Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Feb. 21, 2020 | Jun. 30, 2019 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2019 | ||
Document Fiscal Year Focus | 2019 | ||
Document Fiscal Period Focus | FY | ||
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 $.0001 par value | ||
Security Exchange Name | NASDAQ | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Well-known Seasoned Issuer | Yes | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Large Accelerated Filer | ||
Entity Small Business | false | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Entity 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 Annual Report | true | ||
Document Transition Report | false | ||
Entity Common Stock, Shares Outstanding | 37,642,199 | ||
Entity Public Float | $ 853,358,707 | ||
Documents Incorporated by Reference | Documents Incorporated by Reference Portions of the Registrant’s Definitive Proxy Statement relating to the Annual Meeting of Stockholders, scheduled to be held on June 11, 2020, are incorporated by reference into Part III of this report. |
Balance Sheets
Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Current assets | ||
Cash and cash equivalents | $ 269,208 | $ 369,290 |
Restricted cash | 63 | |
Prepaid expenses and other current assets | 1,732 | 843 |
Total current assets | 271,003 | 370,133 |
Property and equipment, net | 3,538 | 1,137 |
Restricted cash | 437 | |
Operating lease assets | 9,853 | |
Total assets | 284,831 | 371,270 |
Current liabilities | ||
Accounts payable | 3,684 | 3,377 |
Accrued expenses | 15,403 | 8,985 |
Other current liabilities | 682 | |
Total current liabilities | 19,769 | 12,362 |
Operating lease liabilities | 9,535 | |
Other non-current liabilities | 88 | |
Total liabilities | 29,304 | 12,450 |
Commitments and contingencies | ||
Stockholders’ equity | ||
Common stock, $0.0001 par value, 120,000,000 shares authorized as of December 31, 2019 and December 31, 2018, respectively; 37,638,260 and 37,268,792 shares issued as of December 31, 2019 and December 31, 2018, respectively; 37,611,594 and 37,242,126 shares outstanding as of December 31, 2019 and December 31, 2018, respectively | 4 | 4 |
Treasury stock, 26,666 shares | (8) | (8) |
Additional paid-in capital | 592,384 | 573,230 |
Accumulated deficit | (336,853) | (214,406) |
Total stockholders’ equity | 255,527 | 358,820 |
Total liabilities and stockholders' equity | $ 284,831 | $ 371,270 |
Balance Sheets (Parenthetical)
Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2019 | Dec. 31, 2018 |
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 | 37,638,260 | 37,268,792 |
Common stock, shares, outstanding | 37,611,594 | 37,242,126 |
Treasury stock, shares | 26,666 | 26,666 |
Statements of Operations
Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Income Statement [Abstract] | |||
Revenue from Contract with Customer, Product and Service [Extensible List] | us-gaap:GrantMember | us-gaap:GrantMember | us-gaap:GrantMember |
Operating expenses | |||
Research and development | $ 89,002 | $ 70,683 | $ 53,881 |
General and administrative | 40,039 | 18,603 | 7,087 |
Total operating expenses | 129,041 | 89,286 | 60,968 |
Operating loss | (129,041) | (89,286) | (60,968) |
Other income (expense) | |||
Other income | 6,594 | 3,998 | 888 |
Change in fair value in warrant liability and other liabilities | (41) | ||
Total other income, net | 6,594 | 3,998 | 847 |
Net loss | (122,447) | (85,288) | (60,121) |
Accretion of redeemable convertible preferred stock | (4,757) | ||
Net loss attributable to common stockholders | $ (122,447) | $ (85,288) | $ (64,878) |
Net loss per share attributable to common stockholders, basic and diluted | $ (3.27) | $ (2.56) | $ (3.57) |
Weighted average common shares outstanding, basic and diluted | 37,499,256 | 33,316,719 | 18,197,970 |
Statements of Redeemable Conver
Statements of Redeemable Convertible Preferred Stock and Stockholders' Equity (Deficit) - USD ($) $ in Thousands | Total | Series C Redeemable Convertible Preferred Stock | Series B Redeemable Convertible Preferred Stock | Series A Redeemable Convertible Preferred Stock | Series 1 Redeemable Convertible Preferred Stock | Common Stock | Treasury Stock | Additional Paid-in Capital | Accumulated Deficit |
Balance at Dec. 31, 2016 | $ (64,993) | $ (8) | $ (64,985) | ||||||
Temporary equity, balance (in shares) at Dec. 31, 2016 | 5,609,398 | 7,642,734 | 4,998,895 | 682,026 | |||||
Temporary equity, balance at Dec. 31, 2016 | $ 51,424 | $ 40,355 | $ 14,431 | $ 1,370 | |||||
Balance (in shares) at Dec. 31, 2016 | 1,504,947 | (26,666) | |||||||
Temporary equity accretion of redeemable, convertible preferred stock | 3,732 | 620 | 235 | 171 | |||||
Accretion of redeemable, convertible preferred stock | (4,757) | $ (745) | (4,012) | ||||||
Initial public offering | 108,503 | $ 1 | 108,502 | ||||||
Initial public offering (in shares) | 7,781,564 | ||||||||
Automatic conversion of preferred stock | 112,337 | $ (55,156) | $ (40,975) | $ (14,666) | $ (1,541) | $ 2 | 112,335 | ||
Automatic conversion of preferred stock, in shares | (5,609,398) | (7,642,734) | (4,998,895) | (682,026) | 18,933,053 | ||||
Automatic conversion of preferred warrants | 208 | 208 | |||||||
Exercise of common stock options | 214 | 214 | |||||||
Exercise of common stock options (in shares) | 160,579 | ||||||||
Exercise of common stock warrants | 1 | 1 | |||||||
Exercise of common stock warrants, in shares | 40,368 | ||||||||
Stock-based compensation | 3,394 | 3,394 | |||||||
IPO/Stock financing costs | (1,398) | (1,398) | |||||||
Net loss during year | (60,121) | (60,121) | |||||||
Balance at Dec. 31, 2017 | 93,388 | $ 3 | $ (8) | 222,511 | (129,118) | ||||
Balance (in shares) at Dec. 31, 2017 | 28,420,511 | (26,666) | |||||||
Public offering (Follow-on Financings) | 303,522 | $ 1 | 303,521 | ||||||
Public offering (Follow-on Financings), shares | 7,360,000 | ||||||||
Public offering (ATM) | 36,068 | 36,068 | |||||||
Public offering (ATM), shares | 752,008 | ||||||||
Exercise of common stock options | 1,797 | 1,797 | |||||||
Exercise of common stock options (in shares) | 736,273 | ||||||||
Stock-based compensation | 10,225 | 10,225 | |||||||
IPO/Stock financing costs | (892) | (892) | |||||||
Net loss during year | (85,288) | (85,288) | |||||||
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 | $ 2,705 | 2,705 | |||||||
Exercise of common stock options (in shares) | 369,468 | 369,468 | |||||||
Stock-based compensation | $ 16,449 | 16,449 | |||||||
Net loss during year | (122,447) | (122,447) | |||||||
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) |
Statements of Cash Flows
Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Cash flows from operating activities | |||
Net loss | $ (122,447) | $ (85,288) | $ (60,121) |
Adjustments to reconcile net loss to net cash used in operating activities | |||
Depreciation and amortization | 356 | 175 | 89 |
Stock-based compensation | 16,449 | 10,225 | 3,394 |
Gain/loss on disposal of property and equipment | 8 | 6 | |
Increase in fair value of warrant activity | 41 | ||
Change in operating assets and liabilities | |||
Prepaid expenses and other assets | (219) | 113 | (253) |
Accounts payable | 248 | (1,002) | 1,578 |
Accrued Expenses | 6,042 | 1,446 | 4,709 |
Deferred Rent | 16 | 38 | |
Net cash used in operating activities | (99,571) | (74,307) | (50,519) |
Cash flows from investing activities | |||
Purchases of property and equipment | (2,716) | (709) | (294) |
Net cash used in investing activities | (2,716) | (709) | (294) |
Cash flows from financing activities | |||
Proceeds from stock options and warrants exercised | 2,705 | 1,797 | 215 |
Proceeds from public offering, net of underwriting fees and commissions | 339,589 | 108,503 | |
Payment of public offering costs | (892) | (1,398) | |
Net cash provided by financing activities | 2,705 | 340,494 | 107,320 |
Net change in cash, cash equivalents and restricted cash | (99,582) | 265,478 | 56,507 |
Cash, cash equivalents and restricted cash | |||
Beginning of period | 369,290 | 103,812 | 47,305 |
End of period | 269,708 | 369,290 | 103,812 |
Non-cash investing and financing activities | |||
Upfront project costs and other current assets in accounts payable and accrued expenses | 43 | 107 | |
Accretion of redeemable convertible preferred stock | 4,757 | ||
Purchases of equipment in accounts payable and accrued expenses | 41 | $ 100 | |
Conversion of preferred stock and preferred warrants to common stock and common warrants | $ 112,545 | ||
Operating lease liabilities arising from obtaining right-of-use asset | $ 8,947 |
Description of Business
Description of Business | 12 Months Ended |
Dec. 31, 2019 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Description of Business | 1. Description of business G1 Therapeutics, Inc. (the “Company”) is a clinical-stage biopharmaceutical company based in Research Triangle Park, North Carolina focused on the discovery, development and commercialization of novel small molecule therapeutics for the treatment of patients with cancer. The Company was incorporated on May 19, 2008 in the state of Delaware. The Company is advancing three clinical-stage programs. Trilaciclib is a first-in-class therapy designed to improve outcomes for patients who are treated with chemotherapy. Rintodestrant (formerly known as G1T48) is a potential best-in-class oral selective estrogen receptor degrader (SERD) for the treatment of ER+ breast cancer. Lerociclib is a differentiated oral CDK4/6 inhibitor designed to enable more effective combination treatment strategies across multiple oncology indications, including estrogen receptor-positive, HER2-negative (ER+, HER2-) breast cancer. The Company also has an active discovery program focused on cyclin-dependent kinase targets. The Company owns the global rights to all of its product candidates. Trilaciclib, the Company’s most advanced clinical-stage candidate, is a first-in-class therapy designed to preserve bone marrow and immune system function during chemotherapy and improve patient outcomes. The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for trilaciclib based on myelopreservation data from three randomized, double-blind, placebo-controlled small cell lung cancer (SCLC) clinical trials, as well as safety data collected across all completed and ongoing clinical trials. The Breakthrough Therapy program is designed to expedite development and review of drugs intended for serious or life-threatening conditions. Based on written feedback from its pre-New Drug Application (NDA) meeting with the FDA, the Company began a rolling NDA submission for trilaciclib for myelopreservation in SCLC in the fourth quarter of 2019 and expects to complete the NDA submission in the second quarter of 2020. Based on discussions with European regulatory authorities, the Company plans to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for trilaciclib for myelopreservation in SCLC in the second half of 2020. In September 2019, the Company presented updated data from a randomized Phase 2 trial of trilaciclib in combination with chemotherapy in metastatic triple-negative breast cancer (mTNBC). The results of the trial demonstrated significant improvement in overall survival, or “OS” (preliminary). Though the trial did not meet the primary myelopreservation endpoints, patients receiving trilaciclib were able to receive ~50% more cycles of chemo, without additional hematological toxicity. These data were presented at the 2019 European Society for Medical Oncology (ESMO) Congress and were concurrently published in The Lancet Oncology. In January 2020, the Company announced that trilaciclib will be included in a new randomized, investigational treatment arm for the ongoing I-SPY 2 TRIAL™ for neoadjuvant treatment of locally advanced breast cancer. The trial, run by the non-profit Quantum Leap Healthcare Collaborative, is designed to rapidly screen promising experimental treatments and identify those most effective in specific patient subgroups based on molecular characteristics (biomarker signatures). The Company is planning to initiate a randomized, placebo-controlled Phase 3 trial in colorectal cancer in the fourth quarter of 2020. The Company is developing rintodestrant, a potential best-in-class oral SERD, as a monotherapy and in combination with the CDK4/6 inhibitors, initially Ibrance® (palbociclib), for the treatment of ER+ breast cancer. In 2018, the Company initiated a Phase 1/2a (dose escalation/dose expansion) clinical trial in ER+, HER2- breast cancer. Preliminary data from the Phase 1 potion of this trial were presented at the 2019 ESMO Congress, showing that rintodestrant was well tolerated and demonstrated evidence of anti-tumor activity in heavily pre-treated patients. We have completed enrollment of the dose escalation and dose expansion portions of the trial and expect to initiate enrollment of patients receiving rintodestrant in combination with palbociclib in the second quarter of 2020. Palbociclib is being provided under a non-exclusive clinical supply agreement that we signed with Pfizer in February 2020. Lerociclib is a differentiated oral CDK4/6 inhibitor being developed for use in combination with other targeted therapies in multiple oncology indications, including ER+, HER2- breast cancer. In 2018, the Company reported encouraging preliminary Phase 1b data from its Phase 1/2 trial in ER+, HER2- breast cancer (in combination with fulvestrant) and will report additional Phase 1b/2a data from this trial at the San Antonio Breast Cancer Symposium on December 11, 2019. The Company also initiated a Phase 1b/2 combination trial with the epidermal growth factor receptor (EGFR) inhibitor, Tagrisso® (osimertinib) in non-small cell lung cancer. Initial safety and tolerability data from this trial were presented at the 2019 ESMO Congress. The Company is currently exploring partnering opportunities to continue to advance clinical development of lerociclib. The Company’s financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business. As of December 31, 2019, the Company had an accumulated deficit of $336.9 million. The Company has reported a net loss in all fiscal periods since inception and expects to incur substantial losses in the future to conduct research and development and pre-commercialization activities. As of December 31, 2019, the Company had cash and cash equivalents of $269.2 million. The Company expects that its existing cash and cash equivalents will enable it to fund its operating expenses and capital expenditure requirements for greater than 12 months from the date of filing this Annual Report. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of significant accounting policies Basis of presentation The Company has prepared the accompanying financial statements in conformity with generally accepted accounting principles in the United States of America (“U.S. GAAP”). 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. Actual results could differ from those estimates. These estimates include the Company’s common stock valuation, stock compensation, warrant valuation and deferred tax asset valuation allowance. Cash and cash equivalents The Company considers all highly liquid investments purchased with an original maturity of three months or less at the date of purchase to be cash equivalents. Cash and cash equivalents at December 31, 2019 and 2018 consist of amounts on deposit in banks, including checking accounts, money market accounts and certificates of deposit. Cash deposits are all in financial institutions in the United States. As part of the lease for the new office space, the Company obtained a standby letter of credit in the amount of $0.5 million related to the security deposit. This letter of credit is secured by money market funds at the financial institution. Therefore, these funds are classified as restricted cash on the balance sheet. The letter of credit will be reduced ratably on each anniversary of the commencement of the lease until the end of the lease term. Concentration of credit risk Financial instruments that potentially subject the Company to credit risk consist of cash and cash equivalents. Deposits with financial institutions are insured, up to certain limits, by the Federal Deposit Insurance Corporation (“FDIC”). The Company’s cash deposits often exceed the FDIC insurance limit; however, all deposits are maintained with high credit quality institutions and the Company has not experienced any losses in such accounts. The financial condition of financial institutions is periodically reassessed, and the Company believes the risk of any loss is minimal. The Company believes the risk of any loss on cash due to credit risk is minimal. Property and equipment Property and equipment are stated at cost less accumulated depreciation. Depreciation is generally calculated using the straight-line method over the following estimated useful lives: Computer equipment 5 years Laboratory equipment 5 years Furniture and fixtures 7 years Leasehold improvements 7 years Costs associated with maintenance and repairs are charged to expense as incurred. Property and equipment held under leasehold improvements are amortized over the shorter of the lease term or the estimated useful life of the related asset. Impairment of long-lived assets The Company evaluates its long-lived assets for indicators of possible impairment by comparison of the carrying amounts to future net undiscounted cash flows expected to be generated by such assets when events or changes in circumstances indicate the carrying amount of an asset may not be recoverable. Should an impairment exist, the impairment loss would be measured based on the excess carrying value of the asset over the asset’s fair value based on discounted estimates of future cash flows. For the years ended December 31, 2019, 2018 and 2017, the Company’s management evaluated its long-lived assets and determined no impairment charge was needed. Warrant liability Warrants to purchase the Company’s redeemable convertible preferred stock were classified as liabilities and recorded at their estimated fair value. In each reporting period, any change in fair value of the warrants has been recorded as expense in the case of an increase in fair value and income in the case of a decrease in fair value. 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 involved 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. Fair value of financial instruments 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 December 31, 2019 and 2018 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 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 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, 2018 Assets Money market funds $ 352,934 $ — $ — $ 352,934 Certificates of Deposit 15,501 — — 15,501 Total assets at fair value: $ 368,435 $ — $ — $ 368,435 Patent costs Costs associated with the submission of patent applications are expensed as incurred given the uncertainty of the future economic benefits of the patents. Patent-related legal expenses included in general and administrative costs were approximately $2,114 thousand, $1,352 thousand, and $997 thousand for the years ended December 31, 2019, 2018 and 2017, respectively. Income taxes 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 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. The Company accounts for stock-based non-employee compensation arrangements by recording the expense of such services based on the fair value of the equity instrument as estimated using the Black-Scholes pricing model. The fair value of the equity instrument is charged to operating expense over the term of the service agreement. In accordance with the implementation of ASU No. 2018-07 on January 1, 2019, the fair value of non-employee stock options is no longer be re-measured each reporting period. Segment information The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions. All of the Company’s assets are held in the United States. Comprehensive loss Comprehensive loss includes net loss as well as other changes in stockholders’ equity (deficit) that result from transactions and economic events other than those with stockholders. There was no difference between net loss and comprehensive loss for each of the periods presented in the accompanying financial statements. Redeemable convertible preferred stock The Company classifies its redeemable convertible preferred stock, for which the Company does not control the redemption, outside of permanent equity. The Company records redeemable convertible preferred stock at fair value upon issuance, net of any offering costs, and the carrying value is adjusted to the redemption value at the end of each reporting period. These adjustments are effected through charges against additional paid-in capital and accumulated deficit. Leases We determine if an arrangement is a lease at inception. Operating lease assets represent our right to use an underlying asset for the lease term and lease liabilities represent our obligation to make lease payments arising from the lease. Operating leases are included in operating lease assets, other current liabilities, and operating lease liabilities on our balance sheet at December 31, 2019. Operating lease assets and operating lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at commencement date. As most of our leases do not provide an implicit rate, we use our incremental borrowing rate based on the information available at commencement date to determine the present value of future payments. Our lease terms may include options to extend or terminate the lease when it is reasonably certain that we will exercise that option. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term. Prior period amounts continue to be reported in accordance with our historic accounting under previous lease guidance, Topic 840. See “Adoption of New Accounting Standards – Impact of Adoption of Topic 842” below, for more information about the impact of the adoption of Topic 842. Recent Accounting Pronouncements Adoption of New Accounting Standards In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) (“ASU 2016-02”). This guidance revises the accounting related to leases by requiring lessees to recognize a lease liability and a right-of-use asset for all leases. In January 2019, the Company adopted ASU 2016-02 using the modified retrospective transition method with an effective date as of the beginning of our fiscal year, January 1, 2019. Prior period amounts have not been adjusted and continue to be reported in accordance with our historical reporting under previous lease guidance, ASC Topic 840. As part of the adoption, we have elected to account for separate lease and associated non-lease components as a single lease component for our real estate leases. In June 2018, the FASB issued ASU No. 2018-07, Improvements to Nonemployee Share-Based Payment Accounting Impact of Adoption of Topic 842 With the adoption of Topic 842 on January 1, 2019, the Company recognized operating lease assets and operating lease liabilities of $1.5 million and $1.6 million, respectively, with the difference due to the de-recognition of current and non-current deferred rent. There was no impact to the opening accumulated deficit as of January 1, 2019. The impact of the adoption of Topic 842 on the accompanying balance sheet as of January 1, 2019 was as follows (in thousands): December 31, 2018 Adjustments Due to the Adoption of Topic 842 January 1, 2019 Operating lease assets $ — $ 1,533 $ 1,533 Accrued expenses 8,985 (9 ) 8,976 Operating lease liabilities: Other current liabilities — 352 352 Non-current operating lease liabilities — 1,278 1,278 Other non-current liabilities 88 (88 ) — Stockholders' equity 358,820 — 358,820 Recently Issued Accounting Standards In August 2018, the FASB issued ASU No. 2018-15, Goodwill and Other—Internal-Use Software (Subtopic 350-40): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract . |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2019 | |
Property Plant And Equipment [Abstract] | |
Property and Equipment | 3. Property and equipment Property and equipment consists of the following (in thousands): December 31, 2019 December 31, 2018 Computer equipment $ 332 $ 246 Laboratory equipment 871 611 Furniture and fixtures 1,071 293 Leasehold improvements 1,941 238 Construction in progress — 71 Accumulated depreciation (677 ) (322 ) Property and equipment, net $ 3,538 $ 1,137 Depreciation expenses relating to property and equipment were $356 thousand, $175 thousand, and $89 thousand for the years ended December 31, 2019, 2018 and 2017, respectively. |
Patent License Agreement
Patent License Agreement | 12 Months Ended |
Dec. 31, 2019 | |
Patent License Agreement [Abstract] | |
Patent License Agreement | 4. 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 $0.5 million was incurred during 2019. 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 with in 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 | 12 Months Ended |
Dec. 31, 2019 | |
Payables And Accruals [Abstract] | |
Accrued Expenses | 5. Accrued expenses Accrued expenses are comprised as follows (in thousands): December 31, 2019 December 31, 2018 Accrued external research $ 2,737 $ 1,242 Accrued professional fees $ 1,487 $ 349 Accrued external clinical study costs 7,996 4,692 Accrued compensation expense 3,183 2,693 Deferred rent, current portion - 9 Accrued expenses $ 15,403 $ 8,985 |
Leases
Leases | 12 Months Ended |
Dec. 31, 2019 | |
Leases [Abstract] | |
Leases | 6. Leases As described in our “Note 2. Basis of Presentation and Summary of Significant Accounting Policies”, we adopted Topic 842 as of January 1, 2019. Prior period amounts have not been adjusted and continue to be reported in accordance with our historic accounting under Topic 840. Pursuant to a lease agreement dated January 10, 2014 (the “Lease”), on April 1, 2014, the Company leased office and lab space with a free rent period and escalating rent payments; the Lease had an expiration date of July 31, 2017. The Lease was amended on January 27, 2016 to lease new larger office and lab space beginning in August 2016 with a discounted rent period and escalating rent payments and the Lease term was extended to December 31, 2022. The amendment also contained an option for a five-year In November 2018, the Company signed a new lease to secure approximately 60,000 square feet of laboratory and office space at 700 Park Offices Drive in Research Triangle Park, NC (“700 Lease”). The 700 Lease commenced on September 2, 2019 and has an expiration date of September 30, 2027 for the initial term with the Company having the option to renew for an additional 5 years. The term of the renewal option contained in the Lease was not included in the measurement of the operating lease asset and liability since exercise of the option was uncertain. As part of the 700 Lease, the Company obtained a standby letter of credit in the amount of $0.5 million related to the security deposit. This letter of credit is secured by money market funds at the financial institution. Therefore, these funds are classified as restricted cash on the balance sheet. The letter of credit will be reduced ratably on each anniversary of the commencement of the 700 Lease until the end of the lease term. The tables below reflect the Company’s lease position and weighted-average lease terms and discount rates for our operating leases as of December 31, 2019. Operating lease liabilities are based on the net present value of the remaining lease payments over the remaining lease term. In determining the present value of lease payments, we use our incremental borrowing rate based on the information available at the lease commencement date. (in thousands) Classification on the Balance Sheet December 31, 2019 Assets Operating lease assets Operating lease assets $ 9,853 Total lease assets $ 9,853 Liabilities Current Operating Other current liabilities $ 682 Non-current Operating Operating lease liabilities 9,535 Total lease liabilities $ 10,217 Lease Term and Discount Rate December 31, 2019 Weighted-average remaining lease term (years) Operating leases 7.2 Weighted-average discount rate Operating leases 7.7 % The table below presents information related to the lease costs for operating leases (in thousands): Year Ended December 31, (in thousands) Classification 2019 2018 2017 Operating lease costs (a) Research and development $ 609 $ 298 $ 207 General and administrative 368 83 45 Total operating lease costs $ 977 $ 381 $ 252 (a) Includes variable lease costs which are immaterial The table below reconciles the undiscounted cash flow for each of the first five years and total of the remaining years to the operating lease liabilities recorded on the balance sheet as of December 31, 2019 (in thousands): Operating leases Years ending December 31, 2020 1,459 2021 2,015 2022 2,072 2023 1,634 2024 1,679 Thereafter 4,855 Total future minimum lease payments $ 13,714 Less: present value adjustment (3,497 ) Total operating lease liabilities $ 10,217 Cash payments included in the measurement of our operating leases were $688 thousand for the twelve months ended December 31, 2019. ASC 840 Disclosures The Company elected the alternative modified transition method and included the following table previously disclosed. The following is a schedule by years of minimum future rental payments on noncancelable operating leases as of December 31, 2018 (in thousands): 2019 $ 680 2020 1,427 2021 1,960 2022 2,015 2023 1,577 2024 and thereafter 6,155 $ 13,814 |
Stockholders_ Equity
Stockholders’ Equity | 12 Months Ended |
Dec. 31, 2019 | |
Equity [Abstract] | |
Stockholders’ Equity | 7. Stockholders’ Equity Redeemable convertible preferred stock The Company has determined that the Series C, Series B, Series A and Series 1 redeemable convertible preferred stock were redeemable, after a stated period of time, based on voting thresholds that vary by stockholder class, as outlined in the Company’s certificate of incorporation. The Company classified its redeemable convertible preferred stock outside of permanent equity and into mezzanine equity. The Company recorded its redeemable convertible preferred stock at fair value upon issuance, net of any issuance costs or discounts, and the carrying value is increased by periodic accretion to its redemption value until the earliest possible date of redemption. These increases were recorded as charges against additional paid-in-capital until the additional paid-in-capital balance is reduced to zero. At that time, additional accretion adjustments were recorded as additions to accumulated deficit. In April 2016, the Company’s Board of Directors and stockholders approved the Fifth Amended and Restated Certification of Incorporation which increased the authorized number of shares of its redeemable convertible preferred stock to 57,108,717, of which 2,112,025 were be designated as Series 1 redeemable convertible preferred stock, 14,996,692 as Series A redeemable convertible preferred stock, 23,000,000 as Series B redeemable convertible preferred stock and 17,000,000 as Series C redeemable convertible preferred stock. In the second quarter of 2016, the Company authorized 16,828,217 shares of its Series C redeemable convertible preferred stock and issued 5,609,398 shares of its Series C redeemable convertible preferred stock for cash consideration at a price of $8.91 per share. Total additional proceeds amounted to $50.0 million. Prior to the IPO, the holders of the Company’s convertible preferred stock had certain voting and dividend rights, as well as liquidation preferences and conversion privileges. All rights, preferences and privileges associated with the convertible preferred stock were terminated at the time of the Company’s IPO in conjunction with the conversion of all outstanding shares of convertible preferred stock into shares of common stock. On May 22, 2017, the Company closed its IPO of 7,781,564 shares of the Company’s common stock at a public offering price of $15.00 per share, including 781,564 shares of common stock issued upon exercise by the underwriters of their option to purchase additional shares. The gross proceeds from the IPO were $116.7 million and net proceeds were $107.1 million, after deducting underwriting discounts and commissions and other offering expenses payable by the Company. Upon closing of the IPO, all outstanding shares of the Company’s preferred stock were automatically converted into 18,933,053 shares of common stock. In connection with the IPO, the Board of Directors and the stockholders of the Company approved a one-for-three Preferred stock Upon completion of the IPO, all outstanding preferred stock was automatically converted into 18,933,053 shares of common stock. The Company is also authorized to issue 5,000,000 shares of undesignated preferred stock in one or more series. As December 31, 2019, no shares of preferred stock were issued or outstanding. Common stock The Company’s common stock has a par value of $0.0001 per share and consists of 120,000,000 authorized shares as of December 31, 2019 and 2018, respectively. Holders of common stock are entitled to one vote per share and are entitled to receive dividends, as if and when declared by the Company’s Board of Directors. The Company has reserved authorized shares of common stock for future issuance at December 31, 2019 and December 31, 2018 as follows: December 31, 2019 December 31, 2018 Common stock options outstanding 5,744,036 4,502,133 Options available for grant under Equity Incentive Plans 938,738 1,547,306 6,682,774 6,049,439 |
Stock option plan
Stock option plan | 12 Months Ended |
Dec. 31, 2019 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock option plan | 8. Stock option plan 2011 Equity Incentive Plan In March 2011, the Company adopted the 2011 Equity Incentive Plan (the “Plan”). As amended, 4,400,640 shares of common stock were reserved for issuance under the 2011 Plan. Eligible plan participants included employees, directors, officers, consultants and advisors of the Company. The 2011 plan permitted the granting of incentive stock options, nonqualified stock options and other stock- based awards. 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, 2018, and in accordance with the “evergreen” provision of the 2017 plan, an additional 1,066,692 shares were made available for issuance. Effective January 1, 2019, 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 B oard of D irectors or C ompensation C ommittee of the B oard. 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 December 31, 2019, there were a total of 938,738 shares of common stock available for future issuance under the 2017 Plan. Stock-based Compensation During the years ended December 31, 2019, 2018 and 2017, the Company recorded employee share-based compensation expense of $16,351, $8,157, and $1,772, respectively. The Company recorded non-employee share-based compensation expense of $98, $2,068, and $1,622 during the years ended December 31, 2019, 2018 and 2017, respectively. Total share-based compensation expense included in the statements of operations is as follows: Year Ended December 31, 2019 2018 2017 in thousands Research and development $ 6,261 $ 5,218 $ 2,531 General and administrative 10,188 5,007 863 Total stock-based compensation expense $ 16,449 $ 10,225 $ 3,394 The fair value of each option grant is estimated on the grant date using the Black-Scholes option-pricing model, using the following weighted average assumptions: Year Ended December 31, 2019 2018 2017 Expected volatility 74.2 - 82.1% 74.9 - 86.5% 74.2 - 79.3% Weighted-average risk free rate 1.4 - 2.6% 2.3 - 3.0% 1.9 - 2.2% Dividend yield —% —% —% Expected term (in years) 6.02 6.04 6.01 Weighted-average grant-date fair value per share $ 14.94 $ 26.42 $ 10.71 The expected term of stock options represents the weighted-average period the stock options are expected to remain outstanding and is based on the option vesting term, contractual terms and industry peers as the Company did not have sufficient historical information to develop reasonable expectations about future exercise patterns and post-vesting employment termination behavior. The expected stock price volatility assumptions for the Company’s stock options were determined by examining the historical volatilities for industry peers as the Company does not have sufficient history to estimate volatility using only its common stock. In 2019, the Company began incorporating its historical stock price in conjunction with selected similar publicly traded companies. The Company plans to continue to use the guideline peer group volatility information until the historical volatility of its common stock is sufficient to measure expected volatility for future option grants. The risk-free interest rate assumption at the date of grant is based on the U.S. Treasury instruments whose term was consistent with the expected term of the Company’s stock options. The expected dividend assumption is based on the Company’s history and expectation of dividend payouts. Stock option activity during 2019 is as follows: Weighted average Weighted Remaining average contractual Aggregate Options exercise for intrinsic outstanding price life (Years) value (in thousands) Balance as of December 31, 2018 4,502,133 $ 14.13 7.6 $ 46,575 Cancelled (326,654 ) $ 20.49 Granted 1,938,025 $ 22.06 Exercised (369,468 ) $ 7.32 Balance as of December 31, 2019 5,744,036 $ 16.88 7.5 $ 72,251 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 As of December 31, 2019, there was $42,049 of total unrecognized share-based compensation costs, which is expected to be recognized over a weighted-average period of 2.69 years. Prior to our initial public offering, the fair value of our common shares underlying our stock options was estimated on each grant date by our board of directors. In order to determine the fair value of our common shares underlying granted stock options, our board of directors considered, among other things, timely valuations of our common shares prepared by an unrelated third-party valuation firm in accordance with the guidance provided by the American Institute of Certified Public Accountants Practice Guide, Valuation of Privately-Held-Company Equity Securities Issued as Compensation. Since the IPO, the board of directors has determined the fair value of each common share underlying share-based awards based on the closing price of the common shares as reported by Nasdaq on the date of grant. |
Net Loss Per Common Share
Net Loss Per Common Share | 12 Months Ended |
Dec. 31, 2019 | |
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 years ended December 31, 2019, 2018 and 2017, the following potentially dilutive securities have been excluded from the computations of diluted weighted-average shares outstanding because the effect would be anti-dilutive: Year Ended December 31, 2019 2018 2017 Stock options issued and outstanding 5,443,730 4,318,731 3,838,358 Stock warrants — — 11,385 5,443,730 4,318,731 3,849,743 Amounts in the table above reflect the common stock equivalents of the noted instruments. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 10. Income taxes 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 FASB ASC 740, Accounting for Income Taxes The components of income tax expense (benefit) attributable to continuing operations are as follows: Year ended December 31, 2019 2018 2017 Current Expense: Federal $ — $ — $ — State — — — — — — Deferred Expense: Federal — — — State — — — $ — $ — $ — The differences between the company’s income tax expense attributable to continuing operations and the expense computed at the 21% U.S. statutory income tax rate were as follows (in thousands): Year ended December 31, 2019 2018 2017 Federal income tax benefit at statutory rate: $ (25,714 ) $ (17,910 ) $ (20,441 ) Increase (reduction) in income tax resulting from: State Income Taxes (2,369 ) (1,518 ) (1,623 ) Increase in Valuation Allowance 29,499 26,614 8,977 Write off Sec. 382 Limited Carryforwards 1,858 — — Equity Financing Expenses — — 39 Stock Compensation 461 (3,011 ) 152 Research and Development Credit (3,529 ) (4,187 ) (1,882 ) Effect on Tax Cuts & Job Acts Rate Reduction — — 14,770 Other (206 ) 12 8 $ — $ — $ — The tax effects of temporary differences and operating loss carryforwards that gave rise to significant portions of the deferred tax assets and deferred tax liabilities were as follows at December 31, 2019 and 2018 (in thousands): Year ended December 31, 2019 2018 Deferred tax assets Accrued expenses $ 2,205 $ 1,413 Deferred rent — 23 Operating lease liabilities 2,348 — Stock compensation 4,865 2,038 Charitable contributions 6 2 Capitalized patents and licenses 2,156 1,544 R&D credits 10,874 7,521 Net operating loss carryforwards 65,869 43,997 Deferred tax assets 88,323 56,538 Deferred tax liabilities Operating lease assets (2,263 ) — Property, plant and equipment, primarily due to differences in depreciation (60 ) (37 ) Deferred tax liabilities (2,323 ) (37 ) Valuation allowance (86,000 ) (56,501 ) Net deferred tax assets $ — $ — At December 31, 2019 and December 31, 2018, the Company evaluated all significant available positive and negative evidence, including the existence of losses in recent years and management’s forecast of future taxable income, and, as a result, determined it was more likely than not that federal and state deferred tax assets, including benefits related to net operating loss carryforwards, would not be realized. The valuation allowance was increased from $56.5 million at December 31, 2018 to $86.0 million at December 31, 2019. The increase in valuation allowance was due primarily to the increase in net operating loss carryforwards and income tax credits. The table below summarizes changes in the deferred tax valuation allowance (in thousands): 2019 2018 2017 Balance at beginning of year $ 56,501 $ 29,887 $ 20,910 Charges to costs and expenses 31,357 26,614 8,977 Write-offs (1,858 ) — — Balance at end of year 86,000 56,501 29,887 At December 31, 2019, the Company has federal net operating loss carryforwards (“NOLs”) of approximately $286.1 million, which are available to offset future taxable income. Of the $286.1 million available, $92.7 million will begin to expire in 2029. The remaining $193.4 million has an indefinite carryforward period. Under the Tax Cuts and Jobs Act (“Tax Act”), federal NOLs arising after December 31, 2017 may be carried forward indefinitely. However, for NOLs arising after December 31, 2017, NOL carryforwards will be limited to 80% of taxable income. The Company’s NOLs generated in 2017 and in prior years will not be subject to the 80% limitation under the Tax Act. In addition, the Company has state net operating loss carryforwards totaling approximately $292.9 million, which are available to offset future state taxable income. State net operating losses begin to expire in 2024. Because the Company has incurred cumulative net operating losses since inception, all tax years remain open to examination by U.S. federal and state income tax authorities. As of December 31, 2019, the Company also had federal research and development (R&D) credit carryforwards of approximately $10.9 million available to offset future income tax which begin to expire in 2034. In accordance with FASB ASC 740, Accounting for Income Taxes On December 22, 2017, the Tax Act was signed into law. The only significant impact to the Company was the remeasurement of its net deferred tax asset in 2017 based on the newly enacted 21% federal corporate income tax rate, which was effective beginning in tax year 2018. Section 382 Limitation The Company’s ability to utilize its net operating loss and research and development credit carryforwards may be substantially limited due to ownership changes that may have occurred or that could occur in the future, as required by Section 382 of the Internal Revenue Code of 1986, as amended (the Code), as well as similar state provisions. These ownership changes may limit the amount of NOL and R&D credit carryforwards that can be utilized annually to offset future taxable income and tax, respectively. In general, an “ownership change,” as defined by Section 382 of the Code, results from a transaction or series of transactions over a three-year period resulting in an ownership change of more than 50 percent of the outstanding stock of a company by certain stockholders or public groups. In April 2019, the Company c ompleted an evaluation study as to whether an “ownership change” had occurred and determined that the limitation would be $8.0 million on federal net operating loss carryforwards, $1.2 million on state net operating loss carryforwards, and $0.1 million on R&D tax credit carryforwards, thereby reducing the federal net operating loss which remains to approximately $286.1 million, state net operating loss which remains to $292.9 million, and the R&D tax credit carryforward to $10.9 million at December 31, 2019. The Company continues to maintain a valuation allowance on the remaining NOLs as it believes that it is more likely than not all of the deferred tax asset associated with the NOLs will not be realized regardless of whether an “ownership change” has occurred. |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2019 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 11. Related party transactions The Company paid approximately $6 thousand, $6 thousand, $11 thousand to the Chairman of the Board of Directors for scientific advisory services outside of his role on the board of directors during the years ended December 31, 2019, 2018 and 2017, respectively. |
Quarterly Results of Operations
Quarterly Results of Operations (Unaudited) | 12 Months Ended |
Dec. 31, 2019 | |
Quarterly Financial Information Disclosure [Abstract] | |
Quarterly Results of Operations (Unaudited) | 12. Quarterly Results of Operations (Unaudited) The following table contains quarterly financial information for 2019 and 2018. The Company believes that the following information reflects all normal recurring adjustments necessary for a fair statement of the information for the periods presented. The operating results for any quarter are not necessarily indicative of results for any future period. Three Months Ended (unaudited) (in thousands, except share and per share amounts) March 31, June 30, September 30, December 31, 2019 2019 2019 2019 Total operating expenses $ 25,881 $ 32,583 $ 34,024 $ 36,553 Operating loss (25,881 ) (32,583 ) (34,024 ) (36,553 ) Total other income (expense), net 1,929 1,893 1,660 1,112 Net loss $ (23,952 ) $ (30,690 ) $ (32,364 ) $ (35,441 ) Net loss attributable to common stockholders $ (23,952 ) $ (30,690 ) $ (32,364 ) $ (35,441 ) Net loss per share attributable to common stockholders, basic and diluted $ (0.64 ) $ (0.82 ) $ (0.86 ) $ (0.94 ) Weighted average common shares outstanding, basic and diluted 37,396,980 37,470,926 37,540,380 37,586,218 March 31, June 30, September 30, December 31, 2018 2018 2018 2018 Total operating expenses $ 20,725 $ 21,653 $ 20,822 $ 26,086 Operating loss (20,725 ) (21,653 ) (20,822 ) (26,086 ) Total other income (expense), net 315 785 904 1,994 Net loss and comprehensive loss $ (20,410 ) $ (20,868 ) $ (19,918 ) $ (24,092 ) Net loss attributable to common stockholders $ (20,410 ) $ (20,868 ) $ (19,918 ) $ (24,092 ) Net loss per share attributable to common stockholders, basic and diluted $ (0.70 ) $ (0.64 ) $ (0.59 ) $ (0.65 ) Weighted average common shares outstanding, basic and diluted 29,360,470 32,781,921 33,829,437 37,203,233 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of presentation The Company has prepared the accompanying financial statements in conformity with generally accepted accounting principles in the United States of America (“U.S. GAAP”). |
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. Actual results could differ from those estimates. These estimates include the Company’s common stock valuation, stock compensation, warrant valuation and deferred tax asset valuation allowance. |
Cash and Cash Equivalents | Cash and cash equivalents The Company considers all highly liquid investments purchased with an original maturity of three months or less at the date of purchase to be cash equivalents. Cash and cash equivalents at December 31, 2019 and 2018 consist of amounts on deposit in banks, including checking accounts, money market accounts and certificates of deposit. Cash deposits are all in financial institutions in the United States. As part of the lease for the new office space, the Company obtained a standby letter of credit in the amount of $0.5 million related to the security deposit. This letter of credit is secured by money market funds at the financial institution. Therefore, these funds are classified as restricted cash on the balance sheet. The letter of credit will be reduced ratably on each anniversary of the commencement of the lease until the end of the lease term. |
Concentration of Credit Risk | Concentration of credit risk Financial instruments that potentially subject the Company to credit risk consist of cash and cash equivalents. Deposits with financial institutions are insured, up to certain limits, by the Federal Deposit Insurance Corporation (“FDIC”). The Company’s cash deposits often exceed the FDIC insurance limit; however, all deposits are maintained with high credit quality institutions and the Company has not experienced any losses in such accounts. The financial condition of financial institutions is periodically reassessed, and the Company believes the risk of any loss is minimal. The Company believes the risk of any loss on cash due to credit risk is minimal. |
Property and Equipment | Property and equipment Property and equipment are stated at cost less accumulated depreciation. Depreciation is generally calculated using the straight-line method over the following estimated useful lives: Computer equipment 5 years Laboratory equipment 5 years Furniture and fixtures 7 years Leasehold improvements 7 years Costs associated with maintenance and repairs are charged to expense as incurred. Property and equipment held under leasehold improvements are amortized over the shorter of the lease term or the estimated useful life of the related asset. |
Impairment of Long-Lived Assets | Impairment of long-lived assets The Company evaluates its long-lived assets for indicators of possible impairment by comparison of the carrying amounts to future net undiscounted cash flows expected to be generated by such assets when events or changes in circumstances indicate the carrying amount of an asset may not be recoverable. Should an impairment exist, the impairment loss would be measured based on the excess carrying value of the asset over the asset’s fair value based on discounted estimates of future cash flows. For the years ended December 31, 2019, 2018 and 2017, the Company’s management evaluated its long-lived assets and determined no impairment charge was needed. |
Warrant Liability | Warrant liability Warrants to purchase the Company’s redeemable convertible preferred stock were classified as liabilities and recorded at their estimated fair value. In each reporting period, any change in fair value of the warrants has been recorded as expense in the case of an increase in fair value and income in the case of a decrease in fair value. |
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 involved 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. |
Fair Value of Financial Instruments | Fair value of financial instruments 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 December 31, 2019 and 2018 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 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 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, 2018 Assets Money market funds $ 352,934 $ — $ — $ 352,934 Certificates of Deposit 15,501 — — 15,501 Total assets at fair value: $ 368,435 $ — $ — $ 368,435 |
Patent Costs | Patent costs Costs associated with the submission of patent applications are expensed as incurred given the uncertainty of the future economic benefits of the patents. Patent-related legal expenses included in general and administrative costs were approximately $2,114 thousand, $1,352 thousand, and $997 thousand for the years ended December 31, 2019, 2018 and 2017, respectively. |
Income Taxes | Income taxes 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. The Company accounts for stock-based non-employee compensation arrangements by recording the expense of such services based on the fair value of the equity instrument as estimated using the Black-Scholes pricing model. The fair value of the equity instrument is charged to operating expense over the term of the service agreement. In accordance with the implementation of ASU No. 2018-07 on January 1, 2019, the fair value of non-employee stock options is no longer be re-measured each reporting period. |
Segment Information | Segment information The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions. All of the Company’s assets are held in the United States. |
Comprehensive Loss | Comprehensive loss Comprehensive loss includes net loss as well as other changes in stockholders’ equity (deficit) that result from transactions and economic events other than those with stockholders. There was no difference between net loss and comprehensive loss for each of the periods presented in the accompanying financial statements. |
Redeemable Convertible Preferred Stock | Redeemable convertible preferred stock The Company classifies its redeemable convertible preferred stock, for which the Company does not control the redemption, outside of permanent equity. The Company records redeemable convertible preferred stock at fair value upon issuance, net of any offering costs, and the carrying value is adjusted to the redemption value at the end of each reporting period. These adjustments are effected through charges against additional paid-in capital and accumulated deficit. |
Leases | Leases We determine if an arrangement is a lease at inception. Operating lease assets represent our right to use an underlying asset for the lease term and lease liabilities represent our obligation to make lease payments arising from the lease. Operating leases are included in operating lease assets, other current liabilities, and operating lease liabilities on our balance sheet at December 31, 2019. Operating lease assets and operating lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at commencement date. As most of our leases do not provide an implicit rate, we use our incremental borrowing rate based on the information available at commencement date to determine the present value of future payments. Our lease terms may include options to extend or terminate the lease when it is reasonably certain that we will exercise that option. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term. Prior period amounts continue to be reported in accordance with our historic accounting under previous lease guidance, Topic 840. See “Adoption of New Accounting Standards – Impact of Adoption of Topic 842” below, for more information about the impact of the adoption of Topic 842. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements Adoption of New Accounting Standards In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) (“ASU 2016-02”). This guidance revises the accounting related to leases by requiring lessees to recognize a lease liability and a right-of-use asset for all leases. In January 2019, the Company adopted ASU 2016-02 using the modified retrospective transition method with an effective date as of the beginning of our fiscal year, January 1, 2019. Prior period amounts have not been adjusted and continue to be reported in accordance with our historical reporting under previous lease guidance, ASC Topic 840. As part of the adoption, we have elected to account for separate lease and associated non-lease components as a single lease component for our real estate leases. In June 2018, the FASB issued ASU No. 2018-07, Improvements to Nonemployee Share-Based Payment Accounting Impact of Adoption of Topic 842 With the adoption of Topic 842 on January 1, 2019, the Company recognized operating lease assets and operating lease liabilities of $1.5 million and $1.6 million, respectively, with the difference due to the de-recognition of current and non-current deferred rent. There was no impact to the opening accumulated deficit as of January 1, 2019. The impact of the adoption of Topic 842 on the accompanying balance sheet as of January 1, 2019 was as follows (in thousands): December 31, 2018 Adjustments Due to the Adoption of Topic 842 January 1, 2019 Operating lease assets $ — $ 1,533 $ 1,533 Accrued expenses 8,985 (9 ) 8,976 Operating lease liabilities: Other current liabilities — 352 352 Non-current operating lease liabilities — 1,278 1,278 Other non-current liabilities 88 (88 ) — Stockholders' equity 358,820 — 358,820 Recently Issued Accounting Standards In August 2018, the FASB issued ASU No. 2018-15, Goodwill and Other—Internal-Use Software (Subtopic 350-40): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract . |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Schedule of Property and Equipment Estimated Useful Lives | Depreciation is generally calculated using the straight-line method over the following estimated useful lives: Computer equipment 5 years Laboratory equipment 5 years Furniture and fixtures 7 years Leasehold improvements 7 years |
Summary of Financials Instruments and Respective Fair Values | At December 31, 2019 and 2018 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 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 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, 2018 Assets Money market funds $ 352,934 $ — $ — $ 352,934 Certificates of Deposit 15,501 — — 15,501 Total assets at fair value: $ 368,435 $ — $ — $ 368,435 |
ASU 2016-02 (Topic 842) | |
Schedule of Impact of Adoption of Topic 842 on Accompanying Balance Sheet | The impact of the adoption of Topic 842 on the accompanying balance sheet as of January 1, 2019 was as follows (in thousands): December 31, 2018 Adjustments Due to the Adoption of Topic 842 January 1, 2019 Operating lease assets $ — $ 1,533 $ 1,533 Accrued expenses 8,985 (9 ) 8,976 Operating lease liabilities: Other current liabilities — 352 352 Non-current operating lease liabilities — 1,278 1,278 Other non-current liabilities 88 (88 ) — Stockholders' equity 358,820 — 358,820 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Property Plant And Equipment [Abstract] | |
Schedule of Property and Equipment | Property and equipment consists of the following (in thousands): December 31, 2019 December 31, 2018 Computer equipment $ 332 $ 246 Laboratory equipment 871 611 Furniture and fixtures 1,071 293 Leasehold improvements 1,941 238 Construction in progress — 71 Accumulated depreciation (677 ) (322 ) Property and equipment, net $ 3,538 $ 1,137 |
Accrued expenses (Tables)
Accrued expenses (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Payables And Accruals [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses are comprised as follows (in thousands): December 31, 2019 December 31, 2018 Accrued external research $ 2,737 $ 1,242 Accrued professional fees $ 1,487 $ 349 Accrued external clinical study costs 7,996 4,692 Accrued compensation expense 3,183 2,693 Deferred rent, current portion - 9 Accrued expenses $ 15,403 $ 8,985 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Leases [Abstract] | |
Summary of Lease Position and Weighted-Average Lease Term and Discount Rate of Operating Leases | The tables below reflect the Company’s lease position and weighted-average lease terms and discount rates for our operating leases as of December 31, 2019. Operating lease liabilities are based on the net present value of the remaining lease payments over the remaining lease term. In determining the present value of lease payments, we use our incremental borrowing rate based on the information available at the lease commencement date. (in thousands) Classification on the Balance Sheet December 31, 2019 Assets Operating lease assets Operating lease assets $ 9,853 Total lease assets $ 9,853 Liabilities Current Operating Other current liabilities $ 682 Non-current Operating Operating lease liabilities 9,535 Total lease liabilities $ 10,217 Lease Term and Discount Rate December 31, 2019 Weighted-average remaining lease term (years) Operating leases 7.2 Weighted-average discount rate Operating leases 7.7 % |
Summary of Information Related to Lease Costs for Operating Leases | The table below presents information related to the lease costs for operating leases (in thousands): Year Ended December 31, (in thousands) Classification 2019 2018 2017 Operating lease costs (a) Research and development $ 609 $ 298 $ 207 General and administrative 368 83 45 Total operating lease costs $ 977 $ 381 $ 252 (a) Includes variable lease costs which are immaterial |
Reconciliation of Undiscounted Cash Flow to Operating Lease Liabilities | The table below reconciles the undiscounted cash flow for each of the first five years and total of the remaining years to the operating lease liabilities recorded on the balance sheet as of December 31, 2019 (in thousands): Operating leases Years ending December 31, 2020 1,459 2021 2,015 2022 2,072 2023 1,634 2024 1,679 Thereafter 4,855 Total future minimum lease payments $ 13,714 Less: present value adjustment (3,497 ) Total operating lease liabilities $ 10,217 |
Schedule of Minimum Future Rental Payments on Noncancelable Operating Leases | The following is a schedule by years of minimum future rental payments on noncancelable operating leases as of December 31, 2018 (in thousands): 2019 $ 680 2020 1,427 2021 1,960 2022 2,015 2023 1,577 2024 and thereafter 6,155 $ 13,814 |
Stockholders_ Equity (Tables)
Stockholders’ Equity (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Equity [Abstract] | |
Summary of common stock shares reserved for future issuance | The Company has reserved authorized shares of common stock for future issuance at December 31, 2019 and December 31, 2018 as follows: December 31, 2019 December 31, 2018 Common stock options outstanding 5,744,036 4,502,133 Options available for grant under Equity Incentive Plans 938,738 1,547,306 6,682,774 6,049,439 |
Stock option plan (Tables)
Stock option plan (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Summary of Stock Option Activity | Stock option activity during 2019 is as follows: Weighted average Weighted Remaining average contractual Aggregate Options exercise for intrinsic outstanding price life (Years) value (in thousands) Balance as of December 31, 2018 4,502,133 $ 14.13 7.6 $ 46,575 Cancelled (326,654 ) $ 20.49 Granted 1,938,025 $ 22.06 Exercised (369,468 ) $ 7.32 Balance as of December 31, 2019 5,744,036 $ 16.88 7.5 $ 72,251 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 |
Employee and Non-employee Stock Options | |
Summary of Share-Based Compensation Expense Included in Statements of Operations | Total share-based compensation expense included in the statements of operations is as follows: Year Ended December 31, 2019 2018 2017 in thousands Research and development $ 6,261 $ 5,218 $ 2,531 General and administrative 10,188 5,007 863 Total stock-based compensation expense $ 16,449 $ 10,225 $ 3,394 |
Summary of Fair Value of Stock Options Granted Using Black-Scholes Options Pricing Model | The fair value of each option grant is estimated on the grant date using the Black-Scholes option-pricing model, using the following weighted average assumptions: Year Ended December 31, 2019 2018 2017 Expected volatility 74.2 - 82.1% 74.9 - 86.5% 74.2 - 79.3% Weighted-average risk free rate 1.4 - 2.6% 2.3 - 3.0% 1.9 - 2.2% Dividend yield —% —% —% Expected term (in years) 6.02 6.04 6.01 Weighted-average grant-date fair value per share $ 14.94 $ 26.42 $ 10.71 |
Net Loss Per Common Share (Tabl
Net Loss Per Common Share (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Earnings Per Share [Abstract] | |
Schedule of Potentially Dilutive Securities Excluded from Computations of Diluted Weighted-average Shares Outstanding | For the years ended December 31, 2019, 2018 and 2017, the following potentially dilutive securities have been excluded from the computations of diluted weighted-average shares outstanding because the effect would be anti-dilutive: Year Ended December 31, 2019 2018 2017 Stock options issued and outstanding 5,443,730 4,318,731 3,838,358 Stock warrants — — 11,385 5,443,730 4,318,731 3,849,743 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Components of Income Tax Expense (Benefit) Attributable to Continuing Operations | The components of income tax expense (benefit) attributable to continuing operations are as follows: Year ended December 31, 2019 2018 2017 Current Expense: Federal $ — $ — $ — State — — — — — — Deferred Expense: Federal — — — State — — — $ — $ — $ — |
Summary of Differences Between the Income Tax Expense Attributable to Continuing Operations and the Expense Computed at U.S. Statutory Income Tax Rate | The differences between the company’s income tax expense attributable to continuing operations and the expense computed at the 21% U.S. statutory income tax rate were as follows (in thousands): Year ended December 31, 2019 2018 2017 Federal income tax benefit at statutory rate: $ (25,714 ) $ (17,910 ) $ (20,441 ) Increase (reduction) in income tax resulting from: State Income Taxes (2,369 ) (1,518 ) (1,623 ) Increase in Valuation Allowance 29,499 26,614 8,977 Write off Sec. 382 Limited Carryforwards 1,858 — — Equity Financing Expenses — — 39 Stock Compensation 461 (3,011 ) 152 Research and Development Credit (3,529 ) (4,187 ) (1,882 ) Effect on Tax Cuts & Job Acts Rate Reduction — — 14,770 Other (206 ) 12 8 $ — $ — $ — |
Components of Tax Effects of Temporary Differences and Operating Loss Carryforwards Including Significant Portions of Deferred Tax Assets and Deferred Tax Liabilities | The tax effects of temporary differences and operating loss carryforwards that gave rise to significant portions of the deferred tax assets and deferred tax liabilities were as follows at December 31, 2019 and 2018 (in thousands): Year ended December 31, 2019 2018 Deferred tax assets Accrued expenses $ 2,205 $ 1,413 Deferred rent — 23 Operating lease liabilities 2,348 — Stock compensation 4,865 2,038 Charitable contributions 6 2 Capitalized patents and licenses 2,156 1,544 R&D credits 10,874 7,521 Net operating loss carryforwards 65,869 43,997 Deferred tax assets 88,323 56,538 Deferred tax liabilities Operating lease assets (2,263 ) — Property, plant and equipment, primarily due to differences in depreciation (60 ) (37 ) Deferred tax liabilities (2,323 ) (37 ) Valuation allowance (86,000 ) (56,501 ) Net deferred tax assets $ — $ — |
Summary of Changes in the Deferred Tax Valuation Allowance | The table below summarizes changes in the deferred tax valuation allowance (in thousands): 2019 2018 2017 Balance at beginning of year $ 56,501 $ 29,887 $ 20,910 Charges to costs and expenses 31,357 26,614 8,977 Write-offs (1,858 ) — — Balance at end of year 86,000 56,501 29,887 |
Quarterly Results of Operatio_2
Quarterly Results of Operations (Unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Quarterly Financial Information Disclosure [Abstract] | |
Quarterly Results of Operations | The following table contains quarterly financial information for 2019 and 2018. The Company believes that the following information reflects all normal recurring adjustments necessary for a fair statement of the information for the periods presented. The operating results for any quarter are not necessarily indicative of results for any future period. Three Months Ended (unaudited) (in thousands, except share and per share amounts) March 31, June 30, September 30, December 31, 2019 2019 2019 2019 Total operating expenses $ 25,881 $ 32,583 $ 34,024 $ 36,553 Operating loss (25,881 ) (32,583 ) (34,024 ) (36,553 ) Total other income (expense), net 1,929 1,893 1,660 1,112 Net loss $ (23,952 ) $ (30,690 ) $ (32,364 ) $ (35,441 ) Net loss attributable to common stockholders $ (23,952 ) $ (30,690 ) $ (32,364 ) $ (35,441 ) Net loss per share attributable to common stockholders, basic and diluted $ (0.64 ) $ (0.82 ) $ (0.86 ) $ (0.94 ) Weighted average common shares outstanding, basic and diluted 37,396,980 37,470,926 37,540,380 37,586,218 March 31, June 30, September 30, December 31, 2018 2018 2018 2018 Total operating expenses $ 20,725 $ 21,653 $ 20,822 $ 26,086 Operating loss (20,725 ) (21,653 ) (20,822 ) (26,086 ) Total other income (expense), net 315 785 904 1,994 Net loss and comprehensive loss $ (20,410 ) $ (20,868 ) $ (19,918 ) $ (24,092 ) Net loss attributable to common stockholders $ (20,410 ) $ (20,868 ) $ (19,918 ) $ (24,092 ) Net loss per share attributable to common stockholders, basic and diluted $ (0.70 ) $ (0.64 ) $ (0.59 ) $ (0.65 ) Weighted average common shares outstanding, basic and diluted 29,360,470 32,781,921 33,829,437 37,203,233 |
Description of Business - Addit
Description of Business - Additional Information (Details) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019USD ($)Product | Dec. 31, 2018USD ($) | |
Description Of Business [Line Items] | ||
Number of clinical-stage product candidates from pipeline | Product | 3 | |
Accumulated deficit | $ 336,853 | $ 214,406 |
Cash and cash equivalents | $ 269,208 | $ 369,290 |
Minimum | ||
Description Of Business [Line Items] | ||
Expected period to fund operations by existing cash resources | 12 months |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Details) - USD ($) | 12 Months Ended | |||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Nov. 30, 2018 | |
Summary Of Significant Accounting Policies [Line Items] | ||||
Impairment charge of long-lived assets | $ 0 | $ 0 | $ 0 | |
Unrecognized income tax benefits | 0 | 0 | ||
Accrued income taxes | 0 | 0 | ||
Patent | General and Administrative Costs | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Legal expenses | 2,114,000 | $ 1,352,000 | $ 997,000 | |
Standby Letter of Credit | Restricted Cash | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Security deposit | $ 500,000 | $ 500,000 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Schedule of Property and Equipment Estimated Useful Lives (Details) | 12 Months Ended |
Dec. 31, 2019 | |
Computer Equipment | |
Property Plant And Equipment [Line Items] | |
Estimated useful lives | 5 years |
Laboratory Equipment | |
Property Plant And Equipment [Line Items] | |
Estimated useful lives | 5 years |
Furniture and Fixtures | |
Property Plant And Equipment [Line Items] | |
Estimated useful lives | 7 years |
Leasehold Improvements | |
Property Plant And Equipment [Line Items] | |
Estimated useful lives | 7 years |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Summary of Financials Instruments and Respective Fair Values (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Assets | ||
Assets at fair value | $ 268,436 | $ 368,435 |
Money Market Funds | ||
Assets | ||
Assets at fair value | 252,563 | 352,934 |
Certificates of Deposit | ||
Assets | ||
Assets at fair value | 15,873 | 15,501 |
Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Assets | ||
Assets at fair value | 268,436 | 368,435 |
Quoted Prices in Active Markets for Identical Assets (Level 1) | Money Market Funds | ||
Assets | ||
Assets at fair value | 252,563 | 352,934 |
Quoted Prices in Active Markets for Identical Assets (Level 1) | Certificates of Deposit | ||
Assets | ||
Assets at fair value | $ 15,873 | $ 15,501 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Schedule of Impact of Adoption of Topic 842 on Accompanying Balance Sheet (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Jan. 01, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Summary Of Significant Accounting Policies [Line Items] | |||||
Operating lease assets | $ 9,853 | ||||
Accrued expenses | 15,403 | $ 8,985 | |||
Operating lease liabilities: | |||||
Other current liabilities | $ 682 | ||||
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | us-gaap:OtherLiabilitiesCurrent | us-gaap:OtherCurrentLiabilitiesMember | |||
Non-current operating lease liabilities | $ 9,535 | ||||
Other non-current liabilities | $ 88 | ||||
Stockholders' equity | $ 255,527 | $ 358,820 | $ 93,388 | $ (64,993) | |
ASU 2016-02 (Topic 842) | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Operating lease assets | $ 1,533 | ||||
Accrued expenses | 8,976 | ||||
Operating lease liabilities: | |||||
Other current liabilities | $ 352 | ||||
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | us-gaap:OtherCurrentLiabilitiesMember | ||||
Non-current operating lease liabilities | $ 1,278 | ||||
Stockholders' equity | 358,820 | ||||
ASU 2016-02 (Topic 842) | Adjustments Due to the Adoption of Topic 842 | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Operating lease assets | 1,533 | ||||
Accrued expenses | (9) | ||||
Operating lease liabilities: | |||||
Other current liabilities | $ 352 | ||||
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | us-gaap:OtherCurrentLiabilitiesMember | ||||
Non-current operating lease liabilities | $ 1,278 | ||||
Other non-current liabilities | $ (88) |
Property and Equipment - Schedu
Property and Equipment - Schedule of Property and Equipment (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Property Plant And Equipment [Line Items] | ||
Accumulated depreciation | $ (677) | $ (322) |
Property and equipment, net | 3,538 | 1,137 |
Computer Equipment | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 332 | 246 |
Laboratory Equipment | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 871 | 611 |
Furniture and Fixtures | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 1,071 | 293 |
Leasehold Improvements | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 1,941 | 238 |
Construction in Progress | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 71 |
Property and Equipment - Additi
Property and Equipment - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Property Plant And Equipment [Abstract] | |||
Depreciation expenses relating to property and equipment | $ 356 | $ 175 | $ 89 |
Patent License Agreement - Addi
Patent License Agreement - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | 37 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2019 | |
Patent License Agreement [Line Items] | |||||
Non-refundable license issue fee | $ 89,002 | $ 70,683 | $ 53,881 | ||
University | |||||
Patent License Agreement [Line Items] | |||||
License agreement date | Nov. 23, 2016 | ||||
License agreement amendment date | Mar. 24, 2017 | ||||
Milestone payments | $ 500 | $ 600 | |||
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 with in 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 | ||||
University | License | |||||
Patent License Agreement [Line Items] | |||||
Non-refundable license issue fee | $ 500 |
Accrued Expenses - Schedule of
Accrued Expenses - Schedule of Accrued Expenses (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Payables And Accruals [Abstract] | ||
Accrued external research | $ 2,737 | $ 1,242 |
Accrued professional fees | 1,487 | 349 |
Accrued external clinical study costs | 7,996 | 4,692 |
Accrued compensation expense | 3,183 | 2,693 |
Deferred rent, current portion | 9 | |
Accrued expenses | $ 15,403 | $ 8,985 |
Leases - Additional Information
Leases - Additional Information (Details) $ in Thousands | Jan. 27, 2016 | Jan. 10, 2014 | Nov. 30, 2018USD ($)ft² | Dec. 31, 2019USD ($) |
Operating Leased Assets [Line Items] | ||||
Lease expiration date | Dec. 31, 2022 | Jul. 31, 2017 | Sep. 30, 2027 | |
Renewal term | 5 years | 5 years | ||
Laboratory and office space lease to secure | ft² | 60,000 | |||
Lease commencement date | Sep. 2, 2019 | |||
Cash payments for measurement of operating leases | $ 688 | |||
Standby Letter of Credit | Restricted Cash | ||||
Operating Leased Assets [Line Items] | ||||
Security deposit | $ 500 | $ 500 |
Leases - Summary of Lease Posit
Leases - Summary of Lease Position and Weighted-Average Lease Term and Discount Rate of Operating Leases (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Assets | ||
Operating lease assets | $ 9,853 | |
Total lease assets | 9,853 | |
Liabilities | ||
Current operating lease liabilities | $ 682 | |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | us-gaap:OtherLiabilitiesCurrent | us-gaap:OtherCurrentLiabilitiesMember |
Non-current operating lease liabilities | $ 9,535 | |
Total lease liabilities | $ 10,217 | |
Weighted-average remaining lease term (years) | ||
Operating leases | 7 years 2 months 12 days | |
Weighted-average discount rate | ||
Operating leases | 7.70% |
Leases - Summary of Information
Leases - Summary of Information Related to Lease Costs for Operating Leases (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Operating Leased Assets [Line Items] | |||
Total operating lease costs | $ 977 | $ 381 | $ 252 |
Research and Development | |||
Operating Leased Assets [Line Items] | |||
Operating lease costs | 609 | 298 | 207 |
General and Administrative | |||
Operating Leased Assets [Line Items] | |||
Operating lease costs | $ 368 | $ 83 | $ 45 |
Leases - Reconciliation of Undi
Leases - Reconciliation of Undiscounted Cash Flow to Operating Lease Liabilities (Details) $ in Thousands | Dec. 31, 2019USD ($) |
Leases [Abstract] | |
2020 | $ 1,459 |
2021 | 2,015 |
2022 | 2,072 |
2023 | 1,634 |
2024 | 1,679 |
Thereafter | 4,855 |
Total future minimum lease payments | 13,714 |
Less: present value adjustment | (3,497) |
Total operating lease liabilities | $ 10,217 |
Leases - Schedule of Minimum Fu
Leases - Schedule of Minimum Future Rental Payments on Noncancelable Operating Leases (Details) $ in Thousands | Dec. 31, 2018USD ($) |
Leases [Abstract] | |
2019 | $ 680 |
2020 | 1,427 |
2021 | 1,960 |
2022 | 2,015 |
2023 | 1,577 |
2024 and thereafter | 6,155 |
Total minimum future rentals | $ 13,814 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Details) $ / shares in Units, $ in Thousands | May 22, 2017USD ($)$ / sharesshares | Dec. 31, 2019$ / sharesshares | Dec. 31, 2018USD ($)$ / sharesshares | Dec. 31, 2017USD ($) | Jun. 30, 2016USD ($)$ / sharesshares | Apr. 30, 2016shares |
Class Of Stock [Line Items] | ||||||
Proceeds from initial public offering, net of underwriting discounts and commissions | $ | $ 339,589 | $ 108,503 | ||||
Reverse stock split description | In connection with the IPO, the Board of Directors and the stockholders of the Company approved a one-for-three reverse stock split of the Company’s common stock. | |||||
Reverse stock split ratio | 0.33 | |||||
Reverse stock split effective date | May 11, 2017 | |||||
Undesignated preferred stock, shares authorized to issue | 5,000,000 | |||||
Preferred stock, shares issued | 0 | |||||
Preferred stock, shares outstanding | 0 | |||||
Common stock, par value | $ / shares | $ 0.0001 | $ 0.0001 | ||||
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 | |||||
IPO | ||||||
Class Of Stock [Line Items] | ||||||
Number of aggregate shares committed by purchasers | 7,781,564 | |||||
Common stock, price per share | $ / shares | $ 15 | |||||
Gross proceeds from issuance of common stock | $ | $ 116,700 | |||||
Proceeds from initial public offering, net of underwriting discounts and commissions | $ | $ 107,100 | |||||
Underwriters Option to Purchase | ||||||
Class Of Stock [Line Items] | ||||||
Number of aggregate shares committed by purchasers | 781,564 | |||||
Fifth Amended and Restated Certification of Incorporation | ||||||
Class Of Stock [Line Items] | ||||||
Preferred stock, shares authorized | 57,108,717 | |||||
Additional proceeds amount | $ | $ 50,000 | |||||
Series 1 Redeemable Convertible Preferred Stock | Fifth Amended and Restated Certification of Incorporation | ||||||
Class Of Stock [Line Items] | ||||||
Preferred stock, shares authorized | 2,112,025 | |||||
Series A Redeemable Convertible Preferred Stock | Fifth Amended and Restated Certification of Incorporation | ||||||
Class Of Stock [Line Items] | ||||||
Preferred stock, shares authorized | 14,996,692 | |||||
Series B Redeemable Convertible Preferred Stock | Fifth Amended and Restated Certification of Incorporation | ||||||
Class Of Stock [Line Items] | ||||||
Preferred stock, shares authorized | 23,000,000 | |||||
Series C Redeemable Convertible Preferred Stock | Fifth Amended and Restated Certification of Incorporation | ||||||
Class Of Stock [Line Items] | ||||||
Preferred stock, shares authorized | 16,828,217 | 17,000,000 | ||||
Preferred stock, shares issued | 5,609,398 | |||||
Preferred stock, price per shares | $ / shares | $ 8.91 | |||||
Convertible Preferred Stock | IPO | ||||||
Class Of Stock [Line Items] | ||||||
Conversion of outstanding preferred stock to common stock | 18,933,053 |
Stockholders' Equity - Summary
Stockholders' Equity - Summary of Common Stock Shares Reserved for Future Issuance (Details) - shares | Dec. 31, 2019 | Dec. 31, 2018 |
Class Of Stock [Line Items] | ||
Common stock, shares reserved for future issuance | 6,682,774 | 6,049,439 |
Common Stock Options Outstanding | ||
Class Of Stock [Line Items] | ||
Common stock, shares reserved for future issuance | 5,744,036 | 4,502,133 |
Options Available For Grant Under Equity Incentive Plan | ||
Class Of Stock [Line Items] | ||
Common stock, shares reserved for future issuance | 938,738 | 1,547,306 |
Stock option plan - Additional
Stock option plan - Additional Information (Details) - USD ($) $ in Thousands | Jan. 01, 2019 | Jan. 01, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | May 31, 2017 | Mar. 31, 2011 |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Stock-based compensation | $ 16,449 | $ 10,225 | $ 3,394 | ||||
Employee Stock Options | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Stock options, maximum term | 10 years | ||||||
Stock-based compensation | $ 16,351 | 8,157 | 1,772 | ||||
Unrecognized stock-based compensation costs | $ 42,049 | ||||||
Weighted-average recognition period | 2 years 8 months 8 days | ||||||
Non-employee Stock Options | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Stock-based compensation | $ 98 | $ 2,068 | $ 1,622 | ||||
2017 Equity Incentive Plan | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Number of shares approved for grant under equity incentive plan | 1,932,000 | ||||||
Number of shares available for grant under equity incentive plan | 938,738 | ||||||
Number of additional shares approved for grant under equity incentive plan | 1,096,553 | 1,066,692 | |||||
2011 Equity Incentive Plan | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Number of shares approved for grant under equity incentive plan | 4,400,640 | ||||||
Number of shares available for grant under equity incentive plan | 0 |
Stock option plan - Summary of
Stock option plan - Summary of Share-Based Compensation Expense Included in Statements of Operations (Details) - Employee and Non-employee Stock Options - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Total stock-based compensation expense | $ 16,449 | $ 10,225 | $ 3,394 |
Research and Development | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Total stock-based compensation expense | 6,261 | 5,218 | 2,531 |
General and Administrative | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Total stock-based compensation expense | $ 10,188 | $ 5,007 | $ 863 |
Stock option plan - Fair Value
Stock option plan - Fair Value of Stock Options Granted Using Black-Scholes Options Pricing Model (Details) - Employee and Non-employee Stock Options - $ / shares | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Expected volatility, minimum | 74.20% | 74.90% | 74.20% |
Expected volatility, maximum | 82.10% | 86.50% | 79.30% |
Weighted-average risk free rate, minimum | 1.40% | 2.30% | 1.90% |
Weighted-average risk free rate, maximum | 2.60% | 3.00% | 2.20% |
Expected term (in years) | 6 years 7 days | 6 years 14 days | 6 years 3 days |
Weighted-average grant-date fair value per share | $ 14.94 | $ 26.42 | $ 10.71 |
Stock option plan - Summary o_2
Stock option plan - Summary of Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Options outstanding | ||
Beginning balance | 4,502,133 | |
Cancelled | (326,654) | |
Granted | 1,938,025 | |
Exercised | (369,468) | |
Ending balance | 5,744,036 | 4,502,133 |
Exercisable | 3,001,179 | |
Vested and expected to vest | 5,744,036 | |
Weighted average exercise price | ||
Beginning balance | $ 14.13 | |
Cancelled | 20.49 | |
Granted | 22.06 | |
Exercised | 7.32 | |
Ending balance | 16.88 | $ 14.13 |
Exercisable | 8.93 | |
Vested and expected to vest | $ 16.88 | |
Weighted average, Remaining contractual for life (Years) | ||
Balance | 7 years 6 months | 7 years 7 months 6 days |
Exercisable | 6 years 1 month 6 days | |
Vested and expected to vest | 7 years 6 months | |
Weighted average, Aggregate intrinsic value | ||
Balance | $ 72,251 | $ 46,575 |
Exercisable | 58,797 | |
Vested and expected to vest | $ 72,251 |
Net Loss Per Common Share (Deta
Net Loss Per Common Share (Details) - shares | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Potentially dilutive securities excluded from computations of diluted weighted-average shares outstanding | 5,443,730 | 4,318,731 | 3,849,743 |
Employee and Non-employee Stock Options | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Potentially dilutive securities excluded from computations of diluted weighted-average shares outstanding | 5,443,730 | 4,318,731 | 3,838,358 |
Stock Warrants | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Potentially dilutive securities excluded from computations of diluted weighted-average shares outstanding | 11,385 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) | 1 Months Ended | 12 Months Ended | ||
Apr. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Income Taxes [Line Items] | ||||
Unrecognized income tax benefits | $ 0 | $ 0 | ||
Unrecognized income tax benefits impact on effective income tax rate | 0 | 0 | ||
Accrued income taxes | $ 0 | $ 0 | ||
U.S. statutory income tax rate | 21.00% | 21.00% | 21.00% | |
Valuation allowance | $ 86,000,000 | $ 56,501,000 | ||
Federal research and development credit carryforwards | 10,874,000 | $ 7,521,000 | ||
Federal | ||||
Income Taxes [Line Items] | ||||
Net operating loss carryforwards | $ 286,100,000 | |||
Net operating loss carryforwards expiration year | 2029 | |||
Net operating loss carryforwards expire in 2029 | $ 92,700,000 | |||
Net operating loss carryforwards indefinite expiration period | 193,400,000 | |||
Federal research and development credit carryforwards | 10,900,000 | |||
Operating loss carryforwards limitation | $ 8,000,000 | |||
State | ||||
Income Taxes [Line Items] | ||||
Net operating loss carryforwards | $ 292,900,000 | |||
Net operating loss carryforwards expiration year | 2024 | |||
Operating loss carryforwards limitation | 1,200,000 | |||
Research and Development (R&D) Credit Carryforwards | ||||
Income Taxes [Line Items] | ||||
Tax credit carryforwards limitation | $ 100,000 | |||
Research and Development (R&D) Credit Carryforwards | Federal | ||||
Income Taxes [Line Items] | ||||
Net operating loss carryforwards | $ 10,900,000 | |||
Expiration year for tax credit carryforwards | 2034 |
Income Taxes - Summary of Diffe
Income Taxes - Summary of Differences Between the Income Tax Expense Attributable to Continuing Operations and the Expense Computed at U.S. Statutory Income Tax Rate (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | |||
Federal income tax benefit at statutory rate: | $ (25,714) | $ (17,910) | $ (20,441) |
Increase (reduction) in income tax resulting from: | |||
State Income Taxes | (2,369) | (1,518) | (1,623) |
Increase in Valuation Allowance | 29,499 | 26,614 | 8,977 |
Write off Sec. 382 Limited Carryforwards | 1,858 | ||
Equity Financing Expenses | 39 | ||
Stock Compensation | 461 | (3,011) | 152 |
Research and Development Credit | (3,529) | (4,187) | (1,882) |
Effect on Tax Cuts & Job Acts Rate Reduction | 14,770 | ||
Other | $ (206) | $ 12 | $ 8 |
Income Taxes - Components of Ta
Income Taxes - Components of Tax Effects of Temporary Differences and Operating Loss Carryforwards Including Significant Portions of Deferred Tax Assets and Deferred Tax Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Deferred tax assets | ||
Accrued expenses | $ 2,205 | $ 1,413 |
Deferred rent | 23 | |
Operating lease liabilities | 2,348 | |
Stock compensation | 4,865 | 2,038 |
Charitable contributions | 6 | 2 |
Capitalized patents and licenses | 2,156 | 1,544 |
R&D credits | 10,874 | 7,521 |
Net operating loss carryforwards | 65,869 | 43,997 |
Deferred tax assets | 88,323 | 56,538 |
Deferred tax liabilities | ||
Operating lease assets | (2,263) | |
Property, plant and equipment, primarily due to differences in depreciation | (60) | (37) |
Deferred tax liabilities | (2,323) | (37) |
Valuation allowance | $ (86,000) | $ (56,501) |
Income Taxes - Summary of Chang
Income Taxes - Summary of Changes in the Deferred Tax Valuation Allowance (Details) - Valuation Allowance of Deferred Tax Assets - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Valuation Allowance [Line Items] | |||
Balance at beginning of year | $ 56,501 | $ 29,887 | $ 20,910 |
Charges to costs and expenses | 31,357 | 26,614 | 8,977 |
Write-offs | (1,858) | ||
Balance at end of year | $ 86,000 | $ 56,501 | $ 29,887 |
Related Party Transactions - Ad
Related Party Transactions - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Scientific Advisory | Chairman of the Board of Directors | |||
Related Party Transaction [Line Items] | |||
Consulting fees | $ 6 | $ 6 | $ 11 |
Quarterly Financial Information
Quarterly Financial Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Quarterly Financial Information Disclosure [Abstract] | |||||||||||
Total operating expenses | $ 36,553 | $ 34,024 | $ 32,583 | $ 25,881 | $ 26,086 | $ 20,822 | $ 21,653 | $ 20,725 | $ 129,041 | $ 89,286 | $ 60,968 |
Operating loss | (36,553) | (34,024) | (32,583) | (25,881) | (26,086) | (20,822) | (21,653) | (20,725) | (129,041) | (89,286) | (60,968) |
Total other income (expense), net | 1,112 | 1,660 | 1,893 | 1,929 | 1,994 | 904 | 785 | 315 | 6,594 | 3,998 | 847 |
Net loss | (35,441) | (32,364) | (30,690) | (23,952) | (24,092) | (19,918) | (20,868) | (20,410) | (122,447) | (85,288) | (60,121) |
Accretion of redeemable convertible preferred stock | (4,757) | ||||||||||
Net loss attributable to common stockholders | $ (35,441) | $ (32,364) | $ (30,690) | $ (23,952) | $ (24,092) | $ (19,918) | $ (20,868) | $ (20,410) | $ (122,447) | $ (85,288) | $ (64,878) |
Net loss per share attributable to common stockholders, basic and diluted | $ (0.94) | $ (0.86) | $ (0.82) | $ (0.64) | $ (0.65) | $ (0.59) | $ (0.64) | $ (0.70) | $ (3.27) | $ (2.56) | $ (3.57) |
Weighted average common shares outstanding, basic and diluted | 37,586,218 | 37,540,380 | 37,470,926 | 37,396,980 | 37,203,233 | 33,829,437 | 32,781,921 | 29,360,470 | 37,499,256 | 33,316,719 | 18,197,970 |