DEI Document
DEI Document - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2018 | Feb. 15, 2019 | Jun. 30, 2018 | |
Entity [Abstract] | |||
Entity Registrant Name | MENLO THERAPEUTICS INC. | ||
Entity Central Index Key | 1,566,044 | ||
Trading Symbol | MNLO | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | true | ||
Entity Ex Transition Period | true | ||
Entity Shell Company | false | ||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2018 | ||
Document Fiscal Year Focus | 2,018 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false | ||
Entity Common Stock, Shares Outstanding | 23,258,184 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Public Float | $ 88.6 |
Balance Sheets
Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Current assets: | ||
Cash and cash equivalents | $ 49,510 | $ 10,206 |
Short-term investments | 86,740 | 49,295 |
Accounts receivable | 786 | |
Prepaid expenses and other current assets | 3,250 | 3,574 |
Total current assets | 139,500 | 63,861 |
Long-term investments | 2,978 | |
Property and equipment, net | 146 | 28 |
Prepaid and other long-term assets | 282 | |
Total assets | 139,928 | 66,867 |
Current liabilities: | ||
Accounts payable | 3,290 | 2,462 |
Accrued expenses and other current liabilities | 6,254 | 3,559 |
Deferred revenue, current | 1,796 | |
Total current liabilities | 9,544 | 7,817 |
Deferred revenue, long-term | 6,735 | |
Other non-current liabilities | 7 | 22 |
Total liabilities | 9,551 | 14,574 |
Commitments and contingencies (see Note 6) | ||
Stockholders’ equity (deficit): | ||
Preferred stock: $0.0001 par value; 20,000,000 shares and no shares authorized at December 31, 2018 and 2017, respectively; no shares issued and outstanding at December 31, 2018 and 2017, respectively | ||
Common stock: $0.0001 par value; 300,000,000 shares and 55,000,000 shares authorized at December 31, 2018 and 2017, respectively; 23,233,184 and 5,298,593 shares issued and outstanding at December 31, 2018 and 2017, respectively | 3 | 1 |
Additional paid-in capital | 241,106 | 2,207 |
Accumulated other comprehensive loss | (96) | (51) |
Accumulated deficit | (110,636) | (59,191) |
Total stockholders’ equity (deficit) | 130,377 | (57,034) |
Total liabilities, convertible preferred stock and stockholders’ equity (deficit) | $ 139,928 | 66,867 |
Series A Convertible Preferred Stock | ||
Current liabilities: | ||
Convertible preferred stock | 14,183 | |
Series B Convertible Preferred Stock | ||
Current liabilities: | ||
Convertible preferred stock | 44,820 | |
Series C Convertible Preferred Stock | ||
Current liabilities: | ||
Convertible preferred stock | $ 50,324 |
Balance Sheets (Parenthetical)
Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Convertible preferred stock, par value per share (in USD per share) | $ 0.001 | |
Convertible preferred stock authorized (shares) | 28,322,761 | |
Preferred stock, par value per share (in USD per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized (shares) | 20,000,000 | 0 |
Preferred stock, shares issued (shares) | 0 | 0 |
Preferred stock, shares outstanding (shares) | 0 | 0 |
Common stock, par value per share (in USD per share) | $ 0.0001 | $ 0.0001 |
Common stock authorized (shares) | 300,000,000 | 55,000,000 |
Common stock issued (shares) | 23,233,184 | 5,298,593 |
Common stock outstanding (shares) | 23,233,184 | 5,298,593 |
Series A Convertible Preferred Stock | ||
Convertible preferred stock, par value per share (in USD per share) | $ 0.001 | $ 0.001 |
Convertible preferred stock authorized (shares) | 0 | 14,300 |
Convertible preferred stock issued (shares) | 0 | 14,300 |
Convertible preferred stock outstanding (shares) | 0 | 14,300 |
Convertible preferred stock, liquidation value | $ 0 | $ 14,300 |
Series B Convertible Preferred Stock | ||
Convertible preferred stock, par value per share (in USD per share) | $ 0.001 | $ 0.001 |
Convertible preferred stock authorized (shares) | 0 | 14,106,583 |
Convertible preferred stock issued (shares) | 0 | 14,106,583 |
Convertible preferred stock outstanding (shares) | 0 | 14,106,583 |
Convertible preferred stock, liquidation value | $ 0 | $ 45,000 |
Series C Convertible Preferred Stock | ||
Convertible preferred stock, par value per share (in USD per share) | $ 0.001 | $ 0.001 |
Convertible preferred stock authorized (shares) | 0 | 14,201,878 |
Convertible preferred stock issued (shares) | 0 | 11,854,463 |
Convertible preferred stock outstanding (shares) | 0 | 11,854,463 |
Convertible preferred stock, liquidation value | $ 0 | $ 50,500 |
Statements of Operations and Co
Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Income Statement [Abstract] | |||
Collaboration and license revenue | $ 10,640 | $ 4,582 | $ 674 |
Type of Revenue [Extensible List] | us-gaap:LicenseAndServiceMember | us-gaap:LicenseAndServiceMember | us-gaap:LicenseAndServiceMember |
Operating expenses: | |||
Research and development | $ 52,989 | $ 29,007 | $ 11,255 |
General and administrative | 12,186 | 5,168 | 3,751 |
Total operating expenses | 65,175 | 34,175 | 15,006 |
Loss from operations | (54,535) | (29,593) | (14,332) |
Interest income and other expense, net | 3,090 | 517 | 264 |
Net loss attributable to common stockholders | (51,445) | (29,076) | (14,068) |
Other comprehensive loss: | |||
Unrealized loss on available-for-sale securities | (45) | (25) | (26) |
Comprehensive loss | $ (51,490) | $ (29,101) | $ (14,094) |
Net loss attributable to common stockholder per share, basic and diluted | $ (2.37) | $ (5.69) | $ (2.82) |
Weighted-average number of common shares used to compute basic and diluted net loss per share | 21,668,689 | 5,108,121 | 4,987,133 |
Statement of Convertible Prefer
Statement of Convertible Preferred Stock and Stockholders' Equity (Deficit) - USD ($) $ in Thousands | Total | Series A Convertible Preferred Stock | Series B Convertible Preferred Stock | Series C Convertible Preferred Stock | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Other Comprehensive Loss |
Balance, beginning at Dec. 31, 2015 | $ (15,953) | $ 1 | $ 93 | $ (16,047) | ||||
Preferred stock, beginning at Dec. 31, 2015 | 14,300 | 14,106,583 | ||||||
Preferred stock, beginning at Dec. 31, 2015 | $ 14,183 | $ 44,820 | ||||||
Common stock, beginning (shares) at Dec. 31, 2015 | 5,280,058 | |||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Vesting of early exercised stock options | 33 | 33 | ||||||
Stock-based compensation | 573 | 573 | ||||||
Unrealized loss on available-for-sale securities | (26) | $ (26) | ||||||
Net loss | (14,068) | (14,068) | ||||||
Balance, ending at Dec. 31, 2016 | (29,441) | $ 1 | 699 | (30,115) | (26) | |||
Preferred stock, ending at Dec. 31, 2016 | 14,300 | 14,106,583 | ||||||
Preferred stock, ending at Dec. 31, 2016 | $ 14,183 | $ 44,820 | ||||||
Common stock, ending (shares) at Dec. 31, 2016 | 5,280,058 | |||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Issuance of preferred stock | $ 50,324 | |||||||
Issuance of preferred stock (shares) | 11,854,463 | |||||||
Issuance of common stock onexercise of stock options | $ 34 | 34 | ||||||
Exercise of unvested stock options (shares) | 18,535 | 18,535 | ||||||
Vesting of early exercised stock options | $ 22 | 22 | ||||||
Stock-based compensation | 1,452 | 1,452 | ||||||
Unrealized loss on available-for-sale securities | (25) | (25) | ||||||
Net loss | (29,076) | (29,076) | ||||||
Balance, ending at Dec. 31, 2017 | $ (57,034) | $ 1 | 2,207 | (59,191) | (51) | |||
Preferred stock, ending at Dec. 31, 2017 | 14,300 | 14,106,583 | 11,854,463 | |||||
Preferred stock, ending at Dec. 31, 2017 | $ 14,183 | $ 44,820 | $ 50,324 | |||||
Common stock, ending (shares) at Dec. 31, 2017 | 5,298,593 | 5,298,593 | ||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Conversion of preferred stock to common stock | $ 109,327 | $ (14,183) | $ (44,820) | $ (50,324) | $ 1 | 109,326 | ||
Conversion of preferred stock to common stock (shares) | (14,300) | (14,106,583) | (11,854,463) | 9,629,405 | ||||
Issuance of common stock under public offering, net | 125,417 | $ 1 | 125,416 | |||||
Issuance of common stock under public offering, net (shares) | 8,050,000 | |||||||
Issuance of common stock onexercise of stock options | $ 496 | 496 | ||||||
Exercise of unvested stock options (shares) | 255,186 | 255,186 | ||||||
Vesting of early exercised stock options | $ 23 | 23 | ||||||
Stock-based compensation | 3,638 | 3,638 | ||||||
Unrealized loss on available-for-sale securities | (45) | (45) | ||||||
Net loss | (51,445) | (51,445) | ||||||
Balance, ending at Dec. 31, 2018 | $ 130,377 | $ 3 | $ 241,106 | $ (110,636) | $ (96) | |||
Preferred stock, ending at Dec. 31, 2018 | 0 | 0 | 0 | |||||
Common stock, ending (shares) at Dec. 31, 2018 | 23,233,184 | 23,233,184 |
Statement of Convertible Pref_2
Statement of Convertible Preferred Stock and Stockholders' Equity (Deficit) (Parenthetical) $ in Thousands | 12 Months Ended |
Dec. 31, 2017USD ($) | |
Preferred Stock | Series C Convertible Preferred Stock | |
Preferred stock issuance costs | $ 173 |
Statement of Cash Flows
Statement of Cash Flows - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Operating activities | |||
Net loss | $ (51,445,000) | $ (29,076,000) | $ (14,068,000) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation and amortization | 22,000 | 8,000 | 4,000 |
Amortization of premium on investment securities | (774,000) | 66,000 | 158,000 |
Stock-based compensation expense | 3,638,000 | 1,452,000 | 573,000 |
Gain on disposal of equipment | 19,000 | 0 | |
Accrued interest | 31,000 | 0 | |
Change in operating assets and liabilities: | |||
Accounts receivable | 786,000 | (786,000) | 0 |
Prepaid expenses and other current assets | 324,000 | (1,790,000) | (555,000) |
Other long-term assets | (282,000) | 66,000 | (66,000) |
Accounts payable | 825,000 | 620,000 | 889,000 |
Accrued expenses and other current liabilities | 2,719,000 | 2,976,000 | 466,000 |
Deferred revenue | (8,531,000) | (1,796,000) | 10,327,000 |
Other non-current liabilities | (15,000) | (12,000) | 7,000 |
Net cash used in operating activities | (52,733,000) | (28,222,000) | (2,265,000) |
Investing activities | |||
Purchase of property and equipment | (140,000) | (27,000) | (31,000) |
Purchase of investments | (126,700,000) | (64,148,000) | (55,309,000) |
Proceeds from sales of investments | 5,100,000 | 6,000,000 | 3,600,000 |
Proceeds from maturities of investments | 87,864,000 | 43,085,000 | 14,224,000 |
Net cash used in investing activities | (33,876,000) | (15,090,000) | (37,516,000) |
Financing activities | |||
Issuance of common stock pursuant to public offering, net of issuance costs | 125,417,000 | ||
Proceeds from issuance of convertible preferred stock, net of issuance costs | 50,324,000 | 0 | |
Proceeds from the exercise of stock options | 496,000 | 34,000 | 0 |
Deferred financing costs | (867,000) | 0 | |
Net cash provided by financing activities | 125,913,000 | 49,491,000 | 0 |
Net increase (decrease) in cash and cash equivalents | 39,304,000 | 6,179,000 | (39,781,000) |
Cash and cash equivalents at beginning of period | 10,206,000 | 4,027,000 | 43,808,000 |
Cash and cash equivalents at end of period | 49,510,000 | 10,206,000 | 4,027,000 |
Noncash financing activities | |||
Conversion of preferred stock to common stock | $ 109,327,000 | ||
Deferred financing costs | $ 316,000 | $ 0 |
Formation and Business of the C
Formation and Business of the Company | 12 Months Ended |
Dec. 31, 2018 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Formation and Business of the Company | 1. Formation and Business of the Company Menlo Therapeutics Inc. (the “Company”) is a late‑stage biopharmaceutical company focused on the development and commercialization of serlopitant for the treatment of pruritus, or itch, associated with various conditions such as prurigo nodularis, psoriasis and chronic pruritus of unknown origin, or CPUO. We believe that serlopitant, a highly selective small molecule inhibitor of the neurokinin 1 receptor, or NK1-R, given as a once-daily, oral tablet, has the potential to significantly alleviate pruritus. The Company was incorporated in Delaware in October 2011. Since commencing operations, the Company has devoted substantially all of its resources to developing its product candidate, serlopitant, including conducting clinical trials and providing general and administrative support for these operations. Initial Public Offering In January 2018, the Company completed its initial public offering (“IPO”) of shares of its common stock, pursuant to which the Company issued 8,050,000 shares of common stock, which includes 1,050,000 shares issued pursuant to the over-allotment option granted to its underwriters and received net proceeds of approximately $125.4 million, after deducting underwriting discounts, commissions and offering expenses. In connection with the completion of the Company's IPO, all shares of convertible preferred stock converted into 9,629,405 shares of common stock. Liquidity and Capital Resources The accompanying 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. The financial statements do not reflect any adjustments relating to the recoverability and reclassification of assets and liabilities that might be necessary if the Company is unable to continue as a going concern. Since inception, the Company has incurred losses and negative cash flows from operations. For the 12 months ended December 31, 2018, the Company incurred a net loss of $51.4 million and used $52.7 million of cash in operations. As of December 31, 2018, the Company had cash, cash equivalents and investments of $136.3 million and an accumulated deficit of $110.6 million. Management expects to continue to incur additional substantial losses in the foreseeable future as a result of the Company’s research and development activities. Management plans to finance operations through equity or debt financings or other capital sources, including potential collaborations or other strategic transactions. There can be no assurances that, in the event that the Company requires additional financing, such financing will be available on terms which are favorable to the Company, or at all. If the Company is unable to raise additional funding to meet its working capital needs in the future, it will be forced to delay or reduce the scope of its research programs and/or limit or cease its operations. The Company believes that its existing cash, cash equivalents and investments as of December 31, 2018 will provide sufficient funds to enable it to meet its obligations for at least the next 12 months from the issuance of the Company’s financial statements as of and for the 12 months ended December 31, 2018. |
Significant Accounting Policies
Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Significant Accounting Policies | 2. Significant Accounting Policies Basis of Presentation These financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and include all adjustments necessary for the fair presentation of the Company’s financial position for the periods presented. Reverse Stock Split On January 8, 2018, the Company effected a reverse split of shares of the Company’s common stock at a ratio of 1-for-2.6975 pursuant to an amendment to the amended and restated certificate of incorporation approved by the Company’s board of directors and stockholders. The par value and the authorized shares of the common stock were not adjusted as a result of the reverse split. All issued and outstanding common stock share and per share amounts contained in the financial statements have been retroactively adjusted to reflect this reverse split for all periods presented, and the conversion ratio of the preferred stock was adjusted accordingly. Segments The Company operates in one segment. Management uses one measurement of profitability and does not segregate its business for internal reporting. All long‑lived assets are maintained in the United States of America. Use of Estimates Preparation of financial statements in conformity with U.S. GAAP, requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of expenses during the reporting periods covered by the financial statements and accompanying notes. On an ongoing basis, management evaluates its estimates, including those related to revenue recognition, stock‑based compensation expense, the resolution of uncertain tax positions and valuation allowance, recovery of long‑lived assets and accruals for research and development costs. Management bases its estimates on historical experience on various assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results could differ materially from those estimates. Risk and Uncertainties The Company’s future results of operations involve a number of risks and uncertainties. Factors that could affect the Company’s future operating results and cause actual results to vary materially from expectations include, but are not limited to, uncertainty of results of clinical trials and reaching milestones, uncertainty of regulatory approval of the Company’s potential drug candidate, uncertainty of market acceptance of the Company’s product candidate, competition from substitute products and larger companies, securing and protecting proprietary technology, strategic relationships and dependence on key individuals and sole source suppliers. The Company’s product candidate requires clearances from the U.S. Food and Drug Administration (“FDA”) or other international regulatory agencies prior to commercial sales. There can be no assurance that the product candidate will receive the necessary clearances. If the Company was denied clearance, clearance was delayed or the Company was unable to maintain clearance, it could have a materially adverse impact on the Company. The Company expects to incur substantial operating losses for the next several years and will need to obtain additional financing in order to complete clinical studies and launch and commercialize any product candidates for which it receives regulatory approval. There can be no assurance that such financing will be available or will be at terms acceptable by the Company. Cash and Cash Equivalents Cash and cash equivalents are stated at fair value. Cash equivalents include only securities having an original maturity of three months or less at the time of purchase. The Company limits its credit risk associated with cash and cash equivalents by placing its investments with an institution it believes is highly creditworthy and with highly rated money market funds. As of December 31, 2018 and 2017, cash and cash equivalents consisted of bank deposits, cash and investments in money market funds. Investment Securities The Company classifies its investment securities as available‑for‑sale. Those investments with maturities less than 12 months at the date of purchase are considered short‑term investments. Those investments with maturities greater than 12 months at the date of purchase are considered long‑term investments. The Company’s investment securities classified as available‑for‑sale are recorded at fair value based upon quoted market prices at period end. Unrealized gains and losses, deemed temporary in nature, are reported as a separate component of comprehensive income or loss. A decline in the fair value of any security below cost that is deemed other than temporary results in a charge to earnings and the corresponding establishment of a new cost basis for the security. Premiums (discounts) are amortized (accreted) over the life of the related security as an adjustment to yield using the straight‑line interest method. Dividend and interest income are recognized when earned. Realized gains and losses are included in earnings and are derived using the specific identification method for determining the cost of securities sold. Property and Equipment, Net Property and equipment are stated at cost and depreciated using the straight‑line method over the estimated useful lives of the assets, generally between three and five years. Maintenance and repairs are charged to expense as incurred, and improvements are capitalized. When assets are retired or otherwise disposed of, the cost and accumulated depreciation are removed from the balance sheet and any resulting gain or loss is reflected in operations in the period realized. Fair Value of Financial Instruments The carrying amounts of the Company’s financial instruments, which include cash, accounts payable and accrued liabilities and other current liabilities, and deferred revenue approximate their fair values due to their short maturities. Concentration of Credit Risk Financial instruments that potentially subject the Company to significant concentrations of credit risk consist principally of cash, cash equivalents and investments. As of December 31, 2018 and 2017, the majority of our cash, cash equivalents and investments are held by two U.S. financial institutions in excess of federally insured limits. We invest cash in excess of our current needs in United States Treasury and government agency securities, highly‑rated short or medium‑term debt securities and money market funds and, by policy, diversify our investments to limit the amount of credit exposure. The Company has an investment policy which limits the Company to investing in highly rated corporate and government notes, and no individual investment may comprise more than 5% of the total portfolio except for securities issued by the U.S. Treasury, U.S. government agencies and money market funds, which are exempt from this restriction. Income Taxes The Company accounts for income taxes under the asset and liability method which requires, among other things, that deferred income taxes be provided for temporary differences between the tax basis of the Company’s assets and liabilities and their financial statement reported amounts. Management makes estimates, assumptions and judgments to determine the Company’s provision for income taxes and also for deferred tax assets and liabilities, and any valuation allowances recorded against the Company’s deferred tax assets. The Company assesses the likelihood that its deferred tax assets will be recovered from future taxable income and to the extent the Company believes that recovery is not more likely than not, the Company must establish a valuation allowance. The Company has adopted ASC 740-10, Accounting for Uncertainty in Income Taxes, that prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of uncertain tax positions taken or expected to be taken in the Company’s income tax return, and also provides guidance on derecognition, classification, interest and penalties, accounting in interim periods, disclosure and transition. To date, there have been no interest or penalties charged in relation to the unrecognized tax benefits. Research and Development Expenses Research and development costs are expensed as incurred. Substantially all of our research and development expenses consist of expenses incurred in connection with the development of serlopitant. These expenses include certain payroll and personnel expenses including stock‑based compensation expense, consulting costs, contract manufacturing costs, and fees paid to clinical research organizations, or CROs, to conduct research and development. Nonrefundable advance payments for goods or services that will be used or rendered for future research and development activities are deferred and capitalized and recognized as an expense as the goods are delivered or the related services are performed. The Company estimates non‑clinical study and clinical trial expenses based on the services performed pursuant to contracts with research institutions and clinical research organizations that conduct and manage non‑clinical studies and clinical trials on its behalf. In accruing service fees, the Company estimates the time period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from the estimate, the Company will adjust the accrual accordingly. Payments made to third parties under these arrangements in advance of the receipt of the related services are recorded as prepaid expenses until the services are rendered. Stock-Based Compensation The Company measures and recognizes compensation expense for all stock‑based awards made to employees, directors and non‑employees, based on estimated fair values recognized using the straight‑line method over the requisite service period and is reduced for forfeitures as they occur. The fair value of options to purchase common stock granted to employees is estimated on the grant date using the Black‑Scholes option valuation model. The calculation of stock‑based compensation expense requires that the Company make certain assumptions and judgments about a number of complex and subjective variables used in the Black‑Scholes model, including the expected term, expected volatility of the underlying common stock, risk‑free interest rate. The Company accounts for options issued to non‑employees using the Black‑Scholes option valuation model and is measured and recognized as the stock options are earned. Convertible Preferred Stock The Company recorded convertible preferred stock at fair value on the dates of issuance, net of issuance costs. The convertible preferred stock is recorded outside of stockholders’ equity (deficit) because, in the event of certain deemed liquidation events considered not solely within the Company’s control, such as a merger, acquisition and sale of all or substantially all of the Company’s assets, the convertible preferred stock will become redeemable at the option of the holders. All outstanding convertible preferred stock converted into common stock in January 2018 upon the effectiveness of the IPO. Comprehensive Income (Loss) Comprehensive income (loss) is defined as the change in equity of the Company during a period from transactions and other events and circumstances excluding transactions resulting from investments and distributions to owners. Comprehensive loss consists of the net loss and changes in accumulated other comprehensive income, which are comprised of unrealized gains (losses) on available‑for‑sale investments. Revenue Recognition The Company records revenue based on a five-step model in accordance with Accounting Standards Codification ("ASC") 606, Revenue from Contracts with Customers ("ASC 606"). For the Company’s collaboration agreement, which is discussed further under Note 5, the Company identifies the performance obligations, determines the transaction price, allocates the contract transaction price to the performance obligations, and recognizes the revenue when (or as) the performance obligation is satisfied. The Company identifies the performance obligations included within the agreement and evaluates which performance obligations are distinct. Upfront payments for licenses are evaluated to determine if the license is capable of being distinct from the obligations of the Company to participate on certain development and/or commercialization committees with the collaboration partners and supply manufactured drug product for clinical trials. For performance obligations that the Company satisfies over time, the Company utilizes the input method and revenue is recognized by consistently applying a method of measuring progress toward complete satisfaction of that performance obligation. The Company periodically reviews its estimated periods of performance based on the progress under each arrangement and accounts for the impact of any changes in estimated periods of performance on a prospective basis. Milestone payments are a form of variable consideration as the payments are contingent upon achievement of a substantive event. Milestone payments are estimated and included in the transaction price when the Company determines that it is probable that there will not be a significant reversal of cumulative revenue recognized in future periods. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such milestones and any related constraint, and if necessary, adjusts the estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect license, collaboration or other revenues and earnings in the period of adjustment. Research and development revenues and cost reimbursements are based upon negotiated rates for the Company’s full-time employee equivalents (“FTE”) and actual out-of-pocket costs. FTE rates are set based upon the Company’s costs, and which the Company believes approximate fair value. None of the revenues recognized to date are refundable if the relevant research effort is not successful. In accordance with ASC 606, the Company is required to adjust the transaction price for the effects of the time value of money if the timing of payments agreed to by the parties to the contract, explicitly or implicitly, provides the Company or its customer with a significant benefit of financing the transfer of goods or services. The Company concluded that its collaboration agreement did not contain a significant financing component because the payment structure of its agreements arise from reasons other than providing a significant benefit of financing. Net Loss per Share of Common Stock Basic net loss per common share is calculated by dividing the net loss attributable to common stockholders by the weighted‑average number of common shares outstanding during the period, without consideration for potentially dilutive securities. Diluted net loss per share is computed by dividing the net loss attributable to common stockholders by the weighted‑average number of common shares and potentially dilutive securities outstanding for the period. For purposes of the diluted net loss per share calculation, convertible preferred stock and common stock options are considered to be potentially dilutive securities. Because the Company has reported a net loss for the years ended December 31, 2018, 2017 and 2016, diluted net loss per common share is the same as basic net loss per common share for those periods. Recent Accounting Pronouncements In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2014‑09, Revenue from Contracts with Customers (Topic 606) Revenue Recognition Revenue from Contracts with Customers (Topic 606): Deferral of the Effective Date In February 2016, the FASB issued ASU 2016‑02, Leases Targeted Improvements to ASC 842 In June 2016, the FASB issued ASU 2016-13, Financial Instruments — Credit Losses — Measurement of Credit Losses on Financial Instruments In February 2018, the FASB issued ASU 2018-02, Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income In June 2018, the FASB issued ASU 2018-07 Improvements to Nonemployee Share-Based Payment Accounting (Topic 718) In August 2018, the SEC adopted the final rule under SEC Release No. 33-10532, Disclosure Update and Simplification In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820) |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2018 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 3. Fair Value Measurements The fair value of our financial instruments reflects the amounts that we estimate we would receive in connection with the sale of an asset or pay in connection with the transfer of a liability in an orderly transaction between market participants at the measurement date (exit price). We disclose and recognize the fair value of our assets and liabilities using a hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The hierarchy gives the highest priority to valuations based upon unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to valuations based upon unobservable inputs that are significant to the valuation (Level 3 measurements). The guidance establishes three levels of the fair value hierarchy as follows: Level 1 ‑ Inputs that reflect unadjusted quoted prices in active markets for identical assets or liabilities that we have the ability to access at the measurement date; Level 2 ‑ Inputs other than quoted prices that are observable for the assets or liability either directly or indirectly, including inputs in markets that are not considered to be active; Level 3 ‑ Inputs that are unobservable. Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. Our assessment of the significance of a particular input to the fair value measurement in its entirety requires management to make judgments and consider factors specific to the asset or liability. The Company recognizes transfers between levels of the fair value hierarchy as of the end of the reporting period. There were no transfers within the hierarchy during the years ended December 31, 2018 and 2017. A summary of the assets and liabilities carried at fair value in accordance with the hierarchy defined above is as follows (in thousands): Fair Value Measurements Using Level 1 Level 2 Level 3 Total December 31, 2018 Assets: Money market funds $ 5,802 $ — $ — $ 5,802 Corporate notes — 41,035 — 41,035 Commercial paper — 63,036 — 63,036 Asset backed securities — 12,213 — 12,213 Government notes — 12,476 — 12,476 Total assets $ 5,802 $ 128,760 $ — $ 134,562 Fair Value Measurements Using Level 1 Level 2 Level 3 Total December 31, 2017 Assets: Money market funds $ 8,685 $ — $ — $ 8,685 Corporate notes 5,103 40,995 — 46,098 Government notes 6,175 — — 6,175 Total assets $ 19,963 $ 40,995 $ — $ 60,958 The Company uses a market approach for determining the fair value of all its Level 1 and Level 2 money market funds and marketable securities. To value its money market funds, the Company values the funds at $1 stable net asset value, which is the market pricing convention for identical assets that the Company has the ability to access. The investments are classified as available‑for‑sale securities. At December 31, 2018 and 2017, the balance in the Company’s accumulated other comprehensive income was comprised solely of activity related to the Company’s available‑for‑sale securities. There were no realized gains or losses recognized on the sale or maturity of available‑for‑sale securities for the years ended December 31, 2018 and 2017 and as a result, the Company did not reclassify any amounts out of accumulated other comprehensive income for the year. The Company has a limited number of available‑for‑sale securities in insignificant loss positions as of December 31, 2018 and 2017, which the Company does not intend to sell and has concluded it will not be required to sell before recovery of the amortized cost for the investment at maturity. The following table summarizes the available‑for‑sale securities (in thousands): Amortized Cost Unrealized Gains Unrealized Losses Fair Value December 31, 2018 Money market funds $ 5,802 $ — $ — $ 5,802 Corporate notes 41,103 2 (70 ) 41,035 Commercial paper 63,036 — — 63,036 Asset backed securities 12,236 — (23 ) 12,213 Government notes 12,481 — (5 ) 12,476 $ 134,658 $ 2 $ (98 ) $ 134,562 Amortized Cost Unrealized Gains Unrealized Losses Fair Value December 31, 2017 Money market funds $ 8,685 $ — $ — $ 8,685 Corporate notes 46,133 — (35 ) 46,098 Government notes 6,191 — (16 ) 6,175 $ 61,009 $ — $ (51 ) $ 60,958 |
Balance Sheets Components
Balance Sheets Components | 12 Months Ended |
Dec. 31, 2018 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Balance Sheets Components | 4. Balance Sheets Components Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consisted of the following (in thousands): December 31, 2018 2017 Accrued personnel expenses $ 2,649 $ 1,108 Accrued clinical and development expenses 3,349 2,250 Other 256 201 Total $ 6,254 $ 3,559 |
License Agreements
License Agreements | 12 Months Ended |
Dec. 31, 2018 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
License Agreements | 5. License Agreements In December 2012, the Company entered into an exclusive worldwide royalty free license agreement with Merck Sharp & Dohme Corp., or “Merck” for exclusive worldwide rights for the development and commercialization of serlopitant and two other NK 1 In May 2018, the Company paid a $3.0 million milestone payment associated with the initiation of the Company’s Phase 3 clinical program for pruritus associated with prurigo nodularis. Future milestone payments are considered a form of variable consideration and accrued for when the Company determines that it is probable that there will not be a significant reversal of the accrual in future periods. JT Torii Collaboration Agreement In August 2016, the Company entered into a license and collaboration agreement (the “Collaboration Agreement”) with Japan Tobacco Inc. and Torii Pharmaceutical Co. Ltd. (together referred to as “JT Torii”). Under the Collaboration Agreement, the Company granted to JT Torii the rights to develop and commercialize products containing serlopitant in Japan, for the treatment of diseases and conditions other than nausea or vomiting. In exchange, JT Torii paid the Company an upfront, non‑refundable payment of $11.0 million. In addition, the Company was entitled to receive aggregate payments of up to $28.0 million upon the achievement of specified development and regulatory milestones, and $15.0 million upon the achievement of a commercial milestone, as well as tiered royalties from the mid-single digits up to the mid‑teens on sales of licensed products in Japan. The Company’s performance obligations under the license agreement included the transfer of intellectual property rights in the form of licenses, obligations to participate on certain development and/or commercialization committees with the collaboration partners and supply manufactured drug product for clinical trials. In the second quarter of 2018, the Company and JT Torii agreed to terminate the Collaboration Agreement and JT Torii halted development activities in Japan. As a result, the Company has reacquired full ownership of the development and commercialization rights to serlopitant in Japan and accelerated recognition of the remaining deferred revenue of $8.1 million during the quarter. In the second quarter of 2018, the Company also earned and recognized a $2.0 million milestone payment related to JT Torii’s receipt of investigational new drug application (“IND”) enabling past clinical study reports delivered by the Company under the Collaboration Agreement. Under the Collaboration Agreement, the Company was reimbursed by JT Torii for the non-commercial supplies of serlopitant at the same rate it was charged by the third-party manufacturer for such supplies, which price did not include a significant or incremental discount for JT Torii. The assessment of performance obligations required judgment in order to determine the allocation of revenue to each deliverable and the appropriate period of time over which the revenue should be recognized. Under the Collaboration Agreement, the Company determined that the license was not distinct from the research and development services because JT Torii could not use the license with its available resources to obtain any economic value without the Company’s participation. The license and the services were combined as one unit of accounting and upfront payments were recorded initially as deferred revenue in the balance sheet. Revenue was then recognized over an estimated performance period as performance of services was being completed. The Company recognized the upfront fee based on performance of the obligation using input method over the period of performance, which represented the estimated development period in the territories based on the initial development plan managed by the joint steering committee. The original term of the agreement was through the expiration of the patents associated with serlopitant. Under the Collaboration Agreement, two of the milestones, which amount to $2.0 million each, related to the preparation of an IND for submission to regulatory authorities in the territory were considered substantive given that they are triggered by the Company’s performance relative to the achievement of pre-specified, “at risk” milestone events, including the submission of all completed trials clinical data packages and the validation of the manufacturing process. The Company earned and recognized a $2.0 million milestone payment during each of the years ended December 31, 2018 and 2017. On September 1, 2017, the Company entered into a new services agreement with JT Torii to provide research and development services, including regulatory, chemistry and manufacturing support and related materials that is distinct from the original Collaboration Agreement. The Company evaluated the new services agreement and determined that the research and materials delivered to JT Torii represented another contract that provides distinct goods and services to JT Torii. The fees received under the services agreement were recognized as and when such services were performed by the Company and JT Torii consumed the benefits of those services. During the years ended December 31, 2018, 2017, and 2016, the Company recognized revenue of $10.6, $4.6, and $0.7 million respectively in the statement of operations related to the services agreement and Collaboration Agreement. The services agreement terminated upon the termination of the Collaboration Agreement. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2018 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 6. Commitments and Contingencies Legal Matters The Company’s industry is characterized by frequent claims and litigation, including claims regarding intellectual property. As a result, the Company may be subject to various legal proceedings from time to time. The results of any future litigation cannot be predicted with certainty, and regardless of the outcome, litigation can have an adverse impact on the Company because of defense and settlement costs, diversion of management resources and other factors. On November 8, 2018, a putative securities class action complaint captioned Pavel Savelstrov v. Menlo Therapeutics, Inc., et al., Case No.18-CIV-06049, was filed in state court in the Superior Court of the State of California, County of San Mateo, against the Company, certain of its current executive officers and its directors, and certain underwriters in the Company’s initial public offering. On January 28, 2019, a putative securities class action complaint captioned Hugh McKay v. Menlo Therapeutics, Inc., et al. , was filed in state court in the Superior Court of the State of California, County of San Mateo, against the Company, certain of its current executive officers and its directors, and certain underwriters in the Company’s initial public offering. The complaints allege violations of Sections 11, 12(a)(2) and 15 of the Securities Act of 1933 due to allegedly false and misleading statements in connection with the Company’s initial public offering. The Company believes that the lawsuits are without merit and intends to vigorously defend itself. Accordingly, the Company cannot reasonably estimate any range of potential future charges, and the Company has not recorded any accrual for a contingent liability associated with these legal proceeding. Leases The Company conducts its operations using leased office facilities. In September 2017, the Company entered into a lease agreement. The 30 month lease, beginning on October 1, 2017, provides approximately 14,000 square feet of office space in Redwood City, California. Base annual rent is approximately $55,000 per month, with annual increases. The Company recognizes rent expense on a straight‑line basis over the respective lease period. Rent expense for the years ended December 31, 2018, 2017 and 2016 was $0.8 million, $0.4 million and $0.2 million, respectively. As of December 31, 2018, total future minimum lease payments under our operating leases are as follows (in thousands): Year ending December 31: 2019 $ 675 2020 173 Total future minimum lease payments $ 848 Indemnification As permitted under Delaware law and in accordance with the Company’s bylaws, the Company is required to indemnify its officers and directors for certain events or occurrences while the officer or director is or was serving in such capacity. The Company is also party to indemnification agreements with its directors. The Company believes the fair value of the indemnification rights and agreements is minimal. Accordingly, the Company has not recorded any liabilities for these indemnification rights and agreements as of December 31, 2018. Contingencies From time to time, we may have certain contingent liabilities that arise in the ordinary course of our business activities. We accrue a liability for such matters when it is probable that future expenditures will be made and such expenditures can be reasonably estimated. |
Convertible Preferred Stock
Convertible Preferred Stock | 12 Months Ended |
Dec. 31, 2018 | |
Equity [Abstract] | |
Convertible Preferred Stock | 7 . Convertible Preferred Stock As of December 31, 2017, the Company’s Certificate of Incorporation, as amended, authorized the Company to issue up to 28,322,761 shares of convertible preferred stock, par value of $0.001, of which 14,300 were designated Series A convertible preferred stock and 14,106,583 are designated Series B convertible preferred stock, and 14,201,878 shares are designated Series C convertible preferred stock. In July 2017, the Company issued 11,854,463 shares of Series C convertible preferred stock to investors at $4.26 per share with gross proceeds of $50.5 million. In January 2018, the Company completed its initial public offering (“IPO”) of shares of its common stock, pursuant to which the Company issued 8,050,000 shares of common stock, which includes 1,050,000 shares issued pursuant to the over-allotment option granted to its underwriters and received net proceeds of approximately $125.4 million, after deducting underwriting discounts, commissions and offering expenses. In connection with the completion of the Company's IPO, all shares of convertible preferred stock converted into 9,629,405 shares of common stock. As of December 31, 2018, the Company had no outstanding convertible preferred stock. Liquidation Preference In the event of any liquidation, dissolution, or winding up of the Company, either voluntary or involuntary, the holders of the then outstanding shares of Series A convertible stock and Series B convertible preferred stock and Series C convertible preferred stock were first entitled to receive the amount of $1,000 and $3.19 and $4.26 per share, respectively plus all declared but unpaid dividends for such shares, prior and in preference to any distribution of any assets of the Company to the holders of the common stock. Upon the occurrence of such event, the proceeds distributed among the holders of the Series A, B and C convertible preferred stock were insufficient to permit the full payment of the aforesaid preferential amounts to each holder the convertible preferred stock, then the entire proceeds legally available for distribution to the convertible preferred stock were to be distributed ratably among the holders of the Series A, B and C convertible preferred stock in proportion to the full preferential amount that each such holder of convertible preferred stock is otherwise entitled to receive. Upon completion of the distributions required by the above‑mentioned liquidation preferences, any remaining proceeds were to be distributed among the holders of Series B and C convertible preferred stock and common stock pro rata based on the number of shares of common stock held by each, assuming full conversion of the Series B and C convertible preferred stock to common stock at the then‑effective conversion price for such shares. Dividends The holders of shares of Series A, B and C convertible preferred stock were entitled to receive non‑cumulative dividends, out of any assets legally available, prior and in preference to any declaration or payment of any dividend on the common stock, at the applicable dividend rate of $80.00 per annum for each share of Series A convertible preferred stock, $0.2552 per annum for each share of Series B convertible preferred stock and $0.3408 per share per annum for each share of Series C convertible preferred stock, all subject to adjustment from time to time for recapitalizations, payable when and if declared by the Company’s board of directors. The Company has never declared any dividends on its convertible preferred stock. Voting The holder of each share of Series B and C convertible preferred stock were entitled to one vote for each share of common stock into which such preferred stock could then be converted and, with respect to such vote, such holder has full voting rights and powers equal to the voting rights and powers of the holders of common stock and was entitled to notice of any stockholders’ meeting in accordance with the Company’s bylaws. The holders of shares of Series A convertible preferred stock did not have a right to vote, other than as required by Delaware law and for certain directors, as set forth below. The holders of shares of Series A convertible preferred stock were entitled to elect two of the Company’s directors. The holders of Series B convertible preferred stock were entitled to elect two of the Company’s directors. The holders of Series C convertible preferred stock were entitled to elect one of the Company’s directors. The holders of outstanding common stock were entitled to elect three of the Company’s directors. The holders of convertible preferred stock and common stock, voting together as a single class, and not as separate series, and on an as converted basis, were entitled to elect any remaining directors of the Company, subject to the approval of the then serving members of the Company’s directors. Conversion The holder of each share of convertible preferred stock had the option to convert each share of convertible preferred stock into such number of fully paid and nonassessable shares of common stock as is determined by dividing the applicable original issue price for such series by the applicable conversion price for such series in effect on the date the certificate is surrendered for conversion. Each share of convertible preferred stock automatically converted into shares of common stock at the conversion rate at the time in effect for such series of convertible preferred stock immediately pursuant to a registration statement under the Securities Act of 1933, with gross proceeds of not less than $40.0 million in the aggregate and an offering price to the public of no less than $17.21 per share. The conversion price of the convertible preferred stock was initially set at an amount equal to the issue price. The Series B and C convertible preferred stock conversion price was subject to adjustment for stock dividends, stock splits, re‑capitalization and upon the occurrence of certain triggering events related to anti‑dilution protection rights. In the event that a future preferred stock financing should occur at a price lower than the last preferred financing round, the conversion ratios of the existing preferred stock are changed to protect the ownership position of existing investors. |
Common Stock
Common Stock | 12 Months Ended |
Dec. 31, 2018 | |
Equity [Abstract] | |
Common Stock | 8 . Common Stock As of December 31, 2018, the Company’s Certificate of Incorporation, as amended, authorizes the Company to issue 300,000,000 shares of $0.0001 par value common stock. Each share of common stock is entitled to one vote. The holders of common stock are also entitled to receive dividends whenever funds are legally available and when and if declared by the board of directors, subject to the prior rights of holders of all classes of preferred stock outstanding. The Company has never declared any dividends on common stock. |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock-Based Compensation | 9 . Stock-Based Compensation Under the Company’s 2011 Stock Incentive Plan (the “2011 Plan”), the Company may grant options to purchase common stock, restricted stock awards, or directly issue shares of common stock to employees, directors and consultants of the Company. Under the 2011 Plan, options granted are exercisable over a maximum term of 10 years from the date of grant and generally vest over a period of four years. The Company adopted a 2018 Omnibus Incentive Plan (the “2018 Plan”), effective January 2018. The 2018 Plan provides for the grant of incentive stock options, non-qualified stock options, stock appreciation rights, restricted stock, restricted stock units, dividend equivalent rights and other stock and cash-based awards (including annual cash incentives and long-term cash incentives). The Company has reserved 3,000,000 shares of common stock for issuance pursuant to awards under the 2018 Plan. As of December 31, 2018, the Company has 1,319,109 shares of common stock available for issuance under the 2018 Plan. The Company adopted a 2018 Employee Stock Purchase Plan, or ESPP in January 2018. The ESPP enables eligible employees of the Company and designated affiliates to purchase shares of common stock at a discount of 15%. Six month offer periods under the ESPP commenced on September 1, 2018. The Company has reserved 325,000 shares of common stock for issuance under the ESPP. Total stock‑based compensation expense for employees and non‑employees recognized in the statements of operations was as follows (in thousands): Year Ended December 31, 2018 2017 2016 Research and development $ 1,734 $ 792 $ 257 General and administrative 1,904 660 316 Total stock-based compensation expense $ 3,638 $ 1,452 $ 573 In connection with services rendered by non-employees, the Company recorded stock-based compensation expense of $0.5 million, $0.6 million, and $0.3 million in 2018, 2017 and 2016, respectively. At December 31, 2018, there was approximately $11.9 million of unamortized compensation expense, which was expected to be recognized over a weighted average period of 3.0 years. 2011 and 2018 Plan The table below summarizes stock option and restricted award activity under the 2011 Plan and 2018 Plan: Number of Shares Outstanding Weighted- Average Exercise Price Weighted- Average Remaining Contractual Term (Years) Aggregate Intrinsic Value (in thousands) Balances at January 1, 2016 — Granted 1,485,132 $ 1.99 Balances at December 31, 2016 1,485,132 1.99 9.32 $ 3,805 Granted 1,040,329 5.56 Exercised (1) (18,535 ) 1.83 Balances at December 31, 2017 2,506,926 3.50 8.79 $ 24,033 Granted 1,700,013 7.58 Exercised (1) (255,186 ) 1.94 Forfeited/expired (46,283 ) 5.94 Balances at December 31, 2018 3,905,470 $ 5.35 8.65 $ 2,509 (1) Includes early exercise of 317,405 options during the year ended December 31, 2016, of which 59,513 and 139,636 remain unvested as of December 31, 2018 and December 31, 2017, respectively. Upon vesting of restricted shares and exercise of options, the Company issues common stock from its authorized shares. During the years ended December 31, 2018, 2017 and 2016, the Company received $496,000, $34,000 and zero upon the exercise of stock options, respectively. As of December 31, 2018 and 2017, the Company had recorded a liability of $18,000 and $43,000, respectively for the early exercise of stock options, recorded as other current liabilities and other non‑current liabilities. When options are subject to the Company’s repurchase right, the Company may buy back any unvested shares at their original exercise price in the event of an employee’s termination prior to full vesting. The aggregate grant date fair value of employee options vesting during the years ended December 31, 2018, 2017 and 2016 was approximately $2.6 million, $0.5 million and $0.2 million, respectively. The aggregate intrinsic value of shares exercised during the years ended December 31, 2018, 2017 and December 31, 2016 was $1.8 million, $0.2 million and zero, respectively. The weighted average grant date fair value of stock options granted was $5.00, $5.56 and $1.79 per share during the years ended December 31, 2018, 2017, and 2016, respectively. Stock Awards Granted to Employees and Directors Stock‑based compensation expense is based on the grant date fair value. The Company recognizes compensation expense for all stock‑based options and restricted awards on a straight‑line basis over the requisite service period of the awards, which is generally the option vesting term of four years. The fair value of each option award is estimated on the date of grant using the Black-Scholes option valuation model. The Company determines the price volatility based on the historical volatilities of industry peers as it has no trading history for its common stock price. Industry peers consist of several public companies in the biotechnology industry with comparable characteristics, including clinical trials progress and therapeutic indications. The expected term of the options is based on the average period the stock options are expected to remain outstanding. As the Company does not have sufficient historical information to develop reasonable expectations about future exercise patterns and post-vesting employment termination behavior, the expected term is calculated as the midpoint between the weighted-average vesting term and the contractual expiration period also known as the simplified method. The risk-free rate is based on U.S. Treasury zero coupon issues with remaining terms consistent with the expected terms of the stock options, as determined at the time of grant. To date, the Company has not declared or paid any cash dividends and does not have any plans to do so in the future. Therefore, the Company used an expected divided yield of zero. The following assumptions were used to calculate the fair value of awards granted to employees and directors during the years indicated: Year Ended December 31, 2018 2017 2016 Expected term (in years) 6.0 - 6.1 6.0 - 6.1 4.6 - 6.1 Volatility 72% - 73% 75% - 100% 68% - 74% Risk-free interest rate 2.8% - 3.0% 1.9% - 2.3% 1.3% - 2.1% Dividend yield — — — Stock-Based Compensation for Non-employees Stock‑based compensation expense related to stock awards granted to non‑employees is recognized as the awards vest. The Company believes that the fair value of the stock‑based awards granted is more reliably measurable than the fair value of the services received. The fair value of stock awards granted is calculated using the Black‑Scholes option valuation model. The fair values of common stock awards granted to non‑employees were calculated using the following assumptions for the periods presented: Year Ended December 31, 2018 2017 2016 Expected term (in years) 7.3 - 10 8.3 - 10 9.3 - 10.0 Volatility 68% - 79% 74% - 100% 84% - 86% Risk-free interest rate 2.8% - 3.0% 2.1% - 2.5% 1.6% - 2.5% Dividend yield — — — Employee Stock Purchase Plans The fair value of each ESPP award is estimated on the first day of the offering period using the Black-Scholes option pricing model and is recognized in expense over the service period using the straight-line method. The key input assumptions used to estimate fair value of these awards include the exercise price of the award of $7.78, the expected option term of 0.5 years, the expected volatility of the Company’s stock over the option’s expected term of 2.13%, the risk-free interest rate over the option’s expected term of 2.27%, and the Company’s expected dividend yield at zero. |
Net Loss per Share Attributable
Net Loss per Share Attributable to Common Stockholders | 12 Months Ended |
Dec. 31, 2018 | |
Earnings Per Share [Abstract] | |
Net Loss per Share Attributable to Common Stockholders | 10 . Net Loss per Share Attributable to Common Stockholders The following table sets forth the computation of basic and diluted net loss per share attributable to common stockholders (in thousands, except share and per share data): Year Ended December 31, 2018 2017 2016 Numerator: Net loss attributable to common stockholders, basic and diluted $ (51,445 ) $ (29,076 ) $ (14,068 ) Denominator: Weighted-average common shares outstanding 21,764,636 5,285,542 5,280,058 Less: weighted-average common shares subject to repurchase (95,947 ) (177,421 ) (292,925 ) Weighted-average common shares used to compute basic and diluted net loss per share 21,668,689 5,108,121 4,987,133 Net loss per share attributable to common stockholders: Basic and diluted $ (2.37 ) $ (5.69 ) $ (2.82 ) The following outstanding shares of potentially dilutive securities were excluded from the computation of diluted net loss per share attributable to common stockholders for the periods presented because including them would have been antidilutive: December 31, 2018 2017 2016 Stock options outstanding 3,905,470 2,506,926 1,485,132 Outstanding common stock subject to repurchase 59,513 139,636 222,077 Shares issuable related to ESPP 59,735 — — Convertible preferred stock issuable upon conversion to common stock — 9,629,405 5,234,800 Total 4,024,718 12,275,967 6,942,009 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 11 . Income Taxes The Company did not record a provision or benefit for income taxes during the years ended December 31, 2018, 2017 and 2016. The tax effect of temporary differences and carryforwards that give rise to significant portions of the deferred tax assets are as follows (in thousands): Year Ended December 31, 2018 2017 2016 Deferred Tax Assets NOLs $ 22,248 $ 10,404 $ 10,458 Depreciation and Amortization 241 226 328 Stock-Based Compensation 627 274 161 Research & Development Credits 3,972 2,063 586 Deferred Revenue — 1,791 — Other Accruals 507 235 98 Total Deferred Tax Assets $ 27,595 $ 14,993 $ 11,631 Valuation Allowance (27,595 ) (14,993 ) (11,631 ) Net Deferred Tax Assets $ — $ — $ — Realization of deferred tax assets is dependent upon future earnings, if any, the timing and amount of which are uncertain. Accordingly, the net deferred tax assets have been fully offset by a valuation allowance. The net change in the total valuation allowance for the years ended December 31, 2018, 2017 and 2016 was an increase of approximately $12.6 million, $3.4 million, and $5.0 million, respectively. As of December 31, 2018 and 2017, the Company had net operating loss carryforwards for federal income tax purposes of $100.6 million and $44.3 million, respectively which expire beginning in the year 2031 and federal research and development tax credits of $4.1 million and $2.1 million, respectively which expire beginning in the year 2031. As of December 31, 2018 and 2017, the Company had net operating loss carryforwards for state income tax purposes of $16.8 million and $15.0 million, respectively which expire beginning in the year 2031 and state research and development tax credits of $1.4 million and $0.9 million, respectively which do not expire. Federal and state tax laws impose substantial restrictions on the utilization of the net operating loss and credit carryforwards in the event of an ownership change as defined in Section 382 of the Internal Revenue Code. Accordingly, the Company’s ability to utilize these carryforwards may be limited as a result of such ownership change. Such a limitation could result in the expiration of carryforwards before they are utilized. The Company has adopted ASC 740-10, Accounting for Uncertainty in Income Taxes The Company recognizes interest and penalties related to uncertain tax positions in income tax expense. To the extent accrued interest and penalties do not ultimately become payable, amounts accrued will be reduced and reflected as a reduction of the provision for income taxes in the period that such determination is made. As of December 31, 2018 the Company had no accrued interest and penalties related to uncertain tax positions. The Company filed US and California tax returns with varying statues of limitations. The federal and California tax years from 2011 to 2017 remain open to examination due to the carryover of unused net operating losses and tax credits. The Company does not expect any material changes to the estimated amount of liability associated with its uncertain tax positions within the next 12 months. Uncertain Tax Positions The following table summarizes the activity related to unrecognized tax benefits (in thousands): For the year ended December 31, 2018 2017 2016 Tax Benefits: Unrecognized Benefit beginning of period $ 803 $ 229 $ 93 Gross Increases - prior period tax positions — 59 — Gross Increases - current period tax positions 652 515 136 Total Unrecognized Benefit - end of period $ 1,455 $ 803 $ 229 Tax Reform On December 22, 2017, the Tax Cuts and Jobs Act of 2017 (the “Tax Act”) was signed into law making significant changes to the Internal Revenue Code. Changes include, but are not limited to, a corporate tax rate decrease from 34% to 21% (the “Rate Reduction”) effective for tax years beginning after December 31, 2017. The Company reduced deferred tax assets at December 31, 2017 for the effect of the Rate Reduction. The Rate Reduction did not impact the Company's provision for income taxes for 2017 due to the full valuation allowance on deferred tax assets. Staff Accounting Bulletin No. 118 ("SAB 118") was issued to address the application of US GAAP in situations when a registrant does not have the necessary information available, prepared, or analyzed (including computations) in reasonable detail to complete the accounting for certain income tax effects of the Act. The Company determined that $7.0 million of the reduction in deferred tax assets resulting from Rate Reduction was both provisional and a reasonable estimate at December 31, 2017. Additionally, the Company is still in the process of analyzing certain provisions of the Act including the application of new executive compensation limitation provisions under Internal Revenue Section 162(m). These items are subject to revisions from further analysis of the Tax Act and interpretation of any additional guidance issued by the U.S. Treasury Department, IRS, FASB, and other standard-setting and regulatory bodies. |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2018 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 12 . Related Party Transactions From 2011 through 2016, the Company has operated with significant consulting and management services provided by Velocity Pharmaceutical Development, LLC (“VPD”). Development services fees paid to VPD under the Development Services Agreement was $1.0 million for the year ended December 31, 2016. The Company also reimbursed VPD for consulting, travel and other expenses incurred on our behalf. As of December 31, 2018 and 2017, the Company did not have any outstanding liabilities or fees to VPD. Several managing directors of VPD have served as officers and directors of the Company. David Collier, M.D., a former member of the Company’s board of directors, is the Chief Executive Officer of VPD, and Xiaoming Zhang, Ph.D., our Senior Vice President, Non‑Clinical and Pharmaceutical Development, is a Venture Partner of VPD. |
Selected Unaudited Quarterly Fi
Selected Unaudited Quarterly Financial Data | 12 Months Ended |
Dec. 31, 2018 | |
Quarterly Financial Information Disclosure [Abstract] | |
Selected Unaudited Quarterly Financial Data | 13. The following tables show a summary of the Company’s unaudited quarterly financial data for each of the four quarters of 2018 and 2017 (in thousands, except per share amounts): Three Months Ended December 31, 2018 September 30, 2018 June 30, 2018 March 31, 2018 Collaboration and service revenue $ — $ — $ 10,143 $ 497 Operating expenses 18,440 13,702 19,316 13,717 Other income (expense), net 846 855 826 563 Net loss (17,594 ) (12,847 ) (8,347 ) (12,657 ) Basic and diluted net loss per common share (1) $ (0.76 ) $ (0.56 ) $ (0.36 ) $ (0.72 ) Three Months Ended December 31, 2017 September 30, 2017 June 30, 2017 March 31, 2017 Collaboration and service revenue $ 2,775 $ 909 $ 449 $ 449 Operating expenses 12,252 9,244 6,674 6,004 Other income (expense), net 200 163 72 81 Net loss (9,277 ) (8,172 ) (6,153 ) (5,474 ) Basic and diluted net loss per common share (1) $ (1.80 ) $ (1.59 ) $ (1.21 ) $ (1.08 ) (1) Basic and diluted net loss per common share are computed independently for each of the quarters presented. Therefore, the sum of quarterly basic and diluted per share information may not equal annual basic and diluted net loss per common share. |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation These financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and include all adjustments necessary for the fair presentation of the Company’s financial position for the periods presented. |
Reverse Stock Split | Reverse Stock Split On January 8, 2018, the Company effected a reverse split of shares of the Company’s common stock at a ratio of 1-for-2.6975 pursuant to an amendment to the amended and restated certificate of incorporation approved by the Company’s board of directors and stockholders. The par value and the authorized shares of the common stock were not adjusted as a result of the reverse split. All issued and outstanding common stock share and per share amounts contained in the financial statements have been retroactively adjusted to reflect this reverse split for all periods presented, and the conversion ratio of the preferred stock was adjusted accordingly. |
Segments | Segments The Company operates in one segment. Management uses one measurement of profitability and does not segregate its business for internal reporting. All long‑lived assets are maintained in the United States of America. |
Use of Estimates | Use of Estimates Preparation of financial statements in conformity with U.S. GAAP, requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of expenses during the reporting periods covered by the financial statements and accompanying notes. On an ongoing basis, management evaluates its estimates, including those related to revenue recognition, stock‑based compensation expense, the resolution of uncertain tax positions and valuation allowance, recovery of long‑lived assets and accruals for research and development costs. Management bases its estimates on historical experience on various assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results could differ materially from those estimates. |
Risk and Uncertainties | Risk and Uncertainties The Company’s future results of operations involve a number of risks and uncertainties. Factors that could affect the Company’s future operating results and cause actual results to vary materially from expectations include, but are not limited to, uncertainty of results of clinical trials and reaching milestones, uncertainty of regulatory approval of the Company’s potential drug candidate, uncertainty of market acceptance of the Company’s product candidate, competition from substitute products and larger companies, securing and protecting proprietary technology, strategic relationships and dependence on key individuals and sole source suppliers. The Company’s product candidate requires clearances from the U.S. Food and Drug Administration (“FDA”) or other international regulatory agencies prior to commercial sales. There can be no assurance that the product candidate will receive the necessary clearances. If the Company was denied clearance, clearance was delayed or the Company was unable to maintain clearance, it could have a materially adverse impact on the Company. The Company expects to incur substantial operating losses for the next several years and will need to obtain additional financing in order to complete clinical studies and launch and commercialize any product candidates for which it receives regulatory approval. There can be no assurance that such financing will be available or will be at terms acceptable by the Company. |
Cash and Cash Equivalents | Cash and Cash Equivalents Cash and cash equivalents are stated at fair value. Cash equivalents include only securities having an original maturity of three months or less at the time of purchase. The Company limits its credit risk associated with cash and cash equivalents by placing its investments with an institution it believes is highly creditworthy and with highly rated money market funds. As of December 31, 2018 and 2017, cash and cash equivalents consisted of bank deposits, cash and investments in money market funds. |
Investment Securities | Investment Securities The Company classifies its investment securities as available‑for‑sale. Those investments with maturities less than 12 months at the date of purchase are considered short‑term investments. Those investments with maturities greater than 12 months at the date of purchase are considered long‑term investments. The Company’s investment securities classified as available‑for‑sale are recorded at fair value based upon quoted market prices at period end. Unrealized gains and losses, deemed temporary in nature, are reported as a separate component of comprehensive income or loss. A decline in the fair value of any security below cost that is deemed other than temporary results in a charge to earnings and the corresponding establishment of a new cost basis for the security. Premiums (discounts) are amortized (accreted) over the life of the related security as an adjustment to yield using the straight‑line interest method. Dividend and interest income are recognized when earned. Realized gains and losses are included in earnings and are derived using the specific identification method for determining the cost of securities sold. |
Property and Equipment, Net | Property and Equipment, Net Property and equipment are stated at cost and depreciated using the straight‑line method over the estimated useful lives of the assets, generally between three and five years. Maintenance and repairs are charged to expense as incurred, and improvements are capitalized. When assets are retired or otherwise disposed of, the cost and accumulated depreciation are removed from the balance sheet and any resulting gain or loss is reflected in operations in the period realized. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The carrying amounts of the Company’s financial instruments, which include cash, accounts payable and accrued liabilities and other current liabilities, and deferred revenue approximate their fair values due to their short maturities. |
Concentration of Credit Risk | Concentration of Credit Risk Financial instruments that potentially subject the Company to significant concentrations of credit risk consist principally of cash, cash equivalents and investments. As of December 31, 2018 and 2017, the majority of our cash, cash equivalents and investments are held by two U.S. financial institutions in excess of federally insured limits. We invest cash in excess of our current needs in United States Treasury and government agency securities, highly‑rated short or medium‑term debt securities and money market funds and, by policy, diversify our investments to limit the amount of credit exposure. The Company has an investment policy which limits the Company to investing in highly rated corporate and government notes, and no individual investment may comprise more than 5% of the total portfolio except for securities issued by the U.S. Treasury, U.S. government agencies and money market funds, which are exempt from this restriction. |
Income Taxes | Income Taxes The Company accounts for income taxes under the asset and liability method which requires, among other things, that deferred income taxes be provided for temporary differences between the tax basis of the Company’s assets and liabilities and their financial statement reported amounts. Management makes estimates, assumptions and judgments to determine the Company’s provision for income taxes and also for deferred tax assets and liabilities, and any valuation allowances recorded against the Company’s deferred tax assets. The Company assesses the likelihood that its deferred tax assets will be recovered from future taxable income and to the extent the Company believes that recovery is not more likely than not, the Company must establish a valuation allowance. The Company has adopted ASC 740-10, Accounting for Uncertainty in Income Taxes, that prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of uncertain tax positions taken or expected to be taken in the Company’s income tax return, and also provides guidance on derecognition, classification, interest and penalties, accounting in interim periods, disclosure and transition. To date, there have been no interest or penalties charged in relation to the unrecognized tax benefits. |
Research and Development Expenses | Research and Development Expenses Research and development costs are expensed as incurred. Substantially all of our research and development expenses consist of expenses incurred in connection with the development of serlopitant. These expenses include certain payroll and personnel expenses including stock‑based compensation expense, consulting costs, contract manufacturing costs, and fees paid to clinical research organizations, or CROs, to conduct research and development. Nonrefundable advance payments for goods or services that will be used or rendered for future research and development activities are deferred and capitalized and recognized as an expense as the goods are delivered or the related services are performed. The Company estimates non‑clinical study and clinical trial expenses based on the services performed pursuant to contracts with research institutions and clinical research organizations that conduct and manage non‑clinical studies and clinical trials on its behalf. In accruing service fees, the Company estimates the time period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from the estimate, the Company will adjust the accrual accordingly. Payments made to third parties under these arrangements in advance of the receipt of the related services are recorded as prepaid expenses until the services are rendered. |
Stock-Based Compensation | Stock-Based Compensation The Company measures and recognizes compensation expense for all stock‑based awards made to employees, directors and non‑employees, based on estimated fair values recognized using the straight‑line method over the requisite service period and is reduced for forfeitures as they occur. The fair value of options to purchase common stock granted to employees is estimated on the grant date using the Black‑Scholes option valuation model. The calculation of stock‑based compensation expense requires that the Company make certain assumptions and judgments about a number of complex and subjective variables used in the Black‑Scholes model, including the expected term, expected volatility of the underlying common stock, risk‑free interest rate. The Company accounts for options issued to non‑employees using the Black‑Scholes option valuation model and is measured and recognized as the stock options are earned. |
Convertible Preferred Stock | Convertible Preferred Stock The Company recorded convertible preferred stock at fair value on the dates of issuance, net of issuance costs. The convertible preferred stock is recorded outside of stockholders’ equity (deficit) because, in the event of certain deemed liquidation events considered not solely within the Company’s control, such as a merger, acquisition and sale of all or substantially all of the Company’s assets, the convertible preferred stock will become redeemable at the option of the holders. All outstanding convertible preferred stock converted into common stock in January 2018 upon the effectiveness of the IPO. |
Comprehensive Income (Loss) | Comprehensive Income (Loss) Comprehensive income (loss) is defined as the change in equity of the Company during a period from transactions and other events and circumstances excluding transactions resulting from investments and distributions to owners. Comprehensive loss consists of the net loss and changes in accumulated other comprehensive income, which are comprised of unrealized gains (losses) on available‑for‑sale investments. |
Revenue Recognition | Revenue Recognition The Company records revenue based on a five-step model in accordance with Accounting Standards Codification ("ASC") 606, Revenue from Contracts with Customers ("ASC 606"). For the Company’s collaboration agreement, which is discussed further under Note 5, the Company identifies the performance obligations, determines the transaction price, allocates the contract transaction price to the performance obligations, and recognizes the revenue when (or as) the performance obligation is satisfied. The Company identifies the performance obligations included within the agreement and evaluates which performance obligations are distinct. Upfront payments for licenses are evaluated to determine if the license is capable of being distinct from the obligations of the Company to participate on certain development and/or commercialization committees with the collaboration partners and supply manufactured drug product for clinical trials. For performance obligations that the Company satisfies over time, the Company utilizes the input method and revenue is recognized by consistently applying a method of measuring progress toward complete satisfaction of that performance obligation. The Company periodically reviews its estimated periods of performance based on the progress under each arrangement and accounts for the impact of any changes in estimated periods of performance on a prospective basis. Milestone payments are a form of variable consideration as the payments are contingent upon achievement of a substantive event. Milestone payments are estimated and included in the transaction price when the Company determines that it is probable that there will not be a significant reversal of cumulative revenue recognized in future periods. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such milestones and any related constraint, and if necessary, adjusts the estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect license, collaboration or other revenues and earnings in the period of adjustment. Research and development revenues and cost reimbursements are based upon negotiated rates for the Company’s full-time employee equivalents (“FTE”) and actual out-of-pocket costs. FTE rates are set based upon the Company’s costs, and which the Company believes approximate fair value. None of the revenues recognized to date are refundable if the relevant research effort is not successful. In accordance with ASC 606, the Company is required to adjust the transaction price for the effects of the time value of money if the timing of payments agreed to by the parties to the contract, explicitly or implicitly, provides the Company or its customer with a significant benefit of financing the transfer of goods or services. The Company concluded that its collaboration agreement did not contain a significant financing component because the payment structure of its agreements arise from reasons other than providing a significant benefit of financing. |
Net Loss per Share of Common Stock | Net Loss per Share of Common Stock Basic net loss per common share is calculated by dividing the net loss attributable to common stockholders by the weighted‑average number of common shares outstanding during the period, without consideration for potentially dilutive securities. Diluted net loss per share is computed by dividing the net loss attributable to common stockholders by the weighted‑average number of common shares and potentially dilutive securities outstanding for the period. For purposes of the diluted net loss per share calculation, convertible preferred stock and common stock options are considered to be potentially dilutive securities. Because the Company has reported a net loss for the years ended December 31, 2018, 2017 and 2016, diluted net loss per common share is the same as basic net loss per common share for those periods. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2014‑09, Revenue from Contracts with Customers (Topic 606) Revenue Recognition Revenue from Contracts with Customers (Topic 606): Deferral of the Effective Date In February 2016, the FASB issued ASU 2016‑02, Leases Targeted Improvements to ASC 842 In June 2016, the FASB issued ASU 2016-13, Financial Instruments — Credit Losses — Measurement of Credit Losses on Financial Instruments In February 2018, the FASB issued ASU 2018-02, Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income In June 2018, the FASB issued ASU 2018-07 Improvements to Nonemployee Share-Based Payment Accounting (Topic 718) In August 2018, the SEC adopted the final rule under SEC Release No. 33-10532, Disclosure Update and Simplification In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820) |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Fair Value Disclosures [Abstract] | |
Summary of Assets and Liabilities Carried at Fair Value | A summary of the assets and liabilities carried at fair value in accordance with the hierarchy defined above is as follows (in thousands): Fair Value Measurements Using Level 1 Level 2 Level 3 Total December 31, 2018 Assets: Money market funds $ 5,802 $ — $ — $ 5,802 Corporate notes — 41,035 — 41,035 Commercial paper — 63,036 — 63,036 Asset backed securities — 12,213 — 12,213 Government notes — 12,476 — 12,476 Total assets $ 5,802 $ 128,760 $ — $ 134,562 Fair Value Measurements Using Level 1 Level 2 Level 3 Total December 31, 2017 Assets: Money market funds $ 8,685 $ — $ — $ 8,685 Corporate notes 5,103 40,995 — 46,098 Government notes 6,175 — — 6,175 Total assets $ 19,963 $ 40,995 $ — $ 60,958 |
Summary of Available-for-sale Securities | The following table summarizes the available‑for‑sale securities (in thousands): Amortized Cost Unrealized Gains Unrealized Losses Fair Value December 31, 2018 Money market funds $ 5,802 $ — $ — $ 5,802 Corporate notes 41,103 2 (70 ) 41,035 Commercial paper 63,036 — — 63,036 Asset backed securities 12,236 — (23 ) 12,213 Government notes 12,481 — (5 ) 12,476 $ 134,658 $ 2 $ (98 ) $ 134,562 Amortized Cost Unrealized Gains Unrealized Losses Fair Value December 31, 2017 Money market funds $ 8,685 $ — $ — $ 8,685 Corporate notes 46,133 — (35 ) 46,098 Government notes 6,191 — (16 ) 6,175 $ 61,009 $ — $ (51 ) $ 60,958 |
Balance Sheets Components (Tabl
Balance Sheets Components (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Schedule of Accrued Expenses and Other Current Liabilities | Accrued expenses and other current liabilities consisted of the following (in thousands): December 31, 2018 2017 Accrued personnel expenses $ 2,649 $ 1,108 Accrued clinical and development expenses 3,349 2,250 Other 256 201 Total $ 6,254 $ 3,559 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Commitments And Contingencies Disclosure [Abstract] | |
Schedule of Future Minimum Operating Lease Payments | As of December 31, 2018, total future minimum lease payments under our operating leases are as follows (in thousands): Year ending December 31: 2019 $ 675 2020 173 Total future minimum lease payments $ 848 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Schedule of Share-based Compensation, Allocation of Recognized Period Costs | Total stock‑based compensation expense for employees and non‑employees recognized in the statements of operations was as follows (in thousands): Year Ended December 31, 2018 2017 2016 Research and development $ 1,734 $ 792 $ 257 General and administrative 1,904 660 316 Total stock-based compensation expense $ 3,638 $ 1,452 $ 573 |
Schedule of Stock Option and Restricted Stock Activity | The table below summarizes stock option and restricted award activity under the 2011 Plan and 2018 Plan: Number of Shares Outstanding Weighted- Average Exercise Price Weighted- Average Remaining Contractual Term (Years) Aggregate Intrinsic Value (in thousands) Balances at January 1, 2016 — Granted 1,485,132 $ 1.99 Balances at December 31, 2016 1,485,132 1.99 9.32 $ 3,805 Granted 1,040,329 5.56 Exercised (1) (18,535 ) 1.83 Balances at December 31, 2017 2,506,926 3.50 8.79 $ 24,033 Granted 1,700,013 7.58 Exercised (1) (255,186 ) 1.94 Forfeited/expired (46,283 ) 5.94 Balances at December 31, 2018 3,905,470 $ 5.35 8.65 $ 2,509 (1) Includes early exercise of 317,405 options during the year ended December 31, 2016, of which 59,513 and 139,636 remain unvested as of December 31, 2018 and December 31, 2017, respectively. |
Employees and Directors | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions | The following assumptions were used to calculate the fair value of awards granted to employees and directors during the years indicated: Year Ended December 31, 2018 2017 2016 Expected term (in years) 6.0 - 6.1 6.0 - 6.1 4.6 - 6.1 Volatility 72% - 73% 75% - 100% 68% - 74% Risk-free interest rate 2.8% - 3.0% 1.9% - 2.3% 1.3% - 2.1% Dividend yield — — — |
Non-employees | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Schedule of Fair Value Assumptions | The fair values of common stock awards granted to non‑employees were calculated using the following assumptions for the periods presented: Year Ended December 31, 2018 2017 2016 Expected term (in years) 7.3 - 10 8.3 - 10 9.3 - 10.0 Volatility 68% - 79% 74% - 100% 84% - 86% Risk-free interest rate 2.8% - 3.0% 2.1% - 2.5% 1.6% - 2.5% Dividend yield — — — |
Net Loss per Share Attributab_2
Net Loss per Share Attributable to Common Stockholders (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Earnings Per Share [Abstract] | |
Schedule of Earnings Per Share, Basic and Diluted | The following table sets forth the computation of basic and diluted net loss per share attributable to common stockholders (in thousands, except share and per share data): Year Ended December 31, 2018 2017 2016 Numerator: Net loss attributable to common stockholders, basic and diluted $ (51,445 ) $ (29,076 ) $ (14,068 ) Denominator: Weighted-average common shares outstanding 21,764,636 5,285,542 5,280,058 Less: weighted-average common shares subject to repurchase (95,947 ) (177,421 ) (292,925 ) Weighted-average common shares used to compute basic and diluted net loss per share 21,668,689 5,108,121 4,987,133 Net loss per share attributable to common stockholders: Basic and diluted $ (2.37 ) $ (5.69 ) $ (2.82 ) |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | The following outstanding shares of potentially dilutive securities were excluded from the computation of diluted net loss per share attributable to common stockholders for the periods presented because including them would have been antidilutive: December 31, 2018 2017 2016 Stock options outstanding 3,905,470 2,506,926 1,485,132 Outstanding common stock subject to repurchase 59,513 139,636 222,077 Shares issuable related to ESPP 59,735 — — Convertible preferred stock issuable upon conversion to common stock — 9,629,405 5,234,800 Total 4,024,718 12,275,967 6,942,009 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Schedule of Deferred Tax Assets and Liabilities | The tax effect of temporary differences and carryforwards that give rise to significant portions of the deferred tax assets are as follows (in thousands): Year Ended December 31, 2018 2017 2016 Deferred Tax Assets NOLs $ 22,248 $ 10,404 $ 10,458 Depreciation and Amortization 241 226 328 Stock-Based Compensation 627 274 161 Research & Development Credits 3,972 2,063 586 Deferred Revenue — 1,791 — Other Accruals 507 235 98 Total Deferred Tax Assets $ 27,595 $ 14,993 $ 11,631 Valuation Allowance (27,595 ) (14,993 ) (11,631 ) Net Deferred Tax Assets $ — $ — $ — |
Summary of Unrecognized Tax Benefits | The following table summarizes the activity related to unrecognized tax benefits (in thousands): For the year ended December 31, 2018 2017 2016 Tax Benefits: Unrecognized Benefit beginning of period $ 803 $ 229 $ 93 Gross Increases - prior period tax positions — 59 — Gross Increases - current period tax positions 652 515 136 Total Unrecognized Benefit - end of period $ 1,455 $ 803 $ 229 |
Selected Unaudited Quarterly _2
Selected Unaudited Quarterly Financial Data (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Quarterly Financial Information Disclosure [Abstract] | |
Summary of Unaudited Quarterly Financial Data | The following tables show a summary of the Company’s unaudited quarterly financial data for each of the four quarters of 2018 and 2017 (in thousands, except per share amounts): Three Months Ended December 31, 2018 September 30, 2018 June 30, 2018 March 31, 2018 Collaboration and service revenue $ — $ — $ 10,143 $ 497 Operating expenses 18,440 13,702 19,316 13,717 Other income (expense), net 846 855 826 563 Net loss (17,594 ) (12,847 ) (8,347 ) (12,657 ) Basic and diluted net loss per common share (1) $ (0.76 ) $ (0.56 ) $ (0.36 ) $ (0.72 ) Three Months Ended December 31, 2017 September 30, 2017 June 30, 2017 March 31, 2017 Collaboration and service revenue $ 2,775 $ 909 $ 449 $ 449 Operating expenses 12,252 9,244 6,674 6,004 Other income (expense), net 200 163 72 81 Net loss (9,277 ) (8,172 ) (6,153 ) (5,474 ) Basic and diluted net loss per common share (1) $ (1.80 ) $ (1.59 ) $ (1.21 ) $ (1.08 ) (1) Basic and diluted net loss per common share are computed independently for each of the quarters presented. Therefore, the sum of quarterly basic and diluted per share information may not equal annual basic and diluted net loss per common share. |
Formation and Business of the_2
Formation and Business of the Company (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||||||||
Jan. 31, 2018 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Schedule Of Capitalization Equity [Line Items] | ||||||||||||
Proceeds from issuance initial public offering, net | $ 125,417 | |||||||||||
Net loss | $ (17,594) | $ (12,847) | $ (8,347) | $ (12,657) | $ (9,277) | $ (8,172) | $ (6,153) | $ (5,474) | (51,445) | $ (29,076) | $ (14,068) | |
Net cash used in operating activities | (52,733) | (28,222) | $ (2,265) | |||||||||
Cash, cash equivalents and investments | 136,300 | 136,300 | ||||||||||
Accumulated deficit | $ (110,636) | $ (59,191) | $ (110,636) | $ (59,191) | ||||||||
IPO | ||||||||||||
Schedule Of Capitalization Equity [Line Items] | ||||||||||||
Shares issued (shares) | 8,050,000 | |||||||||||
Proceeds from issuance initial public offering, net | $ 125,400 | |||||||||||
Over-Allotment Option | ||||||||||||
Schedule Of Capitalization Equity [Line Items] | ||||||||||||
Shares issued (shares) | 1,050,000 | |||||||||||
Convertible Stock Converted into Shares of Common Stock | ||||||||||||
Schedule Of Capitalization Equity [Line Items] | ||||||||||||
Common shares issued upon conversion of convertible stock (shares) | 9,629,405 |
Significant Accounting Polici_3
Significant Accounting Policies - Reverse Stock Split (Details) | Jan. 08, 2018 |
Common Stock | |
Class of Stock [Line Items] | |
Number of shares issued for every share converted in reverse stock split | 0.3707 |
Significant Accounting Polici_4
Significant Accounting Policies - Segments (Details) | 12 Months Ended |
Dec. 31, 2018Segment | |
Accounting Policies [Abstract] | |
Number of operating segments | 1 |
Significant Accounting Polici_5
Significant Accounting Policies - Property and Equipment, Net (Details) | 12 Months Ended |
Dec. 31, 2018 | |
Minimum | |
Property, Plant and Equipment [Line Items] | |
Estimated useful lives of plant and equipment | 3 years |
Maximum | |
Property, Plant and Equipment [Line Items] | |
Estimated useful lives of plant and equipment | 5 years |
Significant Accounting Polici_6
Significant Accounting Policies - Additional Information (Details) - financial_institution | Dec. 31, 2018 | Dec. 31, 2017 |
Accounting Policies [Abstract] | ||
Number of financial institutions holding majority of Company cash and cash equivalents and investments in excess of federally insured limits | 2 | 2 |
Individual investment limit as a percentage of the total investment portfolio (percent) | 5.00% |
Significant Accounting Polici_7
Significant Accounting Policies - Revenue Recognition (Details) | 12 Months Ended |
Dec. 31, 2018USD ($) | |
Accounting Policies [Abstract] | |
Revenues recognized refundable | $ 0 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - USD ($) $ / shares in Units, $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Total assets | $ 134,562 | $ 60,958 |
Corporate notes | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Investments | 41,035 | 46,098 |
Government notes | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Investments | 12,476 | 6,175 |
Asset backed securities | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Investments | 12,213 | |
Money market funds | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Money market funds | $ 5,802 | 8,685 |
Net asset value | $ 1 | |
Commercial paper | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Investments | $ 63,036 | |
Level 1 | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Total assets | 5,802 | 19,963 |
Level 1 | Corporate notes | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Investments | 5,103 | |
Level 1 | Government notes | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Investments | 6,175 | |
Level 1 | Money market funds | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Money market funds | 5,802 | 8,685 |
Level 2 | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Total assets | 128,760 | 40,995 |
Level 2 | Corporate notes | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Investments | 41,035 | $ 40,995 |
Level 2 | Government notes | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Investments | 12,476 | |
Level 2 | Asset backed securities | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Investments | 12,213 | |
Level 2 | Commercial paper | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Investments | $ 63,036 |
Fair Value Measurements (Availa
Fair Value Measurements (Available-for-Sale Securities) (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 |
Schedule of Available-for-sale Securities [Line Items] | ||||
Money market funds, amortized cost | $ 49,510 | $ 10,206 | $ 4,027 | $ 43,808 |
Amortized Cost | 134,658 | 61,009 | ||
Unrealized Gains | 2 | |||
Unrealized Losses | (98) | (51) | ||
Fair Value | 134,562 | 60,958 | ||
Corporate notes | ||||
Schedule of Available-for-sale Securities [Line Items] | ||||
Available-for-sale securities, amortized cost | 41,103 | 46,133 | ||
Available-for-sale securities, unrealized gains | 2 | |||
Available-for-sale securities, unrealized losses | (70) | (35) | ||
Available-for-sale securities, fair value | 41,035 | 46,098 | ||
Asset backed securities | ||||
Schedule of Available-for-sale Securities [Line Items] | ||||
Available-for-sale securities, amortized cost | 12,236 | |||
Available-for-sale securities, unrealized losses | (23) | |||
Available-for-sale securities, fair value | 12,213 | |||
Government notes | ||||
Schedule of Available-for-sale Securities [Line Items] | ||||
Available-for-sale securities, amortized cost | 12,481 | 6,191 | ||
Available-for-sale securities, unrealized losses | (5) | (16) | ||
Available-for-sale securities, fair value | 12,476 | 6,175 | ||
Money market funds | ||||
Schedule of Available-for-sale Securities [Line Items] | ||||
Money market funds, amortized cost | 5,802 | 8,685 | ||
Money market funds | 5,802 | $ 8,685 | ||
Commercial paper | ||||
Schedule of Available-for-sale Securities [Line Items] | ||||
Available-for-sale securities, amortized cost | 63,036 | |||
Available-for-sale securities, fair value | $ 63,036 |
Balance Sheets Components (Deta
Balance Sheets Components (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | ||
Accrued personnel expenses | $ 2,649 | $ 1,108 |
Accrued clinical and development expenses | 3,349 | 2,250 |
Other | 256 | 201 |
Total | $ 6,254 | $ 3,559 |
License Agreements (Details)
License Agreements (Details) $ in Millions | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||
May 31, 2018USD ($) | Aug. 31, 2016USD ($)Milestone | Dec. 31, 2012USD ($) | Jun. 30, 2018USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Number of milestones | Milestone | 2 | ||||||
Merck | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Collaborative agreement, milestone payments paid | $ 3 | ||||||
Merck | License | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Licensing fee | $ 1 | ||||||
JT Torii | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Accelerated recognition of deferred revenue, amount of revenue recognized | $ 8.1 | ||||||
Research and development arrangement, contract to perform for others, compensation earned | $ 2 | ||||||
JT Torii | Research and Development Arrangement | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Research and development arrangement, contract to perform for others, compensation earned | $ 10.6 | $ 4.6 | $ 0.7 | ||||
Development and Regulatory Milestones | Merck | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Collaborative arrangements, potential milestone payments | $ 25 | ||||||
Development and Regulatory Milestones | JT Torii | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Collaborative arrangements, potential milestone proceeds | $ 28 | ||||||
Collaboration Agreement | JT Torii | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Collaborative agreement, upfront payment received | 11 | ||||||
Commercial Milestone | JT Torii | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Collaborative arrangements, potential milestone proceeds | 15 | ||||||
Development and Regulatory Milestone, Preparation of Investigational New Drug Submission, Milestone One | JT Torii | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Collaborative arrangements, potential milestone proceeds | $ 2 | ||||||
Research and development arrangement, contract to perform for others, compensation earned | $ 2 | $ 2 |
Commitments and Contingencies_2
Commitments and Contingencies (Details) | Oct. 01, 2017USD ($)ft² | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) |
Acquired Indefinite-lived Intangible Assets [Line Items] | ||||
Operating lease, rent expense | $ 800,000 | $ 400,000 | $ 200,000 | |
Redwood City, California | ||||
Acquired Indefinite-lived Intangible Assets [Line Items] | ||||
Operating lease, term of contract | 30 months | |||
Leased office space, square footage | ft² | 14,000 | |||
Operating lease, monthly expense | $ 55,000 |
Commitments and Contingencies -
Commitments and Contingencies - Future Minimum Operating Lease Payments (Details) $ in Thousands | Dec. 31, 2018USD ($) |
Year ending December 31: | |
2,019 | $ 675 |
2,020 | 173 |
Total future minimum lease payments | $ 848 |
Convertible Preferred Stock (De
Convertible Preferred Stock (Details) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | ||||
Jan. 31, 2018USD ($)shares | Jul. 31, 2017USD ($)$ / sharesshares | Dec. 31, 2018USD ($)director$ / sharesshares | Dec. 31, 2017$ / sharesshares | Dec. 31, 2016shares | Dec. 31, 2015shares | |
Class of Stock [Line Items] | ||||||
Preferred stock authorized (shares) | shares | 28,322,761 | |||||
Preferred stock, par value per share (in USD per share) | $ / shares | $ 0.001 | |||||
Proceeds from issuance initial public offering, net | $ | $ 125,417 | |||||
Number of directors common shareholders are entitled to elect | director | 3 | |||||
Threshold proceeds of public stock offering of Company common shares that triggers automatic conversion of preferred convertible shares into common shares | $ | $ 40,000 | |||||
Threshold price per share in public stock offering of Company common shares that triggers automatic conversion of preferred convertible shares into common shares (in USD per share) | $ / shares | $ 17.21 | |||||
IPO | ||||||
Class of Stock [Line Items] | ||||||
Proceeds from issuance initial public offering, net | $ | $ 125,400 | |||||
Shares issued (shares) | shares | 8,050,000 | |||||
Common shares issued upon conversion of convertible stock (shares) | shares | 9,629,405 | |||||
Over-Allotment Option | ||||||
Class of Stock [Line Items] | ||||||
Shares issued (shares) | shares | 1,050,000 | |||||
Series A Convertible Preferred Stock | ||||||
Class of Stock [Line Items] | ||||||
Preferred stock authorized (shares) | shares | 0 | 14,300 | ||||
Preferred stock, par value per share (in USD per share) | $ / shares | $ 0.001 | $ 0.001 | ||||
Convertible preferred stock outstanding (shares) | shares | 0 | 14,300 | 14,300 | 14,300 | ||
Preferred stock, liquiditiy preference per share (in USD per share) | $ / shares | $ 1,000 | |||||
Preferred stock, dividend per annum (in USD per share) | $ / shares | $ 80 | |||||
Number of directors preferred shareholders are entitled to elect | director | 2 | |||||
Series B Convertible Preferred Stock | ||||||
Class of Stock [Line Items] | ||||||
Preferred stock authorized (shares) | shares | 0 | 14,106,583 | ||||
Preferred stock, par value per share (in USD per share) | $ / shares | $ 0.001 | $ 0.001 | ||||
Convertible preferred stock outstanding (shares) | shares | 0 | 14,106,583 | 14,106,583 | 14,106,583 | ||
Preferred stock, liquiditiy preference per share (in USD per share) | $ / shares | $ 3.19 | |||||
Preferred stock, dividend per annum (in USD per share) | $ / shares | $ 0.2552 | |||||
Number of directors preferred shareholders are entitled to elect | director | 2 | |||||
Series C Convertible Preferred Stock | ||||||
Class of Stock [Line Items] | ||||||
Preferred stock authorized (shares) | shares | 0 | 14,201,878 | ||||
Preferred stock, par value per share (in USD per share) | $ / shares | $ 0.001 | $ 0.001 | ||||
Issuance of preferred stock (shares) | shares | 11,854,463 | 11,854,463 | ||||
Preferred shares issued, price per share (in USD per share) | $ / shares | $ 4.26 | |||||
Proceeds from issuance initial public offering, net | $ | $ 50,500 | |||||
Convertible preferred stock outstanding (shares) | shares | 0 | 11,854,463 | ||||
Preferred stock, liquiditiy preference per share (in USD per share) | $ / shares | $ 4.26 | |||||
Preferred stock, dividend per annum (in USD per share) | $ / shares | $ 0.3408 | |||||
Number of directors preferred shareholders are entitled to elect | director | 1 | |||||
Convertible preferred stock | ||||||
Class of Stock [Line Items] | ||||||
Convertible preferred stock outstanding (shares) | shares | 0 |
Common Stock (Details)
Common Stock (Details) - $ / shares | Dec. 31, 2018 | Dec. 31, 2017 |
Equity [Abstract] | ||
Common stock authorized (shares) | 300,000,000 | 55,000,000 |
Common stock, par value per share (in USD per share) | $ 0.0001 | $ 0.0001 |
Stock-Based Compensation (Detai
Stock-Based Compensation (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |||
Jan. 31, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Jan. 23, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Total stock-based compensation expense | $ 3,638,000 | $ 1,452,000 | $ 573,000 | ||
Unamortized compensation expense | $ 11,900,000 | ||||
Unamortized compensation expense, recognition period | 3 years | ||||
Proceeds from the exercise of stock options | $ 496,000 | 34,000 | 0 | ||
Liability for early exercise of stock options | 18,000 | 43,000 | |||
Aggregate grant date fair value of options vested during the year | 2,600,000 | 500,000 | 200,000 | ||
Aggregate instrinsic value of shares exercised during the year | $ 1,800,000 | $ 200,000 | $ 0 | ||
Weighted average grant date fair value of options granted (in USD per share) | $ 5 | $ 5.56 | $ 1.79 | ||
Expected dividend yield | $ 0 | ||||
Non-employees | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Total stock-based compensation expense | $ 500,000 | $ 600,000 | $ 300,000 | ||
Expected dividend yield | 0.00% | 0.00% | 0.00% | ||
Employees and Directors | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Expected dividend yield | 0.00% | 0.00% | 0.00% | ||
Research and development | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Total stock-based compensation expense | $ 1,734,000 | $ 792,000 | $ 257,000 | ||
General and administrative | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Total stock-based compensation expense | $ 1,904,000 | $ 660,000 | $ 316,000 | ||
2011 Stock Incentive Plan | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Option vesting period | 4 years | ||||
2011 Stock Incentive Plan | Stock Options | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Option expiration period | 10 years | ||||
Option vesting period | 4 years | ||||
2018 Omnibus Incentive Plan | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Shares available under the Plan (shares) | 3,000,000 | ||||
Shares available for issuance under the Plan (shares) | 1,319,109 | ||||
2018 Employee Stock Purchase Plan | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Shares available under the Plan (shares) | 325,000 | ||||
Purchase of common stock offer period under the plan | 6 months | ||||
Discount rate from price of common stock on purchase date | 15.00% | ||||
Commencement date to purchase common stock under the ESPP | Sep. 1, 2018 | ||||
2018 Employee Stock Purchase Plan | Employees and Directors | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Exercise price of the award | $ 7.78 | ||||
Expected option term | 6 months | ||||
Expected volatility | 2.13% | ||||
Risk-free interest rate | 2.27% | ||||
Expected dividend yield | 0.00% |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock Option and Restricted Stock Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Balances, beginning (shares) | 2,506,926 | 1,485,132 | |
Granted (shares) | 1,700,013 | 1,040,329 | 1,485,132 |
Exercised (shares) | (255,186) | (18,535) | |
Forfeited/Expired (shares) | (46,283) | ||
Balances, ending (shares) | 3,905,470 | 2,506,926 | 1,485,132 |
Outstanding, exercise price per share (in USD per share) | $ 3.50 | $ 1.99 | |
Granted, exercise price per share (in USD per share) | 7.58 | 5.56 | $ 1.99 |
Exercised, exercise price per share (in USD per share) | 1.94 | 1.83 | |
Forfeited/expired, exercise price per share (in USD per share) | 5.94 | ||
Outstanding, exercise price per share (in USD per share) | $ 5.35 | $ 3.50 | $ 1.99 |
Options outstanding, weighted average remaining contractual term | 8 years 7 months 24 days | 8 years 9 months 14 days | 9 years 3 months 25 days |
Options exercised, weighted average remaining contractual term | 8 years 9 months 14 days | ||
Options outstanding, aggregate intrinsic value | $ 24,033 | $ 3,805 | |
Options outstanding, aggregate intrinsic value | 2,509 | 24,033 | $ 3,805 |
Exercised, aggregate intrinsic value | $ 1,800 | $ 200 | $ 0 |
Early Exercised Stock Options | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Exercised (shares) | (317,405) | ||
Unvested options included in early exercise (shares) | 59,513 | 139,636 |
Stock-Based Compensation - Fair
Stock-Based Compensation - Fair Value Assumptions for Director, Employee and Non-Employee Grants (Details) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Employees and Directors | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Volatility, minimum (percent) | 72.00% | 75.00% | 68.00% |
Volatility, maximum (percent) | 73.00% | 100.00% | 74.00% |
Risk-free interest rate, minimum (percent) | 2.80% | 1.90% | 1.30% |
Risk-free interest rate, maximum (percent) | 3.00% | 2.30% | 2.10% |
Dividend yield (percent) | 0.00% | 0.00% | 0.00% |
Employees and Directors | Minimum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected term (in years) | 6 years | 6 years | 4 years 7 months 6 days |
Employees and Directors | Maximum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected term (in years) | 6 years 1 month 6 days | 6 years 1 month 6 days | 6 years 1 month 6 days |
Non-employees | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Volatility, minimum (percent) | 68.00% | 74.00% | 84.00% |
Volatility, maximum (percent) | 79.00% | 100.00% | 86.00% |
Risk-free interest rate, minimum (percent) | 2.80% | 2.10% | 1.60% |
Risk-free interest rate, maximum (percent) | 3.00% | 2.50% | 2.50% |
Dividend yield (percent) | 0.00% | 0.00% | 0.00% |
Non-employees | Minimum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected term (in years) | 7 years 3 months 18 days | 8 years 3 months 18 days | 9 years 3 months 18 days |
Non-employees | Maximum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected term (in years) | 10 years | 10 years | 10 years |
Net Loss per Share Attributab_3
Net Loss per Share Attributable to Common Stockholders (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Earnings Per Share [Abstract] | |||||||||||
Net loss attributable to common stockholders, basic | $ (51,445) | $ (29,076) | $ (14,068) | ||||||||
Weighted-average common shares outstanding | 21,764,636 | 5,285,542 | 5,280,058 | ||||||||
Less: weighted-average common shares subject to repurchase | (95,947) | (177,421) | (292,925) | ||||||||
Weighted-average common shares used to compute basic and diluted net loss per share | 21,668,689 | 5,108,121 | 4,987,133 | ||||||||
Net loss attributable to common stockholders per share, basic and diluted | $ (0.76) | $ (0.56) | $ (0.36) | $ (0.72) | $ (1.80) | $ (1.59) | $ (1.21) | $ (1.08) | $ (2.37) | $ (5.69) | $ (2.82) |
Net Loss per Share Attributab_4
Net Loss per Share Attributable to Common Stockholders - Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share (Details) - shares | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Potentially dilutive securities excluded from the calculation of EPS | 4,024,718 | 12,275,967 | 6,942,009 |
Convertible preferred stock issuable upon conversion to common stock | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Potentially dilutive securities excluded from the calculation of EPS | 9,629,405 | 5,234,800 | |
Outstanding common stock subject to repurchase | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Potentially dilutive securities excluded from the calculation of EPS | 59,513 | 139,636 | 222,077 |
Stock options outstanding | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Potentially dilutive securities excluded from the calculation of EPS | 3,905,470 | 2,506,926 | 1,485,132 |
Shares issuable related to ESPP | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Potentially dilutive securities excluded from the calculation of EPS | 59,735 |
Income Taxes - Deferred Tax Ass
Income Taxes - Deferred Tax Assets and Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Income Tax Disclosure [Abstract] | |||
NOLs | $ 22,248 | $ 10,404 | $ 10,458 |
Depreciation and Amortization | 241 | 226 | 328 |
Stock-Based Compensation | 627 | 274 | 161 |
Research & Development Credits | 3,972 | 2,063 | 586 |
Deferred Revenue | 1,791 | 0 | |
Other Accruals | 507 | 235 | 98 |
Total Deferred Tax Assets | 27,595 | 14,993 | 11,631 |
Valuation Allowance | (27,595) | (14,993) | (11,631) |
Net Deferred Tax Assets | $ 0 | $ 0 | $ 0 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Operating Loss Carryforwards [Line Items] | |||
Increase in valuation allowance | $ 12,600 | $ 3,400 | $ 5,000 |
Accrued interest and penalties related to uncertain tax positions | $ 0 | ||
Statutory rate | 21.00% | 34.00% | |
Reduction in deferred tax assets resulting from the rate reduction | $ 7,000 | ||
Federal Tax | |||
Operating Loss Carryforwards [Line Items] | |||
Operating loss carryforwards | $ 100,600 | 44,300 | |
State Tax | |||
Operating Loss Carryforwards [Line Items] | |||
Operating loss carryforwards | 16,800 | 15,000 | |
Research Development Tax Credit | Federal Tax | |||
Operating Loss Carryforwards [Line Items] | |||
Tax credit carryforward | 4,100 | 2,100 | |
Research Development Tax Credit | State Tax | |||
Operating Loss Carryforwards [Line Items] | |||
Tax credit carryforward | $ 1,400 | $ 900 |
Income Taxes - Uncertain Tax Po
Income Taxes - Uncertain Tax Positions (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Income Tax Disclosure [Abstract] | |||
Unrecognized Benefit beginning of period | $ 803 | $ 229 | $ 93 |
Gross Increases - prior period tax positions | 59 | 0 | |
Gross Increases - current period tax positions | 652 | 515 | 136 |
Unrecognized Benefit - end of period | $ 1,455 | $ 803 | $ 229 |
Related Party Transactions (Det
Related Party Transactions (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2018 | Dec. 31, 2017 | |
Related Party Transaction [Line Items] | |||
Accounts payable | $ 0 | $ 0 | |
Velocity Pharmaceutical Development, LLC | Development Services Fees | |||
Related Party Transaction [Line Items] | |||
Related party expenses | $ 1,000,000 |
Selected Unaudited Quarterly _3
Selected Unaudited Quarterly Financial Data (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Quarterly Financial Information Disclosure [Abstract] | |||||||||||
Collaboration and service revenue | $ 10,143 | $ 497 | $ 2,775 | $ 909 | $ 449 | $ 449 | $ 10,640 | $ 4,582 | $ 674 | ||
Type of Revenue [Extensible List] | us-gaap:LicenseAndServiceMember | us-gaap:LicenseAndServiceMember | us-gaap:LicenseAndServiceMember | us-gaap:LicenseAndServiceMember | us-gaap:LicenseAndServiceMember | us-gaap:LicenseAndServiceMember | us-gaap:LicenseAndServiceMember | us-gaap:LicenseAndServiceMember | us-gaap:LicenseAndServiceMember | us-gaap:LicenseAndServiceMember | us-gaap:LicenseAndServiceMember |
Operating expenses | $ 18,440 | $ 13,702 | $ 19,316 | $ 13,717 | $ 12,252 | $ 9,244 | $ 6,674 | $ 6,004 | $ 65,175 | $ 34,175 | $ 15,006 |
Other income (expense), net | 846 | 855 | 826 | 563 | 200 | 163 | 72 | 81 | |||
Net loss | $ (17,594) | $ (12,847) | $ (8,347) | $ (12,657) | $ (9,277) | $ (8,172) | $ (6,153) | $ (5,474) | $ (51,445) | $ (29,076) | $ (14,068) |
Net loss attributable to common stockholder per share, basic and diluted | $ (0.76) | $ (0.56) | $ (0.36) | $ (0.72) | $ (1.80) | $ (1.59) | $ (1.21) | $ (1.08) | $ (2.37) | $ (5.69) | $ (2.82) |