Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2020 | Nov. 04, 2020 | |
Document Type | 10-Q | |
Document Period End Date | Sep. 30, 2020 | |
Entity Registrant Name | Cellectar Biosciences, Inc. | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 26,813,593 | |
Entity Central Index Key | 0001279704 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2020 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false | |
Common Stock [Member] | ||
Trading Symbol | CLRB | |
Title of 12(b) Security | Common stock, par value $0.00001 | |
Security Exchange Name | NASDAQ | |
Warrant [Member] | ||
Trading Symbol | CLRBZ | |
Title of 12(b) Security | Warrant to purchase common stock, expiring April 20, 2021 | |
Security Exchange Name | NASDAQ |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) | Sep. 30, 2020 | Dec. 31, 2019 |
CURRENT ASSETS: | ||
Cash and cash equivalents | $ 18,841,944 | $ 10,614,722 |
Prepaid expenses and other current assets | 960,906 | 770,951 |
Total current assets | 19,802,850 | 11,385,673 |
Fixed assets, net | 374,697 | 435,083 |
Right-of-use asset, net | 299,982 | 348,841 |
Long-term assets | 219,121 | 75,000 |
Other assets | 6,214 | |
TOTAL ASSETS | 20,696,650 | 12,250,811 |
CURRENT LIABILITIES: | ||
Accounts payable and accrued liabilities | 3,839,318 | 2,663,873 |
Lease liability | 116,257 | 105,885 |
Total current liabilities | 3,955,575 | 2,769,758 |
LONG-TERM LIABILITIES: | ||
Lease liability | 333,375 | 421,644 |
Loan payable | 184,000 | |
Total long-term liabilities | 517,375 | 421,644 |
TOTAL LIABILITIES | 4,472,950 | 3,191,402 |
COMMITMENTS AND CONTINGENCIES (Note 7) | ||
STOCKHOLDERS' EQUITY: | ||
Series C preferred stock: 215 issued and outstanding as of September 30, 2020 and December 31, 2019 | 1,148,204 | 1,148,204 |
Common stock, $0.00001 par value; 80,000,000 shares authorized; 26,813,593 and 9,386,689 shares issued and outstanding as of September 30, 2020 and December 31, 2019, respectively | 268 | 94 |
Additional paid-in capital | 138,235,579 | 119,592,366 |
Accumulated deficit | (123,160,351) | (111,681,255) |
Total stockholders' equity | 16,223,700 | 9,059,409 |
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ 20,696,650 | $ 12,250,811 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS(Parenthetical) - $ / shares | Sep. 30, 2020 | Dec. 31, 2019 |
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 | 26,813,593 | 9,386,689 |
Common stock, shares outstanding | 26,813,593 | 9,386,689 |
Series C Preferred Stock [Member] | ||
Preferred stock, issued | 215 | 215 |
Preferred stock, outstanding | 215 | 215 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
COSTS AND EXPENSES: | ||||
Research and development | $ 2,683,944 | $ 2,703,831 | $ 7,765,673 | $ 6,821,775 |
General and administrative | 1,225,993 | 1,260,048 | 3,725,153 | 3,972,275 |
Total costs and expenses | 3,909,937 | 3,963,879 | 11,490,826 | 10,794,050 |
LOSS FROM OPERATIONS | (3,909,937) | (3,963,879) | (11,490,826) | (10,794,050) |
OTHER INCOME (EXPENSE): | ||||
Gain on revaluation of derivative warrants | 46,000 | 43,000 | ||
Interest income, net | 374 | 14,072 | 11,730 | 38,041 |
Total other income, net | 374 | 60,072 | 11,730 | 81,041 |
NET LOSS | $ (3,909,563) | $ (3,903,807) | $ (11,479,096) | $ (10,713,009) |
BASIC AND DILUTED NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS PER COMMON SHARE | $ (0.15) | $ (0.42) | $ (0.69) | $ (1.51) |
SHARES USED IN COMPUTING BASIC AND DILUTED NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS PER COMMON SHARE | 26,326,782 | 9,386,703 | 16,539,183 | 7,098,285 |
CONSOLIDATED STATEMENTS OF STOC
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) | Preferred Stock [Member] | Common Stock [Member] | Additional Paid-In Capital [Member] | Accumulated Deficit [Member] | Total |
BALANCE at Dec. 31, 2018 | $ 2,526,049 | $ 47 | $ 108,323,208 | $ (97,588,343) | $ 13,260,961 |
BALANCE (in shares) at Dec. 31, 2018 | 473 | 4,732,387 | |||
Stock-based compensation | 207,654 | 207,654 | |||
Vested restricted stock (in shares) | 9,334 | ||||
Retired shares (in shares) | (12) | ||||
Conversion of preferred shares into common shares | $ (736,987) | $ 4 | 736,983 | ||
Conversion of preferred shares into common shares (in shares) | (138) | 345,000 | |||
Net loss | (3,621,641) | (3,621,641) | |||
BALANCE at Mar. 31, 2019 | $ 1,789,062 | $ 51 | 109,267,845 | (101,209,984) | 9,846,974 |
BALANCE (in shares) at Mar. 31, 2019 | 335 | 5,086,709 | |||
BALANCE at Dec. 31, 2018 | $ 2,526,049 | $ 47 | 108,323,208 | (97,588,343) | 13,260,961 |
BALANCE (in shares) at Dec. 31, 2018 | 473 | 4,732,387 | |||
Net loss | (10,713,009) | ||||
BALANCE at Sep. 30, 2019 | $ 1,148,204 | $ 94 | 119,384,474 | (108,301,352) | 12,231,420 |
BALANCE (in shares) at Sep. 30, 2019 | 215 | 9,386,703 | |||
BALANCE at Mar. 31, 2019 | $ 1,789,062 | $ 51 | 109,267,845 | (101,209,984) | 9,846,974 |
BALANCE (in shares) at Mar. 31, 2019 | 335 | 5,086,709 | |||
Stock-based compensation | 301,471 | 301,471 | |||
Issuance of common stock and warrants, net of issuance costs | $ 40 | 9,024,529 | 9,024,569 | ||
Sale of shares (in shares) | 4,000,000 | ||||
Retired shares (in shares) | (6) | ||||
Conversion of preferred shares into common shares | $ (640,858) | $ 3 | 640,855 | ||
Conversion of preferred shares into common shares (in shares) | (120) | 300,000 | |||
Net loss | (3,187,561) | (3,187,561) | |||
BALANCE at Jun. 30, 2019 | $ 1,148,204 | $ 94 | 119,234,700 | (104,397,545) | 15,985,453 |
BALANCE (in shares) at Jun. 30, 2019 | 215 | 9,386,703 | |||
Stock-based compensation | 149,774 | 149,774 | |||
Net loss | (3,903,807) | (3,903,807) | |||
BALANCE at Sep. 30, 2019 | $ 1,148,204 | $ 94 | 119,384,474 | (108,301,352) | 12,231,420 |
BALANCE (in shares) at Sep. 30, 2019 | 215 | 9,386,703 | |||
BALANCE at Dec. 31, 2019 | $ 1,148,204 | $ 94 | 119,592,366 | (111,681,255) | 9,059,409 |
BALANCE (in shares) at Dec. 31, 2019 | 215 | 9,386,689 | |||
Stock-based compensation | 144,146 | 144,146 | |||
Vested restricted stock (in shares) | 9,334 | ||||
Retired shares (in shares) | (8) | ||||
Net loss | (3,957,608) | (3,957,608) | |||
BALANCE at Mar. 31, 2020 | $ 1,148,204 | $ 94 | 119,736,512 | (115,638,863) | 5,245,947 |
BALANCE (in shares) at Mar. 31, 2020 | 215 | 9,396,015 | |||
BALANCE at Dec. 31, 2019 | $ 1,148,204 | $ 94 | 119,592,366 | (111,681,255) | 9,059,409 |
BALANCE (in shares) at Dec. 31, 2019 | 215 | 9,386,689 | |||
Net loss | (11,479,096) | ||||
BALANCE at Sep. 30, 2020 | $ 1,148,204 | $ 268 | 138,235,579 | (123,160,351) | 16,223,700 |
BALANCE (in shares) at Sep. 30, 2020 | 215 | 26,813,593 | |||
BALANCE at Mar. 31, 2020 | $ 1,148,204 | $ 94 | 119,736,512 | (115,638,863) | 5,245,947 |
BALANCE (in shares) at Mar. 31, 2020 | 215 | 9,396,015 | |||
Stock-based compensation | 92,643 | 92,643 | |||
Issuance of common stock and warrants, net of issuance costs | $ 146 | 18,258,435 | 18,258,581 | ||
Sale of shares (in shares) | 14,601,628 | ||||
Conversion of preferred shares into common shares | $ 14 | 14 | |||
Conversion of preferred shares into common shares (in shares) | 1,474,740 | ||||
Net loss | (3,611,925) | (3,611,925) | |||
BALANCE at Jun. 30, 2020 | $ 1,148,204 | $ 254 | 138,087,590 | (119,250,788) | 19,985,260 |
BALANCE (in shares) at Jun. 30, 2020 | 215 | 25,472,383 | |||
Stock-based compensation | 116,292 | 116,292 | |||
Conversion of preferred shares into common shares | $ 14 | 31,697 | 31,711 | ||
Conversion of preferred shares into common shares (in shares) | 1,341,210 | ||||
Net loss | (3,909,563) | (3,909,563) | |||
BALANCE at Sep. 30, 2020 | $ 1,148,204 | $ 268 | $ 138,235,579 | $ (123,160,351) | $ 16,223,700 |
BALANCE (in shares) at Sep. 30, 2020 | 215 | 26,813,593 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (11,479,096) | $ (10,713,009) |
Adjustments to reconcile net loss to cash used in operating activities: | ||
Depreciation and amortization | 105,529 | 100,216 |
Stock-based compensation expense | 353,081 | 658,899 |
Noncash lease Expense | 48,859 | 41,542 |
Gain on revaluation of derivative warrants | (43,000) | |
Changes in: | ||
Prepaid expenses and other current assets | (189,955) | (331,451) |
Lease liability | (77,897) | (57,263) |
Accounts payable and accrued liabilities | 1,175,445 | 1,331,523 |
Cash used in operating activities | (10,064,034) | (9,012,543) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchases of fixed assets | (45,143) | (18,817) |
Cash used in investing activities | (45,143) | (18,817) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from issuance of common stock and warrants, net of underwriting issuance costs | 18,258,581 | 9,024,569 |
Deferred issuance costs | (137,907) | |
Proceeds from long-term obligations | 184,000 | |
Proceeds from issuance of warrants | 31,697 | |
Issuance of common stock in connection with exercise of warrants | 28 | |
Payments on capital lease obligations | (2,213) | |
Cash provided by financing activities | 18,336,399 | 9,022,356 |
NET INCREASE IN CASH AND CASH EQUIVALENTS | 8,227,222 | (9,004) |
CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD | 10,614,722 | 13,310,616 |
CASH AND CASH EQUIVALENTS AT END OF PERIOD | 18,841,944 | 13,301,612 |
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION | ||
Cash paid for interest expense | $ 1,584 | 1,936 |
Obtaining a right-of-use asset in exchange for a lease liability | 405,000 | |
Lease liability established through right-of-use asset | $ 609,000 |
NATURE OF BUSINESS, ORGANIZATIO
NATURE OF BUSINESS, ORGANIZATION AND GOING CONCERN | 9 Months Ended |
Sep. 30, 2020 | |
NATURE OF BUSINESS, ORGANIZATION AND GOING CONCERN | |
NATURE OF BUSINESS, ORGANIZATION AND GOING CONCERN | 1. NATURE OF BUSINESS, ORGANIZATION AND GOING CONCERN Cellectar Biosciences, Inc. (the Company) is a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer leveraging our proprietary phospholipid drug conjugate™ (PDCs™) delivery platform that are designed to specifically target cancer cells and deliver improved efficacy and better safety as a result of fewer off-target effects. The COVID-19 pandemic has created uncertainties in the expected timelines for clinical stage biopharmaceutical companies such as us, and because of such uncertainties, it is difficult for us to accurately predict expected outcomes at this time. The Company has not yet experienced any significant impacts as a result of the pandemic and have continued to enroll patients in our clinical studies. However, COVID-19 may impact our future ability to recruit patients for clinical studies, obtain adequate supply of CLR 131 and obtain additional financing. 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 $123,160,351 at September 30, 2020. The Company has devoted substantially all its efforts toward research and development and has, during the nine months ended September 30, 2020, generated an operating loss of approximately $11,491,000. The Company expects that it will continue to generate operating losses for the foreseeable future. The Company believes that it has sufficient liquidity to fund operations for at least 12 months from the filing of these financial statements, therefore, the accompanying financial statements have been prepared on a basis that assumes 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’s ability to execute its operating plan beyond that time 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 as there can be no assurance that the Company obtain the necessary funding. The accompanying Condensed Consolidated Balance Sheet as of December 31, 2019 has been derived from audited financial statements. The accompanying unaudited Condensed Consolidated Balance Sheet as of September 30, 2020, the Condensed Consolidated Statements of Operations, the Condensed Statements of Stockholders’ Equity for the three and nine months ended September 30, 2020 and 2019, the Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2020 and 2019 and the related interim information contained within the notes to the Condensed Consolidated Financial Statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and with the instructions, rules and regulations of the Securities and Exchange Commission (“SEC”) for interim financial information. Accordingly, they do not include all the information and the notes required by U.S. GAAP for complete financial statements. In the opinion of management, the unaudited interim condensed consolidated financial statements reflect all adjustments which are of a nature necessary for the fair presentation of the Company’s consolidated financial position at September 30, 2020 and consolidated results of its operations, stockholders’ equity and cash flows for the nine months ended September 30, 2020 and 2019. The results for the three or nine months ended September 30, 2020 are not necessarily indicative of future results. These unaudited condensed consolidated financial statements should be read in conjunction with the audited financial statements and related notes thereto included in the Company’s Form 10-K for the fiscal year ended December 31, 2019, which was filed with the SEC on March 9, 2020. Principles of Consolidation — The consolidated financial statements include the accounts of the Company and the accounts of its wholly-owned subsidiary. All significant intercompany accounts and transactions have been eliminated in consolidation. 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). Because of 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. The Company’s 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 fixed asset impairment charges recorded during the nine months ended September 30, 2020 or year ended December 31, 2019. Right-of-Us e Asset and Lease Liabilities — In February 2016, the Financial Accounting Standard Board (“FASB”) issued Accounting Standard Update (“ASU”) 2016‑02, Leases (ASC 842), which supersedes the existing guidance for lease accounting, Leases (Topic 840). ASU 2016‑02 required lessees to recognize Right-Of-Use (“ROU”) Asset and Lease Liability for virtually all of their leases (other than leases that meet the definition of a short-term lease). On January 1, 2019, the Company adopted FASB Accounting Standards Codification (“ASC”) Topic 842 using the modified retrospective method for all material leases that existed at or commenced after January 1, 2019. ROU Assets are amortized over their estimated useful life, which represents the full term of the lease. 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 2020 and 2019 ranged from one year 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 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 September 30, 2020 and December 31, 2019. 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 as a result of 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 June 30, 2019. 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 June 30, 2019, these warrants represented the only outstanding derivative instruments issued or held by the Company and expired on August 20, 2019. 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 September 30, 2020 and December 31, 2019 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 September 30, 2020, and December 31, 2019, uninsured cash balances totaled approximately $18,600,000 and $10,100,000, respectively. Leases — In February 2016, the FASB issued ASU 2016-02, Leases (ASC 842), which supersedes the existing guidance for lease accounting, Leases (Topic 840). ASU 2016-02 required lessees to recognize Right-Of-Use Asset and Lease Liability for virtually all of their leases (other than leases that meet the definition of a short-term lease). Lessor accounting remains largely unchanged except for changes in the definition and classification of leases. Because of the immaterial financial impact, the Company will not apply ASC 842 to leases that individually have total lease payments of less than $100,000 over their life of service to the Company. |
FAIR VALUE
FAIR VALUE | 9 Months Ended |
Sep. 30, 2020 | |
FAIR VALUE | |
FAIR VALUE | 2. 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. |
STOCKHOLDERS' EQUITY
STOCKHOLDERS' EQUITY | 9 Months Ended |
Sep. 30, 2020 | |
STOCKHOLDERS' EQUITY | |
STOCKHOLDERS' EQUITY | 3. STOCKHOLDERS’ EQUITY June 2020 Public Offering On June 5, 2020, the Company issued and sold 14,601,628 shares of common stock, 2,789,700 pre-funded warrants exercisable for one share of our common stock at an exercise price of $0.00001 per share and 8,695,664 Series H warrants to purchase 8,695,664 shares of common stock. The public offering price of a share of common stock together with one-half of a Series H warrant to purchase one share of common stock was $1.15. The public offering price of a pre-funded warrant together with one-half of a Series H Warrant was $1.1499. The Series H warrants have an exercise price of $1.2075 per share and are exercisable for five years from the date of issuance. As of September 30, 2020, all 2,789,700 pre-funded warrants and 26,250 Series H warrants have been exercised. In accordance with the concept of ASC 820 regarding the June 2020 public offering, the Company allocated value of the proceeds to the common stock and warrants utilizing a relative fair value basis. Using the Nasdaq closing trading price for our stock on June 5, 2020, the Company computed the fair value of the shares sold. The fair value of the warrants was estimated using the Black-Scholes option-pricing model at that same date. This valuation did not impact total Stockholders' Equity of $20.0 million, but is an internal proportionate calculation allocating the gross proceeds of approximately $12.1 million to common stock and $7.9 million to warrants. Gross offering proceeds to the Company were $20.0 million, with net proceeds to the Company of approximately $18.3 million after deducting placement agent fees and related offering expenses. The Company intends to use the net proceeds from the offering for research and development, funding clinical studies, working capital and general corporate purposes. The common stock, pre-funded warrants and Series H warrants were offered by the Company pursuant to a registration statement on Form S-1 filed on May 8, 2020 with the SEC under the Securities Act of 1933, as amended (the "Act") and an additional registration statement filed on June 2, 2020 pursuant to Rule 462(b) under the Act. May 2019 Public Offering On May 20, 2019, the Company issued and sold 1,982,000 shares of common stock at an offering price of $2.50 per share. In a concurrent private placement, the Company issued to the purchasers of our common stock, Series F warrants to purchase an aggregate of 1,982,000 shares of common stock. The Series F warrants were immediately exercisable, expire five years after the date of issuance, and have an exercise price of $2.40. In a separate concurrent private placement transaction, the Company sold 2,018,000 shares of common stock together with Series G warrants to purchase an aggregate of up to 2,018,000 shares of common stock. The shares of common stock and Series G warrants were priced at $2.50 per fixed combination. The warrants sold in the private placement were immediately exercisable, expire five years after the date of issuance, and have an exercise price of $2.40. In accordance with the concept of ASC 820 regarding the May 2019 public offering, the Company allocated value to the proceeds to the common stock and warrants utilizing a relative fair value basis. Using the Nasdaq closing trading price for our stock on May 20, 2019, the Company computed the fair value of the shares sold. The fair value of the warrants was estimated using the Black-Scholes option-pricing model at that same date. This valuation did not impact total Stockholders’ Equity of $10.0 million, but is an internal proportionate calculation allocating the gross proceeds of approximately $6 million to common stock and $4.0 million to warrants. Gross offering proceeds to the Company were $10.0 million, with net proceeds to the Company of approximately $9.0 million after deducting placement agent fees and related offering expenses. The Company used the net proceeds from the offering for research and development, funding clinical studies, working capital and general corporate purposes. The registered direct offering described above was made pursuant to a registration statement on Form S-3 previously filed with and subsequently declared effective by the SEC. The unregistered common shares and warrants were offered pursuant to the exemption from registration afforded by Section 4(a)(2) under the Act, and Regulation D promulgated thereunder. The offerings’ unregistered common shares and warrants were ultimately registered through our May 31, 2019 filing of Form S-1 and acceptance of this Registration Statement by the SEC. Common Stock Warrants The following table summarizes information with regard to outstanding warrants to purchase common stock as of September 30, 2020. Number of Shares Issuable Upon Exercise of Outstanding Exercise Offering Warrants Price Expiration Date June 2020 Series H Warrants 8,669,414 $ June 5, 2025 May 2019 Series F Warrants 1,982,000 $ May 20, 2024 May 2019 Series G Warrants 2,018,000 $ May 20, 2024 July 2018 Series E Warrants 4,140,000 $ July 31, 2023 October 2017 Series D Warrants 310,856 $ October 14, 2024 November 2016 Public Offering Series C 415,785 $ November 29, 2021 April 2016 Underwritten Registered Series A 362,694 $ April 20,2021 October 2015 Incremental Series A 30,006 $ October 20,2021 October 2015 Private Placement Series A 8,636 $ April 1, 2021 October 2015 Offering – Placement Agent 375 $ October 1, 2020 Total 17,937,766 |
STOCK-BASED COMPENSATION
STOCK-BASED COMPENSATION | 9 Months Ended |
Sep. 30, 2020 | |
STOCK-BASED COMPENSATION | |
STOCK-BASED COMPENSATION | 4. STOCK-BASED COMPENSATION Accounting for Stock-Based Compensation During the nine-month periods ended September 30, 2020 and 2019 options granted were 653,750 and 411,930, respectively. The following table summarizes amounts charged to expense for stock-based compensation related to employee and director stock option grants and recorded in connection with stock options granted to non-employee consultants: Nine Months Ended September 30, 2020 2019 Employee and director stock option grants: Research and development $ 50,071 $ 47,825 General and administrative 303,010 611,074 Total stock-based compensation $ 353,081 $ 658,899 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 the Company’s historical volatility since its common stock has been publicly traded. 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, for the nine months ended September 30, 2020 and for the year ended December 31, 2019. Ultimately, the actual expense recognized over the vesting period will be for only those shares that vest. Dividends. The Company has not historically recorded dividends related to stock options. Exercise prices for all grants made during the nine months ended September 30, 2020 were equal to the market value of the Company’s common stock on the date of grant. Stock Option Activity A summary of stock option activity is as follows: Weighted Number of Average Shares Issuable Remaining Upon Exercise Weighted Contracted Aggregate of Outstanding Average Term in Intrinsic Options Exercise Price Years Value Outstanding at December 31, 2019 610,714 $ $ 34,750 Granted 653,750 $ Forfeited (80,000) $ Outstanding at September 30, 2020 1,184,464 $ $ — Exercisable, September 30, 2020 432,096 $ $ — Unvested, September 30, 2020 752,368 $ $ — 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. There have been no option exercises to date. Shares of common stock issued upon the exercise of options are from authorized but unissued shares. As of September 30, 2020, there was approximately $904,000 of total unrecognized compensation cost related to unvested stock-based compensation arrangements. Of this total amount, the Company expects to recognize approximately $114,000, $425,000, $292,000, and $73,000 during 2020, 2021, 2022, and 2023 respectively. The Company’s expense estimates are based upon the expectation that all unvested options will vest in the future, less the forfeiture rate discussed above. The weighted-average grant-date fair value of vested and unvested options outstanding at September 30, 2020 was $6.91 and $1.45, respectively. 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 vested annually over a three year period. The following table summarizes the restricted stock grants: Weighted Average Grant Date Total Grant Number of Fair Value Date Fair Shares Per Share Value Outstanding at December 31, 2019 9,334 $ 21.00 $ 196,000 Vested (9,334) $ 21.00 $ (196,000) Outstanding at September 30, 2020 — $ — $ — |
INCOME TAXES
INCOME TAXES | 9 Months Ended |
Sep. 30, 2020 | |
INCOME TAXES | |
INCOME TAXES | 5. INCOME TAXES The Company accounts for income taxes in accordance with the liability method of accounting. Deferred tax assets or liabilities are computed based on the difference between the financial statement and income tax basis of assets and liabilities, and net operating loss carryforwards, (“NOLs”) using the enacted tax rates. Deferred income tax expense or benefit is based on changes in the asset or liability from period to period. The Company did not record a provision or benefit for federal, state or foreign income taxes for the nine months ended September 30, 2020 or 2019 because the Company has experienced losses on a tax basis since inception. Because of the limited operating history, continuing losses and uncertainty associated with the utilization of the NOLs in the future, management has provided a full allowance against the value of its gross deferred tax assets. The Company also accounts for the uncertainty in income taxes related to the recognition and measurement of a tax position taken or expected to be taken in an income tax return. The Company follows the applicable accounting guidance on derecognition, classification, interest and penalties, accounting in interim periods, disclosure and transition related to the uncertainty in income tax positions. No uncertain tax positions have been identified. |
NET LOSS PER SHARE
NET LOSS PER SHARE | 9 Months Ended |
Sep. 30, 2020 | |
NET LOSS PER SHARE | |
NET LOSS PER SHARE | 6. NET LOSS PER SHARE Basic net income (loss) per share is computed by dividing net income (loss) by the weighted average number of shares of common stock outstanding during the period. Diluted net income (loss) per share for the three and nine months ended September 30, 2020 and September 30, 2019 is computed by dividing net income (loss) 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, non-vested restricted stock, preferred shares convertible into common stock and, pre-funded warrants. Since there is a net loss attributable to common stockholders for the three and nine months ended September 30, 2020 and September 30, 2019, the inclusion of common stock equivalents in the computation for that period would be antidilutive. The following potentially dilutive securities have been excluded from the computation of diluted net income (loss) per share since their inclusion would be antidilutive: Nine Months Ended September 30, 2020 2019 Warrants 17,937,766 9,268,352 Preferred shares as convertible into common stock 537,500 537,500 Stock options 1,184,464 610,714 Non-vested restricted stock — 9,334 Total potentially dilutive shares 19,659,730 10,425,900 |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 9 Months Ended |
Sep. 30, 2020 | |
COMMITMENTS AND CONTINGENCIES | |
COMMITMENTS AND CONTINGENCIES | 7. 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 2018 and terminates in February 2024. The Company has an option to extend the term of the lease for one additional 60‑month period. 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 is 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. Madison, Wisconsin The Company presently rents office space in Madison and is rented for approximately $3,000 per month under an agreement that expires on August 31, 2021. Legal From time to time, the Company may become engaged in litigation or other legal proceedings as part of our ordinary course of business but are not currently party to any litigation or legal proceedings that, in the opinion of management, are likely to have a material adverse effect on its business. |
LEASES
LEASES | 9 Months Ended |
Sep. 30, 2020 | |
LEASES | |
LEASES | 8. LEASES Operating Lease Liability In June 2018, the Company executed an agreement for office space in the Borough of Florham Park, Morris County, New Jersey to be used as its headquarters (“HQ Lease”). The HQ Lease commenced upon completion of certain improvements in October 2018 and terminates in February 2024 with an option to extend the term of the lease for one additional 60‑month period. During 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 amortized the deferred liability as a reduction to rent expense in the consolidated statement of operations over the term of the lease. For fiscal year 2018, rent expense was recognized on a straight-line basis and accordingly the difference between the recorded rent expense and the actual cash payments had been recorded as deferred rent current and deferred rent, long-term of each balance sheet date on the consolidated balance sheet. As of December 31, 2018, the Lease Liability was measured at the present value of the lease payments to be made over the lease term. Lease payments comprise of fixed and variable payments to be made by the Company to the Lessor during the lease term minus any incentives or rebates or abatements receivable by the Company from the Lessor or owner. Payments for non-lease components did not form part of lease payments. The lease term calculation included renewal options only in the case if these options are specified in the lease agreement and if failure to exercise the renewal option imposes a significant economic penalty. As there are no such significant economic penalties in the HQ Lease and renewal cannot be reasonably assured, the valuation of the HQ Lease does not include any renewal options. The Company has not entered into any leases with related parties. Under the HQ Lease, the Company will pay monthly fixed rent based on approximate rate per rentable square foot which ranges between approximately $12,400 to $13,600 over the lease period. In addition, the Company received certain rent abatements and lease incentives subject to the limitations in the HQ Lease. The HQ Lease’s net ROU asset and ROU lease liability are approximately $300,000 and ($450,000), respectively, as of September 30, 2020 and rental expense for the nine months ended September 30, 2020 is approximately $85,000. On January 1, 2019, the Company adopted ASC 842 using the modified retrospective method for all material leases that existed at or commenced after January 1, 2019 and elected to apply the practical expedients in ASC 842‑10‑65‑1 (f) and (gg) to the HQ Lease. The Company accounts for short-term leases (i.e., lease term of 12 months or less) by making the short-term lease policy election and will not apply the recognition and measurement requirements of ASC 842. As a result of the immaterial financial impact, the Company will not apply ASC 842’s extensive calculation and reporting requirement against the leases that individually have total lease payments of less than $100,000 over their life of service to the Company. The adoption of ASC 842 did not have a material net impact on the Company’s Condensed Consolidated Statements of Operations as of the effective date. See Note 1 for additional details. Discount Rate The Company has determined the interest rate implicit in the lease considering factors such as Company’s credit rating, borrowing terms offered by the U.S. Small Business Administration, amount of lease payments, quality of collateral and alignment of the borrowing term and lease term. The Company considers 10% per annum as reasonable to use as the incremental borrowing rate for purposes of the calculation of lease liabilities. Maturity Analysis of Short-Term and Operating Leases The following table approximates the dollar maturity of the Company’s undiscounted payments for its short-term leases and operating lease liabilities as of September 30, 2020: Remainder of 2020 $ 39,000 Years ending December 31, 2021 155,000 2022 158,000 2023 161,000 2024 14,000 Total undiscounted lease payments 527,000 Less: Imputed interest (77,000) Present value of lease liabilities $ 450,000 |
LOAN PAYABLE
LOAN PAYABLE | 9 Months Ended |
Sep. 30, 2020 | |
LOAN PAYABLE. | |
LOAN PAYABLE | 9. LOAN PAYABLE On April 21, 2020, the Company received loan proceeds in the amount of approximately $184,000 under the Paycheck Protection Program (“PPP”). The PPP, established as part of the Coronavirus Aid, Relief and Economic Security Act (“CARES Act”), provides for loans to qualifying businesses for amounts up to 2.5 times of the average monthly payroll expenses of the qualifying business. The loans and accrued interest are forgivable after twenty four weeks as long as the borrower uses the loan proceeds for eligible purposes, including payroll, benefits, rent and utilities, and maintains its payroll levels. The amount of loan forgiveness will be reduced if the borrower terminates employees or reduces salaries during the twenty four-week period. The unforgiven portion of the PPP loan is payable over two years at an interest rate of 1%, with a deferral of payments for the first six months. The Company intends to use the proceeds for purposes consistent with the PPP requirements. While the Company currently believes that its use of the loan proceeds will meet the conditions for forgiveness of the loan, the Company cannot assure you that it will not take actions that could cause the Company to be ineligible for forgiveness of the loan, in whole or in part. |
NATURE OF BUSINESS, ORGANIZAT_2
NATURE OF BUSINESS, ORGANIZATION AND GOING CONCERN (Policies) | 9 Months Ended |
Sep. 30, 2020 | |
NATURE OF BUSINESS, ORGANIZATION AND GOING CONCERN | |
Principles of Consolidation | Principles of Consolidation — The consolidated financial statements include the accounts of the Company and the accounts of its wholly-owned subsidiary. All significant intercompany accounts and transactions have been eliminated in consolidation. |
Fixed Assets Right-of-Use Asset and Lease Liabilities | 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). Because of 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. The Company’s 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 fixed asset impairment charges recorded during the nine months ended September 30, 2020 or year ended December 31, 2019. Right-of-Us e Asset and Lease Liabilities — In February 2016, the Financial Accounting Standard Board (“FASB”) issued Accounting Standard Update (“ASU”) 2016‑02, Leases (ASC 842), which supersedes the existing guidance for lease accounting, Leases (Topic 840). ASU 2016‑02 required lessees to recognize Right-Of-Use (“ROU”) Asset and Lease Liability for virtually all of their leases (other than leases that meet the definition of a short-term lease). On January 1, 2019, the Company adopted FASB Accounting Standards Codification (“ASC”) Topic 842 using the modified retrospective method for all material leases that existed at or commenced after January 1, 2019. ROU Assets are amortized over their estimated useful life, which represents the full term of the lease. |
Stock-Based Compensation | 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 2020 and 2019 ranged from one year 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 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 — 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 — 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 September 30, 2020 and December 31, 2019. |
Fair Value of Financial Instruments | 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 as a result of 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 | 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 June 30, 2019. 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 June 30, 2019, these warrants represented the only outstanding derivative instruments issued or held by the Company and expired on August 20, 2019. |
Concentration of Credit Risk | 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 September 30, 2020 and December 31, 2019 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 September 30, 2020, and December 31, 2019, uninsured cash balances totaled approximately $18,600,000 and $10,100,000, respectively. |
Leases | Leases — In February 2016, the FASB issued ASU 2016-02, Leases (ASC 842), which supersedes the existing guidance for lease accounting, Leases (Topic 840). ASU 2016-02 required lessees to recognize Right-Of-Use Asset and Lease Liability for virtually all of their leases (other than leases that meet the definition of a short-term lease). Lessor accounting remains largely unchanged except for changes in the definition and classification of leases. Because of the immaterial financial impact, the Company will not apply ASC 842 to leases that individually have total lease payments of less than $100,000 over their life of service to the Company. |
STOCKHOLDERS' EQUITY (Tables)
STOCKHOLDERS' EQUITY (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
STOCKHOLDERS' EQUITY | |
Schedule of Outstanding Warrants to Purchase Common Stock | The following table summarizes information with regard to outstanding warrants to purchase common stock as of September 30, 2020. Number of Shares Issuable Upon Exercise of Outstanding Exercise Offering Warrants Price Expiration Date June 2020 Series H Warrants 8,669,414 $ June 5, 2025 May 2019 Series F Warrants 1,982,000 $ May 20, 2024 May 2019 Series G Warrants 2,018,000 $ May 20, 2024 July 2018 Series E Warrants 4,140,000 $ July 31, 2023 October 2017 Series D Warrants 310,856 $ October 14, 2024 November 2016 Public Offering Series C 415,785 $ November 29, 2021 April 2016 Underwritten Registered Series A 362,694 $ April 20,2021 October 2015 Incremental Series A 30,006 $ October 20,2021 October 2015 Private Placement Series A 8,636 $ April 1, 2021 October 2015 Offering – Placement Agent 375 $ October 1, 2020 Total 17,937,766 |
STOCK-BASED COMPENSATION (Table
STOCK-BASED COMPENSATION (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
STOCK-BASED COMPENSATION | |
Schedule of Accounting for Stock-Based Compensation | The following table summarizes amounts charged to expense for stock-based compensation related to employee and director stock option grants and recorded in connection with stock options granted to non-employee consultants: Nine Months Ended September 30, 2020 2019 Employee and director stock option grants: Research and development $ 50,071 $ 47,825 General and administrative 303,010 611,074 Total stock-based compensation $ 353,081 $ 658,899 |
Schedule of Stock Options Activity | A summary of stock option activity is as follows: Weighted Number of Average Shares Issuable Remaining Upon Exercise Weighted Contracted Aggregate of Outstanding Average Term in Intrinsic Options Exercise Price Years Value Outstanding at December 31, 2019 610,714 $ $ 34,750 Granted 653,750 $ Forfeited (80,000) $ Outstanding at September 30, 2020 1,184,464 $ $ — Exercisable, September 30, 2020 432,096 $ $ — Unvested, September 30, 2020 752,368 $ $ — |
Schedule of Restricted Stock Grants | The following table summarizes the restricted stock grants: Weighted Average Grant Date Total Grant Number of Fair Value Date Fair Shares Per Share Value Outstanding at December 31, 2019 9,334 $ 21.00 $ 196,000 Vested (9,334) $ 21.00 $ (196,000) Outstanding at September 30, 2020 — $ — $ — |
NET LOSS PER SHARE (Tables)
NET LOSS PER SHARE (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
NET LOSS PER SHARE | |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | The following potentially dilutive securities have been excluded from the computation of diluted net income (loss) per share since their inclusion would be antidilutive: Nine Months Ended September 30, 2020 2019 Warrants 17,937,766 9,268,352 Preferred shares as convertible into common stock 537,500 537,500 Stock options 1,184,464 610,714 Non-vested restricted stock — 9,334 Total potentially dilutive shares 19,659,730 10,425,900 |
LEASES (Tables)
LEASES (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
LEASES | |
Schedule of Lessee, Operating Lease, Liability, Maturity | The following table approximates the dollar maturity of the Company’s undiscounted payments for its short-term leases and operating lease liabilities as of September 30, 2020: Remainder of 2020 $ 39,000 Years ending December 31, 2021 155,000 2022 158,000 2023 161,000 2024 14,000 Total undiscounted lease payments 527,000 Less: Imputed interest (77,000) Present value of lease liabilities $ 450,000 |
NATURE OF BUSINESS, ORGANIZAT_3
NATURE OF BUSINESS, ORGANIZATION AND GOING CONCERN - Additional Information (Details) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | Jun. 30, 2019 | Dec. 31, 2018 | |
Retained Earnings (Accumulated Deficit) | $ 123,160,351 | $ 123,160,351 | $ 111,681,255 | ||||
Operating Income (Loss) | (3,909,937) | $ (3,963,879) | (11,490,826) | $ (10,794,050) | |||
Cash, Cash Equivalents, Restricted Cash and Restricted Cash Equivalents, Total | 18,841,944 | $ 13,301,612 | 18,841,944 | $ 13,301,612 | 10,614,722 | $ 13,310,616 | |
Impairment Charges | 0 | 0 | |||||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range, Number of Exercisable Options | 49,425 | ||||||
Cash, Uninsured Amount | 18,600,000 | 18,600,000 | $ 10,100,000 | ||||
Lessee Operating Lease Liability Payments Due | 527,000 | $ 527,000 | |||||
Leasehold Improvements [Member] | |||||||
Property, Plant and Equipment, Useful Life | 64 months | ||||||
Maximum [Member] | |||||||
Property, Plant and Equipment, Useful Life | 10 years | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Expiration Period | 3 years | ||||||
Lessee Operating Lease Liability Payments Due | $ 100,000 | $ 100,000 | |||||
Minimum [Member] | |||||||
Property, Plant and Equipment, Useful Life | 3 years | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Expiration Period | 1 year |
STOCKHOLDERS' EQUITY - Addition
STOCKHOLDERS' EQUITY - Additional Information (Details) - USD ($) | Jun. 05, 2020 | May 20, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Mar. 31, 2020 | Dec. 31, 2019 | Mar. 31, 2019 | Dec. 31, 2018 |
Class of Warrant or Right [Line Items] | ||||||||||
Stock Issued During Period, Shares, New Issues | 1,982,000 | |||||||||
Share Price | $ 2.50 | |||||||||
Issuance of common stock and warrants, net of issuance costs | $ 10,000,000 | $ 18,258,581 | $ 9,024,569 | |||||||
Proceeds from issuance of common stock and warrants, net of underwriting issuance costs | 6,000,000 | $ 18,258,581 | $ 9,024,569 | |||||||
Proceeds from warrants | 4,000,000 | $ 31,697 | ||||||||
Net proceeds from stockholders' equity | 9,000,000 | |||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 17,937,766 | |||||||||
Common Stock, Shares Authorized | 80,000,000 | 80,000,000 | ||||||||
Common Stock, Par or Stated Value Per Share | $ 0.00001 | $ 0.00001 | ||||||||
Proceeds from Warrant Exercises | $ 28 | |||||||||
Stockholders' Equity Attributable to Parent | 19,985,260 | 15,985,453 | $ 16,223,700 | 12,231,420 | $ 5,245,947 | $ 9,059,409 | $ 9,846,974 | $ 13,260,961 | ||
Proceeds from Issuance or Sale of Equity | 9,000,000 | |||||||||
Stock Issued During Period, Value, New Issues | $ 10,000,000 | $ 18,258,581 | $ 9,024,569 | |||||||
Series F warrants [Member] | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Warrants expiration period | 5 years | |||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 2.40 | |||||||||
Exercise price of warrants (in dollars per share) | 2.40 | |||||||||
Series G warrants [Member] | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Share Price | $ 2.50 | |||||||||
June 2020 Pre Funded Warrants [Member] | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Stock Issued During Period, Shares, New Issues | 14,601,628 | |||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 2,789,700 | |||||||||
Class of Warrant or Right, Number of Securities Called by Each Warrant or Right | 1 | |||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.00001 | |||||||||
Number of warrants exercised | 2,789,700 | |||||||||
Number of share of common stock per warrant | 1 | |||||||||
Exercise price of warrants (in dollars per share) | $ 0.00001 | |||||||||
June 2020 Series H Warrants [Member] | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Issuance of common stock and warrants, net of issuance costs | $ 20,000,000 | |||||||||
Proceeds from issuance of common stock and warrants, net of underwriting issuance costs | 12,100,000 | |||||||||
Proceeds from warrants | 7,900,000 | |||||||||
Net proceeds from stockholders' equity | $ 18,300,000 | |||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 8,695,664 | |||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 1.2075 | |||||||||
Warrants and Rights Outstanding, Term | 5 years | |||||||||
Number of warrants exercised | 26,250 | |||||||||
Stockholders' Equity Attributable to Parent | $ 20,000,000 | |||||||||
Public Offering Price Of Share And Warrants | $ 1.15 | |||||||||
Public Offering Price Of Warrants | $ 1.1499 | |||||||||
Proceeds from Issuance or Sale of Equity | $ 18,300,000 | |||||||||
Stock Issued During Period, Value, New Issues | $ 20,000,000 | |||||||||
Exercise price of warrants (in dollars per share) | $ 1.2075 | |||||||||
Series C Preferred Stock [Member] | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Preferred Stock, Shares Outstanding | 215 | 215 | ||||||||
Private Placement [Member] | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Warrants expiration period | 5 years | |||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 2.40 | |||||||||
Exercise price of warrants (in dollars per share) | $ 2.40 | |||||||||
Private Placement [Member] | Series F warrants [Member] | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Warrants issued | 1,982,000 | |||||||||
Private Placement [Member] | Series G warrants [Member] | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Stock Issued During Period, Shares, New Issues | 2,018,000 | |||||||||
Warrants issued | 2,018,000 | |||||||||
Common Stock [Member] | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Stock Issued During Period, Shares, New Issues | 14,601,628 | 4,000,000 | ||||||||
Issuance of common stock and warrants, net of issuance costs | $ 146 | $ 40 | ||||||||
Stockholders' Equity Attributable to Parent | 254 | 94 | $ 268 | $ 94 | $ 94 | $ 94 | $ 51 | $ 47 | ||
Stock Issued During Period, Value, New Issues | $ 146 | $ 40 |
STOCKHOLDERS' EQUITY (Details)
STOCKHOLDERS' EQUITY (Details) | Sep. 30, 2020$ / sharesshares |
Class of Warrant or Right [Line Items] | |
Number of Shares Issuable Upon Exercise of Outstanding Warrants (in shares) | 17,937,766 |
June 2020 Series H Warrants [Member] | |
Class of Warrant or Right [Line Items] | |
Number of Shares Issuable Upon Exercise of Outstanding Warrants (in shares) | 8,669,414 |
Exercise price of warrants (in dollars per share) | $ / shares | $ 1.21 |
May 2019 Series F Warrants [Member] | |
Class of Warrant or Right [Line Items] | |
Number of Shares Issuable Upon Exercise of Outstanding Warrants (in shares) | 1,982,000 |
Exercise price of warrants (in dollars per share) | $ / shares | $ 2.40 |
May 2019 Series G Warrants [Member] | |
Class of Warrant or Right [Line Items] | |
Number of Shares Issuable Upon Exercise of Outstanding Warrants (in shares) | 2,018,000 |
Exercise price of warrants (in dollars per share) | $ / shares | $ 2.40 |
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 of warrants (in dollars per share) | $ / shares | $ 4 |
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 of warrants (in dollars per share) | $ / shares | $ 17.80 |
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 of warrants (in dollars per share) | $ / shares | $ 15 |
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 of warrants (in dollars per share) | $ / shares | $ 30.40 |
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 of warrants (in dollars per share) | $ / shares | $ 21.30 |
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 of warrants (in dollars per share) | $ / shares | $ 21.30 |
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 of warrants (in dollars per share) | $ / shares | $ 283 |
STOCK-BASED COMPENSATION (Detai
STOCK-BASED COMPENSATION (Details) - USD ($) | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
Compensation Cost for Share-based Payment Arrangements, Allocation of Share-based Compensation Costs by Plan [Line Items] | ||
Total stock-based compensation | $ 353,081 | $ 658,899 |
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 | 50,071 | 47,825 |
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 | $ 303,010 | $ 611,074 |
STOCK-BASED COMPENSATION - Stoc
STOCK-BASED COMPENSATION - Stock Option Activity (Details) - Stock Option Activity [Member] - USD ($) | Dec. 31, 2019 | Sep. 30, 2020 |
Share-based Compensation, Stock Options, Activity [Line Items] | ||
Outstanding - Number of Shares Issuable Upon Exercise of Outstanding Options | 610,714 | |
Granted - Number of Shares Issuable Upon Exercise of Outstanding Options | 653,750 | |
Forfeited - Number of Shares Issuable Upon Exercise of Outstanding Options | (80,000) | |
Outstanding - Number of Shares Issuable Upon Exercise of Outstanding Options | 610,714 | 1,184,464 |
Exercisable - Number of Shares Issuable Upon Exercise of Outstanding Options | 432,096 | |
Unvested - Number of Shares Issuable Upon Exercise of Outstanding Options | 752,368 | |
Outstanding - Weighted Average Exercise Price (in dollars per share) | $ 6.78 | |
Granted - Weighted Average Exercise Price (in dollars per share) | 1.84 | |
Forfeited - Weighted Average Exercise Price (in dollars per share) | 2.46 | |
Outstanding - Weighted Average Exercise Price (in dollars per share) | $ 6.78 | 4.34 |
Exercisable - Weighted Average Exercise Price (in dollars per share) | 8.62 | |
Unvested - Weighted Average Exercise Price (in dollars per share) | $ 1.88 | |
Outstanding - Weighted Average Remaining Contracted Term in Years | 8 years 9 months 29 days | 8 years 9 months 26 days |
Exercisable - Weighted Average Remaining Contracted Term in Years | 7 years 11 months 9 days | |
Unvested - Weighted Average Remaining Contracted Term in Years | 9 years 3 months 29 days | |
Outstanding - Aggregate Intrinsic Value | $ 34,750 | $ 0 |
Exercisable - Aggregate Intrinsic Value (in dollars) | 0 | |
Unvested - Aggregate Intrinsic Value (in dollars) | $ 0 |
STOCK-BASED COMPENSATION - Rest
STOCK-BASED COMPENSATION - Restricted Stock Grants (Details) - Non-vested restricted stock [Member] | 9 Months Ended |
Sep. 30, 2020USD ($)$ / sharesshares | |
Number of Shares | |
Number of Shares Outstanding Beginning | shares | 9,334 |
Number of Shares Vested | shares | (9,334) |
Number of Shares Outstanding Ending | shares | 0 |
Weighted Average Grant Date Fair Value Per Share | |
Weighted Average Grant Date Fair Value Per Share Outstanding Beginning | $ / shares | $ 21 |
Weighted Average Grant Date Fair Value Per Share Vested | $ / shares | 21 |
Weighted Average Grant Date Fair Value Per Share Outstanding Ending | $ / shares | $ 0 |
Total Grant Date Fair Value | |
Total Grant Date Fair Value Outstanding Beginning | $ | $ 196,000 |
Total Grant Date Fair Value Vested | $ | (196,000) |
Total Grant Date Fair Value Outstanding Ending | $ | $ 0 |
STOCK-BASED COMPENSATION - Addi
STOCK-BASED COMPENSATION - Additional Information (Details) - USD ($) | Sep. 30, 2020 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2017 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 653,750 | 411,930 | |||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized | $ 904,000 | $ 904,000 | |||
Employee Service Share Based Compensation Nonvested Total Compensation In Current Year | 114,000 | ||||
Employee Service Share Based Compensation Nonvested Total Compensation In Year Two | 425,000 | ||||
Employee Service Share Based Compensation Nonvested Total Compensation In Year Three | 292,000 | ||||
Employee Service Share Based Compensation Nonvested Total Compensation in Year Four | $ 73,000 | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested and Expected to Vest, Outstanding, Weighted Average Exercise Price | $ 1.45 | $ 1.45 | |||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Grants in Period, Weighted Average Grant Date Fair Value | $ 6.91 | ||||
Non-vested 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 | 46,000 | ||||
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 | ||||
Employee [Member] | Non-vested restricted stock [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Annual Forfeiture Rate Percentage | 2.00% | 2.00% |
NET LOSS PER SHARE (Details)
NET LOSS PER SHARE (Details) - Convertible Debt [Member] - shares | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total potentially dilutive shares | 19,659,730 | 10,425,900 |
Warrant [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total potentially dilutive shares | 17,937,766 | 9,268,352 |
Preferred shares as convertible into common stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total potentially dilutive shares | 537,500 | 537,500 |
Stock Option Activity [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total potentially dilutive shares | 1,184,464 | 610,714 |
Non-vested restricted stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total potentially dilutive shares | 9,334 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Details) | 9 Months Ended | |
Sep. 30, 2020USD ($) | Jun. 04, 2018ft² | |
Lessee Operating Lease Liability Undiscounted Excess Amount | $ 77,000 | |
Lessee Operating Lease Liability Payments Due | 527,000 | |
Florham Park New Jersey [Member] | ||
Area of Land | ft² | 3,893 | |
Lessee Operating Lease Renewal Term | 60 months | |
Payments for Leases Security Deposits | 75,000 | |
Lessee Operating Lease Liability Undiscounted Excess Amount | 828,000 | |
Lessee Operating Lease Liability Payments Due | 783,000 | |
Operating Leases Rent Expense | $ 12,500 | |
Lease Rent Escalation Percentage | 2.00% | |
Madison Wisconsin [Member] | ||
Operating Leases Rent Expense | $ 3,000 |
LEASES - Short-term Leases and
LEASES - Short-term Leases and Operating Lease Liabilities (Details) | Sep. 30, 2020USD ($) |
LEASES | |
Remainder of 2020 Years ending December 31, | $ 39,000 |
2021 | 155,000 |
2022 | 158,000 |
2023 | 161,000 |
2024 | 14,000 |
Total undiscounted lease payments | 527,000 |
Less: Imputed interest | (77,000) |
Present value of lease liabilities | $ 450,000 |
LEASES - Additional Information
LEASES - Additional Information (Details) - USD ($) | 9 Months Ended | ||
Sep. 30, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Lessee, Lease, Description [Line Items] | |||
Deferred Lease Liability | $ 176,000 | ||
Operating Leases Rent Expense Net | $ 85,000 | ||
Right-of-use asset, net | 299,982 | $ 348,841 | |
Operating Lease, Liability | $ (450,000) | ||
Operating Lease, Weighted Average Discount Rate, Percent | 10.00% | ||
Lessee Operating Lease Liability Payments Due | $ 527,000 | ||
Maximum [Member] | |||
Lessee, Lease, Description [Line Items] | |||
Operating Leases Rent Expense Net | 13,600 | ||
Lessee Operating Lease Liability Payments Due | 100,000 | ||
Minimum [Member] | |||
Lessee, Lease, Description [Line Items] | |||
Operating Leases Rent Expense Net | $ 12,400 |
LOAN PAYABLE (Details)
LOAN PAYABLE (Details) - Paycheck Protection Program [Member] | Apr. 21, 2020USD ($) |
Proceeds from loans | $ 184,000 |
Loans interest rate | 1.00% |