Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Mar. 31, 2017 | Jun. 30, 2016 | |
Document And Entity Information | |||
Entity Registrant Name | Immune Therapeutics, Inc. | ||
Entity Central Index Key | 1,559,356 | ||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2016 | ||
Amendment Flag | false | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filer | No | ||
Entity Current Reporting Status | Yes | ||
Entity Filer Category | Smaller Reporting Company | ||
Entity Public Float | $ 31,415,587 | ||
Entity Common Stock, Shares Outstanding | 273,640,164 | ||
Trading Symbol | IMUN | ||
Document Fiscal Period Focus | FY | ||
Document Fiscal Year Focus | 2,016 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2016 | Dec. 31, 2015 |
Current Assets: | ||
Cash and cash equivalents | $ 74,389 | $ 23,149 |
Accounts receivable | 16,197 | |
Total current assets | 74,389 | 39,346 |
Fixed Assets: | ||
Computer equipment, net of accumulated depreciation of $7,888 and $6,331 respectively | 1,850 | 1,682 |
Deposits | 200 | 200 |
Total assets | 76,439 | 41,228 |
Current Liabilities: | ||
Accounts payable | 1,818,605 | 1,924,672 |
Accrued liabilities | 3,156,759 | 1,281,039 |
Current portion of notes payable | 4,225,419 | 2,793,701 |
Total current liabilities | 9,200,783 | 5,999,412 |
Total liabilities | 9,200,783 | 5,999,412 |
Stockholders' Deficit: | ||
Common stock - par value $0.0001; 500,000,000 shares authorized; 250,428,133 and 174,850,047 shares issued and outstanding respectively | 25,043 | 17,485 |
Additional paid in capital | 360,420,026 | 343,434,786 |
Stock issuances due | 962,429 | 1,140,303 |
Prepaid services | (822,500) | (660,417) |
Accumulated deficit | (365,718,976) | (349,861,173) |
Deficit attributable to common stockholders | (5,133,978) | (3,857,732) |
Non-controlling interest | (3,990,366) | (2,100,452) |
Total stockholders' deficit | (9,124,344) | (5,958,184) |
Total liabilities and stockholders' deficit | $ 76,439 | $ 41,228 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - USD ($) | Dec. 31, 2016 | Dec. 31, 2015 |
Statement of Financial Position [Abstract] | ||
Accumulated depreciation | $ 7,888 | $ 6,331 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 500,000,000 | 500,000,000 |
Common stock, shares issued | 250,428,133 | 174,850,047 |
Common stock, shares outstanding | 250,428,133 | 174,850,047 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Income Statement [Abstract] | ||
Revenues, net | $ 3,463 | $ 16,197 |
Operating expenses: | ||
Selling, general and administrative | 3,886,599 | 2,734,414 |
Research and development expense | 444,165 | 977,203 |
Stock issued for services general and administrative | 5,212,304 | 6,240,143 |
Warrant valuation | 4,730,726 | 46,189 |
Depreciation and amortization expense | 1,557 | 594,785 |
Impairment of intangible assets | 5,226,352 | |
Total operating expenses | 14,275,351 | 15,819,086 |
Loss from operations | (14,271,888) | (15,802,889) |
Other expense: | ||
Interest expense | (3,446,564) | (270,989) |
Impairment of investment | (32,000) | |
Loss on settlement of debt | (2,100,549) | (843,573) |
Total other expense | (5,547,113) | (1,146,562) |
Net loss | (19,819,001) | (16,949,451) |
Net loss attributable to non-controlling interest | (297,600) | (2,706,939) |
Net loss attributable to common shareholders | $ (19,521,401) | $ (14,242,512) |
Basic loss per share attributed to common shareholders | $ (0.09) | $ (0.09) |
Weighted average number of shares outstanding | 216,687,993 | 153,247,023 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity/ (Deficit) - USD ($) | Common Stock [Member] | Additional Paid-In Capital [Member] | Stock to Be Issued [Member] | Prepaid Services [Member] | Accumulated Deficit [Member] | Non-Controlling Interest [Member] | Total |
Balance at Dec. 31, 2014 | $ 13,442 | $ 337,985,787 | $ 847,279 | $ (3,553,185) | $ (333,547,378) | $ 606,487 | $ 2,352,432 |
Balance, shares at Dec. 31, 2014 | 134,417,210 | ||||||
Issuance of common stock for prepaid services | $ 1,667 | 2,730,708 | 535,000 | (1,436,000) | $ 1,831,376 | ||
Issuance of common stock for prepaid services, shares | 16,672,504 | 16,922,504 | |||||
Amortization of prepaid services | 4,328,768 | $ 4,328,768 | |||||
Issuance of common stock for investment | $ 40 | 31,960 | 32,000 | ||||
Issuance of common stock for investment, shares | 400,000 | ||||||
Issuance of common stock for legal settlement | $ 100 | 79,900 | 80,000 | ||||
Issuance of common stock for legal settlement, shares | 1,000,000 | ||||||
Issuance of common stock for interest expense | $ 6 | 15,619 | 15,625 | ||||
Issuance of common stock for interest expense, shares | 62,500 | ||||||
Issuance of common stock in exchange for debt | $ 1,406 | 1,954,971 | (257,000) | 1,699,377 | |||
Issuance of common stock in exchange for debt, shares | 14,058,833 | ||||||
Issuance of common stock for cash and exercise of warrants | $ 824 | 589,651 | 15,025 | 605,500 | |||
Issuance of common stock for cash and exercise of warrants, shares | 8,239,000 | ||||||
Issuance and modification of common stock warrants | 46,189 | 46,189 | |||||
Net loss | (14,242,512) | (2,706,939) | (16,949,451) | ||||
Balance at Dec. 31, 2015 | $ 17,485 | 343,434,786 | 1,140,303 | (660,417) | (347,789,889) | (2,100,452) | (5,958,184) |
Balance, shares at Dec. 31, 2015 | 174,850,047 | ||||||
Issuance of common stock for prepaid services | $ 3,262 | 5,678,998 | (307,875) | (3,072,535) | $ 2,301,850 | ||
Issuance of common stock for prepaid services, shares | 32,633,910 | 32,633,910 | |||||
Amortization of prepaid services | 2,910,452 | $ 2,910,452 | |||||
Issuance of common stock for interest expense | $ 463 | 403,287 | 403,750 | ||||
Issuance of common stock for interest expense, shares | 4,621,296 | ||||||
Issuance of common stock in exchange for debt | $ 3,625 | 5,242,272 | 155,001 | 5,400,898 | |||
Issuance of common stock in exchange for debt, shares | 36,235,380 | ||||||
Issuance of common stock for cash and exercise of warrants | $ 193 | 224,807 | (25,000) | 200,000 | |||
Issuance of common stock for cash and exercise of warrants, shares | 1,937,500 | ||||||
Issuance and modification of common stock warrants | 4,730,726 | 4,730,726 | |||||
Discount on warrants issued in connection with notes payable | 682,665 | 682,665 | |||||
Issuance of common stock for legal expenses | $ 15 | 22,485 | 22,500 | ||||
Issuance of common stock for legal expenses, shares | 150,000 | ||||||
Issuance of stock of Cytocom | 1,592,314 | (1,592,314) | |||||
Net loss | (19,521,401) | (297,600) | (19,819,001) | ||||
Balance at Dec. 31, 2016 | $ 25,043 | $ 360,420,026 | $ 962,429 | $ (822,500) | $ (365,718,976) | $ (3,990,366) | $ (9,124,344) |
Balance, shares at Dec. 31, 2016 | 250,428,133 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
CASH FLOWS FROM OPERATING ACTIVITIES | ||
Net loss including non-controlling interest | $ (19,819,001) | $ (16,949,451) |
Adjustments to reconcile net loss to net cash flows used in operating activities: | ||
Depreciation | 1,557 | 2,552 |
Amortization | 592,233 | |
Stock issued for services | 2,324,350 | 1,911,375 |
Amortization of stock issued for prepaid services | 2,910,452 | 4,328,768 |
Impairment of intangible assets | 5,226,352 | |
Impairment of investment | 32,000 | |
Loss on settlement of debt and accounts payable | 2,100,549 | 843,573 |
Stock warrant expense | 4,730,726 | 46,189 |
Stock issued for loan expenses and interest | 403,750 | 15,625 |
Amortization of debt discount | 989,035 | |
Expenses paid by lenders | 115,202 | |
Accounts receivable write off | 2,661 | |
Changes in operating assets and liabilities: | ||
Accounts receivable | 13,536 | (16,197) |
Prepaid expenses and other current assets | 39,983 | |
Accrued liabilities | 2,846,461 | 194,201 |
Accounts payable | 540,983 | 900,484 |
Net cash used in operating activities | (2,839,739) | (2,832,313) |
CASH FLOWS FROM INVESTING ACTIVITIES | ||
Purchase of computer equipment | (1,725) | |
Net cash provided used in investing activities | (1,725) | |
CASH FLOWS FROM FINANCING ACTIVITIES | ||
Proceeds from sale of common stock and exercise of warrants | 200,000 | 605,500 |
Proceeds from notes payable | 2,768,631 | 2,057,975 |
Repayment of notes payable | (75,927) | |
Net cash provided by financing activities | 2,892,704 | 2,663,475 |
Increase/(decrease) in cash | 51,240 | (168,838) |
Cash and cash equivalents, beginning of year | 23,149 | 191,987 |
Cash and cash equivalents, end of year | 74,389 | 23,149 |
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION: | ||
Cash paid for interest | 29,567 | 20,500 |
SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING AND FINANCING ACTIVITIES: | ||
Conversion of notes payable, accrued liabilities and accounts payable to common stock | 3,363,731 | 855,804 |
Accrued liabilities converted to note payable | 388,143 | |
Settlement of note payable by issuance of new note payable | 50,000 | |
Notes payable for expenses paid by lender | 115,201 | 46,933 |
Debt discounts on notes payable | $ 1,007,716 |
Organization and Description of
Organization and Description of Business | 12 Months Ended |
Dec. 31, 2016 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Description of Business | 1. Organization and Description of Business Immune Therapeutics, Inc. (the “Company,” “we,” or “our”) was initially incorporated in Florida on December 2, 1993 as Resort Clubs International, Inc. (“Resort Clubs”). It was formed to manage and market golf course properties in resort markets throughout the United States. Galliano International Ltd. (“Galliano”) was incorporated in Delaware on May 27, 1998 and began trading in November 1999 through the filing of a 15C-211. On November 10, 2004, Galliano merged with Resort Clubs. Resort Clubs was the surviving corporation. On August 23, 2010, Resort Clubs changed its name to pH Environmental Inc. (“pH Environmental”). On April 23, 2012, pH Environmental completed a name change to TNI BioTech, Inc., and on April 24, 2012, we executed a share exchange agreement for the acquisition of all of the outstanding shares of TNI BioTech IP, Inc. On September 4, 2014, a majority of our shareholders approved an amendment to our Amended and Restated Articles of Incorporation, as amended, to change our name to Immune Therapeutics, Inc. We filed our name change amendment with the Secretary of State of Florida on October 27, 2014 changing our name to Immune Therapeutics, Inc. The Company currently has an office in Orlando, Florida. In July 2012, the Company’s focus turned to acquiring patents that would protect and advance the development of new uses of opioid-related immune- therapies, such as low dose naltrexone (“LDN”) and Methionine [Met5]-enkephalin (“MENK”). In October 2012, the Company formed TNI BioTech International, Ltd., a BVI company in Tortola, British Virgin Islands, which was set up to allow the Company to market and sell LDN in those countries outside the U.S. in which we have been able to obtain approval to sell the Company’s products. In August 2013, the Company formed its United Kingdom subsidiary, TNI BioTech, LTD (the “UK Subsidiary”). The UK Subsidiary received approval to be considered a micro, small or medium-sized enterprise (“SME”) with the European Medicines Agency (“EMA”) on August 21, 2013. The designation provides the UK Subsidiary with significant discounts when holding meetings or submitting filings to the EMA. On September 19, 2013, the UK Subsidiary submitted a pre-submission package to the EMA regarding Crohn’s Disease. The EMA granted the UK Subsidiary a meeting that took place on September 27, 2013. The UK Subsidiary is eligible to benefit from the provisions for administrative and financial assistance for SMEs set out in Regulation (EC) No 2049/2005. The Company will apply to obtain EMA benefits once funding becomes available. In December 2013, the Company formed a new subsidiary, Cytocom Inc., to focus on conducting LDN and MENK clinical trials in the United States. In December 2014, the Company completed the distribution of common stock of Cytocom Inc. to its shareholders. As part of the transaction, the Company retained exclusive rights to all international patents, in-country approvals, formulations, trademarks, manufacturing, marketing, sales, and distributions rights in emerging nations, including Africa, Central America, South America, Russia, India, China, Far East, and The Commonwealth of Independent States (former Soviet Union). The Company will continue to have access to existing clinical data as well as any new data generated by Cytocom Inc. during drug development. On December 8, 2014, the number of Cytocom Inc. shares of common stock that were issued to our shareholders totaled 113,242,522 shares. In connection with the transaction, Cytocom Inc. issued 140,100,000 shares of its common stock to the Company, which gave the Company a 55.3% stake in Cytocom Inc. on that date. In April 2016, the Board of Directors and a majority of shareholders of Cytocom approved a reverse stock split of Cytocom’s outstanding common stock with one new share of stock for each twenty old shares of common stock. Cytocom effectuated and finalized the reverse split in June 2016. At December 31, 2016, the Company’s equity interest had been further reduced to 13%, by subsequent issuances of Cytocom common stock to shareholders in settlement of notes payable. In March 2014, the Company incorporated Airmed Biopharma Limited, an Irish corporation with an address in Dublin, Ireland, and Airmed Holdings Limited, an Irish company domiciled in Bermuda. The Irish companies were set up to benefit from incentives granted by the Irish government for the establishment of pharmaceutical companies (many of the world’s leading pharmaceutical companies have located in Ireland), and so that the Company could take advantage of Ireland’s status as a member of the European Union and the European Economic Area. An Irish limited liability company enjoys a low corporate income tax rate of 12.5%, one of the lowest in the world. The Irish-domiciled company hopes to qualify for tax incentives for Irish holding/headquartered companies and to benefit from the network of double tax treaties that reduce withholding taxes. TNI BioTech International, Ltd. will manage our international distribution, using product that is manufactured in Ireland and elsewhere. We are focused on the development and commercialization of therapeutic treatments for cancer, HIV/AIDS and autoimmune diseases and immune disorders by combating these severe and fatal diseases through the stimulation and/or regulation of the body’s immune system. Our growth strategy includes the near-term commercialization of our existing immunotherapies targeting cancer, Crohn’s disease and/or HIV/AIDS. Going Concern The Company has incurred significant net losses since inception and has relied on its ability to fund its operations through private equity financings. Management expects operating losses and negative cash flows to continue at more significant levels in the future. As the Company continues to incur losses, transition to profitability is dependent upon the successful development, approval, and commercialization of its product candidate and the achievement of a level of revenues adequate to support the Company’s cost structure. The Company may never achieve profitability, and unless and until it does, the Company will continue to need to raise additional cash. Management intends to fund future operations through additional private or public debt or equity offerings, and may seek additional capital through arrangements with strategic partners or from other sources. Based on the Company’s operating plan, existing working capital at December 31, 2016 was not sufficient to meet the cash requirements to fund planned operations through December 31, 2017 without additional sources of cash. These conditions raise substantial doubt about the Company’s ability to continue as a going concern. The accompanying financial statements have been prepared assuming that the Company will continue as a going concern and do not include adjustments that might result from the outcome of this uncertainty. This basis of accounting contemplates the recovery of the Company’s assets and the satisfaction of liabilities in the normal course of business. The Company experienced a net loss from operations of $19,819,001 and used cash and cash equivalents for operations in the amount of $2,839,739 during the year ended December 31, 2016, resulting in a stockholders’ deficit of $9,124,344. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2016 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The accompanying consolidated financial statements have been prepared in accordance with United States (U.S.) generally accepted accounting principles (U.S. GAAP) and include all adjustments necessary for the fair presentation of the Company’s financial position for the periods presented. The Company qualifies as an “emerging growth company” as defined in Section 101 of the Jumpstart our Business Startups Act (“JOBS Act”) as we do not have more than $1,000,000,000 in annual gross revenue for the year ended December 31, 2016. We are electing to use the extended transition period for complying with new or revised accounting standards under Section 102(b)(1) of the JOBS Act. Revenue Recognition Revenue from product sales is recognized upon passage of title and risk of loss to customers. Provisions for discounts, rebates and sales incentives to customers, and returns and other adjustments are provided for in the period the related sales are recorded. Historical data are not yet readily available and reliable for use in estimating the amount of the reduction in gross sales. Revenue from the launch of a new product, from an improved version of an existing product, or for shipments in excess of a customer’s normal requirements will be recorded when the conditions noted above are met. In those situations, management will record a returns reserve for such revenue, if necessary. If in future the Company participates in selling arrangements that include multiple deliverables (e.g., instruments, reagents, procedures, and service agreements), under these arrangements, the Company will recognize revenue upon delivery of the product or performance of the service and will allocate the revenue based on the relative selling price of each deliverable, which will be based primarily on vendor specific objective evidence. Revenue from license of product rights is recorded over the periods earned. In May 2014, the Financial Accounting Standards Board issued Accounting Standards Update No. 2014-09, Revenue from Contracts with Customers, which provides a single comprehensive model for accounting for revenue from contracts with customers and will supersede most existing revenue recognition guidance. Early adoption is not permitted. The standard becomes effective for the Company in the first quarter of 2018. The Company is currently evaluating the effect, if any, that the standard will have on its consolidated financial statements and related disclosures. Use of Estimates The preparation of the Company’s financial statements in conformity with U.S. generally accepted accounting principles requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from such estimates. Cash, Cash Equivalents, and Short-Term Investments The Company considers all highly liquid investments with original maturities at the date of purchase of three months or less to be cash equivalents. Cash and cash equivalents include bank demand deposits, marketable securities with maturities of three months or less at purchase, and money market funds that invest primarily in certificates of deposits, commercial paper and U.S. government and U.S. government agency obligations. Cash equivalents are reported at fair value. Concentration of Credit Risk Financial instruments that potentially subject the Company to concentrations of credit risk are primarily cash and cash equivalents. The Company is exposed to credit risk, subject to federal deposit insurance, in the event of a default by the financial institutions holding its cash and cash equivalents to the extent of amounts recorded on the balance sheets. The cash accounts are insured by the Federal Deposit Insurance Corporation up to $250,000. At December 31, 2016, the Company has no cash balances in excess of insured limits. Segment and Geographic Information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one operating segment and does not segment the business for internal reporting or decision making. Fair Value of Financial Instruments In accordance with the reporting requirements of Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) Topic 825, “ Financial Instruments” Fair Value Measurements The ASC Topic 820, Fair Value Measurement, Fixed Assets Fixed assets are stated at cost, less accumulated depreciation. Depreciation is determined on a straight-line basis over the estimated useful lives of the assets, which generally range from three to five years. Maintenance and repairs are charged against expense as incurred. Depreciation expense for the years ended December 31, 2016 and December 31, 2015 was $1,557 and $2,552, respectively. Intangible Assets Costs incurred to acquire and/or develop the Company’s product licenses and patents are capitalized and amortized by straight-line methods over estimated useful lives of ten to sixteen years. Intangible assets are stated at the lower of cost or estimated fair value. During the years ended December 31, 2016 and December 31, 2015, the Company capitalized $nil and $nil respectively, of such costs incurred for the Company’s acquisition of licenses for the patents. (See Note 10). Amortization expense for the years ended December 31, 2016 and December 31, 2015 was $0 and $592,233, respectively. Impairment of Long-Lived Assets The Company evaluates long-lived assets for impairment whenever events or change in circumstances indicate that the carrying amount of an asset may not be recoverable as prescribed by ASC Topic 360-10-05, “ Property, Plant and Equipment Research and Development Costs Research and development costs are charged to expense as incurred and are typically comprised of salaries and benefits, pre-clinical studies, clinical trial activities, drug development and manufacturing, fees paid to consultants and other entities that conduct certain research and development activities on the Company’s behalf and third-party service fees, including clinical research organizations and investigative sites. Costs for certain development activities, such as clinical trials are recognized based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations, or information provided by vendors on their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the financial statements as operating expenses. Income Taxes The Company follows ASC Topic 740, Income Taxes, The standard addresses the determination of whether tax benefits claimed or expected to be claimed on a tax return should be recorded in the financial statements. Under ASC Topic 740, the Company may recognize the tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination by the tax authorities, based on the technical merits of the position. The tax benefits recognized in the financial statements from such a position should be measured based on the largest benefit that has a greater than fifty percent likelihood of being realized upon ultimate settlement. ASC Topic 740 also provides guidance on de-recognition, classification, interest and penalties on income taxes, accounting in interim periods and requires increased disclosures. At the date of adoption, and as of December 31, 2016 and 2015, the Company does not have a liability for unrecognized tax uncertainties. The Company’s policy is to record interest and penalties on uncertain tax positions as income tax expense. As of December 31, 2016, and 2015, the Company has not accrued any interest or penalties related to uncertain tax positions. Stock-Based Compensation and Issuance of Stock for Non-Cash Consideration The Company measures and recognizes compensation expense for all share-based payment awards made to employees and directors, including employee stock options, based on estimated fair values equaling either the market value of the shares issued or the value of consideration received, whichever is more readily determinable. The majority of the non-cash consideration pertains to services rendered by consultants and others and has been valued at the fair value of the Company’s common stock at the date of the agreement. The Company’s accounting policy for equity instruments issued to consultants and vendors in exchange for goods and services follows the provisions of ASC Topic 505-50, “ Equity-Based Payments to Non-Employees Non-controlling Interest In accordance with ASC Topic 810, Consolidation Net Loss per Share Basic net loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted average number of common shares outstanding for the period, without consideration for common stock equivalents. Diluted net loss per share is calculated by dividing the net loss by the weighted-average number of common share equivalents outstanding for the period determined using the treasury-stock method and the if-converted method. Dilutive common stock equivalents are comprised of common stock purchase warrants outstanding. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding due to the Company’s net loss position. A calculation of basic and diluted net loss per share follows: For the year ended December 31, 2016 2015 Historical net loss per share: Numerator Net loss $ (19,819,001 ) $ (16,949,451 ) Non-controlling interest (297,600 ) (2,706,939 ) Net loss attributed to common stockholders $ (19,521,401 ) $ (14,242,512 ) Denominator Weighted-average common shares outstanding— Denominator for basic and diluted net loss per share 216,687,993 153,247,023 Basic and diluted net loss per share attributed to common stockholders $ (0.09 ) $ (0.09 ) The Company’s potential dilutive securities which include stock and warrants have been excluded from the computation of diluted net loss per share as the effect would be to reduce the net loss per share. Therefore, the weighted-average Common stock outstanding used to calculate both basic and diluted net loss per share is the same. The following shares of potentially dilutive securities have been excluded from the computations of diluted weighted average shares outstanding as the effect of including such securities would be antidilutive: Year Ended December 31, 2016 2015 Common Stock Purchase Warrants 59,191,904 9,131,500 Recent Accounting Standards During the year ended December 31, 2016 and through March 31, 2017, there were several new accounting pronouncements issued by the Financial Accounting Standards Board. Each of these pronouncements, as applicable, has been or will be adopted by the Company. Management does not believe the adoption of any of these accounting pronouncements has had or will have a material impact on the Company’s consolidated financial statements. The Company qualifies as an “emerging growth company” as defined in Section 101 of the Jumpstart our Business Startups Act (“JOBS Act”) as we do not have more than $1,000,000,000 in annual gross revenue and did not have such amount as of December 31, 2016, our last fiscal year. We are electing to use the extended transition period for complying with new or revised accounting standards under Section 102(b)(1) of the JOBS Act. |
Fixed Assets
Fixed Assets | 12 Months Ended |
Dec. 31, 2016 | |
Fixed Assets: | |
Fixed Assets | 3. Fixed Assets December 31, 2016 2015 Fixed assets: Computer equipment $ 9,738 $ 8,013 Less accumulated depreciation (7,888 ) (6,331 ) Property and equipment, net $ 1,850 $ 1,682 The Company utilizes the straight-line method for depreciation, using three to five-year depreciable asset lives. Depreciation expense was not material for all periods presented. |
Accrued Liabilities
Accrued Liabilities | 12 Months Ended |
Dec. 31, 2016 | |
Payables and Accruals [Abstract] | |
Accrued Liabilities | 4. Accrued Liabilities Accrued expenses and other liabilities consist of the following: December 31, 2016 2015 Accrued payroll to officers and others 1,126,261 758,342 Accrued interest and penalties - notes payable 1,902,018 236,671 Estimated legal settlement 128,087 282,136 Other accrued liabilities 393 323 State payroll taxes - 3,567 Total accrued expenses and other liabilities $ 3,156,759 $ 1,281,039 |
Notes Payable
Notes Payable | 12 Months Ended |
Dec. 31, 2016 | |
Debt Disclosure [Abstract] | |
Notes Payable | 5. Notes Payable Notes payable consist of the following: December 31, 2016 December 31, 2015 Promissory note issued July 29, 2014 to Ira Gaines. In 2016, the maturity date on the note was extended to December 1, 2017. The note earns interest at a rate of 18% per annum. $ 100,000 $ 100,000 Promissory notes issued between November 26, 2014 and September 30, 2015, to raise up to $2,000,000 in debt. Lenders earn interest at a rate of 10% per annum, plus a pro-rata share of two percent of the Company’s gross receipts for sales of IRT-103-LDN in perpetuity. Notes will be repaid in 36 monthly installments of principal and interest commencing no later than October 15, 2015. Principal of $425,500 and accrued interest of $37,427 were converted to 5,309,092 shares of common stock in the year ended December 31, 2016, Notes aggregating $286,000 were in default at December 31, 2016, as the Company was unable to pay installments on those notes on their due dates. No demands for repayment have been made by the lenders. 286,000 711,500 Promissory note issued October 17, 2014 to Roger Bozarth. The note matures on October 17, 2015 and earns interest at a rate of 2% per annum. The lender converted this note and $2,139 in accrued interest to 114,237 shares of common stock in January 2016. - 7,000 Promissory notes issued between May 1, 2015 and December 31, 2016, and maturing between June 14, 2015 and September 30, 2017. Lenders on loans aggregating $505,994 earn interest at rates between 2% and 18% per annum. On loans aggregating $198,500, interest is payable in a fixed amount not tied to a specific interest rate. Notes aggregating $100,000 were in default at December 31, 2016, as the Company was unable to repay those notes on their due dates. No demands for repayment have been made by the lenders. 704,494 669,933 Promissory note issued January 26, 2015 to Robert J. Dailey. The note is senior to, and has priority in right of payment over, all indebtedness of the Company. The note earns interest at a rate of 2% per annum and was due on July 30, 2015. Principal of $200,000 and accrued interest of $4,778 was converted to 3,722,015 shares of common stock in 2016. - 200,000 Promissory notes issued by Cytocom Inc. between April 29, 2015 and December 31, 2015. Lenders earn interest at rates between 5% and 10% per annum. These notes mature on September 30, 2016. $375,000 of principal and $12,036 in accrued interest was converted to 4,837,960 shares of common stock in 2016. The Company was unable to repay the remaining notes at maturity and the notes are in default, although no demand for repayment has been made by the lenders. 425,000 800,000 Promissory notes issued in December 2015. Lenders earn interest at a rate of 10% per month. Notes are repayable on March 9, 2016. $30,000 of principal and $49,000 of interest and penalties were converted to 987,500 shares of common stock in 2016. The Company was unable to repay the remaining note at maturity and the note is in default. The Company is obligated to pay late-payment penalties totaling $5,000 per day on the remaining obligation. 100,000 130,000 Promissory note issued November 24, 2015 as settlement of amounts owing to a law firm. The Lender earns interest at the rate of 10% per annum. The note and $10,036 in interest was converted to 1,235,536 shares of common stock in July 2016. - 175,268 Promissory notes issued between May 5, 2016 and June 2, 2016 that mature between October 1, 2016 and January 31, 2017, and include stock conversion features, warrants and original issue debt discounts. Notes aggregating $304,882 were paid on February 8, 2017. The remaining note's maturity date was extended and is in default on March 31, 2017. No demand for repayment has been made by the lender. 554,882 - Promissory notes issued to an officer of the Company effective November 3, 2015 and maturing November 3, 2016 for settlement of accrued payroll, bearing interest at 10% per annum and including a stock conversion feature. 112,737 - Promissory note issued in July 2016. The note was repayable on October 5, 2016 but was extended to December 31, 2016. The note earns interest at 6% per month. The Company was unable to repay the note at maturity and the note is in default. 50,000 - Promissory note issued in July 2016 with an original issuance discount of $30,000. Net proceeds were $150,000. The note is repayable on April 7, 2017. 180,000 - Promissory notes issued in August 2016 for $149,854 as a settlement of amounts owed to a law firm. The notes accrue interest at 5% per annum and are payable in 18 equal monthly installments of $8,641.88. The note was in default on December 31, 2016. 120,987 - Promissory notes issued between July 1, 2016 and December 31, 2016. Lenders earn interest at 2% per annum. The notes mature on September 30, 2017. Notes aggregating $239,000 were converted in the fourth quarter of 2016. 256,000 - Notes aggregating $1,354,000 were issued in the fourth quarter of 2016. The notes accrue interest at 2% per annum and mature between November 1, 2017 and December 31, 2017. 1,354,000 - Less: Original issue discounts on notes payable and warrants issued with notes. (18,681 ) - Total 4,225,419 2,793,701 Less: Current Portion $ (4,225,419 ) $ (2,793,701 ) Long-Term debt, less current portion $ - $ - As of December 31, 2016, the Company had accrued $399,271 in unpaid interest and $1,502,747 in unpaid default penalties. During the year ended December 31, 2016, 4,621,296 shares with a fair value of $403,750 were issued by the Company for interest expense under promissory notes. As of December 31, 2015, the Company had accrued $236,671 in unpaid interest. During the year ended December 31, 2015, 62,500 shares with a fair value of $15,625 were issued by the Company for interest expense under promissory notes. |
Capital Structure - Common Stoc
Capital Structure - Common Stock and Common Stock Purchase Warrants | 12 Months Ended |
Dec. 31, 2016 | |
Equity [Abstract] | |
Capital Structure - Common Stock and Common Stock Purchase Warrants | 6. Capital Structure—Common Stock and Common Stock Purchase Warrants Each holder of common stock is entitled to vote on all matters and is entitled to one vote for each share held. No holder of shares of stock of any class shall be entitled as a matter of right to subscribe for or purchase or receive any part of any new or additional issue of shares of stock of any class, or of securities convertible into shares of stock or any class, whether now hereafter authorized or whether issued for money, for consideration other than money, or by way of dividend. As of December 31, 2016 and 2015, the Company was authorized to issue 500,000,000 common shares at a par value of $0.0001 per share. As of December 31, 2016, the Company had 250,428,133 shares of common stock outstanding and 174,850,047 outstanding as of December 31, 2015. Stock Warrants In 2016, the Company issued 50,222,904 warrants, exercisable into one share of common stock of the Company for each warrant at prices between $0.03 and $2.00 per share. The warrants expire between Oct 2017 and Dec 2021. When the Company sells its stock to stockholders for cash, it periodically issues warrants to those stockholders to acquire additional stock at prices agreed at the date of the original sale. The Company incurs a cost for the rights attached to the warrants, which is calculated using the Black-Scholes Model. This expense is reported in the Statements of Operations above as the Warrant valuation expense. During 2016, there were no modifications of the terms of any warrants issued by the Company. Following is a summary of outstanding stock warrants at December 31, 2016 and 2015 and activity during the years then ended: Number of Shares Exercise Price Weighted Average Price Warrants as of December 31, 2015 9,131,500 $ 0.07-15 $ 1.47 Issued 50,222,904 $ 0.03-2.00 $ 0.16 Expired (162,500 ) $ 5.00 $ 5.00 Exercised 0 $ 0 $ 0 Warrants as of December 31, 2016 59,191,904 $ 0.03-15.00 $ 0.35 Summary of outstanding warrants as of December 31, 2016: Expiration Date Number of Shares Exercise Price Remaining Life (years) Fourth Quarter 2017 350,000 $ 1.50-9.00 1.00 First Quarter 2018 127,500 $ 15.00 1.25 Second Quarter 2018 33,334 $ 15.00 1.50 Third Quarter 2018 250,000 $ 1.50 1.75 Fourth Quarter 2018 6,089,166 $ 1.00-1.50 2.00 First Quarter 2019 4,024,000 $ 0.50-2.00 2.25 Second Quarter 2019 135,000 $ 0.07-0.23 2.50 Third Quarter 2019 260,000 $ 0.50-1.50 2.75 Fourth Quarter 2019 400,000 $ 0.14 3.00 Second Quarter 2020 300,000 $ 0.50 3.50 Fourth Quarter 2020 1,000,000 $ 0.20 4.00 First Quarter 2021 12,600,000 $ 0.20 4.25 Second Quarter 2021 23,806,237 $ 0.03-0.20 4.50 Third Quarter 2021 9,166,667 $ 0.03-0.20 4.75 |
Stock Compensation
Stock Compensation | 12 Months Ended |
Dec. 31, 2016 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock Compensation | 7. Stock Compensation Shares Issued for Services During the years ended December 31, 2016 and 2015, the Company issued 32,633,910 and 16,672,504 shares of common stock respectively for consulting fees. The Company valued these shares based upon the fair value of the common stock at the dates of the agreements. The consulting fees are amortized over the contract periods which are typically between 12 and 24 months. The amortization of prepaid services totaled $2,910,452 and $4,328,768 for the years ended December 31, 2016 and 2015. |
Income Taxes - Results of Opera
Income Taxes - Results of Operations | 12 Months Ended |
Dec. 31, 2016 | |
Income Tax Disclosure [Abstract] | |
Income Taxes - Results of Operations | 8. Income Taxes Results of Operations There was no income tax expense reflected in the results of operations for the years ended December 31, 2016 and 2015 because the Company incurred a net loss in both years. Deferred tax assets: 2016 2015 Net operating losses $ 27,153,000 $ 22,611,000 Stock based compensation 63,108,000 60,914,000 Amortization, depreciation, and impairment 6,765,000 6,765,000 Capitalization of start-up costs for tax purposes 1,854,000 1,854,000 Loss on debt conversion of debt 1,216,000 502,000 Total deferred tax assets 99,382,000 92,646,000 Valuation allowance (99,382,000 ) (92,646,000 ) Total deferred tax assets, net $ - $ - The Company has recognized no tax benefit for the losses generated for the periods through December 31, 2016. ASC Topic 740 requires that a valuation allowance be provided if it is more likely than not that some portion or all of a deferred tax asset will not be realized. The Company’s ability to realize the benefit of its deferred tax asset will depend on the generation of future taxable income. Because the Company has yet to recognize revenue, we believe that the full valuation allowance should be provided. Our effective tax rate for fiscal years 2016 and 2015 was 0%. Our tax rate can be affected by recurring items, such as tax rates in foreign jurisdictions and the relative amount of income we earn in jurisdictions. It may also be affected by discrete items that may occur in any given year, but are not consistent from year to year. As of December 31, 2016, we have estimated federal and state income tax net operating loss (“NOL”) carry-forwards of approximately $79,900,000, which will expire in 2032-2035. 2016 2015 Amount Percent Amount Percent Benefits for income tax at federal statutory rate $ 6,738,000 34 % $ 5,763,000 34 % Change in valuation allowance (6,983,000 ) (34 )% $ (5,762,000 ) (34 ) Permanent differences (2,000 ) - (1,000 ) - Change in estimates 247,000 - - - $ - - $ - - % |
Licenses and Supply Agreements
Licenses and Supply Agreements | 12 Months Ended |
Dec. 31, 2016 | |
Licenses And Supply Agreements | |
Licenses and Supply Agreements | 9. Licenses and Supply Agreements Patent and Subsidiary Acquisition The Company entered into a share exchange agreement on April 24, 2012 to acquire all of the outstanding shares of TNI BioTech IP, Inc. (“TNI IP”), a biotechnology firm incorporated in Florida and formed to acquire patents related to the treatment of cancer and HIV/AIDS and autoimmune diseases, using Met-enkephalin (“MENK”) and Naltrexone (“LDN”). The goal of TNI IP’s management was to enable mankind and civilization to combat fatal diseases by activating and mobilizing the body’s own immune system using TNI IP’s patented use of MENK. The first patents acquired by TNI IP were acquired from Dr. Nicholas P. Plotnikoff and Professor Fengping Shan in 2012. TNI IP was acquired in exchange for 20,250,000 shares of the Company’s common stock, of which 8,000,000 shares were issued to Dr. Plotnikoff for the acquisition of patents and the remaining 12,250,000 shares were issued to the founders of TNI IP in exchange for all of their right, title and interest in their TNI IP shares. The goodwill arising on the acquisition of TNI BioTech IP, Inc. was valued at $98,000,000 and license agreements arising from the acquisition of TNI IP were valued at $16,006,000. In connection with the share exchange, we entered into a Sale of Technology Agreement with Dr. Nicholas P. Plotnikoff on March 4, 2012, wherein Dr. Plotnikoff agreed to transfer and assign all of his rights, title and interest in: European Patent United Kingdom, Germany, France, Ireland EP 1401471 BI Methods for inducing sustained immune response; Russian Patent Russian Federation patent number 2313364; The Patent Office of the People’s Republic of China, Application No.: 200810165784.8 China Patent CN1015113407 A The Patent Office of the People’s Republic of China ISSN: 1006-2858 CN 21-1349/R; Patent Agencies Government of India Patent, Application number 1627/KOLNP/2003 number 220265 an Enkephalin Peptide Composition; and the US Patent Pending, US Patent Application 10/146.999 e. The Company received all the production formulations and technology designs from Dr. Plotnikoff necessary for the manufacturing, formulation, production and protocols of the MENK treatment of cancer and HIV/AIDS. As consideration for entering into the Sale of Technology Agreement, Dr. Plotnikoff received 8,000,000 shares of common stock, a royalty of a single-digit percentage on all sales of MENK and was granted the position of Non-Executive Chairman of the Board of Directors. At the time of the acquisition, the valuation of goodwill and other intangible assets were determined using the fair market price for the Company’s common stock, which were exchanged for shares of TNI IP. In the fourth quarter of 2012, the Company performed an annual valuation to determine whether any goodwill or intangible assets that had been acquired by the Company were impaired. The result of this valuation was that material impairments were identified. The Company recognized an impairment of the goodwill arising on the acquisition of TNI IP of $98,000,000. Patent License Agreements On August 13, 2012, the Company signed an exclusive License Agreement with Ms. Jacqueline Young (the “Young Agreement”) for the intellectual property developed by Dr. Bernard Bihari relating to treatments with opioid antagonists such as naltrexone and Met-enkephalin for a variety of diseases and conditions including malignant lymphoma, chronic lymphocytic leukemia, Hodgkin’s lymphoma, and non-Hodgkin’s lymphoma, chronic herpes virus infections, chronic herpes viral infections such as chronic genital herpes caused by the herpes simplex virus Type 2 and chronic infections due to the Epstein-Barr virus and a treatment method for humans infected with HTLV-III (AIDS) virus, including patients clinically diagnosed as suffering from AIDS and those suffering from AIDS-related complex (ARC). The Bihari patents were acquired in exchange for 540,000 shares of the Company’s common stock with a fair value of $972,000 and assumed liabilities of $400,000, which is payable to Ms. Young over a twenty-four month period in equal installments to reimburse her for the costs of a New York City office in accordance with the Young Agreement. The patent liability at December 31, 2013 totaled $118,333. The cost of the patent totaled $1,372,000. Additionally, the Company will pay the licensor a royalty payment of 1% of gross MENK sales and provide the licensor a position as non-executive chairman of the Company. The Young Agreement is valid for the life of the patents and expires on a country by country basis in each country where patent rights exist, upon the expiration of the last to expire patent in each country or in the event the patent in such country is held to be invalid and/or unenforceable (by a court or government body of competent jurisdiction) or admitted to be invalid or unenforceable. Additionally, we can cancel the Young Agreement upon 120 days’ written notice and shall pay all royalties and fees that have accrued under the Young Agreement. We have the exclusive rights to the intellectual property; however, Ms. Young retains a right to practice the patents licensed under the Young Agreement solely for noncommercial, academic research purposes. On December 24, 2012, the Company signed an agreement for the acquisition of patent rights (the “Smith Agreement”) for the intellectual property of Dr. Jill Smith and LDN Research Group, LLC (collectively, the “Licensor Parties”), whose members are Dr. Ian S. Zagon, Dr. Patricia J. McLaughlin and Moshe Rogosnitzky and orphan drug designation by the FDA to a novel late-stage drug, trademarked “LDN,” for the treatment of Pediatric Crohn’s disease. The patent covers methods and formulations for treatment of the inflammatory and ulcerative diseases of the bowel, using naltrexone in low doses as an opioid antagonist. These patents were acquired in exchange for 300,000 shares of our common stock with a fair value of $2,715,000 and payment of $165,384 (consisting of a $100,000 initial license fee and payment of $65,384 of expenses), which totaled $2,880,384. The Smith Agreement requires the Company to (i) use commercially reasonable efforts to develop, commercialize, market and sell licensed products in a manner consistent with a business plan, (ii) expend a minimum amount of funds per annum to develop and commercialize licensed products as soon as practicable, (iii) obtain all requisite regulatory approvals needed to use or sell licensed products in the field of use, and (iv) make the first commercial sale of a licensed product by March of 2017. The Company is required to pay an annual license fee, an annual running royalty on net sales of each licensed product or a minimum royalty, whichever is greater, and a sublicense fee on payments received by the Company from sublicensees. The Company has an exclusive, worldwide license to make, have made, use, lease, import, offer for sale and sell licensed products and to use the method under the patent rights. The Smith Agreement will terminate on the expiration or abandonment of the last patent to expire or ten years after the sale of the first licensed product. The Company may terminate the Smith Agreement upon 90 days’ written notice, provided all sublicenses are terminated and all amounts due and owing are paid to the Licensor Parties. The Licensor Parties may terminate the agreement ten days’ after notice to the Company if the Company is ten days late in payment or there is a breach that remains uncured for ten days after written notice of such breach. The Company is also required to pay milestone payments after substantial achievement of certain milestone events for each licensed product including payment: upon initiation of each Phase III trial; upon positive completion of each Phase III clinical trial of the therapeutic use of an LDN compound in the field of use; when a New Drug Application (“NDA”) is accepted for review by the FDA; and when FDA approval to market the NDA is approved. The Company will issue shares upon reaching certain milestones including upon the first dosing of the first patient in a Phase III clinical trial for each licensed product, upon the first sale of each licensed product, and upon the achievement of a set dollar amount in cumulative sales for each licensed product covered by NDAs. As part of the Smith Agreement, the Company has the right to apply to the FDA for the transfer of the orphan drug status for the use of naltrexone for the treatment of pediatric Crohn’s disease and ulcerative colitis, the Investigation New Drug Application (“IND”), and the right to acquire the relevant clinical data set from Dr. Jill Smith. Dr. Jill Smith made arrangements to transfer the IND to the Company as well as the relevant clinical data set, and the FDA has acknowledged that the Company is now the sponsor for this IND. On September 24, 2014, the Company and the Licensor Parties jointly agreed to terminate the Smith Agreement, and in place thereof, have the Licensor Parties grant a similar license in their patent rights to Cytocom Inc. pursuant to a Patent License Agreement between the Licensor Parties, Cytocom Inc. and the Company with substantially similar terms as set forth in the Smith Agreement. Pursuant to this agreement, the Company issued 1,000,000 shares of its common stock valued at $270,000, upon execution to the Licensor Parties and the Company guaranteed the obligations of Cytocom Inc. to the Licensor Parties under the agreement. On January 18, 2013, the Company signed an exclusive licensing agreement with The Penn State Research Foundation to license all of the intellectual property developed by Dr. Ian S. Zagon, Dr. Patricia J. McLaughlin and Dr. Jill P. Smith for the treatment of cancer titled “Opioid Growth Factor and Cancer” and “Combination Therapy with Opioid Growth Factor and Taxanes for the Treatment of Cancer” (the “Foundation Agreement”). The Foundation Agreement requires the Company to: (a) use commercially reasonable efforts to develop, commercialize, market and sell licensed products in a manner consistent with a business plan; (b) expend a minimum amount of funds per annum to develop and commercialize licensed products as soon as practicable; (c) obtain all requisite regulatory approvals needed to use or sell licensed products in the field of use; and (d) make the first commercial sale of a licensed product by December 31, 2016. The Foundation Agreement provides that the Company must pay to the licensor an initial license fee, a license maintenance fee on each anniversary of the effective date of the Foundation Agreement, and an annual running royalty on net sales for each licensed product or a minimum royalty, whichever is greater. In addition, the Company must pay a sublicense fee on payments received by the Company from sublicensees. The Foundation Agreement also requires the Company to make payments upon the achievement of certain milestone events including: initiation of each Phase II trial; initiation of each Phase III trial; when the NDA is accepted for review by the FDA; and when FDA approval to market is approved. The Company must also issue shares upon certain milestones including upon the first dosing of the first patient in a Phase II clinical trial for each licensed product, upon the first dosing of the first patient in a Phase III clinical trial for each licensed product, upon the first sale of each licensed product, and upon the achievement of a set dollar amount of cumulative sales for each licensed product covered by NDAs. The Foundation Agreement terminates on the expiration or abandonment of the last patent to expire or become abandoned. The Company may terminate the Foundation Agreement at any time upon 60 days’ prior written notice and ceasing to make and sell all licensed products, the termination of all sublicenses and payment of all monies owed under the Foundation Agreement. The licensor may terminate the agreement 30 days after notice to the Company if the Company is 30 days late in payment or a breach that remains uncured for 45 days after written notice of such breach. In May of 2013, the Company executed a Patent License Agreement with Professor Fengping Shan (the “Shan Agreement”) pursuant to which it obtained exclusive rights to develop and commercialize the licensed technology. The licensed technology is the intellectual property developed and owned by Professor Shan (i) relating to the treatment of a variety of diseases and conditions with MENK including multiple forms of lymphoma and cancer and (ii) a treatment method for humans infected with the HLTV-III (AIDS) virus including AIDS and AIDS related complex (ARC). The licensed technology includes the methods and formulations for these treatments including all INDs, communications with regulatory agencies, patient data, and letters relating to these treatments. The licensed technology also includes certain patents developed by Professor Shan. Under the Shan Agreement, the Company must issue 500,000 shares to Professor Shan upon final transfer of the licenses, and reimburse Professor Shan for all out of pocket expenses in connection with the patents. The Company will pay Professor Shan a running royalty on gross sales subject to decreases if third party intellectual property is needed to complete such sale or product. The Shan Agreement lasts for the duration of each of the licensed patents however the Company may terminate the Shan Agreement on 120 days’ written notice to Professor Shan. On August 6, 2014, Professor Fengping Shan executed an Assignment pursuant to which he transferred to the Company his entire right, title and interest in and to the licensed patents under the Shan Agreement and CN 201210302259 Application of combination of low-dose naltrexone and methionine-enkephalin to preparation of anti-cancer drug for the consideration of 500,000 shares of common stock valued at $140,000. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2016 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 10. Commitments and Contingencies Malawi Treatment Facilities On July 14, 2012, GB Oncology and Imaging Group LTD (“GBOIG”) in partnership with the Company signed a letter of intent agreement to collaborate with the Government of Malawi to assist in expanding the treatment of cancer, HIV/AIDS and other infectious diseases. In December of 2014, the Government of Malawi completed an oncology clinic at the Queen Elizabeth Central Hospital in Blantyre, Malawi for the treatment of cancer and infectious diseases. In 2015, the Company submitted protocols seeking permission from the Pharmacy, Medicines and Poisons Board of Malawi (“PMPB”) to conduct two trials involving Lodonal™ in Malawi: a. The first protocol, submitted jointly with The Jack Brewer Foundation (“JBF Worldwide”), received PMPB approval on November 11, 2015. The protocol covers a 12-month trial for a “Single Visit Approach to Cervical Cancer Prevention.” The approach is designed to deliver a preventive and simple procedure that can be performed in a clinical setting without the use of a laboratory and to allow for immediate treatment of any precancerous lesions utilizing Wallach LL100 Cryosurgical systems. The protocol provides for 50% of the patient group to be put on Lodonal™ to determine if the drug lowers the number of opportunistic infections during the year, and if it can be shown that LDN increases CD4, CE8, NK and T cell count, which would show that the incidence rates of opportunistic infection could decrease with Lodonal™ and that Lodonal™ could be used as a prophylaxis to prevent substantial HIV-related morbidity in Malawi. The PMPB approved the trial in late 2016 and recruitment began in late 2016 and continued through first quarter of 2017, with the trial now ongoing. b. The second protocol, which has not yet been approved, covers a trial using Lodonal™ for the treatment of cancer. The Company has put this trial on hold as it may not be necessary with the approval in Nigeria in addition to the pending approval in Kenya and Senegal for Lodonal™ for the treatment of cancer. Distribution Agreements in Nigeria Effective November 9, 2012, we signed an exclusive Distribution Agreement with G-Ex Technologies/St. Maris Pharma and GB Pharma Holdings, LLC for the Federal Republic of Nigeria. The parties have been unable to perform under the agreement because a certificate of free sale was not obtained by the Company until November of 2013, and no extension has been granted. In October 2013, the Company announced the signing of a Distribution Agreement with AHAR Pharma, a Nigerian company, to market Lodonal™, in Nigeria for the treatment of autoimmune diseases and cancer. AHAR intends to distribute Lodonal™ through a local distributor network, an Internet client base and directly to hospitals, pharmacists and doctors in Nigeria. The Company expects to implement the agreement in 2016. Under the agreement, the Company is obligated to provide delivery of an initial supply of between 1 million and 1.5 million doses of Lodonal™ product to cover AHAR Pharma’s first-year purchase commitment. In August 2015, the Company announced the signing of a letter of intent with GB Pharma/AHAR and Fidson Healthcare Plc., in terms of which Fidson will promote Lodonal TM TM Agreements with Hubei Qianjiang Pharmaceutical Company On October 18, 2012, the Company and Hubei Qianjiang Pharmaceutical Co., Ltd. (“Qianjiang Pharmaceutical”), signed a Venture Cooperation Agreement on New Drug Methionine Enkephalin (the “Venture Agreement”) pursuant to which Qianjiang Pharmaceutical acquired an exclusive license for the production of MENK in China. The Venture Agreement requires that Qianjiang Pharmaceutical conduct drug research and pilot testing for MENK, organize pre-clinical studies, and apply for clinical trials for MENK with the Chinese State Food and Drug Administration. Under the Venture Agreement, Qianjiang Pharmaceutical must open a co-administration account for the development of MENK in China. Qianjiang Pharmaceutical must pay the Company, upon the marketing of MENK products, a half-year amount equaling 6% of its gross sales from MENK of the preceding half year. The Company may cancel the Venture Agreement if Qianjiang Pharmaceutical does not pay expenses for a period exceeding six months or does not commence clinical trials within 12-months after receiving certain approvals. Qianjiang Pharmaceutical may cancel the Venture Agreement if the Company fails to perform its obligations for a period of six months or the failure to receive approval of clinical trials is due to the Company’s MENK technologies. The Venture Agreement was amended on February 24, 2013 to expand the clinical trials from pancreatic to both pancreatic and liver cancer and amended on March 6, 2014 to require Qianjiang Pharmaceutical to commence studies and clinical trials in China and place funds in the co-administration account. On August 6, 2014, the Company entered into a Supplementary Agreement on New Drug Methionine – Enkephalin Cooperation (the “Amendment”) with Qianjiang Pharmaceutical, amending the Venture Agreement, as amended. The Company and Qianjiang Pharmaceutical executed the Amendment to accelerate clinical trials in both the United States and China, and agreed to immediately initiate three month Good Laboratory Practice (“GLP”) Toxicology Studies (rat and dog) within 30 days of signing the Amendment. The Amendment requires that the GLP Toxicology Studies Trials are conducted in China in accordance with international standards and standards acceptable to the FDA and that the studies include the following: Exploratory Toxicology (nGLP) ● Dose range finding studies ● Different species and methods of administration ● Multiple dosing regimens ● Estimate the response vs. dose given Definitive Toxicology (GLP) ● Performed in collaboration with Calvert Laboratories (USA) and MPI/Medicillon (China) ● General toxicology studies ● Different species and methods of administration ● Immunogenicity study with NHPs Special Toxicology Studies (planned) Pursuant to the Amendment, Qianjiang Pharmaceutical has made certain funds available from the co-administrative account opened by Qianjiang Pharmaceutical under the Venture Agreement, in accordance with an approved budget and timeline set forth in the Amendment. A portion of these funds are expected to be used by Cytocom to run PK and Dosing trials for MENK in the United States in 2016. The Amendment requires Cytocom and Qianjiang Pharmaceutical to meet with the China State Food and Drug Administration to determine that PK and Dosing Trials completed in the United States will be acceptable. All developments and trials run by Cytocom in the U.S. or the European Union will be used for requesting registration approval in China. In February 2013, the Company signed a Strategic Framework Agreement for Cooperation with Qianjiang Pharmaceutical. Under the agreement, the parties will work together to further the development of new products and conduct research and development on the Company’s licensed patented technology. Specifically, the parties aim to co-invest to develop and market products focusing on HIV, cancer and related autoimmune system therapies, develop co-ventured manufacturing facilities in China, and develop co-ventured distribution of the developed products in China and Africa. The agreement does not have a definitive term, as each new agreement resulting from the cooperation will set forth the material terms, including, but not limited to, fees, duration and termination therein. In December of 2016 Qianjiang Pharmaceutical completed the following documents: Exploratory Toxicology (nGLP) ● Dose range finding studies ● Different species and methods of administration ● Multiple dosing regimens ● Estimate the response vs. dose given Definitive Toxicology (GLP) ● Performed in collaboration with Calvert Laboratories (USA) and MPI/Medicillon (China) ● General toxicology studies ● Different species and methods of administration ● Immunogenicity study with NHPs In addition to the pharmacology and toxicology studies, Qianjiang Pharmaceutical and China Peptide completed the formulation and CMC necessary to scale up manufacturing of MENK. Contract Manufacturing Agreements On May 16, 2016, the Company entered into an agreement with Complete Pharmacy and Medical Solutions, LLC (“CPMS”) to compound, package and distribute the LDN tablets, capsules and/or creams in the United States. The initial term of the agreement is three years, with the option to renew for an additional year. The agreement may be terminated by (i) mutual agreement, (ii) in the event of a breach, provided however that if the Company terminates the agreement, the Company will be required to reimburse CPMS for all unused packaging materials for the LDN, which unused packaging materials CPMS will provide to IMUN. If CPMS does not receive and ship at least 1,000 orders (prescriptions) during the term of the agreement, the Company will be required to reimburse CPMS for 100% of the “ramp up costs” (defined as all costs and expenses of labor and materials related to the testing, and required FDA and other governmental documentation/approvals of test data) of providing and producing the LDN, even where the Company cancels/terminates the agreement, which provision shall survive the cancellation/termination of the agreement. On October 25, 2016, the Company and Acromax Dominicana, SA ("Acromax") entered into a contract for manufacturing of LDN tablets, capsules and/or creams ("Agreement"). Subject to the terms and conditions of the Agreement, Acromax will obtain all necessary licenses and permits to carry out the manufacturing and packaging of LDN in exchange for a fixed fee per tablet plus an additional fee for packaging, shipping and customs clearance. The Agreement has an initial term of five years unless terminated by either party in accordance with the terms. In January of 2017, Acromax obtained from the Ministry of Public Health and Social Assistance a Medications and Specialized Pharmaceuticals Registration Certification for Lodonal TM TM TM Operating Leases At December 31, 2016, the Company was a party to agreements to lease office space in Orlando, Florida. Cash rental expense for the years ended December 31, 2016 and 2015 was $16,041 and $53,205 respectively. Legal Proceedings On November 11, 2016, the Company received a fax containing a copy of a lawsuit supposedly filed against the Company on November 10, 2016. The Company has not been served and has not been provided a case number or evidence that the suit has been filed and is relying on the information in the facsimile received as the basis for this disclosure. Apparently, Kacem Enterprise, Inc. is suing the Company and certain of its consultants and their related entities for $21,777 plus interest, costs and attorneys’ fees for fees Kacem Enterprise claims it is owed for travel related expenses incurred by certain consultants of the Company. The suit was supposedly filed in the Circuit Court of Arlington, Virginia. The Company has not accrued any amount for these claims, on the basis that the claims should have been filed only against the consultants. |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2016 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 11. Related Party Transactions None. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2016 | |
Subsequent Events [Abstract] | |
Subsequent Events | 12. Subsequent Events Between January 1, 2017 and March 31, 2017, the Company issued shares as follows: Number of Shares Issuance of common stock to employees and consultants 6,045,460 Issuance of common stock in exchange for debt 10,010,638 Issuance of common stock pursuant to a court order and settlement agreement 3,000,000 Issuance of common stock for the exercise of a warrant 1,656,447 As of March 29, 2017, the Company had outstanding 273,640,638 shares of common stock. Between January 1, 2017 and March 23, 2017, the Company issued 150,000 warrants for services and employment, exercisable into one share of common stock of the Company for each warrant at a price of $0.20 per share. The warrants expire in February 2022. Between January 1, 2017 and March 23, 2017, the Company borrowed $735,000. On February 8, 2017, the Company paid $321,845 in principal and interest to repay a note payable. |
Summary of Significant Accoun19
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2016 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying consolidated financial statements have been prepared in accordance with United States (U.S.) generally accepted accounting principles (U.S. GAAP) and include all adjustments necessary for the fair presentation of the Company’s financial position for the periods presented. The Company qualifies as an “emerging growth company” as defined in Section 101 of the Jumpstart our Business Startups Act (“JOBS Act”) as we do not have more than $1,000,000,000 in annual gross revenue for the year ended December 31, 2016. We are electing to use the extended transition period for complying with new or revised accounting standards under Section 102(b)(1) of the JOBS Act. |
Revenue Recognition | Revenue Recognition Revenue from product sales is recognized upon passage of title and risk of loss to customers. Provisions for discounts, rebates and sales incentives to customers, and returns and other adjustments are provided for in the period the related sales are recorded. Historical data are not yet readily available and reliable for use in estimating the amount of the reduction in gross sales. Revenue from the launch of a new product, from an improved version of an existing product, or for shipments in excess of a customer’s normal requirements will be recorded when the conditions noted above are met. In those situations, management will record a returns reserve for such revenue, if necessary. If in future the Company participates in selling arrangements that include multiple deliverables (e.g., instruments, reagents, procedures, and service agreements), under these arrangements, the Company will recognize revenue upon delivery of the product or performance of the service and will allocate the revenue based on the relative selling price of each deliverable, which will be based primarily on vendor specific objective evidence. Revenue from license of product rights is recorded over the periods earned. In May 2014, the Financial Accounting Standards Board issued Accounting Standards Update No. 2014-09, Revenue from Contracts with Customers, which provides a single comprehensive model for accounting for revenue from contracts with customers and will supersede most existing revenue recognition guidance. Early adoption is not permitted. The standard becomes effective for the Company in the first quarter of 2018. The Company is currently evaluating the effect, if any, that the standard will have on its consolidated financial statements and related disclosures. |
Use of Estimates | Use of Estimates The preparation of the Company’s financial statements in conformity with U.S. generally accepted accounting principles requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from such estimates. |
Cash, Cash Equivalents, and Short-term Investments | Cash, Cash Equivalents, and Short-Term Investments The Company considers all highly liquid investments with original maturities at the date of purchase of three months or less to be cash equivalents. Cash and cash equivalents include bank demand deposits, marketable securities with maturities of three months or less at purchase, and money market funds that invest primarily in certificates of deposits, commercial paper and U.S. government and U.S. government agency obligations. Cash equivalents are reported at fair value. |
Concentration of Credit Risk | Concentration of Credit Risk Financial instruments that potentially subject the Company to concentrations of credit risk are primarily cash and cash equivalents. The Company is exposed to credit risk, subject to federal deposit insurance, in the event of a default by the financial institutions holding its cash and cash equivalents to the extent of amounts recorded on the balance sheets. The cash accounts are insured by the Federal Deposit Insurance Corporation up to $250,000. At December 31, 2016, the Company has no cash balances in excess of insured limits. |
Segment and Geographic Information | Segment and Geographic Information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one operating segment and does not segment the business for internal reporting or decision making. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments In accordance with the reporting requirements of Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) Topic 825, “ Financial Instruments” |
Fair Value Measurements | Fair Value Measurements The ASC Topic 820, Fair Value Measurement, |
Fixed Assets | Fixed Assets Fixed assets are stated at cost, less accumulated depreciation. Depreciation is determined on a straight-line basis over the estimated useful lives of the assets, which generally range from three to five years. Maintenance and repairs are charged against expense as incurred. Depreciation expense for the years ended December 31, 2016 and December 31, 2015 was $1,557 and $2,552, respectively. |
Intangible Assets | Intangible Assets Costs incurred to acquire and/or develop the Company’s product licenses and patents are capitalized and amortized by straight-line methods over estimated useful lives of ten to sixteen years. Intangible assets are stated at the lower of cost or estimated fair value. During the years ended December 31, 2016 and December 31, 2015, the Company capitalized $nil and $nil respectively, of such costs incurred for the Company’s acquisition of licenses for the patents. (See Note 10). Amortization expense for the years ended December 31, 2016 and December 31, 2015 was $0 and $592,233, respectively. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets The Company evaluates long-lived assets for impairment whenever events or change in circumstances indicate that the carrying amount of an asset may not be recoverable as prescribed by ASC Topic 360-10-05, “ Property, Plant and Equipment |
Research and Development Costs | Research and Development Costs Research and development costs are charged to expense as incurred and are typically comprised of salaries and benefits, pre-clinical studies, clinical trial activities, drug development and manufacturing, fees paid to consultants and other entities that conduct certain research and development activities on the Company’s behalf and third-party service fees, including clinical research organizations and investigative sites. Costs for certain development activities, such as clinical trials are recognized based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations, or information provided by vendors on their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the financial statements as operating expenses. |
Income Taxes | Income Taxes The Company follows ASC Topic 740, Income Taxes, The standard addresses the determination of whether tax benefits claimed or expected to be claimed on a tax return should be recorded in the financial statements. Under ASC Topic 740, the Company may recognize the tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination by the tax authorities, based on the technical merits of the position. The tax benefits recognized in the financial statements from such a position should be measured based on the largest benefit that has a greater than fifty percent likelihood of being realized upon ultimate settlement. ASC Topic 740 also provides guidance on de-recognition, classification, interest and penalties on income taxes, accounting in interim periods and requires increased disclosures. At the date of adoption, and as of December 31, 2016 and 2015, the Company does not have a liability for unrecognized tax uncertainties. The Company’s policy is to record interest and penalties on uncertain tax positions as income tax expense. As of December 31, 2016, and 2015, the Company has not accrued any interest or penalties related to uncertain tax positions. |
Stock-Based Compensation and Issuance of Stock for Non-Cash Consideration | Stock-Based Compensation and Issuance of Stock for Non-Cash Consideration The Company measures and recognizes compensation expense for all share-based payment awards made to employees and directors, including employee stock options, based on estimated fair values equaling either the market value of the shares issued or the value of consideration received, whichever is more readily determinable. The majority of the non-cash consideration pertains to services rendered by consultants and others and has been valued at the fair value of the Company’s common stock at the date of the agreement. The Company’s accounting policy for equity instruments issued to consultants and vendors in exchange for goods and services follows the provisions of ASC Topic 505-50, “ Equity-Based Payments to Non-Employees |
Non-controlling Interest | Non-controlling Interest In accordance with ASC Topic 810, Consolidation |
Net Loss Per Share | Net Loss per Share Basic net loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted average number of common shares outstanding for the period, without consideration for common stock equivalents. Diluted net loss per share is calculated by dividing the net loss by the weighted-average number of common share equivalents outstanding for the period determined using the treasury-stock method and the if-converted method. Dilutive common stock equivalents are comprised of common stock purchase warrants outstanding. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding due to the Company’s net loss position. A calculation of basic and diluted net loss per share follows: For the year ended December 31, 2016 2015 Historical net loss per share: Numerator Net loss $ (19,819,001 ) $ (16,949,451 ) Non-controlling interest (297,600 ) (2,706,939 ) Net loss attributed to common stockholders $ (19,521,401 ) $ (14,242,512 ) Denominator Weighted-average common shares outstanding— Denominator for basic and diluted net loss per share 216,687,993 153,247,023 Basic and diluted net loss per share attributed to common stockholders $ (0.09 ) $ (0.09 ) The Company’s potential dilutive securities which include stock and warrants have been excluded from the computation of diluted net loss per share as the effect would be to reduce the net loss per share. Therefore, the weighted-average Common stock outstanding used to calculate both basic and diluted net loss per share is the same. The following shares of potentially dilutive securities have been excluded from the computations of diluted weighted average shares outstanding as the effect of including such securities would be antidilutive: Year Ended December 31, 2016 2015 Common Stock Purchase Warrants 59,191,904 9,131,500 |
Recent Accounting Standards | Recent Accounting Standards During the year ended December 31, 2016 and through March 31, 2017, there were several new accounting pronouncements issued by the Financial Accounting Standards Board. Each of these pronouncements, as applicable, has been or will be adopted by the Company. Management does not believe the adoption of any of these accounting pronouncements has had or will have a material impact on the Company’s consolidated financial statements. The Company qualifies as an “emerging growth company” as defined in Section 101 of the Jumpstart our Business Startups Act (“JOBS Act”) as we do not have more than $1,000,000,000 in annual gross revenue and did not have such amount as of December 31, 2016, our last fiscal year. We are electing to use the extended transition period for complying with new or revised accounting standards under Section 102(b)(1) of the JOBS Act. |
Summary of Significant Accoun20
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Accounting Policies [Abstract] | |
Schedule of Basic and Diluted Net Loss Per Share | A calculation of basic and diluted net loss per share follows: For the year ended December 31, 2016 2015 Historical net loss per share: Numerator Net loss $ (19,819,001 ) $ (16,949,451 ) Non-controlling interest (297,600 ) (2,706,939 ) Net loss attributed to common stockholders $ (19,521,401 ) $ (14,242,512 ) Denominator Weighted-average common shares outstanding— Denominator for basic and diluted net loss per share 216,687,993 153,247,023 Basic and diluted net loss per share attributed to common stockholders $ (0.09 ) $ (0.09 ) |
Schedule of Antidilutive Securities | The following shares of potentially dilutive securities have been excluded from the computations of diluted weighted average shares outstanding as the effect of including such securities would be antidilutive: Year Ended December 31, 2016 2015 Common Stock Purchase Warrants 59,191,904 9,131,500 |
Fixed Assets (Tables)
Fixed Assets (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Fixed Assets: | |
Schedule of Fixed Assets | December 31, 2016 2015 Fixed assets: Computer equipment $ 9,738 $ 8,013 Less accumulated depreciation (7,888 ) (6,331 ) Property and equipment, net $ 1,850 $ 1,682 |
Accrued Liabilities (Tables)
Accrued Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Liabilities | Accrued expenses and other liabilities consist of the following: December 31, 2016 2015 Accrued payroll to officers and others 1,126,261 758,342 Accrued interest and penalties - notes payable 1,902,018 236,671 Estimated legal settlement 128,087 282,136 Other accrued liabilities 393 323 State payroll taxes - 3,567 Total accrued expenses and other liabilities $ 3,156,759 $ 1,281,039 |
Notes Payable (Tables)
Notes Payable (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Debt Disclosure [Abstract] | |
Schedule of Notes Payable | Notes payable consist of the following: December 31, 2016 December 31, 2015 Promissory note issued July 29, 2014 to Ira Gaines. In 2016, the maturity date on the note was extended to December 1, 2017. The note earns interest at a rate of 18% per annum. $ 100,000 $ 100,000 Promissory notes issued between November 26, 2014 and September 30, 2015, to raise up to $2,000,000 in debt. Lenders earn interest at a rate of 10% per annum, plus a pro-rata share of two percent of the Company’s gross receipts for sales of IRT-103-LDN in perpetuity. Notes will be repaid in 36 monthly installments of principal and interest commencing no later than October 15, 2015. Principal of $425,500 and accrued interest of $37,427 were converted to 5,309,092 shares of common stock in the year ended December 31, 2016, Notes aggregating $286,000 were in default at December 31, 2016, as the Company was unable to pay installments on those notes on their due dates. No demands for repayment have been made by the lenders. 286,000 711,500 Promissory note issued October 17, 2014 to Roger Bozarth. The note matures on October 17, 2015 and earns interest at a rate of 2% per annum. The lender converted this note and $2,139 in accrued interest to 114,237 shares of common stock in January 2016. - 7,000 Promissory notes issued between May 1, 2015 and December 31, 2016, and maturing between June 14, 2015 and September 30, 2017. Lenders on loans aggregating $505,994 earn interest at rates between 2% and 18% per annum. On loans aggregating $198,500, interest is payable in a fixed amount not tied to a specific interest rate. Notes aggregating $100,000 were in default at December 31, 2016, as the Company was unable to repay those notes on their due dates. No demands for repayment have been made by the lenders. 704,494 669,933 Promissory note issued January 26, 2015 to Robert J. Dailey. The note is senior to, and has priority in right of payment over, all indebtedness of the Company. The note earns interest at a rate of 2% per annum and was due on July 30, 2015. Principal of $200,000 and accrued interest of $4,778 was converted to 3,722,015 shares of common stock in 2016. - 200,000 Promissory notes issued by Cytocom Inc. between April 29, 2015 and December 31, 2015. Lenders earn interest at rates between 5% and 10% per annum. These notes mature on September 30, 2016. $375,000 of principal and $12,036 in accrued interest was converted to 4,837,960 shares of common stock in 2016. The Company was unable to repay the remaining notes at maturity and the notes are in default, although no demand for repayment has been made by the lenders. 425,000 800,000 Promissory notes issued in December 2015. Lenders earn interest at a rate of 10% per month. Notes are repayable on March 9, 2016. $30,000 of principal and $49,000 of interest and penalties were converted to 987,500 shares of common stock in 2016. The Company was unable to repay the remaining note at maturity and the note is in default. The Company is obligated to pay late-payment penalties totaling $5,000 per day on the remaining obligation. 100,000 130,000 Promissory note issued November 24, 2015 as settlement of amounts owing to a law firm. The Lender earns interest at the rate of 10% per annum. The note and $10,036 in interest was converted to 1,235,536 shares of common stock in July 2016. - 175,268 Promissory notes issued between May 5, 2016 and June 2, 2016 that mature between October 1, 2016 and January 31, 2017, and include stock conversion features, warrants and original issue debt discounts. Notes aggregating $304,882 were paid on February 8, 2017. The remaining note's maturity date was extended and is in default on March 31, 2017. No demand for repayment has been made by the lender. 554,882 - Promissory notes issued to an officer of the Company effective November 3, 2015 and maturing November 3, 2016 for settlement of accrued payroll, bearing interest at 10% per annum and including a stock conversion feature. 112,737 - Promissory note issued in July 2016. The note was repayable on October 5, 2016 but was extended to December 31, 2016. The note earns interest at 6% per month. The Company was unable to repay the note at maturity and the note is in default. 50,000 - Promissory note issued in July 2016 with an original issuance discount of $30,000. Net proceeds were $150,000. The note is repayable on April 7, 2017. 180,000 - Promissory notes issued in August 2016 for $149,854 as a settlement of amounts owed to a law firm. The notes accrue interest at 5% per annum and are payable in 18 equal monthly installments of $8,641.88. The note was in default on December 31, 2016. 120,987 - Promissory notes issued between July 1, 2016 and December 31, 2016. Lenders earn interest at 2% per annum. The notes mature on September 30, 2017. Notes aggregating $239,000 were converted in the fourth quarter of 2016. 256,000 - Notes aggregating $1,354,000 were issued in the fourth quarter of 2016. The notes accrue interest at 2% per annum and mature between November 1, 2017 and December 31, 2017. 1,354,000 - Less: Original issue discounts on notes payable and warrants issued with notes. (18,681 ) - Total 4,225,419 2,793,701 Less: Current Portion $ (4,225,419 ) $ (2,793,701 ) Long-Term debt, less current portion $ - $ - |
Capital Structure - Common St24
Capital Structure - Common Stock and Common Stock Purchase Warrants (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Equity [Abstract] | |
Schedule of Outstanding Stock Warrants | Following is a summary of outstanding stock warrants at December 31, 2016 and 2015 and activity during the years then ended: Number of Shares Exercise Price Weighted Average Price Warrants as of December 31, 2015 9,131,500 $ 0.07-15 $ 1.47 Issued 50,222,904 $ 0.03-2.00 $ 0.16 Expired (162,500 ) $ 5.00 $ 5.00 Exercised 0 $ 0 $ 0 Warrants as of December 31, 2016 59,191,904 $ 0.03-15.00 $ 0.35 |
Summary of Outstanding Warrants | Summary of outstanding warrants as of December 31, 2016: Expiration Date Number of Shares Exercise Price Remaining Life (years) Fourth Quarter 2017 350,000 $ 1.50-9.00 1.00 First Quarter 2018 127,500 $ 15.00 1.25 Second Quarter 2018 33,334 $ 15.00 1.50 Third Quarter 2018 250,000 $ 1.50 1.75 Fourth Quarter 2018 6,089,166 $ 1.00-1.50 2.00 First Quarter 2019 4,024,000 $ 0.50-2.00 2.25 Second Quarter 2019 135,000 $ 0.07-0.23 2.50 Third Quarter 2019 260,000 $ 0.50-1.50 2.75 Fourth Quarter 2019 400,000 $ 0.14 3.00 Second Quarter 2020 300,000 $ 0.50 3.50 Fourth Quarter 2020 1,000,000 $ 0.20 4.00 First Quarter 2021 12,600,000 $ 0.20 4.25 Second Quarter 2021 23,806,237 $ 0.03-0.20 4.50 Third Quarter 2021 9,166,667 $ 0.03-0.20 4.75 |
Income Taxes - Results of Ope25
Income Taxes - Results of Operations (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Income Tax Disclosure [Abstract] | |
Schedule of Deferred Tax Assets | 2016 2015 Net operating losses $ 27,153,000 $ 22,611,000 Stock based compensation 63,108,000 60,914,000 Amortization, depreciation, and impairment 6,765,000 6,765,000 Capitalization of start-up costs for tax purposes 1,854,000 1,854,000 Loss on debt conversion of debt 1,216,000 502,000 Total deferred tax assets 99,382,000 92,646,000 Valuation allowance (99,382,000 ) (92,646,000 ) Total deferred tax assets, net $ - $ - |
Schedule of Income Taxes NOL | 2016 2015 Amount Percent Amount Percent Benefits for income tax at federal statutory rate $ 6,738,000 34 % $ 5,763,000 34 % Change in valuation allowance (6,983,000 ) (34 )% $ (5,762,000 ) (34 ) Permanent differences (2,000 ) - (1,000 ) - Change in estimates 247,000 - - - $ - - $ - - % |
Subsequent Events (Tables)
Subsequent Events (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Subsequent Events [Abstract] | |
Summary of Issued Shares | Between January 1, 2017 and March 31, 2017, the Company issued shares as follows: Number of Shares Issuance of common stock to employees and consultants 6,045,460 Issuance of common stock in exchange for debt 10,010,638 Issuance of common stock pursuant to a court order and settlement agreement 3,000,000 Issuance of common stock for the exercise of a warrant 1,656,447 |
Organization and Description 27
Organization and Description of Business (Details Narrative) - USD ($) | Dec. 08, 2014 | Apr. 30, 2016 | Mar. 31, 2014 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2013 | Dec. 31, 2014 |
Net loss | $ 19,819,001 | $ 16,949,451 | |||||
Cash equivalents | 2,839,739 | ||||||
Stockholders equity | $ 9,124,344 | $ 5,958,184 | $ (2,352,432) | ||||
Cytocom Inc., [Member] | |||||||
Number of shares issued during period | 113,242,522 | 140,100,000 | |||||
Percentage of stake issued during period | 13.00% | 55.30% | |||||
Reserve stock split description | the Board of Directors and a majority of shareholders of Cytocom approved a reverse stock split of Cytocoms outstanding common stock with one new share of stock for each twenty old shares of common stock. | ||||||
Irish Limited Liability [Member] | |||||||
Percentage of low corporate income tax rate | 12.50% |
Summary of Significant Accoun28
Summary of Significant Accounting Policies (Details Narrative) | 12 Months Ended | |
Dec. 31, 2016USD ($)Segment | Dec. 31, 2015USD ($) | |
Maximum of annual gross revenue | $ 1,000,000,000 | $ 1,000,000,000 |
Federal deposit insurance corporation value | $ 250,000 | |
Number of operating segment | Segment | 1 | |
Depreciation expense | $ 1,557 | 2,552 |
Intangible assets cost capitalized and amortized | ||
Amortization expense | 0 | 592,233 |
Impairment loss | 5,226,352 | |
Accrued interest or penalties related to uncertain tax positions | ||
Minimum [Member] | ||
Property and equipment useful lives | 3 years | |
Minimum [Member] | Property and Equipment [Member] | ||
Property and equipment useful lives | 3 years | |
Maximum [Member] | ||
Property and equipment useful lives | 5 years | |
Maximum [Member] | Property and Equipment [Member] | ||
Property and equipment useful lives | 5 years |
Summary of Significant Accoun29
Summary of Significant Accounting Policies - Schedule of Basic and Diluted Net Loss Per Share (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Accounting Policies [Abstract] | ||
Numerator, Net loss | $ (19,819,001) | $ (16,949,451) |
Numerator, Non-controlling interest | (297,600) | (2,706,939) |
Numerator, Net loss attributed to Common stockholders | $ (19,521,401) | $ (14,242,512) |
Denominator, Weighted-average common shares outstanding-Denominator for basic and diluted net loss per share | 216,687,993 | 153,247,023 |
Denominator, Basic and diluted net loss per share attributed to common stockholders | $ (0.09) | $ (0.09) |
Summary of Significant Accoun30
Summary of Significant Accounting Policies - Schedule of Antidilutive Securities (Details) - shares | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Common Stock Purchase Warrants [Member] | ||
Potentially dilutive securities | 59,191,904 | 9,131,500 |
Fixed Assets (Details Narrative
Fixed Assets (Details Narrative) | 12 Months Ended |
Dec. 31, 2016 | |
Minimum [Member] | |
Depreciable asset lives | 3 years |
Maximum [Member] | |
Depreciable asset lives | 5 years |
Fixed Assets - Schedule of Fixe
Fixed Assets - Schedule of Fixed Assets (Details) - USD ($) | Dec. 31, 2016 | Dec. 31, 2015 |
Fixed Assets: | ||
Computer equipment | $ 9,738 | $ 8,013 |
Less accumulated depreciation | (7,888) | (6,331) |
Property and equipment, net | $ 1,850 | $ 1,682 |
Accrued Liabilities - Schedule
Accrued Liabilities - Schedule of Accrued Liabilities (Details) - USD ($) | Dec. 31, 2016 | Dec. 31, 2015 |
Payables and Accruals [Abstract] | ||
Accrued payroll to officers and others | $ 1,126,261 | $ 758,342 |
Accrued interest and penalties - notes payable | 1,902,018 | 236,671 |
Estimated legal settlement | 128,087 | 282,136 |
Other accrued liabilities | 393 | 323 |
State payroll taxes | 3,567 | |
Total accrued expenses and other liabilities | $ 3,156,759 | $ 1,281,039 |
Notes Payable (Details Narrativ
Notes Payable (Details Narrative) - Promissory Notes [Member] - USD ($) | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Accrued unpaid interest | $ 399,271 | $ 236,671 |
Accrued unpaid default penalties | $ 1,502,747 | |
Issuance of common stock for interest expense, shares | 4,621,296 | 62,500 |
Issuance of common stock for interest expense | $ 403,750 | $ 15,625 |
Notes Payable - Schedule of Not
Notes Payable - Schedule of Notes Payable (Details) - USD ($) | Dec. 31, 2016 | Jul. 31, 2016 | Dec. 31, 2015 |
Total | $ 4,225,419 | $ 2,793,701 | |
Less: Original issue discounts on notes payable and warrants issued with notes | (18,681) | $ 30,000 | |
Less: Current portion | (4,225,419) | (2,793,701) | |
Long-Term debt, less current portion | |||
Notes Payable One [Member] | |||
Total | 100,000 | 100,000 | |
Notes Payable Two [Member] | |||
Total | 286,000 | 711,500 | |
Notes Payable Three [Member] | |||
Total | 7,000 | ||
Notes Payable Four [Member] | |||
Total | 704,494 | 669,933 | |
Notes Payable Five [Member] | |||
Total | 200,000 | ||
Notes Payable Six [Member] | |||
Total | 425,000 | 800,000 | |
Notes Payable Seven [Member] | |||
Total | 100,000 | 130,000 | |
Notes Payable Eight [Member] | |||
Total | 175,268 | ||
Notes Payable Nine [Member] | |||
Total | 554,882 | ||
Notes Payable Ten [Member] | |||
Total | 112,737 | ||
Notes Payable Eleven [Member] | |||
Total | 50,000 | ||
Notes Payable Twelve [Member] | |||
Total | 180,000 | ||
Notes Payable Thirteen [Member] | |||
Total | 120,987 | ||
Notes Payable Fourteen [Member] | |||
Total | 256,000 | ||
Notes Payable Fifteen [Member] | |||
Total | $ 1,354,000 |
Notes Payable - Schedule of N36
Notes Payable - Schedule of Notes Payable (Details) (Parenthetical) | Aug. 31, 2016USD ($)Installments | Jul. 31, 2016USD ($) | Jun. 02, 2016USD ($) | May 05, 2016USD ($) | Nov. 24, 2015USD ($)shares | Nov. 03, 2015 | Jan. 26, 2015 | Oct. 17, 2014 | Jul. 29, 2014 | Jan. 31, 2016USD ($)shares | Dec. 31, 2015USD ($) | Dec. 31, 2016USD ($)Dosesshares | Sep. 30, 2015USD ($) |
Note matures date | Apr. 7, 2017 | Nov. 3, 2016 | |||||||||||
Percentage of interest rate per annum | 5.00% | 6.00% | 10.00% | 10.00% | |||||||||
Maximum amount raise in debt | $ 149,854 | $ 304,882 | $ 304,882 | $ 2,000,000 | |||||||||
Number of installments, months | 18 | 36 | |||||||||||
Debt instrument, periodic payment, principal | $ 8,642 | ||||||||||||
Debt instrument maturity date description | October 1, 2016 and January 31, 2017 | October 1, 2016 and January 31, 2017 | |||||||||||
Original issuance discount | $ 30,000 | $ (18,681) | |||||||||||
Proceeds from issuance of debt | $ 150,000 | ||||||||||||
December 31, 2017 [Member] | |||||||||||||
Percentage of interest rate per annum | 2.00% | ||||||||||||
Notes aggregating default amount | $ 1,354,000 | ||||||||||||
Debt instrument maturity date description | November 1, 2017 and December 31, 2017 | ||||||||||||
Lenders [Member] | |||||||||||||
Note matures date | Sep. 30, 2017 | ||||||||||||
Percentage of interest rate per annum | 2.00% | ||||||||||||
Notes aggregating default amount | $ 239,000 | ||||||||||||
Debt instrument maturity date description | between July 1, 2016 and December 31, 2016 | ||||||||||||
Cytocom Inc., [Member] | |||||||||||||
Note matures date | Sep. 30, 2016 | ||||||||||||
Debt instrument, periodic payment, principal | $ 375,000 | ||||||||||||
Accrued interest | $ 12,036 | ||||||||||||
Notes and interest converted into shares | shares | 4,837,960 | ||||||||||||
Minimum [Member] | Cytocom Inc., [Member] | |||||||||||||
Percentage of interest rate per annum | 5.00% | ||||||||||||
Maximum [Member] | Cytocom Inc., [Member] | |||||||||||||
Percentage of interest rate per annum | 10.00% | ||||||||||||
Ira Gaines [Member] | |||||||||||||
Note matures date | Dec. 1, 2017 | ||||||||||||
Percentage of interest rate per annum | 18.00% | ||||||||||||
Lenders [Member] | |||||||||||||
Debt instrument, periodic payment, principal | $ 425,500 | ||||||||||||
Accrued interest | $ 2,139 | $ 37,427 | |||||||||||
Notes and interest converted into shares | shares | 114,237 | 5,309,092 | |||||||||||
Notes aggregating default amount | $ 286,000 | ||||||||||||
Lenders [Member] | Minimum [Member] | |||||||||||||
Percentage of interest rate per annum | 2.00% | ||||||||||||
Lenders [Member] | Maximum [Member] | |||||||||||||
Percentage of interest rate per annum | 18.00% | ||||||||||||
Lenders [Member] | May 1, 2015 [Member] | |||||||||||||
Note matures date | Sep. 30, 2017 | ||||||||||||
Accrued interest | $ 198,500 | ||||||||||||
Aggregating loan | 505,994 | ||||||||||||
Roger Bozarth [Member] | |||||||||||||
Note matures date | Oct. 17, 2015 | ||||||||||||
Percentage of interest rate per annum | 2.00% | ||||||||||||
Lenders [Member] | |||||||||||||
Notes aggregating default amount | 100,000 | ||||||||||||
Robert J. Dailey [Member] | |||||||||||||
Note matures date | Jul. 30, 2015 | ||||||||||||
Percentage of interest rate per annum | 2.00% | ||||||||||||
Debt instrument, periodic payment, principal | 200,000 | ||||||||||||
Accrued interest | $ 4,778 | ||||||||||||
Notes and interest converted into shares | shares | 3,722,015 | ||||||||||||
Lender [Member] | |||||||||||||
Note matures date | Mar. 9, 2016 | ||||||||||||
Percentage of interest rate per annum | 10.00% | ||||||||||||
Debt instrument, periodic payment, principal | $ 30,000 | ||||||||||||
Accrued interest | $ 49,000 | ||||||||||||
Notes and interest converted into shares | shares | 987,500 | ||||||||||||
Pay late-payment penalties per day | $ 5,000 | ||||||||||||
Lender [Member] | |||||||||||||
Percentage of interest rate per annum | 10.00% | ||||||||||||
Notes and interest converted into shares | shares | 1,235,536 | ||||||||||||
Value of notes that converted into shares | $ 10,536 |
Capital Structure - Common St37
Capital Structure - Common Stock and Common Stock Purchase Warrants (Details Narrative) - $ / shares | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Common stock, shares authorized | 500,000,000 | 500,000,000 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares issued | 250,428,133 | 174,850,047 |
Common stock, shares outstanding | 250,428,133 | 174,850,047 |
Number of warrants issued during period | 50,222,904 | |
Warrant expire term | expire between Oct 2017 and Dec 2021 | |
Minimum [Member] | ||
Warrant price per share | $ 0.03 | |
Maximum [Member] | ||
Warrant price per share | $ 2 |
Capital Structure - Common St38
Capital Structure - Common Stock and Common Stock Purchase Warrants - Schedule of Outstanding Stock Warrants (Details) - Warrant [Member] | 12 Months Ended |
Dec. 31, 2016$ / sharesshares | |
Warrants, Number of shares Beginning balance | shares | 9,131,500 |
Warrants, Number of shares Issued | shares | 50,222,904 |
Warrants, Number of shares Expired | shares | (162,500) |
Warrants, Number of shares Exercised | shares | 0 |
Warrants, Number of shares Ending balance | shares | 59,191,904 |
Exercise Price, Expired | $ 5 |
Exercise Price, Exercised | 0 |
Weighted average exercise price, Beginning balance | 1.47 |
Weighted average exercise price, Issued | 0.16 |
Weighted average exercise price, Expired | 5 |
Weighted average exercise price, Exercised | 0 |
Weighted average exercise price, Ending balance | 0.35 |
Minimum [Member] | |
Exercise Price, Beginning balance | 0.07 |
Exercise Price, Issued | 0.03 |
Exercise Price, Ending balance | 0.03 |
Maximum [Member] | |
Exercise Price, Beginning balance | 15 |
Exercise Price, Issued | 2 |
Exercise Price, Ending balance | $ 15 |
Capital Structure - Common St39
Capital Structure - Common Stock and Common Stock Purchase Warrants - Summary of Outstanding Warrants (Details) | 12 Months Ended |
Dec. 31, 2016$ / sharesshares | |
Fourth Quarter 2017 [Member] | |
Number of Shares | shares | 350,000 |
Exercise Price Lower Limit | $ 1.50 |
Exercise Price Upper Limit | $ 9 |
Remaining Life (years) | 1 year |
First Quarter 2018 [Member] | |
Number of Shares | shares | 127,500 |
Exercise Price Upper Limit | $ 15 |
Remaining Life (years) | 1 year 3 months |
Second Quarter 2018 [Member] | |
Number of Shares | shares | 33,334 |
Exercise Price Upper Limit | $ 15 |
Remaining Life (years) | 1 year 6 months |
Third Quarter 2018 [Member] | |
Number of Shares | shares | 250,000 |
Exercise Price Upper Limit | $ 1.50 |
Remaining Life (years) | 1 year 9 months |
Fourth Quarter 2018 [Member] | |
Number of Shares | shares | 6,089,166 |
Exercise Price Lower Limit | $ 1 |
Exercise Price Upper Limit | $ 1.50 |
Remaining Life (years) | 2 years |
First Quarter 2019 [Member] | |
Number of Shares | shares | 4,024,000 |
Exercise Price Lower Limit | $ 0.50 |
Exercise Price Upper Limit | $ 2 |
Remaining Life (years) | 2 years 3 months |
Second Quarter 2019 [Member] | |
Number of Shares | shares | 135,000 |
Exercise Price Lower Limit | $ 0.07 |
Exercise Price Upper Limit | $ 0.23 |
Remaining Life (years) | 2 years 6 months |
Third Quarter 2019 [Member] | |
Number of Shares | shares | 260,000 |
Exercise Price Lower Limit | $ 0.50 |
Exercise Price Upper Limit | $ 1.50 |
Remaining Life (years) | 2 years 9 months |
Fourth Quarter 2019 [Member] | |
Number of Shares | shares | 400,000 |
Exercise Price Upper Limit | $ 0.14 |
Remaining Life (years) | 3 years |
Second Quarter 2020 [Member] | |
Number of Shares | shares | 300,000 |
Exercise Price Upper Limit | $ 0.50 |
Remaining Life (years) | 3 years 6 months |
Fourth Quarter 2020 [Member] | |
Number of Shares | shares | 1,000,000 |
Exercise Price Upper Limit | $ 0.20 |
Remaining Life (years) | 4 years |
First Quarter 2021 [Member] | |
Number of Shares | shares | 12,600,000 |
Exercise Price Upper Limit | $ 0.20 |
Remaining Life (years) | 4 years 3 months |
Second Quarter 2021 [Member] | |
Number of Shares | shares | 23,806,237 |
Exercise Price Lower Limit | $ 0.03 |
Exercise Price Upper Limit | $ 0.20 |
Remaining Life (years) | 4 years 6 months |
Third Quarter 2021 [Member] | |
Number of Shares | shares | 9,166,667 |
Exercise Price Lower Limit | $ 0.03 |
Exercise Price Upper Limit | $ 0.20 |
Remaining Life (years) | 4 years 9 months |
Stock Compensation (Details Nar
Stock Compensation (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Number of common stock issued for consulting fees | 32,633,910 | 16,922,504 |
Amortization of prepaid services | $ 2,910,452 | $ 4,328,768 |
Minimum [Member] | ||
Consulting fees amortized period | 12 months | |
Maximum [Member] | ||
Consulting fees amortized period | 24 months |
Income Taxes - Results of Ope41
Income Taxes - Results of Operations (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Income Tax Disclosure [Abstract] | ||
Effective tax rate | 0.00% | 0.00% |
Operating loss carryforwards | $ 79,900,000 | |
Operating loss carryforwards expire term | expire in 2032-2035. |
Income Taxes - Results of Ope42
Income Taxes - Results of Operations - Schedule of Deferred Tax Assets (Details) - USD ($) | Dec. 31, 2016 | Dec. 31, 2015 |
Income Tax Disclosure [Abstract] | ||
Net operating losses | $ 27,153,000 | $ 22,611,000 |
Stock based compensation | 63,108,000 | 60,914,000 |
Amortization, depreciation, and impairment | 6,765,000 | 6,765,000 |
Capitalization of start-up costs for tax purposes | 1,854,000 | 1,854,000 |
Loss on debt conversion of debt | 1,216,000 | 502,000 |
Total deferred tax assets | 99,382,000 | 92,646,000 |
Valuation allowance | 99,382,000 | (92,646,000) |
Total deferred tax assets, net |
Income Taxes - Results of Ope43
Income Taxes - Results of Operations - Schedule of Income Taxes NOL (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Income Tax Disclosure [Abstract] | ||
Benefits for income tax at federal statutory rate | $ 6,738,000 | $ 5,763,000 |
Change in valuation allowance | (6,983,000) | (5,762,000) |
Permanent differences | (2,000) | (1,000) |
Change in estimates | $ 247,000 | |
Benefits for income tax at federal statutory rate, percent | 34.00% | 34.00% |
Change in valuation allowance, percent | (34.00%) | (34.00%) |
Permanent differences, percent | ||
Non-deductible impairment of goodwill, percent |
Licenses and Supply Agreements
Licenses and Supply Agreements (Details Narrative) - USD ($) | Sep. 24, 2014 | Aug. 06, 2014 | Dec. 24, 2012 | Aug. 13, 2012 | Apr. 24, 2012 | May 31, 2013 | Dec. 31, 2013 |
Young Agreement [Member] | |||||||
Patent liability | $ 118,333 | ||||||
Cost of patent | $ 1,372,000 | ||||||
Percentage of royalty payment | 1.00% | ||||||
Smith Agreement [Member] | |||||||
Number of shares acquired in exchange for common stock | 1,000,000 | 300,000 | |||||
Acquisition value | $ 270,000 | $ 2,880,384 | |||||
Fair market value acquired | 2,715,000 | ||||||
Payments to acquire patents | 165,384 | ||||||
Smith Agreement [Member] | Initial License Fee [Member] | |||||||
Payments to acquire patents | 100,000 | ||||||
Smith Agreement [Member] | Expenses [Member] | |||||||
Payments to acquire patents | $ 65,384 | ||||||
Shan Agreement [Member] | |||||||
Number of common stock shares issued during period | 500,000 | ||||||
Number of shares issue upon final transfer of licenses | 500,000 | ||||||
TNI BioTech IP, Inc. [Member] | |||||||
Number of shares acquired in exchange for common stock | 20,250,000 | ||||||
Acquisition value | $ 98,000,000 | ||||||
Dr. Plotnikoff [Member] | |||||||
Number of shares acquired in exchange for common stock | 8,000,000 | ||||||
TNI IP's Management [Member] | |||||||
Number of shares acquired in exchange for common stock | 12,250,000 | ||||||
Acquisition value | $ 16,006,000 | ||||||
Dr. Bernard Bihari [Member] | Young Agreement [Member] | |||||||
Number of shares acquired in exchange for common stock | 540,000 | ||||||
Acquisition value | $ 972,000 | ||||||
Assumed liabilities | $ 400,000 |
Commitments and Contingencies (
Commitments and Contingencies (Details Narrative) - USD ($) | Oct. 18, 2012 | Oct. 31, 2013 | Dec. 31, 2016 | Dec. 31, 2015 |
Cash rental expense | $ 53,205 | |||
AHAR Pharma [Member] | ||||
Distribution agreement, description | the Company is obligated to provide delivery of an initial supply of between 1 million and 1.5 million doses of Lodonal product to cover AHAR Pharmas first-year purchase commitment. | |||
Agreements With Hubei Qianjiang Pharmaceutical Company [Member] | ||||
Percentage of gross sales | 6.00% | |||
Complete Pharmacy and Medical Solutions, LLC [Member] | ||||
Ramp up costs, percentage | 100.00% | |||
Kacem Enterprise, Inc [Member] | ||||
Consultants interest cost and attorneys' fees | $ 21,777 |
Subsequent Events (Details Narr
Subsequent Events (Details Narrative) - USD ($) | Feb. 08, 2017 | Mar. 23, 2017 | Dec. 31, 2016 | Mar. 29, 2017 | Dec. 31, 2015 |
Common stock, shares outstanding | 250,428,133 | 174,850,047 | |||
Warrant expire term | expire between Oct 2017 and Dec 2021 | ||||
Subsequent Event [Member] | |||||
Common stock, shares outstanding | 273,640,638 | ||||
Number of warrant issued for services and employment | 150,000 | ||||
Warrant price per share | $ 0.20 | ||||
Warrant expire term | February 2,022 | ||||
Borrowed amount | $ 735,000 | ||||
Repayment for principal and interest of note payable | $ 321,845 |
Subsequent Events - Summary of
Subsequent Events - Summary of Issued Shares (Details) - Subsequent Event [Member] | 3 Months Ended |
Mar. 31, 2017shares | |
Issuance of common stock to employees and consultants | 6,045,460 |
Issuance of common stock in exchange for debt | 10,010,638 |
Issuance of common stock pursuant to court order and settlement agreement | 3,000,000 |
Issuance of common stock for exercise of warrant | 1,656,447 |