Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2019 | Aug. 12, 2019 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2019 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q2 | |
Trading Symbol | NVUS | |
Entity Registrant Name | Novus Therapeutics, Inc. | |
Entity Central Index Key | 0001404281 | |
Entity Current Reporting Status | Yes | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Shell Company | false | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | true | |
Entity Common Stock, Shares Outstanding | 12,974,923 | |
Entity File Number | 001-36620 | |
Entity Tax Identification Number | 201000967 | |
Entity Address, Address Line One | 19900 MacArthur Blvd. | |
Entity Address, Address Line Two | Suite 550 | |
Entity Address, City or Town | Irvine | |
Entity Address, State or Province | California | |
Entity Address, Postal Zip Code | 92612 | |
City Area Code | (949) | |
Local Phone Number | 238-8090 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash | $ 13,703 | $ 12,972 |
Prepaid expenses and other current assets | 1,478 | 1,304 |
Total current assets | 15,181 | 14,276 |
Property and equipment, net | 10 | 14 |
Operating lease asset, net | 403 | |
Goodwill | 1,867 | 1,867 |
Other assets | 755 | 869 |
Total assets | 18,216 | 17,026 |
Current liabilities: | ||
Accounts payable | 753 | 689 |
Current operating lease liability | 173 | |
Accrued expenses and other liabilities | 1,022 | 1,845 |
Total current liabilities | 1,948 | 2,534 |
Non-current operating lease liability | 236 | |
Total liabilities | 2,184 | 2,534 |
Commitments and contingencies (Note 5) | ||
Stockholders’ equity: | ||
Preferred stock, $0.001 par value, 5,000,000 shares authorized and none issued and outstanding at June 30, 2019 and December 31, 2018 | ||
Common stock, $0.001 par value, 200,000,000 shares authorized at June 30, 2019 and December 31, 2018; 12,974,923 and 9,422,143 shares issued and outstanding at June 30, 2019 and December 31, 2018, respectively | 13 | 9 |
Additional paid-in capital | 66,564 | 56,054 |
Accumulated deficit | (50,545) | (41,571) |
Total stockholders’ equity | 16,032 | 14,492 |
Total liabilities and stockholders’ equity | $ 18,216 | $ 17,026 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2019 | Dec. 31, 2018 |
Statement Of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares issued | 12,974,923 | 9,422,143 |
Common stock, shares outstanding | 12,974,923 | 9,422,143 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Operating expenses | ||||
Research and development | $ 2,297 | $ 1,329 | $ 5,286 | $ 2,426 |
General and administrative | 1,792 | 1,860 | 3,678 | 3,558 |
Total operating expenses | 4,089 | 3,189 | 8,964 | 5,984 |
Loss from operations | (4,089) | (3,189) | (8,964) | (5,984) |
Other income (expense), net | (4) | (10) | (11) | |
Net loss and comprehensive loss | $ (4,093) | $ (3,189) | $ (8,974) | $ (5,995) |
Net loss per share, basic and diluted | $ (0.35) | $ (0.34) | $ (0.85) | $ (0.70) |
Weighted-average common shares outstanding, basic and diluted | 11,751,110 | 9,407,024 | 10,595,511 | 8,582,723 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Common Stock [Member] | Additional Paid-In Capital [Member] | Accumulated Deficit [Member] |
Beginning Balance at Dec. 31, 2017 | $ 19,452 | $ 7 | $ 46,951 | $ (27,506) |
Beginning Balance, Shares at Dec. 31, 2017 | 7,110,414 | |||
Issuance of common stock at-the-market, net of issuance costs | 7,491 | $ 2 | 7,489 | |
Issuance of common stock at-the-market, net of issuance costs, Shares | 2,296,610 | |||
Stock-based compensation | 565 | 565 | ||
Net loss and other comprehensive loss | (5,995) | (5,995) | ||
Ending Balance at Jun. 30, 2018 | 21,513 | $ 9 | 55,005 | (33,501) |
Ending Balance, Shares at Jun. 30, 2018 | 9,407,024 | |||
Beginning Balance at Mar. 31, 2018 | 24,298 | $ 9 | 54,601 | (30,312) |
Beginning Balance, Shares at Mar. 31, 2018 | 9,407,024 | |||
Stock-based compensation | 404 | 404 | ||
Net loss and other comprehensive loss | (3,189) | (3,189) | ||
Ending Balance at Jun. 30, 2018 | 21,513 | $ 9 | 55,005 | (33,501) |
Ending Balance, Shares at Jun. 30, 2018 | 9,407,024 | |||
Beginning Balance at Dec. 31, 2018 | 14,492 | $ 9 | 56,054 | (41,571) |
Beginning Balance, Shares at Dec. 31, 2018 | 9,422,143 | |||
Issuance of common stock at-the-market, net of issuance costs | 107 | 107 | ||
Issuance of common stock at-the-market, net of issuance costs, Shares | 25,218 | |||
Issuance of common stock and warrants in registered direct offering, net of issuance costs | 9,569 | $ 4 | 9,565 | |
Issuance of common stock and warrants in registered direct offering, net of issuance costs, shares | 3,449,112 | |||
Issuance of common stock in connection with vesting of restricted stock units, Shares | 78,450 | |||
Stock-based compensation | 838 | 838 | ||
Net loss and other comprehensive loss | (8,974) | (8,974) | ||
Ending Balance at Jun. 30, 2019 | 16,032 | $ 13 | 66,564 | (50,545) |
Ending Balance, Shares at Jun. 30, 2019 | 12,974,923 | |||
Beginning Balance at Mar. 31, 2019 | 9,929 | $ 9 | 56,372 | (46,452) |
Beginning Balance, Shares at Mar. 31, 2019 | 9,447,361 | |||
Issuance of common stock and warrants in registered direct offering, net of issuance costs | 9,569 | $ 4 | 9,565 | |
Issuance of common stock and warrants in registered direct offering, net of issuance costs, shares | 3,449,112 | |||
Issuance of common stock in connection with vesting of restricted stock units, Shares | 78,450 | |||
Stock-based compensation | 627 | 627 | ||
Net loss and other comprehensive loss | (4,093) | (4,093) | ||
Ending Balance at Jun. 30, 2019 | $ 16,032 | $ 13 | $ 66,564 | $ (50,545) |
Ending Balance, Shares at Jun. 30, 2019 | 12,974,923 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Operating activities | ||||
Net loss | $ (4,093) | $ (3,189) | $ (8,974) | $ (5,995) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||||
Depreciation and amortization | 4 | 5 | ||
Amortization of operating lease asset | 86 | |||
Stock-based compensation | 626 | 404 | 838 | 565 |
Changes in operating assets and liabilities: | ||||
Prepaid expenses and other assets | (60) | (192) | ||
Accounts payable and accrued expenses | (759) | 12 | ||
Operating lease liability | (80) | |||
Net cash used in operating activities | (8,945) | (5,605) | ||
Financing activities | ||||
Proceeds from issuances of common stock, net | 9,676 | 7,491 | ||
Net cash provided by financing activities | 9,676 | 7,491 | ||
Net change in cash | 731 | 1,886 | ||
Cash at beginning of period | 12,972 | 17,303 | ||
Cash at end of period | $ 13,703 | $ 19,189 | $ 13,703 | $ 19,189 |
Description of Business
Description of Business | 6 Months Ended |
Jun. 30, 2019 | |
Accounting Policies [Abstract] | |
Description of Business | Note 1. Description of Business Novus Therapeutics is a specialty pharmaceutical company focused on developing products for disorders of the ear, nose, and throat (“ENT”). Unless otherwise indicated, references to the terms “Novus” or the “Company” refer to Novus Therapeutics, Inc. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2019 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Note 2. Summary of Significant Accounting Policies Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the U.S. (“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, 2018 included in the Annual Report on Form 10-K filed by the Company with the SEC on March 28, 2019, as amended. The results of operations and comprehensive loss for the three and six months ended June 30, 2019 are not necessarily indicative of results expected for the full fiscal year or any other future period. Principles of Consolidation Novus, a Delaware corporation, owns 100% of the issued and outstanding common stock or other ownership interest in Otic Pharma, Ltd., a private limited company organized under the laws of the State of Israel (“Otic”). Otic owns 100% of the issued and outstanding common stock or other ownership interest in its U.S. subsidiary, Otic Pharma, Inc. The functional currency of the Company’s foreign subsidiary is the U.S. Dollar; however, certain expenses, assets and liabilities are transacted at the local currency. These transactions are translated from the local currency into U.S. Dollars at exchange rates during or at the end of the reporting period. The impact of the currency translation is not significant. 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 $4.1 million and $9.0 million Adequate additional funding may not be available to us on acceptable terms on a timely basis, or at all. In the first half of 2019, the Company has implemented, and will continue to implement, certain cost cutting measures to reduce its cash flow requirements. Consistent with the actions the Company has taken in the past, it will execute the appropriate steps to enable the continued operations of the business and preservation of the value of its assets beyond the next twelve months, including but not limited to actions such as reduced personnel-related costs, delay or curtailment of the Company’s research and development activities, and other discretionary expenses that are within the Company’s control. These initiatives, if required, may have an adverse impact on the Company’s ability to achieve certain of its planned objectives as it seeks strategic alternatives. On August 8, 2019, the Company received written notice (the “Notification Letter”) from the Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that it is not in compliance with the minimum bid price requirements set forth in Nasdaq Listing Rule 5550(a)(2) for continued listing on The Nasdaq Capital Market. Nasdaq Listing Rule 5550(a)(2) requires listed securities maintain a minimum closing bid price of $1.00 per share, and Listing Rule 5810(c)(3)(A) provides that a failure to meet the minimum closing bid price requirement exists if the deficiency continues for a period of 30 consecutive business days. Based on the closing bid price of the Company’s common stock for the 30 consecutive business days prior to the date of the Notification Letter, the Company does not currently meet the minimum closing bid price requirement. The Notification Letter does not impact the Company’s listing on The Nasdaq Capital Market at this time. The Notification Letter states that the Company has 180 calendar days, or until February 4, 2020, to regain compliance with Nasdaq Listing Rule 5550(a)(2). To regain compliance, the closing bid price of the Company’s common stock must be at least $1.00 per share for a minimum of 10 consecutive business days at any time prior to February 4, 2020. In the event that the Company does not regain compliance by February 4, 2020, the Company may be eligible for additional time to reach compliance with the minimum bid price requirement . If our common stock is delisted by NASDAQ, our common stock may be eligible to trade on the OTC Bulletin Board or another market. Any such alternative would likely result in it being more difficult for us to raise additional capital through the public or private sale of equity securities and for investors to dispose of, or obtain accurate quotations as to the market value of, the common stock and could result in a decrease in the trading price of our common stock. In addition, there can be no assurance that the common stock would be eligible for trading on any such alternative exchange or markets. At the time of issuance of the condensed consolidated financial statements for the period ended June 30, 2019, the Company concluded that there is substantial doubt regarding the Company’s ability to continue as a going concern for the twelve months from the date of issuance of the condensed consolidated financial statements. The financial information and the condensed consolidated financial statements included in this filing have been prepared on a basis that assumes that we will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. This financial information and these financial statements do not include any adjustments that may result from an unfavorable outcome of this uncertainty. Our ability to continue as a going concern is dependent upon our ability to successfully secure sources of financing and ultimately achieve profitable operations Use of Estimates The preparation of the Company’s 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, operating lease liability, 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 condensed 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 or restricted cash at June 30, 2019 and December 31, 2018. Concentration of Credit Risk and Other Risks and Uncertainties As of June 30, 2019 and December 31, 2018, all of the Company’s long-lived assets were located in the U.S. Financial instruments that are subject to concentration of credit risk consist primarily of cash equivalents. The Company’s policy is to invest cash in institutional money market funds to limit the amount of credit exposure. At times, the Company maintains cash equivalents in short‑term money market funds and it has not experienced any losses on its cash equivalents. The Company’s products will require approval from the U.S. Food and Drug Administration (“FDA”) and foreign regulatory agencies before commercial sales can commence. There can be no assurance that its products will receive any of these required approvals. The denial or delay of such approvals may impact the Company’s business in the future. 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. 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 annually as of October 1 st 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 operating lease right-of-use assets and 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, as well as reasonable shutdown costs. 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, 2019. 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. For the Three Months Ended June 30, For the Six Months Ended June 30, 2019 2018 2019 2018 (In thousands, except share and per share data) Net loss used in the calculation of basic and diluted loss per share $ (4,093 ) $ (3,189 ) $ (8,974 ) $ (5,995 ) Net loss per share, basic and diluted $ (0.35 ) $ (0.34 ) $ (0.85 ) $ (0.70 ) Weighted-average number of common shares, basic and diluted 11,751,110 9,407,024 10,595,511 8,582,723 The computation of diluted earnings per share excludes stock options, warrants, and restricted stock units that are anti-dilutive. As of June 30, 2019 and 2018, common share equivalents of 8,233,947 shares and 1,517,588 shares were anti-dilutive, respectively. 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. Restricted Stock Units (“RSU”) and Performance-Based Restricted Stock Units (“PRSU”) are measured and recognized based on the quoted market price of our common stock on the date of grant. Effective as of August 1, 2018, the Board of Directors amended the Company’s 2014 Stock Incentive Plan (the “2014 Plan”) and the Company’s 2014 Employee Stock Purchase Plan (the “ESPP” and, together with the 2014 Plan, the “Plans”) to reduce the share reserves under the Plans. These reductions were made to equitably adjust the share reserves in accordance with the terms of the Plans. As a result of these equitable adjustments: (1) the number of shares of common stock authorized for issuance under the 2014 Plan (excluding shares underlying outstanding awards as of August 1, 2018) was reduced to 766,500 shares and the maximum number of shares that can be added to the 2014 Plan under evergreen provision set forth in Section 4(a)(1)(C) of the 2014 Plan was reduced to 550,000 shares annually; and (2) the number of shares of common stock authorized for future issuance under the ESPP was reduced to 209,500 shares (excluding shares previously issued under the ESPP prior to August 1, 2018) and the maximum number of shares that can be added to the ESPP under the evergreen provision set forth in the ESPP was reduced to 135,000 shares annually. The 2014 Plan and ESPP were amended and restated as of August 1, 2018 to reflect these equitable adjustments. The number of shares reserved for issuance under the 2014 Plan and ESPP were 874,955 and 303,721 shares, respectively, as of June 30, 2019 Stock-based compensation expense related to stock options granted to nonemployees is recognized based on the estimated fair value of the stock options on grant date, determined using the Black-Scholes option pricing model. The awards generally vest over the period the Company expects to receive services from nonemployees. Similar to stock options granted to employees, the fair value of stock options granted nonemployees, determined using the Black-Scholes option pricing model, involves assumptions that 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 on stock options granted to nonemployees, the Company determined the contractual term is the appropriate periods for expected life on stock options granted to nonemployees. 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. Income Taxes The Company’s policy related to accounting for uncertainty in income taxes prescribes a recognition threshold and measurement attribute criteria for the financial statement recognition and measurement of tax positions taken or expected to be taken in a tax return. For those benefits to be recognized, a tax position must be more likely than not to be sustained upon examination by taxing authorities. As of December 31, 2018, there are no unrecognized tax benefits included in the balance sheet that would, if recognized, affect the Company’s effective tax rate, and the Company has noted no material changes through June 30, 2019. The Company has not recognized interest and penalties in the balance sheets or statements of operations and comprehensive loss. The Company is subject to tax in the U.S., Israel and California. Recently Issued Accounting Pronouncements In January 2017, the Financial Accounting Standards Board (“FASB”) Accounting Standards Update (“ASU”) Intangibles – Goodwill and Other (Topic 350) condensed In August 2018, the FASB issued ASU No. 2018-13, “Fair Value Measurement (Topic 820): Disclosure Framework — Changes to the Disclosure Requirements for Fair Value Measurement” In August 2018, the FASB issued ASU 2018-15, Customer's Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract Recently Adopted Accounting Pronouncements On January 1, 2019, the Company adopted ASU 2016-02, Leases (Topic 842) along with related clarifications and improvements. This pronouncement requires lessees to recognize a liability for lease obligations with lease terms greater than twelve months, which represents the discounted obligation to make future lease payments, and a corresponding right-of-use asset on the balance sheet. The guidance also changes the definition of a lease and expands required disclosures of key information about leasing arrangements that is intended to give financial statement users the ability to assess the amount, timing, and potential uncertainty of cash flows related to leases. The Company elected the optional transition method to apply the standard as of the effective date and therefore, did not restate prior periods to apply the standard to the comparative periods presented on our condensed consolidated financial statements. The Company elected practical expedients as follows as of January 1, 2019: Practical expedient package The Company has not reassessed whether any expired or existing contracts are, or contain, leases. The Company has not reassessed the lease classification for any expired or existing leases. The Company has not reassessed initial direct costs for any expired or existing leases. Hindsight practical expedient The Company has not elected the hindsight practical expedient, which permits the use of hindsight when determining lease term and impairment of operating lease assets. As a result of adopting ASC 842 as of January 1, 2019, the Company recorded an operating lease right-of-use asset of $489,000 and related operating lease liability of $491,000, respectively, primarily related to the Company’s office lease, based on the present value of the future lease payments on the date of adoption. 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 |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 6 Months Ended |
Jun. 30, 2019 | |
Prepaid Expense And Other Assets Current [Abstract] | |
Prepaid Expenses and Other Current Assets | Note 3. Prepaid Expenses and Other Current Assets Prepaid expenses and other assets consisted of the following (in thousands): June 30, December 31, 2019 2018 Prepaid insurance $ 396 $ 413 Prepaid other 265 261 Insurance receivable 739 583 Other current assets 78 47 Total prepaid expenses and other current assets $ 1,478 $ 1,304 |
Accrued Expenses and Other Liab
Accrued Expenses and Other Liabilities | 6 Months Ended |
Jun. 30, 2019 | |
Payables And Accruals [Abstract] | |
Accrued Expenses and Other Liabilities | Note 4. Accrued Expenses and Other Liabilities Accrued expenses and other liabilities consisted of the following (in thousands): June 30, December 31, 2019 2018 Accrued clinical $ 419 $ 735 Accrued compensation and related expenses 238 194 Accrued vacation 200 160 Accrued professional services 149 742 Accrued other 16 14 Total accrued expenses and other liabilities $ 1,022 $ 1,845 |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2019 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 5. Commitments and Contingencies Operating Leases The Company leases office space under a single operating lease. Total rental expense for all operating leases in the accompanying condensed consolidated statements of operations and comprehensive loss was $47,000 and $42,000 for the three months ended June 30, 2019 and 2018, respectively, and $95,000 and $84,000 for the six months ended June 30, 2019 and 2018, respectively. In September 2015, the Company 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 effective October 31, 2018. The Company determines if a contract contains a lease at inception. Our material operating lease consist of a single office space. Our office lease has remaining terms of 2.25 years and does not include options to extend the lease for additional periods. Operating lease assets and liabilities are recognized at the lease commencement date. Operating lease liabilities represent the present value of lease payments not yet paid. Operating lease assets represent our right to use an underlying asset and are based upon the operating lease liabilities adjusted for prepayments or accrued lease payments, initial direct costs, lease incentives, and impairment of operating lease assets Our leases typically contain rent escalations over the lease term. We recognize expense for these leases on a straight-line basis over the lease term. Additionally Our lease agreement does not contain any material residual value guarantees or material restrictive covenants. The Company has no lease agreements with lease and non-lease components. Related to the adoption of Topic 842, our policy elections were as follows: Separation of lease and non-lease components While we do not currently have any lease agreement with lease and non-lease components, we elected this expedient to account for lease and non-lease components as separate components. Short-term policy We have elected the short-term lease recognition exemption for all applicable classes of underlying assets. Short-term disclosures include only those leases with a term greater than one month and 12 months or less, and expense is recognized on a straight-line basis over the lease term. Leases with an initial term of 12 months or less, that do not include an option to purchase the underlying asset that we are reasonably certain to exercise, are not recorded on the balance sheet. The components of lease expense were as follows: Six Months Ended June 30, 2019 Operating lease cost (a) $ 97 (a) Other information related to leases was as follows (in thousands, except lease term and discount rate): Six Months Ended June 30, 2019 Supplemental Cash Flows Information Cash paid for amounts included in the measurement of lease liability: Operating cash flows from operating lease $ 89 Operating lease asset obtained in exchange for lease obligation: Operating lease 489 Remaining lease term Operating lease 2.25 years Discount rate Operating lease 3.25 % 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): Years ending 2019 (remainder of) $ 91 2020 188 2021 146 Total minimum lease payments 425 Less imputed interest (16 ) Present value of lease liabilities $ 409 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 research and development programs and generating sales. The Company has no obligation to repay these grants, if the research and development program fails, is unsuccessful or aborted or if no sales are generated. The Company had not yet generated sales as of June 30, 2019; 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 OP0201, a potential first-in-class treatment option for patients at risk for or with otitis media (middle ear inflammation with or without infection), which is often caused by Eustachian tube dysfunction (“ETD”). Under the terms of the agreement, the Company is obligated to use commercially reasonable efforts to seek approval for and commercialize at least one product for otitis media in the U.S. and key European markets (France, Germany, Italy, Spain, and the United Kingdom). The Company is responsible for prosecuting, maintaining, and enforcing all intellectual property and will be the sole owner of improvements. Under the agreement with the Licensors, the Company paid license fees totaling $750,000 and issued 9,780 common shares to the Licensors, which was expensed to research and development during the year ended December 31, 2015. In December 2015, the Licensors completed transfer of all technology, including the active Investigational New Drug application to the Company. The Company is obligated to pay up to $42.1 million in development and regulatory milestones if OP0201 is approved for three indications in the U.S., two in Europe, and two in Japan. The Company is also obligated to pay up to $36.0 million in sales-based milestones, beginning with sales exceeding $1.0 billion in a calendar year. The Company is also obligated to pay a tiered royalty for a period up to eight years, on a country-by-country basis. The royalty ranges from a low-single to mid-single percentage of net sales. The Company made a $300,000 milestone payment in March 2019 related to the first patient enrolled in a phase 2 study. There were no milestones achieved during the three months ended June 30, 2019 or the year ended December 31, 2018. Legal Matters The Company is involved in various lawsuits and claims arising in the ordinary course of business, including actions with respect to intellectual property, employment, and contractual matters. In connection with these matters, the Company assesses, on a regular basis, the probability and range of possible loss based on the developments in these matters. A liability is recorded in the financial statements if it is believed to be probable that a loss has been incurred and the amount of the loss can be reasonably estimated. Because litigation is inherently unpredictable and unfavorable results could occur, assessing contingencies is highly subjective and requires judgments about future events. The Company regularly reviews outstanding legal matters to determine the adequacy of the liabilities accrued and related disclosures. The amount of ultimate loss may differ from these estimates. Each matter presents its own unique circumstances, and prior litigation does not necessarily provide a reliable basis on which to predict the outcome, or range of outcomes, in any individual proceeding. Because of the uncertainties related to the occurrence, amount, and range of loss on any pending litigation or claim, the Company does not consider a liability probable and is currently unable to predict their ultimate outcome, and, with respect to any pending litigation or claim where no liability has been accrued, to make a meaningful estimate of the reasonably possible loss or range of loss that could result from an unfavorable outcome. In the event that opposing litigants in outstanding litigation proceedings or claims ultimately succeed at trial and any subsequent appeals on their claims, any potential loss or charges in excess of any established accruals, individually or in the aggregate, could have a material adverse effect on the Company’s business, financial condition, results of operations, and/or cash flows in the period in which the unfavorable outcome occurs or becomes probable, and potentially in future periods. Legal Proceedings On September 22, 2014, Tokai Pharmaceuticals, Inc. (“Tokai”), the legal predecessor of the Company, 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 (the “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. the Company is unable to predict the ultimate outcome of these actions, and therefore • Jackie888 Action Jackie888, Inc. v. Tokai Pharmaceuticals, Inc., et al., • Wu Action On December 5, 2016, a putative securities class action was filed in the Massachusetts State Court, entitled Wu v. Tokai Pharmaceuticals, Inc., et al., 16-3725 BLS (“Wu Action”). The plaintiff seeks to represent a class of purchasers of Tokai common stock in or traceable to Tokai’s IPO. On December 19, 2016, defendants removed the Wu Action to the U.S. District Court for the District of Massachusetts, where it was captioned Wu v. Tokai Pharmaceuticals, Inc., et al., 16-cv-12550. On January 6, 2017, plaintiff filed a motion to remand the Wu Action to Massachusetts State Court. On September 28, 2017, the court stayed the case pending a decision by the United States Supreme Court in Cyan, Inc. v. Beaver County Employees Retirement Fund , S. Ct. Case No. 15-1439. On March 20, 2018, the United States Supreme Court ruled in Cyan that state courts have subject matter jurisdiction over covered class actions alleging only Securities Act claims and that such actions are not removable to federal court. On March 22, 2018, plaintiff moved for leave to submit the Cyan decision in support of plaintiff’s remand motion. On March 27, 2018 the Wu Action was remanded to the Massachusetts State Court. On May 3, 2018, plaintiff filed an amended class action complaint. Following the refiling of the Jackie888 Action in Massachusetts State Court (discussed above), on June 28, 2018, plaintiff Wu moved to consolidate the Jackie888 Action with the Wu Action. On June 29, 2018, plaintiffs Jackie888 and Wu filed a consolidated complaint. On July 6, 2018, the Jackie888 Action was consolidated with the Wu Action. Defendants moved to dismiss the consolidated complaint on August 15, 2018, plaintiffs filed their opposition thereto on September 28, 2018, and defendants filed their reply in support of their motion on October 19, 2018. In addition, Defendants moved to strike the class allegations in the consolidated complaint on August 15, 2018, plaintiffs filed their opposition thereto on September 11, 2018, and defendants filed their reply in support of their motion on September 21, 2018. The court held a hearing on November 15, 2018 on defendants’ motion to strike. On December 20, 2018, the court denied defendants’ motion to strike. The court held a hearing on December 20, 2018 on defendants’ motion to dismiss. On January 8, 2019, the court denied defendants’ motion to dismiss. On February 6, 2019, the court entered a scheduling order, pursuant to which discovery on merits issues was stayed pending the court’s resolution of class certification. On April 18, 2019, the court held a hearing as to plaintiff Wu’s failure to respond to defendant’s discovery requests. The court issued an order requiring plaintiff Wu to serve written responses to the pending discovery requests by May 10, 2019. Plaintiff Wu failed to serve written responses by the deadline and her claims were subsequently dismissed with prejudice by the court on May 16, 2019. In the same order, the court also de-consolidated the Wu Action from the Jackie888 Action. • Angelos Action On July 25, 2017, a purported stockholder of Tokai filed a lawsuit in the U.S. District Court for the District of Massachusetts, entitled Peter B. Angelos v. Tokai Pharmaceuticals, Inc., et al., No. 1:17-cv-11365-MLW. On September 7, 2018, plaintiff filed an amended complaint. Defendants moved to dismiss the amended complaint on October 15, 2018. Plaintiff opposed defendants’ motion on November 19, 2018, defendants filed a reply in support of their motion on December 17, 2018, and plaintiff filed a sur-reply in support of his opposition on January 8, 2019. The court set a hearing for February 25, 2019 on defendants’ motion to dismiss but later cancelled the hearing. On July 9, 2019, the court scheduled the hearing for defendants’ motion to dismiss on September 18, 2019. 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, 2019. |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2019 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Note 6. 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 23% in the year 2018 and is expected to be subject to an Israeli corporate tax rate of 23% in the year 2019 and thereafter. The Company was subject to a blended U.S. tax rate (federal as well as state corporate tax) of 21% in 2018 and is expected to be subject to a blended U.S. tax rate of 21% in 2019. |
Stockholders' Equity
Stockholders' Equity | 6 Months Ended |
Jun. 30, 2019 | |
Equity [Abstract] | |
Stockholders' Equity | Note 7. Stockholders’ Equity Equity Distribution Agreement On July 23, 2018, the Company filed a prospectus supplement (the “2018 Prospectus”) under which the Company may offer and sell, from time to time, pursuant to an equity distribution agreement with Piper Jaffray & Co., up to $9.8 million in shares of its common stock. 25,218 shares have been sold under the 2018 Prospectus for gross proceeds of approximately $110,000 as of June 30, 2019. 2019 Equity Offering On April 30, 2019, the Company entered into a securities purchase agreement with certain investors pursuant to which the Company agreed to sell, in a registered direct offering, an aggregate 3,449,112 shares of its common stock for gross proceeds of approximately $10.7 million under its effective shelf registration statement on Form S-3 (File No. 333-226286), which became effective on July 31, 2018. In a concurrent private placement, the Company also agreed pursuant to the securities purchase agreement to issue to such investors Series A warrants to purchase up to 3,449,112 shares of its common stock at an exercise price of $4.00 with a term of eighteen months and Series B warrants to purchase up 3,449,112 shares of its common stock at an exercise price of $4.00 with a term of five years. The Series B warrants become exercisable only upon the exercise of the Series A warrants. In addition, we have agreed to issue to the placement agent warrants to purchase up to 172,456 shares of common stock representing 5.0% of the aggregate number of shares of common stock sold in this offering. The placement agent warrants will have substantially the same terms as the Series A Warrants issued to the investors in the concurrent private placement, except that the placement agent warrants will have an exercise price equal to $3.87 or 125% of the offering price per share and will expire on April 30, 2024. All the warrants issued in connection with the 2019 Equity Offering contained put options that allow the holders of the warrants the right to receive, for each warrant share that would have been issuable upon an exercise immediately prior to the occurrence of an effective change in control event defined as a fundamental transaction, the number of shares of common stock of the successor or acquiring corporation or of the Company, if it is the surviving corporation, and any additional consideration receivable as a result of such fundamental transaction by a holder of the number of shares of common stock for which this warrant is exercisable immediately prior to such fundamental transaction. The Company evaluated the embedded put option contained in the warrants under the guidance of ASC 815, Derivatives and Hedging Stock-Based Compensation Total stock-based compensation expense was recognized in our Condensed Consolidated Statements of Operations and Comprehensive Loss as follows (in thousands): For the Three Months Ended June 30, For the Six Months Ended June 30, 2019 2018 2019 2018 Research and development $ 186 $ 45 $ 222 $ 75 General and administrative 440 359 616 490 Total stock-based compensation $ 626 $ 404 $ 838 $ 565 During the six months ended June 30, 2019, PRSUs awarded to employees totaling 78,450 shares vested and resulted in the recognition of $379,000 in stock-based compensation expense. |
Subsequent Events
Subsequent Events | 6 Months Ended |
Jun. 30, 2019 | |
Subsequent Events [Abstract] | |
Subsequent Events | Note 8. Subsequent Events On August 8, 2019, the Company received written notice (the “Notification Letter”) from the Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that it is not in compliance with the minimum bid price requirements set forth in Nasdaq Listing Rule 5550(a)(2) for continued listing on The Nasdaq Capital Market. Nasdaq Listing Rule 5550(a)(2) requires listed securities maintain a minimum closing bid price of $1.00 per share, and Listing Rule 5810(c)(3)(A) provides that a failure to meet the minimum closing bid price requirement exists if the deficiency continues for a period of 30 consecutive business days. Based on the closing bid price of the Company’s common stock for the 30 consecutive business days prior to the date of the Notification Letter, the Company does not currently meet the minimum closing bid price requirement. The Notification Letter does not impact the Company’s listing on The Nasdaq Capital Market at this time. The Notification Letter states that the Company has 180 calendar days, or until February 4, 2020, to regain compliance with Nasdaq Listing Rule 5550(a)(2). To regain compliance, the closing bid price of the Company’s common stock must be at least $1.00 per share for a minimum of 10 consecutive business days at any time prior to February 4, 2020. In the event that the Company does not regain compliance by February 4, 2020, the Company may be eligible for additional time to reach compliance with the minimum bid price requirement. If our common stock is delisted by NASDAQ, our common stock may be eligible to trade on the OTC Bulletin Board or another market. Any such alternative would likely result in it being more difficult for us to raise additional capital through the public or private sale of equity securities and for investors to dispose of, or obtain accurate quotations as to the market value of, the common stock and could result in a decrease in the trading price of our common stock. In addition, there can be no assurance that the common stock would be eligible for trading on any such alternative exchange or markets. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2019 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the U.S. (“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, 2018 included in the Annual Report on Form 10-K filed by the Company with the SEC on March 28, 2019, as amended. The results of operations and comprehensive loss for the three and six months ended June 30, 2019 are not necessarily indicative of results expected for the full fiscal year or any other future period. |
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 Pharma, Ltd., a private limited company organized under the laws of the State of Israel (“Otic”). Otic owns 100% of the issued and outstanding common stock or other ownership interest in its U.S. subsidiary, Otic Pharma, Inc. The functional currency of the Company’s foreign subsidiary is the U.S. Dollar; however, certain expenses, assets and liabilities are transacted at the local currency. These transactions are translated from the local currency into U.S. Dollars at exchange rates during or at the end of the reporting period. The impact of the currency translation is not significant. 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 $4.1 million and $9.0 million Adequate additional funding may not be available to us on acceptable terms on a timely basis, or at all. In the first half of 2019, the Company has implemented, and will continue to implement, certain cost cutting measures to reduce its cash flow requirements. Consistent with the actions the Company has taken in the past, it will execute the appropriate steps to enable the continued operations of the business and preservation of the value of its assets beyond the next twelve months, including but not limited to actions such as reduced personnel-related costs, delay or curtailment of the Company’s research and development activities, and other discretionary expenses that are within the Company’s control. These initiatives, if required, may have an adverse impact on the Company’s ability to achieve certain of its planned objectives as it seeks strategic alternatives. On August 8, 2019, the Company received written notice (the “Notification Letter”) from the Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that it is not in compliance with the minimum bid price requirements set forth in Nasdaq Listing Rule 5550(a)(2) for continued listing on The Nasdaq Capital Market. Nasdaq Listing Rule 5550(a)(2) requires listed securities maintain a minimum closing bid price of $1.00 per share, and Listing Rule 5810(c)(3)(A) provides that a failure to meet the minimum closing bid price requirement exists if the deficiency continues for a period of 30 consecutive business days. Based on the closing bid price of the Company’s common stock for the 30 consecutive business days prior to the date of the Notification Letter, the Company does not currently meet the minimum closing bid price requirement. The Notification Letter does not impact the Company’s listing on The Nasdaq Capital Market at this time. The Notification Letter states that the Company has 180 calendar days, or until February 4, 2020, to regain compliance with Nasdaq Listing Rule 5550(a)(2). To regain compliance, the closing bid price of the Company’s common stock must be at least $1.00 per share for a minimum of 10 consecutive business days at any time prior to February 4, 2020. In the event that the Company does not regain compliance by February 4, 2020, the Company may be eligible for additional time to reach compliance with the minimum bid price requirement . If our common stock is delisted by NASDAQ, our common stock may be eligible to trade on the OTC Bulletin Board or another market. Any such alternative would likely result in it being more difficult for us to raise additional capital through the public or private sale of equity securities and for investors to dispose of, or obtain accurate quotations as to the market value of, the common stock and could result in a decrease in the trading price of our common stock. In addition, there can be no assurance that the common stock would be eligible for trading on any such alternative exchange or markets. At the time of issuance of the condensed consolidated financial statements for the period ended June 30, 2019, the Company concluded that there is substantial doubt regarding the Company’s ability to continue as a going concern for the twelve months from the date of issuance of the condensed consolidated financial statements. The financial information and the condensed consolidated financial statements included in this filing have been prepared on a basis that assumes that we will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. This financial information and these financial statements do not include any adjustments that may result from an unfavorable outcome of this uncertainty. Our ability to continue as a going concern is dependent upon our ability to successfully secure sources of financing and ultimately achieve profitable operations |
Use of Estimates | Use of Estimates The preparation of the Company’s 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, operating lease liability, 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 condensed |
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 or restricted cash at June 30, 2019 and December 31, 2018. |
Concentration of Credit Risk and Other Risks and Uncertainties | Concentration of Credit Risk and Other Risks and Uncertainties As of June 30, 2019 and December 31, 2018, all of the Company’s long-lived assets were located in the U.S. Financial instruments that are subject to concentration of credit risk consist primarily of cash equivalents. The Company’s policy is to invest cash in institutional money market funds to limit the amount of credit exposure. At times, the Company maintains cash equivalents in short‑term money market funds and it has not experienced any losses on its cash equivalents. The Company’s products will require approval from the U.S. Food and Drug Administration (“FDA”) and foreign regulatory agencies before commercial sales can commence. There can be no assurance that its products will receive any of these required approvals. The denial or delay of such approvals may impact the Company’s business in the future. 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. |
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 annually as of October 1 st |
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 operating lease right-of-use assets and 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, as well as reasonable shutdown costs. 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, 2019. |
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. For the Three Months Ended June 30, For the Six Months Ended June 30, 2019 2018 2019 2018 (In thousands, except share and per share data) Net loss used in the calculation of basic and diluted loss per share $ (4,093 ) $ (3,189 ) $ (8,974 ) $ (5,995 ) Net loss per share, basic and diluted $ (0.35 ) $ (0.34 ) $ (0.85 ) $ (0.70 ) Weighted-average number of common shares, basic and diluted 11,751,110 9,407,024 10,595,511 8,582,723 The computation of diluted earnings per share excludes stock options, warrants, and restricted stock units that are anti-dilutive. As of June 30, 2019 and 2018, common share equivalents of 8,233,947 shares and 1,517,588 shares were anti-dilutive, respectively. |
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. Restricted Stock Units (“RSU”) and Performance-Based Restricted Stock Units (“PRSU”) are measured and recognized based on the quoted market price of our common stock on the date of grant. Effective as of August 1, 2018, the Board of Directors amended the Company’s 2014 Stock Incentive Plan (the “2014 Plan”) and the Company’s 2014 Employee Stock Purchase Plan (the “ESPP” and, together with the 2014 Plan, the “Plans”) to reduce the share reserves under the Plans. These reductions were made to equitably adjust the share reserves in accordance with the terms of the Plans. As a result of these equitable adjustments: (1) the number of shares of common stock authorized for issuance under the 2014 Plan (excluding shares underlying outstanding awards as of August 1, 2018) was reduced to 766,500 shares and the maximum number of shares that can be added to the 2014 Plan under evergreen provision set forth in Section 4(a)(1)(C) of the 2014 Plan was reduced to 550,000 shares annually; and (2) the number of shares of common stock authorized for future issuance under the ESPP was reduced to 209,500 shares (excluding shares previously issued under the ESPP prior to August 1, 2018) and the maximum number of shares that can be added to the ESPP under the evergreen provision set forth in the ESPP was reduced to 135,000 shares annually. The 2014 Plan and ESPP were amended and restated as of August 1, 2018 to reflect these equitable adjustments. The number of shares reserved for issuance under the 2014 Plan and ESPP were 874,955 and 303,721 shares, respectively, as of June 30, 2019 Stock-based compensation expense related to stock options granted to nonemployees is recognized based on the estimated fair value of the stock options on grant date, determined using the Black-Scholes option pricing model. The awards generally vest over the period the Company expects to receive services from nonemployees. Similar to stock options granted to employees, the fair value of stock options granted nonemployees, determined using the Black-Scholes option pricing model, involves assumptions that 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 on stock options granted to nonemployees, the Company determined the contractual term is the appropriate periods for expected life on stock options granted to nonemployees. 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. |
Income Taxes | Income Taxes The Company’s policy related to accounting for uncertainty in income taxes prescribes a recognition threshold and measurement attribute criteria for the financial statement recognition and measurement of tax positions taken or expected to be taken in a tax return. For those benefits to be recognized, a tax position must be more likely than not to be sustained upon examination by taxing authorities. As of December 31, 2018, there are no unrecognized tax benefits included in the balance sheet that would, if recognized, affect the Company’s effective tax rate, and the Company has noted no material changes through June 30, 2019. The Company has not recognized interest and penalties in the balance sheets or statements of operations and comprehensive loss. The Company is subject to tax in the U.S., Israel and California. |
Recently Issued or Adopted Accounting Pronouncements | Recently Issued Accounting Pronouncements In January 2017, the Financial Accounting Standards Board (“FASB”) Accounting Standards Update (“ASU”) Intangibles – Goodwill and Other (Topic 350) condensed In August 2018, the FASB issued ASU No. 2018-13, “Fair Value Measurement (Topic 820): Disclosure Framework — Changes to the Disclosure Requirements for Fair Value Measurement” In August 2018, the FASB issued ASU 2018-15, Customer's Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract Recently Adopted Accounting Pronouncements On January 1, 2019, the Company adopted ASU 2016-02, Leases (Topic 842) along with related clarifications and improvements. This pronouncement requires lessees to recognize a liability for lease obligations with lease terms greater than twelve months, which represents the discounted obligation to make future lease payments, and a corresponding right-of-use asset on the balance sheet. The guidance also changes the definition of a lease and expands required disclosures of key information about leasing arrangements that is intended to give financial statement users the ability to assess the amount, timing, and potential uncertainty of cash flows related to leases. The Company elected the optional transition method to apply the standard as of the effective date and therefore, did not restate prior periods to apply the standard to the comparative periods presented on our condensed consolidated financial statements. The Company elected practical expedients as follows as of January 1, 2019: Practical expedient package The Company has not reassessed whether any expired or existing contracts are, or contain, leases. The Company has not reassessed the lease classification for any expired or existing leases. The Company has not reassessed initial direct costs for any expired or existing leases. Hindsight practical expedient The Company has not elected the hindsight practical expedient, which permits the use of hindsight when determining lease term and impairment of operating lease assets. As a result of adopting ASC 842 as of January 1, 2019, the Company recorded an operating lease right-of-use asset of $489,000 and related operating lease liability of $491,000, respectively, primarily related to the Company’s office lease, based on the present value of the future lease payments on the date of adoption. 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 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Accounting Policies [Abstract] | |
Schedule of Common Share Equivalents Included from Computation of Net Loss Per Share | For the Three Months Ended June 30, For the Six Months Ended June 30, 2019 2018 2019 2018 (In thousands, except share and per share data) Net loss used in the calculation of basic and diluted loss per share $ (4,093 ) $ (3,189 ) $ (8,974 ) $ (5,995 ) Net loss per share, basic and diluted $ (0.35 ) $ (0.34 ) $ (0.85 ) $ (0.70 ) Weighted-average number of common shares, basic and diluted 11,751,110 9,407,024 10,595,511 8,582,723 |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Prepaid Expense And Other Assets Current [Abstract] | |
Prepaid Expenses and Other Assets | Prepaid expenses and other assets consisted of the following (in thousands): June 30, December 31, 2019 2018 Prepaid insurance $ 396 $ 413 Prepaid other 265 261 Insurance receivable 739 583 Other current assets 78 47 Total prepaid expenses and other current assets $ 1,478 $ 1,304 |
Accrued Expenses and Other Li_2
Accrued Expenses and Other Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Payables And Accruals [Abstract] | |
Schedule of Accrued Expenses and Other Liabilities | Accrued expenses and other liabilities consisted of the following (in thousands): June 30, December 31, 2019 2018 Accrued clinical $ 419 $ 735 Accrued compensation and related expenses 238 194 Accrued vacation 200 160 Accrued professional services 149 742 Accrued other 16 14 Total accrued expenses and other liabilities $ 1,022 $ 1,845 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Commitments And Contingencies Disclosure [Abstract] | |
Components of Lease Expense | The components of lease expense were as follows: Six Months Ended June 30, 2019 Operating lease cost (a) $ 97 (a) |
Schedule of Other Information Related to Leases | Other information related to leases was as follows (in thousands, except lease term and discount rate): Six Months Ended June 30, 2019 Supplemental Cash Flows Information Cash paid for amounts included in the measurement of lease liability: Operating cash flows from operating lease $ 89 Operating lease asset obtained in exchange for lease obligation: Operating lease 489 Remaining lease term Operating lease 2.25 years Discount rate Operating lease 3.25 % |
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): Years ending 2019 (remainder of) $ 91 2020 188 2021 146 Total minimum lease payments 425 Less imputed interest (16 ) Present value of lease liabilities $ 409 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Equity [Abstract] | |
Schedule of Stock-Based Compensation Expense Recognized | Stock-Based Compensation Total stock-based compensation expense was recognized in our Condensed Consolidated Statements of Operations and Comprehensive Loss as follows (in thousands): For the Three Months Ended June 30, For the Six Months Ended June 30, 2019 2018 2019 2018 Research and development $ 186 $ 45 $ 222 $ 75 General and administrative 440 359 616 490 Total stock-based compensation $ 626 $ 404 $ 838 $ 565 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Detail) | Aug. 08, 2019$ / shares | Jun. 30, 2019USD ($)shares | Jun. 30, 2018USD ($) | Jun. 30, 2019USD ($)Segmentshares | Jun. 30, 2018USD ($)shares | Dec. 31, 2018USD ($) | Apr. 30, 2019USD ($) | Jan. 01, 2019USD ($) | Aug. 01, 2018shares |
Summary Of Significant Accounting Policies [Line Items] | |||||||||
Net loss | $ (4,093,000) | $ (3,189,000) | $ (8,974,000) | $ (5,995,000) | |||||
Cash | 13,703,000 | 13,703,000 | $ 12,972,000 | ||||||
Working capital | 13,200,000 | 13,200,000 | |||||||
Accumulated deficit | (50,545,000) | $ (50,545,000) | (41,571,000) | ||||||
Cash, cash equivalents and restricted cash, maturity period | three months or less | ||||||||
Cash equivalents or restricted cash | 0 | $ 0 | 0 | ||||||
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 | 8,233,947 | 1,517,588 | |||||||
Unrecognized tax benefits effective tax rate | 0 | $ 0 | $ 0 | ||||||
Unrecognized tax benefits interest and penalties | 0 | 0 | |||||||
Operating lease right of use asset | 403,000 | 403,000 | |||||||
Operating lease liability | $ 409,000 | $ 409,000 | |||||||
ASU 2016-02 [Member] | |||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||
Operating lease right of use asset | $ 489,000 | ||||||||
Operating lease liability | $ 491,000 | ||||||||
2014 Stock Incentive Plan [Member] | |||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||
Number of shares of common stock authorized issuance reduced | shares | 766,500 | ||||||||
Common stock, shares authorized for issuance | shares | 874,955 | 874,955 | |||||||
2014 Stock Incentive Plan Under Evergreen Provision [Member] | |||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||
Number of shares of common stock authorized issuance reduced | shares | 550,000 | ||||||||
2014 Employee Stock Purchase Plan [Member] | |||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||
Common stock, shares authorized for issuance | shares | 303,721 | 303,721 | 209,500 | ||||||
2014 Employee Stock Purchase Plan Under Evergreen Provision [Member] | Maximum [Member] | |||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||
Common stock, shares authorized for issuance | shares | 135,000 | ||||||||
Subsequent Events [Member] | |||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||
Closing bid price per NASDAQ listing notification letter | $ / shares | $ 1 | ||||||||
Consecutive business days for closing bid price of common stock | 30 days | ||||||||
Stock market granted additional calendar days | 180 days | ||||||||
Closing bid price of common stock per NASDAQ listing notification letter | $ / shares | $ 1 | ||||||||
Number of consecutive business days required to regain compliance | 10 days | ||||||||
Securities Purchase Agreement [Member] | |||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||
Gross proceeds from direct offering | $ 10,700,000 | ||||||||
Otic Pharma [Member] | |||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||
Ownership percentage | 100.00% | 100.00% | |||||||
Otic Pharma, Inc. [Member] | |||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||
Ownership percentage | 100.00% | 100.00% |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Schedule of Common Share Equivalents Included from Computation of Net Loss Per Share (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Earnings Per Share [Abstract] | ||||
Net loss used in the calculation of basic and diluted loss per share | $ (4,093) | $ (3,189) | $ (8,974) | $ (5,995) |
Net loss per share, basic and diluted | $ (0.35) | $ (0.34) | $ (0.85) | $ (0.70) |
Weighted-average number of common shares, basic and diluted | 11,751,110 | 9,407,024 | 10,595,511 | 8,582,723 |
Prepaid Expenses and Other Cu_3
Prepaid Expenses and Other Current Assets - Prepaid Expenses and Other Assets (Detail) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Prepaid Expense And Other Assets Current [Abstract] | ||
Prepaid insurance | $ 396 | $ 413 |
Prepaid other | 265 | 261 |
Insurance receivable | 739 | 583 |
Other current assets | 78 | 47 |
Total prepaid expenses and other current assets | $ 1,478 | $ 1,304 |
Accrued Expenses and Other Li_3
Accrued Expenses and Other Liabilities - Schedule of Accrued Expenses and Other Liabilities (Detail) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Accrued Liabilities And Other Liabilities [Abstract] | ||
Accrued clinical | $ 419 | $ 735 |
Accrued compensation and related expenses | 238 | 194 |
Accrued vacation | 200 | 160 |
Accrued professional services | 149 | 742 |
Accrued other | 16 | 14 |
Total accrued expenses and other liabilities | $ 1,022 | $ 1,845 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||||||
Mar. 31, 2019USD ($) | Apr. 30, 2018 | Dec. 31, 2015USD ($) | Nov. 30, 2015USD ($)shares | Sep. 30, 2015ft² | Jun. 30, 2019USD ($)Milestone | Jun. 30, 2018USD ($) | Jun. 30, 2019USD ($) | Jun. 30, 2018USD ($) | Dec. 31, 2018Milestone | |
Other Commitments [Line Items] | ||||||||||
Rental expense | $ 47,000 | $ 42,000 | $ 95,000 | $ 84,000 | ||||||
Remaining term of office lease | 2 years 3 months | |||||||||
Debt outstanding | $ 0 | $ 0 | ||||||||
Number of milestones achieved | Milestone | 0 | 0 | ||||||||
Milestone payment | $ 300,000 | |||||||||
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] | ||||||||||
License fees paid | $ 750,000 | |||||||||
Share issued as consideration | shares | 9,780 | |||||||||
Three-year Operating Lease [Member] | ||||||||||
Other Commitments [Line Items] | ||||||||||
Operating lease expiration term | 3 years | |||||||||
Area of office space | ft² | 5,197 | |||||||||
Leases expiration date | Aug. 31, 2018 | |||||||||
Leases extension date | Sep. 30, 2021 |
Commitments and Contingencies_2
Commitments and Contingencies - Components of Lease Expense (Detail) $ in Thousands | 6 Months Ended |
Jun. 30, 2019USD ($) | |
Commitments And Contingencies Disclosure [Abstract] | |
Operating lease cost | $ 97 |
Commitments and Contingencies_3
Commitments and Contingencies - Schedule of Other Information Related to Leases (Detail) $ in Thousands | 6 Months Ended |
Jun. 30, 2019USD ($) | |
Cash paid for amounts included in the measurement of lease liability: | |
Operating cash flows from operating lease | $ 89 |
Operating lease asset obtained in exchange for lease obligation: | |
Operating lease | $ 489 |
Remaining lease term | |
Operating lease | 2 years 3 months |
Discount rate | |
Operating lease | 3.25% |
Commitments and Contingencies_4
Commitments and Contingencies - Schedule of Future Payments Under Noncancelable Extended Operating Leases (Detail) $ in Thousands | Jun. 30, 2019USD ($) |
Commitments And Contingencies Disclosure [Abstract] | |
2019 (remainder of) | $ 91 |
2020 | 188 |
2021 | 146 |
Total minimum lease payments | 425 |
Less imputed interest | (16) |
Present value of lease liabilities | $ 409 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) | 6 Months Ended | 12 Months Ended |
Jun. 30, 2019 | Dec. 31, 2018 | |
Tax Credit Carryforward [Line Items] | ||
Federal Income tax rate | 21.00% | 21.00% |
Israeli Tax Authority [Member] | Foreign Country [Member] | ||
Tax Credit Carryforward [Line Items] | ||
Income tax rate | 23.00% | 23.00% |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Detail) - USD ($) | Apr. 30, 2019 | Jun. 30, 2019 | Jun. 30, 2019 | Jun. 30, 2018 | Jul. 23, 2018 |
Class Of Stock [Line Items] | |||||
Proceeds from issuance of common stock | $ 9,676,000 | $ 7,491,000 | |||
PRSUs [Member] | |||||
Class Of Stock [Line Items] | |||||
Number of shares vested | 78,450 | ||||
Value of shares vested | $ 379,000 | ||||
Securities Purchase Agreement [Member] | |||||
Class Of Stock [Line Items] | |||||
Common stock shares agreed to sell, gross proceeds value | $ 10,700,000 | ||||
Securities Purchase Agreement [Member] | 2019 Equity Offering [Member] | |||||
Class Of Stock [Line Items] | |||||
Common stock shares agreed to sell | 3,449,112 | ||||
Common stock shares agreed to sell, gross proceeds value | $ 10,700,000 | ||||
Private Placement [Member] | Series A Warrants [Member] | 2019 Equity Offering [Member] | |||||
Class Of Stock [Line Items] | |||||
Warrant exercise price per share | $ 4 | ||||
Warrants exercisable term | 18 months | ||||
Private Placement [Member] | Series B Warrants [Member] | 2019 Equity Offering [Member] | |||||
Class Of Stock [Line Items] | |||||
Warrant exercise price per share | $ 4 | ||||
Warrants exercisable term | 5 years | ||||
Placement Agent [Member] | 2019 Equity Offering [Member] | |||||
Class Of Stock [Line Items] | |||||
Warrant exercise price per share | $ 3.87 | ||||
Percentage of warrants to issue shares of common stock | 5.00% | ||||
Percentage of warrant exercise price per share | 125.00% | ||||
Warrants offering price maturity date | Apr. 30, 2024 | ||||
Common Stock [Member] | |||||
Class Of Stock [Line Items] | |||||
Number of shares vested | 78,450 | 78,450 | |||
Common Stock [Member] | Private Placement [Member] | Series A Warrants [Member] | Maximum [Member] | 2019 Equity Offering [Member] | |||||
Class Of Stock [Line Items] | |||||
Warrants to issue shares of common stock | 3,449,112 | ||||
Common Stock [Member] | Private Placement [Member] | Series B Warrants [Member] | Maximum [Member] | 2019 Equity Offering [Member] | |||||
Class Of Stock [Line Items] | |||||
Warrants to issue shares of common stock | 3,449,112 | ||||
Common Stock [Member] | Placement Agent [Member] | Maximum [Member] | 2019 Equity Offering [Member] | |||||
Class Of Stock [Line Items] | |||||
Warrants to issue shares of common stock | 172,456 | ||||
Piper Jaffray & Co. [Member] | Equity Distribution Agreement and 2018 Prospectus [Member] | |||||
Class Of Stock [Line Items] | |||||
Equity distribution agreement maximum value of common shares issuable | $ 9,800,000 | ||||
Piper Jaffray & Co. [Member] | Equity Distribution Agreement and 2018 Prospectus [Member] | Common Stock [Member] | |||||
Class Of Stock [Line Items] | |||||
Common stock number of shares issued | 25,218 | ||||
Proceeds from issuance of common stock | $ 110,000 |
Stockholders' Equity - Schedule
Stockholders' Equity - Schedule of Stock-Based Compensation Expense Recognized (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Stock-based compensation | $ 626 | $ 404 | $ 838 | $ 565 |
Research and Development [Member] | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Stock-based compensation | 186 | 45 | 222 | 75 |
General and Administrative [Member] | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Stock-based compensation | $ 440 | $ 359 | $ 616 | $ 490 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Detail) - Subsequent Events [Member] | Aug. 08, 2019$ / shares |
Subsequent Event [Line Items] | |
Closing bid price per NASDAQ listing notification letter | $ 1 |
Consecutive business days for closing bid price of common stock | 30 days |
Stock market granted additional calendar days | 180 days |
Closing bid price of common stock per NASDAQ listing notification letter | $ 1 |
Number of consecutive business days required to regain compliance | 10 days |