximum | 1.70% | 2.60% |
Expected term (in years) | 6 years 21 days | 6 years 29 days |
Stock-based Compensation - Summ
Stock-based Compensation - Summary of Stock-Based Compensation Expense Recognized in Statement of Operations by Classification (Details) - Employee and Non-employee Stock Options - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Total stock-based compensation expense | $ 4,727 | $ 3,804 |
Research and development | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Total stock-based compensation expense | 1,800 | 1,494 |
General and administrative | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Total stock-based compensation expense | $ 2,927 | $ 2,310 |
Stock-based Compensation - Su_2
Stock-based Compensation - Summary of Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2020 | Dec. 31, 2019 | |
Options outstanding | ||
Beginning balance | 5,744,036 | |
Cancelled | (247,818) | |
Granted | 1,396,037 | |
Exercised | (125,666) | |
Ending balance | 6,766,589 | 5,744,036 |
Exercisable | 3,260,268 | 3,001,179 |
Vested and expected to vest | 6,766,589 | 5,744,036 |
Weighted average exercise price | ||
Beginning balance | $ 16.88 | |
Cancelled | 33.67 | |
Granted | 18.67 | |
Exercised | 1.74 | |
Ending balance | 16.92 | $ 16.88 |
Exercisable | 10.60 | 8.93 |
Vested and expected to vest | $ 16.92 | $ 16.88 |
Weighted average, Remaining contractual for life (Years) | ||
Balance | 7 years 9 months 18 days | 7 years 6 months |
Exercisable | 6 years 2 months 12 days | 6 years 1 month 6 days |
Vested and expected to vest | 7 years 9 months 18 days | 7 years 6 months |
Weighted average, Aggregate intrinsic value | ||
Balance | $ 19,809 | $ 72,251 |
Exercisable | 19,545 | 58,797 |
Vested and expected to vest | $ 19,809 | $ 72,251 |
Net Loss Per Common Share - Sch
Net Loss Per Common Share - Schedule of Potentially Dilutive Securities Excluded from Computations of Diluted Weighted-average Shares Outstanding (Details) - shares | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Potentially dilutive securities excluded from computations of diluted weighted-average shares outstanding | 6,276,155 | 5,156,076 |
Stock Options Issued and Outstanding | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Potentially dilutive securities excluded from computations of diluted weighted-average shares outstanding | 6,276,155 | 5,156,076 |
Related Party Transactions - Ad
Related Party Transactions - Additional Information (Details) | 3 Months Ended |
Mar. 31, 2020 | |
Scientific Advisory | Chairman of the Board of Directors | |
Related Party Transaction [Line Items] | |
Consulting agreements expiration date | Jun. 30, 2020 |