Eledon Pharmaceuticals (ELDN) 10-K 28 Mar 19 2018 FY Annual report Financial data

Document and Entity Information

Document and Entity Information - USD ($)	12 Months Ended
	Dec. 31, 2018	Mar. 22, 2019	Jun. 29, 2018
Document And Entity Information [Abstract]
Document Type	10-K
Amendment Flag	false
Document Period End Date	Dec. 31, 2018
Document Fiscal Year Focus	2018
Document Fiscal Period Focus	FY
Trading Symbol	NVUS
Entity Registrant Name	Novus Therapeutics, Inc.
Entity Central Index Key	0001404281
Current Fiscal Year End Date	--12-31
Entity Well-known Seasoned Issuer	No
Entity Current Reporting Status	Yes
Entity Voluntary Filers	No
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Shell Company	false
Entity Emerging Growth Company	true
Entity Ex Transition Period	true
Entity Common Stock, Shares Outstanding		9,434,243
Entity Public Float			$ 47,021,457

Consolidated Balance Sheets

Consolidated Balance Sheets - USD ($)	Dec. 31, 2018	Dec. 31, 2017
Current assets:
Cash and cash equivalents	$ 12,972,000	$ 17,233,000
Restricted cash	0	70,000
Prepaid expenses and other current assets	1,304,000	1,697,000
Total current assets	14,276,000	19,000,000
Property and equipment, net	14,000	25,000
Goodwill	1,867,000	1,867,000
Other assets	869,000
Total assets	17,026,000	20,892,000
LIABILITIES AND STOCKHOLDERS’ EQUITY
Accounts payable	689,000	418,000
Accrued severance		668,000
Accrued expenses and other liabilities	1,845,000	354,000
Total liabilities	2,534,000	1,440,000
Commitments and contingencies (Note 6)
Stockholders’ equity:
Preferred stock, $0.001 par value, 5,000,000 shares authorized and none issued and outstanding at December 31, 2018 and 2017
Common stock, $0.001 par value, 200,000,000 shares authorized at December 31, 2018 and 2017; 9,422,143 and 7,110,414 shares issued and outstanding at December 31, 2018 and 2017, respectively	9,000	7,000
Additional paid-in capital	56,054,000	46,951,000
Accumulated deficit	(41,571,000)	(27,506,000)
Total stockholders’ equity	14,492,000	19,452,000
Total liabilities and stockholders’ equity	$ 17,026,000	$ 20,892,000

Consolidated Balance Sheets (Pa

Consolidated Balance Sheets (Parenthetical) - $ / shares	Dec. 31, 2018	Dec. 31, 2017
Statement Of Financial Position [Abstract]
Preferred stock, par value	$ 0.001	$ 0.001
Preferred stock, shares authorized	5,000,000	5,000,000
Preferred stock, shares issued	0	0
Preferred stock, shares outstanding	0	0
Common stock, par value	$ 0.001	$ 0.001
Common stock, shares authorized	200,000,000	200,000,000
Common stock, shares issued	9,422,143	7,110,414
Common stock, shares outstanding	9,422,143	7,110,414

Consolidated Statements of Oper

Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2018	Dec. 31, 2017
Operating expenses
Research and development	$ 6,817	$ 2,022
General and administrative	7,243	11,099
Total operating expenses	14,060	13,121
Loss from operations	(14,060)	(13,121)
Other income (expense), net	(5)	5
Net loss and other comprehensive loss	$ (14,065)	$ (13,116)
Net loss per share, basic and diluted	$ (1.56)	$ (2.30)
Weighted-average common shares outstanding, basic and diluted	9,005,352	4,677,610

Consolidated Statements of Stoc

Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands	Total	Common Stock [Member]	Preferred Stock [Member]	Additional Paid-In Capital [Member]	Receipts on Account of Preferred Stock [Member]	Accumulated Deficit [Member]
Beginning Balance at Dec. 31, 2016	$ (2,702)		$ 19	$ 11,378	$ 291	$ (14,390)
Beginning Balance, Shares at Dec. 31, 2016		394,306	19,533,331
Issuance of preferred stock for exercise of warrants	3,119		$ 8	3,111
Issuance of preferred stock for exercise of warrants, Shares			7,941,493
Issuance of common stock for cashless exercise of warrants, Shares		152,580
Conversion of convertible note and accrued interest to common stock	3,447	$ 1		3,446
Conversion of convertible note and accrued interest to common stock, Shares		323,261
Receipt on account of contingently convertible stock				291	$ (291)
Receipt on account of contingently convertible stock, Shares		104,788
Conversion of preferred stock and accrued dividends to common stock		$ 3	$ (27)	24
Conversion of preferred stock and accrued dividends to common stock, Shares		3,052,758	(27,474,824)
Issuance of common stock in connection with Reverse Merger	23,375	$ 3		23,372
Issuance of common stock in connection with Reverse Merger, Shares		2,515,739
Issuance of common stock for cash	4,000			4,000
Issuance of common stock for cash, Shares		400,400
Issuance of common stock at-the-market	750			750
Issuance of common stock at-the-market, Shares		167,356
Cancellation of fractional common stock, Shares		(774)
Stock-based compensation	579			579
Net loss and other comprehensive loss	(13,116)					(13,116)
Ending Balance at Dec. 31, 2017	19,452	$ 7		46,951		(27,506)
Ending Balance, Shares at Dec. 31, 2017		7,110,414
Issuance of common stock at-the-market	7,491	$ 2		7,489
Issuance of common stock at-the-market, Shares		2,296,610
Exercise of options	$ 71			71
Exercise of options, Shares	15,120	15,119
Stock-based compensation	$ 1,543			1,543
Net loss and other comprehensive loss	(14,065)					(14,065)
Ending Balance at Dec. 31, 2018	$ 14,492	$ 9		$ 56,054		$ (41,571)
Ending Balance, Shares at Dec. 31, 2018		9,422,143

Consolidated Statements of Cash

Consolidated Statements of Cash Flows - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2018	Dec. 31, 2017
Operating activities
Net loss	$ (14,065)	$ (13,116)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization	11	22
Stock-based compensation	1,543	579
Loss on disposal of equipment		49
Changes in operating assets and liabilities:
Prepaid expenses and other assets	(476)	(517)
Accounts payable and accrued expenses	1,094	(1,958)
Net cash used in operating activities	(11,893)	(14,941)
Investing activities
Cash received from merger transaction		23,250
Proceeds from sale of equipment		8
Net cash provided by investing activities		23,258
Financing activities
Proceeds from issuance of common stock, net	7,491	4,750
Proceeds from exercise of warrants		3,119
Proceeds from exercise of stock options	71
Net cash provided by financing activities	7,562	7,869
Net (decrease) increase in cash, cash equivalents and restricted cash	(4,331)	16,186
Cash, cash equivalents and restricted cash at beginning of period	17,303	1,117
Cash, cash equivalents and restricted cash at end of period	$ 12,972	17,303
Noncash activities:
Conversion of promissory note and interest to common stock		3,447
Conversion of contingently issuable shares to common stock		291
Issuance of common stock in merger		23,375
Conversion of preferred shares to common stock		27
Fair value of assets acquired, excluding cash and restricted cash		3,072
Fair value of liabilities assumed		(2,947)
Fair value of net assets acquired in the merger		$ 125

Description of Business

Description of Business	12 Months Ended
	Dec. 31, 2018
Accounting Policies [Abstract]
Description of Business	Note 1. Description of Business Novus Therapeutics is a specialty pharmaceutical company focused on developing products for disorders of the ear, nose, and throat (ENT). Unless otherwise indicated, references to the terms the “combined company”, “Novus”, the “Company”, refer to Otic Pharma, Ltd. prior to the consummation of the Reverse Merger, and Novus Therapeutics, Inc., upon the consummation of the Reverse Merger described herein. The term “Tokai” refers to Tokai Pharmaceuticals, Inc., and its subsidiaries prior to the Reverse Merger. Reverse Merger On December 21, 2016, Tokai, a Delaware corporation, Otic, and the stockholders of Otic Pharma, Ltd., a private limited company organized under the laws of the State of Israel (“Otic”) (each a “Seller” and collectively, the “Sellers”), entered into a Share Purchase Agreement (the “Share Purchase Agreement”), pursuant to which, among other things, each Seller agreed to sell to Tokai, and Tokai agreed to purchase from each Seller, all of the common and preferred shares of Otic (“Otic Shares”) owned by such Seller in exchange for the issuance of a certain number of shares of common stock of Tokai, as determined pursuant to the terms of the Share Purchase Agreement (the “Reverse Merger”). The parties amended and restated the Share Purchase Agreement on March 2, 2017. On May 9, 2017, Tokai, Otic, and the Sellers closed the transaction contemplated by the Share Purchase Agreement, and subsequently effected a reverse stock-split of common stock at a ratio of one-for-nine (see Reverse Stock-Split Private Placement On January 31, 2017, Novus entered into a stock purchase agreement (the “Stock Purchase Agreement”) with certain purchasers named therein (the “Purchasers”), pursuant to which the Purchasers agreed to purchase approximately $4.0 million of the Company’s common stock through the purchase of 400,400 shares of the Company’s common stock at a price of $9.99 per share (the “Private Placement”). The Private Placement closed on May 10, 2017. After giving effect to the issuance of the shares in the Private Placement, the stockholders of Otic owned approximately 64% of the Company’s common stock.

Summary of Significant Accounti

Summary of Significant Accounting Policies	12 Months Ended
	Dec. 31, 2018
Accounting Policies [Abstract]
Summary of Significant Accounting Policies	Note 2. Summary of Significant Accounting Policies Basis of Presentation and Principles of Consolidation The consolidated financial statements are prepared in accordance with accounting principles generally accepted in the U.S. (“GAAP”). Novus, a Delaware corporation, owns 100% of the issued and outstanding common stock or other ownership interest in Otic. Otic owns 100% of the issued and outstanding common stock or other ownership interest in its U.S. subsidiary, Otic Pharma, Inc. The functional currency of the Company’s foreign subsidiary is the U.S. Dollar; however, certain expenses, assets and liabilities are transacted at the local currency. These transactions are translated from the local currency into U.S. Dollars at exchange rates during or at the end of the reporting period. The activities of the Company’s foreign subsidiary are not significant to the consolidated financial statements. All significant intercompany accounts and transactions among the entities have been eliminated in consolidation. Liquidity and Financial Condition The Company has experienced recurring net losses and negative cash flows from operating activities since its inception. The Company recorded a net loss of $14.1 million and used $11.9 million of cash in operating activities for the year ended December 31, 2018. As of December 31, 2018, the Company had cash of $13.0 million, working capital of $11.7 million and an accumulated deficit of $41.6 million. Due to continuing research and development activities, the Company expects to continue to incur net losses into the foreseeable future. In order to continue these activities, the Company will need to raise additional funds through public or private debt and equity financings or strategic collaboration and licensing arrangements. The Company’s ability to raise additional capital in the equity and debt markets is dependent on a number of factors, including, but not limited to, the market demand for the Company’s common stock, which itself is subject to a number of development and business risks and uncertainties, as well as the uncertainty that the Company would be able to raise such additional capital at a price or on terms that are favorable to the Company. Adequate additional funding may not be available to us on acceptable terms on a timely basis, or at all. If the Company is unable to obtain the necessary level of capital through external financing during the first half of 2019, as contemplated in its operating plan, the Company intends to implement certain cost cutting measures commencing in the first half of 2019 to reduce its cash flow requirements. Consistent with the actions the Company has taken in the past, it will execute the appropriate steps to enable the continued operations of the business and preservation of the value of its assets beyond the next twelve months, including but not limited to actions such as reduced personnel-related costs, delay or curtailment of the Company’s research and development activities, and other discretionary expenses that are within the Company’s control. These initiatives, if required, may have an adverse impact on the Company’s ability to achieve certain of its planned objectives during 2019 as it seeks strategic alternatives. At the time of issuance of the consolidated financial statements for the year ended December 31, 2018, the Company concluded that there is substantial doubt regarding the Company’s ability to continue as a going concern for the twelve months from the date of issuance of the consolidated financial statements for the year ended December 31, 2018. The financial information and the consolidated financial statements included in this Annual Report have been prepared on a basis that assumes that we will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. This financial information and these financial statements do not include any adjustments that may result from an unfavorable outcome of this uncertainty. Our ability to continue as a going concern is dependent upon our ability to successfully secure sources of financing and ultimately achieve profitable operations. Use of Estimates The preparation of the Company’s consolidated financial statements in conformity with GAAP requires management to make informed estimates and assumptions that affect the reported amounts of assets, liabilities and expenses and the disclosure of contingent assets and liabilities in the Company’s consolidated financial statements and accompanying notes. The most significant estimates in the Company’s financial statements relate to stock-based compensation, accruals for liabilities, carrying value of goodwill, and other matters that affect the consolidated financial statements and related disclosures. Actual results could differ materially from those estimates under different assumptions or conditions and the differences may be material to the consolidated financial statements. Cash and Cash Equivalents Cash represents cash deposits held at financial institutions. The Company considers all liquid investments purchased with an original maturity of three months or less and that can be liquidated without prior notice or penalty to be cash equivalents. The carrying value of cash equivalents approximate their fair value due to the short-term maturities of these instruments. Cash equivalents are held for the purpose of meeting short-term liquidity requirements, rather than for investment purposes. The Company had no cash equivalents at December 31, 2018 and 2017. Restricted Cash Restricted cash represents cash required to be set aside Fair Value Measurements Financial assets and liabilities are recorded at fair value. The Company measures the fair value of certain of its financial instruments on a recurring basis. A fair value hierarchy is used to rank the quality and reliability of the information used to determine fair values. Financial assets and liabilities carried at fair value will be classified and disclosed in one of the following three categories: Level 1—Quoted prices (unadjusted) in active markets for identical assets and liabilities. Level 2—Inputs other than Level 1 that are observable, either directly or indirectly, such as unadjusted quoted prices for similar assets and liabilities, unadjusted quoted prices in the markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. There have been no transfers of assets for liabilities between these fair value measurement classifications during the periods presented. The Company had no financial instruments, assets or liabilities measured at fair value on a recurring basis at December 31, 2018 and 2017. Concentration of Credit Risk and Other Risks and Uncertainties As of December 31, 2018 and 2017, all of the Company’s long-lived assets were located in the U.S. Financial instruments that are subject to concentration of credit risk consist primarily of cash equivalents. The Company’s policy is to invest cash in institutional money market funds to limit the amount of credit exposure. At times, the Company maintains cash equivalents in short‑term money market funds and it has not experienced any losses on its cash equivalents. The Company’s products will require approval from the U.S. Food and Drug Administration (FDA) and foreign regulatory agencies before commercial sales can commence. There can be no assurance that its products will receive any of these required approvals. The denial or delay of such approvals may impact the Company’s business in the future. In addition, after the approval by the FDA, there is still an ongoing risk of adverse events that did not appear during the product approval process. The Company is subject to risks common to companies in the pharmaceutical industry, including, but not limited to, new technological innovations, clinical development risk, establishment of appropriate commercial partnerships, protection of proprietary technology, compliance with government and environmental regulations, uncertainty of market acceptance of products, product liability, the volatility of its stock price and the need to obtain additional financing. Our facilities and equipment may be affected by natural or man-made disasters. We currently conduct our research, development and management activities in Irvine, California, near known earthquake fault zones. We have taken precautions to safeguard our facilities, equipment and systems, including insurance, health and safety protocols, and off-site storage of computer data. However, our facilities and systems may be vulnerable to earthquakes, fire, storm, power loss, telecommunications failures, physical and software break-ins, software viruses and similar events which could cause substantial delays in our operations, damage or destroy our equipment or inventory, and cause us to incur additional expenses. In addition, the insurance coverage we maintain may not be adequate to cover our losses in any circumstance and may not continue to be available to use on acceptable terms, or at all. Business Combinations Accounting for acquisitions requires extensive use of estimates and judgment to measure the fair value of the identifiable tangible and intangible assets acquired, including in-process research and development and liabilities assumed. Additionally, the Company must determine whether an acquired entity is considered a business or a set of net assets because the excess of the purchase price over the fair value of net assets acquired can only be recognized as goodwill in a business combination. The Company accounted for the merger with Tokai as a business combination under the acquisition method of accounting. Consideration paid to acquire Tokai was measured at fair value and included the exchange of Tokai’s common stock and preferred stock. The allocation of the purchase price resulted in recognition of an intangible asset related to goodwill. The operating activity for Tokai, the acquiree for accounting purposes, was immediately integrated with Otic post‑merger, therefore it is not practical to segregate results of operations related specifically to Tokai since the date of acquisition. As a result of the Reverse Merger, historical common stock, stock options and additional paid-in capital, including share and per share amounts, have been retroactively adjusted to reflect the equity structure of the Company. Reportable Segments Operating segments under GAAP are defined as components of an enterprise about which separate financial information is available that is evaluated regularly by the Chief Operating Decision Maker (CODM), or decision-making group, in deciding how to allocate resources and in assessing performance. The CODM is the Company’s Chief Executive Officer and the Company has determined that it operates in one business segment, which is the development of Goodwill Goodwill represents the difference between the consideration transferred and the fair value of the net assets acquired under the acquisition method of accounting. Goodwill is not amortized but is evaluated for impairment as of October 1 of each year or if indicators of impairment exist that would, more likely than not, reduce the fair value from its carrying amount. The Company performs its goodwill impairment analysis at the reporting unit level, which aligns with the Company’s reporting structure and availability of discrete financial information. If a quantitative assessment is performed the evaluation includes management estimates of cash flow projections based on internal future projections . Key assumptions for these projections include revenue growth, future gross and operating margin growth, and its weighted cost of capital and terminal growth rates. The revenue and margin growth is based on increased sales of new products as the Company maintains investments in research and development. Additional assumed value creators may include increased efficiencies from capital spending. The resulting cash flows are discounted using a weighted average cost of capital. Operating mechanisms and requirements to ensure that growth and efficiency assumptions will ultimately be realized are also considered in the evaluation, including timing and probability of regulatory approvals for Company products to be commercialized. The Company’s market capitalization is also considered as a part of its analysis. The Company’s annual evaluation for impairment of goodwill consists of one reporting unit. In accordance with the Company’s policy, the Company completed its most recent annual evaluation for impairment as of October 1, 2018 using the qualitative assessment and determined that no impairment existed. No impairments were recorded for the years ended and 2017. Long-Lived Assets Property and equipment are recorded at cost. Depreciation is computed using the straight-line method over the estimated useful lives of the respective assets. Additions, major renewals and improvements are capitalized and repair and maintenance costs are charged to expense as incurred. Leasehold improvements are amortized over the remaining life of the initial lease term or the estimated useful lives of the assets, whichever is shorter. The Company reviews property, plant and equipment for impairment whenever events or changes in circumstances indicate that the carrying value of an asset may not be recoverable. An impairment loss would be recognized when estimated future undiscounted cash flows relating to the asset are less than its carrying amount. An impairment loss is measured as the amount by which the carrying amount of an asset exceeds its fair value. Significant management judgment is required in the forecast of future operating results that are used in the preparation of expected cash flows. No impairments of tangible assets have been identified during the years presented. Research and Development Expenses Research and development expenses include personnel and facility-related expenses, outside contracted services including clinical trial costs, manufacturing and process development costs, research costs and other consulting services and non-cash stock-based compensation. Research and development costs are expensed as incurred. Amounts due under contracts with third parties may be either fixed fee or fee for service, and may include upfront payments, monthly payments and payments upon the completion of milestones or receipt of deliverables. Non-refundable advance payments under agreements are capitalized and expensed as the related goods are delivered or services are performed. The Company’s contracts with third parties to perform various clinical trial activities in the on-going development of potential products. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows to its vendors. Payments under the contracts depend on factors such as the achievement of certain events, successful enrollment of patients, and completion of portions of the clinical trial or similar conditions. The Company’s accrual for clinical trials is based on estimates of the services received and efforts expended pursuant to contracts with clinical trial centers and clinical research organizations. These contracts may be terminated by the Company upon written notice and the Company is generally only liable for actual effort expended by the organizations to the date of termination, although in certain instances the Company may be further responsible for termination fees and penalties. The Company estimates its research and development expenses and the related accrual as of each balance sheet date based on the facts and circumstances known to the Company at that time. There have been no material adjustments to the Company’s prior period accrued estimates for clinical trial activities through December 31, 2018. Net Loss Per Share 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 determined using the treasury-stock and if-converted methods. For purposes of the diluted net loss per share calculation, preferred stock, and stock options and warrants are considered to be potentially dilutive securities and are excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive. Therefore, basic and diluted net loss per share was the same for the periods presented due to the Company’s net loss position. Year Ended December 31, 2018 2017 (In thousands, except share and per share data) Net loss available to stockholders of the company $ (14,065 ) $ (13,116 ) Interest accumulated on preferred shares and on preferred shares contingently issuable for little or no cash — (328 ) Net loss attributable to stockholders of preferred shares and to stockholders of preferred shares contingently issuable for little or no cash — 2,666 Net loss used in the calculation of basic and diluted loss per share $ (14,065 ) $ (10,778 ) Net loss per share, basic and diluted $ (1.56 ) $ (2.30 ) Weighted-average number of common shares 9,005,352 4,677,610 The computation of diluted earnings per share excludes stock options, warrants, and restricted stock units that are anti-dilutive. For the year ended December 31, 2018, common share equivalents of 974,817 shares were anti-dilutive. For the year ended December 31, 2017, common share equivalents of 782,340 shares were anti-dilutive. Stock-based Compensation For stock options granted to employees, the Company recognizes compensation expense for all stock-based awards based on the grant-date estimated fair value. The fair value of stock options is determined using the Black-Scholes option pricing model, using assumptions which are subjective and require significant judgment and estimation by management. The risk-free rate assumption was based on observed yields from governmental zero-coupon bonds with an equivalent term. The expected volatility assumption was based on historical volatilities of a group of comparable industry companies whose share prices are publicly available. The peer group was developed based on companies in the pharmaceutical industry. The expected term of stock options represents the weighted-average period that the stock options are expected to be outstanding. Because the Company does not have historical exercise behavior, it determined the expected life assumption using the simplified method, which is an average of the options ordinary vesting period and the contractual term. The expected dividend assumption was based on the Company’s history and expectation of dividend payouts. The Company has not paid and does not expect to pay dividends at any time in the foreseeable future. The Company recognizes forfeitures on an actual basis and as such did not estimate forfeitures to calculate stock-based compensation. Stock-based compensation expense related to stock options granted to non-employees is recognized based on the fair value of the stock options, determined using the Black-Scholes option pricing model, as they are earned. The awards generally vest over the period the Company expects to receive services from the non-employee. Stock options granted to non-employees are subject to periodic revaluation over their vesting terms. Income Taxes The asset and liability approach is used to recognize deferred tax assets and liabilities for the expected future tax consequences of temporary differences between the carrying amounts and the tax bases of assets and liabilities. Tax law and rate changes are reflected in income in the period such changes are enacted. The likelihood of realizing the tax benefits related to a potential deferred tax asset is evaluated, and a valuation allowance is recognized to reduce that deferred tax asset if it is more likely than not that all or some portion of the deferred tax asset will not be realized. Deferred tax assets and liabilities are calculated at the beginning and end of the year; the change in the sum of the deferred tax asset, valuation allowance and deferred tax liability during the year generally is recognized as a deferred tax expense or benefit. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in operations in the period that includes the enactment date. Significant judgment is required in determining the Company’s provision for income taxes, deferred tax assets and liabilities and the valuation allowance recorded against net deferred tax assets. We assess the likelihood that deferred tax assets will be recovered as deductions from future taxable income. The evaluation of the need for a valuation allowance is performed on a jurisdiction-by-jurisdiction basis and includes a review of all available positive and negative evidence. Factors reviewed include projections of pre-tax book income for the foreseeable future, determination of cumulative pre-tax book income after permanent differences, earnings history, and reliability of forecasting. We have provided a full valuation allowance on our deferred tax assets as of December 31, 2018 and 2017 because we believe it is more likely than not that our deferred tax assets will not be realized as of those dates. On December 22, 2017, President Trump signed U.S. tax reform legislation, commonly referred to as the Tax Cuts and Jobs Act (the “Tax Act”), which became effective January 1, 2018. The Tax Act significantly changed the fundamentals of U.S. corporate income taxation by, among many other things, reducing the U.S. federal corporate income tax rate from 35% to 21%, converting to a territorial tax system, and creating various income inclusion and expense limitation provisions. We have performed a review of the Tax Act, and recorded amounts related to the revaluation of our deferred taxes and the realization of certain tax credit carryforwards. However, as the Company records a valuation allowance for its entire deferred income tax asset, there was no impact to the reported amounts in the accompanying consolidated financial statements as a result of the Tax Act. The Company evaluates the accounting for uncertainty in income tax recognized in its consolidated financial statements and determines whether it is more likely than not that a tax position will be sustained upon examination by the appropriate taxing authorities before any part of the benefit is recorded in its consolidated financial statements. For those tax positions where it is “not more likely than not” that a tax benefit will be sustained, no tax benefit is recognized. Where applicable, associated interest and penalties are also recorded. The Company has not accrued any liabilities for any such uncertain tax positions as of December 31, 2018 or 2017. The Company is subject to U.S. federal and state tax authority examinations for all the years since inception due to net operating loss and tax credit carryforwards. The net operating losses and tax credits are subject to adjustment until the statute closes on the year the attributes are ultimately utilized. The Company’s income tax returns are based on calculations and assumptions that are subject to examination by the Internal Revenue Service and other tax authorities. In addition, the calculation of the Company’s tax liabilities involves dealing with uncertainties in the application of complex tax regulations. The Company recognizes liabilities for uncertain tax positions based on a two-step process. The first step is to evaluate the tax position for recognition by determining if the weight of available evidence indicates that it is more likely than not that the position will be sustained on audit, including resolution of related appeals or litigation processes, if any. The second step is to measure the tax benefit as the largest amount that is more than 50% likely of being realized upon settlement. While the Company believes it has appropriate support for the positions taken on its tax returns, the Company regularly assesses the potential outcomes of examinations by tax authorities in determining the adequacy of its provision for income taxes. The Company continually assesses the likelihood and amount of potential revisions and adjusts the income tax provision, income taxes payable and deferred taxes in the period in which the facts that give rise to a revision become known. For additional information, see Note 8. Income Taxes Recently Issued Accounting Pronouncements In August 2018, the SEC adopted the final rule under SEC Release No. 33-10532, Disclosure Update and Simplification, amending certain disclosure requirements that were redundant, duplicative, overlapping, outdated or superseded. In addition, the amendments expanded the disclosure requirements on the analysis of stockholders' equity for interim financial statements. Under the amendments, an analysis of changes in each caption of stockholders' equity presented in the balance sheet must be provided in a note or separate statement. The analysis should present a reconciliation of the beginning balance to the ending balance of each period for which a statement of comprehensive income is required to be filed. This final rule was effective on November 5, 2018. However, as provided for by the SEC in Q&A 105.09, the Company will defer presenting its analysis of stockholders’ equity in its quarterly report in Form 10-Q until its quarter ended March 31, 2019. The Company does not expect the adoption of SEC Release No. 33-10532 to have a material impact on its financial position, results of operations or cash flows. In August 2018, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2018-15, Customer's Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract In August 2018, the FASB issued ASU No. 2018-13, “Fair Value Measurement (Topic 820): Disclosure Framework — Changes to the Disclosure Requirements for Fair Value Measurement” In June 2018, the FASB issued ASU No. 2018-07, Improvements to Nonemployee Share-Based Payment Accounting Compensation—Stock Compensation Equity—Equity-Based Payments to Non-Employees Revenue from Contracts with Customers In February 2018, the FASB issued ASU No. 2018-02, Income Statement—Reporting Comprehensive Income (Topic 220) In July 2017, the FASB issued ASU 2017-11 , “Earnings Per Share (Topic 260) Distinguishing Liabilities from Equity (Topic 480) Derivatives and Hedging (Topic 815)” The Company is currently assessing the impact and timing of adopting this guidance on its consolidated financial statements. In January 2017, the FASB issued ASU No. 2017-04 “ Intangibles – Goodwill and Other (Topic 350): Simplifying the Accounting for Goodwill Impairment The Company is currently assessing the impact and timing of adopting this guidance on its consolidated financial In May 2017, the FASB issued ASU No. 2017-09, “ Stock Compensation – Scope of Modification Accounting” In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) Leases (Topic 842) Targeted Improvements The Company has adopted the requirements of the new lease standard effective January 1, 2019 and has elected the optional transition method to apply the standard as of the effective date and therefore, the Company will not apply the standard to the comparative periods presented in the consolidated financial statements. The Company will elect the transition package of three practical expedients permitted within the standard, which eliminates the requirements to reassess prior conclusions about lease identification, lease classification, and initial direct costs. The Company will not elect the hindsight practical expedient, which permits the use of hindsight when determining lease term and impairment of right-of-use assets. Further, the Company will elect a short-term lease exception policy, permitting the Company to not apply the recognition requirements of this standard to short-term leases (i.e. leases with terms of 12 months or less) and an accounting policy to account for lease and non-lease components as a single component for certain classes of assets. The Company is finalizing its analysis of certain key assumptions that will be utilized at the transition date including the incremental borrowing rate. The standard will have a material impact on the Company’s consolidated balance sheets effective January 1, 2019, but will not have an impact on its consolidated statements of operations as of January 1, 2019. The most significant impact will be the recognition of a right-to-use asset and corresponding lease liability for the Company’s sole operating lease—the Company has no finance leases.

Reverse Merger

Reverse Merger	12 Months Ended
	Dec. 31, 2018
Business Combinations [Abstract]
Reverse Merger	Note 3. Reverse Merger The Company completed the Reverse Merger with Tokai as discussed in Note 1. Based on the terms of the Reverse Merger, the Company concluded that the transaction is a business combination pursuant to ASC 805 Business Combinations On May 9, 2017, Tokai issued 4,027,693 shares of its common stock to the stockholders of Otic and the holders of warrants and options of Otic upon the exercise of such options and warrants in exchange for 840,115 Otic Shares. All warrants were exercised as of the merger date and after consummation of the Reverse Merger, Otic stockholders owned a majority of the fully diluted common stock of Novus Therapeutics, Inc. Purchase Consideration The purchase price for Tokai on May 9, 2017, the closing date of the Reverse Merger, was as follows (in thousands): Fair value of Tokai common stock outstanding (1) $ 14,486 Premium paid (2) 8,889 Purchase price $ 23,375 (1) Comprised of 2,515,739 shares of common stock outstanding at the date of the Reverse Merger based on the closing price of $5.76 per share on May 9, 2017, as adjusted for the one-for-nine reverse stock-split on May 11, 2017. (2) Premium paid over fair value of common stock based on net tangible asset multiple of 1.08x book value of Tokai equity of $21.5 million as of May 9, 2017. Allocation of Purchase Consideration The allocation of the estimated purchase price to the acquired assets and liabilities assumed of Tokai, based on their estimated fair values as of May 9, 2017, the close of the transaction, was as follows (in thousands): Cash, cash equivalents, and restricted cash $ 23,250 Prepaids and other current assets 1,132 Property and equipment 73 Goodwill 1,867 Accounts payable, accrued expenses and other liabilities (2,947 ) Net assets acquired $ 23,375 The Company engaged a third-party valuation firm to assist management in its analysis of the fair value of Tokai. All estimates, key assumptions, and forecasts were either provided by or reviewed by management. While the Company chose to utilize a third-party valuation firm, the fair value analysis and related valuations represent the conclusions of management and not the conclusions or statements of any third party. The excess of the total purchase price over the fair value of assets acquired and liabilities assumed was allocated to goodwill. The Company believes that the historical values of Tokai’s current assets and current liabilities approximated fair value based on the short-term nature of such items. Goodwill, which relates principally to intangible assets that do not qualify for separate recognition under GAAP, Pro Forma Results in Connection with Reverse Merger The operating activity for Tokai, the acquiree for accounting purposes, was immediately integrated with Otic post‑merger, therefore it is not practical to segregate results of operations related specifically to Tokai since the date of acquisition. The unaudited financial information in the following table summarizes the combined results of operations of the Company and Tokai, on a pro forma basis, as if the Reverse Merger had occurred at the beginning of the periods presented (in thousands): Year Ended December 31, 2017 Operating expenses Research and development $ 2,481 General and administrative 9,356 Total operating expenses 11,837 Loss from operations (11,837 ) Other income, net 45 Net loss and other comprehensive loss $ (11,792 ) Net loss per share, basic and diluted $ (2.52 ) Weighted-average shares outstanding, basic and diluted 4,677,610 The above unaudited pro forma information was determined based on historical GAAP results of Otic and Tokai. The unaudited pro forma combined results are not necessarily indicative of what the Company’s combined results of operations would have been if the acquisition was completed at the beginning of the periods presented. The unaudited pro forma combined net loss includes pro forma adjustments primarily relating to the following non-recurring items directly attributable to the business combination: • Elimination of transaction costs of $7.2 million incurred during the year ended December 31, 2017. The amount has been eliminated on a pro forma basis as they are not expected to have a continuing effect on the operating results of the combined company. • An increase in the weighted-average shares outstanding for the period after giving effect to the issuance of Tokai common stock in connection with the Reverse Merger and Private Placement.

Prepaid Expenses Other Assets A

Prepaid Expenses Other Assets Accrued Expenses and Other Liabilities	12 Months Ended
	Dec. 31, 2018
Prepaid Expenses Other Assets Accrued Expenses And Other Liabilities [Abstract]
Prepaid Expenses, Other Assets, Accrued Expenses and Other Liabilities	Note 4. Prepaid Expenses, Other Assets, Accrued Expenses and Other Liabilities Prepaid expenses and other current assets consisted of the following as of December 31, 2018 and December 31, 2017 (in thousands): Year Ended December 31, 2018 2017 Prepaid insurance $ 413 $ 1,518 Prepaid other 261 161 Other current assets 630 18 Total prepaid expenses and other current assets $ 1,304 $ 1,697 Accrued expenses and other liabilities consisted of the following as of December 31, 2018 and December 31, 2017 (in thousands): Year Ended December 31, 2018 2017 Accrued compensation and related expenses $ 742 $ — Accrued clinical 735 85 Accrued professional services 194 158 Accrued vacation 160 111 Accrued other 14 — Total accrued expenses and other liabilities $ 1,845 $ 354

Goodwill

Goodwill	12 Months Ended
	Dec. 31, 2018
Goodwill And Intangible Assets Disclosure [Abstract]
Goodwill	Note 5. Goodwill The changes in the carrying amount of goodwill consisted of the following as of December 31, 2018 and December 31, 2017 (in thousands): Gross Carrying Amount Accumulated Impairment Losses Net Carrying Amount Balance as of January 1, 2017 $ — $ — $ — Additions (1) 1,867 — 1,867 Balance as of December 31, 2017 1,867 — 1,867 Additions — — — Balance as of December 31, 2018 $ 1,867 $ — $ 1,867 (1) Relates to the Reverse Merger (See Note 3. Reverse Merger

Commitments and Contingencies

Commitments and Contingencies	12 Months Ended
	Dec. 31, 2018
Commitments And Contingencies Disclosure [Abstract]
Commitments and Contingencies	Note 6. Commitments and Contingencies Operating Leases The Company leases office space under various operating leases. Total rent expense for all operating leases in the consolidated statements of operations and comprehensive loss was approximately $170,000 and $1.0 million for the year ended December 31, 2018 and 2017, respectively. In February 2015, Tokai entered into a sublease for 15,981 square feet of office space in Boston, Massachusetts. The term of the sublease commenced on April 1, 2015 and initially expired on December 31, 2016 until subsequently extended through July 31, 2018. In November 2017, the Company terminated the lease early and paid an additional $455,000 in advance rent in conjunction with the lease termination. In September 2015, Otic entered into a three-year operating lease for 5,197 square feet of office space in Irvine, California. The lease had an initial expiration date of August 31, 2018 ; however, the Company extended the term of the lease through September 30, 2021 by amending the office lease in April 2018. Future payments under noncancelable operating leases having initial or remaining terms of one year or more are as follows for the succeeding fiscal year and thereafter (in thousands): 2019 $ 180 2020 188 2021 146 Total minimum lease payments $ 514 Restricted Cash and Letter of Credit The Company was required to maintain a letter of credit Grants and Licenses Israeli Innovation Authority Grant From 2012 through 2015, the Company received grants in the amount of approximately $537,000 from the Israeli Innovation Authority (previously the Office of Chief Scientist) of the Israeli Ministry of Economy and Industry designated for investments in research and development. The grants are linked to the U.S. dollar and bear annual interest of LIBOR. The grants are to be repaid as royalties from sales of the products developed by the Company from their investments in research and development. Because the Company has not yet earned revenues related to these investments and cannot estimate potential royalties, no liabilities related to these grants have been recorded as of each period presented. Repayment of the grant is contingent upon the successful completion of the Company’s R&D programs and generating sales. The Company has no obligation to repay these grants, if the R&D program fails, is unsuccessful or aborted or if no sales are generated. The Company had not yet generated sales as of December 31, 2018; therefore, no liability was recorded for the repayment in the accompanying consolidated financial statements. Otodyne License Agreement In November 2015, the Company entered into an exclusive license agreement with Scientific Development and Research, Inc. and Otodyne, Inc. (collectively, the “Licensors”) granting it exclusive worldwide rights to develop and commercialize OP0201, a potential first-in-class treatment option for patients at risk for or with otitis media (middle ear inflammation with or without infection), which is often caused by ETD. Under the terms of the agreement, the Company is obligated to use commercially reasonable efforts to seek approval for and commercialize at least one product for otitis media in the U.S. and key European markets (France, Germany, Italy, Spain, and the United Kingdom). The Company is responsible for prosecuting, maintaining, and enforcing all intellectual property and will be the sole owner of improvements. Under the agreement with the Licensors, the Company paid license fees totaling $750,000 and issued 9,780 common shares to the Licensors, which was expensed to research and development during the year ended December 31, 2015. In December 2015, the Licensors completed transfer of all technology, including the active IND application to the Company. The Company is obligated to pay up to $42.1 million in development and regulatory milestones if OP0201 is approved for three indications in the U.S., two in Europe, and two in Japan. The Company is also obligated to pay up to $36.0 million in sales based milestones, beginning with sales exceeding $1.0 billion in a calendar year. The Company is also obligated to pay a tiered royalty for a period up to eight years, on a country-by-country basis. The royalty ranges from a low-single to mid-single percentage of net sales. There were no milestones achieved during the years ended December 31, 2018 or 2017. Terminated License Agreements In October 2013, the Company (through Tokai) entered into a master license agreement with the University of Maryland, Baltimore (“UMB”), pursuant to which, UMB granted the Company an exclusive, worldwide license, with the right to sublicense, and, under certain patents and patent applications to make, have made, use, sell, offer to sell and import certain anti-androgen steroids, including galeterone, for the prevention, diagnosis, treatment or control of any human or animal disease. In January 2015, the Company (through Tokai) entered into an exclusive license agreement with The Johns Hopkins University (“Johns Hopkins”) pursuant to which Johns Hopkins granted the Company an exclusive, worldwide license under certain patents and patent applications, and a non-exclusive license under certain know-how, in each case with the right to sublicense, and to make, have made, use, sell, offer to sell and import certain assays to identify androgen receptor variants for use as a companion diagnostic with galeterone. On October 5, 2017, the Company submitted notice of termination to all parties. The Company no longer has any obligations to UMB as of December 4, 2017, and to John Hopkins as of January 3, 2018. Legal Matters The Company is involved in various lawsuits and claims arising in the ordinary course of business, including actions with respect to intellectual property, employment, and contractual matters. In connection with these matters, the Company assesses, on a regular basis, the probability and range of possible loss based on the developments in these matters. A liability is recorded in the financial statements if it is believed to be probable that a loss has been incurred and the amount of the loss can be reasonably estimated. Because litigation is inherently unpredictable and unfavorable results could occur, assessing contingencies is highly subjective and requires judgments about future events. The Company regularly reviews outstanding legal matters to determine the adequacy of the liabilities accrued and related disclosures. The amount of ultimate loss may differ from these estimates. Each matter presents its own unique circumstances, and prior litigation does not necessarily provide a reliable basis on which to predict the outcome, or range of outcomes, in any individual proceeding. Because of the uncertainties related to the occurrence, amount, and range of loss on any pending litigation or claim, the Company does not consider a liability probable and is currently unable to predict their ultimate outcome, and, with respect to any pending litigation or claim where no liability has been accrued, to make a meaningful estimate of the reasonably possible loss or range of loss that could result from an unfavorable outcome. In the event that opposing litigants in outstanding litigation proceedings or claims ultimately succeed at trial and any subsequent appeals on their claims, any potential loss or charges in excess of any established accruals, individually or in the aggregate, could have a material adverse effect on the Company’s business, financial condition, results of operations, and/or cash flows in the period in which the unfavorable outcome occurs or becomes probable, and potentially in future periods. Legal Proceedings On September 22, 2014, Tokai completed the initial public offering of its common stock (the IPO”). Subsequent to the IPO, several lawsuits were filed against Tokai, Jodie P. Morrison, Lee H. Kalowski, Seth L. Harrison, Timothy J. Barberich, David A. Kessler, Joseph A. Yanchik, III, and the underwriters of the IPO. The lawsuits allege that, in violation of the Securities Act of 1933 (“Securities Act”), Tokai’s registration statement for the IPO made false and misleading statements and omissions about Tokai’s clinical trials for galeterone. Each lawsuit sought, among other things, unspecified compensatory damages, interest, costs, and attorneys’ fees. Further details on each lawsuit are set forth below. The Company intends to vigorously defend against these claims. Given the uncertainty of litigation, the preliminary stage of these cases, and the legal standards that must be met for, among other things, success on the merits, it cannot estimate the reasonably possible loss or range of loss that may result from these actions. • Jackie888 Action Jackie888, Inc. v. Tokai Pharmaceuticals, Inc., et al., • Wu Action Wu v. Tokai Pharmaceuticals, Inc., et al., Wu v. Tokai Pharmaceuticals, Inc., et al., United States Supreme Court in Cyan, Inc. v. Beaver County Employees Retirement Fund • Angelos Action Peter B. Angelos v. Tokai Pharmaceuticals, Inc., et al., Indemnification In the normal course of business, the Company enters into contracts and agreements that contain a variety of representations and warranties and provide for general indemnification. The Company’s exposure under these agreements is unknown because it involves future claims that may be made against the Company but have not yet been made. To date, the Company has not paid any claims or been required to defend any action related to its indemnification obligations. However, the Company may record charges in the future because of these indemnification obligations. No amounts associated with such indemnifications have been recorded to date. Contingencies From time to time, the Company may have certain contingent liabilities that arise in the ordinary course of business activities. The Company accrues a liability for such matters when it is probable that future expenditures will be made and such expenditures can be reasonably estimated. There have been no contingent liabilities requiring accrual at December 31, 2018 and 2017.

Stock-Based Compensation

Stock-Based Compensation	12 Months Ended
	Dec. 31, 2018
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract]
Stock-Based Compensation	Note 7. Stock-Based Compensation Otic had one stock compensation plan prior to the Reverse Merger, the 2012 Global Share Incentive Plan (the “2012 Plan”). Under the 2012 Plan, stock options, restricted share units and performance share awards may be granted to the Company’s directors, employees and consultants. Options remain outstanding under the 2012 Plan. In connection with the Reverse Merger, all such options converted into options to purchase shares of Tokai common stock, as renamed Novus. Subsequent to the reverse merger, no additional grants will be made from the 2012 Plan. Options granted under the 2012 Plan generally expire ten years from the date of grant. Prior to the Reverse Merger, Tokai had two stock compensation plans, the 2014 Stock Incentive Plan (the “2014 Plan”) and the 2007 Stock Incentive Plan (the “2007 Plan”). The 2014 Plan permits the Company to make grants of incentive stock options, non-statutory stock options, restricted stock, restricted stock units, stock appreciation rights and other stock-based awards to the Company’s employees, officers, directors, consultants and advisors; however, incentive stock options may only be granted to the Company’s employees. The number of shares initially reserved for issuance under the 2014 Plan was 1,700,000 shares of common stock and may be increased by the number of shares under the 2007 Plan that expire, terminate or are otherwise surrendered, cancelled, forfeited or repurchased by the Company. The number of shares of common stock that may be issued under the plan is also subject to an annual increase on the first day of each fiscal year equal to the lesser of (i) 1,800,000 shares of the Company’s common stock, (ii) 4% of the number of shares of the Company’s common stock outstanding on the first day of the applicable fiscal year or (iii) an amount determined by the Company’s board of directors. Options remain outstanding under both the 2007 and the 2014 Plan. The number of shares subject to and the exercise prices applicable to these outstanding options were adjusted in connection with the one for nine reverse stock-split. As of December 31, 2018, there were 84,612 options outstanding under the 2007 plan. Options granted under the 2007 and 2014 Plans generally expire ten years from the date of grant. The Company intends for the 2014 Plan to be its primary stock compensation plan in the future. Effective as of August 1, 2018, the Board of Directors amended the Company’s 2014 Stock Incentive Plan (the “2014 Plan”) and the Company’s 2014 Employee Stock Purchase Plan (the “ESPP” and, together with the 2014 Plan, the “Plans”) to reduce the share reserves under the Plans. These reductions were made to equitably adjust the share reserves in accordance with the terms of the Plans. As a result of these equitable adjustments: (1) the number of shares of common stock authorized for issuance under the 2014 Plan (excluding shares underlying outstanding awards as of August 1, 2018) was reduced to 766,500 shares and the maximum number of shares that can be added to the 2014 Plan under evergreen provision set forth in Section 4(a)(1)(C) of the 2014 Plan was reduced to 550,000 shares annually; and (2) the number of shares of common stock authorized for future issuance under the ESPP was reduced to 209,500 shares (excluding shares previously issued under the ESPP prior to August 1, 2018) and the maximum number of shares that can be added to the ESPP under the evergreen provision set forth in the ESPP was reduced to 135,000 shares annually. The 2014 Plan and ESPP were amended and restated as of August 1, 2018 to reflect these equitable adjustments. Because Otic is considered to be the acquirer for accounting purposes, the pre-Reverse Merger vested stock options granted by Tokai under the 2007 Plan and the 2014 Plan are deemed to have been exchanged for equity awards of the Company and as such the portion of the acquisition date fair value of these equity awards attributable to pre-Reverse Merger service to Tokai were accounted for as a component of the consideration transferred. The exchange of Otic stock options to purchase Tokai common stock, as renamed Novus, was accounted for as a modification of the awards because the legal exchange of the awards is considered a modification of Otic stock options. The modification of the stock options did not result in any incremental compensation expense as the modification did not increase the fair value of the stock options. Stock Option Activity As of December 31, 2018, a total of 764,966 options were available for grant under the 2014 Plan. The following table shows the stock option activity, as follows: Shares Issuable Under Options Weighted Average Exercise Price Weighted Average Remaining Contractual Term Aggregate Intrinsic Value (In years) (In thousands) Outstanding as of January 1, 2017 59,777 $ 18.45 8.8 $ 4.3 Granted 595,800 5.45 Options assumed in the Reverse Merger 137,139 50.25 Exercised — — Forfeited / Canceled (10,376 ) 6.85 Outstanding as of December 31, 2017 782,340 14.28 8.8 $ 8.5 Granted 267,950 5.02 Exercised (15,120 ) 4.74 Forfeited / Canceled (60,353 ) 7.31 Outstanding as of December 31, 2018 974,817 $ 12.31 8.2 $ — Options vested and expected to vest as of December 31, 2018 974,817 $ 12.31 8.2 $ — Options exercisable as of December 31, 2018 548,328 $ 17.57 7.6 $ — As of December 31, 2018, the range of exercise prices was between $3.32 and $119.25 for options outstanding. Intrinsic value is calculated as the difference between the exercise price of the underlying options and the fair value of the common stock for the options that had exercise prices that were lower than the fair value per share of the common stock on the date of exercise. There was no aggregate intrinsic value of options exercised during the years ended December 31, 2018 and 2017. As of December 31, 2018, total unrecognized stock-based compensation expense related to non-vested equity awards was $1.5 million, which is expected to be recognized over an estimated weighted-average period of 1.8 years. Stock-based Compensation Expense Total compensation expense related to all of the Company’s stock-based awards for the years ended December 31, 2018 and December 31, 2017 was comprised of the following (in thousands): Year Ended December 31, 2018 2017 Stock-based compensation classified as: Research and development expense $ 249 $ 69 General and administrative expense 1,294 510 Total stock-based compensation expense $ 1,543 $ 579 Stock-based compensation expense for the year ended December 31, 2018 includes $524,000 of stock-based compensation expense related to a performance-based option grant which vested during 2018. Valuation Assumptions The following table presents the assumptions used in the Black-Scholes option pricing model to determine the fair value of stock options granted in the periods presented Year Ended December 31, 2018 2017 Expected stock price volatility 63% - 86% 79% - 86% Risk-free interest rate 2% - 3% 1% - 3% Expected life of option (in years) 5 - 7 5 - 7 Estimated dividend yield 0% 0% Prior to the Reverse Merger, the fair value of the shares of common stock underlying the stock options had been the responsibility of and determined by the Company’s Board of Directors. Because there had been no public market for the Company’s common stock, the Board of Directors determined fair value of common stock at the time of grant of the option by considering a number of objective and subjective factors including independent third party valuations of the Company’s common stock, sales prices of convertible preferred stock to unrelated third parties, operating and financial performance, the lack of liquidity of capital stock and general and industry specific economic outlook, among other factors.

Income Taxes

Income Taxes	12 Months Ended
	Dec. 31, 2018
Income Tax Disclosure [Abstract]
Income Taxes	Note 8. Income Taxes Income (loss ) before income taxes are as follows (in thousands): Year Ended December 31, 2018 2017 Losses before income taxes: U.S. $ (14,177 ) $ (12,470 ) Non-U.S. 112 (646 ) Total $ (14,065 ) $ (13,116 ) The provision (benefit) for income taxes are as follows (in thousands): Year Ended December 31, 2018 2017 2016 Current: $ — $ — $ — Federal — — — State — — — Foreign — — — — — — Deferred Federal — — — State — — — Foreign — — — — — — Provision (benefit) for income taxes $ — $ — $ — The Company is subject to income taxes under U.S. tax laws. The Company was subject to an Israeli corporate tax rate of 24% in 2017. The Company is On December 22, 2017, H.R. 1/Public Law No. 115-97, known as the Tax Cuts and Jobs Act (the “Tax Act”), was signed into law. The effects of this new federal legislation are recognized upon enactment, which is the date a bill is signed into law. The Tax Act includes numerous changes in existing tax law, including a permanent reduction in the federal corporate income tax rate from 35% to 21%. The rate reduction took effect on January 1, 2018. As a result of the Tax Act, we recorded a $1.9 million reduction in our net deferred tax assets to reflect the rate reduction in the fourth quarter of 2017. However, the revaluation did not result in any additional net income tax expense as our net deferred tax assets are fully offset by a valuation allowance. The SEC staff issued Staff Accounting Bulletin No. 118 (“SAB 118”), which provides guidance on accounting for the tax effects of the Tax Act. SAB 118 provides a measurement period that should not extend beyond one year from the Tax Act enactment date for companies to complete the accounting under ASC 740. In accordance with SAB 118, a company must reflect the income tax effects of those aspects of the Tax Act for which the accounting under ASC 740 is complete. To the extent that a company’s accounting for certain income tax effects of the Tax Act is incomplete but it is able to determine a reasonable estimate, it must record a provisional estimate in the financial statements. If a company cannot determine a provisional estimate to be included in the financial statements, it should continue to apply ASC 740 on the basis of the provisions of the tax laws that were in effect immediately before the enactment of the Tax Act. As of December 22, 2018, the Company’s accounting for the remeasurement of its deferred tax assets was complete and there were no changes to the amount previously recorded. Significant judgment is required in determining the Company’s provision for income taxes, deferred tax assets and liabilities and the valuation allowance recorded against net deferred tax assets. Deferred tax assets and liabilities are determined using the enacted tax rates in effect for the years in which those tax assets are expected to be realized. A valuation allowance is established when it is more likely than not the future realization of all or some of the deferred tax assets will not be achieved. The evaluation of the need for a valuation allowance is performed on a jurisdiction-by-jurisdiction basis, and includes a review of all available positive and negative evidence. Factors reviewed include projections of pre-tax book income for the foreseeable future, determination of cumulative pre-tax book income after permanent differences, earnings history, and reliability of forecasting. Based on its review, the Company concluded that it was more likely than not that they would not realize the benefit of its deferred tax assets in the future. This conclusion was based on historical and projected operating performance, as well as the Company’s expectation that its operations will not generate sufficient taxable income in future periods to realize the tax benefits associated with the deferred tax assets within the statutory carryover periods. Therefore, the Company maintained a full valuation allowance on its deferred tax assets as of December 31, 2018 and 2017. The Company will continue to assess the need for a valuation allowance on its deferred tax assets by evaluating both positive and negative evidence that may exist. Any adjustment to the net deferred tax asset valuation allowance would be recorded in the statement of operations for the period that the adjustment is determined to be required. A reconciliation of the U.S. federal statutory income tax rate to the Company’s effective income tax rate is as follows: Year Ended December 31, 2018 2017 Statutory Federal income tax rate $ (2,953 ) $ (4,460 ) State income taxes, net of Federal tax benefits — — Foreign losses — 59 Tax credits (204 ) (2 ) Change in statutory rates — 1,859 Stock-based compensation 72 135 Permanent items 3 693 Other 90 43 Change in valuation allowance 2,992 1,673 Total provision for income taxes $ — $ — Significant components of the Company’s deferred tax assets and liabilities as of December 31, 2018 and 2017 consisted of the following (in thousands): Year Ended December 31, 2018 2017 Net operating loss carryforwards $ 7,126 $ 4,516 Research and development tax credits 299 95 Accruals and reserves 159 221 Stock compensation 301 48 Depreciation and amortization 126 139 Total deferred tax assets 8,011 5,019 Less: Valuation allowance (8,011 ) (5,019 ) Net deferred tax assets $ — $ — The following table reconciles the beginning and ending amounts of unrecognized tax benefits for the years presented (in thousands): Year Ended December 31, 2018 2017 Gross unrecognized tax benefits at the beginning of the year $ 181 $ — Additions from tax positions taken in the current year 158 75 Additions from tax positions taken in prior years — 106 Reductions from tax positions taken in prior years (11 ) — Tax settlements — — Gross unrecognized tax benefits at the end of the year $ 328 $ 181 The deferred income tax assets have been fully offset by a valuation allowance, as realization is dependent on future earnings, if any, the timing and amount of which are uncertain. The net valuation allowance increased by $3.0 million. The Company’s accounting for deferred taxes involves the evaluation of a number of factors concerning the realizability of its net deferred tax assets. The Company primarily considered such factors as its history of operating losses, the nature of the Company’s deferred tax assets, and the timing, likelihood, and amount, if any, of future taxable income during the periods in which those temporary differences and carryforwards become deductible. At present, the Company does not believe that it is more likely than not that the deferred tax assets will be realized; accordingly, a full valuation allowance has been established and no deferred tax asset is shown in the accompanying balance sheets. As of December 31, 2018, and December 31, 2017, the Company had federal net operating loss carryforwards of approximately $25.0 million and $12.5 million, respectively, available to reduce future taxable income. As of December 31, 2018 and December 31, 2017, the Company also has state net operating loss carryforwards of $0.9 million. Both the federal and California net operating loss carryforwards incurred before 2018 begin expiring in 2034 if not utilized. The 2018 federal net operating loss of $12.5 million carryforward does not expire. As of December 31, 2018, and December 31, 2017, the Company had Israeli net operating losses of $8.2 million and $8.4 million, respectively, which carryforward indefinitely. As of December 31, 2018 and 2017, the Company has federal research and development tax credit carryforwards of approximately $420,000 and $132,000, respectively. If not utilized, the carryforwards will begin expiring in 2025. As of December 31, 2018 and 2017, the Company has state research and development credit carryforwards or approximately $161,000 and $67,000, respectively, which do not expire. Pursuant to Internal Revenue Code (IRC) Sections 382 and 383, annual use of the Company’s net operating loss and research and development credit carryforwards may be limited in the event a cumulative change in ownership of more than 50% occurs within a three-year period. The Company has not completed an IRC Section 382/383 analysis regarding the limitation of net operating loss and research and development credit carryforwards. Due to the existence of the valuation allowance, future changes in the Company’s unrecognized tax benefits will not impact the Company’s effective tax rate. The Company’s ability to use its remaining net operating loss and tax credit carryforwards may be further limited if the Company experiences a Section 382 ownership change in connection with future changes in the Company’s stock ownership. In the U.S., the Company files income tax returns in the U.S. Federal jurisdiction and California. The Company’s tax years for 2015 and forward are subject to examination by the Federal and California tax authorities due to the carryforward of unutilized net operating losses and research and development credits. The Company’s policy is to recognize interest expense and penalties related to income tax matters as a component of income tax expense. There was no accrued interest and penalties associated with uncertain tax positions as of December 31, 2018 and 2017. The Company has not recorded any interest or penalties in 2018 or 2017.

Stockholders' Equity

Stockholders' Equity	12 Months Ended
	Dec. 31, 2018
Equity [Abstract]
Stockholders' Equity	Note 9. Stockholders’ Equity Warrants During 2017, the following transactions represented the exercise of all outstanding warrants for the Company’s preferred stock, for total proceeds of approximately $3.1 million: • In March 2017, OrbiMed Israel Partners Limited Partnership, a related party, exercised a warrant to purchase 978,561 shares of Preferred B shares of the Company at $0.41 per share for an aggregate amount of approximately $400,000. • In May 2017, OrbiMed Israel Partners Limited Partnership, a related party, exercised warrants to purchase 6,458,628 shares of Preferred B shares • In May 2017, Peregrine Management II Ltd., a related party, exercised warrants to purchase 192,454 shares of Preferred B shares • In May 2017, Pontifax, in a cashless exercise of its warrants, purchased 90,804 shares of the Company’s common stock. • In the first half of 2017, individual shareholders, in a cashless exercise, purchased 311,850 of the Company’s preferred stock. As of December 31, 2018 and 2017, no warrants were issued and outstanding. Preferred Stock Upon the Reverse Merger, all shares of preferred stock converted to common stock. As of December 31, 2018 and 2017, no shares of preferred stock were issued and outstanding. Equity Distribution Agreement On August 21, 2017, the Company entered into an equity distribution agreement (the “Equity Distribution Agreement”) with Piper Jaffray & Co. (“Piper Jaffray”), as sales agent, pursuant to which the Company may offer and sell, from time to time, through Piper Jaffray, up to $8.5 million in shares of its common stock. As of December 31, 2017, the Company had sold 167,356 shares of its common stock through the Equity Distribution Agreement for gross proceeds of approximately $774,000. On March 9, 2018, Piper Jaffray sold the remaining 2,296,610 shares of the Company’s common stock under the Equity Distribution Agreement, resulting in total gross proceeds of approximately $7.7 million. No further sales will be made pursuant to the Equity Distribution Agreement. On July 23, 2018, the Company filed a new prospectus supplement (the “2018 Prospectus”) under which the Company may offer and sell, from time to time, through Piper Jaffray, up to an additional $8.8 million in shares of its common stock. No shares have been sold under the 2018 Prospectus as of December 31, 2018.

Summary of Significant Accoun_2

Summary of Significant Accounting Policies (Policies)	12 Months Ended
	Dec. 31, 2018
Accounting Policies [Abstract]
Basis of Presentation and Principles of Consolidation	Basis of Presentation and Principles of Consolidation The consolidated financial statements are prepared in accordance with accounting principles generally accepted in the U.S. (“GAAP”). Novus, a Delaware corporation, owns 100% of the issued and outstanding common stock or other ownership interest in Otic. Otic owns 100% of the issued and outstanding common stock or other ownership interest in its U.S. subsidiary, Otic Pharma, Inc. The functional currency of the Company’s foreign subsidiary is the U.S. Dollar; however, certain expenses, assets and liabilities are transacted at the local currency. These transactions are translated from the local currency into U.S. Dollars at exchange rates during or at the end of the reporting period. The activities of the Company’s foreign subsidiary are not significant to the consolidated financial statements. All significant intercompany accounts and transactions among the entities have been eliminated in consolidation.
Liquidity and Financial Condition	Liquidity and Financial Condition The Company has experienced recurring net losses and negative cash flows from operating activities since its inception. The Company recorded a net loss of $14.1 million and used $11.9 million of cash in operating activities for the year ended December 31, 2018. As of December 31, 2018, the Company had cash of $13.0 million, working capital of $11.7 million and an accumulated deficit of $41.6 million. Due to continuing research and development activities, the Company expects to continue to incur net losses into the foreseeable future. In order to continue these activities, the Company will need to raise additional funds through public or private debt and equity financings or strategic collaboration and licensing arrangements. The Company’s ability to raise additional capital in the equity and debt markets is dependent on a number of factors, including, but not limited to, the market demand for the Company’s common stock, which itself is subject to a number of development and business risks and uncertainties, as well as the uncertainty that the Company would be able to raise such additional capital at a price or on terms that are favorable to the Company. Adequate additional funding may not be available to us on acceptable terms on a timely basis, or at all. If the Company is unable to obtain the necessary level of capital through external financing during the first half of 2019, as contemplated in its operating plan, the Company intends to implement certain cost cutting measures commencing in the first half of 2019 to reduce its cash flow requirements. Consistent with the actions the Company has taken in the past, it will execute the appropriate steps to enable the continued operations of the business and preservation of the value of its assets beyond the next twelve months, including but not limited to actions such as reduced personnel-related costs, delay or curtailment of the Company’s research and development activities, and other discretionary expenses that are within the Company’s control. These initiatives, if required, may have an adverse impact on the Company’s ability to achieve certain of its planned objectives during 2019 as it seeks strategic alternatives. At the time of issuance of the consolidated financial statements for the year ended December 31, 2018, the Company concluded that there is substantial doubt regarding the Company’s ability to continue as a going concern for the twelve months from the date of issuance of the consolidated financial statements for the year ended December 31, 2018. The financial information and the consolidated financial statements included in this Annual Report have been prepared on a basis that assumes that we will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. This financial information and these financial statements do not include any adjustments that may result from an unfavorable outcome of this uncertainty. Our ability to continue as a going concern is dependent upon our ability to successfully secure sources of financing and ultimately achieve profitable operations.
Use of Estimates	Use of Estimates The preparation of the Company’s consolidated financial statements in conformity with GAAP requires management to make informed estimates and assumptions that affect the reported amounts of assets, liabilities and expenses and the disclosure of contingent assets and liabilities in the Company’s consolidated financial statements and accompanying notes. The most significant estimates in the Company’s financial statements relate to stock-based compensation, accruals for liabilities, carrying value of goodwill, and other matters that affect the consolidated financial statements and related disclosures. Actual results could differ materially from those estimates under different assumptions or conditions and the differences may be material to the consolidated financial statements.
Cash and Cash Equivalents	Cash and Cash Equivalents Cash represents cash deposits held at financial institutions. The Company considers all liquid investments purchased with an original maturity of three months or less and that can be liquidated without prior notice or penalty to be cash equivalents. The carrying value of cash equivalents approximate their fair value due to the short-term maturities of these instruments. Cash equivalents are held for the purpose of meeting short-term liquidity requirements, rather than for investment purposes. The Company had no cash equivalents at December 31, 2018 and 2017.
Restricted Cash	Restricted Cash Restricted cash represents cash required to be set aside
Fair Value Measurements	Fair Value Measurements Financial assets and liabilities are recorded at fair value. The Company measures the fair value of certain of its financial instruments on a recurring basis. A fair value hierarchy is used to rank the quality and reliability of the information used to determine fair values. Financial assets and liabilities carried at fair value will be classified and disclosed in one of the following three categories: Level 1—Quoted prices (unadjusted) in active markets for identical assets and liabilities. Level 2—Inputs other than Level 1 that are observable, either directly or indirectly, such as unadjusted quoted prices for similar assets and liabilities, unadjusted quoted prices in the markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. There have been no transfers of assets for liabilities between these fair value measurement classifications during the periods presented. The Company had no financial instruments, assets or liabilities measured at fair value on a recurring basis at December 31, 2018 and 2017.
Concentration of Credit Risk and Other Risks and Uncertainties	Concentration of Credit Risk and Other Risks and Uncertainties As of December 31, 2018 and 2017, all of the Company’s long-lived assets were located in the U.S. Financial instruments that are subject to concentration of credit risk consist primarily of cash equivalents. The Company’s policy is to invest cash in institutional money market funds to limit the amount of credit exposure. At times, the Company maintains cash equivalents in short‑term money market funds and it has not experienced any losses on its cash equivalents. The Company’s products will require approval from the U.S. Food and Drug Administration (FDA) and foreign regulatory agencies before commercial sales can commence. There can be no assurance that its products will receive any of these required approvals. The denial or delay of such approvals may impact the Company’s business in the future. In addition, after the approval by the FDA, there is still an ongoing risk of adverse events that did not appear during the product approval process. The Company is subject to risks common to companies in the pharmaceutical industry, including, but not limited to, new technological innovations, clinical development risk, establishment of appropriate commercial partnerships, protection of proprietary technology, compliance with government and environmental regulations, uncertainty of market acceptance of products, product liability, the volatility of its stock price and the need to obtain additional financing. Our facilities and equipment may be affected by natural or man-made disasters. We currently conduct our research, development and management activities in Irvine, California, near known earthquake fault zones. We have taken precautions to safeguard our facilities, equipment and systems, including insurance, health and safety protocols, and off-site storage of computer data. However, our facilities and systems may be vulnerable to earthquakes, fire, storm, power loss, telecommunications failures, physical and software break-ins, software viruses and similar events which could cause substantial delays in our operations, damage or destroy our equipment or inventory, and cause us to incur additional expenses. In addition, the insurance coverage we maintain may not be adequate to cover our losses in any circumstance and may not continue to be available to use on acceptable terms, or at all.
Business Combinations	Business Combinations Accounting for acquisitions requires extensive use of estimates and judgment to measure the fair value of the identifiable tangible and intangible assets acquired, including in-process research and development and liabilities assumed. Additionally, the Company must determine whether an acquired entity is considered a business or a set of net assets because the excess of the purchase price over the fair value of net assets acquired can only be recognized as goodwill in a business combination. The Company accounted for the merger with Tokai as a business combination under the acquisition method of accounting. Consideration paid to acquire Tokai was measured at fair value and included the exchange of Tokai’s common stock and preferred stock. The allocation of the purchase price resulted in recognition of an intangible asset related to goodwill. The operating activity for Tokai, the acquiree for accounting purposes, was immediately integrated with Otic post‑merger, therefore it is not practical to segregate results of operations related specifically to Tokai since the date of acquisition. As a result of the Reverse Merger, historical common stock, stock options and additional paid-in capital, including share and per share amounts, have been retroactively adjusted to reflect the equity structure of the Company.
Reportable Segments	Reportable Segments Operating segments under GAAP are defined as components of an enterprise about which separate financial information is available that is evaluated regularly by the Chief Operating Decision Maker (CODM), or decision-making group, in deciding how to allocate resources and in assessing performance. The CODM is the Company’s Chief Executive Officer and the Company has determined that it operates in one business segment, which is the development of
Goodwill	Goodwill Goodwill represents the difference between the consideration transferred and the fair value of the net assets acquired under the acquisition method of accounting. Goodwill is not amortized but is evaluated for impairment as of October 1 of each year or if indicators of impairment exist that would, more likely than not, reduce the fair value from its carrying amount. The Company performs its goodwill impairment analysis at the reporting unit level, which aligns with the Company’s reporting structure and availability of discrete financial information. If a quantitative assessment is performed the evaluation includes management estimates of cash flow projections based on internal future projections . Key assumptions for these projections include revenue growth, future gross and operating margin growth, and its weighted cost of capital and terminal growth rates. The revenue and margin growth is based on increased sales of new products as the Company maintains investments in research and development. Additional assumed value creators may include increased efficiencies from capital spending. The resulting cash flows are discounted using a weighted average cost of capital. Operating mechanisms and requirements to ensure that growth and efficiency assumptions will ultimately be realized are also considered in the evaluation, including timing and probability of regulatory approvals for Company products to be commercialized. The Company’s market capitalization is also considered as a part of its analysis. The Company’s annual evaluation for impairment of goodwill consists of one reporting unit. In accordance with the Company’s policy, the Company completed its most recent annual evaluation for impairment as of October 1, 2018 using the qualitative assessment and determined that no impairment existed. No impairments were recorded for the years ended and 2017.
Long-Lived Assets	Long-Lived Assets Property and equipment are recorded at cost. Depreciation is computed using the straight-line method over the estimated useful lives of the respective assets. Additions, major renewals and improvements are capitalized and repair and maintenance costs are charged to expense as incurred. Leasehold improvements are amortized over the remaining life of the initial lease term or the estimated useful lives of the assets, whichever is shorter. The Company reviews property, plant and equipment for impairment whenever events or changes in circumstances indicate that the carrying value of an asset may not be recoverable. An impairment loss would be recognized when estimated future undiscounted cash flows relating to the asset are less than its carrying amount. An impairment loss is measured as the amount by which the carrying amount of an asset exceeds its fair value. Significant management judgment is required in the forecast of future operating results that are used in the preparation of expected cash flows. No impairments of tangible assets have been identified during the years presented.
Research and Development Expenses	Research and Development Expenses Research and development expenses include personnel and facility-related expenses, outside contracted services including clinical trial costs, manufacturing and process development costs, research costs and other consulting services and non-cash stock-based compensation. Research and development costs are expensed as incurred. Amounts due under contracts with third parties may be either fixed fee or fee for service, and may include upfront payments, monthly payments and payments upon the completion of milestones or receipt of deliverables. Non-refundable advance payments under agreements are capitalized and expensed as the related goods are delivered or services are performed. The Company’s contracts with third parties to perform various clinical trial activities in the on-going development of potential products. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows to its vendors. Payments under the contracts depend on factors such as the achievement of certain events, successful enrollment of patients, and completion of portions of the clinical trial or similar conditions. The Company’s accrual for clinical trials is based on estimates of the services received and efforts expended pursuant to contracts with clinical trial centers and clinical research organizations. These contracts may be terminated by the Company upon written notice and the Company is generally only liable for actual effort expended by the organizations to the date of termination, although in certain instances the Company may be further responsible for termination fees and penalties. The Company estimates its research and development expenses and the related accrual as of each balance sheet date based on the facts and circumstances known to the Company at that time. There have been no material adjustments to the Company’s prior period accrued estimates for clinical trial activities through December 31, 2018.
Net Loss Per Share	Net Loss Per Share 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 determined using the treasury-stock and if-converted methods. For purposes of the diluted net loss per share calculation, preferred stock, and stock options and warrants are considered to be potentially dilutive securities and are excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive. Therefore, basic and diluted net loss per share was the same for the periods presented due to the Company’s net loss position. Year Ended December 31, 2018 2017 (In thousands, except share and per share data) Net loss available to stockholders of the company $ (14,065 ) $ (13,116 ) Interest accumulated on preferred shares and on preferred shares contingently issuable for little or no cash — (328 ) Net loss attributable to stockholders of preferred shares and to stockholders of preferred shares contingently issuable for little or no cash — 2,666 Net loss used in the calculation of basic and diluted loss per share $ (14,065 ) $ (10,778 ) Net loss per share, basic and diluted $ (1.56 ) $ (2.30 ) Weighted-average number of common shares 9,005,352 4,677,610 The computation of diluted earnings per share excludes stock options, warrants, and restricted stock units that are anti-dilutive. For the year ended December 31, 2018, common share equivalents of 974,817 shares were anti-dilutive. For the year ended December 31, 2017, common share equivalents of 782,340 shares were anti-dilutive.
Stock-based Compensation	Stock-based Compensation For stock options granted to employees, the Company recognizes compensation expense for all stock-based awards based on the grant-date estimated fair value. The fair value of stock options is determined using the Black-Scholes option pricing model, using assumptions which are subjective and require significant judgment and estimation by management. The risk-free rate assumption was based on observed yields from governmental zero-coupon bonds with an equivalent term. The expected volatility assumption was based on historical volatilities of a group of comparable industry companies whose share prices are publicly available. The peer group was developed based on companies in the pharmaceutical industry. The expected term of stock options represents the weighted-average period that the stock options are expected to be outstanding. Because the Company does not have historical exercise behavior, it determined the expected life assumption using the simplified method, which is an average of the options ordinary vesting period and the contractual term. The expected dividend assumption was based on the Company’s history and expectation of dividend payouts. The Company has not paid and does not expect to pay dividends at any time in the foreseeable future. The Company recognizes forfeitures on an actual basis and as such did not estimate forfeitures to calculate stock-based compensation. Stock-based compensation expense related to stock options granted to non-employees is recognized based on the fair value of the stock options, determined using the Black-Scholes option pricing model, as they are earned. The awards generally vest over the period the Company expects to receive services from the non-employee. Stock options granted to non-employees are subject to periodic revaluation over their vesting terms.
Income Taxes	Income Taxes The asset and liability approach is used to recognize deferred tax assets and liabilities for the expected future tax consequences of temporary differences between the carrying amounts and the tax bases of assets and liabilities. Tax law and rate changes are reflected in income in the period such changes are enacted. The likelihood of realizing the tax benefits related to a potential deferred tax asset is evaluated, and a valuation allowance is recognized to reduce that deferred tax asset if it is more likely than not that all or some portion of the deferred tax asset will not be realized. Deferred tax assets and liabilities are calculated at the beginning and end of the year; the change in the sum of the deferred tax asset, valuation allowance and deferred tax liability during the year generally is recognized as a deferred tax expense or benefit. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in operations in the period that includes the enactment date. Significant judgment is required in determining the Company’s provision for income taxes, deferred tax assets and liabilities and the valuation allowance recorded against net deferred tax assets. We assess the likelihood that deferred tax assets will be recovered as deductions from future taxable income. The evaluation of the need for a valuation allowance is performed on a jurisdiction-by-jurisdiction basis and includes a review of all available positive and negative evidence. Factors reviewed include projections of pre-tax book income for the foreseeable future, determination of cumulative pre-tax book income after permanent differences, earnings history, and reliability of forecasting. We have provided a full valuation allowance on our deferred tax assets as of December 31, 2018 and 2017 because we believe it is more likely than not that our deferred tax assets will not be realized as of those dates. On December 22, 2017, President Trump signed U.S. tax reform legislation, commonly referred to as the Tax Cuts and Jobs Act (the “Tax Act”), which became effective January 1, 2018. The Tax Act significantly changed the fundamentals of U.S. corporate income taxation by, among many other things, reducing the U.S. federal corporate income tax rate from 35% to 21%, converting to a territorial tax system, and creating various income inclusion and expense limitation provisions. We have performed a review of the Tax Act, and recorded amounts related to the revaluation of our deferred taxes and the realization of certain tax credit carryforwards. However, as the Company records a valuation allowance for its entire deferred income tax asset, there was no impact to the reported amounts in the accompanying consolidated financial statements as a result of the Tax Act. The Company evaluates the accounting for uncertainty in income tax recognized in its consolidated financial statements and determines whether it is more likely than not that a tax position will be sustained upon examination by the appropriate taxing authorities before any part of the benefit is recorded in its consolidated financial statements. For those tax positions where it is “not more likely than not” that a tax benefit will be sustained, no tax benefit is recognized. Where applicable, associated interest and penalties are also recorded. The Company has not accrued any liabilities for any such uncertain tax positions as of December 31, 2018 or 2017. The Company is subject to U.S. federal and state tax authority examinations for all the years since inception due to net operating loss and tax credit carryforwards. The net operating losses and tax credits are subject to adjustment until the statute closes on the year the attributes are ultimately utilized. The Company’s income tax returns are based on calculations and assumptions that are subject to examination by the Internal Revenue Service and other tax authorities. In addition, the calculation of the Company’s tax liabilities involves dealing with uncertainties in the application of complex tax regulations. The Company recognizes liabilities for uncertain tax positions based on a two-step process. The first step is to evaluate the tax position for recognition by determining if the weight of available evidence indicates that it is more likely than not that the position will be sustained on audit, including resolution of related appeals or litigation processes, if any. The second step is to measure the tax benefit as the largest amount that is more than 50% likely of being realized upon settlement. While the Company believes it has appropriate support for the positions taken on its tax returns, the Company regularly assesses the potential outcomes of examinations by tax authorities in determining the adequacy of its provision for income taxes. The Company continually assesses the likelihood and amount of potential revisions and adjusts the income tax provision, income taxes payable and deferred taxes in the period in which the facts that give rise to a revision become known. For additional information, see Note 8. Income Taxes
Recently Issued or Adopted Accounting Pronouncements	Recently Issued Accounting Pronouncements In August 2018, the SEC adopted the final rule under SEC Release No. 33-10532, Disclosure Update and Simplification, amending certain disclosure requirements that were redundant, duplicative, overlapping, outdated or superseded. In addition, the amendments expanded the disclosure requirements on the analysis of stockholders' equity for interim financial statements. Under the amendments, an analysis of changes in each caption of stockholders' equity presented in the balance sheet must be provided in a note or separate statement. The analysis should present a reconciliation of the beginning balance to the ending balance of each period for which a statement of comprehensive income is required to be filed. This final rule was effective on November 5, 2018. However, as provided for by the SEC in Q&A 105.09, the Company will defer presenting its analysis of stockholders’ equity in its quarterly report in Form 10-Q until its quarter ended March 31, 2019. The Company does not expect the adoption of SEC Release No. 33-10532 to have a material impact on its financial position, results of operations or cash flows. In August 2018, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2018-15, Customer's Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract In August 2018, the FASB issued ASU No. 2018-13, “Fair Value Measurement (Topic 820): Disclosure Framework — Changes to the Disclosure Requirements for Fair Value Measurement” In June 2018, the FASB issued ASU No. 2018-07, Improvements to Nonemployee Share-Based Payment Accounting Compensation—Stock Compensation Equity—Equity-Based Payments to Non-Employees Revenue from Contracts with Customers In February 2018, the FASB issued ASU No. 2018-02, Income Statement—Reporting Comprehensive Income (Topic 220) In July 2017, the FASB issued ASU 2017-11 , “Earnings Per Share (Topic 260) Distinguishing Liabilities from Equity (Topic 480) Derivatives and Hedging (Topic 815)” The Company is currently assessing the impact and timing of adopting this guidance on its consolidated financial statements. In January 2017, the FASB issued ASU No. 2017-04 “ Intangibles – Goodwill and Other (Topic 350): Simplifying the Accounting for Goodwill Impairment The Company is currently assessing the impact and timing of adopting this guidance on its consolidated financial In May 2017, the FASB issued ASU No. 2017-09, “ Stock Compensation – Scope of Modification Accounting” In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) Leases (Topic 842) Targeted Improvements The Company has adopted the requirements of the new lease standard effective January 1, 2019 and has elected the optional transition method to apply the standard as of the effective date and therefore, the Company will not apply the standard to the comparative periods presented in the consolidated financial statements. The Company will elect the transition package of three practical expedients permitted within the standard, which eliminates the requirements to reassess prior conclusions about lease identification, lease classification, and initial direct costs. The Company will not elect the hindsight practical expedient, which permits the use of hindsight when determining lease term and impairment of right-of-use assets. Further, the Company will elect a short-term lease exception policy, permitting the Company to not apply the recognition requirements of this standard to short-term leases (i.e. leases with terms of 12 months or less) and an accounting policy to account for lease and non-lease components as a single component for certain classes of assets. The Company is finalizing its analysis of certain key assumptions that will be utilized at the transition date including the incremental borrowing rate. The standard will have a material impact on the Company’s consolidated balance sheets effective January 1, 2019, but will not have an impact on its consolidated statements of operations as of January 1, 2019. The most significant impact will be the recognition of a right-to-use asset and corresponding lease liability for the Company’s sole operating lease—the Company has no finance leases.

Summary of Significant Accoun_3

Summary of Significant Accounting Policies (Tables)	12 Months Ended
	Dec. 31, 2018
Accounting Policies [Abstract]
Schedule of Common Share Equivalents Included from Computation of Net Loss Per Share	Year Ended December 31, 2018 2017 (In thousands, except share and per share data) Net loss available to stockholders of the company $ (14,065 ) $ (13,116 ) Interest accumulated on preferred shares and on preferred shares contingently issuable for little or no cash — (328 ) Net loss attributable to stockholders of preferred shares and to stockholders of preferred shares contingently issuable for little or no cash — 2,666 Net loss used in the calculation of basic and diluted loss per share $ (14,065 ) $ (10,778 ) Net loss per share, basic and diluted $ (1.56 ) $ (2.30 ) Weighted-average number of common shares 9,005,352 4,677,610

Reverse Merger (Tables)

Reverse Merger (Tables)	12 Months Ended
	Dec. 31, 2018
Business Combinations [Abstract]
Schedule of Purchase Price Consideration	The purchase price for Tokai on May 9, 2017, the closing date of the Reverse Merger, was as follows (in thousands): Fair value of Tokai common stock outstanding (1) $ 14,486 Premium paid (2) 8,889 Purchase price $ 23,375 (1) Comprised of 2,515,739 shares of common stock outstanding at the date of the Reverse Merger based on the closing price of $5.76 per share on May 9, 2017, as adjusted for the one-for-nine reverse stock-split on May 11, 2017. (2) Premium paid over fair value of common stock based on net tangible asset multiple of 1.08x book value of Tokai equity of $21.5 million as of May 9, 2017.
Summary of Allocation of Estimated Purchase Price to Acquired Assets and Liabilities Assumed	The allocation of the estimated purchase price to the acquired assets and liabilities assumed of Tokai, based on their estimated fair values as of May 9, 2017, the close of the transaction, was as follows (in thousands): Cash, cash equivalents, and restricted cash $ 23,250 Prepaids and other current assets 1,132 Property and equipment 73 Goodwill 1,867 Accounts payable, accrued expenses and other liabilities (2,947 ) Net assets acquired $ 23,375
Summary of Combined Results of Operations of Company and Tokai, on a Pro Forma Basis	The unaudited financial information in the following table summarizes the combined results of operations of the Company and Tokai, on a pro forma basis, as if the Reverse Merger had occurred at the beginning of the periods presented (in thousands): Year Ended December 31, 2017 Operating expenses Research and development $ 2,481 General and administrative 9,356 Total operating expenses 11,837 Loss from operations (11,837 ) Other income, net 45 Net loss and other comprehensive loss $ (11,792 ) Net loss per share, basic and diluted $ (2.52 ) Weighted-average shares outstanding, basic and diluted 4,677,610

Prepaid Expenses Other Assets_2

Prepaid Expenses Other Assets Accrued Expenses and Other Liabilities (Tables)	12 Months Ended
	Dec. 31, 2018
Prepaid Expenses Other Assets Accrued Expenses And Other Liabilities [Abstract]
Prepaid Expenses and Other Current Assets	Prepaid expenses and other current assets consisted of the following as of December 31, 2018 and December 31, 2017 (in thousands): Year Ended December 31, 2018 2017 Prepaid insurance $ 413 $ 1,518 Prepaid other 261 161 Other current assets 630 18 Total prepaid expenses and other current assets $ 1,304 $ 1,697
Schedule of Accrued Expenses and Other Liabilities	Accrued expenses and other liabilities consisted of the following as of December 31, 2018 and December 31, 2017 (in thousands): Year Ended December 31, 2018 2017 Accrued compensation and related expenses $ 742 $ — Accrued clinical 735 85 Accrued professional services 194 158 Accrued vacation 160 111 Accrued other 14 — Total accrued expenses and other liabilities $ 1,845 $ 354

Goodwill (Tables)

Goodwill (Tables)	12 Months Ended
	Dec. 31, 2018
Goodwill And Intangible Assets Disclosure [Abstract]
Schedule of Changes in the Carrying Amount of Goodwill	The changes in the carrying amount of goodwill consisted of the following as of December 31, 2018 and December 31, 2017 (in thousands): Gross Carrying Amount Accumulated Impairment Losses Net Carrying Amount Balance as of January 1, 2017 $ — $ — $ — Additions (1) 1,867 — 1,867 Balance as of December 31, 2017 1,867 — 1,867 Additions — — — Balance as of December 31, 2018 $ 1,867 $ — $ 1,867 (1) Relates to the Reverse Merger (See Note 3. Reverse Merger

Commitments and Contingencies (

Commitments and Contingencies (Tables)	12 Months Ended
	Dec. 31, 2018
Commitments And Contingencies Disclosure [Abstract]
Schedule of Future Payments Under Noncancelable Operating Leases	Future payments under noncancelable operating leases having initial or remaining terms of one year or more are as follows for the succeeding fiscal year and thereafter (in thousands): 2019 $ 180 2020 188 2021 146 Total minimum lease payments $ 514

Stock-Based Compensation (Table

Stock-Based Compensation (Tables)	12 Months Ended
	Dec. 31, 2018
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract]
Summary of Stock Option Activity	The following table shows the stock option activity, as follows: Shares Issuable Under Options Weighted Average Exercise Price Weighted Average Remaining Contractual Term Aggregate Intrinsic Value (In years) (In thousands) Outstanding as of January 1, 2017 59,777 $ 18.45 8.8 $ 4.3 Granted 595,800 5.45 Options assumed in the Reverse Merger 137,139 50.25 Exercised — — Forfeited / Canceled (10,376 ) 6.85 Outstanding as of December 31, 2017 782,340 14.28 8.8 $ 8.5 Granted 267,950 5.02 Exercised (15,120 ) 4.74 Forfeited / Canceled (60,353 ) 7.31 Outstanding as of December 31, 2018 974,817 $ 12.31 8.2 $ — Options vested and expected to vest as of December 31, 2018 974,817 $ 12.31 8.2 $ — Options exercisable as of December 31, 2018 548,328 $ 17.57 7.6 $ —
Schedule of Stock-Based Compensation Expense Related to Stock-Based Awards	Total compensation expense related to all of the Company’s stock-based awards for the years ended December 31, 2018 and December 31, 2017 was comprised of the following (in thousands): Year Ended December 31, 2018 2017 Stock-based compensation classified as: Research and development expense $ 249 $ 69 General and administrative expense 1,294 510 Total stock-based compensation expense $ 1,543 $ 579
Schedule of Assumptions Used in Black-Scholes Option Pricing Model to Determine the Fair Value of Stock Options Granted	The following table presents the assumptions used in the Black-Scholes option pricing model to determine the fair value of stock options granted in the periods presented Year Ended December 31, 2018 2017 Expected stock price volatility 63% - 86% 79% - 86% Risk-free interest rate 2% - 3% 1% - 3% Expected life of option (in years) 5 - 7 5 - 7 Estimated dividend yield 0% 0%

Income Taxes (Tables)

Income Taxes (Tables)	12 Months Ended
	Dec. 31, 2018
Income Tax Disclosure [Abstract]
Summary of Income (Loss) Before Income Taxes	Income (loss ) before income taxes are as follows (in thousands): Year Ended December 31, 2018 2017 Losses before income taxes: U.S. $ (14,177 ) $ (12,470 ) Non-U.S. 112 (646 ) Total $ (14,065 ) $ (13,116 )
Summary of Provision (Benefit) for Income Taxes	The provision (benefit) for income taxes are as follows (in thousands): Year Ended December 31, 2018 2017 2016 Current: $ — $ — $ — Federal — — — State — — — Foreign — — — — — — Deferred Federal — — — State — — — Foreign — — — — — — Provision (benefit) for income taxes $ — $ — $ —
Reconciliation of U.S. Federal Statutory Income Tax Rate	A reconciliation of the U.S. federal statutory income tax rate to the Company’s effective income tax rate is as follows: Year Ended December 31, 2018 2017 Statutory Federal income tax rate $ (2,953 ) $ (4,460 ) State income taxes, net of Federal tax benefits — — Foreign losses — 59 Tax credits (204 ) (2 ) Change in statutory rates — 1,859 Stock-based compensation 72 135 Permanent items 3 693 Other 90 43 Change in valuation allowance 2,992 1,673 Total provision for income taxes $ — $ —
Schedule of Significant Components Deferred Tax Assets and Liabilities	Significant components of the Company’s deferred tax assets and liabilities as of December 31, 2018 and 2017 consisted of the following (in thousands): Year Ended December 31, 2018 2017 Net operating loss carryforwards $ 7,126 $ 4,516 Research and development tax credits 299 95 Accruals and reserves 159 221 Stock compensation 301 48 Depreciation and amortization 126 139 Total deferred tax assets 8,011 5,019 Less: Valuation allowance (8,011 ) (5,019 ) Net deferred tax assets $ — $ —
Reconciliation of Beginning and Ending Amounts of Unrecognized Tax Benefits	The following table reconciles the beginning and ending amounts of unrecognized tax benefits for the years presented (in thousands): Year Ended December 31, 2018 2017 Gross unrecognized tax benefits at the beginning of the year $ 181 $ — Additions from tax positions taken in the current year 158 75 Additions from tax positions taken in prior years — 106 Reductions from tax positions taken in prior years (11 ) — Tax settlements — — Gross unrecognized tax benefits at the end of the year $ 328 $ 181

Description of Business - Addit

Description of Business - Additional Information (Detail) $ / shares in Units, $ in Millions	May 11, 2017	May 09, 2017$ / sharesshares	Jan. 31, 2017USD ($)$ / sharesshares	Dec. 31, 2018
Description Of Business [Line Items]
Stock issued during period, shares, reverse stock splits		840,115
Common stock and options for common stock reverse stock split description				one for nine
Stock conversion, conversion ratio				0.111111111
Stock Purchase Agreement [Member]
Description Of Business [Line Items]
Purchasers agreed to pay under Stock purchase agreement | $			$ 4
Tokai Pharmaceuticals Inc [Member]
Description Of Business [Line Items]
Number of shares Issued under Stock purchase agreement			400,400
Price of shares Issued under Stock purchase agreement | $ / shares			$ 9.99
Tokai Pharmaceuticals, Inc. [Member]
Description Of Business [Line Items]
Stock issued during period, shares, reverse stock splits		4,027,693
Common stock and options for common stock reverse stock split description	one-for-nine
Price of shares Issued under Stock purchase agreement | $ / shares		$ 5.76
Tokai Pharmaceuticals, Inc. [Member] | Reverse Stock-Split [Member]
Description Of Business [Line Items]
Stock conversion, conversion ratio	0.111111111
Otic Pharma [Member]
Description Of Business [Line Items]
Common stock and options for common stock reverse stock split description				one-for-nine
Percentage of ownership			64.00%
Otic Pharma [Member] | Reverse Stock-Split [Member]
Description Of Business [Line Items]
Stock conversion, conversion ratio		0.111111111

Summary of Significant Accoun_4

Summary of Significant Accounting Policies - Additional Information (Detail)	12 Months Ended
	Dec. 31, 2018USD ($)SegmentReporting_Unitshares	Dec. 31, 2017USD ($)shares
Summary Of Significant Accounting Policies [Line Items]
Net loss	$ (14,065,000)	$ (13,116,000)
Cash used in operating activities	(11,893,000)	(14,941,000)
Cash	13,000,000
Working capital	11,700,000
Accumulated deficit	$ (41,571,000)	(27,506,000)
Cash, cash equivalents and restricted cash, maturity period	three months or less
Cash equivalents	$ 0	0
Restricted cash	0	70,000
Financial assets transfers level 1 to 2	0	0
Financial assets transfers level 2 to 1	0	0
Financial liabilities transfers level 1 to 2	0	0
Financial liabilities transfers level 2 to 1	$ 0	0
Number of operating business segments | Segment	1
Number of reporting units | Reporting_Unit	1
Impairment charge	$ 0	$ 0
Impairment of tangible assets	$ 0
Antidilutive securities excluded from computation of earnings per share, amount | shares	974,817	782,340
Federal statutory income tax rate	21.00%	35.00%
Tax benefit	$ 0
Income tax examination, likelihood of settlement, description	The second step is to measure the tax benefit as the largest amount that is more than 50% likely of being realized upon settlement.
Income tax examination, likelihood of settlement, percentage	50.00%
Lease operating description	The Company will elect the transition package of three practical expedients permitted within the standard, which eliminates the requirements to reassess prior conclusions about lease identification, lease classification, and initial direct costs. The Company will not elect the hindsight practical expedient, which permits the use of hindsight when determining lease term and impairment of right-of-use assets. Further, the Company will elect a short-term lease exception policy, permitting the Company to not apply the recognition requirements of this standard to short-term leases (i.e. leases with terms of 12 months or less) and an accounting policy to account for lease and non-lease components as a single component for certain classes of assets.
Lease, Practical Expedients, Package [true false]	true
Lease, Practical Expedient, Use of Hindsight [true false]	false
Fair Value, Measurements, Recurring [Member]
Summary Of Significant Accounting Policies [Line Items]
Assets measured at fair value	$ 0	$ 0
Liabilities measured at fair value	$ 0	$ 0
Otic Pharma [Member]
Summary Of Significant Accounting Policies [Line Items]
Ownership percentage	100.00%
Otic Pharma, Inc. [Member]
Summary Of Significant Accounting Policies [Line Items]
Ownership percentage	100.00%

Summary of Significant Accoun_5

Summary of Significant Accounting Policies - Schedule of Common Share Equivalents Included from Computation of Net Loss Per Share (Detail) - USD ($) $ / shares in Units, $ in Thousands	12 Months Ended
	Dec. 31, 2018	Dec. 31, 2017
Earnings Per Share [Abstract]
Net loss and other comprehensive loss	$ (14,065)	$ (13,116)
Interest accumulated on preferred shares and on preferred shares contingently issuable for little or no cash		(328)
Net loss attributable to stockholders of preferred shares and to stockholders of preferred shares contingently issuable for little or no cash		2,666
Net loss used in the calculation of basic and diluted loss per share	$ (14,065)	$ (10,778)
Net loss per share, basic and diluted	$ (1.56)	$ (2.30)
Weighted-average number of common shares	9,005,352	4,677,610

Reverse Merger - Additional Inf

Reverse Merger - Additional Information (Detail) - USD ($) $ in Millions	May 09, 2017	Dec. 31, 2017	Dec. 31, 2018
Business Acquisition [Line Items]
Common stock, shares issued		7,110,414	9,422,143
Tokai Pharmaceuticals, Inc. [Member]
Business Acquisition [Line Items]
Common stock, shares issued	4,027,693
Merger transaction costs		$ 7.2
Otic Pharma [Member]
Business Acquisition [Line Items]
Options and warrants in exchange, shares	840,115

Reverse Merger - Schedule of Pu

Reverse Merger - Schedule of Purchase Price Consideration (Detail) - Tokai Pharmaceuticals, Inc. [Member] $ in Thousands	May 09, 2017USD ($)
Business Acquisition [Line Items]
Total purchase price	$ 23,375
Common Stock [Member]
Business Acquisition [Line Items]
Total purchase price	14,486
Premium Paid [Member]
Business Acquisition [Line Items]
Total purchase price	$ 8,889

Reverse Merger - Schedule of _2

Reverse Merger - Schedule of Purchase Price Consideration (Parenthetical) (Detail) $ / shares in Units, $ in Thousands	May 11, 2017	May 09, 2017USD ($)$ / sharesshares	Dec. 31, 2018USD ($)shares	Dec. 31, 2017USD ($)shares	Dec. 31, 2016USD ($)
Business Acquisition [Line Items]
Common stock outstanding | shares			9,422,143	7,110,414
Common stock reverse stock split description			one for nine
Common stock reverse stock split ratio			0.111111111
Equity | $			$ 14,492	$ 19,452	$ (2,702)
Tokai Pharmaceuticals, Inc. [Member]
Business Acquisition [Line Items]
Common stock outstanding | shares		2,515,739
Closing price per share | $ / shares		$ 5.76
Common stock reverse stock split description	one-for-nine
Premium payment over fair value of common stock based on net tangible asset, rate		1.08
Equity | $		$ 21,500
Reverse Stock-Split [Member] | Tokai Pharmaceuticals, Inc. [Member]
Business Acquisition [Line Items]
Common stock reverse stock split ratio	0.111111111

Reverse Merger - Summary of All

Reverse Merger - Summary of Allocation of Estimated Purchase Price to Acquired Assets and Liabilities Assumed (Detail) - USD ($) $ in Thousands	Dec. 31, 2018	Dec. 31, 2017	May 09, 2017
Business Acquisition [Line Items]
Goodwill	$ 1,867	$ 1,867
Tokai Pharmaceuticals, Inc. [Member]
Business Acquisition [Line Items]
Cash, cash equivalents, and restricted cash			$ 23,250
Prepaids and other current assets			1,132
Property and equipment			73
Goodwill			1,867
Accounts payable, accrued expenses and other liabilities			(2,947)
Net assets acquired			$ 23,375

Reverse Merger - Summary of Com

Reverse Merger - Summary of Combined Results of Operations of Company and Tokai, on a Pro Forma Basis (Detail) $ / shares in Units, $ in Thousands	12 Months Ended
	Dec. 31, 2017USD ($)$ / sharesshares
Operating expenses
Research and development	$ 2,481
General and administrative	9,356
Total operating expenses	11,837
Loss from operations	(11,837)
Other income, net	45
Net loss and other comprehensive loss	$ (11,792)
Net loss per share, basic and diluted | $ / shares	$ (2.52)
Weighted-average shares outstanding, basic and diluted | shares	4,677,610

Prepaid Expenses Other Assets_3

Prepaid Expenses Other Assets Accrued Expenses and Other Liabilities - Prepaid Expenses and Other Current Assets (Detail) - USD ($) $ in Thousands	Dec. 31, 2018	Dec. 31, 2017
Prepaid Expense And Other Assets Current [Abstract]
Prepaid insurance	$ 413	$ 1,518
Prepaid other	261	161
Other current assets	630	18
Total prepaid expenses and other current assets	$ 1,304	$ 1,697

Prepaid Expenses Other Assets_4

Prepaid Expenses Other Assets Accrued Expenses and Other Liabilities - Schedule of Accrued Expenses and Other Liabilities (Detail) - USD ($) $ in Thousands	Dec. 31, 2018	Dec. 31, 2017
Accrued Liabilities And Other Liabilities [Abstract]
Accrued compensation and related expenses	$ 742
Accrued clinical	735	$ 85
Accrued professional services	194	158
Accrued vacation	160	111
Accrued other	14
Total accrued expenses and other liabilities	$ 1,845	$ 354

Goodwill - Schedule of Changes

Goodwill - Schedule of Changes in Carrying Amount of Goodwill (Detail) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2018	Dec. 31, 2017
Goodwill And Intangible Assets Disclosure [Abstract]
Gross Carrying Amount, Beginning balance	$ 1,867
Additions	0	$ 1,867
Gross Carrying Amount, Ending balance	1,867	1,867
Net Carrying Amount, Beginning balance	1,867
Net Carrying Amount, Ending balance	$ 1,867	$ 1,867

Commitments and Contingencies -

Commitments and Contingencies - Additional Information (Detail)	1 Months Ended						12 Months Ended
	Apr. 30, 2018	Nov. 30, 2017USD ($)	Dec. 31, 2015USD ($)	Nov. 30, 2015USD ($)shares	Sep. 30, 2015ft²	Feb. 28, 2015ft²	Dec. 31, 2018USD ($)Milestone	Dec. 31, 2017USD ($)Milestone
Other Commitments [Line Items]
Rent expense							$ 170,000	$ 1,000,000
Restricted cash, as part of current assets							$ 0	$ 70,000
Number of milestones achieved | Milestone							0	0
Indemnification obligations amount							$ 0
Contingent liabilities							0	$ 0
License Agreement [Member]
Other Commitments [Line Items]
Sales based milestone payment			$ 36,000,000
Royalty payment period			8 years
License Agreement [Member] | Maximum [Member]
Other Commitments [Line Items]
Development and regulatory milestone payments			$ 42,100,000
License Agreement [Member] | Minimum [Member]
Other Commitments [Line Items]
Sales required to achieve milestone payment			1,000,000,000
Office of Chief Scientist of Israeli Ministry of Economy and Industry [Member]
Other Commitments [Line Items]
Grants received			$ 537,000
Scientific Development and Research, Inc. and Otodyne, Inc. [Member] | License Agreement [Member]
Other Commitments [Line Items]
License fees paid				$ 750,000
Share issued as consideration | shares				9,780
Letter of Credit [Member] | Tokai's Boston Office [Member]
Other Commitments [Line Items]
Line of credit for benefit of landlord							$ 70,000
Sublease [Member]
Other Commitments [Line Items]
Area of office space | ft²						15,981
Lease commenced date						Apr. 1, 2015
Lease expiration, initial date						Dec. 31, 2016
Leases extension date						Jul. 31, 2018
Additional advance rent paid for lease termination		$ 455,000
Three-year Operating Lease [Member]
Other Commitments [Line Items]
Area of office space | ft²					5,197
Lease expiration, initial date					Aug. 31, 2018
Leases extension date	Sep. 30, 2021
Operating lease expiration term					3 years

Commitments and Contingencies_2

Commitments and Contingencies - Schedule of Future Payments Under Noncancelable Operating Leases (Detail) $ in Thousands	Dec. 31, 2018USD ($)
Commitments And Contingencies Disclosure [Abstract]
2019	$ 180
2020	188
2021	146
Total minimum lease payments	$ 514

Stock-Based Compensation - Addi

Stock-Based Compensation - Additional Information (Details)	May 11, 2017	Dec. 31, 2018USD ($)Plan$ / sharesshares	Dec. 31, 2017USD ($)$ / sharesshares	Aug. 01, 2018shares	Dec. 31, 2016$ / sharesshares
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number of stock compensation plans | Plan		2
Common stock reverse stock split ratio		0.111111111
Common stock reverse stock split description		one for nine
Number of options outstanding		974,817	782,340		59,777
Range of exercise prices | $ / shares		$ 12.31	$ 14.28		$ 18.45
Aggregate intrinsic value of options exercised | $		$ 0	$ 0
Unrecognized stock-based compensation expense | $		$ 1,500,000
Unrecognized stock-based compensation expense, recognized over estimated weighted average period		1 year 9 months 18 days
Stock-based compensation expense | $		$ 1,543,000	$ 579,000
Performance-based Option [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock-based compensation expense | $		$ 524,000
Maximum [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Range of exercise prices | $ / shares		$ 119.25
Minimum [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Range of exercise prices | $ / shares		$ 3.32
2014 Stock Incentive Plan [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Options granted, expiration period		10 years
Common stock, shares authorized for issuance		1,700,000
Maximum annual increase in common stock reserved for future issuance		1,800,000
Additional shares of common stock, percentage		400.00%
Number of shares of common stock authorized issuance reduced				766,500
Options available for grant		764,966
2007 Stock Incentive Plan [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Options granted, expiration period		10 years
Number of options outstanding		84,612
2014 Stock Incentive Plan Under Evergreen Provision [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number of shares of common stock authorized issuance reduced				550,000
2014 Employee Stock Purchase Plan [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Common stock, shares authorized for issuance				209,500
2014 Employee Stock Purchase Plan Under Evergreen Provision [Member] | Maximum [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Common stock, shares authorized for issuance				135,000
Otic Pharma [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number of stock compensation plans | Plan		1
Common stock reverse stock split description		one-for-nine
Tokai Pharmaceuticals, Inc. [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Common stock reverse stock split description	one-for-nine
Tokai Pharmaceuticals, Inc. [Member] | 2012 Global Share Incentive Plan [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Options granted, expiration period		10 years

Stock-Based Compensation - Summ

Stock-Based Compensation - Summary of Stock Option Activity (Details) - USD ($)	12 Months Ended
	Dec. 31, 2018	Dec. 31, 2017	Dec. 31, 2016
Shares Issuable Under Options
Outstanding, beginning balance	782,340	59,777
Granted	267,950	595,800
Options assumed in the Reverse Merger		137,139
Exercised	(15,120)
Forfeited / Canceled	(60,353)	(10,376)
Outstanding, ending balance	974,817	782,340	59,777
Options vested and expected to vest as of December 31, 2018	974,817
Options exercisable as of December 31, 2018	548,328
Weighted Average Exercise Price
Outstanding, beginning balance	$ 14.28	$ 18.45
Granted	5.02	5.45
Options assumed in the Reverse Merger		50.25
Exercised	4.74
Forfeited / Canceled	7.31	6.85
Outstanding, ending balance	12.31	$ 14.28	$ 18.45
Options vested and expected to vest as of December 31, 2018	12.31
Options exercisable as of December 31, 2018	$ 17.57
Weighted Average Remaining Contractual Term (In years)
Outstanding as of January 1, 2017	8 years 2 months 12 days	8 years 9 months 18 days	8 years 9 months 18 days
Options vested and expected to vest as of December 31, 2018	8 years 2 months 12 days
Options exercisable as of December 31, 2018	7 years 7 months 6 days
Aggregate Intrinsic Value
Aggregate intrinsic value, Outstanding		$ 8,500	$ 4,300
Aggregate intrinsic value, Exercised	$ 0	$ 0

Stock-Based Compensation - Sche

Stock-Based Compensation - Schedule of Stock-Based Compensation Expense Related to Stock-Based Awards (Detail) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2018	Dec. 31, 2017
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]
Stock-based compensation expense	$ 1,543	$ 579
Research and Development [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]
Stock-based compensation expense	249	69
General and Administrative [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]
Stock-based compensation expense	$ 1,294	$ 510

Stock-Based Compensation - Sc_2

Stock-Based Compensation - Schedule of Assumptions Used in Black-Scholes Option Pricing Model to Determine the Fair Value of Stock Options Granted (Detail)	12 Months Ended
	Dec. 31, 2018	Dec. 31, 2017
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]
Expected stock price volatility, minimum	63.00%	79.00%
Expected stock price volatility, maximum	86.00%	86.00%
Risk-free interest rate, minimum	2.00%	1.00%
Risk-free interest rate, maximum	3.00%	3.00%
Estimated dividend yield	0.00%	0.00%
Minimum [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]
Expected life of option (in years)	5 years	5 years
Maximum [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]
Expected life of option (in years)	7 years	7 years

Income Taxes - Summary of Incom

Income Taxes - Summary of Income (Loss) Before Income Taxes (Detail) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2018	Dec. 31, 2017
Losses before income taxes:
U.S.	$ (14,177)	$ (12,470)
Non-U.S.	112	(646)
Total	$ (14,065)	$ (13,116)

Income Taxes - Additional Infor

Income Taxes - Additional Information (Detail) - USD ($)	3 Months Ended	12 Months Ended
	Dec. 31, 2017	Dec. 31, 2018	Dec. 31, 2017
Tax Credit Carryforward [Line Items]
Federal Income tax rate		21.00%	35.00%
Federal statutory income tax rate		21.00%	35.00%
Recorded reduction in net deferred tax assets	$ 1,900,000
Net valuation allowance increased		$ 3,000,000
Research and development tax credit carryforwards for federal and state	95,000	$ 299,000	$ 95,000
Period for which cumulative change in ownership annual use net operating loss and research and development credit carryforwards		3 years
Accrued interest and penalties associated with uncertain tax positions	0	$ 0	0
Interest or penalties recorded during the year		$ 0	0
Minimum [Member]
Tax Credit Carryforward [Line Items]
Percentage of cumulative change in ownership		50.00%
Domestic Tax Authority [Member]
Tax Credit Carryforward [Line Items]
Federal net operating loss carryforwards	12,500,000	$ 25,000,000	12,500,000
Net operating loss carryforward expiration period		2034
Federal net operating loss carryforwards, not to expiration		$ 12,500,000
Research and development tax credit carryforwards for federal and state	132,000	$ 420,000	132,000
Research and development tax credit carryforwards expiration period		2025
State and Local Jurisdiction [Member]
Tax Credit Carryforward [Line Items]
State net operating loss carryforwards	900,000	$ 900,000	900,000
Research and development tax credit carryforwards for federal and state	67,000	$ 161,000	$ 67,000
Research and development tax credit carryforwards expiration description		As of December 31, 2018 and 2017, the Company has state research and development credit carryforwards or approximately $161,000 and $67,000, respectively, which do not expire.
Israeli Tax Authority [Member] | Foreign Country [Member]
Tax Credit Carryforward [Line Items]
Income tax rate		23.00%	24.00%
Foreign operating losses carryforwards	$ 8,400,000	$ 8,200,000	$ 8,400,000
California [Member] | State and Local Jurisdiction [Member]
Tax Credit Carryforward [Line Items]
Net operating loss carryforward expiration period		2034

Income Taxes - Reconciliation o

Income Taxes - Reconciliation of U.S. Federal Statutory Income Tax Rate (Detail) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2018	Dec. 31, 2017
Income Tax Disclosure [Abstract]
Statutory Federal income tax rate	$ (2,953)	$ (4,460)
Foreign losses		59
Tax credits	(204)	(2)
Change in statutory rates		1,859
Stock-based compensation	72	135
Permanent items	3	693
Other	90	43
Change in valuation allowance	$ 2,992	$ 1,673

Income Taxes - Schedule of Sign

Income Taxes - Schedule of Significant Components Deferred Tax Assets and Liabilities (Detail) - USD ($) $ in Thousands	Dec. 31, 2018	Dec. 31, 2017
Income Tax Disclosure [Abstract]
Net operating loss carryforwards	$ 7,126	$ 4,516
Research and development tax credits	299	95
Accruals and reserves	159	221
Stock compensation	301	48
Depreciation and amortization	126	139
Total deferred tax assets	8,011	5,019
Less: Valuation allowance	$ (8,011)	$ (5,019)

Income Taxes - Reconciliation_2

Income Taxes - Reconciliation of Beginning and Ending Amounts of Unrecognized Tax Benefits (Detail) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2018	Dec. 31, 2017
Income Tax Disclosure [Abstract]
Gross unrecognized tax benefits at the beginning of the year	$ 181
Additions from tax positions taken in the current year	158	$ 75
Additions from tax positions taken in prior years		106
Reductions from tax positions taken in prior years	(11)
Gross unrecognized tax benefits at the end of the year	$ 328	$ 181

Stockholders' Equity - Addition

Stockholders' Equity - Additional Information (Detail) - USD ($)	Mar. 09, 2018	May 31, 2017	Mar. 31, 2017	Dec. 31, 2018	Dec. 31, 2017	Jul. 23, 2018	Aug. 21, 2017	Jun. 30, 2017
Class of Stock [Line Items]
Proceeds from exercise of warrants					$ 3,119,000
Warrant issued				0	0
Warrant outstanding				0	0
Preferred stock, shares issued				0	0
Preferred stock, shares outstanding				0	0
Proceeds from issuance of common stock				$ 7,491,000	$ 4,750,000
Piper Jaffray & Co. [Member] | Equity Distribution Agreement [Member]
Class of Stock [Line Items]
Equity distribution agreement maximum value of common shares issuable							$ 8,500,000
Proceeds from issuance of common stock	$ 7,700,000				774,000
Piper Jaffray & Co. [Member] | Equity Distribution Agreement and 2018 Prospectus [Member]
Class of Stock [Line Items]
Maximum value of additional common shares issuable						$ 8,800,000
Preferred Stock [Member]
Class of Stock [Line Items]
Number of warrants exercised to purchase shares								311,850
Proceeds from exercise of warrants					$ 3,100,000
Common Stock [Member] | Piper Jaffray & Co. [Member] | Equity Distribution Agreement [Member]
Class of Stock [Line Items]
Common stock number of shares issued	2,296,610				167,356
Common Stock [Member] | Piper Jaffray & Co. [Member] | Equity Distribution Agreement and 2018 Prospectus [Member]
Class of Stock [Line Items]
Common stock number of shares issued				0
OrbiMed Israel Partners Limited Partnership [Member] | Common Stock [Member]
Class of Stock [Line Items]
Number of warrants exercised to purchase shares		51,477
Peregrine Management II Ltd. [Member] | Common Stock [Member]
Class of Stock [Line Items]
Number of warrants exercised to purchase shares		10,299
Pontifax [Member] | Common Stock [Member]
Class of Stock [Line Items]
Number of warrants exercised to purchase shares		90,804
Preferred Class B [Member] | OrbiMed Israel Partners Limited Partnership [Member]
Class of Stock [Line Items]
Number of warrants exercised to purchase shares		6,458,628	978,561
Warrant exercise price		$ 0.41	$ 0.41
Proceeds from exercise of warrants		$ 2,600,000	$ 400,000
Preferred Class B [Member] | Peregrine Management II Ltd. [Member]
Class of Stock [Line Items]
Number of warrants exercised to purchase shares		192,454
Warrant exercise price		$ 0.41
Proceeds from exercise of warrants		$ 79,000