Document And Entity Information
Document And Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Feb. 22, 2019 | Jun. 30, 2018 | |
Document Information [Line Items] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2018 | ||
Document Fiscal Year Focus | 2,018 | ||
Document Fiscal Period Focus | FY | ||
Entity Registrant Name | Cellectar Biosciences, Inc. | ||
Entity Central Index Key | 1,279,704 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Public Float | $ 10,374,683 | ||
Trading Symbol | CLRB | ||
Entity Common Stock, Shares Outstanding | 4,757,709 | ||
Entity Shell Company | false | ||
Entity Emerging Growth Company | false | ||
Entity Small Business | true |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
CURRENT ASSETS: | ||
Cash and cash equivalents | $ 13,255,616 | $ 10,006,421 |
Restricted cash | 55,000 | 55,000 |
Prepaid expenses and other current assets | 641,218 | 412,173 |
Total current assets | 13,951,834 | 10,473,594 |
Fixed assets, net | 543,339 | 244,713 |
Goodwill | 0 | 1,675,462 |
Long-term assets | 540,823 | 465,823 |
Other assets | 18,086 | 11,872 |
TOTAL ASSETS | 15,054,082 | 12,871,464 |
CURRENT LIABILITIES: | ||
Accounts payable and accrued liabilities | 1,543,819 | 1,867,758 |
Derivative liability | 43,000 | 105,050 |
Capital lease obligations, current portion | 2,213 | 3,036 |
Deferred rent | 33,090 | 138,944 |
Total current liabilities | 1,622,122 | 2,114,788 |
LONG-TERM LIABILITIES: | ||
Capital lease obligation, less current portion | 0 | 2,213 |
Deferred rent, less current portion | 170,999 | 0 |
Total long-term liabilities | 170,999 | 2,213 |
TOTAL LIABILITIES | 1,793,121 | 2,117,001 |
COMMITMENTS AND CONTINGENCIES (Note 12) | ||
STOCKHOLDERS' EQUITY: | ||
Common stock, $0.00001 par value; 80,000,000 shares authorized; 4,732,387 and 1,666,144 shares issued and outstanding at December 31, 2018 and 2017, respectively | 47 | 16 |
Additional paid-in capital | 108,323,208 | 94,107,981 |
Accumulated deficit | (97,588,343) | (84,349,316) |
Total stockholders' equity | 13,260,961 | 10,754,463 |
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | 15,054,082 | 12,871,464 |
Series B Preferred Stock [Member] | ||
STOCKHOLDERS' EQUITY: | ||
Preferred Stock Value | 0 | 995,782 |
Series C Preferred Stock [Member] | ||
STOCKHOLDERS' EQUITY: | ||
Preferred Stock Value | $ 2,526,049 | $ 0 |
CONSOLIDATED BALANCE SHEETS _Pa
CONSOLIDATED BALANCE SHEETS [Parenthetical] - $ / shares | Dec. 31, 2018 | Dec. 31, 2017 |
Preferred stock, par value (in dollars per share) | $ 0.00001 | $ 0.00001 |
Preferred stock, shares authorized | 7,000 | 7,000 |
Common stock, par value (in dollars per share) | $ 0.00001 | $ 0.00001 |
Common stock, shares authorized | 80,000,000 | 80,000,000 |
Common stock, shares issued | 4,732,387 | 1,666,144 |
Common stock, shares outstanding | 4,732,387 | 1,666,144 |
Series B Preferred Stock [Member] | ||
Preferred stock, issued | 0 | 18 |
Preferred stock, outstanding | 0 | 18 |
Series C Preferred Stock [Member] | ||
Preferred stock, issued | 473 | 0 |
Preferred stock, outstanding | 473 | 0 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
COSTS AND EXPENSES: | ||
Research and development | $ 6,835,229 | $ 9,465,666 |
General and administrative | 4,820,073 | 4,135,304 |
Impairment of goodwill | 1,675,462 | 0 |
Total costs and expenses | 13,330,764 | 13,600,970 |
LOSS FROM OPERATIONS | (13,330,764) | (13,600,970) |
OTHER INCOME: | ||
Gain on revaluation of derivative warrants | 62,050 | 22,075 |
Interest income, net | 29,687 | 16,605 |
Total other income, net | 91,737 | 38,680 |
NET LOSS | (13,239,027) | (13,562,290) |
DEEMED DIVIDEND ON PREFERRED STOCK | (2,241,795) | (1,448,945) |
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS | $ (15,480,822) | $ (15,011,235) |
BASIC AND DILUTED NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS PER COMMON SHARE | $ (5.23) | $ (10.70) |
SHARES USED IN COMPUTING BASIC AND DILUTED NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS PER COMMON SHARE | 2,961,972 | 1,403,132 |
CONSOLIDATED STATEMENTS OF STOC
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) | Total | Preferred Stock [Member] | Common Stock [Member] | Additional Paid-In Capital [Member] | Accumulated Deficit [Member] |
BALANCE AT DECEMBER at Dec. 31, 2016 | $ 13,539,872 | $ 865,136 | $ 10 | $ 83,461,752 | $ (70,787,026) |
BALANCE AT DECEMBER (in shares) at Dec. 31, 2016 | 17 | 1,036,832 | |||
Issuance of common stock, warrants and preferred stock, net of issuance costs | 7,054,865 | $ 2,265,257 | $ 2 | 4,789,606 | 0 |
Issuance of common stock, warrants and preferred stock, net of issuance costs (in shares) | 41 | 195,438 | |||
Warrant exercises | 2,963,259 | $ 0 | $ 2 | 2,963,257 | 0 |
Warrant exercises (in shares) | 0 | 197,550 | |||
Stock-based compensation | 758,757 | $ 0 | $ 0 | 758,757 | 0 |
Cashless option exercise | 0 | $ 0 | $ 0 | 0 | 0 |
Cashless option exercise (in shares) | 0 | 240 | |||
Conversion of preferred shares into common shares | 0 | $ (2,134,611) | $ 2 | 2,134,609 | 0 |
Conversion of preferred shares into common shares (in shares) | (40) | 236,084 | |||
Net loss | (13,562,290) | $ 0 | $ 0 | 0 | (13,562,290) |
BALANCE AT DECEMBER at Dec. 31, 2017 | 10,754,463 | $ 995,782 | $ 16 | 94,107,981 | (84,349,316) |
BALANCE AT DECEMBER (in shares) at Dec. 31, 2017 | 18 | 1,666,144 | |||
Issuance of common stock, warrants and preferred stock, net of issuance costs | 15,025,078 | $ 5,949,301 | $ 14 | 9,075,763 | 0 |
Issuance of common stock, warrants and preferred stock, net of issuance costs (in shares) | 1,114 | 1,355,000 | |||
Stock-based compensation | 721,209 | $ 0 | $ 0 | 721,209 | 0 |
Vested restricted stock | 0 | $ 0 | $ 0 | 0 | 0 |
Vested restricted stock (in shares) | 0 | 12,667 | |||
Reverse stock split fractional shares | (762) | $ 0 | $ 0 | (762) | 0 |
Reverse stock split fractional shares (in shares) | 0 | (105) | |||
Retired shares | 0 | $ 0 | $ 0 | 0 | 0 |
Retired shares (in shares) | 0 | (104) | |||
Conversion of preferred shares into common shares | 0 | $ (4,419,034) | $ 17 | 4,419,017 | 0 |
Conversion of preferred shares into common shares (in shares) | (659) | 1,698,785 | |||
Net loss | (13,239,027) | $ 0 | $ 0 | 0 | (13,239,027) |
BALANCE AT DECEMBER at Dec. 31, 2018 | $ 13,260,961 | $ 2,526,049 | $ 47 | $ 108,323,208 | $ (97,588,343) |
BALANCE AT DECEMBER (in shares) at Dec. 31, 2018 | 473 | 4,732,387 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (13,239,027) | $ (13,562,290) |
Adjustments to reconcile net loss to cash used in operating activities: | ||
Depreciation and amortization | 82,265 | 1,546,048 |
Stock-based compensation | 721,209 | 758,757 |
Impairment of goodwill | 1,675,462 | 0 |
Gain on revaluation of derivative warrants | (62,050) | (22,075) |
Gain on disposal of fixed assets | (50,898) | 0 |
Changes in: | ||
Prepaid expenses and other current assets | (229,045) | 281,396 |
Accounts payable and accrued liabilities | (258,794) | 451,325 |
Other assets | (81,214) | (473,462) |
Cash used in operating activities | (11,442,092) | (11,020,301) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchases of fixed assets | (384,993) | (346,703) |
Proceeds from sale of fixed assets | 55,000 | 0 |
Cash used in investing activities | (329,993) | (346,703) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Payments on capital lease obligations | (3,036) | (2,727) |
Reverse stock split fractional shares | (762) | 0 |
Proceeds from issuance of common stock, net of underwriting issuance costs | 9,075,777 | 4,905,945 |
Proceeds from issuance of preferred stock | 5,949,301 | 2,265,257 |
Change in deferred issuance costs | 0 | (116,337) |
Proceeds from conversion of warrants | 0 | 2,963,259 |
Payments on long-term obligations | 0 | (86,591) |
Cash provided by financing activities | 15,021,280 | 9,928,806 |
INCREASE (DECREASE) IN CASH, CASH EQUIVALENTS, AND RESTRICTED CASH | 3,249,195 | (1,438,198) |
CASH, CASH EQUIVALENTS, AND RESTRICTED CASH AT BEGINNING OF PERIOD | 10,061,421 | 11,499,619 |
CASH, CASH EQUIVALENTS, AND RESTRICTED CASH AT END OF PERIOD | 13,310,616 | 10,061,421 |
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION | ||
Cash paid for interest expense | 0 | 364 |
Beneficial conversion feature and related deemed dividend on preferred stock | $ 2,241,795 | $ 1,448,945 |
NATURE OF BUSINESS, ORGANIZATIO
NATURE OF BUSINESS, ORGANIZATION AND GOING CONCERN | 12 Months Ended |
Dec. 31, 2018 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature Of Business Organization and Going Concern Disclosure [Text Block] | 1. NATURE OF BUSINESS, ORGANIZATION AND GOING CONCERN Cellectar Biosciences, Inc. (the Company) is a clinical stage biopharmaceutical company focused on the development of targeted treatments for cancer and leveraging its proprietary phospholipid drug conjugate (PDC™) platform to develop the next generation of tumor targeting treatments. The Company is subject to a number of risks similar to those of other small pharmaceutical companies. Principal among these risks are dependence on key individuals, competition from substitute products and larger companies, the successful development and marketing of its products in a highly regulated environment and the need to obtain additional financing necessary to fund future operations. The accompanying financial statements have been prepared on a basis that assumes that the Company will continue as a going concern and that contemplates the continuity of operations, realization of assets and the satisfaction of liabilities and commitments in the normal course of business. The Company has incurred losses since inception in devoting substantially all of its efforts toward research and development and has an accumulated deficit of approximately $97,588,000 at December 31, 2018. During the year ended December 31, 2018 the Company generated a net loss of approximately $13,239,000 and the Company expects that it will continue to generate operating losses for the foreseeable future. These conditions raise substantial doubt about the Company’s ability to continue as a going concern. The Company believes that its cash balance at December 31, 2018 is adequate to fund operations at budgeted levels into first quarter 2020. The Company’s ability to execute its operating plan beyond first quarter 2020 depends on its ability to obtain additional funding via the sale of equity and/or debt securities, a strategic transaction or otherwise. The Company plans to continue to actively pursue financing alternatives, but there can be no assurance that it will obtain the necessary funding, raising substantial doubt about the Company’s ability to continue as a going concern within one year of the date these financial statements are issued. The accompanying financial statements do not include any adjustments that might result from the outcome of this uncertainty. |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Significant Accounting Policies [Text Block] | 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES The accompanying consolidated financial statements reflect the application of certain accounting policies, as described in this note and elsewhere in the accompanying notes to the consolidated financial statements. The consolidated financial statements as of and for the twelve months ended December 31, 2018 are presented on a consolidated basis. Principles of Consolidation — The consolidated financial statements include the accounts of the Company and the accounts of its wholly-owned subsidiary. All inter-company accounts and transactions have been eliminated in consolidation. Use of Estimates — The preparation of financial statements in conformity with accounting principles generally accepted in the U.S. requires management to make estimates and judgments that may affect the reported amounts of assets, liabilities, revenue and expenses and disclosure of contingent assets and liabilities. On an on-going basis, management evaluates its estimates including those related to unbilled vendor amounts, share-based compensation and derivative liability valuation. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities. Actual results may differ from those estimates under different assumptions or conditions. Changes in estimates are reflected in reported results in the period in which they become known. Reclassifications — Certain prior year amounts have been reclassified for consistency with the current year presentation. These reclassifications had no effect on the reported results of operations. An adjustment has been made to the Consolidated Statements of Cash Flows for fiscal year ended December 31, 2017, to identify the long-term other assets of approximately $466,000. This change in classification does not affect previously reported cash flows from operating activities in the Consolidated Statements of Cash Flows. Cash and Cash Equivalents — All short-term investments purchased with original maturities of three months or less are considered to be cash equivalents. Restricted Cash — The Company accounts for cash and claims to cash that are committed for other than current operations as restricted cash. Restricted cash at December 31, 2018 and 2017 consists of a certificate of deposit of $55,000 required under the Company’s lease agreement for its Madison, Wisconsin facility (see Note 12). Fixed Assets — Property and equipment are stated at cost. Depreciation on property and equipment is provided using the straight-line method over the estimated useful lives of the assets (3 to 10 years). Due to the significant value of leasehold improvements purchased, leasehold improvements are depreciated over 64 months (their estimated useful life), which represents the full term of the lease. Our only long-lived assets are property and equipment. The Company periodically evaluates long-lived assets for potential impairment. Whenever events or circumstances change, an assessment is made as to whether there has been impairment to the value of long-lived assets by determining whether projected undiscounted cash flows generated by the applicable asset exceed its net book value as of the assessment date. There were no long-lived asset impairment charges recorded during the years ended December 31, 2018 or 2017. (see Note 5) In December 2017, the Company concluded that the manufacturing processes would be transferred to a third party. As part of the transfer, the Company also began the process of de-commissioning the manufacturing facility. In connection with the de-commissioning, the Company determined that certain research and development assets will no longer be used by the Company and had materially ceased being used by December 31, 2017. As a result, the Company reassessed the estimated useful life of the research and development assets and concluded they should be accelerated beginning on December 1, 2017 through December 31, 2017 (one month remaining life). The Company also reassessed the estimated useful life of the leasehold improvements and concluded that they should be accelerated beginning on December 1, 2017 through December 31, 2017 (one month remaining life). These reassessments of the estimated useful lives have been accounted for as changes in an estimate. Goodwill —Goodwill is not amortized but is required to be evaluated for impairment annually or whenever events or changes in circumstances suggest that the carrying value of an asset may not be recoverable. The Company evaluates goodwill for impairment annually in the fourth fiscal quarter and additionally on an interim basis if an event occurs or there is a change in circumstances, such as a significant decline in the Company’s stock price or a material adverse change in the business climate, which would more likely than not reduce the fair value of the reporting unit below its carrying amount (see Note 4). In January 2017, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2017-04, Simplifying the Test for Goodwill. The standard streamlines the methodology for calculating whether goodwill is impaired based upon whether the carrying amount of goodwill exceeds the reporting unit’s fair value. ASU 2017-04 applies to public business entities and those other entities that have goodwill reported in their financial statements and have not elected the private company alternative for the subsequent measurement of goodwill and is effective for annual and interim reporting periods beginning after December 15, 2019, with early adoption permitted. The Company adopted ASU No. 2017-04 during the year ended December 31, 2018. Stock-Based Compensation — The Company uses the Black-Scholes option-pricing model to calculate the grant-date fair value of stock option awards. The resulting compensation expense, net of expected forfeitures, for awards that are not performance-based is recognized on a straight-line basis over the service period of the award, which for grants issued in 2018 ranged from seven months to three years for stock options. For stock options with performance-based vesting provisions, recognition of compensation expense, net of expected forfeitures, commences if and when the achievement of the performance criteria is deemed probable. The compensation expense, net of expected forfeitures, for performance-based stock options is recognized over the relevant performance period. Non-employee stock-based compensation is accounted for in accordance with the guidance of FASB Accounting Standards Codification (“ASC”) Topic 505, Equity. As such, the Company recognizes expense based on the estimated fair value of options granted to non-employees over their vesting period, which is generally the period during which services are rendered and deemed completed by such non-employees. Research and Development — Research and development costs are expensed as incurred. To the extent that such costs are reimbursed by the federal government on a fixed price, best efforts basis and the federal government is the sole customer for such research and development, the funding is recognized as a reduction of research and development expenses. Income Taxes — Income taxes are accounted for using the liability method of accounting. Under this method, deferred tax assets and liabilities are determined based on temporary differences between the financial statement basis and tax basis of assets and liabilities and net operating loss and credit carryforwards using enacted tax rates in effect for the year in which the differences are expected to reverse. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. Valuation allowances are established when it is more likely than not that some portion of the deferred tax assets will not be realized. Management has provided a full valuation allowance against the Company’s gross deferred tax asset. Tax positions taken or expected to be taken in the course of preparing tax returns are required to be evaluated to determine whether the tax positions are “more likely than not” to be sustained by the applicable tax authority. Tax positions deemed not to meet a more-likely-than-not threshold would be recorded as tax expense in the current year. There were no uncertain tax positions that require accrual to or disclosure in the financial statements as of December 31, 2018 and 2017. Fair Value of Financial Instruments — The guidance under FASB ASC Topic 825, Financial Instruments , requires disclosure of the fair value of certain financial instruments. Financial instruments in the accompanying financial statements consist of cash equivalents, prepaid expenses and other assets, accounts payable and long-term obligations. The carrying amount of cash equivalents, and accounts payable approximate their fair value due to their short-term nature. The carrying value of long-term obligations, including the current portion, approximates fair value because the fixed interest rate approximates current market rates of interest available in the market. Derivative Instruments — The Company generally does not use derivative instruments to hedge exposures to cash flow or market risks; however, certain warrants to purchase common stock that do not meet the requirements for classification as equity, in accordance with the Derivatives and Hedging Topic of the FASB ASC, are classified as liabilities. In such instances, net-cash settlement is assumed for financial reporting purposes, even when the terms of the underlying contracts do not provide for a net-cash settlement. These warrants are considered derivative instruments because the agreements contain a certain type of cash settlement feature, contain “down-round” provisions whereby the number of shares for which the warrants are exercisable, and/or the exercise price of the warrants are subject to change in the event of certain issuances of stock at prices below the then-effective exercise price of the warrants. The number of shares issuable under such warrants was 49,425 at December 31, 2018 and 2017, respectively. The primary underlying risk exposures pertaining to the warrants and their related fair value is the change in fair value of the underlying common stock, the market price of traded warrants, and estimated timing and probability of future financings. Such financial instruments are initially recorded at fair value with subsequent changes in fair value recorded as a component of gain or loss on derivatives on the consolidated statements of operations in each reporting period. If these instruments subsequently meet the requirements for equity classification, the Company reclassifies the fair value to equity. At December 31, 2018 and 2017, these warrants represented the only outstanding derivative instruments issued or held by the Company. Concentration of Credit Risk — Financial instruments that subject the Company to credit risk consist of cash and equivalents on deposit with financial institutions. The Company’s excess cash as of December 31, 2018 and 2017 is on deposit in interest-bearing transaction accounts with well-established financial institutions. At times, such amounts may exceed the FDIC insurance limits. As of December 31, 2018, uninsured cash balances totaled approximately $12,800,000. Leases — In February 2016, the FASB issued Accounting Standards Update (“ASU”) 2016-02, Leases (Topic 842) which supersedes FASB ASC Topic 840, Leases (Topic 840) and provides principles for the recognition, measurement, presentation and disclosure of leases for both lessees and lessors. The new standard requires lessees to apply a dual approach, classifying leases as either finance or operating leases based on the principle of whether or not the lease is effectively a financed purchase by the lessee. This classification will determine whether lease expense is recognized based on an effective interest method or on a straight-line basis over the term of the lease, respectively. A lessee is also required to record a right-of-use asset and a lease liability for all leases with a term of greater than twelve months regardless of classification. Leases with a term of twelve months or less will be accounted for similar to existing guidance for operating leases. The standard is effective for annual and interim periods beginning after December 15, 2018, with early adoption permitted upon issuance. The Company will elect the transition method to initially apply ASU 2016-02 transition provisions at the effective date (i.e., 1 January 2019) recognizing any adjustment that results from applying the ASU 2016-02 transition requirements as a cumulative-effect adjustment to the opening balance of retained earnings in the period of adoption and not restating comparative periods presented. The Company believes the impact on its balance sheet of adopting ASU 2016-02 on January 1, 2019, the date of transition, will be to record a right-of use asset and a lease liability. Recent Accounting Pronouncements - I n July 2017, the FASB issued ASU No. 2017-11, Earnings Per Share (Topic 260), Distinguishing Liabilities from Equity (Topic 480), Derivatives and Hedging (Topic 815). The amendments in Part I of this Update change the classification analysis of certain equity-linked financial instruments (or embedded features) with down round features. When determining whether certain financial instruments should be classified as liabilities or equity instruments, a down round feature no longer precludes equity classification when assessing whether the instrument is indexed to an entity’s own stock. The amendments also clarify existing disclosure requirements for equity-classified instruments. As a result, a freestanding equity-linked financial instrument (or embedded conversion option) no longer would be accounted for as a derivative liability at fair value as a result of the existence of a down round feature. The standard is effective for annual and interim periods beginning after December 15, 2018, with early adoption permitted upon issuance. The Company believes the impact of adopting ASU 2017-11 will not have a material impact on its results of operations, cash flows and financial position. |
FAIR VALUE
FAIR VALUE | 12 Months Ended |
Dec. 31, 2018 | |
Fair Value Disclosures [Abstract] | |
Fair Value Disclosures [Text Block] | 3. FAIR VALUE In accordance with Fair Value Measurements and Disclosures Topic of the FASB ASC 820, the Company groups its financial assets and financial liabilities generally measured at fair value in three levels, based on the markets in which the assets and liabilities are traded and the reliability of the assumptions used to determine fair value. Level 1: Input prices quoted in an active market for identical financial assets or liabilities. Level 2: Inputs other than prices quoted in Level 1, such as prices quoted for similar financial assets and liabilities in active markets, prices for identical assets, and liabilities in markets that are not active or other inputs that are observable or can be corroborated by observable market data. Level 3: Input prices quoted that are significant to the fair value of the financial assets or liabilities which are not observable or supported by an active market. To the extent that the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. The Company issued warrants to purchase an aggregate of 8,250 shares of common stock in a February 2013 public offering (the “February 2013 Public Offering Warrants”). On February 20, 2014, warrants to purchase 2,750 of common stock expired. On May 20, 2016, warrants to purchase 1,625 shares of common stock were exercised. The remaining warrants to purchase 3,875 expired on February 20, 2018. In August 2014, as part of an underwritten public offering, the Company issued warrants to purchase 49,425 shares of common stock (the “August 2014 Warrants”). The August 2014 Warrants are listed on the NASDAQ Capital Market under the symbol “CLRBW,” however, there are certain periods where trading volume is low; therefore, they are classified as Level 2 within the hierarchy. The following tables set forth the Company’s financial instruments carried at fair value using the lowest level of input applicable to each financial instrument as of December 31, 2018 and 2017: December 31, 2018 Level 1 Level 2 Level 3 Fair Value Liabilities: August 2014 Warrants $ — $ 43,000 — $ 43,000 Total $ — $ 43,000 $ — $ 43,000 December 31, 2017 Level 1 Level 2 Level 3 Fair Value Liabilities: February 2013 Public Offering Warrants $ — $ — $ 5,050 $ 5,050 August 2014 Warrants — 100,000 — 100,000 Total $ — $ 100,000 $ 5,050 $ 105,050 In order to estimate the value of the February 2013 Public Offering Warrants considered to be derivative instruments, the Company used a modified option-pricing model together with assumptions that consider, among other variables, the fair value of the underlying stock, risk-free interest rates, volatility, the contractual term of the warrants, future financing requirements and dividend rates. The future financing estimates were based on the Company’s estimates of anticipated cash requirements over the term of the warrants as well as the frequency of required financings based on its assessment of its historical financing trends and anticipated future events. Due to the nature of these inputs and the valuation technique utilized, these warrants were classified within the Level 3 hierarchy and expired in February 2018. The following table summarizes the modified option-pricing assumptions used: Year Ended December 31, 2018 2017 Volatility N/A 76-118 % Risk-free interest rate N/A 1.03-1.39 % Expected life (years) N/A 0.14-0.89 Dividend N/A 0 % The following table summarizes the changes in the fair market value of the Company’s warrants which are classified within the Level 3 fair value hierarchy. Year Ended December 31, 2018 2017 Beginning fair value of warrants $ 5,050 $ 27,125 Gain on derivatives resulting from change in fair value or extinguishment (5,050 ) (22,075 ) Ending fair value of warrants $ — $ 5,050 To estimate the fair value of the August 2014 Warrants, the Company calculated the weighted average closing price for the trailing 10 trading day period that ended on the balance sheet date. |
GOODWILL
GOODWILL | 12 Months Ended |
Dec. 31, 2018 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Goodwill Disclosure [Text Block] | 4. GOODWILL Goodwill represents the excess of the purchase price of an acquired business over the fair value of the underlying net tangible and intangible assets. As of December 31, 2017, the Company had recorded goodwill of $1,675,462 associated with the acquisition of Cellectar, Inc. on April 8, 2011. The acquisition was accounted for using the purchase method of accounting as a reverse acquisition whereby Cellectar was the accounting acquirer and Novelos was the acquired company. The Company is required to perform an annual impairment test related to goodwill which is performed in the fourth quarter of each year, or sooner if changes in circumstances suggest that the carrying value of an asset may not be recoverable. For the December 31, 2018 goodwill impairment test the Company decided to bypass the qualitative assessment and proceeded to the first step of the goodwill impairment test. The first step of the goodwill impairment test compares the fair value of the reporting unit with its carrying amount. We used the Company’s market capitalization as of December 31, 2018 (Level 1 Input) to assess its fair value. Enterprise market capitalization was determined based on stock price and taking into consideration recent stock price trends. As of December 31, 2018, the Company’s carrying value of its net assets exceeded its market capitalization. The Company adopted ASU No, 2017-04 during the year ended December 31, 2018, therefore, no additional calculation was necessary. As a result of this test the Company’s total goodwill was determined to be impaired and an impairment charge of $1,675,462 was recorded for the year ended December 31, 2018. No impairment was deemed to exist at December 31, 2017. |
FIXED ASSETS
FIXED ASSETS | 12 Months Ended |
Dec. 31, 2018 | |
Property, Plant and Equipment [Abstract] | |
Property, Plant and Equipment Disclosure [Text Block] | 5. FIXED ASSETS Fixed assets consisted of the following at December 31: 2018 2017 Office and laboratory equipment $ 410,634 $ 3,751,059 Computer software 4,000 4,000 Leasehold improvements 309,897 2,333,443 Total fixed assets 724,531 6,088,502 Less– accumulated depreciation and amortization (181,192 ) (5,843,789 ) Fixed assets, net $ 543,339 $ 244,713 For the years ended December 31, 2018 and 2017, the Company incurred approximately $82,000 and $1,546,000 of depreciation and amortization expense, respectively. |
NOTES PAYABLE
NOTES PAYABLE | 12 Months Ended |
Dec. 31, 2018 | |
Debt Disclosure [Abstract] | |
Notes Payable Disclosure [Text Block] | 6. NOTES PAYABLE During the three months ended March 31, 2017, the two loans with initial principal amounts totaling $450,000 from the Wisconsin Economic Development Corporation, dated September 15, 2010, were paid in full. |
ACCRUED EXPENSES
ACCRUED EXPENSES | 12 Months Ended |
Dec. 31, 2018 | |
Payables and Accruals [Abstract] | |
Accounts Payable, Accrued Liabilities, and Other Liabilities Disclosure, Current [Text Block] | 7. ACCRUED EXPENSES Supply of CLR 131 Accounts payable and accrued liabilities approximately consist of the following: 2018 2017 Incentive compensation $ 408,000 $ 341,000 Accounts payable 612,000 933,000 Clinical costs 332,000 329,000 Professional fees 64,000 178,000 Insurance 69,000 — Other 59,000 87,000 $ 1,544,000 $ 1,868,000 |
STOCKHOLDERS' EQUITY
STOCKHOLDERS' EQUITY | 12 Months Ended |
Dec. 31, 2018 | |
Equity [Abstract] | |
Stockholders' Equity Note Disclosure [Text Block] | 8. STOCKHOLDERS’ EQUITY July 2018 Public Offering On July 31, 2018, the Company sold 1,355,000 shares of common stock, 1,114 shares of Series C Convertible Preferred Stock (the “Series C Preferred Stock”) convertible into 2,785,000 shares of common stock and Series E warrants to purchase 4,140,000 shares of common stock. The public offering price of a share of common stock together with a Series E warrant to purchase one share of common stock was $4.00. The public offering price of a share of Series C Preferred Stock, each of which is convertible into 2,500 shares of Common Stock, together with a Series E warrant to purchase 2,500 shares of common stock was $10,000. The Series E warrants have an exercise price of $4.00 per share and are exercisable until July 31, 2023. Gross offering proceeds to the Company were $16.56 million, with net proceeds to the Company of approximately $15.0 million after deducting underwriting discounts and commissions and related offering expenses. In order to account for the July 2018 public offering, the Company allocated the proceeds to the common stock, the Series C Preferred Stock and the Series E warrants on a relative fair value basis. Then using the effective conversion price of the Series C Preferred Stock, the Company determined that there was a beneficial conversion feature (“BCF”) of $2,241,795. The BCF did not impact total Stockholders’ Equity but is reflected as a deemed dividend in arriving at net loss attributable to common stockholders. The Series C Preferred Stock includes a beneficial ownership blocker but has no dividend rights (except to the extent that dividends are also paid on the common stock), liquidation preference or other preferences over common stock, and subject to limited exceptions, has no voting rights. As of December 31, 2018, 641 shares of Series C Preferred Stock were converted into 1,602,500 shares of common stock. Reverse Stock Split At a special meeting held on July 12, 2018, our stockholders approved an amendment to our certificate of incorporation to affect a reverse split of our common stock at a ratio between 1:5 to 1:10 and authorized the Board to determine the ratio at which the reverse split would be. The Board authorized the ratio of the reverse split, and effective at the close of business on July 16, 2018, the Company implemented a 1-for-10 reverse stock split of its outstanding common stock. The accompanying consolidated financial statements and accompanying notes to the consolidated financial statements give retroactive effect to the reverse stock split for all periods presented. The shares of common stock that the Company is authorized to issue remains unchanged at 80,000,000 and the par value remains at $0.00001 per share. Accordingly, stockholders’ equity reflects the reverse stock split by reclassifying from common stock to additional paid-in capital an amount equal to the par value of the decreased shares resulting from the reverse stock split. Authorized Share Increase At a special meeting held on September 12, 2017, the Company’s stockholders approved the ratification of the approval of the Certificate of Amendment to our Certificate of Incorporation to increase the number of authorized shares by 40,000,000 to 80,000,000 which was previously approved by the Company’s stockholders at our annual meeting of stockholders held on May 31, 2017. October 2017 Registered Direct Offering On October 12, 2017, the Company closed on a registered direct offering (the “October 2017 Registered Direct Offering”), priced at-the-market, of 195,438 shares of its common stock and 41.0412949 shares of its Series B Preferred Stock. The Series B Preferred Stock was offered at $100,000 per share and is immediately convertible into approximately 5,337 shares of common stock for a total of 219,037 shares upon conversion at a price of $18.7375 per share. The common stock was offered at $18.7375 per share. Gross offering proceeds to the Company were $7.76 million. In a concurrent private placement, the Company offered purchasers in the registered direct offering Series D warrants to purchase an aggregate of 310,856 shares of common stock, or 0.75 shares of common stock for each share of common stock purchased directly or issuable upon conversion of shares of preferred stock. The Series B Preferred Stock is non-voting, has no dividend rights (except to the extent dividends are also paid on common stock), liquidation preference, or other preferences over common stock. The Series D warrants are immediately exercisable at an exercise price of $17.80 per share and expire seven years from the closing. The Series D warrants, which are callable by the Company under certain circumstances, will not trade. Gross proceeds were approximately $7.8 million with net proceeds to the Company of approximately $7.1 million. In order to account for the October 2017 Registered Direct Offering, the Company allocated the proceeds to the common stock, the Series B Preferred Stock and the Series D warrants on a relative fair value basis. Then using the effective conversion price of the Series B Preferred Stock, the Company determined that there was a beneficial conversion feature of $1,448,945. On or prior to December 31, 2017, 23 shares of Series B Preferred Stock issued in the October 2017 Registered Direct Offering were converted into 122,751 shares of common stock. During the twelve months ended December 31, 2018 the remaining 18 shares of Series B Preferred Stock were converted into 96,284 shares of common stock. Common Stock Warrants The following table summarizes information with regard to outstanding warrants to purchase common stock as of December 31, 2018. Offering Number of Shares Issuable Upon Exercise of Outstanding Warrants Exercise Price Expiration Date July 2018 Series E Warrants 4,140,000 $ 4.00 July 31, 2023 October 2017 Series D Warrants 310,856 $ 17.80 October 14, 2024 November 2016 Public Offering Series C 415,785 $ 15.00 November 29, 2021 April 2016 Underwritten Registered Series A 362,694 $ 30.40 April 20,2021 October 2015 Incremental Series A 30,006 $ 21.30 October 20,2021 October 2015 Private Placement Series A 8,636 $ 21.30 April 1, 2021 October 2015 Offering – Placement Agent 375 $ 283.00 October 1, 2020 August 2014 Public Offering (1) 50,395 $ 468.00 August 20, 2019 Total 5,318,747 (1) These warrants have a certain type of cash settlement feature and they have been accounted for as derivative instruments as described in Note 1, with the exception of 970 warrants issued in August 2014. |
STOCK-BASED COMPENSATION
STOCK-BASED COMPENSATION | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Disclosure of Compensation Related Costs, Share-based Payments [Text Block] | 9. STOCK-BASED COMPENSATION Accounting for Stock-Based Compensation Increase in 2015 Stock Incentive Plan . At the 2018 annual meeting of stockholders held on May 31, 2018, the Company’s stockholders approved an increase in the number of shares of common stock available for issuance under our 2015 Stock Incentive Plan by 120,000 shares. 2015 Stock Incentive Plan. The 2015 Stock Incentive Plan was adopted on June 9, 2015 authorizing an aggregate of 42,000 shares for issuance (after taking into account the 2018 and 2016 10:1 reverse stock splits). On May 31, 2017, our stockholders approved the Amended and Restated 2015 Stock Incentive Plan (the “2015 Plan”) to increase the authorized shares by 120,000 shares. On May 31, 2018, our stockholders approved the Amended and Restated 2015 Stock Incentive Plan to increase the authorized shares by 120,000. A total of 282,000 shares of common stock are authorized for issuance under the 2015 Plan for grants of incentive or nonqualified stock options, rights to purchase restricted and unrestricted shares of common stock, stock appreciation rights and performance share grants. A committee of the board of directors determines exercise prices, vesting periods and any performance requirements on the date of grant, subject to the provisions of the Plan. Options are granted at or above the fair market value of the common stock at the grant date and expire on the tenth anniversary of the grant date. Vesting periods are generally between one and four years. Options granted pursuant to the Plan generally will become fully vested upon a termination event occurring within one year following a change in control, as defined. A termination event is defined as either termination of employment or services other than for cause or constructive termination of employees or consultants resulting from a significant reduction in either the nature or scope of duties and responsibilities, a reduction in compensation or a required relocation. Upon adoption of the 2015 Plan, shares were no longer available for grant under our 2006 Stock Incentive Plan (the “2006 Plan”). All outstanding awards under the 2006 Plan remained in effect according to the terms of the 2006 Plan and the respective agreements relating to such awards. In addition, any shares that are currently available under the 2006 Plan and any shares underlying awards under the 2006 Plan which are forfeited, cancelled, reacquired by the Company or otherwise terminated will be added to the number of shares available for grant under the 2015 Plan. As of December 31, 2018, there are an aggregate of 44,473 shares available for future grants under the 2015 Plan. 2006 Stock Option Plan. Prior to the approval of the 2015 Stock Incentive Plan, option grants to directors and employees were made under the 2006 Plan. A total of 7,000 shares of common stock were authorized for issuance under the 2006 Plan for grants of incentive or nonqualified stock options, rights to purchase restricted and unrestricted shares of common stock, stock appreciation rights and performance share grants. A committee of the board of directors determined exercise prices, vesting periods and any performance requirements on the date of grant, subject to the provisions of the 2006 Plan. Options were granted at or above the fair market value of the common stock at the grant date and expire on the tenth anniversary of the grant date. Vesting periods were generally between one and four years. Restricted Stock Grant s. During 2017, the Company issued 46,000 shares under the 2015 Plan of restricted common stock with a weighted average grant date fair value of $20.96. The shares vest annually over a three year period. The following table summarizes the restricted stock grants: Number of Shares Weighted Average Grant Date Fair Value Per Share Total Grant Date Fair Value Outstanding at December 31, 2016 — — — Granted 46,000 $ 20.96 $ 964,000 Vested — — — Forfeited (8,000 ) 21.00 (168,000 ) Outstanding at December 31, 2017 38,000 20.95 796,000 Granted — — — Vested (12,665 ) 20.95 (265,000 ) Forfeited (6,667 ) 20.80 (139,000 ) Outstanding at December 31, 2018 18,668 $ 21.00 $ 392,000 The following table summarizes amounts charged to expense for stock-based compensation related to employee and director stock option grants: Year Ended December 31, 2018 2017 Employee and director stock options and stock grants: Research and development $ 94,865 $ 147,821 General and administrative 626,344 610,936 Total stock-based compensation $ 721,209 $ 758,757 Assumptions Used In Determining Fair Value Valuation and amortization method . The fair value of each stock award is estimated on the grant date using the Black-Scholes option-pricing model. The estimated fair value of employee stock options is amortized to expense using the straight-line method over the required service period which is generally the vesting period. The estimated fair value of the non-employee options is amortized to expense over the period during which a non-employee is required to provide services for the award (usually the vesting period). Volatility. The Company estimates volatility based on an average of (1) the Company’s historical volatility since its common stock has been publicly traded and (2) review of volatility estimates of publicly held drug development companies with similar market capitalizations. Risk-free interest rate . The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the time of grant commensurate with the expected term assumption. Expected term . The expected term of stock options granted is based on an estimate of when options will be exercised in the future. The Company applied the simplified method of estimating the expected term of the options, as described in the SEC’s Staff Accounting Bulletins 107 and 110, as the historical experience is not indicative of the expected behavior in the future. The expected term, calculated under the simplified method, is applied to groups of stock options that have similar contractual terms. Using this method, the expected term is determined using the average of the vesting period and the contractual life of the stock options granted. The Company applied the simplified method to non-employees who have a truncation of term based on termination of service and utilizes the contractual life of the stock options granted for those non-employee grants which do not have a truncation of service. Forfeitures. The Company records stock-based compensation expense only for those awards that are expected to vest. A forfeiture rate is estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from initial estimates. An annual forfeiture rate of 2% was applied to all unvested options for employees and directors, respectively, during the periods ended December 31, 2018 and 2017. Ultimately, the actual expense recognized over the vesting period will be for only those shares that vest. The following table summarizes weighted-average values and assumptions used for options granted to employees, directors and consultants in the periods indicated: Year Ended December 31, 2018 2017 Volatility 91-106 % 107-110 % Risk-free interest rate 2.64-3.05 % 1.89-2.18 % Expected life (years) 6 6 Dividend 0 % 0 % Weighted-average exercise price $ 2.99 $ 1.91 Weighted-average grant-date fair value $ 2.30 $ 1.58 Stock Option Activity A summary of stock option activity is as follows: Number of Shares Issuable Upon Exercise of Outstanding Options Weighted Average Exercise Price Weighted Average Remaining Contracted Term in Years Aggregate Intrinsic Value Outstanding at December 31, 2016 47,133 $ 75.90 Granted 11,230 $ 19.10 Exercised (2,083 ) $ 14.80 Expired (201 ) $ 1,166.10 Forfeited (2,914 ) $ 14.80 Outstanding at December 31, 2017 53,165 $ 73.82 Granted 184,129 $ 2.99 Expired (2,344 ) $ 463.16 Forfeited (2,607 ) $ 19.46 Outstanding at December 31, 2018 232,343 $ 14.37 Exercisable, December 31, 2018 45,448 $ 51.97 7.85 $ — Unvested, December 31, 2018 186,895 $ 5.23 9.65 $ — Exercise prices for all grants made during the twelve months ended December 31, 2018 and 2017 were equal to or greater than the market value of the Company’s common stock on the date of grant. The aggregate intrinsic value of options outstanding is calculated based on the positive difference between the estimated per-share fair value of common stock at the end of the respective period and the exercise price of the underlying options. Shares of common stock issued upon the exercise of options are from authorized but unissued shares. The weighted-average grant-date fair value of options granted during the years ended December 31, 2018 and 2017 was $2.30 and $15.80, respectively. The total fair value of shares vested during the years ended December 31, 2018 and 2017 was $416,734 and $636,071, respectively. The weighted-average grant-date fair value of vested and unvested options outstanding at December 31, 2018 was $42.42 and $4.10, respectively. The weighted-average grant-date fair value of vested and unvested options outstanding at December 31, 2017 was $77.40 and $29.10, respectively. The weighted average grant date fair value of options expired during the years ended December 31, 2018 and December 31, 2017 was $191.38 and $611.20, respectively. The weighted average grant date fair value of options forfeited during the years ended December 31, 2018 and December 31, 2017 was $15.91 and $11.90, respectively. The number of options vested during the years ended December 31, 2018 and December 31, 2017 was 22,345 and 20,360, respectively. The number of options unvested at January 1, 2018 and January 1, 2017 was 27,718 and 39,742, respectively. The weighted average grant date fair value of options unvested at January 1, 2018 and January 1, 2017 was $29.13 and $32.70, respectively. As of December 31, 2018, there was $1,111,887 of total unrecognized compensation cost related to unvested stock-based compensation arrangements. Of this total amount, the Company expects to recognize $761,369, $233,413, and $117,105 during 2019, 2020, and 2021 respectively. The Company expects options to purchase 186,505 shares to vest in the future. |
INCOME TAXES
INCOME TAXES | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Income Tax Disclosure [Text Block] | 10. INCOME TAXES 2018 2017 Tax provision (benefit) Current Federal $ — $ — State — — Total current — — Deferred Federal (2,688,003 ) 13,626,404 State (45,138 ) 1,969,262 Total deferred (2,733,141 ) 15,595,666 Change in valuation allowance 2,733,141 (15,595,666 ) Total $ — $ — Deferred tax assets consisted of the following at December 31: 2018 2017 Deferred tax assets Federal net operating loss $ 26,562,715 $ 24,353,504 Federal research and development tax credit carryforwards 5,439,062 4,947,879 State net operating losses and tax credit carryforwards 1,589,926 1,589,927 Capitalized research and development expenses 5,959,275 5,772,165 Stock-based compensation expense 1,565,130 1,445,078 Depreciable assets — 166,793 Other 103,189 121,680 Total deferred tax assets 41,219,297 38,397,026 Deferred tax liabilities Depreciable assets (89,129 ) — Total deferred tax liabilities (89,129 ) — Net deferred tax assets 41,130,168 38,397,026 Less– valuation allowance (41,130,168 ) (38,397,026 ) Total deferred tax assets $ — $ — A reconciliation of income taxes computed using the U.S. federal statutory rate to that reflected in operations is as follows: Year ended December 31, 2018 2017 Income tax benefit using U.S. federal statutory rate (21.00 )% 34.00 % State income taxes (0.27 )% (9.58 )% Permanent items 2.56 % (2.55 )% Federal tax credits (3.44 )% 8.43 % Change in valuation allowance 20.65 % 115 % Federal rate change — % (143.50 )% Other 1.50 % (1.80 )% Total 0.00 % 0.00 % As of December 31, 2018, the Company had federal and state net operating loss carryforwards (“NOLs”) of approximately $126,489,000 and $15,862,000 respectively. in 2028 through 2031. In addition, the Company has federal and state research and development and orphan drug credits of approximately $5,403,000 and $805,000, respectively, which expire in 2019 through 2038 and in 2024 through 2033, respectively. The amount of NOLs and tax credit carryforwards which may be utilized annually in future periods will be limited pursuant to Section 382 of the Internal Revenue Code as a result of substantial changes in the Company’s ownership that have occurred or that may occur in the future. The Company has not quantified the amount of such limitations. Because of the Company’s continuing losses and uncertainty associated with the utilization of the deferred tax assets in the future, management has provided a full allowance against the net deferred tax asset. The Company did not have unrecognized tax benefits or accrued interest and penalties at any time during the years ended December 31, 2018 or 2017 and does not anticipate having unrecognized tax benefits over the next twelve months. The Company is subject to audit by the IRS and state taxing authorities for tax periods commencing January 1, 2015. Additionally, the Company may be subject to examination by the IRS for years beginning prior to January 1, 2015 as a result of its NOLs. However, any adjustment related to these periods would be limited to the amount of the NOL generated in the year(s) under examination. On December 22, 2017 The Tax Cuts and Jobs Act (the “Act”) was enacted. The Act significantly revised the U.S. corporate income tax law by lowering the corporate Federal income tax rate from 35% to 21%. As of December 31, 2017, the Company has assessed the effects of the corporate rate reduction on its existing deferred tax balances which resulted in the valuation allowance equal to the effect of the rate reduction on the ending deferred tax asset. In addition to the rate reduction, the Act requires companies with foreign subsidiaries to pay |
NET LOSS PER SHARE
NET LOSS PER SHARE | 12 Months Ended |
Dec. 31, 2018 | |
Earnings Per Share [Abstract] | |
Earnings Per Share [Text Block] | 11. NET LOSS PER SHARE Basic net loss per share is computed by dividing net loss attributable to common stockholders by the weighted average number of shares of common stock outstanding during the period. Diluted net loss attributable to common stockholders per share is computed by dividing net loss attributable to common stockholders, as adjusted, by the sum of the weighted average number of shares of common stock and the dilutive potential common stock equivalents then outstanding. Potential common stock equivalents consist of stock options and warrants. Since there is a net loss attributable to common stockholders for the years ended December 31, 2018 and 2017, the inclusion of common stock equivalents in the computation for those periods would be antidilutive. Accordingly, basic and diluted net loss per share is the same for all periods presented. The following potentially dilutive securities have been excluded from the computation of diluted net loss per share since their inclusion would be antidilutive: Year Ended December 31, 2018 2017 Warrants 5,318,747 1,183,007 Stock options 232,343 53,165 Non-vested restricted stock 18,668 38,000 Preferred shares convertible to common 1,182,500 1,020,006 Total potentially dilutive shares 6,752,258 2,294,178 |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 12 Months Ended |
Dec. 31, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies Disclosure [Text Block] | 12. COMMITMENTS AND CONTINGENCIES Real Property Leases Florham Park, New Jersey On June 4, 2018, the Company entered in an Agreement of Lease for 3,893 square feet for its new corporate headquarters in Florham Park, New Jersey. The lease commencement date was October 19, 2018 and terminates on February 29, 2024. The Company has an option to extend the term of the lease for one additional 60-month period. During the year ended December 31, 2018, the landlord made certain improvements to the facility. As of December 31, 2018, the Company recorded a deferred lease liability of approximately $176,000 for the improvements funded by the landlord in deferred rent current and deferred rent, long-term on the consolidated balance sheet. The Company amortizes the deferred liability as a reduction to rent expense in the consolidated statement of operations over the term of the lease. Under the terms of the lease, the Company paid a security deposit of $75,000 and the aggregate rent due over the term of the lease is approximately $828,000, which will be reduced to approximately $783,000 after certain rent abatements. The Company will also be required to pay its proportionate share of certain operating expenses and real estate taxes applicable to the leased premises. After certain rent abatements the rent is approximately $12,500 per month for the first year and then escalates thereafter by 2% per year for the duration of the term. Rent expense is recognized on a straight-line basis and accordingly the difference between the recorded rent expense and the actual cash payments has been recorded as deferred rent current and deferred rent, long-term of each balance sheet date on the consolidated balance sheet. Madison, Wisconsin On September 5, 2007, the Company entered into a 36-month lease for office and manufacturing space, commencing September 15, 2007. The lease provided for the option to extend the lease under its original terms for seven additional two-year terms. Rent was $8,050 per month for the first year and then escalated thereafter by 3% per year for the duration of the term including any lease extension terms. The lease also required the payment of monthly rent of $1,140 for approximately 3,400 square feet of expansion space. The monthly rent for the expansion space was fixed until such time as the expansion space is occupied at which time the rent would increase to the current per square foot rate in effect under the original lease terms. The Company is responsible for certain building-related costs such as property taxes, insurance, and repairs and maintenance. Rent expense is recognized on a straight-line basis and accordingly the difference between the recorded rent expense and the actual cash payments has been recorded as deferred rent as of each balance sheet date. Due to the significant value of leasehold improvements purchased during the initial 3-year lease term and the economic penalty for not extending the building lease, straight-line rent expense and the associated deferred rent has been calculated over 17 years, which represents the full term of the lease, including all extensions. The Company is required to remove certain alterations, additions and improvements upon termination of the lease that altered a portion of the rentable space. In no event shall the cost of such removal, at commercially reasonable rates, paid by the Company exceed $55,000 (the “Capped Amount”). Any amount in excess of the Capped Amount shall be the obligation of the landlord. The Company is required to maintain a certificate of deposit equal to the Capped Amount during the term of the lease, which amount is shown as restricted cash on the accompanying balance sheets. This space was vacated in 2018 due to our decision to outsource our manufacturing. The company additionally extended the lease on a month by month basis through February 6, 2019 to accommodate certain alterations required under the lease agreement. As of December 31, 2018, the Company has recorded a liability of approximately $55,000, in connection with its remaining obligations under the lease. The Company presently rents office space in Madison consists of approximately 300 square feet and is rented for approximately $3,300 per month under an agreement that expires on August 31, 2019. Future minimum lease payments, excluding reimbursements under noncancelable operating leases at December 31, 2018 are as follows: Years ending December 31, 2019 $ 138,619 2020 152,626 2021 155,403 2022 158,235 2023 161,123 Thereafter 13,610 $ 779,616 Total rent expense was approximately $29,000 and $130,000 for the years ended December 31, 2018 and 2017, respectively. Supply of CLR 131 O n August 7, 2018, the Company was informed by Centre for Probe Development and Commercialization (“CPDC”), its sole supplier of CLR 131, that CPDC is subject to an Import Alert 66-40 (the “Import Alert”) by the U.S.FDA. While the basis for the Import Alert was not related to CLR 131, or CPDC’s production facility associated with CLR 131, CPDC informed the Company on August 8, 2018 that CPDC would not be able to supply CLR 131 to it until the Import Alert is lifted or alternative agreements are reached with the FDA. On November 8, 2018, the FDA notified the Company that CLR 131 would be exempted from the Import Alert placed on CPDC in relation to our ongoing clinical studies. As a result, the Company has resumed patient enrollment in its CLR 131 hematology studies. The Company awaits either the lifting of the Import Alert or the granting of an exemption from the FDA for any future shipments into the U.S. in connection with its Phase 1 study of pediatric patients with neuroblastoma, sarcomas, lymphomas (including Hodgkin’s lymphoma) and malignant brain tumors. As a result of the supply disruption, the Company is experiencing delays in initiation of this clinical study. At this time, the Company is sourcing clinical sites outside the U.S. which would allow it to begin enrollment of this clinical study. Legal The Company is involved in legal matters and disputes in the ordinary course of business. We do not anticipate that the outcome of such matters and disputes will materially affect the Company’s financial statements. |
EMPLOYEE RETIREMENT PLAN
EMPLOYEE RETIREMENT PLAN | 12 Months Ended |
Dec. 31, 2018 | |
Retirement Benefits [Abstract] | |
Compensation and Employee Benefit Plans [Text Block] | 13. EMPLOYEE RETIREMENT PLAN The Company has a defined contribution plan under Section 401(k) of the Internal Revenue Code that allows eligible employees who meet minimum age requirements to contribute a portion of their annual compensation on a pre-tax basis. The Company has not made any matching contributions under this plan. |
SUMMARY OF SIGNIFICANT ACCOUN_2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Consolidation, Policy [Policy Text Block] | Principles of Consolidation — The consolidated financial statements include the accounts of the Company and the accounts of its wholly-owned subsidiary. All inter-company accounts and transactions have been eliminated in consolidation. |
Use of Estimates, Policy [Policy Text Block] | Use of Estimates — The preparation of financial statements in conformity with accounting principles generally accepted in the U.S. requires management to make estimates and judgments that may affect the reported amounts of assets, liabilities, revenue and expenses and disclosure of contingent assets and liabilities. On an on-going basis, management evaluates its estimates including those related to unbilled vendor amounts, share-based compensation and derivative liability valuation. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities. Actual results may differ from those estimates under different assumptions or conditions. Changes in estimates are reflected in reported results in the period in which they become known. |
Reclassification, Policy [Policy Text Block] | Reclassifications — Certain prior year amounts have been reclassified for consistency with the current year presentation. These reclassifications had no effect on the reported results of operations. An adjustment has been made to the Consolidated Statements of Cash Flows for fiscal year ended December 31, 2017, to identify the long-term other assets of approximately $466,000. This change in classification does not affect previously reported cash flows from operating activities in the Consolidated Statements of Cash Flows. |
Cash and Cash Equivalents, Policy [Policy Text Block] | Cash and Cash Equivalents — All short-term investments purchased with original maturities of three months or less are considered to be cash equivalents. |
Cash and Cash Equivalents, Restricted Cash and Cash Equivalents, Policy [Policy Text Block] | Restricted Cash — The Company accounts for cash and claims to cash that are committed for other than current operations as restricted cash. Restricted cash at December 31, 2018 and 2017 consists of a certificate of deposit of $55,000 required under the Company’s lease agreement for its Madison, Wisconsin facility (see Note 12). |
Property, Plant and Equipment, Policy [Policy Text Block] | Fixed Assets — Property and equipment are stated at cost. Depreciation on property and equipment is provided using the straight-line method over the estimated useful lives of the assets (3 to 10 years). Due to the significant value of leasehold improvements purchased, leasehold improvements are depreciated over 64 months (their estimated useful life), which represents the full term of the lease. Our only long-lived assets are property and equipment. The Company periodically evaluates long-lived assets for potential impairment. Whenever events or circumstances change, an assessment is made as to whether there has been impairment to the value of long-lived assets by determining whether projected undiscounted cash flows generated by the applicable asset exceed its net book value as of the assessment date. There were no long-lived asset impairment charges recorded during the years ended December 31, 2018 or 2017. (see Note 5) In December 2017, the Company concluded that the manufacturing processes would be transferred to a third party. As part of the transfer, the Company also began the process of de-commissioning the manufacturing facility. In connection with the de-commissioning, the Company determined that certain research and development assets will no longer be used by the Company and had materially ceased being used by December 31, 2017. As a result, the Company reassessed the estimated useful life of the research and development assets and concluded they should be accelerated beginning on December 1, 2017 through December 31, 2017 (one month remaining life). The Company also reassessed the estimated useful life of the leasehold improvements and concluded that they should be accelerated beginning on December 1, 2017 through December 31, 2017 (one month remaining life). These reassessments of the estimated useful lives have been accounted for as changes in an estimate. |
Goodwill and Intangible Assets, Goodwill, Policy [Policy Text Block] | Goodwill —Goodwill is not amortized but is required to be evaluated for impairment annually or whenever events or changes in circumstances suggest that the carrying value of an asset may not be recoverable. The Company evaluates goodwill for impairment annually in the fourth fiscal quarter and additionally on an interim basis if an event occurs or there is a change in circumstances, such as a significant decline in the Company’s stock price or a material adverse change in the business climate, which would more likely than not reduce the fair value of the reporting unit below its carrying amount (see Note 4). In January 2017, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2017-04, Simplifying the Test for Goodwill. The standard streamlines the methodology for calculating whether goodwill is impaired based upon whether the carrying amount of goodwill exceeds the reporting unit’s fair value. ASU 2017-04 applies to public business entities and those other entities that have goodwill reported in their financial statements and have not elected the private company alternative for the subsequent measurement of goodwill and is effective for annual and interim reporting periods beginning after December 15, 2019, with early adoption permitted. The Company adopted ASU No. 2017-04 during the year ended December 31, 2018. |
Share-based Compensation, Option and Incentive Plans Policy [Policy Text Block] | Stock-Based Compensation — The Company uses the Black-Scholes option-pricing model to calculate the grant-date fair value of stock option awards. The resulting compensation expense, net of expected forfeitures, for awards that are not performance-based is recognized on a straight-line basis over the service period of the award, which for grants issued in 2018 ranged from seven months to three years for stock options. For stock options with performance-based vesting provisions, recognition of compensation expense, net of expected forfeitures, commences if and when the achievement of the performance criteria is deemed probable. The compensation expense, net of expected forfeitures, for performance-based stock options is recognized over the relevant performance period. Non-employee stock-based compensation is accounted for in accordance with the guidance of FASB Accounting Standards Codification (“ASC”) Topic 505, Equity. As such, the Company recognizes expense based on the estimated fair value of options granted to non-employees over their vesting period, which is generally the period during which services are rendered and deemed completed by such non-employees. |
Research and Development Expense, Policy [Policy Text Block] | Research and Development — Research and development costs are expensed as incurred. To the extent that such costs are reimbursed by the federal government on a fixed price, best efforts basis and the federal government is the sole customer for such research and development, the funding is recognized as a reduction of research and development expenses. |
Income Tax, Policy [Policy Text Block] | Income Taxes — Income taxes are accounted for using the liability method of accounting. Under this method, deferred tax assets and liabilities are determined based on temporary differences between the financial statement basis and tax basis of assets and liabilities and net operating loss and credit carryforwards using enacted tax rates in effect for the year in which the differences are expected to reverse. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. Valuation allowances are established when it is more likely than not that some portion of the deferred tax assets will not be realized. Management has provided a full valuation allowance against the Company’s gross deferred tax asset. Tax positions taken or expected to be taken in the course of preparing tax returns are required to be evaluated to determine whether the tax positions are “more likely than not” to be sustained by the applicable tax authority. Tax positions deemed not to meet a more-likely-than-not threshold would be recorded as tax expense in the current year. There were no uncertain tax positions that require accrual to or disclosure in the financial statements as of December 31, 2018 and 2017. |
Fair Value of Financial Instruments, Policy [Policy Text Block] | Fair Value of Financial Instruments — The guidance under FASB ASC Topic 825, Financial Instruments , requires disclosure of the fair value of certain financial instruments. Financial instruments in the accompanying financial statements consist of cash equivalents, prepaid expenses and other assets, accounts payable and long-term obligations. The carrying amount of cash equivalents, and accounts payable approximate their fair value due to their short-term nature. The carrying value of long-term obligations, including the current portion, approximates fair value because the fixed interest rate approximates current market rates of interest available in the market. |
Derivatives, Policy [Policy Text Block] | Derivative Instruments — The Company generally does not use derivative instruments to hedge exposures to cash flow or market risks; however, certain warrants to purchase common stock that do not meet the requirements for classification as equity, in accordance with the Derivatives and Hedging Topic of the FASB ASC, are classified as liabilities. In such instances, net-cash settlement is assumed for financial reporting purposes, even when the terms of the underlying contracts do not provide for a net-cash settlement. These warrants are considered derivative instruments because the agreements contain a certain type of cash settlement feature, contain “down-round” provisions whereby the number of shares for which the warrants are exercisable, and/or the exercise price of the warrants are subject to change in the event of certain issuances of stock at prices below the then-effective exercise price of the warrants. The number of shares issuable under such warrants was 49,425 at December 31, 2018 and 2017, respectively. The primary underlying risk exposures pertaining to the warrants and their related fair value is the change in fair value of the underlying common stock, the market price of traded warrants, and estimated timing and probability of future financings. Such financial instruments are initially recorded at fair value with subsequent changes in fair value recorded as a component of gain or loss on derivatives on the consolidated statements of operations in each reporting period. If these instruments subsequently meet the requirements for equity classification, the Company reclassifies the fair value to equity. At December 31, 2018 and 2017, these warrants represented the only outstanding derivative instruments issued or held by the Company. |
Concentration Risk, Credit Risk, Policy [Policy Text Block] | Concentration of Credit Risk — Financial instruments that subject the Company to credit risk consist of cash and equivalents on deposit with financial institutions. The Company’s excess cash as of December 31, 2018 and 2017 is on deposit in interest-bearing transaction accounts with well-established financial institutions. At times, such amounts may exceed the FDIC insurance limits. As of December 31, 2018, uninsured cash balances totaled approximately $12,800,000. |
Lessee, Leases [Policy Text Block] | Leases — In February 2016, the FASB issued Accounting Standards Update (“ASU”) 2016-02, Leases (Topic 842) which supersedes FASB ASC Topic 840, Leases (Topic 840) and provides principles for the recognition, measurement, presentation and disclosure of leases for both lessees and lessors. The new standard requires lessees to apply a dual approach, classifying leases as either finance or operating leases based on the principle of whether or not the lease is effectively a financed purchase by the lessee. This classification will determine whether lease expense is recognized based on an effective interest method or on a straight-line basis over the term of the lease, respectively. A lessee is also required to record a right-of-use asset and a lease liability for all leases with a term of greater than twelve months regardless of classification. Leases with a term of twelve months or less will be accounted for similar to existing guidance for operating leases. The standard is effective for annual and interim periods beginning after December 15, 2018, with early adoption permitted upon issuance. The Company will elect the transition method to initially apply ASU 2016-02 transition provisions at the effective date (i.e., 1 January 2019) recognizing any adjustment that results from applying the ASU 2016-02 transition requirements as a cumulative-effect adjustment to the opening balance of retained earnings in the period of adoption and not restating comparative periods presented. The Company believes the impact on its balance sheet of adopting ASU 2016-02 on January 1, 2019, the date of transition, will be to record a right-of use asset and a lease liability. |
New Accounting Pronouncements, Policy [Policy Text Block] | Recent Accounting Pronouncements - I n July 2017, the FASB issued ASU No. 2017-11, Earnings Per Share (Topic 260), Distinguishing Liabilities from Equity (Topic 480), Derivatives and Hedging (Topic 815). The amendments in Part I of this Update change the classification analysis of certain equity-linked financial instruments (or embedded features) with down round features. When determining whether certain financial instruments should be classified as liabilities or equity instruments, a down round feature no longer precludes equity classification when assessing whether the instrument is indexed to an entity’s own stock. The amendments also clarify existing disclosure requirements for equity-classified instruments. As a result, a freestanding equity-linked financial instrument (or embedded conversion option) no longer would be accounted for as a derivative liability at fair value as a result of the existence of a down round feature. The standard is effective for annual and interim periods beginning after December 15, 2018, with early adoption permitted upon issuance. The Company believes the impact of adopting ASU 2017-11 will not have a material impact on its results of operations, cash flows and financial position. |
FAIR VALUE (Tables)
FAIR VALUE (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Fair Value, Liabilities Measured on Recurring Basis [Table Text Block] | The following tables set forth the Company’s financial instruments carried at fair value using the lowest level of input applicable to each financial instrument as of December 31, 2018 and 2017: December 31, 2018 Level 1 Level 2 Level 3 Fair Value Liabilities: August 2014 Warrants $ — $ 43,000 — $ 43,000 Total $ — $ 43,000 $ — $ 43,000 December 31, 2017 Level 1 Level 2 Level 3 Fair Value Liabilities: February 2013 Public Offering Warrants $ — $ — $ 5,050 $ 5,050 August 2014 Warrants — 100,000 — 100,000 Total $ — $ 100,000 $ 5,050 $ 105,050 |
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Table Text Block] | The following table summarizes the modified option-pricing assumptions used: Year Ended December 31, 2018 2017 Volatility N/A 76-118 % Risk-free interest rate N/A 1.03-1.39 % Expected life (years) N/A 0.14-0.89 Dividend N/A 0 % |
Schedule Of Changes In Fair Value Warrants Classified Level Three [Table Text Block] | The following table summarizes the changes in the fair market value of the Company’s warrants which are classified within the Level 3 fair value hierarchy. Year Ended December 31, 2018 2017 Beginning fair value of warrants $ 5,050 $ 27,125 Gain on derivatives resulting from change in fair value or extinguishment (5,050 ) (22,075 ) Ending fair value of warrants $ — $ 5,050 |
FIXED ASSETS (Tables)
FIXED ASSETS (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Property, Plant and Equipment [Abstract] | |
Property, Plant and Equipment [Table Text Block] | Fixed assets consisted of the following at December 31: 2018 2017 Office and laboratory equipment $ 410,634 $ 3,751,059 Computer software 4,000 4,000 Leasehold improvements 309,897 2,333,443 Total fixed assets 724,531 6,088,502 Less– accumulated depreciation and amortization (181,192 ) (5,843,789 ) Fixed assets, net $ 543,339 $ 244,713 |
ACCRUED EXPENSES (Tables)
ACCRUED EXPENSES (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Payables and Accruals [Abstract] | |
Schedule of Accounts Payable and Accrued Liabilities [Table Text Block] | Accounts payable and accrued liabilities approximately consist of the following: 2018 2017 Incentive compensation $ 408,000 $ 341,000 Accounts payable 612,000 933,000 Clinical costs 332,000 329,000 Professional fees 64,000 178,000 Insurance 69,000 — Other 59,000 87,000 $ 1,544,000 $ 1,868,000 |
STOCKHOLDERS' EQUITY (Tables)
STOCKHOLDERS' EQUITY (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Equity [Abstract] | |
Schedule of Stockholders' Equity Note, Warrants or Rights [Table Text Block] | The following table summarizes information with regard to outstanding warrants to purchase common stock as of December 31, 2018. Offering Number of Shares Issuable Upon Exercise of Outstanding Warrants Exercise Price Expiration Date July 2018 Series E Warrants 4,140,000 $ 4.00 July 31, 2023 October 2017 Series D Warrants 310,856 $ 17.80 October 14, 2024 November 2016 Public Offering Series C 415,785 $ 15.00 November 29, 2021 April 2016 Underwritten Registered Series A 362,694 $ 30.40 April 20,2021 October 2015 Incremental Series A 30,006 $ 21.30 October 20,2021 October 2015 Private Placement Series A 8,636 $ 21.30 April 1, 2021 October 2015 Offering – Placement Agent 375 $ 283.00 October 1, 2020 August 2014 Public Offering (1) 50,395 $ 468.00 August 20, 2019 Total 5,318,747 (1) These warrants have a certain type of cash settlement feature and they have been accounted for as derivative instruments as described in Note 1, with the exception of 970 warrants issued in August 2014. |
STOCK-BASED COMPENSATION (Table
STOCK-BASED COMPENSATION (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Schedule of Share-based Compensation, Restricted Stock Units Award Activity [Table Text Block] | The following table summarizes the restricted stock grants: Number of Shares Weighted Average Grant Date Fair Value Per Share Total Grant Date Fair Value Outstanding at December 31, 2016 — — — Granted 46,000 $ 20.96 $ 964,000 Vested — — — Forfeited (8,000 ) 21.00 (168,000 ) Outstanding at December 31, 2017 38,000 20.95 796,000 Granted — — — Vested (12,665 ) 20.95 (265,000 ) Forfeited (6,667 ) 20.80 (139,000 ) Outstanding at December 31, 2018 18,668 $ 21.00 $ 392,000 |
Schedule of Compensation Cost for Share-based Payment Arrangements, Allocation of Share-based Compensation Costs by Plan [Table Text Block] | The following table summarizes amounts charged to expense for stock-based compensation related to employee and director stock option grants: Year Ended December 31, 2018 2017 Employee and director stock options and stock grants: Research and development $ 94,865 $ 147,821 General and administrative 626,344 610,936 Total stock-based compensation $ 721,209 $ 758,757 |
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions [Table Text Block] | The following table summarizes weighted-average values and assumptions used for options granted to employees, directors and consultants in the periods indicated: Year Ended December 31, 2018 2017 Volatility 91-106 % 107-110 % Risk-free interest rate 2.64-3.05 % 1.89-2.18 % Expected life (years) 6 6 Dividend 0 % 0 % Weighted-average exercise price $ 2.99 $ 1.91 Weighted-average grant-date fair value $ 2.30 $ 1.58 |
Share-based Compensation, Stock Options, Activity [Table Text Block] | A summary of stock option activity is as follows: Number of Shares Issuable Upon Exercise of Outstanding Options Weighted Average Exercise Price Weighted Average Remaining Contracted Term in Years Aggregate Intrinsic Value Outstanding at December 31, 2016 47,133 $ 75.90 Granted 11,230 $ 19.10 Exercised (2,083 ) $ 14.80 Expired (201 ) $ 1,166.10 Forfeited (2,914 ) $ 14.80 Outstanding at December 31, 2017 53,165 $ 73.82 Granted 184,129 $ 2.99 Expired (2,344 ) $ 463.16 Forfeited (2,607 ) $ 19.46 Outstanding at December 31, 2018 232,343 $ 14.37 Exercisable, December 31, 2018 45,448 $ 51.97 7.85 $ — Unvested, December 31, 2018 186,895 $ 5.23 9.65 $ — |
INCOME TAXES (Tables)
INCOME TAXES (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Schedule of Components of Income Tax Expense (Benefit) [Table Text Block] | 2018 2017 Tax provision (benefit) Current Federal $ — $ — State — — Total current — — Deferred Federal (2,688,003 ) 13,626,404 State (45,138 ) 1,969,262 Total deferred (2,733,141 ) 15,595,666 Change in valuation allowance 2,733,141 (15,595,666 ) Total $ — $ — |
Schedule of Deferred Tax Assets and Liabilities [Table Text Block] | Deferred tax assets consisted of the following at December 31: 2018 2017 Deferred tax assets Federal net operating loss $ 26,562,715 $ 24,353,504 Federal research and development tax credit carryforwards 5,439,062 4,947,879 State net operating losses and tax credit carryforwards 1,589,926 1,589,927 Capitalized research and development expenses 5,959,275 5,772,165 Stock-based compensation expense 1,565,130 1,445,078 Depreciable assets — 166,793 Other 103,189 121,680 Total deferred tax assets 41,219,297 38,397,026 Deferred tax liabilities Depreciable assets (89,129 ) — Total deferred tax liabilities (89,129 ) — Net deferred tax assets 41,130,168 38,397,026 Less– valuation allowance (41,130,168 ) (38,397,026 ) Total deferred tax assets $ — $ — |
Schedule of Effective Income Tax Rate Reconciliation [Table Text Block] | A reconciliation of income taxes computed using the U.S. federal statutory rate to that reflected in operations is as follows: Year ended December 31, 2018 2017 Income tax benefit using U.S. federal statutory rate (21.00 )% 34.00 % State income taxes (0.27 )% (9.58 )% Permanent items 2.56 % (2.55 )% Federal tax credits (3.44 )% 8.43 % Change in valuation allowance 20.65 % 115 % Federal rate change — % (143.50 )% Other 1.50 % (1.80 )% Total 0.00 % 0.00 % |
NET LOSS PER SHARE (Tables)
NET LOSS PER SHARE (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Earnings Per Share [Abstract] | |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share [Table Text Block] | The following potentially dilutive securities have been excluded from the computation of diluted net loss per share since their inclusion would be antidilutive: Year Ended December 31, 2018 2017 Warrants 5,318,747 1,183,007 Stock options 232,343 53,165 Non-vested restricted stock 18,668 38,000 Preferred shares convertible to common 1,182,500 1,020,006 Total potentially dilutive shares 6,752,258 2,294,178 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Future Minimum Rental Payments for Operating Leases [Table Text Block] | Future minimum lease payments, excluding reimbursements under noncancelable operating leases at December 31, 2018 are as follows: Years ending December 31, 2019 $ 138,619 2020 152,626 2021 155,403 2022 158,235 2023 161,123 Thereafter 13,610 $ 779,616 |
NATURE OF BUSINESS, ORGANIZAT_2
NATURE OF BUSINESS, ORGANIZATION AND GOING CONCERN (Details Textual) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Net Income (Loss) Attributable to Parent | $ (13,239,027) | $ (13,562,290) |
Retained Earnings (Accumulated Deficit) | $ (97,588,343) | $ (84,349,316) |
SUMMARY OF SIGNIFICANT ACCOUN_3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Textual) - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Cash, Cash Equivalents, Restricted Cash and Restricted Cash Equivalents | $ 13,310,616 | $ 10,061,421 | $ 11,499,619 |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range, Number of Exercisable Options | 49,425 | 49,425 | |
Other Assets | $ 466,000 | ||
Cash, Uninsured Amount | $ 12,800,000 | ||
Change in Accounting Estimate, Description | As a result, the Company reassessed the estimated useful life of the research and development assets and concluded they should be accelerated beginning on December 1, 2017 through December 31, 2017 (one month remaining life). The Company also reassessed the estimated useful life of the leasehold improvements and concluded that they should be accelerated beginning on December 1, 2017 through December 31, 2017 (one month remaining life). These reassessments of the estimated useful lives have been accounted for as changes in an estimate. | ||
Leasehold Improvements [Member] | |||
Property, Plant and Equipment, Useful Life | 64 months | ||
Maximum [Member] | |||
Property, Plant and Equipment, Useful Life | 10 years | ||
Minimum [Member] | |||
Property, Plant and Equipment, Useful Life | 3 years | ||
Certificates of Deposit [Member] | |||
Cash, Cash Equivalents, Restricted Cash and Restricted Cash Equivalents | $ 55,000 | $ 55,000 |
FAIR VALUE (Details)
FAIR VALUE (Details) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Liabilities: | ||
Derivative Liability, Current | $ 43,000 | $ 105,050 |
February 2013 Public Offering Warrants [Member] | ||
Liabilities: | ||
Derivative Liability, Current | 5,050 | |
August 2014 Warrants [Member] | ||
Liabilities: | ||
Derivative Liability, Current | 43,000 | 100,000 |
Fair Value, Inputs, Level 1 [Member] | ||
Liabilities: | ||
Derivative Liability, Current | 0 | 0 |
Fair Value, Inputs, Level 1 [Member] | February 2013 Public Offering Warrants [Member] | ||
Liabilities: | ||
Derivative Liability, Current | 0 | |
Fair Value, Inputs, Level 1 [Member] | August 2014 Warrants [Member] | ||
Liabilities: | ||
Derivative Liability, Current | 0 | 0 |
Fair Value, Inputs, Level 2 [Member] | ||
Liabilities: | ||
Derivative Liability, Current | 43,000 | 100,000 |
Fair Value, Inputs, Level 2 [Member] | February 2013 Public Offering Warrants [Member] | ||
Liabilities: | ||
Derivative Liability, Current | 0 | |
Fair Value, Inputs, Level 2 [Member] | August 2014 Warrants [Member] | ||
Liabilities: | ||
Derivative Liability, Current | 43,000 | 100,000 |
Fair Value, Inputs, Level 3 [Member] | ||
Liabilities: | ||
Derivative Liability, Current | 0 | 5,050 |
Fair Value, Inputs, Level 3 [Member] | February 2013 Public Offering Warrants [Member] | ||
Liabilities: | ||
Derivative Liability, Current | 5,050 | |
Fair Value, Inputs, Level 3 [Member] | August 2014 Warrants [Member] | ||
Liabilities: | ||
Derivative Liability, Current | $ 0 | $ 0 |
FAIR VALUE (Details 1)
FAIR VALUE (Details 1) - 2013 Warrants [Member] | 12 Months Ended |
Dec. 31, 2017 | |
Dividend | |
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | |
Fair Value Assumptions Rate | 0.00% |
Maximum [Member] | Volatility | |
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | |
Fair Value Assumptions Rate | 118.00% |
Maximum [Member] | Risk-free interest rate | |
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | |
Fair Value Assumptions Rate | 1.39% |
Maximum [Member] | Expected life (years) | |
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | |
Fair Value Assumptions Term | 10 months 20 days |
Minimum [Member] | Volatility | |
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | |
Fair Value Assumptions Rate | 76.00% |
Minimum [Member] | Risk-free interest rate | |
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | |
Fair Value Assumptions Rate | 1.03% |
Minimum [Member] | Expected life (years) | |
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | |
Fair Value Assumptions Term | 1 month 20 days |
FAIR VALUE (Details 2)
FAIR VALUE (Details 2) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Gain on derivatives resulting from change in fair value or extinguishment | $ 62,050 | $ 22,075 |
Fair Value, Inputs, Level 3 [Member] | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Beginning fair value of warrants | 5,050 | 27,125 |
Gain on derivatives resulting from change in fair value or extinguishment | (5,050) | (22,075) |
Ending fair value of warrants | $ 0 | $ 5,050 |
FAIR VALUE (Details Textual)
FAIR VALUE (Details Textual) - shares | 1 Months Ended | ||||
May 20, 2016 | Feb. 20, 2014 | Dec. 31, 2018 | Aug. 31, 2014 | Feb. 28, 2013 | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 5,318,747 | ||||
February 2013 Public Offering Warrants [Member] | |||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 8,250 | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Non-Option Equity Instruments, Expirations | 2,750 | ||||
Number Of Warrants Exercised | 1,625 | ||||
Warrants Expiration Date | Feb. 20, 2018 | ||||
February 2013 Public Offering Warrants [Member] | Fair Value, Inputs, Level 3 [Member] | |||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||
Class of Warrant or Right, Outstanding | 3,875 | ||||
August 2014 Public Offering Warrants [Member] | |||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 49,425 |
GOODWILL (Details Textual)
GOODWILL (Details Textual) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Asset Impairment Charges | $ 1,675,462 | |
Goodwill | $ 0 | $ 1,675,462 |
FIXED ASSETS (Details)
FIXED ASSETS (Details) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Property, Plant and Equipment [Line Items] | ||
Total fixed assets | $ 724,531 | $ 6,088,502 |
Less– accumulated depreciation and amortization | (181,192) | (5,843,789) |
Fixed assets, net | 543,339 | 244,713 |
Office Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total fixed assets | 410,634 | 3,751,059 |
Computer Software, Intangible Asset [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total fixed assets | 4,000 | 4,000 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total fixed assets | $ 309,897 | $ 2,333,443 |
FIXED ASSETS (Details Textual)
FIXED ASSETS (Details Textual) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Depreciation, Depletion and Amortization | $ 82,265 | $ 1,546,048 |
NOTES PAYABLE (Details Textual)
NOTES PAYABLE (Details Textual) | Mar. 31, 2017USD ($) |
Secured Debt [Member] | |
Line of Credit Facility [Line Items] | |
Notes Payable, Noncurrent | $ 450,000 |
ACCRUED EXPENSES (Details)
ACCRUED EXPENSES (Details) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Incentive compensation | $ 408,000 | $ 341,000 |
Accounts payable | 612,000 | 933,000 |
Clinical study costs | 332,000 | 329,000 |
Professional fees | 64,000 | 178,000 |
Insurance | 69,000 | 0 |
Other | 59,000 | 87,000 |
Accounts Payable and Accrued Liabilities, Current | $ 1,543,819 | $ 1,867,758 |
STOCKHOLDERS' EQUITY (Details)
STOCKHOLDERS' EQUITY (Details) - $ / shares | 12 Months Ended | ||
Dec. 31, 2018 | Jul. 31, 2018 | ||
Class of Warrant or Right [Line Items] | |||
Number of Shares Issuable Upon Exercise of Outstanding Warrants (in shares) | 5,318,747 | ||
Exercise Price (in dollars per share) | $ 4 | ||
July 2018 Series E Warrants [Member] | |||
Class of Warrant or Right [Line Items] | |||
Number of Shares Issuable Upon Exercise of Outstanding Warrants (in shares) | 4,140,000 | ||
Exercise Price (in dollars per share) | $ 4 | ||
Warrants Expiration Date | Jul. 31, 2023 | ||
October 2017 Series D Warrants [Member] | |||
Class of Warrant or Right [Line Items] | |||
Number of Shares Issuable Upon Exercise of Outstanding Warrants (in shares) | 310,856 | ||
Exercise Price (in dollars per share) | $ 17.80 | ||
Warrants Expiration Date | Oct. 14, 2024 | ||
November 2016 Public Offering Series C [Member] | |||
Class of Warrant or Right [Line Items] | |||
Number of Shares Issuable Upon Exercise of Outstanding Warrants (in shares) | 415,785 | ||
Exercise Price (in dollars per share) | $ 15 | ||
Warrants Expiration Date | Nov. 29, 2021 | ||
April 2016 Underwritten Registered Series A [Member] | |||
Class of Warrant or Right [Line Items] | |||
Number of Shares Issuable Upon Exercise of Outstanding Warrants (in shares) | 362,694 | ||
Exercise Price (in dollars per share) | $ 30.40 | ||
Warrants Expiration Date | Apr. 20, 2021 | ||
October 2015 Incremental Series A [Member] | |||
Class of Warrant or Right [Line Items] | |||
Number of Shares Issuable Upon Exercise of Outstanding Warrants (in shares) | 30,006 | ||
Exercise Price (in dollars per share) | $ 21.30 | ||
Warrants Expiration Date | Oct. 20, 2021 | ||
October 2015 Private Placement Series A [Member] | |||
Class of Warrant or Right [Line Items] | |||
Number of Shares Issuable Upon Exercise of Outstanding Warrants (in shares) | 8,636 | ||
Exercise Price (in dollars per share) | $ 21.30 | ||
Warrants Expiration Date | Apr. 1, 2021 | ||
October 2015 Offering - Placement Agent [Member] | |||
Class of Warrant or Right [Line Items] | |||
Number of Shares Issuable Upon Exercise of Outstanding Warrants (in shares) | 375 | ||
Exercise Price (in dollars per share) | $ 283 | ||
Warrants Expiration Date | Oct. 1, 2020 | ||
August 2014 Public Offering [Member] | |||
Class of Warrant or Right [Line Items] | |||
Number of Shares Issuable Upon Exercise of Outstanding Warrants (in shares) | [1] | 50,395 | |
Exercise Price (in dollars per share) | [1] | $ 468 | |
Warrants Expiration Date | [1] | Aug. 20, 2019 | |
[1] | These warrants have a certain type of cash settlement feature and they have been accounted for as derivative instruments as described in Note 1, with the exception of 970 warrants issued in August 2014. |
STOCKHOLDERS' EQUITY (Details T
STOCKHOLDERS' EQUITY (Details Textual) - USD ($) | Oct. 12, 2017 | Jul. 31, 2018 | Jul. 16, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | Sep. 12, 2017 | Aug. 31, 2014 |
Class of Warrant or Right [Line Items] | |||||||
Stock Issued During Period, Shares, New Issues | 1,355,000 | ||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 5,318,747 | ||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 4 | ||||||
Common Stock, Shares Authorized | 80,000,000 | 80,000,000 | |||||
Convertible Preferred Stock, Shares Issued upon Conversion | 2,785,000 | ||||||
Stock Issued During Period, Value, New Issues | $ 15,025,078 | $ 7,054,865 | |||||
Stock Issued During Period On Exercise Of Warrants, Value | 2,963,259 | ||||||
Proceeds from Warrant Exercises | $ 0 | 2,963,259 | |||||
Stockholders' Equity, Reverse Stock Split | At a special meeting held on July 12, 2018, our stockholders approved an amendment to our certificate of incorporation to affect a reverse split of our common stock at a ratio between 1:5 to 1:10 and authorized the Board to determine the ratio at which the reverse split would be. The Board authorized the ratio of the reverse split, and effective at the close of business on July 16, 2018, the Company implemented a 1-for-10 reverse stock split of its outstanding common stock. The accompanying consolidated financial statements and accompanying notes to the consolidated financial statements give retroactive effect to the reverse stock split for all periods presented. The shares of common stock that the Company is authorized to issue remains unchanged at 80,000,000 and the par value remains at $0.00001 per share. Accordingly, stockholders' equity reflects the reverse stock split by reclassifying from common stock to additional paid-in capital an amount equal to the par value of the decreased shares resulting from the reverse stock split. | ||||||
Share Price | $ 4 | ||||||
Proceeds from Issuance or Sale of Equity | $ 16,560,000 | ||||||
Class of Warrant or Right, Date from which Warrants or Rights Exercisable | Jul. 31, 2023 | ||||||
Net Proceeds from Issuance or Sale of Equity After Deducting Underwriting Discounts and Commissions and Related Offering Expenses | $ 15,000,000 | ||||||
Stock Issued During Period, Value, Stock Options Exercised | $ 0 | ||||||
Warrant [Member] | |||||||
Class of Warrant or Right [Line Items] | |||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 4,140,000 | ||||||
Series B Preferred Stock [Member] | |||||||
Class of Warrant or Right [Line Items] | |||||||
Convertible Preferred Stock, Shares Issued upon Conversion | 122,751 | ||||||
Conversion of Stock, Shares Converted | 18 | 23 | |||||
Preferred Stock, Shares Outstanding | 0 | 18 | |||||
Preferred Stock Convertible Beneficial Conversion Feature | $ 1,448,945 | ||||||
Convertible Preferred Stock, Shares Issuable upon Conversion | 96,284 | ||||||
Series C Preferred Stock [Member] | |||||||
Class of Warrant or Right [Line Items] | |||||||
Stock Issued During Period, Shares, New Issues | 1,114 | ||||||
Preferred Stock, Shares Outstanding | 473 | 0 | |||||
Preferred Stock Convertible Beneficial Conversion Feature | $ 2,241,795 | ||||||
Convertible Preferred Stock, Terms of Conversion | Series C Preferred Stock, each of which is convertible into 2,500 shares of Common Stock​​​​​​​, together with a Series E warrant to purchase 2,500 shares of common stock | ||||||
Share Price | $ 10,000 | ||||||
Stock Issued During Period, Value, Stock Options Exercised | $ 641 | ||||||
October 2017 Registered public offering [Member] | |||||||
Class of Warrant or Right [Line Items] | |||||||
Stock Issued During Period, Value, New Issues | $ 7,760,000 | ||||||
October 2017 Registered public offering [Member] | Series B Preferred Stock [Member] | |||||||
Class of Warrant or Right [Line Items] | |||||||
Stock Issued During Period, Shares, New Issues | 41.0412949 | ||||||
Shares Issued, Price Per Share | $ 100,000 | ||||||
Convertible Preferred Stock, Shares Issued upon Conversion | 5,337 | ||||||
Convertible Preferred Stock, Total Number of Shares Issued upon Conversion | 219,037 | ||||||
August 2014 Underwritten Offering [Member] | |||||||
Class of Warrant or Right [Line Items] | |||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 970 | ||||||
Common Stock [Member] | |||||||
Class of Warrant or Right [Line Items] | |||||||
Stock Issued During Period, Shares, New Issues | 1,355,000 | 195,438 | |||||
Common Stock, Shares Authorized | 80,000,000 | 40,000,000 | |||||
Stock Issued During Period, Value, New Issues | $ 14 | $ 2 | |||||
Preferred Stock, Shares Outstanding | 1,602,500 | ||||||
Stock Issued During Period On Exercise Of Warrants, Value | 2 | ||||||
Stock Issued During Period, Value, Stock Options Exercised | $ 0 | ||||||
Common Stock [Member] | October 2017 Registered public offering [Member] | |||||||
Class of Warrant or Right [Line Items] | |||||||
Stock Issued During Period, Shares, New Issues | 195,438 | ||||||
Convertible Preferred Stock Conversion Price | $ 18.7375 | ||||||
Series D Warrants [Member] | October 2017 Registered public offering [Member] | |||||||
Class of Warrant or Right [Line Items] | |||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 310,856 | ||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 17.80 | ||||||
Stock Issued During Period On Exercise Of Warrants, Value | $ 7,800,000 | ||||||
Common Stock, Conversion Basis | 0.75 | ||||||
Proceeds from Warrant Exercises | $ 7,100,000 |
STOCK-BASED COMPENSATION (Detai
STOCK-BASED COMPENSATION (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Weighted Average Grant Date Fair Value Per Share | ||
Weighted Average Grant Date Fair Value Per Share Granted | $ 2.30 | $ 1.58 |
Restricted Stock [Member] | ||
Number of Shares | ||
Number of Shares Outstanding Beginning | 38,000 | 0 |
Number of Shares Granted | 0 | 46,000 |
Number of Shares Vested | (12,665) | 0 |
Number of Shares Forfeited | (6,667) | (8,000) |
Number of Shares Outstanding Ending | 18,668 | 38,000 |
Weighted Average Grant Date Fair Value Per Share | ||
Weighted Average Grant Date Fair Value Per Share Outstanding Beginning | $ 20.95 | $ 0 |
Weighted Average Grant Date Fair Value Per Share Granted | 0 | 20.96 |
Weighted Average Grant Date Fair Value Per Share Vested | 20.95 | 0 |
Weighted Average Grant Date Fair Value Per Share Forfeited | 20.80 | 21 |
Weighted Average Grant Date Fair Value Per Share Outstanding Ending | $ 21 | $ 20.95 |
Total Grant Date Fair Value | ||
Total Grant Date Fair Value Outstanding Beginning | $ 796,000 | $ 0 |
Total Grant Date Fair Value Granted | 0 | 964,000 |
Total Grant Date Fair Value Vested | (265,000) | 0 |
Total Grant Date Fair Value Forfeited | (139,000) | (168,000) |
Total Grant Date Fair Value Outstanding Ending | $ 392,000 | $ 796,000 |
STOCK-BASED COMPENSATION (Det_2
STOCK-BASED COMPENSATION (Details 1) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Compensation Cost for Share-based Payment Arrangements, Allocation of Share-based Compensation Costs by Plan [Line Items] | ||
Total stock-based compensation | $ 721,209 | $ 758,757 |
Employee and director stock option grants [Member] | Research and development [Member] | ||
Compensation Cost for Share-based Payment Arrangements, Allocation of Share-based Compensation Costs by Plan [Line Items] | ||
Total stock-based compensation | 94,865 | 147,821 |
Employee and director stock option grants [Member] | General and administrative [Member] | ||
Compensation Cost for Share-based Payment Arrangements, Allocation of Share-based Compensation Costs by Plan [Line Items] | ||
Total stock-based compensation | $ 626,344 | $ 610,936 |
STOCK-BASED COMPENSATION (Det_3
STOCK-BASED COMPENSATION (Details 2) - $ / shares | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected life (years) | 6 years | 6 years |
Dividend | 0.00% | 0.00% |
Weighted-average exercise price | $ 2.99 | $ 1.91 |
Weighted-average grant-date fair value | $ 2.30 | $ 1.58 |
Maximum [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Volatility | 106.00% | 110.00% |
Risk-free interest rate | 3.05% | 2.18% |
Minimum [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Volatility | 91.00% | 107.00% |
Risk-free interest rate | 2.64% | 1.89% |
STOCK-BASED COMPENSATION (Det_4
STOCK-BASED COMPENSATION (Details 3) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Share-based Compensation, Stock Options, Activity [Line Items] | ||
Granted - Weighted Average Exercise Price (in dollars per share) | $ 2.99 | $ 1.91 |
Stock Option Activity [Member] | ||
Share-based Compensation, Stock Options, Activity [Line Items] | ||
Outstanding - Number of Shares Issuable Upon Exercise of Outstanding Options | 53,165 | 47,133 |
Granted - Number of Shares Issuable Upon Exercise of Outstanding Options | 184,129 | 11,230 |
Exercised - Number of Shares Issuable Upon Exercise of Outstanding Options | (2,083) | |
Expired- Number of Shares Issuable Upon Exercise of Outstanding Options | (2,344) | (201) |
Forfeited - Number of Shares Issuable Upon Exercise of Outstanding Options | (2,607) | (2,914) |
Outstanding - Number of Shares Issuable Upon Exercise of Outstanding Options | 232,343 | 53,165 |
Exercisable - Number of Shares Issuable Upon Exercise of Outstanding Options | 45,448 | |
Unvested - Number of Shares Issuable Upon Exercise of Outstanding Options | 186,895 | |
Outstanding - Weighted Average Exercise Price (in dollars per share) | $ 73.82 | $ 75.90 |
Granted - Weighted Average Exercise Price (in dollars per share) | 2.99 | 19.10 |
Exercised - Weighted Average Exercise Price (in dollars per share) | 14.80 | |
Expired- Weighted Average Exercise Price (in dollars per share) | 463.16 | 1,166.10 |
Forfeited - Weighted Average Exercise Price (in dollars per share) | 19.46 | 14.80 |
Outstanding - Weighted Average Exercise Price (in dollars per share) | 14.37 | $ 73.82 |
Exercisable - Weighted Average Exercise Price (in dollars per share) | 51.97 | |
Unvested - Weighted Average Exercise Price (in dollars per share) | $ 5.23 | |
Exercisable - Weighted Average Remaining Contracted Term in Years | 7 years 10 months 6 days | |
Unvested - Weighted Average Remaining Contracted Term in Years | 9 years 7 months 24 days | |
Exercisable - Aggregate Intrinsic Value (in dollars) | $ 0 | |
Unvested - Aggregate Intrinsic Value (in dollars) | $ 0 |
STOCK-BASED COMPENSATION (Det_5
STOCK-BASED COMPENSATION (Details Textual) - USD ($) | 1 Months Ended | 12 Months Ended | ||||
May 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | May 31, 2018 | Dec. 31, 2016 | Jun. 09, 2015 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Employee Service Share Based Compensation Nonvested Total Compensation In Current Year | $ 761,369 | |||||
Employee Service Share Based Compensation Nonvested Total Compensation In Year Two | 233,413 | |||||
Employee Service Share Based Compensation Nonvested Total Compensation In Year Three | $ 117,105 | |||||
Share Based Compensation Arrangement By Share Based Payment Award Options Unvested and Expected To Vest Outstanding Number (in shares) | 186,505 | |||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized | $ 1,111,887 | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Grants in Period, Weighted Average Grant Date Fair Value | $ 2.30 | $ 1.58 | ||||
Common Stock, Capital Shares Reserved for Future Issuance | 282,000 | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested in Period, Fair Value | $ 416,734 | $ 636,071 | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested, Weighted Average Grant Date Fair Value | $ 42.42 | $ 77.40 | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value | 191.38 | 611.20 | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Nonvested Options Forfeited, Weighted Average Grant Date Fair Value | $ 15.91 | $ 11.90 | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested, Number of Shares | 22,345 | 20,360 | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Nonvested, Number of Shares | 27,718 | 39,742 | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Option, Nonvested, Weighted Average Exercise Price | $ 4.10 | $ 29.13 | $ 32.70 | |||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 44,473 | |||||
Stock Incentive Plan 2015 [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Common Stock, Capital Shares Reserved for Future Issuance | 42,000 | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Additional Shares Authorized | 120,000 | |||||
Restricted Stock [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Grants in Period, Weighted Average Grant Date Fair Value | $ 0 | $ 20.96 | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Grants in Period | 0 | 46,000 | ||||
Restricted Stock [Member] | Stock Incentive Plan 2015 [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Grants in Period, Weighted Average Grant Date Fair Value | $ 20.96 | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period | 3 years | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Grants in Period | 46,000 | |||||
Employee [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Annual Forfeiture Rate Percentage | 2.00% | 2.00% |
INCOME TAXES (Details)
INCOME TAXES (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Current | ||
Federal | $ 0 | $ 0 |
State | 0 | 0 |
Total current | 0 | 0 |
Deferred | ||
Federal | (2,688,003) | 13,626,404 |
State | (45,138) | 1,969,262 |
Total deferred | (2,733,141) | 15,595,666 |
Change in valuation allowance | 2,733,141 | (15,595,666) |
Total | $ 0 | $ 0 |
INCOME TAXES (Details 1)
INCOME TAXES (Details 1) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Deferred tax assets | ||
Federal net operating loss | $ 26,562,715 | $ 24,353,504 |
Federal research and development tax credit carryforwards | 5,439,062 | 4,947,879 |
State net operating losses and tax credit carryforwards | 1,589,926 | 1,589,927 |
Capitalized research and development expenses | 5,959,275 | 5,772,165 |
Stock-based compensation expense | 1,565,130 | 1,445,078 |
Depreciable assets | 0 | 166,793 |
Other | 103,189 | 121,680 |
Total deferred tax assets | 41,219,297 | 38,397,026 |
Deferred tax liabilities | ||
Depreciable assets | (89,129) | 0 |
Total deferred tax liabilities | (89,129) | 0 |
Net deferred tax assets | 41,130,168 | 38,397,026 |
Less- valuation allowance | (41,130,168) | (38,397,026) |
Total deferred tax assets | $ 0 | $ 0 |
INCOME TAXES (Details 2)
INCOME TAXES (Details 2) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Effective Income Tax Rate Reconciliation [Line Items] | ||
Income tax benefit using U.S. federal statutory rate | (21.00%) | 34.00% |
State income taxes | (0.27%) | (9.58%) |
Permanent items | 2.56% | (2.55%) |
Federal tax credits | (3.44%) | 8.43% |
Change in valuation allowance | 20.65% | 115.00% |
Federal rate change | 0.00% | (143.50%) |
Other | 1.50% | (1.80%) |
Total | 0.00% | 0.00% |
INCOME TAXES (Details Textual)
INCOME TAXES (Details Textual) | 12 Months Ended |
Dec. 31, 2018USD ($) | |
Income Taxes [Line Items] | |
Effective Income Tax Rate Reconciliation, at Federal Statutory Income Tax Rate, Percent | 35.00% |
Domestic Tax Authority [Member] | |
Income Taxes [Line Items] | |
Operating Loss Carryforwards | $ 126,489,000 |
Net Operating Loss Carryforwards Expiration Period | 2019 through 2037 |
Research And Development And Investment Tax Credits | $ 5,403,000 |
Research And Development And Investment Tax Credits Expiration Period | 2019 through 2038 |
State and Local Jurisdiction [Member] | |
Income Taxes [Line Items] | |
Operating Loss Carryforwards | $ 15,862,000 |
Net Operating Loss Carryforwards Expiration Period | 2028 through 2031 |
Research And Development And Investment Tax Credits | $ 805,000 |
Research And Development And Investment Tax Credits Expiration Period | 2024 through 2033 |
NET LOSS PER SHARE (Details)
NET LOSS PER SHARE (Details) - Convertible Debt [Member] - shares | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 6,752,258 | 2,294,178 |
Warrants [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 5,318,747 | 1,183,007 |
Stock options [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 232,343 | 53,165 |
Non-vested restricted stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 18,668 | 38,000 |
Preferred shares as converted into common stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 1,182,500 | 1,020,006 |
COMMITMENTS AND CONTINGENCIES_2
COMMITMENTS AND CONTINGENCIES (Details) | Dec. 31, 2018USD ($) |
2,019 | $ 138,619 |
2,020 | 152,626 |
2,021 | 155,403 |
2,022 | 158,235 |
2,023 | 161,123 |
Thereafter | 13,610 |
Total | $ 779,616 |
COMMITMENTS AND CONTINGENCIES_3
COMMITMENTS AND CONTINGENCIES (Details Textual) | Sep. 05, 2007USD ($) | Dec. 31, 2018USD ($)ft² | Dec. 31, 2017USD ($) | Jun. 04, 2018ft² |
Lessee, Operating Lease, Option to Extend | The Company has an option to extend the term of the lease for one additional 60-month period. | |||
Lessee, Operating Lease, Liability, Payments, Due | $ 783,000 | |||
Operating Leases, Rent Expense | $ 8,050 | 29,000 | $ 130,000 | |
Florham Park New Jersey [Member] | ||||
Area of Land | ft² | 3,893 | |||
Payments for Leases Security Deposits | 75,000 | |||
Lessee, Operating Lease, Liability, Undiscounted Excess Amount | 828,000 | |||
Lessee, Operating Lease, Liability, Payments, Due | $ 176,000 | |||
Lease Expiration Date | Feb. 29, 2024 | |||
Operating Leases, Rent Expense | $ 12,500 | |||
Lease Rent Escalation Percentage | 2.00% | |||
Madison Wisconsin [Member] | ||||
Area of Land | ft² | 300 | |||
Lessee, Operating Lease, Term of Contract | 36 months | |||
Lessee, Operating Lease, Liability, Payments, Due | $ 55,000 | |||
Lease Expiration Date | Aug. 31, 2019 | |||
Operating Leases, Rent Expense | $ 3,300 | |||
Lease Rent Escalation Percentage | 3.00% | |||
Lease Rent Expansion Space | $ 1,140 | |||
Expansion Space For Lease | ft² | 3,400 | |||
Lease Term | 3 years | |||
Property, Plant and Equipment, Useful Life | 17 years | |||
Maximum Renovation Expense | $ 55,000 |