Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Mar. 16, 2018 | Jun. 30, 2017 | |
Document and Entity Information [Abstract] | |||
Entity Registrant Name | Actinium Pharmaceuticals, Inc. | ||
Entity Central Index Key | 1,388,320 | ||
Trading Symbol | atnm | ||
Amendment Flag | false | ||
Current Fiscal Year End Date | --12-31 | ||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2017 | ||
Document Fiscal Year Focus | 2,017 | ||
Document Fiscal Period Focus | FY | ||
Entity Well Known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Filer Category | Accelerated Filer | ||
Entity Public Float | $ 71,393,269 | ||
Entity Common Stock, Shares Outstanding | 110,198,660 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 |
Current Assets: | ||
Cash and cash equivalents | $ 17,399,636 | $ 20,519,294 |
Restricted cash - current | 34,733 | |
Prepaid expenses and other current assets | 439,322 | 1,836,451 |
Total Current Assets | 17,838,958 | 22,390,478 |
Property and equipment, net of accumulated depreciation | 57,350 | 88,549 |
Security deposit | 49,859 | 49,859 |
Restricted cash | 390,940 | |
Total Assets | 18,337,107 | 22,528,886 |
Current Liabilities: | ||
Accounts payable and accrued expenses | 4,625,088 | 4,194,874 |
Accounts payable and accrued expenses - related parties | 25,000 | 25,000 |
Derivative liabilities | 15,916 | 300,683 |
Total Current Liabilities | 4,666,004 | 4,520,557 |
Total Liabilities | 4,666,004 | 4,520,557 |
Commitments and contingencies | ||
Stockholders' Equity: | ||
Preferred stock, $0.001 par value; 50,000,000 shares authorized, 0 shares issued and outstanding | ||
Common stock, $0.001 par value; 400,000,000 shares authorized; 80,072,334 and 55,801,742 shares issued and outstanding, respectively | 80,072 | 55,802 |
Additional paid-in capital | 176,744,068 | 154,504,329 |
Accumulated deficit | (163,153,037) | (136,551,802) |
Total Stockholders' Equity | 13,671,103 | 18,008,329 |
Total Liabilities and Stockholders' Equity | $ 18,337,107 | $ 22,528,886 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2017 | Dec. 31, 2016 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 50,000,000 | 50,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 400,000,000 | 400,000,000 |
Common stock, shares issued | 80,072,334 | 55,801,742 |
Common stock, shares outstanding | 80,072,334 | 55,801,742 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Income Statement [Abstract] | |||
Revenue | |||
Operating expenses: | |||
Research and development, net of reimbursements | 17,699,503 | 17,786,655 | 13,501,895 |
General and administrative | 9,155,347 | 8,983,303 | 11,274,404 |
Depreciation expense | 55,938 | 77,523 | 53,465 |
Total operating expenses | 26,910,788 | 26,847,481 | 24,829,764 |
Loss from operations | (26,910,788) | (26,847,481) | (24,829,764) |
Other income (expense): | |||
Interest income (expense) | 5,430 | (5,007) | (7,868) |
Gain on change in fair value of derivative liabilities | 304,123 | 2,530,764 | 3,812,318 |
Total other income (expense) | 309,553 | 2,525,757 | 3,804,450 |
Net loss | $ (26,601,235) | $ (24,321,724) | $ (21,025,314) |
Net loss per common share - basic and diluted | $ (0.4) | $ (0.5) | $ (0.55) |
Weighted average common shares outstanding - basic and diluted | 66,746,389 | 48,463,268 | 38,158,480 |
Consolidated Statement of Chang
Consolidated Statement of Changes in Stockholders' Equity (Deficit) - USD ($) | Common Stock | Additional Paid-In Capital | Accumulated Deficit | Total |
Beginning Balance at Dec. 31, 2014 | $ 29,972 | $ 89,252,262 | $ (91,204,764) | $ (1,922,530) |
Beginning Balance, Shares at Dec. 31, 2014 | 29,971,839 | |||
Stock-based compensation | $ 345 | 7,061,277 | 7,061,622 | |
Stock-based compensation, Shares | 344,784 | |||
Proceeds from the sale of common stock and warrants, net of offering costs | $ 11,994 | 37,625,965 | 37,637,959 | |
Proceeds from the sale of common stock and warrants, net of offering costs, Shares | 11,993,641 | |||
Issuance of common stock from exercise of options | $ 20 | 15,660 | 15,680 | |
Issuance of common stock from exercise of options, Shares | 20,000 | |||
Issuance of common stock from exercise of warrants | $ 1,736 | 156,204 | 157,940 | |
Issuance of common stock from exercise of warrants, Shares | 1,736,277 | |||
Transfer of warrant derivatives from liability to equity classification | 48,691 | 48,691 | ||
Net loss | (21,025,314) | (21,025,314) | ||
Ending Balance at Dec. 31, 2015 | $ 44,067 | 134,160,059 | (112,230,078) | 21,974,048 |
Ending Balance, Shares at Dec. 31, 2015 | 44,066,541 | |||
Stock-based compensation | $ 82 | 4,297,696 | 4,297,778 | |
Stock-based compensation, Shares | 81,700 | |||
Proceeds from the sale of common stock and warrants, net of offering costs | $ 11,504 | 16,011,163 | 16,022,667 | |
Proceeds from the sale of common stock and warrants, net of offering costs, Shares | 11,504,427 | |||
Issuance of common stock from exercise of options | $ 23 | 18,082 | 18,105 | |
Issuance of common stock from exercise of options, Shares | 23,212 | |||
Issuance of common stock from exercise of warrants | $ 126 | (126) | ||
Issuance of common stock from exercise of warrants, Shares | 125,862 | |||
Transfer of warrant derivatives from liability to equity classification | 17,455 | 17,455 | ||
Net loss | (24,321,724) | (24,321,724) | ||
Ending Balance at Dec. 31, 2016 | $ 55,802 | 154,504,329 | (136,551,802) | 18,008,329 |
Ending Balance, Shares at Dec. 31, 2016 | 55,801,742 | |||
Stock-based compensation | $ 93 | 3,474,282 | 3,474,375 | |
Stock-based compensation, Shares | 93,385 | |||
Proceeds from the sale of common stock and warrants, net of offering costs | $ 24,173 | 18,765,461 | 18,789,634 | |
Proceeds from the sale of common stock and warrants, net of offering costs, Shares | 24,172,973 | |||
Issuance of common stock from exercise of warrants | $ 4 | (4) | ||
Issuance of common stock from exercise of warrants, Shares | 4,234 | |||
Net loss | (26,601,235) | (26,601,235) | ||
Ending Balance at Dec. 31, 2017 | $ 80,072 | $ 176,744,068 | $ (163,153,037) | $ 13,671,103 |
Ending Balance, Shares at Dec. 31, 2017 | 80,072,334 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Cash Flows From Operating Activities: | |||
Net loss | $ (26,601,235) | $ (24,321,724) | $ (21,025,314) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Stock-based compensation expense | 3,493,731 | 4,297,778 | 7,061,622 |
Depreciation expense | 55,938 | 77,523 | 53,465 |
Gain on change in fair value of derivative liabilities | (304,123) | (2,530,764) | (3,812,318) |
(Increase) decrease in: | |||
Prepaid expenses and other current assets | 1,397,129 | (1,032,988) | 162,083 |
Increase (decrease) in: | |||
Accounts payable and accrued expenses | 405,214 | 2,720,938 | (793,949) |
Accounts payable and accrued expenses - related party | (189,357) | ||
Net Cash Used In Operating Activities | (21,553,346) | (20,789,237) | (18,543,768) |
Cash Flows From Investing Activities: | |||
Payment of security deposit | (49,859) | ||
Restricted cash | (356,207) | ||
Purchase of property and equipment | (24,739) | (59,960) | (47,788) |
Net Cash Used In Investing Activities | (380,946) | (109,819) | (47,788) |
Cash Flows From Financing Activities: | |||
Payments on note payable | (265,695) | (283,552) | |
Sales of shares of common stock, net of offering costs | 18,814,634 | 16,022,667 | 37,637,959 |
Proceeds from the exercise of stock options | 18,105 | 15,680 | |
Proceeds from the exercise of warrants | 157,940 | ||
Net Cash Provided By Financing Activities | 18,814,634 | 15,775,077 | 37,528,027 |
Net change in cash | (3,119,658) | (5,123,979) | 18,936,471 |
Cash at beginning of year | 20,519,294 | 25,643,273 | 6,706,802 |
Cash at end of year | 17,399,636 | 20,519,294 | 25,643,273 |
Supplemental disclosures of cash flow information: | |||
Cash paid for interest | 5,007 | 7,868 | |
Cash paid for taxes | |||
Supplemental disclosure of non-cash investing and financing activities: | |||
Stock issuance costs included in accounts payable and accrued expenses | 25,000 | ||
Insurance prepaid through premium finance | 265,695 | ||
Fair value of warrants issued with stock | 4,738,161 | ||
Transfer from derivative liability classification to equity classification | $ 17,455 | $ 48,691 |
Description of Business and Sum
Description of Business and Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2017 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Description of Business and Summary of Significant Accounting Policies | Note 1 - Description of Business and Summary of Significant Accounting Policies Nature of Business - 131 Actinium’s CD33 program drug candidates consist of the anti-CD33 monoclonal antibody lintuzumab conjugated with the alpha-particle actinium-225 (“ 225 225 The Company is presently conducting the SIERRA trial (Study of Iomab-B in Elderly Relapsed or Refractory Acute Myeloid Leukemia). Assuming this pivotal Phase 3 clinical trial for Iomab-B meets its primary point, it will form the basis for a Biologics Licensing Application (“BLA”) with the FDA. The Company has received guidance from the FDA as part of its IND filing that it would be acceptable to file a Biologics License Application submission that includes the single, pivotal Phase 3 SIERRA clinical study if it is successful. The Company is also conducting a Phase 2 clinical trial for Actimab-A, a Phase 1 clinical trial to study Actimab-M in refractory multiple myeloma, and is also developing it AWE Technology Platform that utilizes 225 As of March 2018, the Company’s patent portfolio includes: 68 issued and pending patent applications, of which 11 are issued in the United States, 4 are pending in the United States, and 53 are issued internationally and pending internationally. Additionally, several non-provisional patent applications have and are expected to be filed in 2018 based on provisional patent applications filed in 2017 and 2018. This is part of an ongoing strategy to continue to strengthen Actinium’s intellectual property position. Approximately one quarter of its patents are in-licensed from third parties and the remainder are Actinium-owned. These patents cover key areas of our business, including use of the 225 225 Principles of Consolidation - Use of Estimates in Financial Statement Presentation - Cash and Cash Equivalents - Property and Equipment - Derivatives - Fair Value of Financial Instruments - Level 1 Inputs - Unadjusted quoted prices in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date. Level 2 Inputs - Inputs other than quoted prices included in Level 1 that are observable for the asset or liability, either directly or indirectly. These might include quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, inputs other than quoted prices that are observable for the asset or liability (such as interest rates, volatilities, prepayment speeds, credit risks, etc.) or inputs that are derived principally from or corroborated by market data by correlation or other means. Level 3 Inputs - Unobservable inputs for determining the fair values of assets or liabilities that reflect an entity’s own assumptions about the assumptions that market participants would use in pricing the assets or liabilities. The following tables set forth assets and liabilities measured at fair value on a recurring basis by level within the fair value hierarchy as of December 31, 2017 and 2016. As required by ASC 820 “ Fair Value Measurements and Disclosures” Level 1 Level 2 Level 3 Total Derivative liabilities: At December 31, 2017 $ - $ - $ 15,916 $ 15,916 At December 31, 2016 $ - $ - $ 300,683 $ 300,683 Income Taxes - The Company recognizes tax positions when the positions meet a “more-likely-than-not” recognition threshold. There were no tax positions for which it is considered reasonably possible that the total amounts of unrecognized tax benefits will significantly increase or decrease within the next year. The Company recognizes interest related to unrecognized tax benefits in interest expense and penalties in operating expenses. Research and Development Costs - Share-Based Payments - Net Loss Per Common Share December 31, December 31, December 31, Options 5,174,592 5,906,886 3,971,583 Warrants 25,662,340 8,964,752 9,018,470 Total 30,836,932 14,871,638 12,990,053 Subsequent Events Reclassifications - Recent Accounting Pronouncements – Leases In April 2016, the FASB issued ASU No. 2016-10, “ Revenue from Contracts with Customers: Identifying Performance Obligations and Licensing (Topic 606) Revenue from Contracts with Customers: Principal versus Agent Considerations (Reporting Revenue Gross verses Net) (Topic 606) In May 2016, the FASB issued ASU No. 2016-12, “ Revenue from Contracts with Customers (Topic 606): Narrow-Scope Improvements and Practical Expedients” Management does not believe that any recently issued, but not yet effective accounting pronouncements, when adopted, will have a material effect on the consolidated financial statements. |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2017 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | Note 2 - Related Party Transactions MSKCC: On February 11, 2002, the Company entered into a License, Development and Commercialization Agreement with Sloan-Kettering Institute of Cancer Research (“SKI”), an entity related to Memorial Sloan-Kettering Cancer Institute, Inc. (“MSKCC”). The agreement was amended in August 2006. Pursuant to the agreement, the Company licensed certain intellectual property from SKI, including critical patents with respect to the Company’s core technology that also supports ongoing research and clinical development of related drug candidates. MSKCC agreed, subject to certain conditions, to utilize the funds paid for certain clinical and preclinical programs and activities related to the Company’s drug development and clinical study programs, including the payment of certain costs and expenses that would otherwise have been borne by the Company. The Company is obligated to make the following milestone payments: Milestones Payments (1) filing of an New Drug Application (“NDA”) or regulatory approval for each licensed product $ 750,000 (2) upon the receipt of regulatory approval from the U.S. FDA for each licensed product 1,750,000 Under the agreement, the Company shall pay to MSKCC on a country-by-country basis a royalty of 2% of net sales of all licensed products until the later of: (1) 10 years from the first commercial sale, or (2) when the patents expire. For the years ended December 31, 2017, 2016 and 2015, the Company incurred $0.1 million, $0.1 million and $0.2 million, respectively, for maintenance fees and research conducted by MSKCC. On December 21, 2015, Actinium entered into an investor rights agreement with MSKCC. Under the terms of the agreement, MSKCC has agreed to forebear from transferring or otherwise disposing of its approximately 5.7 million shares of the Company’s common stock (other than pursuant to a piggyback registration as described below) until the start of the Actimab-A Phase 2 clinical study. The Company started the Actimab-A Phase 2 clinical study in September 2016. Thereafter MSKCC is permitted to sell its shares subject to a weekly volume limitation of 150,000 shares (which limit may be increased to up to 250,000 shares per week to the extent any prior weekly allotments are not fully used) and applicable law so long as MSKCC maintains at least 25% of its current shareholding in Actinium through December 31, 2016. Actinium has granted MSKCC piggyback registration rights that would be triggered in the event Actinium were to engage in a public registered offering of its shares for its own account where other shareholders are participating as selling shareholders or where such public registered offering is for the account of other selling shareholders. In addition, Actinium granted MSKCC unlimited Form S-3 registration rights with respect to its shares following December 31, 2016. As of December 31, 2017, MSKCC owned 1,230,954 shares of our common stock. |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 12 Months Ended |
Dec. 31, 2017 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
Prepaid Expenses and Other Current Assets | Note 3 - Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consisted of the following at December 31, 2017 and 2016: December 31, December 31, 2017 2016 Prepaid insurance $ 72,371 $ 332,809 Prepaid clinical trial expenses 226,997 1,093,441 Other prepaid expenses 139,954 410,201 Total prepaid expenses and other current assets $ 439,322 $ 1,836,451 |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2017 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | Note 4 - Property and Equipment Property and equipment consisted of the following at December 31, 2017 and 2016: December 31, December 31, Lives 2017 2016 Lab equipment 3 years $ 116,070 $ 116,070 Office equipment 3 years 156,940 142,933 Less: accumulated depreciation (215,660 ) (170,454 ) Property and equipment, net $ 57,350 $ 88,549 |
Derivatives
Derivatives | 12 Months Ended |
Dec. 31, 2017 | |
Derivative Instruments and Hedging Activities Disclosure [Abstract] | |
Derivatives | Note 5 - Derivatives The Company has determined that certain warrants the Company issued contain provisions that protect holders from future issuances of the Company’s common stock at prices below such warrants’ respective exercise prices. These provisions could result in modification of the warrants’ exercise price based on a variable that is not an input to the fair value of a “fixed-for-fixed” option as defined under FASB ASC Topic No. 815 - 40. The warrants granted in connection with two issuances of the Company’s common stock contain anti-dilution provisions that provide for a reduction in the exercise price of such warrants in the event that future common stock or common stock equivalents are issued at a price per share that is less than the exercise price of such warrant at the time. The amount of any such adjustment is determined in accordance with the provisions of the warrants and depend upon the number of shares of common stock issued and the exercise price of the warrant at the time. Activities for derivative warrant instruments during the years ended December 31, 2017 and 2016 were as follows: Shares Fair Value Balance, December 31, 2015 1,627,369 $ 2,848,902 Transfer from liability to equity classification (12,109 ) (17,455 ) Change in fair value - (2,530,764 ) Balance, December 31, 2016 1,615,260 300,683 Modification of warrants - 19,356 Expiration of derivative warrants (1,558,048 ) - Change in fair value - (304,123 ) Balance, December 31, 2017 57,212 $ 15,916 On March 14, 2017, the Company canceled derivative warrants to purchase 57,212 common shares of the Company, dated December 19, 2012 and issued a new warrant to purchase 57,212 common shares of the Company, see Note 7. As a result of the replacement, the Company recorded an additional expense of $19,356 for the incremental value of the derivative warrant. During the year ended December 31, 2016, 183,718 warrants were exercised, of which 12,109 were derivative warrants. The fair value of these derivative warrants totaling $17,455 were measured on the various exercise dates and reclassified to additional paid-in capital. The fair values of the derivative warrants were calculated using a binomial valuation model with the following assumptions at each balance sheet date. December 31, December 31, 2017 2016 Market value of common stock on measurement date (1) $ 0.66 $ 0.88 Adjusted exercise price $ 1.67 $ 2.34 Risk free interest rate (2) 2.09 % 0.85 % Warrant lives in years 4.1 years 2.0 years Expected volatility (3) 80 % 61 – 69 % Expected dividend yield (4) - - Probability of stock offering in any period over 5 years (5) 100 % 100 % Offering price (6) $ 0.50 $ 1.25 (1) The market value of common stock at the above measurement dates is based on the Company’s closing price quoted on the NYSE American. (2) The risk-free interest rate was determined by the Company’s management using the Treasury Bill rate as of the respective measurement date. (3) The volatility was estimated using the historical volatilities of the Company’s common stock traded in NYSE American. (4) Management does not expect to pay dividends for the foreseeable future. (5) Management determines the probability of future stock offering at each evaluation date. (6) Represents the estimated offering price in future offerings as determined by management. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2017 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 6 - Commitments and Contingencies License and Research Agreements The Company has entered into license and research and development agreements with third parties under which the Company was obligated to make upfront payments as well as milestone and royalty payments. Notable inclusions in this category are: a. AbbVie Biotherapeutics Corp. - The Company entered into a Product Development and Patent License Agreement with AbbVie Biotherapeutics Corp. in 2003 to secure exclusive rights to a specific antibody when conjugated with alpha emitting radioisotopes. Upon execution of the agreement, the Company made a license fee payment of $3,000,000. The Company agreed to make milestone payments totaling $7,750,000 for the achievement of certain contracted milestones. Under the agreement, the Company shall pay to AbbVie Biotherapeutics Corp. on a country-by-country basis a royalty of 12% of net sales of all licensed products until the later of: (1) 12.5 years after the first commercial sale, or (2) when the patents expire. The Company met its first milestone in 2012 and upon reaching the milestone the Company paid AbbVie Biotherapeutics Corp. a milestone payment of $750,000. The milestone payment for the Phase 1 Clinical Trial was recorded as research and development expense. In September 2016, the Company met its second milestone and as of December 31, 2017, $750,000 was included in accounts payable and accrued expenses on the balance sheet. b. MSKCC - see Note 2 - Related Party Transactions. c. Oak Ridge National Laboratory (“ORNL”) – The Company is contracted to purchase radioactive material to be used for research and development, with a renewal option at the contract end. On January 9, 2017, the Company signed a contract with ORNL to purchase $0.7 million of radioactive material. During the years ended December 31, 2017, 2016 and 2015, the Company purchased material from ORNL of approximately $0.6 million, $1.0 million and $0.8 million, respectively. On December 13, 2017, the Company signed a contract with ORNL to purchase $0.2 million of radioactive material during calendar year 2018. d. On June 15, 2012, the Company entered into a license and sponsored research agreement with Fred Hutchinson Cancer Research Center (“FHCRC”) to build upon previous and ongoing clinical trials, with BC8 (licensed antibody). FHCRC has currently completed both a Phase 1 and Phase 2 clinical trial with BC8. The Company has been granted exclusive rights to the BC8 antibody and related master cell bank developed by FHCRC A milestone payment of $1 million will be due to FHCRC upon FDA approval of the first drug. Upon commercial sale of the drug, royalty payments of 2% of net sales will be due to FHCRC. For the years ended December 31, 2017, 2016 and 2015, the Company incurred expenses of approximately $45,000, $0.4 million and $0.3 million, respectively, related to this agreement. e. On February 27, 2014, the Company entered into a manufacturing agreement with Goodwin Biotechnology Inc. (“Goodwin”). Goodwin oversees the current Good Manufacturing Practices (“cGMP”) production of a monoclonal antibody to be used in the Phase 3 clinical trial of Iomab-B. As of December 31, 2017, the remaining cost of the service agreement (only) is approximately $1.8 million. For each of the years ended December 31, 2017, 2016 and 2015, the Company paid Goodwin approximately $1.4 million, $0.7 million and $4.2 million, respectively. f. On February 16, 2016, the Company entered into an agreement with Medpace, Inc. (“Medpace”), a Contract Research Organization. Medpace provides project management services for the Iomab-B study. The total project is estimated to cost approximately $7.2 million. Medpace bills the Company when services are rendered and the Company records the related expense to research and development costs. For the years ended December 31, 2017 and 2016, the Company paid Medpace approximately $2.8 million and $2.6 million, respectively. g. On August 4, 2016, the Company entered into a CRO agreement with George Clinical Services, (“George”). George provides project management services for the study of Actimab-A used for a Phase 2 clinical trial. The total project is estimated to cost approximately $4.6 million. For the years ended December 31, 2017 and 2016, the Company paid George approximately $0.7 million and $0.1 million, respectively. Lease Agreements The Company does not own any real property. It currently leases office space located at 275 Madison Avenue, 7th Floor, New York, NY 10016. The lease expires September 6, 2022 with an annual rental rate of $312,660 per year through June 6, 2019 and an annual rate of $341,610 for the remaining period. The Company is also responsible for certain other costs, such as insurance, taxes, utilities, and maintenance. The Company issued a letter of credit of $390,825 in connection with the lease and maintains a $390,940 certified deposit as collateral for the letter of credit. On June 8, 2017, the Company also entered into a license agreement for furniture and fixtures located at its office space. Pursuant to the terms of the agreement, the Company leases the furniture, fixtures, equipment and tenant improvements located in the office space for the same term as the office space for $7,529 per month. The Company shall have at any time during the term of this amended agreement the right to purchase the furniture, fixtures and equipment. Future minimum obligations on all of the Company’s leases are: For the year ending December 31: 2018 $ 403,008 2019 419,896 2020 431,958 2021 431,958 Thereafter 287,972 Total $ 1,974,792 |
Equity
Equity | 12 Months Ended |
Dec. 31, 2017 | |
Equity [Abstract] | |
Equity | Note 7 - Equity During the year ended December 31, 2017, the Company issued 2,672,973 shares of common stock for gross proceeds of approximately $4.0 million as part of its At-The-Market (“ATM”) sales agreement with an investment bank. The Company paid expenses of approximately $0.2 million resulting in net proceeds of $3.8 million. On August 2, 2017, the Company completed an underwritten public offering of 21,500,000 shares of its common stock and warrants to purchase 18,275,000 shares of the Company’s common stock at an offering price to the public of $0.75 per share and related warrant. The warrants have an exercise price of $1.05 per share and have a term of five years. The gross proceeds from this offering were approximately $16.1 million, before deducting underwriting discounts and commissions and other estimated offering expenses payable by the Company resulting in net proceeds of approximately $15.0 million. On October 4, 2016, the Company sold 8,000,000 shares of its common stock at a price of $1.25 per share to the public through an underwritten public offering. On February 11, 2015, the Company completed an underwritten offering of 4,444,444 shares of its common stock and warrants to purchase 3,333,333 shares of its common stock at a price to the public of $4.50 per share. The warrants are exercisable for a period of 4 years at an exercise price of $6.50 per share and had a relative fair value of $3,540,659 on the issuance date. The Company received net proceeds of approximately $18.5 million, after deducting underwriting discounts and commissions. On June 9, 2015, the Company closed a financing with certain investors in which it raised approximately $5,000,000 in gross proceeds or $4,480,000 in net proceeds, after deducting placement agent’s fees and other offering expenses. Investors purchased 1,923,078 shares of the Company’s common stock, at a price per share of $2.60. During the year ended December 31, 2017, the Company issued 67,385 common shares for consulting services. The shares have a total value of $99,056 based on the Company’s stock price on the grant date at $1.47 per share. During the year ended December 31, 2017, the Company issued 4,234 common shares for the cashless exercise of warrants. During the year ended December 31, 2016, the Company issued 125,862 common shares for the cashless exercise of warrants. During the year ended December 31, 2016, the Company also issued 23,212 common shares for $18,105 cash received from the exercise of options. During the year ended December 31, 2015, the Company issued 1,532,124 common shares for the cashless exercise of warrants. During the year ended December 31, 2015, the Company also issued 224,153 common shares for $173,620 cash received from the exercise of options and warrants. Approval of the 2013 Amended and Restated Stock Plan In September 2013, the Board of Directors of the Company approved the Company’s 2013 Stock Plan. The expiration date of the plan is September 9, 2023 and the total number of underlying shares of the Company’s common stock available for grant to employees, directors and consultants of the Company under the plan was 2,750,000 shares. In December 2015, the shareholders of the Company approved the second amendment to the plan and increased the number of shares authorized under the plan to 9,250,000 shares. In December 2016, the shareholders of the Company approved the fifth amendment to the plan and increased the number of shares authorized under the plan to 12,750,000 shares. In December 2017, the shareholders of the Company approved the sixth amendment to the plan and increased the number of shares authorized under the plan to 17,750,000 shares. Approval of the Equity Incentive Plan In September 2013, the Board approved the Company’s 2013 Equity Incentive Plan. The expiration date of the plan is September 9, 2023 and the total number of shares of the Company’s common stock available for grant to employees, directors and consultants of the Company under the plan is 450,000 shares. In December 2013, the shareholders of the Company approved the plan and increased the number of shares authorized under the plan to 1,000,000 shares. Restricted Stock During the year ended December 31, 2017, the Company issued 26,000 common shares for restricted shares that became fully vested. During the year ended December 31, 2017, the Company also granted 59,393 common shares for consulting services. The shares have a total value of $65,813 based on the services provided and have yet to be issued. During the year ended December 31, 2016, the Company granted 250,700 shares of restricted common stock to consultants with a fair value of $0.4 million based on the stock price on the grant dates. Of the 250,700 restricted share awards granted in 2016, 60,700 shares vested at the date of grant, 150,000 shares vest over a six-month period and 40,000 shares vest over 2 years. During the year ended December 31, 2016, the Company issued common shares totaling 21,000 for restricted shares granted in 2015 and prior years and 60,700 for restricted shares granted in 2016. During the year ended December 31, 2015, the Company granted 479,651 shares of restricted common stock to consultants with a fair value of $2.3 million based on the stock price on the grant dates. Of the 479,651 restricted share awards granted in 2015, 329,651 shares vested at the date of grant and 150,000 shares vest over a six-month period. During the year ended December 31, 2015, the Company cancelled 126,265 shares of restricted stock originally granted to employees and issued a total of 152,499 options. As a result of the cancellation of the 126,265 restricted shares, the Company recorded an expense of $0.8 million for the grant-date fair value of the restricted stock for which the requisite service is expected to be rendered. As of December 31, 2017, the Company has yet to issue 281,301 common shares for restricted shares that have vested. During the year ended December 31, 2017, 2016 and 2015, the Company recorded approximately $0.2 million, $0.6 million and $3.4 million, respectively, in stock-based compensation for all of the restricted shares granted. Stock Options Following is a summary of option activities for the years ended December 31, 2017, 2016 and 2015: Number of Units Weighted Weighted Aggregate Outstanding, December 31, 2014 3,013,084 $ 5.98 8.35 4,728,842 Granted 1,554,499 2.78 Cancelled (576,000 ) 8.70 Exercised (20,000 ) 0.78 Outstanding, December 31, 2015 3,971,583 $ 4.34 8.01 2,964,146 Granted 2,225,000 1.92 Cancelled (266,485 ) 2.51 Exercised (23,212 ) 0.78 Outstanding, December 31, 2016 5,906,886 3.52 7.90 51,704 Granted 2,597,500 1.32 Cancelled (3,329,794 ) 2.85 Outstanding, December 31, 2017 5,174,592 2.83 7.95 2,648 Exercisable, December 31, 2017 2,415,632 3.98 6.38 - On June 6, 2017, Sergio Traversa, a director, resigned from the Company and the Company entered into an agreement with Mr. Traversa. Pursuant to the agreement, all the outstanding vested options (which originally were to expire 90 days from termination date) as well as 68,200 unvested options granted prior to December 31, 2016, shall be exercisable until the end of the term of each option grant agreement. As a result of the modification, the Company recorded an additional expense of approximately $174,000 for the incremental fair value of the options, calculated using the Black-Scholes option-pricing model. Variables used in the Black-Scholes option-pricing model include: (1) discount rate range from 0.97% to 1.39% (2) expected life of 3 months to 8.9 years, (3) expected volatility range from 45.72% to 79.81%, and (4) zero expected dividends. During the year ended December 31, 2017, the Company granted its employees and members of the Board of Directors 2,597,500 options to purchase the Company’s common stock with an exercise price ranging from $0.57 to $1.58 per share, a term of 10 years, and a vesting period from 4 to 4.2 years. The options have an aggregated fair value of $2.4 million that was calculated using the Black-Scholes option-pricing model. Variables used in the Black-Scholes option-pricing model include: (1) discount rate range from 1.84% to 2.28% (2) expected life of 6 years, (3) expected volatility range from 80.83% to 82.37%, and (4) zero expected dividends. The estimated option life was determined based on the “simplified method,” giving consideration to the overall vesting period and the contractual terms of the award. This method was used because the Company does not have sufficient historical option exercise data. During the year ended December 31, 2016, the Company granted employees, consultants, and its board members 2,225,000 options to purchase the Company’s common stock with exercise prices ranging from $0.95 to $2.25 with a 10-year term vesting over a 4-year period. The options have an aggregated fair value of $3.1 million that was calculated using the Black-Scholes option-pricing model. Variables used in the Black-Scholes option-pricing model include: (1) discount rate of 1.28% - 1.97% (2) expected life of 6 years, (3) expected volatility of 81.45% - 87.95%, and (4) zero expected dividends. During the year ended December 31, 2015, the Company granted employees, consultants, and its board members 1,554,499 options to purchase the Company’s common stock with exercise prices ranging from $1.79 to $3.58 and a 10 year with vesting ranging from 1 to 4.17 years. The options have an aggregated fair value of $3.2 million that was calculated using the Black-Scholes option-pricing model. Variables used in the Black-Scholes option-pricing model include: (1) discount rate of 1.56% - 1.91% (2) expected life of 6 years, (3) expected volatility of 85.01% - 94.89%, and (4) zero expected dividends. During the year ended December 31, 2017, options to purchase 3,329,794 common shares were cancelled upon the termination of employees and a board member. During the years ended December 31, 2016 and 2015, the Company received gross proceeds of $18,105 and $15,680 for the exercise of options for 23,212 shares and 20,000 shares, respectively, of the Company’s common stock. There were no exercises of options during the year ended December 31, 2017. The fair values of all options issued and outstanding are being amortized over their respective vesting periods. The unrecognized compensation expense at December 31, 2017 was approximately $3.3 million. During each of the years ended December 31, 2017, 2016 and 2015, the Company recorded total option expense of approximately $3.1 million, $3.6 million and $3.4 million, respectively. Warrants Following is a summary of warrant activities for the years ended December 31, 2017, 2016 and 2015: Number of Units Weighted Weighted Aggregate Outstanding, December 31, 2014 7,698,497 1.64 3.97 34,317,224 Granted 3,333,333 6.50 Exercised (2,013,360 ) 0.41 Outstanding, December 31, 2015 9,018,470 3.73 2.93 10,199,230 Granted 130,000 0.96 Exercised (183,718 ) 0.90 Outstanding, December 31, 2016 8,964,752 3.72 1.95 1,445,786 Granted 18,496,575 1.05 Exercised (9,364 ) 0.78 Cancelled (1,789,623 ) 2.22 Outstanding, December 31, 2017 25,662,340 1.89 3.62 995,373 Exercisable, December 31, 2017 25,462,340 1.85 3.61 995,373 Certain warrants were issued to the Company’s Executive Chairman (now Chairman and CEO) as part of investment banking and advisory services either prior to and outside of his role as a Board Member and subsequently Chairman and CEO. On March 14, 2017, the Company canceled a warrant to purchase 57,212 shares of Common Stock of the Company, dated December 19, 2012 and issued a new warrant to its Chairman and CEO to purchase 57,212 common shares with the term of the warrant expiring on February 11, 2022. The new warrant has the same exercise price in effect as the exercise price as the old warrant but the expiration date was modified from December 19, 2017 to February 11, 2022. The Company also amended the warrant to purchase Common Stock of the Company, dated January 31, 2012, issued to its Chairman and CEO and an entity affiliated with its Chairman and CEO to purchase 64,746 and 99,617 common shares, respectively. Pursuant to the terms of the warrant amendments, the term of the warrants was extended to February 11, 2022 from January 31, 2019. As a result of the replacement and modification, the Company recorded an additional non-cash expense of $64,091 for the incremental fair value of the new warrants. On August 2, 2017, the Company completed an underwritten offering of 21,500,000 shares of its common stock and warrants to purchase an aggregate of 18,275,000 shares of its common stock at a price of $0.75 per share and related warrant. The warrants are exercisable for a period of 5 years at an exercise price of $1.05 per share. The transaction date relative fair value of the warrants of $4.9 million was determined utilizing the Black-Scholes option pricing model. Variables used in the Black-Scholes option-pricing model include (1) discount rate of 1.83%, (2) expected term of 5 years, (3) expected volatility of 82%, and (4) zero expected dividends. During the year ended December 31, 2016, the Company granted 130,000 warrants to consultants. The warrants are exercisable for periods ranging from 5 to 10 years at exercise prices ranging from $0.98 to $1.77 per share. The fair value of the warrants was approximately $116,000 at the grant date and was determined utilizing the Black-Scholes option pricing model. Variables used in the Black-Scholes option-pricing model include (1) discount rate range of 1.13% to 1.20%, (2) expected term of 5-10 years, (3) expected volatility range of 79.79% to 84.84%, and (4) zero expected dividends. On February 11, 2015, the Company completed an underwritten offering of 4,444,444 shares of its common stock and warrants to purchase 3,333,333 shares of its common stock at a price of $4.50 per share. The warrants are exercisable for a period of 4 years at an exercise price of $6.50 per share. The transaction date relative fair value of the warrants of $3.5 million was determined utilizing the Black-Scholes option pricing model. Variables used in the Black-Scholes option-pricing model include (1) discount rate of 1.26%, (2) expected term of 4 years, (3) expected volatility of 72%, and (4) zero expected dividends. During the years ended December 31, 2017, 2016 and 2015, warrants to purchase 9,364, 183,718 and 2,013,360 shares of the Company’s common stock were exercised by the warrant holders, respectively. The Company issued 4,234, 125,892 and 1,736,277 shares of common stock as a result of these exercises, respectively. During the years ended December 31, 2017, 2016 and 2015, the Company recorded stock-based compensation expense related to the warrants of approximately $50,000 (excluding the $64,091 addition expense due to the replacement and modification), $0.1 million and $0.2 million, respectively. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Note 8 – Income Taxes Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of the Company’s deferred tax assets and liabilities at December 31, 2017 and 2016 are as follows: 2017 2016 Deferred tax assets: Net operating losses carry forward $ 30,826,534 $ 38,874,255 Share-based compensation 3,731,413 8,081,711 Research & Development/Orphan Drug Credits 6,324,998 830,085 Others 11,369 16,329 Less: valuation allowance (40,894,314 ) (47,802,380 ) Deferred tax assets, net $ - $ - The Company has recorded a valuation allowance of $40.9 million and $47.8 million against its deferred tax assets at December 31, 2017 and 2016, respectively, because management determined that it is not more-likely-than not that those assets will be realized. For federal income tax purposes, the Company has approximately $123.3 million of unused net operating losses (“NOLs”) at December 31, 2017 available for carry forward to future years. These NOLs will begin to expire if unused in 2018. For state income tax purposes, the Company has approximately $77.5 million of unused NOLs at December 31, 2017 available for carry forward to future years. These NOLs will begin to expire if unused in 2035. The Company has Federal Research and Development tax credits of approximately $1.3 million at December 31, 2017 which will begin to expire if unused in 2033 and Orphan Drug Credits of $5.0 million which will begin to expire if unused in 2027. Federal and state tax laws impose limitations on the utilization of net operating losses and credit carryforwards in the event of an ownership change for tax purposes, as defined in Section 382 of the Internal Revenue Code. Accordingly, the Company’s ability to utilize these carryforwards may be limited as a result of an ownership change which may have already happened or may happen in the future. Such an ownership change could result in a limitation in the use of the net operating losses in future years and possibly a reduction of the net operating losses available. On December 22, 2017, the Tax Cuts and Jobs Act was signed into legislation and reduces the corporate tax rate to 21%, effective January 1, 2018. Consequently, the Company has recorded a decrease related to its deferred tax assets of $17.9 million with a corresponding adjustment to the valuation allowance of $17.9 million for the year ended December 31, 2017. The difference between the income tax provision and the amount that would result if the U.S. Federal statutory rate of 34% were applied to pre-tax loss for the years ended December 31, 2017, 2016 and 2015 are as follows: For the year ended December 31, 2017 December 31, 2016 December 31, 2015 Federal income taxes at 34% $ (9,044,420 ) (34.0 )% $ (8,269,386 ) (34.0 )% $ (7,148,607 ) (34.0 )% State income taxes (1,940,945 ) (7.3 )% 973,547 4.0 % Change in Federal statutory rate 17,939,714 67.4 % - - % - - % Deferred true-up 3,090,815 11.8 % (10,511,380 ) (43.3 )% 1,104,763 5.2 % Research and Development/Orphan Drug Tax Credit (3,029,074 ) (11.4 )% (141,769 ) (0.6 )% - - % Unrealized derivative gain/loss (120,870 ) (0.5 )% (956,840 ) (3.9 )% Other 12,845 0.0 % 13,632 0.1 % - - % Change in valuation allowance (6,908,065 ) (26.0 )% 18,892,196 77.7 % 6,043,844 28.8 % Provision for income tax $ - - $ - - $ - - |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2017 | |
Subsequent Events [Abstract] | |
Subsequent Events | Note 9 – Subsequent Events On March 6 and March 9, 2018, the Company completed a rights offering pursuant to its effective registration statement on Form S-3, as amended (Registration Statement No. 333-216748), previously filed with and declared effective by the Securities and Exchange Commission (the “SEC”), and a prospectus and prospectus supplements filed with the SEC (the “Rights Offering”). Pursuant to the Rights Offering, Actinium sold an aggregate of 30,125,326 units consisting of an aggregate of 30,125,326 shares of common stock, 7,531,304 series A warrants and 22,593,967 series B warrants, with each series A warrant exercisable for one share of Common Stock at an exercise price of $0.60 per share and each series B warrant exercisable for one share of Common Stock at an exercise price of $0.70 per share, resulting in gross proceeds to Actinium of approximately $15.1 million, and net proceeds of approximately $13.9 million after deducting expenses relating to dealer-manager fees and expenses, and excluding any proceeds received upon exercise of any warrants. During January and February 2018, the Company issued 1,000 shares of common stock to an employee for vesting of a restricted stock grant. During January and February 2018, the Company granted its employees options to purchase 785,000 common shares at an average price of $0.64 per share. |
Description of Business and S16
Description of Business and Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2017 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Principles of Consolidation | Principles of Consolidation - |
Use of Estimates in Financial Statement Presentation | Use of Estimates in Financial Statement Presentation - |
Cash and Cash Equivalents | Cash and Cash Equivalents - |
Property and Equipment | Property and Equipment - |
Derivatives | Derivatives - |
Fair Value of Financial Instruments | Fair Value of Financial Instruments - Level 1 Inputs - Unadjusted quoted prices in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date. Level 2 Inputs - Inputs other than quoted prices included in Level 1 that are observable for the asset or liability, either directly or indirectly. These might include quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, inputs other than quoted prices that are observable for the asset or liability (such as interest rates, volatilities, prepayment speeds, credit risks, etc.) or inputs that are derived principally from or corroborated by market data by correlation or other means. Level 3 Inputs - Unobservable inputs for determining the fair values of assets or liabilities that reflect an entity’s own assumptions about the assumptions that market participants would use in pricing the assets or liabilities. The following tables set forth assets and liabilities measured at fair value on a recurring basis by level within the fair value hierarchy as of December 31, 2017 and 2016. As required by ASC 820 “ Fair Value Measurements and Disclosures” Level 1 Level 2 Level 3 Total Derivative liabilities: At December 31, 2017 $ - $ - $ 15,916 $ 15,916 At December 31, 2016 $ - $ - $ 300,683 $ 300,683 |
Income Taxes | Income Taxes - The Company recognizes tax positions when the positions meet a “more-likely-than-not” recognition threshold. There were no tax positions for which it is considered reasonably possible that the total amounts of unrecognized tax benefits will significantly increase or decrease within the next year. The Company recognizes interest related to unrecognized tax benefits in interest expense and penalties in operating expenses. |
Research and Development Costs | Research and Development Costs - |
Share-Based Payments | Share-Based Payments - |
Net Loss Per Common Share | Net Loss Per Common Share December 31, December 31, December 31, Options 5,174,592 5,906,886 3,971,583 Warrants 25,662,340 8,964,752 9,018,470 Total 30,836,932 14,871,638 12,990,053 |
Subsequent Events | Subsequent Events |
Reclassifications | Reclassifications - |
Recent Accounting Pronouncements | Recent Accounting Pronouncements – Leases In April 2016, the FASB issued ASU No. 2016-10, “ Revenue from Contracts with Customers: Identifying Performance Obligations and Licensing (Topic 606) Revenue from Contracts with Customers: Principal versus Agent Considerations (Reporting Revenue Gross verses Net) (Topic 606) In May 2016, the FASB issued ASU No. 2016-12, “ Revenue from Contracts with Customers (Topic 606): Narrow-Scope Improvements and Practical Expedients” Management does not believe that any recently issued, but not yet effective accounting pronouncements, when adopted, will have a material effect on the consolidated financial statements. |
Description of Business and S17
Description of Business and Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Summary of set forth liabilities measured at fair value on a recurring basis | Level 1 Level 2 Level 3 Total Derivative liabilities: At December 31, 2017 $ - $ - $ 15,916 $ 15,916 At December 31, 2016 $ - $ - $ 300,683 $ 300,683 |
Schedule of antidilutive securities excluded from computation of earnings per share | December 31, December 31, December 31, Options 5,174,592 5,906,886 3,971,583 Warrants 25,662,340 8,964,752 9,018,470 Total 30,836,932 14,871,638 12,990,053 |
Related Party Transactions (Tab
Related Party Transactions (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Related Party Transactions [Abstract] | |
Summary of milestone payments | Milestones Payments (1) filing of an New Drug Application (“NDA”) or regulatory approval for each licensed product $ 750,000 (2) upon the receipt of regulatory approval from the U.S. FDA for each licensed product 1,750,000 |
Prepaid Expenses and Other Cu19
Prepaid Expenses and Other Current Assets (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
Summary of prepaid expenses and other current assets | December 31, December 31, 2017 2016 Prepaid insurance $ 72,371 $ 332,809 Prepaid clinical trial expenses 226,997 1,093,441 Other prepaid expenses 139,954 410,201 Total prepaid expenses and other current assets $ 439,322 $ 1,836,451 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Property, Plant and Equipment [Abstract] | |
Summary of property and equipment | December 31, December 31, Lives 2017 2016 Lab equipment 3 years $ 116,070 $ 116,070 Office equipment 3 years 156,940 142,933 Less: accumulated depreciation (215,660 ) (170,454 ) Property and equipment, net $ 57,350 $ 88,549 |
Derivatives (Tables)
Derivatives (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Derivative Instruments and Hedging Activities Disclosure [Abstract] | |
Schedule of derivative warrant instruments activity | Shares Fair Value Balance, December 31, 2015 1,627,369 $ 2,848,902 Transfer from liability to equity classification (12,109 ) (17,455 ) Change in fair value - (2,530,764 ) Balance, December 31, 2016 1,615,260 300,683 Modification of warrants - 19,356 Expiration of derivative warrants (1,558,048 ) - Change in fair value - (304,123 ) Balance, December 31, 2017 57,212 $ 15,916 |
Summary of fair values of derivative warrants | December 31, December 31, 2017 2016 Market value of common stock on measurement date (1) $ 0.66 $ 0.88 Adjusted exercise price $ 1.67 $ 2.34 Risk free interest rate (2) 2.09 % 0.85 % Warrant lives in years 4.1 years 2.0 years Expected volatility (3) 80 % 61 – 69 % Expected dividend yield (4) - - Probability of stock offering in any period over 5 years (5) 100 % 100 % Offering price (6) $ 0.50 $ 1.25 (1) The market value of common stock at the above measurement dates is based on the Company’s closing price quoted on the NYSE American. (2) The risk-free interest rate was determined by the Company’s management using the Treasury Bill rate as of the respective measurement date. (3) The volatility was estimated using the historical volatilities of the Company’s common stock traded in NYSE American. (4) Management does not expect to pay dividends for the foreseeable future. (5) Management determines the probability of future stock offering at each evaluation date. (6) Represents the estimated offering price in future offerings as determined by management. |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of future minimum obligations on the lease | For the year ending December 31: 2018 $ 403,008 2019 419,896 2020 431,958 2021 431,958 Thereafter 287,972 Total $ 1,974,792 |
Equity (Tables)
Equity (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Warrant [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Summary of option and warrant activities | Number of Units Weighted Weighted Aggregate Outstanding, December 31, 2014 7,698,497 1.64 3.97 34,317,224 Granted 3,333,333 6.50 Exercised (2,013,360 ) 0.41 Outstanding, December 31, 2015 9,018,470 3.73 2.93 10,199,230 Granted 130,000 0.96 Exercised (183,718 ) 0.90 Outstanding, December 31, 2016 8,964,752 3.72 1.95 1,445,786 Granted 18,496,575 1.05 Exercised (9,364 ) 0.78 Cancelled (1,789,623 ) 2.22 Outstanding, December 31, 2017 25,662,340 1.89 3.62 995,373 Exercisable, December 31, 2017 25,462,340 1.85 3.61 995,373 |
Stock Options [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Summary of option and warrant activities | Number of Units Weighted Weighted Aggregate Outstanding, December 31, 2014 3,013,084 $ 5.98 8.35 4,728,842 Granted 1,554,499 2.78 Cancelled (576,000 ) 8.70 Exercised (20,000 ) 0.78 Outstanding, December 31, 2015 3,971,583 $ 4.34 8.01 2,964,146 Granted 2,225,000 1.92 Cancelled (266,485 ) 2.51 Exercised (23,212 ) 0.78 Outstanding, December 31, 2016 5,906,886 3.52 7.90 51,704 Granted 2,597,500 1.32 Cancelled (3,329,794 ) 2.85 Outstanding, December 31, 2017 5,174,592 2.83 7.95 2,648 Exercisable, December 31, 2017 2,415,632 3.98 6.38 - |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | |
Schedule of components of deferred tax assets and liabilities | 2017 2016 Deferred tax assets: Net operating losses carry forward $ 30,826,534 $ 38,874,255 Share-based compensation 3,731,413 8,081,711 Research & Development/Orphan Drug Credits 6,324,998 830,085 Others 11,369 16,329 Less: valuation allowance (40,894,314 ) (47,802,380 ) Deferred tax assets, net $ - $ - |
Schedule of difference between income tax provision and U.S federal statutory rate | For the year ended December 31, 2017 December 31, 2016 December 31, 2015 Federal income taxes at 34% $ (9,044,420 ) (34.0 )% $ (8,269,386 ) (34.0 )% $ (7,148,607 ) (34.0 )% State income taxes (1,940,945 ) (7.3 )% 973,547 4.0 % Change in Federal statutory rate 17,939,714 67.4 % - - % - - % Deferred true-up 3,090,815 11.8 % (10,511,380 ) (43.3 )% 1,104,763 5.2 % Research and Development/Orphan Drug Tax Credit (3,029,074 ) (11.4 )% (141,769 ) (0.6 )% - - % Unrealized derivative gain/loss (120,870 ) (0.5 )% (956,840 ) (3.9 )% Other 12,845 0.0 % 13,632 0.1 % - - % Change in valuation allowance (6,908,065 ) (26.0 )% 18,892,196 77.7 % 6,043,844 28.8 % Provision for income tax $ - - $ - - $ - - |
Description of Business and S25
Description of Business and Summary of Significant Accounting Policies (Details) - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 |
Summary of liabilities measured at fair value on a recurring basis | ||
Derivative liabilities | $ 15,916 | $ 300,683 |
Level 1 [Member] | ||
Summary of liabilities measured at fair value on a recurring basis | ||
Derivative liabilities | ||
Level 2 [Member] | ||
Summary of liabilities measured at fair value on a recurring basis | ||
Derivative liabilities | ||
Level 3 [Member] | ||
Summary of liabilities measured at fair value on a recurring basis | ||
Derivative liabilities | $ 15,916 | $ 300,683 |
Description of Business and S26
Description of Business and Summary of Significant Accounting Policies (Details 1) - shares | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Total | 30,836,932 | 14,871,638 | 12,990,053 |
Options [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Total | 5,174,592 | 5,906,886 | 3,971,583 |
Warrants [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Total | 25,662,340 | 8,964,752 | 9,018,470 |
Description of Business and S27
Description of Business and Summary of Significant Accounting Policies (Details Textual) | 12 Months Ended |
Dec. 31, 2017 | |
Furniture and Fixtures [Member] | |
Description of Business and Summary of Significant Accounting Policies (Textual) | |
Estimated useful lives | Three years. |
Property and equipment depreciation method | Straight-line basis. |
Machinery and Equipment [Member] | |
Description of Business and Summary of Significant Accounting Policies (Textual) | |
Estimated useful lives | Three years. |
Property and equipment depreciation method | Straight-line basis. |
Related Party Transactions (Det
Related Party Transactions (Details) - Memorial Sloan Kettering Cancer Center [Member] | 12 Months Ended |
Dec. 31, 2017USD ($) | |
Receipt Of Regulatory Approval From U S Fda [Member] | |
Summary of milestone payments related to related party | |
Milestone payments on approval | $ 1,750,000 |
New Drug Application [Member] | |
Summary of milestone payments related to related party | |
Milestone payments on approval | $ 750,000 |
Related Party Transactions (D29
Related Party Transactions (Details Textual) - USD ($) | Jun. 09, 2015 | Dec. 21, 2015 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 |
Investor [Member] | |||||
Related Party Transactions (Textual) | |||||
Number of shares common stock | 1,923,078 | ||||
Memorial Sloan Kettering Cancer Center [Member] | |||||
Related Party Transactions (Textual) | |||||
Royalty description | Under the agreement, the Company shall pay to MSKCC on a country-by-country basis a royalty of 2% of net sales of all licensed products until the later of: (1) 10 years from the first commercial sale, or (2) when the patents expire. | ||||
Maintenance fees | $ 100,000 | $ 100,000 | $ 200,000 | ||
Number of shares common stock | 5,700,000 | 1,230.954 | |||
Sale of stock, Description | MSKCC is permitted to sell its shares subject to a weekly volume limitation of 150,000 shares (which limit may be increased to up to 250,000 shares per week to the extent any prior weekly allotments are not fully used) and applicable law so long as MSKCC maintains at least 25% of its current shareholding in Actinium through December 31, 2016. |
Prepaid Expenses and Other Cu30
Prepaid Expenses and Other Current Assets (Details) - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | ||
Prepaid insurance | $ 72,371 | $ 332,809 |
Prepaid clinical trial expenses | 226,997 | 1,093,441 |
Other prepaid expenses | 139,954 | 410,201 |
Total prepaid expenses and other current assets | $ 439,322 | $ 1,836,451 |
Property and Equipment (Details
Property and Equipment (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Summary of property and equipment | ||
Less: accumulated depreciation | $ (215,660) | $ (170,454) |
Property and equipment, net | $ 57,350 | 88,549 |
Lab Equipment [Member] | ||
Summary of property and equipment | ||
Useful Lives | 3 years | |
Property and equipment, gross | $ 116,070 | 116,070 |
Office Equipment [Member] | ||
Summary of property and equipment | ||
Useful Lives | 3 years | |
Property and equipment, gross | $ 156,940 | $ 142,933 |
Derivatives (Details)
Derivatives (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Derivative Instruments and Hedging Activities Disclosure [Abstract] | ||
Beginning balance, Shares subject to warrants | 1,615,260 | 1,627,369 |
Transfer from liability to equity classification, Shares subject to warrants | (12,109) | |
Modification of warrants, Shares subject to warrants | ||
Expiration of derivative warrants,Shares subject to warrants | (1,558,048) | |
Change in fair value, Shares subject to warrants | ||
Ending Balance, Shares subject to warrants | 57,212 | 1,615,260 |
Beginning balance, Fair Value | $ 300,683 | $ 2,848,902 |
Transfer from liability to equity classification, Fair Value | (17,455) | |
Modification of warrants, Fair Value | 19,356 | |
Expiration of derivative warrants, Fair Value | ||
Change in fair value, Fair Value | (304,123) | (2,530,764) |
Ending Balance, Fair Value | $ 15,916 | $ 300,683 |
Derivatives (Details 1)
Derivatives (Details 1) - Derivative [Member] - $ / shares | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | ||
Summary of fair values of derivative warrants on basis of valuation model | |||
Market value of common stock on measurement date | [1] | $ 0.66 | $ 0.88 |
Adjusted exercise price | $ 1.67 | $ 2.34 | |
Risk free interest rate | [2] | 2.09% | 0.85% |
Warrant lives in years | 4 years 1 month 6 days | 2 years | |
Expected volatility | [3] | 80.00% | |
Expected dividend yield | [4] | 0.00% | 0.00% |
Probability of stock offering in any period over 5 years | [5] | 100.00% | 100.00% |
Offering price | [6] | $ 0.50 | $ 1.25 |
Minimum [Member] | |||
Summary of fair values of derivative warrants on basis of valuation model | |||
Expected volatility | [3] | 61.00% | |
Maximum [Member] | |||
Summary of fair values of derivative warrants on basis of valuation model | |||
Expected volatility | [3] | 69.00% | |
[1] | The market value of common stock at the above measurement dates is based on the Company's closing price quoted on the NYSE American | ||
[2] | The risk-free interest rate was determined by management using the Treasury Bill rate as of the respective measurement date. | ||
[3] | The volatility was estimated using the historical volatilities of the Company's common stock traded in NYSE American. | ||
[4] | Management does not expect to pay dividends for the foreseeable future. | ||
[5] | Management determines the probability of future stock offering at each evaluation date. | ||
[6] | Represents the estimated offering price in future offerings as determined by management. |
Derivatives (Details Textual)
Derivatives (Details Textual) - USD ($) | Aug. 02, 2017 | Mar. 14, 2017 | Feb. 11, 2015 | Feb. 11, 2015 | Dec. 31, 2017 | Dec. 31, 2016 |
Derivatives (Textual) | ||||||
Incremental value of derivative warrant | $ 19,356 | |||||
Public offering [Member] | ||||||
Derivatives (Textual) | ||||||
Warrant to purchase of common stock | 18,275,000 | 3,333,333 | ||||
Fair value of warrants | $ 3,540,659 | $ 3,500,000 | ||||
Warrant [Member] | ||||||
Derivatives (Textual) | ||||||
Probability of stock offering period | 5 years | 5 years | ||||
Warrant to purchase of common stock | 57,212 | |||||
Number of warrants exercised | 183,718 | |||||
Derivative warrants | 12,109 | |||||
Fair value of warrants | $ 17,455 |
Commitments and Contingencies35
Commitments and Contingencies (Details) | Dec. 31, 2017USD ($) |
Future minimum obligations on the lease are: | |
2,018 | $ 403,008 |
2,019 | 419,896 |
2,020 | 431,958 |
2,021 | 431,958 |
Thereafter | 287,972 |
Total | $ 1,974,792 |
Commitments and Contingencies36
Commitments and Contingencies (Details Textual) - USD ($) | Dec. 13, 2017 | Jun. 08, 2017 | Aug. 04, 2016 | Jun. 15, 2012 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 |
Commitments and Contingencies (Textual) | |||||||
Rent for office | $ 7,529 | ||||||
Incurred expenses | $ 17,699,503 | $ 17,786,655 | $ 13,501,895 | ||||
Cost of lease agreement | 312,660 | ||||||
Accounts payable and accrued expenses | $ 4,625,088 | 4,194,874 | |||||
Lease agreements, description | The lease expires September 6, 2024 with an annual rental rate of $312,660 per year through June 6, 2021 and an annual rate of $341,610 for the remaining period. | ||||||
Lines of credit | $ 390,825 | ||||||
Deposit | 390,940 | ||||||
Fred Hutchinson Cancer Research Center [Member] | |||||||
Commitments and Contingencies (Textual) | |||||||
Milestones Payments | $ 1,000,000 | ||||||
Description of royalty payment | Royalty payments of 2% of net sales will be due to FHCRC. | ||||||
Incurred expenses | 45,000 | ||||||
Medpace Inc [Member] | |||||||
Commitments and Contingencies (Textual) | |||||||
Incurred expenses | 2,800,000 | 2,600,000 | |||||
Total project estimated to cost | 7,200,000 | ||||||
Oak Ridge National Laboratory [Member] | |||||||
Commitments and Contingencies (Textual) | |||||||
Purchase of materials | $ 2,000,000 | 600,000 | 1,000,000 | 800,000 | |||
George Clinical Services [Member] | |||||||
Commitments and Contingencies (Textual) | |||||||
Project estimated cost | $ 4,600,000 | 700,000 | 100,000 | ||||
Goodwin Biotechnology Inc [Member] | |||||||
Commitments and Contingencies (Textual) | |||||||
Project remaining cost | 1,800,000 | ||||||
Incurred expenses | 4,200,000 | $ 700,000 | $ 1,400,000 | ||||
Product Development and Patent License Agreement [Member] | AbbVie Biotherapeutics Corp. [Member] | |||||||
Commitments and Contingencies (Textual) | |||||||
License fee payment | $ 3,000,000 | ||||||
Description of royalty payment | The Company shall pay to AbbVie Biotherapeutics Corp. on a country-by-country basis a royalty of 12% of net sales of all licensed products until the later of: (1) 12.5 years after the first commercial sale, or (2) when the patents expire. | ||||||
Royalty of net sales percentage | 12.00% | ||||||
First commercial sale period | 12 years 6 months | ||||||
Accounts payable and accrued expenses | $ 750,000 |
Equity (Details)
Equity (Details) - Stock Options [Member] - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Summary of stock option/ warrant activities | |||
Number of Units, Outstanding, Beginning | 5,906,886 | 3,971,583 | 3,013,084 |
Number of Units, Granted | 2,597,500 | 2,225,000 | 1,554,499 |
Number of Units, Cancelled | (3,329,794) | (266,485) | (576,000) |
Number of Units, Exercised | (23,212) | (20,000) | |
Number of Units, Outstanding, Ending | 5,174,592 | 5,906,886 | 3,971,583 |
Number of Units, Exercisable | 2,415,632 | ||
Weighted Average Exercise Price, Outstanding, Beginning | $ 3.52 | $ 4.34 | $ 5.98 |
Weighted Average Exercise Price, Granted | 1.32 | 1.92 | 2.78 |
Weighted Average Exercise Price, Cancelled | 2.85 | 2.51 | 8.70 |
Weighted Average Exercise Price, Exercised | 0.78 | 0.78 | |
Weighted Average Exercise Price, Outstanding, Ending | 2.83 | $ 3.52 | $ 4.34 |
Weighted Average Exercise Price, Exercisable | $ 3.98 | ||
Weighted Average Remaining Contractual Term (in years), Outstanding, Beginning | 7 years 10 months 25 days | 8 years 4 days | 8 years 4 months 6 days |
Weighted Average Remaining Contractual Term (in years), Outstanding, Ending | 7 years 11 months 12 days | 7 years 10 months 25 days | 8 years 4 days |
Weighted Average Remaining Contractual Term (in years), Exercisable | 6 years 4 months 17 days | ||
Aggregate Intrinsic Value, Outstanding, Beginning | $ 51,704 | $ 2,964,146 | $ 4,728,842 |
Aggregate Intrinsic Value, Outstanding, Ending | 2,648 | $ 51,704 | $ 2,964,146 |
Aggregate Intrinsic Value, Exercisable |
Equity (Details 1)
Equity (Details 1) - Warrants [Member] - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Summary of stock option/ warrant activities | |||
Number of Units, Outstanding, Beginning | 8,964,752 | 9,018,470 | 7,698,497 |
Number of Units, Granted | 18,496,575 | 130,000 | 3,333,333 |
Number of Units, Cancelled | (1,789,623) | ||
Number of Units, Outstanding, Ending | 25,662,340 | 8,964,752 | 9,018,470 |
Number of Units, Exercisable | 25,462,340 | ||
Weighted Average Exercise Price, Outstanding, Beginning | $ 3.72 | $ 3.73 | $ 1.64 |
Weighted Average Exercise Price, Granted | 1.05 | 0.96 | 6.50 |
Weighted Average Exercise Price, Exercised | 0.78 | 0.90 | 0.41 |
Weighted Average Exercise Price, Cancelled | 2.22 | ||
Weighted Average Exercise Price, Outstanding, Ending | 1.89 | $ 3.72 | $ 3.73 |
Weighted Average Exercise Price, Exercisable | $ 1.85 | ||
Weighted Average Remaining Contractual Term (in years), Outstanding, Beginning | 1 year 11 months 12 days | 2 years 11 months 4 days | 3 years 11 months 19 days |
Weighted Average Remaining Contractual Term (in years), Outstanding, Ending | 3 years 7 months 13 days | 1 year 11 months 12 days | 2 years 11 months 4 days |
Weighted Average Remaining Contractual Term (in years), Exercisable | 3 years 7 months 10 days | ||
Aggregate Intrinsic Value, Outstanding, Beginning | $ 1,445,786 | $ 10,199,230 | $ 34,317,224 |
Aggregate Intrinsic Value, Outstanding, Ending | 995,373 | $ 1,445,786 | $ 10,199,230 |
Aggregate Intrinsic Value, Exercisable | $ 995,373 |
Equity (Details Textual)
Equity (Details Textual) - USD ($) | Aug. 02, 2017 | Jun. 06, 2017 | Mar. 14, 2017 | Oct. 04, 2016 | Jun. 09, 2015 | Feb. 11, 2015 | Jan. 31, 2012 | Dec. 21, 2015 | Feb. 11, 2015 | Dec. 31, 2013 | Sep. 30, 2013 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 |
Equity (Textual) | ||||||||||||||
Net proceeds from issuance of shares | $ 3,800,000 | |||||||||||||
Total unrecognized compensation expense | $ 3,300,000 | |||||||||||||
Mr. Traversa [Member] | ||||||||||||||
Equity (Textual) | ||||||||||||||
Stock based compensation expense, Travesa options | Pursuant to the agreement, all the outstanding vested options (which originally were to expire 90 days from termination date) as well as 68,200 unvested options granted prior to December 31, 2016, shall be exercisable until the end of the term of each option grant agreement. | |||||||||||||
Fair value assumptions, expected dividend rate | 0.00% | |||||||||||||
Total option expense | $ 174,000 | |||||||||||||
Executive Chairman [Member] | ||||||||||||||
Equity (Textual) | ||||||||||||||
Warrant to purchase of common stock | 64,746 | |||||||||||||
CEO [Member] | ||||||||||||||
Equity (Textual) | ||||||||||||||
Warrant to purchase of common stock | 99,617 | |||||||||||||
Public offering [Member] | ||||||||||||||
Equity (Textual) | ||||||||||||||
Issuance of common stock, shares | 21,500,000 | 4,444,444 | ||||||||||||
Proceeds from common stock issued | $ 16,100,000 | $ 8,000,000 | ||||||||||||
Exercise price | $ 1.05 | $ 6.50 | $ 6.50 | |||||||||||
Warrants, vesting period | 5 years | |||||||||||||
Fair value assumptions, expected discount rate | 1.26% | |||||||||||||
Fair value assumptions, expected term | 4 years | |||||||||||||
Fair value assumptions, expected volatility rate | 72.00% | |||||||||||||
Fair value assumptions, expected dividend rate | 0.00% | |||||||||||||
Warrant to purchase of common stock | 18,275,000 | 3,333,333 | ||||||||||||
Offering price | $ 0.75 | $ 1.25 | $ 4.50 | $ 4.50 | ||||||||||
Net proceeds from public offering | $ 15,000,000 | $ 18,500,000 | ||||||||||||
Fair value of warrants | $ 3,540,659 | $ 3,500,000 | ||||||||||||
Warrants exercisable term | 4 years | |||||||||||||
Underwritten offering common stock | 4,444,444 | |||||||||||||
Warrant [Member] | ||||||||||||||
Equity (Textual) | ||||||||||||||
Stock-based compensation expense | $ 50,000 | $ 100,000 | $ 2,000,000 | |||||||||||
Exercise price | $ 1.05 | |||||||||||||
Common shares issued for cashless exercise of warrants | 1,736,277 | 1,532,124 | ||||||||||||
Additional common stock issued for exercise of options and warrants | 23,212 | 224,153 | ||||||||||||
Proceeds from stock options and warrants exercised | $ 18,105 | $ 173,620 | ||||||||||||
Number of stock option/restricted shares canceled | 1,789,623 | |||||||||||||
Number of stock option/warrants granted | 18,496,575 | 130,000 | 3,333,333 | |||||||||||
Fair value of stock options and warrants | $ 64,091 | |||||||||||||
Fair value assumptions, expected discount rate | 1.83% | |||||||||||||
Fair value assumptions, expected term | 5 years | |||||||||||||
Fair value assumptions, expected volatility rate | 82.00% | |||||||||||||
Fair value assumptions, expected dividend rate | 0.00% | |||||||||||||
Warrant to purchase of common stock | 18,275,000 | 57,212 | 9,364 | 183,718 | 2,013,360 | |||||||||
Share Price | $ 0.75 | |||||||||||||
Fair value of warrants | $ 4,900,000 | |||||||||||||
Warrants exercisable term | 5 years | |||||||||||||
Underwritten offering common stock | 21,500,000 | |||||||||||||
Common Stock [Member] | ||||||||||||||
Equity (Textual) | ||||||||||||||
Issuance of common stock, shares | 2,672,973 | |||||||||||||
Offering costs | $ 200,000 | |||||||||||||
Common shares issued for cashless exercise of warrants | 4,234 | 125,892 | 1,736,277 | |||||||||||
Investor [Member] | ||||||||||||||
Equity (Textual) | ||||||||||||||
Proceeds from common stock issued | $ 5,000,000 | |||||||||||||
Sale of stock, shares | 1,923,078 | |||||||||||||
Net proceeds from sale of stock | $ 4,480,000 | |||||||||||||
Offering price | $ 2.60 | |||||||||||||
Memorial Sloan Kettering Cancer Center [Member] | ||||||||||||||
Equity (Textual) | ||||||||||||||
Sale of stock, shares | 5,700,000 | 1,230.954 | ||||||||||||
Consultants [Member] | ||||||||||||||
Equity (Textual) | ||||||||||||||
Common shares for consulting services, value | $ 99,056 | |||||||||||||
Common shares for consulting services, shares | 67,385 | |||||||||||||
Share Price | $ 1.47 | |||||||||||||
Consultants [Member] | Warrant [Member] | ||||||||||||||
Equity (Textual) | ||||||||||||||
Fair value of warrants | $ 116,000 | |||||||||||||
Maximum [Member] | Mr. Traversa [Member] | ||||||||||||||
Equity (Textual) | ||||||||||||||
Fair value assumptions, expected discount rate | 1.39% | |||||||||||||
Fair value assumptions, expected term | 8 years 10 months 25 days | |||||||||||||
Fair value assumptions, expected volatility rate | 79.81% | |||||||||||||
Maximum [Member] | Warrant [Member] | ||||||||||||||
Equity (Textual) | ||||||||||||||
Exercise price | $ 1.77 | |||||||||||||
Fair value assumptions, expected discount rate | 1.20% | |||||||||||||
Fair value assumptions, expected term | 10 years | |||||||||||||
Fair value assumptions, expected volatility rate | 84.84% | |||||||||||||
Warrants exercisable term | 10 years | |||||||||||||
Minimum [Member] | Mr. Traversa [Member] | ||||||||||||||
Equity (Textual) | ||||||||||||||
Fair value assumptions, expected discount rate | 0.97% | |||||||||||||
Fair value assumptions, expected term | 3 months | |||||||||||||
Fair value assumptions, expected volatility rate | 45.72% | |||||||||||||
Minimum [Member] | Warrant [Member] | ||||||||||||||
Equity (Textual) | ||||||||||||||
Exercise price | $ 0.98 | |||||||||||||
Fair value assumptions, expected discount rate | 1.13% | |||||||||||||
Fair value assumptions, expected term | 5 years | |||||||||||||
Fair value assumptions, expected volatility rate | 79.79% | |||||||||||||
Warrants exercisable term | 5 years | |||||||||||||
2013 Equity Incentive Plan [Member] | ||||||||||||||
Equity (Textual) | ||||||||||||||
Number of additional shares authorized | 1,000,000 | |||||||||||||
2013 Equity Incentive Plan [Member] | Employees, directors and consultants [Member] | ||||||||||||||
Equity (Textual) | ||||||||||||||
Number of stock option/warrants granted | 450,000 | |||||||||||||
Plan expiration date | Sep. 9, 2023 | |||||||||||||
2013 Stock Plan [Member] | ||||||||||||||
Equity (Textual) | ||||||||||||||
Number of additional shares authorized | 17,750,000 | 12,750,000 | 9,250,000 | |||||||||||
2013 Stock Plan [Member] | Employees, directors and consultants [Member] | ||||||||||||||
Equity (Textual) | ||||||||||||||
Number of stock option/warrants granted | 2,750,000 | |||||||||||||
Plan expiration date | Sep. 9, 2023 | |||||||||||||
Stock Options [Member] | ||||||||||||||
Equity (Textual) | ||||||||||||||
Number of stock option/restricted shares canceled | 3,329,794 | 266,485 | 576,000 | |||||||||||
Number of stock option/warrants granted | 2,597,500 | 2,225,000 | 1,554,499 | |||||||||||
Stock options, term | 10 years | 10 years | 10 years | |||||||||||
Fair value of stock options and warrants | $ 2,400,000 | $ 3,100,000 | $ 3,200,000 | |||||||||||
Fair value assumptions, expected term | 6 years | 6 years | 6 years | |||||||||||
Fair value assumptions, expected dividend rate | 0.00% | 0.00% | 0.00% | |||||||||||
Total option expense | $ 3,100,000 | $ 3,600,000 | $ 3,400,000 | |||||||||||
Gross proceeds | $ 18,105 | $ 15,680 | ||||||||||||
Warrants exercised, shares | 23,212 | 20,000 | ||||||||||||
Stock Options [Member] | Maximum [Member] | ||||||||||||||
Equity (Textual) | ||||||||||||||
Exercise price | $ 1.58 | $ 2.25 | $ 3.58 | |||||||||||
Stock options, vesting period | 4 years | 10 years | 4 years 2 months 1 day | |||||||||||
Fair value assumptions, expected discount rate | 2.28% | 1.97% | 1.91% | |||||||||||
Fair value assumptions, expected volatility rate | 82.37% | 87.95% | 94.89% | |||||||||||
Stock Options [Member] | Minimum [Member] | ||||||||||||||
Equity (Textual) | ||||||||||||||
Exercise price | $ 0.57 | $ 0.95 | $ 1.79 | |||||||||||
Stock options, vesting period | 1 year | 4 years | 4 years | |||||||||||
Fair value assumptions, expected discount rate | 1.84% | 1.28% | 1.56% | |||||||||||
Fair value assumptions, expected volatility rate | 80.83% | 81.45% | 85.01% | |||||||||||
Restricted Stock [Member] | ||||||||||||||
Equity (Textual) | ||||||||||||||
Issuance of common stock, shares | 21,000 | |||||||||||||
Stock-based compensation expense | $ 200,000 | $ 600,000 | $ 3,400,000 | |||||||||||
Number of shares yet to issue of restricted stock, vested | 281,301 | |||||||||||||
Restricted stock granted, shares | 60,700 | |||||||||||||
Restricted Stock [Member] | Consultants [Member] | ||||||||||||||
Equity (Textual) | ||||||||||||||
Number of shares of restricted stock, vested | 26,000 | |||||||||||||
Common shares for consulting services, value | $ 65,813 | |||||||||||||
Common shares for consulting services, shares | 59,393 | 250,700 | 479,651 | |||||||||||
Restricted stock granted value | $ 400,000 | $ 2,300,000 | ||||||||||||
Restricted stock granted, shares | 60,700 | 329,651 | ||||||||||||
Description of restricted stock | Of the 250,700 restricted share awards granted in 2016, 60,700 shares vested at the date of grant, 150,000 shares vest over a six-month period and 40,000 shares vest over 2 years. | Of the 479,651 restricted share awards granted in 2015, 329,651 shares vested at the date of grant and 150,000 shares vest over a six-month period. | ||||||||||||
Restricted Stock [Member] | Employees [Member] | ||||||||||||||
Equity (Textual) | ||||||||||||||
Number of stock option/restricted shares canceled | 126,265 | |||||||||||||
Number of common stock options, granted | 152,499 | |||||||||||||
Restricted stock granted value | $ 800,000 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 |
Deferred tax assets: | ||
Net operating losses carry forward | $ 30,826,534 | $ 38,874,255 |
Share-based compensation | 3,731,413 | 8,081,711 |
Research & Development/Orphan Drug Credits | 6,324,998 | 830,085 |
Others | 11,369 | 16,329 |
Less: valuation allowance | (40,894,314) | (47,802,380) |
Deferred tax assets, net | $ 0 | $ 0 |
Income Taxes (Details 1)
Income Taxes (Details 1) - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Income Tax Disclosure [Abstract] | |||
Federal income taxes at 34% | $ (9,044,420) | $ (8,269,386) | $ (7,148,607) |
Federal income taxes at 34%, percentage | (34.00%) | (34.00%) | (34.00%) |
State income taxes | $ (1,940,945) | $ 973,547 | |
State income taxes, percentage | (7.30%) | 4.00% | |
Change in Federal statutory rate | $ 17,939,714 | ||
Change in Federal statutory rate, percentage | 67.40% | ||
Deferred true-up | $ 3,090,815 | $ (10,511,380) | $ 1,104,763 |
Deferred true-up, percentage | 11.80% | (43.30%) | 5.20% |
Research and Development/Orphan Drug Tax Credit | $ (3,029,074) | $ (141,769) | |
Research and Development/Orphan Drug Tax Credit, percentage | (11.40%) | (0.60%) | |
Unrealized derivative gain/loss | $ (120,870) | $ (956,840) | |
Unrealized derivative gain/loss, percentage | (0.50%) | (3.90%) | |
Other | $ 12,845 | $ 13,632 | |
Other, percentage | 0.00% | 0.10% | |
Change in valuation allowance | $ (6,908,065) | $ 18,892,196 | $ 6,043,844 |
Change in valuation allowance, percentage | (26.00%) | 77.70% | 28.80% |
Provision for income tax | |||
Provision for income tax, percentage |
Income Taxes (Details Textual)
Income Taxes (Details Textual) - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
U.S. Federal statutory rate | 34.00% | 34.00% | 34.00% |
Deferred tax assets, valuation allowance | $ 40,894,314 | $ 47,802,380 | |
Decrease related to tax cuts and jobs act | 17,900,000 | ||
Orphan Drug Credits [Member] | |||
Net operating losses | $ 5,000,000 | ||
Net operating loss expiration date | Dec. 31, 2027 | ||
Domestic Tax Authority [Member] | |||
Net operating losses | $ 123,300,000 | ||
Net operating loss expiration date | Dec. 31, 2018 | ||
Domestic Tax Authority [Member] | Research Tax Credit Carryforward [Member] | |||
Net operating losses | $ 1,300,000 | ||
Net operating loss expiration date | Dec. 31, 2033 | ||
State and Local Jurisdiction [Member] | |||
Net operating losses | $ 77,500,000 | ||
Net operating loss expiration date | Dec. 31, 2035 |
Subsequent Events (Details)
Subsequent Events (Details) - Subsequent Event [Member] - USD ($) | Mar. 09, 2018 | Feb. 28, 2018 |
Subsequent Events (Textual) | ||
Number of warrants | 30,125,326 | |
Aggregate shares of common stock | 30,125,326 | |
Gross proceeds | $ 15,100,000 | |
Net proceeds | $ 13,900,000 | |
Restricted stock grant for employee | 1,000 | |
Employees options to purchase granted | 785,000 | |
Options to purchase average price | $ 0.64 | |
Common Class B [Member] | ||
Subsequent Events (Textual) | ||
Number of warrants | 22,593,967 | |
Exercise price per share | $ 0.70 | |
Common Class A [Member] | ||
Subsequent Events (Textual) | ||
Number of warrants | 7,531,304 | |
Exercise price per share | $ 0.60 |