Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2018 | Aug. 03, 2018 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2018 | |
Document Fiscal Year Focus | 2,018 | |
Document Fiscal Period Focus | Q2 | |
Trading Symbol | NVUS | |
Entity Registrant Name | Novus Therapeutics, Inc. | |
Entity Central Index Key | 1,404,281 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Smaller Reporting Company | |
Entity Common Stock, Shares Outstanding | 9,422,143 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) | Jun. 30, 2018 | Dec. 31, 2017 |
Current assets: | ||
Cash | $ 19,189,000 | $ 17,233,000 |
Restricted cash | 0 | 70,000 |
Prepaid expenses and other current assets | 1,889,000 | 1,697,000 |
Total current assets | 21,078,000 | 19,000,000 |
Property and equipment, net | 20,000 | 25,000 |
Goodwill | 1,867,000 | 1,867,000 |
Total assets | 22,965,000 | 20,892,000 |
Current liabilities: | ||
Accounts payable | 706,000 | 418,000 |
Accrued severance | 224,000 | 668,000 |
Accrued expenses and other liabilities | 522,000 | 354,000 |
Total liabilities | 1,452,000 | 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 June 30, 2018 and December 31, 2017 | ||
Common stock, $0.001 par value, 200,000,000 shares authorized at June 30, 2018 and December 31, 2017; 9,407,024 and 7,110,414 shares issued and outstanding at June 30, 2018 and December 31, 2017, respectively | 9,000 | 7,000 |
Additional paid-in capital | 55,005,000 | 46,951,000 |
Accumulated deficit | (33,501,000) | (27,506,000) |
Total stockholders’ equity | 21,513,000 | 19,452,000 |
Total liabilities and stockholders’ equity | $ 22,965,000 | $ 20,892,000 |
Condensed Consolidated Balance3
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2018 | Dec. 31, 2017 |
Statement Of Financial Position [Abstract] | ||
Preferred shares, par value | $ 0.001 | $ 0.001 |
Preferred shares, shares authorized | 5,000,000 | 5,000,000 |
Preferred shares, shares issued | 0 | 0 |
Preferred shares, 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 | 9,407,024 | 7,110,414 |
Common stock, shares outstanding | 9,407,024 | 7,110,414 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | |
Operating expenses | ||||
Research and development | $ 1,329 | $ 533 | $ 2,426 | $ 1,012 |
General and administrative | 1,860 | 6,133 | 3,558 | 7,039 |
Total operating expenses | 3,189 | 6,666 | 5,984 | 8,051 |
Loss from operations | (3,189) | (6,666) | (5,984) | (8,051) |
Other income (expense), net | 4 | (11) | 15 | |
Net loss and comprehensive loss | $ (3,189) | $ (6,662) | $ (5,995) | $ (8,036) |
Net loss per share, basic and diluted | $ (0.34) | $ (1.32) | $ (0.70) | $ (2.51) |
Weighted-average common shares outstanding, basic and diluted | 9,407,024 | 4,154,842 | 8,582,723 | 2,270,907 |
Condensed Consolidated Stateme5
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | Dec. 31, 2017 | |
Operating activities | |||||
Net loss | $ (3,189) | $ (6,662) | $ (5,995) | $ (8,036) | |
Adjustments to reconcile net loss to net cash used in operating activities: | |||||
Depreciation and amortization | 5 | 16 | |||
Stock-based compensation | 565 | 236 | |||
Loss on disposal of fixed assets | 31 | ||||
Changes in operating assets and liabilities: | |||||
Prepaid expenses and other assets | (192) | (1,167) | |||
Accounts payable and accrued expenses | 12 | 7 | |||
Net cash used in operating activities | (5,605) | (8,913) | |||
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 | 4,000 | |||
Proceeds from exercise of warrants | 3,119 | ||||
Net cash provided by financing activities | 7,491 | 7,119 | |||
Net increase in cash and restricted cash | 1,886 | 21,464 | |||
Cash and restricted cash at beginning of period | 17,303 | 1,117 | $ 1,117 | ||
Cash and restricted cash at end of period | $ 19,189 | $ 22,581 | $ 19,189 | 22,581 | $ 17,303 |
Noncash activities: | |||||
Conversion of promissory notes 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 stock 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 | 6 Months Ended |
Jun. 30, 2018 | |
Accounting Policies [Abstract] | |
Description of Business | Note 1. Description of Business Novus Therapeutics, Inc. 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 Pharma, Ltd., a private limited company organized under the laws of the State of Israel (“Otic”), and the stockholders of 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 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 | 6 Months Ended |
Jun. 30, 2018 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Note 2. Summary of Significant Accounting Policies Basis of Presentation The accompanying unaudited financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) and Article 10 of Regulation S-X requirements as set forth by the Securities and Exchange Commission (“SEC”) for interim financial information and reflect all adjustments and disclosures, which are, in the opinion of management, of a normal and recurring nature, and considered necessary for a fair presentation of the financial information contained herein. Pursuant to these rules and regulations, the unaudited condensed consolidated financial statements do not include all information and notes necessary for a complete presentation of results of operations and comprehensive loss, financial position, and cash flows in conformity with GAAP. The accompanying unaudited condensed consolidated financial statements and notes should be read in conjunction with the audited financial statements and accompanying notes of Novus for the year ended December 31, 2017 included in the Annual Report on Form 10-K filed by the Company with the SEC on April 2, 2018. The results of operations and comprehensive loss for the three and six months ended June 30, 2018 are not necessarily indicative of results expected for the full fiscal year or any other future period. There have been no significant and material changes in our critical accounting policies and significant judgments and estimates during the three and six months ended June 30, 2018, except as described below. Principles of Consolidation 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. All significant intercompany accounts and transactions among the entities have been eliminated from the condensed consolidated financial statements. 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 $3.2 million and $6.0 million for the three months and six months ended June 30, 2018, respectively. As of June 30, 2018, the Company had cash of $19.2 million, working capital of $19.6 million and an accumulated deficit of $33.5 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 may need to raise additional funds through future public or private debt and equity financings or strategic collaboration and licensing arrangements. If the Company issues equity or convertible debt securities to raise additional funding, its existing stockholders may experience dilution, it may incur significant financing costs, and the new equity or convertible debt securities may have rights, preferences and privileges senior to those of its existing stockholders. If the Company issues debt securities to raise additional funding, it would incur additional debt service obligations, it could become subject to additional restrictions limiting its ability to operate its business, and it may be required to further encumber its assets. Sufficient additional funding may not be available or be available on acceptable terms. If so, the Company may need to delay, reduce the scope of, or put on hold research and development activities while the Company seeks strategic alternatives. 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. The Company has performed an analysis and concluded substantial doubt does not exist with respect to the Company being able to continue as a going concern and the Company has sufficient cash resources to continue for a period of at least twelve months from the date of issuance of the accompanying unaudited condensed consolidated financial statements. Reverse Stock-Split On May 11, 2017, Novus effected a reverse stock-split of its issued and outstanding common stock and options for common stock at a ratio of one-for-nine. The Company filed an Amended and Restated Certificate of Incorporation with the Secretary of State of the State of Delaware effecting the reverse stock-split. The accompanying condensed consolidated financial statements and notes give retroactive effect to the reverse stock-split for all periods presented. Use of Estimates The preparation of the Company’s 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 unaudited condensed 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 condensed 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. 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 June 30, 2018 and December 31, 2017. Restricted Cash Restricted cash represents cash required to be set aside Concentration of Credit Risk and Other Risks and Uncertainties As of June 30, 2018 and December 31, 2017, all of the Company’s long-lived assets were located in the United States. 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. 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. 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 intangible assets 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 developing Goodwill Goodwill represents the difference between the consideration transferred and the fair value of the assets acquired and liabilities assumed under the acquisition method of accounting. Goodwill is not amortized but is evaluated for impairment during the last fiscal quarter of the year or if indicators of impairment exist that would, more likely than not, reduce the fair value from its carrying amount. The Company determined there were no impairment indicators as of June 30, 2018 and December 31, 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 carrying value of long-lived assets, including intangible assets, is evaluated whenever events or changes in business circumstances or the Company’s planned use of long-lived assets indicate, based on undiscounted future operating cash flows, that their carrying amounts may not be fully recoverable or that their useful lives are no longer appropriate. When an indicator of impairment exists, undiscounted future operating cash flows of long-lived assets are compared to their respective carrying value. If the carrying value is greater than the undiscounted future operating cash flows of long-lived assets, the long-lived assets are written down to their respective fair values and an impairment loss is recorded. Fair value is determined primarily using the discounted cash flows expected to be generated from the use of assets. 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 periods 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 June 30, 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, convertible notes and accrued interest, stock options, warrants and restricted stock units 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. Three Months Ended June 30, Six Months Ended June 30, 2018 2017 2018 2017 (In thousands, except share and per share data) Net loss available to stockholders of the company $ (3,189 ) $ (6,662 ) $ (5,995 ) $ (8,036 ) Interest accumulated on preferred shares and on preferred shares contingently issuable for little or no cash — (98 ) — (328 ) Net loss attributable to shareholders of preferred shares and to shareholders of preferred shares contingently issuable for little or no cash — 1,279 — 2,666 Net loss used in the calculation of basic and diluted loss per share $ (3,189 ) $ (5,481 ) $ (5,995 ) $ (5,698 ) Net loss per share, basic and diluted $ (0.34 ) $ (1.32 ) $ (0.70 ) $ (2.51 ) Weighted-average number of common shares 9,407,024 4,154,842 8,582,723 2,270,907 The computation of diluted earnings per share excludes stock options, warrants, and restricted stock units that are anti-dilutive. For the three and six months ended June 30, 2018, common share equivalents of 996,983 shares and 949,204 shares were anti-dilutive, respectively. For the three and six months ended June 30, 2017, common share equivalents of 587,819 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. For the three and six months ended June 30, 2018, no excess tax benefits for tax deductions related to share-based awards were recognized in the accompanying condensed consolidated statements of operations and comprehensive loss as no stock options were exercised. 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 Company includes interest and penalties related to income taxes, including unrecognized tax benefits, within income tax expense. 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 7. Income Taxes Recently Issued Accounting Pronouncements In February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2016-02, Leases (Topic 842) In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments In January 2017, the FASB issued ASU No. 2017-04, Intangibles – Goodwill and Other (Topic 350) In February 2018, the FASB issued ASU No. 2018-02, Income Statement—Reporting Comprehensive Income (Topic 220) In June 2018, the FASB issued ASU No. Improvements to Nonemployee Share-Based Payment Accounting Compensation—Stock Compensation Equity—Equity-Based Payments to Non-Employees Revenue from Contracts with Customers Recently Adopted Accounting Pronouncements In January 2016, the FASB issued ASU No. 2016-01, Financial Instruments—Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities In October 2016, the FASB issued ASU No. 2016-16, Income Taxes (Topic 740): Intra-Entity Transfer of Assets Other than Inventory In January 2017, the FASB issued ASU No. 2017-01, Clarifying the Definition of a Business (Topic 805) In May 2017, the FASB issued ASU No. 2017-09, Scope of Modification Accounting Compensation – Stock Compensation ASU No. 2017-09 In March 2018, the FASB issued ASU No. 2018-05, Income Taxes (Topic 740): Amendments to SEC Paragraphs Pursuant to SEC Staff Accounting Bulletin No. 118 The Company has evaluated the potential impacts of SAB 118 and has applied this guidance to its condensed consolidated financial statements and related disclosures beginning the first quarter of 2018. For additional information on SAB 118 and the impacts of the Act on the Company’s condensed consolidated financial statements and related disclosures, Note 7. Income Taxes No other new accounting pronouncement issued or effective during the fiscal period had or is expected to have a material impact on the Company’s condensed consolidated financial statements or disclosures. |
Reverse Merger
Reverse Merger | 6 Months Ended |
Jun. 30, 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 Topic 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, is 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 approximate 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, was calculated as the difference between the fair value of the consideration expected to be transferred and the values assigned to the identifiable tangible and intangible assets acquired and liabilities assumed. Goodwill is not expected to be deductible for tax purposes. 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 Three Months Ended June 30, 2017 Six Months Ended June 30, 2017 Operating expenses Research and development $ 686 $ 1,471 General and administrative 2,592 5,474 Total operating expenses 3,278 6,945 Loss from operations (3,278 ) (6,945 ) Other income, net 18 55 Net loss and other comprehensive loss $ (3,260 ) $ (6,890 ) Net loss per share, basic and diluted $ (0.47 ) $ (0.99 ) Weighted-average shares outstanding, basic and diluted 6,943,831 6,943,831 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 $5.4 million and $7.0 million incurred during the three and six months ended June 30, 2017, respectively. These amounts have 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 and Other Asse
Prepaid Expenses and Other Assets | 6 Months Ended |
Jun. 30, 2018 | |
Prepaid Expense And Other Assets [Abstract] | |
Prepaid Expenses and Other Assets | Note 4. Prepaid Expenses and Other Assets Prepaid expenses and other assets consisted of the following at June 30, 2018 and December 31, 2017 (in thousands): June 30, December 31, 2018 2017 Prepaid insurance $ 1,565 $ 1,518 Prepaid other 309 161 Other current assets 15 18 Total prepaid expenses and other current assets $ 1,889 $ 1,697 |
Accrued Expenses and Other Liab
Accrued Expenses and Other Liabilities | 6 Months Ended |
Jun. 30, 2018 | |
Payables And Accruals [Abstract] | |
Accrued Expenses and Other Liabilities | Note 5. Accrued Expenses and Other Liabilities Accrued expenses and other liabilities consisted of the following as of June 30, 2018 and December 31, 2017 (in thousands): June 30, December 31, 2018 2017 Accrued clinical $ 64 $ 85 Accrued compensation and related expenses 100 — Accrued professional services 171 158 Accrued vacation 135 111 Accrued other 52 — Total accrued expenses and other liabilities $ 522 $ 354 |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 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 rental expense for all operating leases in the accompanying condensed consolidated statements of operations and comprehensive loss was $42,000 and $141,000 for the three months ended June 30, 2018 and 2017, respectively, and $84,000 and $182,000 for the six months ended June 30, 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 expired on December 31, 2016 and was 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 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 extended operating leases having initial or remaining terms of one year or more are as follows for the remaining fiscal year and thereafter (in thousands): 2018 (remainder of) $ 88 2019 187 2020 195 2021 152 Total minimum lease payments $ 622 Restricted Cash and Letter of Credit The Company was required to maintain a letter of credit totaling $70,000 for the benefit of the landlord of Tokai’s Boston office. The landlord could draw against the letter of credit in the event of default by the Company. The Company held $70,000 in restricted cash as part of current assets on the condensed consolidated balance sheet as of December 31, 2017. Although the Boston office lease was terminated in November 2017, the process to release the restricted cash was not completed as of December 31, 2017. On March 12, 2018, the restricted cash was released and transferred into general funds . 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 out of 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 June 30, 2018; therefore, no liability was recorded for the repayment in the accompanying condensed 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 OP-02, 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 Eustachian tube dysfunction. 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 Investigational New Drug application (“IND”) to the Company. The Company is obligated to pay up to $42.1 million in development and regulatory milestones if OP-02 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 six months ended June 30, 2018 or the year ended December 31, 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 UMB and John Hopkins. 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 Doshi Action On August 1, 2016, a purported stockholder of Tokai filed a putative class action lawsuit in the U.S. District Court for the Southern District of New York against Tokai, Jodie P. Morrison, and Lee H. Kalowski, entitled Doshi v. Tokai Pharmaceuticals, Inc., et al., Garbowski, et al. v. Tokai Pharmaceuticals, Inc., et al., Legal Proceedings Related to Tokai IPO 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., • Garbowski Action Garbowski, et al. 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 June 30, 2018. |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2018 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Note 7. Income Taxes The Company is subject to income taxes under the Israeli and U.S. tax laws. The Company was subject to an Israeli corporate tax rate of 24% in the year 2017 and will be subject to an Israeli corporate tax rate of 23% in the year 2018 and thereafter. The Company was subject to a blended U.S. tax rate (federal as well as state corporate tax) of 35% in 2017 and will be subject to a blended U.S. tax rate of 21% in 2018. On December 22, 2017, H.R. 1/Public Law No. 115-97, commonly known as the Tax Cuts and Jobs Act (the “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 Act included numerous changes in existing tax law, including a permanent reduction in the federal corporate income tax rate from 35% to 21%, converting to a territorial tax system, and creating various income inclusion and expense limitation provisions. The rate reduction was effective beginning January 1, 2018. As a result of the Act, the Company has revalued its net deferred tax assets as of December 31, 2017 to reflect the rate reduction. The SEC staff issued Staff Accounting Bulletin No. 118 (“SAB 118”), which provides guidance on accounting for the tax effects of the Act. SAB 118 provides a measurement period that should not extend beyond one year from the Act enactment date for companies to complete the accounting under ASC Topic 740 Income Taxes Due to insufficient guidance on certain aspects of the Act, such as officer’s compensation, as well as uncertainty around the GAAP treatment associated with many other parts of the Act, such as the implementation of certain international provisions, the Company cannot be certain that all deferred tax assets and liabilities have been established for the future effects of the legislation. Therefore, the final accounting for these provisions is subject to change as further information becomes available and further analysis is complete. Additionally, given the uncertainty and complexity of these new international tax regimes, the Company is continuing to evaluate how these provisions will be accounted for under U.S. generally accepted accounting principles; therefore, the Company has not yet adopted an accounting policy for treating the effects of these provisions as either a component of income tax expense in the period the tax arises, or through adjusting its deferred tax assets and liabilities to account for the estimated future impact of the special international tax regimes. There were no changes to provisional amounts during the second quarter remeasurement period. |
Stockholders' Equity
Stockholders' Equity | 6 Months Ended |
Jun. 30, 2018 | |
Equity [Abstract] | |
Stockholders' Equity | Note 8. Stockholders’ Equity Warrants During 2017, the following transactions represent 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 stockholders, in a cashless exercise, purchased 311,850 of the Company’s preferred stock. As of June 30, 2018 and December 31, 2017, no warrants 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, shares of the Company’s common stock. In connection with the Equity Distribution Agreement on August 21, 2017, the Company filed a prospectus supplement (the “2017 Prospectus) under which the Company was permitted to offer and sell up to $8.5 million in shares of its common stock. From October 2, 2017 through March 9, 2018, the Company sold 2,463,966 shares of its common stock through Piper Jaffray under the Equity Distribution Agreement and 2017 Prospectus for gross proceeds of approximately $8.5 million. During the six months ended June 30, 2018, the Company received approximately $7.5 million in proceeds, net of $232,000 in offering costs. No further sales will be made under the 2017 Prospectus. |
Subsequent Events
Subsequent Events | 6 Months Ended |
Jun. 30, 2018 | |
Subsequent Events [Abstract] | |
Subsequent Events | Note 9. Subsequent Events On July 23, 2018, the Company filed a new prospectus supplement under which the Company may offer and sell, from time to time, through Piper Jaffray, up to an additional $9.8 million in shares of its common stock. |
Summary of Significant Accoun15
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2018 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying unaudited financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) and Article 10 of Regulation S-X requirements as set forth by the Securities and Exchange Commission (“SEC”) for interim financial information and reflect all adjustments and disclosures, which are, in the opinion of management, of a normal and recurring nature, and considered necessary for a fair presentation of the financial information contained herein. Pursuant to these rules and regulations, the unaudited condensed consolidated financial statements do not include all information and notes necessary for a complete presentation of results of operations and comprehensive loss, financial position, and cash flows in conformity with GAAP. The accompanying unaudited condensed consolidated financial statements and notes should be read in conjunction with the audited financial statements and accompanying notes of Novus for the year ended December 31, 2017 included in the Annual Report on Form 10-K filed by the Company with the SEC on April 2, 2018. The results of operations and comprehensive loss for the three and six months ended June 30, 2018 are not necessarily indicative of results expected for the full fiscal year or any other future period. There have been no significant and material changes in our critical accounting policies and significant judgments and estimates during the three and six months ended June 30, 2018, except as described below. |
Principles of Consolidation | Principles of Consolidation 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. All significant intercompany accounts and transactions among the entities have been eliminated from the condensed consolidated financial statements. |
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 $3.2 million and $6.0 million for the three months and six months ended June 30, 2018, respectively. As of June 30, 2018, the Company had cash of $19.2 million, working capital of $19.6 million and an accumulated deficit of $33.5 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 may need to raise additional funds through future public or private debt and equity financings or strategic collaboration and licensing arrangements. If the Company issues equity or convertible debt securities to raise additional funding, its existing stockholders may experience dilution, it may incur significant financing costs, and the new equity or convertible debt securities may have rights, preferences and privileges senior to those of its existing stockholders. If the Company issues debt securities to raise additional funding, it would incur additional debt service obligations, it could become subject to additional restrictions limiting its ability to operate its business, and it may be required to further encumber its assets. Sufficient additional funding may not be available or be available on acceptable terms. If so, the Company may need to delay, reduce the scope of, or put on hold research and development activities while the Company seeks strategic alternatives. 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. The Company has performed an analysis and concluded substantial doubt does not exist with respect to the Company being able to continue as a going concern and the Company has sufficient cash resources to continue for a period of at least twelve months from the date of issuance of the accompanying unaudited condensed consolidated financial statements. |
Reverse Stock-Split | Reverse Stock-Split On May 11, 2017, Novus effected a reverse stock-split of its issued and outstanding common stock and options for common stock at a ratio of one-for-nine. The Company filed an Amended and Restated Certificate of Incorporation with the Secretary of State of the State of Delaware effecting the reverse stock-split. The accompanying condensed consolidated financial statements and notes give retroactive effect to the reverse stock-split for all periods presented. |
Use of Estimates | Use of Estimates The preparation of the Company’s 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 unaudited condensed 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 condensed 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. 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 June 30, 2018 and December 31, 2017. |
Restricted Cash | Restricted Cash Restricted cash represents cash required to be set aside |
Concentration of Credit Risk and Other Risks and Uncertainties | Concentration of Credit Risk and Other Risks and Uncertainties As of June 30, 2018 and December 31, 2017, all of the Company’s long-lived assets were located in the United States. 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. 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. |
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 intangible assets 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 developing |
Goodwill | Goodwill Goodwill represents the difference between the consideration transferred and the fair value of the assets acquired and liabilities assumed under the acquisition method of accounting. Goodwill is not amortized but is evaluated for impairment during the last fiscal quarter of the year or if indicators of impairment exist that would, more likely than not, reduce the fair value from its carrying amount. The Company determined there were no impairment indicators as of June 30, 2018 and December 31, 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 carrying value of long-lived assets, including intangible assets, is evaluated whenever events or changes in business circumstances or the Company’s planned use of long-lived assets indicate, based on undiscounted future operating cash flows, that their carrying amounts may not be fully recoverable or that their useful lives are no longer appropriate. When an indicator of impairment exists, undiscounted future operating cash flows of long-lived assets are compared to their respective carrying value. If the carrying value is greater than the undiscounted future operating cash flows of long-lived assets, the long-lived assets are written down to their respective fair values and an impairment loss is recorded. Fair value is determined primarily using the discounted cash flows expected to be generated from the use of assets. 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 periods 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 June 30, 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, convertible notes and accrued interest, stock options, warrants and restricted stock units 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. Three Months Ended June 30, Six Months Ended June 30, 2018 2017 2018 2017 (In thousands, except share and per share data) Net loss available to stockholders of the company $ (3,189 ) $ (6,662 ) $ (5,995 ) $ (8,036 ) Interest accumulated on preferred shares and on preferred shares contingently issuable for little or no cash — (98 ) — (328 ) Net loss attributable to shareholders of preferred shares and to shareholders of preferred shares contingently issuable for little or no cash — 1,279 — 2,666 Net loss used in the calculation of basic and diluted loss per share $ (3,189 ) $ (5,481 ) $ (5,995 ) $ (5,698 ) Net loss per share, basic and diluted $ (0.34 ) $ (1.32 ) $ (0.70 ) $ (2.51 ) Weighted-average number of common shares 9,407,024 4,154,842 8,582,723 2,270,907 The computation of diluted earnings per share excludes stock options, warrants, and restricted stock units that are anti-dilutive. For the three and six months ended June 30, 2018, common share equivalents of 996,983 shares and 949,204 shares were anti-dilutive, respectively. For the three and six months ended June 30, 2017, common share equivalents of 587,819 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. For the three and six months ended June 30, 2018, no excess tax benefits for tax deductions related to share-based awards were recognized in the accompanying condensed consolidated statements of operations and comprehensive loss as no stock options were exercised. |
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 Company includes interest and penalties related to income taxes, including unrecognized tax benefits, within income tax expense. 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 7. Income Taxes |
Recently Issued or Adopted Accounting Pronouncements | Recently Issued Accounting Pronouncements In February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2016-02, Leases (Topic 842) In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments In January 2017, the FASB issued ASU No. 2017-04, Intangibles – Goodwill and Other (Topic 350) In February 2018, the FASB issued ASU No. 2018-02, Income Statement—Reporting Comprehensive Income (Topic 220) In June 2018, the FASB issued ASU No. Improvements to Nonemployee Share-Based Payment Accounting Compensation—Stock Compensation Equity—Equity-Based Payments to Non-Employees Revenue from Contracts with Customers Recently Adopted Accounting Pronouncements In January 2016, the FASB issued ASU No. 2016-01, Financial Instruments—Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities In October 2016, the FASB issued ASU No. 2016-16, Income Taxes (Topic 740): Intra-Entity Transfer of Assets Other than Inventory In January 2017, the FASB issued ASU No. 2017-01, Clarifying the Definition of a Business (Topic 805) In May 2017, the FASB issued ASU No. 2017-09, Scope of Modification Accounting Compensation – Stock Compensation ASU No. 2017-09 In March 2018, the FASB issued ASU No. 2018-05, Income Taxes (Topic 740): Amendments to SEC Paragraphs Pursuant to SEC Staff Accounting Bulletin No. 118 The Company has evaluated the potential impacts of SAB 118 and has applied this guidance to its condensed consolidated financial statements and related disclosures beginning the first quarter of 2018. For additional information on SAB 118 and the impacts of the Act on the Company’s condensed consolidated financial statements and related disclosures, Note 7. Income Taxes No other new accounting pronouncement issued or effective during the fiscal period had or is expected to have a material impact on the Company’s condensed consolidated financial statements or disclosures. |
Summary of Significant Accoun16
Summary of Significant Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 2018 | |
Accounting Policies [Abstract] | |
Schedule of Common Share Equivalents Included from Computation of Net Loss Per Share | Three Months Ended June 30, Six Months Ended June 30, 2018 2017 2018 2017 (In thousands, except share and per share data) Net loss available to stockholders of the company $ (3,189 ) $ (6,662 ) $ (5,995 ) $ (8,036 ) Interest accumulated on preferred shares and on preferred shares contingently issuable for little or no cash — (98 ) — (328 ) Net loss attributable to shareholders of preferred shares and to shareholders of preferred shares contingently issuable for little or no cash — 1,279 — 2,666 Net loss used in the calculation of basic and diluted loss per share $ (3,189 ) $ (5,481 ) $ (5,995 ) $ (5,698 ) Net loss per share, basic and diluted $ (0.34 ) $ (1.32 ) $ (0.70 ) $ (2.51 ) Weighted-average number of common shares 9,407,024 4,154,842 8,582,723 2,270,907 |
Reverse Merger (Tables)
Reverse Merger (Tables) | 6 Months Ended |
Jun. 30, 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, is 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 Three Months Ended June 30, 2017 Six Months Ended June 30, 2017 Operating expenses Research and development $ 686 $ 1,471 General and administrative 2,592 5,474 Total operating expenses 3,278 6,945 Loss from operations (3,278 ) (6,945 ) Other income, net 18 55 Net loss and other comprehensive loss $ (3,260 ) $ (6,890 ) Net loss per share, basic and diluted $ (0.47 ) $ (0.99 ) Weighted-average shares outstanding, basic and diluted 6,943,831 6,943,831 |
Prepaid Expenses and Other As18
Prepaid Expenses and Other Assets (Tables) | 6 Months Ended |
Jun. 30, 2018 | |
Prepaid Expense And Other Assets [Abstract] | |
Prepaid Expenses and Other Assets | Prepaid expenses and other assets consisted of the following at June 30, 2018 and December 31, 2017 (in thousands): June 30, December 31, 2018 2017 Prepaid insurance $ 1,565 $ 1,518 Prepaid other 309 161 Other current assets 15 18 Total prepaid expenses and other current assets $ 1,889 $ 1,697 |
Accrued Expenses and Other Li19
Accrued Expenses and Other Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2018 | |
Payables And Accruals [Abstract] | |
Schedule of Accrued Expenses and Other Liabilities | Accrued expenses and other liabilities consisted of the following as of June 30, 2018 and December 31, 2017 (in thousands): June 30, December 31, 2018 2017 Accrued clinical $ 64 $ 85 Accrued compensation and related expenses 100 — Accrued professional services 171 158 Accrued vacation 135 111 Accrued other 52 — Total accrued expenses and other liabilities $ 522 $ 354 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 6 Months Ended |
Jun. 30, 2018 | |
Commitments And Contingencies Disclosure [Abstract] | |
Schedule of Future Payments Under Noncancelable Extended Operating Leases | Future payments under noncancelable extended operating leases having initial or remaining terms of one year or more are as follows for the remaining fiscal year and thereafter (in thousands): 2018 (remainder of) $ 88 2019 187 2020 195 2021 152 Total minimum lease payments $ 622 |
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 | Jun. 30, 2018 |
Description Of Business [Line Items] | ||||
Stock issued during period, shares, reverse stock splits | 840,115 | |||
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 | 0.111111111 |
Summary of Significant Accoun22
Summary of Significant Accounting Policies - Additional Information (Detail) | May 11, 2017 | May 09, 2017 | Jun. 30, 2018USD ($)shares | Jun. 30, 2017USD ($)shares | Jun. 30, 2018USD ($)Segmentshares | Jun. 30, 2017USD ($)shares | Dec. 31, 2017USD ($) |
Summary Of Significant Accounting Policies [Line Items] | |||||||
Net loss | $ (3,189,000) | $ (6,662,000) | $ (5,995,000) | $ (8,036,000) | |||
Cash | 19,189,000 | 19,189,000 | $ 17,233,000 | ||||
Working capital | 19,600,000 | 19,600,000 | |||||
Accumulated deficit | (33,501,000) | $ (33,501,000) | (27,506,000) | ||||
Cash, cash equivalents and restricted cash, maturity period | three months or less | ||||||
Cash equivalents | 0 | $ 0 | 0 | ||||
Restricted cash | $ 0 | $ 0 | 70,000 | ||||
Number of operating business segments | Segment | 1 | ||||||
Impairment of goodwill | $ 0 | $ 0 | |||||
Impairment of tangible assets | $ 0 | ||||||
Antidilutive securities excluded from computation of earnings per share, amount | shares | 996,983 | 587,819 | 949,204 | 587,819 | |||
Stock options exercised | shares | 0 | 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% | 50.00% | |||||
Otic Pharma [Member] | |||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||
Ownership percentage | 100.00% | 100.00% | |||||
Common stock and options for common stock reverse stock split description | one-for-nine | ||||||
Otic Pharma [Member] | Reverse Stock-Split [Member] | |||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||
Stock conversion, conversion ratio | 0.111111111 | 0.111111111 | |||||
Otic Pharma, Inc. [Member] | |||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||
Ownership percentage | 100.00% | 100.00% |
Summary of Significant Accoun23
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 | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | |
Earnings Per Share [Abstract] | ||||
Net loss available to stockholders of the company | $ (3,189) | $ (6,662) | $ (5,995) | $ (8,036) |
Interest accumulated on preferred shares and on preferred shares contingently issuable for little or no cash | (98) | (328) | ||
Net loss attributable to shareholders of preferred shares and to shareholders of preferred shares contingently issuable for little or no cash | 1,279 | 2,666 | ||
Net loss used in the calculation of basic and diluted loss per share | $ (3,189) | $ (5,481) | $ (5,995) | $ (5,698) |
Net loss per share, basic and diluted | $ (0.34) | $ (1.32) | $ (0.70) | $ (2.51) |
Weighted-average number of common shares | 9,407,024 | 4,154,842 | 8,582,723 | 2,270,907 |
Reverse Merger - Additional Inf
Reverse Merger - Additional Information (Detail) - USD ($) $ in Millions | May 09, 2017 | Jun. 30, 2017 | Jun. 30, 2017 | Jun. 30, 2018 | Dec. 31, 2017 |
Business Acquisition [Line Items] | |||||
Common stock, shares issued | 9,407,024 | 7,110,414 | |||
Tokai Pharmaceuticals, Inc. [Member] | |||||
Business Acquisition [Line Items] | |||||
Common stock, shares issued | 4,027,693 | ||||
Merger transaction costs | $ 5.4 | $ 7 | |||
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 26
Reverse Merger - Schedule of Purchase Price Consideration (Parenthetical) (Detail) $ / shares in Units, $ in Thousands | May 11, 2017 | May 09, 2017USD ($)$ / sharesshares | Jun. 30, 2018USD ($)shares | Dec. 31, 2017USD ($)shares |
Business Acquisition [Line Items] | ||||
Common stock outstanding | shares | 9,407,024 | 7,110,414 | ||
Equity | $ | $ 21,513 | $ 19,452 | ||
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 | Jun. 30, 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) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended |
Jun. 30, 2017 | Jun. 30, 2017 | |
Operating expenses | ||
Research and development | $ 686 | $ 1,471 |
General and administrative | 2,592 | 5,474 |
Total operating expenses | 3,278 | 6,945 |
Loss from operations | (3,278) | (6,945) |
Other income, net | 18 | 55 |
Net loss and other comprehensive loss | $ (3,260) | $ (6,890) |
Net loss per share, basic and diluted | $ (0.47) | $ (0.99) |
Weighted-average shares outstanding, basic and diluted | 6,943,831 | 6,943,831 |
Prepaid Expenses and Other As29
Prepaid Expenses and Other Assets - Prepaid Expenses and Other Assets (Detail) - USD ($) $ in Thousands | Jun. 30, 2018 | Dec. 31, 2017 |
Prepaid Expense And Other Assets Current [Abstract] | ||
Prepaid insurance | $ 1,565 | $ 1,518 |
Prepaid other | 309 | 161 |
Other current assets | 15 | 18 |
Total prepaid expenses and other current assets | $ 1,889 | $ 1,697 |
Accrued Expenses and Other Li30
Accrued Expenses and Other Liabilities - Schedule of Accrued Expenses and Other Liabilities (Detail) - USD ($) $ in Thousands | Jun. 30, 2018 | Dec. 31, 2017 |
Accrued Liabilities And Other Liabilities [Abstract] | ||
Accrued clinical | $ 64 | $ 85 |
Accrued compensation and related expenses | 100 | |
Accrued professional services | 171 | 158 |
Accrued vacation | 135 | 111 |
Accrued other | 52 | |
Total accrued expenses and other liabilities | $ 522 | $ 354 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||||||
Apr. 30, 2018 | Nov. 30, 2017USD ($) | Dec. 31, 2015USD ($) | Nov. 30, 2015USD ($)shares | Sep. 30, 2015ft² | Feb. 28, 2015USD ($)ft² | Jun. 30, 2018USD ($) | Jun. 30, 2017USD ($) | Jun. 30, 2018USD ($)Milestone | Jun. 30, 2017USD ($) | Dec. 31, 2017USD ($)Milestone | |
Other Commitments [Line Items] | |||||||||||
Rental expense | $ 42,000 | $ 141,000 | $ 84,000 | $ 182,000 | |||||||
Restricted cash, as part of current assets | 0 | $ 0 | $ 70,000 | ||||||||
Number of milestones achieved | Milestone | 0 | 0 | |||||||||
Indemnification obligations amount | 0 | $ 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] | |||||||||||
Share issued as consideration | shares | 9,780 | ||||||||||
Scientific Development and Research, Inc. and Otodyne, Inc. [Member] | License [Member] | License Agreement [Member] | |||||||||||
Other Commitments [Line Items] | |||||||||||
License fees paid | $ 750,000 | ||||||||||
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 | ||||||||||
Leases expiration 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 | ||||||||||
Leases expiration date | Aug. 31, 2018 | ||||||||||
Leases extension date | Sep. 30, 2021 | ||||||||||
Operating lease expiration term | 3 years |
Commitments and Contingencies32
Commitments and Contingencies - Schedule of Future Payments Under Noncancelable Extended Operating Leases (Detail) $ in Thousands | Jun. 30, 2018USD ($) |
Commitments And Contingencies Disclosure [Abstract] | |
2018 (remainder of) | $ 88 |
2,019 | 187 |
2,020 | 195 |
2,021 | 152 |
Total minimum lease payments | $ 622 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Tax Credit Carryforward [Line Items] | ||
Federal Income tax rate | 35.00% | |
Federal statutory income tax rate | 35.00% | |
Israeli Tax Authority [Member] | Foreign Country [Member] | ||
Tax Credit Carryforward [Line Items] | ||
Income tax rate | 24.00% | |
Scenario, Forecast [Member] | Israeli Tax Authority [Member] | Foreign Country [Member] | ||
Tax Credit Carryforward [Line Items] | ||
Income tax rate | 23.00% | |
Scenario Plan [Member] | ||
Tax Credit Carryforward [Line Items] | ||
Federal Income tax rate | 21.00% | |
Federal statutory income tax rate | 21.00% |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Detail) - USD ($) | 1 Months Ended | 5 Months Ended | 6 Months Ended | 12 Months Ended | |||
May 31, 2017 | Mar. 31, 2017 | Mar. 09, 2018 | Jun. 30, 2018 | Jun. 30, 2017 | Dec. 31, 2017 | Aug. 21, 2017 | |
Class of Stock [Line Items] | |||||||
Proceeds from exercise of warrants | $ 3,119,000 | ||||||
Warrant issued | 0 | 0 | |||||
Warrant outstanding | 0 | 0 | |||||
Proceeds from issuance of common stock | $ 7,491,000 | $ 4,000,000 | |||||
Piper Jaffray & Co. [Member] | Equity Distribution Agreement and 2017 Prospectus [Member] | |||||||
Class of Stock [Line Items] | |||||||
Equity distribution agreement maximum value of common shares issuable | $ 8,500,000 | ||||||
Proceeds from issuance of common stock | $ 8,500,000 | 7,500,000 | |||||
Offering costs | $ 232,000 | ||||||
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 and 2017 Prospectus [Member] | |||||||
Class of Stock [Line Items] | |||||||
Common stock number of shares issued | 2,463,966 | ||||||
Common Stock [Member] | OrbiMed Israel Partners Limited Partnership [Member] | |||||||
Class of Stock [Line Items] | |||||||
Number of warrants exercised to purchase shares | 51,477 | ||||||
Common Stock [Member] | Peregrine Management II Ltd. [Member] | |||||||
Class of Stock [Line Items] | |||||||
Number of warrants exercised to purchase shares | 10,299 | ||||||
Common Stock [Member] | Pontifax [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 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Detail) | Jul. 23, 2018USD ($) |
Subsequent Event [Member] | Piper Jaffray & Co. [Member] | Equity Distribution Agreement [Member] | |
Subsequent Event [Line Items] | |
Equity distribution agreement maximum value of common shares issuable | $ 9,800,000 |