Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Apr. 16, 2019 | Jun. 30, 2018 | |
Document And Entity Information | |||
Entity Registrant Name | Immune Therapeutics, Inc. | ||
Entity Central Index Key | 0001559356 | ||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2018 | ||
Amendment Flag | false | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business Flag | true | ||
Entity Emerging Growth Company | false | ||
Entity Ex Transition Period | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 7,651,305 | ||
Entity Common Stock, Shares Outstanding | 455,577,799 | ||
Trading Symbol | IMUN | ||
Document Fiscal Period Focus | FY | ||
Document Fiscal Year Focus | 2018 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Current Assets: | ||
Cash and cash equivalents | $ 5,859 | $ 14,718 |
Inventories | 82,801 | 178,098 |
Total current assets | 88,660 | 192,816 |
Fixed Assets: | ||
Computer equipment, net of accumulated depreciation of $10,447 and $8,714 respectively | 2,766 | 2,529 |
Deposits | 200 | 200 |
Total assets | 91,626 | 195,545 |
Current Liabilities: | ||
Accounts payable | 2,065,476 | 2,319,932 |
Accrued liabilities | 3,302,355 | 2,489,404 |
Notes payable, net of debt discount | 5,187,727 | 4,820,063 |
Derivative liability | 786,706 | 1,669,532 |
Total current liabilities | 11,342,264 | 11,298,931 |
Total liabilities | 11,342,264 | 11,298,931 |
Commitments and Contingencies (Note 11) | ||
Stockholders' Deficit: | ||
Common stock - par value $0.0001; 500,000,000 shares authorized; 434,322,574 and 386,782,473 shares issued and outstanding respectively | 43,433 | 38,679 |
Additional paid in capital | 369,881,037 | 366,625,144 |
Stock issuances due | 35,303 | 103,226 |
Prepaid services | (226,667) | |
Accumulated deficit | (381,210,411) | (373,035,183) |
Deficit attributable to common stockholders | (11,250,638) | (6,494,801) |
Non-controlling interest | (4,608,585) | |
Total stockholders' deficit | (11,250,638) | (11,103,386) |
Total liabilities and stockholders' deficit | $ 91,626 | $ 195,545 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Statement of Financial Position [Abstract] | ||
Accumulated depreciation | $ 10,447 | $ 8,714 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 500,000,000 | 500,000,000 |
Common stock, shares issued | 434,322,574 | 386,782,473 |
Common stock, shares outstanding | 434,322,574 | 386,782,473 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Income Statement [Abstract] | ||
Revenues, net | $ 113,500 | |
Cost of products sold | 47,673 | |
Gross profit | 65,827 | |
Operating expenses: | ||
Selling, general and administrative | 3,232,323 | 2,831,662 |
Research and development expense | 144,099 | 399,443 |
Stock issued for services general and administrative | 772,495 | 2,091,828 |
Warrant valuation | 590,605 | |
Depreciation and amortization expense | 1,733 | 826 |
Total operating expenses | 4,150,650 | 5,914,364 |
Loss from operations | (4,084,823) | (5,914,364) |
Other expense: | ||
Interest expense | (1,183,196) | (1,216,985) |
Gain/(Loss) on valuation of derivative | 494,445 | (1,669,532) |
Gain/(Loss) on settlement of debt | (684,668) | 866,455 |
Loss on deconsolidation | (2,791,172) | |
Loss from equity method investment | (376,196) | |
Total other expense | (4,540,787) | (2,020,062) |
Net loss | (8,625,610) | (7,934,426) |
Net loss attributable to non-controlling interest | (450,382) | (618,219) |
Net loss attributable to common stockholders | $ (8,175,228) | $ (7,316,207) |
Basic loss per share attributed to common stockholders | $ (0.02) | $ (0.02) |
Weighted average number of shares outstanding | 429,662,424 | 320,721,134 |
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, 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 | ||||||
Issuance of common stock for prepaid services | $ 2,900 | 2,352,299 | (859,203) | (1,060,000) | 435,996 | ||
Issuance of common stock for prepaid services, shares | 28,995,460 | ||||||
Amortization of prepaid services | 1,655,833 | 1,655,834 | |||||
Issuance of common stock for interest expense | $ 815 | 393,747 | 394,562 | ||||
Issuance of common stock for interest expense, shares | 8,147,570 | ||||||
Issuance of common stock in exchange for debt | $ 4,499 | 2,167,350 | 2,171,849 | ||||
Issuance of common stock in exchange for debt, shares | 44,987,128 | ||||||
Issuance of common stock for cash and exercise of warrants | $ 5,422 | 701,117 | 706,539 | ||||
Issuance of common stock for cash and exercise of warrants, shares | 54,224,182 | ||||||
Issuance and modification of common stock warrants | 590,605 | 590,605 | |||||
Net loss | (7,316,207) | (618,219) | (7,934,426) | ||||
Balance at Dec. 31, 2017 | $ 38,679 | 366,625,144 | 103,226 | (226,667) | (373,035,183) | (4,608,585) | (11,103,386) |
Balance, shares at Dec. 31, 2017 | 386,782,473 | ||||||
Issuance of common stock for prepaid services | $ 1,698 | 612,053 | (67,923) | 545,828 | |||
Issuance of common stock for prepaid services, shares | 16,988,640 | ||||||
Amortization of prepaid services | 226,667 | 226,667 | |||||
Issuance of common stock for interest expense | $ 121 | 8,980 | 9,101 | ||||
Issuance of common stock for interest expense, shares | 200,000 | ||||||
Issuance of common stock in exchange for debt | $ 3,035 | 668,652 | 671,597 | ||||
Issuance of common stock in exchange for debt, shares | 30,351,461 | ||||||
Issuance of common stock for cash and exercise of warrants | 240,500 | 240,500 | |||||
Issuance and modification of common stock warrants | 1,725,798 | 1,725,798 | |||||
Deconsolidation of Cytocom | 5,058,967 | 5,058,967 | |||||
Net loss | (8,175,228) | (450,382) | (8,625,610) | ||||
Balance at Dec. 31, 2018 | $ 43,433 | $ 369,881,037 | $ 35,303 | $ (381,210,411) | $ (11,250,638) | ||
Balance, shares at Dec. 31, 2018 | 434,322,574 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
CASH FLOWS FROM OPERATING ACTIVITIES | ||
Net loss including non-controlling interest | $ (8,625,610) | $ (7,934,426) |
Adjustments to reconcile net loss to net cash flows used in operating activities: | ||
Depreciation | 1,734 | 826 |
Stock issued for services | 710,150 | 435,995 |
Amortization of stock issued for prepaid services | 226,667 | 1,655,834 |
(Gain)/Loss on derivative | (494,445) | 1,669,532 |
(Gain)/Loss on settlement of debt and accounts payable | 684,668 | (866,455) |
Stock warrant expense | 590,605 | |
Stock issued for loan expenses and interest | 9,100 | 73,863 |
Loss on deconsolidation | 2,791,172 | |
Loss on equity method | 376,196 | |
Amortization of debt discount | 420,747 | 146,386 |
Expenses paid by lenders | 305,005 | 31,361 |
Penalties related to note default | 90,123 | |
Changes in operating assets and liabilities: | ||
Inventory | 95,297 | (178,098) |
Accrued liabilities | 1,698,231 | 1,402,173 |
Accounts payable | 341,562 | 919,141 |
Net cash used in operating activities | (1,369,503) | (2,053,263) |
CASH FLOWS FROM INVESTING ACTIVITIES | ||
Purchase of computer equipment | (1,971) | (1,505) |
Net cash used in investing activities | (1,971) | (1,505) |
CASH FLOWS FROM FINANCING ACTIVITIES | ||
Proceeds from sale of common stock | 240,500 | 706,539 |
Proceeds from notes payable | 859,470 | 1,608,440 |
Due from Cytocom | (152,355) | |
Due to Cytocom | 415,000 | |
Repayment of notes payable | (319,882) | |
Net cash provided by financing activities | 1,362,615 | 1,995,097 |
Decrease in cash | (8,859) | (59,671) |
Cash and cash equivalents, beginning of year | 14,718 | 74,389 |
Cash and cash equivalents, end of year | 5,859 | 14,718 |
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION: | ||
Cash paid for interest | 59,551 | 43,000 |
SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING AND FINANCING ACTIVITIES: | ||
Conversion of notes payable, accrued liabilities and accounts payable to common stock | 792,574 | 3,201,973 |
Debt settled and reclassed to accrued expenses | 243,199 | |
Notes payable for expenses paid by lender | 150,505 | |
Debt discounts on notes payable and warrants | 243,000 | 120,000 |
Transfer from accounts payable to notes payable | 345,321 | 215,314 |
Cashless exercise of warrants | 2,144 | |
Non-cash additions to notes payable | 538,123 | 114,343 |
Warrants issued for accounts payable | 207,500 | |
Shares issued for accrued interest expense | 82,982 | |
Loss on stock accrued to be issued for debt settlement | $ 110,035 |
Organization and Description of
Organization and Description of Business | 12 Months Ended |
Dec. 31, 2018 | |
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 subsidiary, Cytocom Inc., to focus on conducting LDN and MENK clinical trials in the United States. In December 2014, the Company finalized the distribution of common stock of Cytocom Inc. to its shareholders. As part of the transaction, the Company transferred to Cytocom certain of its rights, title and interest in or relating to intellectual property (i) patents, patent applications, and all divisional, continuations and continuations-in-part thereof, together with all reissues, reexaminations, renewals and extensions thereof and all rights to obtain such divisionals, continuations and continuations-in-part, reissues, reexaminations, renewals and extensions, and all utility models and statutory invention registrations and any other such analogous rights, (ii) trademarks, service marks, Internet domain names, trade dress, trade styles, logos, trade names, services names, brand names, corporate names, assumed business names and general intangibles and other source identifiers of a like nature, together with the goodwill associated with any of the foregoing, and all registrations and applications for registrations thereof, together with all renewals and extensions thereof and all rights to obtain such renewals and extensions, (iii) copyrights, mask work rights, database and design rights, moral rights and rights in Internet websites, whether registered or unregistered and whether published or unpublished, all registrations and recordings thereof and all applications in connection therewith, together with all renewals, continuations, reversions and extensions thereof and all rights to obtain such renewals, continuations, reversions and extensions, and (iv) confidential and proprietary information, including, trade secrets and know-how. Cytocom licensed back to the Company a perpetual, non-exclusive, royalty-free right and license to use the assigned intellectual property for veterinary indications and for the marketing rights to emerging markets, access to all clinical data, use of the formulation for LDN and MENK. The parties agreed that until such time as Cytocom was funded, the Company would be responsible for all payments to employees, ongoing general and administrative expenses, licensing fees, patent fees, and drug development costs. 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, 2018 was not sufficient to meet the cash requirements to fund planned operations through December 31, 2018 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 attributable to common shareholders of $8,175,328 and used cash and cash equivalents for operations in the amount of $xxx during the year ended December 31, 2018, and had a stockholders’ deficit of $11,250,638 at December 31, 2018. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The preparation of financial statements and related disclosures in conformity with U.S. generally accepted accounting principles (“GAAP”) and the Company’s discussion and analysis of its financial condition and operating results require the Company’s management to make judgments, assumptions, and estimates that affect the amounts reported in its consolidated financial statements and accompanying notes. Note 1, “Summary of Significant Accounting Policies” of the Notes to Consolidated Financial Statements in Part II, Item 8 of this Form 10-K describes the significant accounting policies and methods used in the preparation of the Company’s consolidated financial statements. Management bases its estimates on historical experience and on various other assumptions it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities. We have identified the policies below as critical to our business operations and the understanding of its results of operations. The Company’s senior management has reviewed these critical accounting policies and related disclosures with the Company’s Board of Directors. The impact and any associated risks related to these policies on our business operations are discussed throughout this section where such policies affect our reported and expected financial results. Our preparation of financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of our financial statements, and the reported amounts of revenues and expenses during the reporting period. There can be no assurance that actual results will not differ from those estimates and such differences may be material. 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, 2017. 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. Non-Controlling Interest in Consolidated Subsidiaries Prior to May 1, 2018, the Company consolidated Cytocom. On May 1, 2018, the Company entered into an amended and restated licensing agreement (the “Restated Agreement”) with Cytocom, Inc., in accordance with which the Company no longer has any ongoing obligations to pay for costs in connection with the assets of Cytocom. On June 4, 2018, the Company and Cytocom entered into a Stock Purchase Agreement (the “Stock Agreement”). Pursuant to the Stock Agreement, the Company cancelled approximately $4,000,000 of debt owed to it by Cytocom in exchange for ten percent (10%) of the issued and outstanding common stock of Cytocom, as calculated on a fully diluted basis on June 4, 2018. At December 31, 2018, the Company’s equity interest in Cytocom stood at 15.5% of Cytocom’s common stock issued and outstanding. Accordingly, the Company deconsolidated Cytocom as of May 1, 2018, and accounts for its retained interest in Cytocom under the equity method of accounting, with the Company’s share of Cytocom’s earnings recorded in “loss from equity method investment” in the consolidated statements of operations. The condensed consolidated financial statements as of December 31, 2018 exclude the assets, liabilities and operating results of Cytocom after May 1, 2018. Revenue Recognition We recognize revenue on sales to customers and distributors upon satisfaction of our performance obligations when the goods are shipped. For consignment sales, we recognize revenue when the goods are pulled from consignment inventory. On January 1, 2018, the Company adopted ASU 2014-09, “Revenue from Contracts with Customers (ASC 606),” using the modified retrospective method. Adoption of the new revenue standard had no impact on the Company’s consolidated balance sheet, results of operations, equity or cash flows as of the adoption date. Sales of Lodonal TM Leases In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842). This standard requires all leases that have a term of over 12 months to be recognized on the balance sheet with the liability for lease payments and the corresponding right-of-use asset initially measured at the present value of amounts expected to be paid over the term. Recognition of the costs of these leases on the income statement will be dependent upon their classification as either an operating or a financing lease. Costs of an operating lease will continue to be recognized as a single operating expense on a straight-line basis over the lease term. Costs for a financing lease will be disaggregated and recognized as both an operating expense (for the amortization of the right-of-use asset) and interest expense (for interest on the lease liability). We have adopted this standard for our interim and annual periods beginning January 1, 2019, and we will apply it on a modified retrospective basis to leases existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements. Early adoption is permitted. At December 31, 2018 we had no leases to which the standard applies. Accordingly, the standard had no material impact on our results of operations in 2018. 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, 2018, 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” Derivative Financial Instruments FASB ASC 820, Fair Value Measurements Fair Value Measurements The ASC Topic 820, Fair Value Measurement, Inventory Inventories comprise finished product, raw materials and materials used for packaging. Inventories are stated at the lower of cost or market with cost based on the first-in, first-out (FIFO) method. Inventory that can be used in either the production of clinical or commercial products is expensed as research and development costs when identified for use in a clinical trials or clinical manufacturing campaigns. Inventory used in marketing activities is charged to selling, general and administrative expense. Inventory as of December 31, 2018 was valued at $82,801, a decrease of $95,297 or 54% from the inventory balance at the end of fiscal 2017. Inventory at year end 2018 was made up primarily of finished pills and related packaging materials. The year-over-year decrease in inventory was due to the shipments of pills during 2018 to Nigeria and to pills used as samples. 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, 2018 and December 31, 2017 was $1,733 and $826, 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, 2018 and 2017, 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, 2018, and 2017, the Company has not accrued any interest or penalties related to uncertain tax positions. In February 2018, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update No. 2018-02, Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income 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 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. 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, 2018 2017 Common Stock Purchase Warrants 281,251,038 84,287,402 Convertible Debt 180,603,978 81,880,906 Recent Accounting Standards During the year ended December 31, 2018, 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, 2018, 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, 2018 | |
Fixed Assets: | |
Fixed Assets | 3. Fixed Assets December 31, 2018 2017 Fixed assets: Computer equipment $ 13,213 $ 11,243 Less accumulated depreciation (10,447 ) (8,714 ) Fixed assets, net $ 2,766 $ 2,529 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, 2018 | |
Payables and Accruals [Abstract] | |
Accrued Liabilities | 5. Accrued Liabilities Accrued expenses and other liabilities consist of the following: December 31, 2018 2017 Accrued payroll to officers and others 2,010,570 1,539,777 Accrued interest and penalties - notes payable 877,571 703,141 Estimated legal settlements 136,057 136,057 Other accrued liabilities 15,512 393 Estimated loss on note conversions - 110,036 Derivative Liability 786.706 1,669,532 Total accrued expenses and other liabilities $ 3,826,416 $ 4,158,936 |
Notes Payable
Notes Payable | 12 Months Ended |
Dec. 31, 2018 | |
Debt Disclosure [Abstract] | |
Notes Payable | 6. Notes Payable Notes payable consist of the following: December 31, 2018 December 31, 2017 Promissory note issued July 29, 2014 to Ira Gaines. In 2016, the maturity date on the note was extended to December 1, 2017. As of December 31, 2018, the note is in default. The note earns interest at a rate of 18% per annum. $ 100,000 $ 100,000 Promissory notes issued between November 26, 2014 and December 31, 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 LDN-LDN in perpetuity. Notes will be repaid in 36 monthly installments of principal and interest commencing no later than October 15, 2015. These notes were in default at December 31, 2018, as the Company was unable to pay installments on their due dates. 286,000 286,000 Promissory notes issued between May 1, 2015 and December 31, 2016, and maturing between June 14, 2015 and December 1, 2017. Lenders on loans aggregating $375,994 earn interest at rates between 2% and 18% per annum. On loans aggregating $100,000, interest is payable in a fixed amount not tied to a specific interest rate. Notes aggregating $725,994 were in default at December 31, 2018, as the Company was unable to repay those notes on their due dates. $130,000 of the notes were deconsolidated on May 1, 2018, and $150,000 of interest was capitalized in July 2018. 725,994 705,994 Promissory notes issued by Cytocom between April 29, 2015 and December 31, 2015. Lenders earn interest at rates between 5% and 10% per annum. These notes mature on December 31, 2016. At December 31, 2018, the notes were in default. These notes were deconsolidated on May 1, 2018. - 425,000 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. The Company was unable to repay the note at maturity and at December 31, 2018 the note was in default. 97,737 97,737 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. This note was extinguished on July 1, 2018. - 50,000 Promissory note for $180,000 was issued in July 2016 with an original issue discount of $30,000. The note is repayable on April 7, 2017. The Company was unable to repay the note at maturity and at December 31, 2018 the note was in default. Under the terms of the note, the principal amount was increased in 2017 to $243,000, and interest accrued at 25% per annum. $161,976 of principal and $20,025 of accrued interest were converted into 7,447,448 shares, of which 5,500,000 shares were issued at the end of 2017. The Company has accrued a $243,199 derivative liability for the $81,024 principal balance attributable to the conversion feature contained in this note. The note was settled in the quarter ended March 31, 2018. - 81,024 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 $8,642. The note was in default on December 31, 2018. The balance due was reclassified as accounts payable. - 17,284 Promissory notes issued between July 1, 2016 and December 31, 2016. Lenders earn interest at 2% per annum. The notes mature on December 31, 2017, and at December 31, 2018 the notes were in default. 206,000 206,000 Notes aggregating $1,354,000 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. As of December 31, 2018 the notes were in default. 1,354,000 1,354,000 Notes aggregating $500,000 issued in the first quarter of 2017. The notes accrue interest at 2% per annum and mature between January 12, 2018 and March 31, 2018. At December 31, 2018, the notes were in default. 500,000 500,000 Promissory note issued January 25, 2017. The lenders earn interest at 7% per month. The note matures on July 5, 2017 and at December 31, 2018 the note was in default. 50,000 50,000 Notes aggregating $300,000 issued in the second quarter of 2017. The notes accrue interest at 2% per annum and mature between April 3, 2018 and May 31, 2018. At December 31, 2018, the notes were in default. 300,000 300,000 Notes aggregating $191,800 issued in the third quarter of 2017. The notes accrue interest at 2% per annum and mature between June 16, 2018 and December 31, 2018. At December 31, 2018, the notes were in default. 191,800 191,800 Promissory note for $425,000 was issued in October 2017 with an original issue discount of $70,000. The note is in default, giving the holder an option to convert the note to stock. In 2018, The defaults also resulted in certain penalties, as a result of which the principal amount of the note outstanding at December 31, 2018 had increased to $455,122. $60,000 of accrued interest owed on the note has been converted to stock. The Company has accrued a $786,706 derivative liability for the remaining conversion right. 455,122 425,000 Notes aggregating $105,500 issued in the fourth quarter of 2017. The notes accrue interest at 2% per annum. At December 31, 2018, the notes were in default. 105,500 105,500 Notes aggregating $47,975 issued in the first quarter of 2018. The notes accrue interest at 2% per annum and mature between May 2018 and January 2019. At December 31, 2018, $10,000 of the notes were in default. 47,975 - Notes aggregating $125,000 issued in the first quarter of 2018. The notes accrue interest between 2% and 12% per annum and mature between April 2018 and June 2018. These notes include warrants between 5,000,000 and 20,000,000 shares with an exercise price of $0.005. At December 31, 2018, the notes were in default. 125,000 - Notes aggregating $65,000 issued in the second quarter of 2018. The notes accrue interest of 2% per annum and mature between July 2018 and October 2018. These notes include warrants between 1,000,000 and 5,000,000 shares with an exercise price of $0.005. At December 31, 2018, the notes were in default. 65,000 - Notes aggregating $193,000 issued in the third quarter of 2018. The notes accrue interest at 2% per annum and mature between November 2018 and January 2019. These notes include warrants between 600,000 and 5,000,000 shares with an exercise price of $0.005. At December 31, 2018, the notes were in default. 193,000 - Notes aggregating $533,855 issued in the fourth quarter of 2018. The notes accrue interest from 2% to 3.5% per annum and mature between February 2019 and December 2019. These notes include warrants between 200,000 and 39,500,000 shares with an exercise price of $0.005 to $0.04. 533,855 - Less: Original issue discounts on notes payable and warrants issued with notes. (149,256 ) (75,277 ) Total $ 5,187,727 $ 4,820,062 As of December 31, 2018, the Company had accrued $877,571 in unpaid interest and default penalties. During the year ended December 31, 2018, 30,351,461 shares with a fair value of $318,182 were issued by the Company for settlement of promissory notes totaling $175,000. As of December 31, 2017, the Company had accrued $703,141 in unpaid interest and default penalties. During the year ended December 31, 2017, 8,147,570 shares with a fair value of $394,562 were issued by the Company for interest expense under promissory notes. |
Derivative Liabilities
Derivative Liabilities | 12 Months Ended |
Dec. 31, 2018 | |
Derivative Instruments and Hedging Activities Disclosure [Abstract] | |
Derivative Liabilities | 7. Derivative Liabilities During the year ended December 31, 2017, notes payable aggregating $506,024 were issued as convertible debt or became convertible and qualified as a derivative liability under FASB ASC 815. As of December 31, 2018, and December 31, 2017, the aggregate fair value of the outstanding derivative liability was $786,706 and $1,669,532 respectively. The Company estimated the fair value of the derivative liability using the Black-Scholes option pricing model using the following key assumptions during the year ended December 31, 2018: Year End December 31, 2018 Volatility 311.78 % Risk-free interest rate 2.8054 % Expected dividends - % Expected term 1.0 – 5 years The Company determines the fair market values of its financial instruments based on the fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. The following three levels of inputs may be used to measure fair value: Level 1 Quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date. Level 2 Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Level 3 Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. The Company uses Level 3 inputs to estimate the fair value of its derivative liabilities. The following schedule summarizes the valuation of financial instruments at fair value in the balance sheets as of December 31, 2018: Fair Value Measurements as of December 31, 2018 Level 1 Level 2 Level 3 Assets Total assets - - - Liabilities Conversion option derivative liability - - 786,706 Total liabilities $ - $ - $ 786,706 The following table sets forth a reconciliation of changes in the fair value of derivative liabilities classified as Level 3 in the fair value hierarchy: Significant Unobservable Inputs (Level 3) Beginning balance $ 1,669,532 Settlement of liability (243,199 ) Change in fair value (494,445 ) Partial settlements of liability (145,182 ) Ending balance $ 786,706 |
Capital Structure - Common Stoc
Capital Structure - Common Stock and Common Stock Purchase Warrants | 12 Months Ended |
Dec. 31, 2018 | |
Equity [Abstract] | |
Capital Structure - Common Stock and Common Stock Purchase Warrants | 8. 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, 2018 and 2017, the Company was authorized to issue 500,000,000 common shares at a par value of $0.0001 per share. As of December 31, 2018, the Company had 434,322,574 shares of common stock outstanding and 386,782,473 outstanding as of December 31, 2017. Stock Warrants In 2018, the Company issued 203,995,454 warrants, exercisable into one share of common stock of the Company for each warrant at prices between $0.01 and $3.74 per share. The warrants expire between December 2019 and June 2032. 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. For the years ended December 31, 2018, and December 31, 2017, the warrant valuation expense was $0 and $4,730,726 respectively. The associated expense in 2018 was recognized as interest expense, because the warrants were issued as part of the issuance of notes payable. During 2018, 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, 2018: Number of Shares Exercise Price Weighted Average Price Warrants as of December 31, 2016 59,191,904 $ 0.03-15.00 $ 0.35 Issued in 2017 66,789,711 $ 0.01-3.74 $ 0.14 Expired and forfeited in 2017 11,053,762 $ 0.01-9.00 $ 0.13 Exercised in 2017 30,640,451 $ 0.01-0.20 $ 0.01 Warrants as of December 31, 2017 84,287,402 $ 0.01-15.00 $ 0.33 Issued in 2018 203,995,454 $ 0.01-3.74 $ 0.11 Expired and forfeited in 2018 6,500,000 $ 15.00 $ 1.45 Exercised in 2018 - $ - $ - Warrants as of December 31, 2018 281,782,856 $ 0.01-3.74 $ 0.09 Summary of outstanding warrants as of December 31, 2018: Expiration Date Number of Shares Exercise Price Remaining Life (years) First Quarter 2019 4,024,000 $ 0.50-2.00 0.25 Second Quarter 2019 135,000 $ 0.07-0.23 0.50 Third Quarter 2019 260,000 $ 0.50-1.50 0.75 Fourth Quarter 2019 22,690,908 $ 0.05-3.74 1.00 Second Quarter 2020 300,000 $ 0.50 1.50 Fourth Quarter 2020 1,000,000 $ 0.20 2.00 First Quarter 2021 12,600,000 $ 0.20 2.25 Second Quarter 2021 5,812,252 $ 0.01408-0.20 2.50 Third Quarter 2021 5,166,667 $ 0.03-0.20 2.75 Fourth Quarter 2021 300,000 $ 0.10 3.00 Second Quarter 2022 1,750,000 $ 0.15 3.50 Third Quarter 2022 2,650,000 $ 0.05-0.10 3.75 Fourth Quarter 2022 9,811,422 $ 0.08-0.29 4.00 First Quarter 2023 8,000,000 $ 0.005-0.0 4 4.25 Second Quarter 2023 15,000,000 $ 0.005-0.20 4.50 Third Quarter 2023 76,700,000 $ 0.005-0.10 4.75 Fourth Quarter 2023 60,774,818 $ 0.005 5.00 First Quarter 2024 30,000,000 $ 0.005 5.25 Third Quarter 2028 3,000,000 $ 0.07 9.75 Second Quarter 2032 21,807,789 $ 0.01-0.0679 13.50 281,782,856 $ 0.005-15.00 |
Stock Compensation
Stock Compensation | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock Compensation | 9. Stock Compensation Shares Issued for Services During the years ended December 31, 2018 and 2017, the Company issued 16,998,640 and 28,995,460 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 $226,667 and $2,091,828 for the years ended December 31, 2018 and 2017, respectively. Included in the shares of common stock issued in 2018 were 3 million shares issued to Vision Pharmaceutica SA pursuant to a Contract for the Supervision and Inspection of Manufacturing Processes dated February 22, 2018. The contract has a term of 10 years. If the Company terminates the contract without cause before its expiration date, the Company is obligated to pay to Vision Pharmaceutica SA the greater of $10,000,000 or 10 times the gross fee to be earned by to Vision Pharmaceutica SA for the remaining term of the contract, calculated on a present value. |
Income Taxes - Results of Opera
Income Taxes - Results of Operations | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Income Taxes - Results of Operations | 10. Income Taxes - Results of Operations There was no income tax expense reflected in the results of operations for the years ended December 31, 2018 and 2017 because the Company incurred a net loss in both years. On December 22, 2018, the President of the United States signed the Tax Cuts and Jobs Act (“U.S. Tax Reform”), which enacts a wide range of changes to the U.S. corporate income tax system. The impact of U.S. Tax Reform primarily represents the Company’s estimates of revaluing the Company’s U.S. deferred tax assets and liabilities based on the rates at which they are expected to be recognized in the future. For U.S. federal purposes the corporate statutory income tax rate was reduced from 35% to 21%, effective for the 2018 tax year. Based on the Company’s historical financial performance, at December 31, 2018, the net deferred tax asset position was re-measured at the lower corporate rate of 21% and a tax expense was recognized to adjust net deferred tax assets to the reduced value. Deferred tax assets: 2018 2017 Net operating losses $ 19,671,000 $ 18,102,000 Stock based compensation 39,256,000 39,054,000 Amortization, depreciation, and impairment 4,178,000 4,178,000 Capitalization of start-up costs for tax purposes 1,145,000 1,145,000 Gain/(loss) on conversion of debt 713,000 569,000 Total deferred tax assets 64,963,000 63,048,000 Valuation allowance (64,963,000 ) (63,048,000 ) Total deferred tax assets, net $ - $ - The Company has recognized no tax benefit for the losses generated for the periods through December 31, 2018. 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 2018 and 2017 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, 2018, we have estimated federal and state income tax net operating loss (“NOL”) carry-forwards of approximately $93,206,000, which will expire in 2032-2037. 2018 2017 Amount Percent Amount Percent Benefits for income tax at federal statutory rate $ 1,811,000 21 % $ 1,666,000 34 % Change in valuation allowance (2,000 ) $ 36,334,000 - Permanent differences - - - - Change in estimates (1,809,000 ) (38,000,000 ) - $ - - % $ - - % |
Licenses and Supply Agreements
Licenses and Supply Agreements | 12 Months Ended |
Dec. 31, 2018 | |
Licenses And Supply Agreements | |
Licenses and Supply Agreements | 11. Licenses and Supply Agreements Patent License Agreements In December 2014, the Company transferred to Cytocom certain of its rights, title and interest in or relating to intellectual property (i) patents, patent applications, and all divisional, continuations and continuations-in-part thereof, together with all reissues, reexaminations, renewals and extensions thereof and all rights to obtain such divisionals, continuations and continuations-in-part, reissues, reexaminations, renewals and extensions, and all utility models and statutory invention registrations and any other such analogous rights, (ii) trademarks, service marks, Internet domain names, trade dress, trade styles, logos, trade names, services names, brand names, corporate names, assumed business names and general intangibles and other source identifiers of a like nature, together with the goodwill associated with any of the foregoing, and all registrations and applications for registrations thereof, together with all renewals and extensions thereof and all rights to obtain such renewals and extensions, (iii) copyrights, mask work rights, database and design rights, moral rights and rights in Internet websites, whether registered or unregistered and whether published or unpublished, all registrations and recordings thereof and all applications in connection therewith, together with all renewals, continuations, reversions and extensions thereof and all rights to obtain such renewals, continuations, reversions and extensions, and (iv) confidential and proprietary information, including, trade secrets and know-how. Cytocom licensed back to the Company a perpetual, non-exclusive, royalty-free right and license to use the assigned intellectual property for veterinary indications and for the marketing rights to emerging markets, access to all clinical data, use of the formulation for LDN and MENK. The Original Agreement also granted the Company rights to market Lodonal™ and Met-Enkephalin (“MENK”) in “Emerging Markets,” which included all countries excluding Canada, Italy, Japan, France, Germany, United Kingdom, European Community and the United States. Pursuant to the Original Agreement, the Company was required to pay Cytocom a 5% royalty on all sales all ongoing drug development and fees due in connection with the underlying patents until such time as Cytocom was funded. On May 1, 2018, the Company entered into an amended and restated licensing agreement (the “Restated Agreement”) with Cytocom. The Restated Agreement restates the licensing arrangement between the Company and Cytocom as provided by the Original Agreement. The Restated Agreement grants the Company distribution and marketing rights for Lodonal™ and MENK for humans in Emerging Markets. In addition, the Company has been granted the rights to distribute and market Lodonal™ and MENK for animal use in the United States. The royalty due to Cytocom has been reduced from 5% to 1% of sales and the Company no longer has any ongoing obligations to pay for the cost in connection with the assets of Cytocom. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 12. Commitments and Contingencies Distribution Agreements in Nigeria 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 first deliveries under the agreement took place in February 2018. Under the original 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. Due to the fact that AHAR Pharma failed to meet its contractual purchase obligations, the Company formally issued notice of default under the agreement. On April 18, 2018, AHAR Pharma transferred its rights under the Distribution Agreement to Fidson Healthcare Plc (“Fidson”), and Fidson signed an exclusive distribution agreement with the Company to distribute Lodonal™. In October 2018, the Company made its second shipment in 2018 of 250,000 pills to Fidson (the first shipment having taken place in February 2018). 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. 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. 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 delivered various documents under the agreements related to its studies of Exploratory Toxicology (nGLP) and Definitive Toxicology (GLP). 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. There has been no progress under the agreements in the past 12 months, since a change of ownership of Qianjiang Pharmaceutical in 2017. The Company continues to hold discussions with new management about the future of the agreements. Contract Manufacturing Agreements On October 25, 2016, the Company and Acromax Dominicana, SA (“Acromax”), which is based in the Dominican Republic, 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. Operating Leases At December 31, 2018, the Company was a party to an agreement to lease office space in Orlando, Florida. Rental expense for the years ended December 31, 2018 and 2017 was $11,775 and $16,777 respectively. Legal Proceedings None. |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2018 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 13. Related Party Transactions Robert Wilson, the son of Noreen Griffin, the Company’s Chief Executive Officer, is employed by the Company. In the year ended December 31, 2018, the Company paid compensation to Mr. Wilson totaling $100,000. In 2018, Mr. Wilson received 500,000 stock options, valued at $24,998. Kelly O’Brien Wilson, the daughter-in-law of Noreen Griffin, the Company’s Chief Executive Officer, is employed by the Company. In the year ended December 31, 2018, the Company paid compensation to Ms. Wilson totaling $136,158. In 2018, Ms. Wilson received 1,200,000 stock options, valued at $59,995. In the year ended December 31, 2018, Peter Aronstam, the Company’s Chief Financial Officer, was entitled to receive compensation of $70,000. A portion of that compensation was deferred to 2019. In 2018, the Company issued two notes payable aggregating $210,000 to Raster Investments, Inc. a trust related to Edward Teraskiewicz, for services performed by Mr. Teraskiewicz for the Company ($150,000) in 2018 and to repay other liabilities ($60,000). The notes bear interest at a rate of 2% per annum. In 2018, Dr. Roscoe Moore served as a senior advisor to the Company under an Independent Senior Advisor Agreement dated November 15, 2017. As compensation for his services in that role, Dr. Moore is to be paid a monthly fee of $1,500. Moore also received 1,875,000 shares of common stock for these services (valued at $37,500). Dr. Moore agreed to defer all 2018 cash compensation under the advisory agreement until 2019. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2018 | |
Subsequent Events [Abstract] | |
Subsequent Events | 14. Subsequent Events Between January 1, 2019 and April 16, 2019, the Company issued shares as follows: Number of Shares Issuance of common stock to employees and consultants 3,000,000 Issuance of common stock for conversion of debt 18,255,739 As of April 16, 2019, the Company had outstanding 455,577,799 shares of common stock. Between January 1, 2019 and April 16, 2019, the Company received $85,000 in notes payable and equity. Terms of the notes and stock purchase agreements are being negotiated. On February 27, 2019, the company issued a note payable for $231,478, as conversion of accounts payable in the same amount. The note accrues interest at 6% per annum with a maturity date of February 27, 2020. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The preparation of financial statements and related disclosures in conformity with U.S. generally accepted accounting principles (“GAAP”) and the Company’s discussion and analysis of its financial condition and operating results require the Company’s management to make judgments, assumptions, and estimates that affect the amounts reported in its consolidated financial statements and accompanying notes. Note 1, “Summary of Significant Accounting Policies” of the Notes to Consolidated Financial Statements in Part II, Item 8 of this Form 10-K describes the significant accounting policies and methods used in the preparation of the Company’s consolidated financial statements. Management bases its estimates on historical experience and on various other assumptions it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities. We have identified the policies below as critical to our business operations and the understanding of its results of operations. The Company’s senior management has reviewed these critical accounting policies and related disclosures with the Company’s Board of Directors. The impact and any associated risks related to these policies on our business operations are discussed throughout this section where such policies affect our reported and expected financial results. Our preparation of financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of our financial statements, and the reported amounts of revenues and expenses during the reporting period. There can be no assurance that actual results will not differ from those estimates and such differences may be material. 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, 2017. 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. |
Non-Controlling Interest in Consolidated Subsidiaries | Non-Controlling Interest in Consolidated Subsidiaries Prior to May 1, 2018, the Company consolidated Cytocom. On May 1, 2018, the Company entered into an amended and restated licensing agreement (the “Restated Agreement”) with Cytocom, Inc., in accordance with which the Company no longer has any ongoing obligations to pay for costs in connection with the assets of Cytocom. On June 4, 2018, the Company and Cytocom entered into a Stock Purchase Agreement (the “Stock Agreement”). Pursuant to the Stock Agreement, the Company cancelled approximately $4,000,000 of debt owed to it by Cytocom in exchange for ten percent (10%) of the issued and outstanding common stock of Cytocom, as calculated on a fully diluted basis on June 4, 2018. At December 31, 2018, the Company’s equity interest in Cytocom stood at 15.5% of Cytocom’s common stock issued and outstanding. Accordingly, the Company deconsolidated Cytocom as of May 1, 2018, and accounts for its retained interest in Cytocom under the equity method of accounting, with the Company’s share of Cytocom’s earnings recorded in “loss from equity method investment” in the consolidated statements of operations. The condensed consolidated financial statements as of December 31, 2018 exclude the assets, liabilities and operating results of Cytocom after May 1, 2018. |
Revenue Recognition | Revenue Recognition We recognize revenue on sales to customers and distributors upon satisfaction of our performance obligations when the goods are shipped. For consignment sales, we recognize revenue when the goods are pulled from consignment inventory. On January 1, 2018, the Company adopted ASU 2014-09, “Revenue from Contracts with Customers (ASC 606),” using the modified retrospective method. Adoption of the new revenue standard had no impact on the Company’s consolidated balance sheet, results of operations, equity or cash flows as of the adoption date. Sales of Lodonal TM |
Leases | Leases In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842). This standard requires all leases that have a term of over 12 months to be recognized on the balance sheet with the liability for lease payments and the corresponding right-of-use asset initially measured at the present value of amounts expected to be paid over the term. Recognition of the costs of these leases on the income statement will be dependent upon their classification as either an operating or a financing lease. Costs of an operating lease will continue to be recognized as a single operating expense on a straight-line basis over the lease term. Costs for a financing lease will be disaggregated and recognized as both an operating expense (for the amortization of the right-of-use asset) and interest expense (for interest on the lease liability). We have adopted this standard for our interim and annual periods beginning January 1, 2019, and we will apply it on a modified retrospective basis to leases existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements. Early adoption is permitted. At December 31, 2018 we had no leases to which the standard applies. Accordingly, the standard had no material impact on our results of operations in 2018. |
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, 2018, 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” |
Derivative Financial Instruments | Derivative Financial Instruments FASB ASC 820, Fair Value Measurements |
Fair Value Measurements | Fair Value Measurements The ASC Topic 820, Fair Value Measurement, |
Inventory | Inventory Inventories comprise finished product, raw materials and materials used for packaging. Inventories are stated at the lower of cost or market with cost based on the first-in, first-out (FIFO) method. Inventory that can be used in either the production of clinical or commercial products is expensed as research and development costs when identified for use in a clinical trials or clinical manufacturing campaigns. Inventory used in marketing activities is charged to selling, general and administrative expense. Inventory as of December 31, 2018 was valued at $82,801, a decrease of $95,297 or 54% from the inventory balance at the end of fiscal 2017. Inventory at year end 2018 was made up primarily of finished pills and related packaging materials. The year-over-year decrease in inventory was due to the shipments of pills during 2018 to Nigeria and to pills used as samples. |
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, 2018 and December 31, 2017 was $1,733 and $826, 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, 2018 and 2017, 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, 2018, and 2017, the Company has not accrued any interest or penalties related to uncertain tax positions. In February 2018, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update No. 2018-02, Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income |
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 |
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. 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, 2018 2017 Common Stock Purchase Warrants 281,251,038 84,287,402 Convertible Debt 180,603,978 81,880,906 |
Recent Accounting Standards | Recent Accounting Standards During the year ended December 31, 2018, 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, 2018, 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 Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
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, 2018 2017 Common Stock Purchase Warrants 281,251,038 84,287,402 Convertible Debt 180,603,978 81,880,906 |
Fixed Assets (Tables)
Fixed Assets (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Fixed Assets: | |
Schedule of Fixed Assets | December 31, 2018 2017 Fixed assets: Computer equipment $ 13,213 $ 11,243 Less accumulated depreciation (10,447 ) (8,714 ) Fixed assets, net $ 2,766 $ 2,529 |
Accrued Liabilities (Tables)
Accrued Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Liabilities | Accrued expenses and other liabilities consist of the following: December 31, 2018 2017 Accrued payroll to officers and others 2,010,570 1,539,777 Accrued interest and penalties - notes payable 877,571 703,141 Estimated legal settlements 136,057 136,057 Other accrued liabilities 15,512 393 Estimated loss on note conversions - 110,036 Derivative Liability 786.706 1,669,532 Total accrued expenses and other liabilities $ 3,826,416 $ 4,158,936 |
Notes Payable (Tables)
Notes Payable (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Debt Disclosure [Abstract] | |
Schedule of Notes Payable | Notes payable consist of the following: December 31, 2018 December 31, 2017 Promissory note issued July 29, 2014 to Ira Gaines. In 2016, the maturity date on the note was extended to December 1, 2017. As of December 31, 2018, the note is in default. The note earns interest at a rate of 18% per annum. $ 100,000 $ 100,000 Promissory notes issued between November 26, 2014 and December 31, 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 LDN-LDN in perpetuity. Notes will be repaid in 36 monthly installments of principal and interest commencing no later than October 15, 2015. These notes were in default at December 31, 2018, as the Company was unable to pay installments on their due dates. 286,000 286,000 Promissory notes issued between May 1, 2015 and December 31, 2016, and maturing between June 14, 2015 and December 1, 2017. Lenders on loans aggregating $375,994 earn interest at rates between 2% and 18% per annum. On loans aggregating $100,000, interest is payable in a fixed amount not tied to a specific interest rate. Notes aggregating $725,994 were in default at December 31, 2018, as the Company was unable to repay those notes on their due dates. $130,000 of the notes were deconsolidated on May 1, 2018, and $150,000 of interest was capitalized in July 2018. 725,994 705,994 Promissory notes issued by Cytocom between April 29, 2015 and December 31, 2015. Lenders earn interest at rates between 5% and 10% per annum. These notes mature on December 31, 2016. At December 31, 2018, the notes were in default. These notes were deconsolidated on May 1, 2018. - 425,000 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. The Company was unable to repay the note at maturity and at December 31, 2018 the note was in default. 97,737 97,737 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. This note was extinguished on July 1, 2018. - 50,000 Promissory note for $180,000 was issued in July 2016 with an original issue discount of $30,000. The note is repayable on April 7, 2017. The Company was unable to repay the note at maturity and at December 31, 2018 the note was in default. Under the terms of the note, the principal amount was increased in 2017 to $243,000, and interest accrued at 25% per annum. $161,976 of principal and $20,025 of accrued interest were converted into 7,447,448 shares, of which 5,500,000 shares were issued at the end of 2017. The Company has accrued a $243,199 derivative liability for the $81,024 principal balance attributable to the conversion feature contained in this note. The note was settled in the quarter ended March 31, 2018. - 81,024 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 $8,642. The note was in default on December 31, 2018. The balance due was reclassified as accounts payable. - 17,284 Promissory notes issued between July 1, 2016 and December 31, 2016. Lenders earn interest at 2% per annum. The notes mature on December 31, 2017, and at December 31, 2018 the notes were in default. 206,000 206,000 Notes aggregating $1,354,000 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. As of December 31, 2018 the notes were in default. 1,354,000 1,354,000 Notes aggregating $500,000 issued in the first quarter of 2017. The notes accrue interest at 2% per annum and mature between January 12, 2018 and March 31, 2018. At December 31, 2018, the notes were in default. 500,000 500,000 Promissory note issued January 25, 2017. The lenders earn interest at 7% per month. The note matures on July 5, 2017 and at December 31, 2018 the note was in default. 50,000 50,000 Notes aggregating $300,000 issued in the second quarter of 2017. The notes accrue interest at 2% per annum and mature between April 3, 2018 and May 31, 2018. At December 31, 2018, the notes were in default. 300,000 300,000 Notes aggregating $191,800 issued in the third quarter of 2017. The notes accrue interest at 2% per annum and mature between June 16, 2018 and December 31, 2018. At December 31, 2018, the notes were in default. 191,800 191,800 Promissory note for $425,000 was issued in October 2017 with an original issue discount of $70,000. The note is in default, giving the holder an option to convert the note to stock. In 2018, The defaults also resulted in certain penalties, as a result of which the principal amount of the note outstanding at December 31, 2018 had increased to $455,122. $60,000 of accrued interest owed on the note has been converted to stock. The Company has accrued a $786,706 derivative liability for the remaining conversion right. 455,122 425,000 Notes aggregating $105,500 issued in the fourth quarter of 2017. The notes accrue interest at 2% per annum. At December 31, 2018, the notes were in default. 105,500 105,500 Notes aggregating $47,975 issued in the first quarter of 2018. The notes accrue interest at 2% per annum and mature between May 2018 and January 2019. At December 31, 2018, $10,000 of the notes were in default. 47,975 - Notes aggregating $125,000 issued in the first quarter of 2018. The notes accrue interest between 2% and 12% per annum and mature between April 2018 and June 2018. These notes include warrants between 5,000,000 and 20,000,000 shares with an exercise price of $0.005. At December 31, 2018, the notes were in default. 125,000 - Notes aggregating $65,000 issued in the second quarter of 2018. The notes accrue interest of 2% per annum and mature between July 2018 and October 2018. These notes include warrants between 1,000,000 and 5,000,000 shares with an exercise price of $0.005. At December 31, 2018, the notes were in default. 65,000 - Notes aggregating $193,000 issued in the third quarter of 2018. The notes accrue interest at 2% per annum and mature between November 2018 and January 2019. These notes include warrants between 600,000 and 5,000,000 shares with an exercise price of $0.005. At December 31, 2018, the notes were in default. 193,000 - Notes aggregating $533,855 issued in the fourth quarter of 2018. The notes accrue interest from 2% to 3.5% per annum and mature between February 2019 and December 2019. These notes include warrants between 200,000 and 39,500,000 shares with an exercise price of $0.005 to $0.04. 533,855 - Less: Original issue discounts on notes payable and warrants issued with notes. (149,256 ) (75,277 ) Total $ 5,187,727 $ 4,820,062 |
Derivative Liabilities (Tables)
Derivative Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Derivative Instruments and Hedging Activities Disclosure [Abstract] | |
Schedule of Estimated Fair Value of Derivative Liability Valuation Assumptions | The Company estimated the fair value of the derivative liability using the Black-Scholes option pricing model using the following key assumptions during the year ended December 31, 2018: Year End December 31, 2018 Volatility 311.78 % Risk-free interest rate 2.8054 % Expected dividends - % Expected term 1.0 – 5 years |
Schedule of Valuation of Financial Instruments | The following schedule summarizes the valuation of financial instruments at fair value in the balance sheets as of December 31, 2018: Fair Value Measurements as of December 31, 2018 Level 1 Level 2 Level 3 Assets Total assets - - - Liabilities Conversion option derivative liability - - 786,706 Total liabilities $ - $ - $ 786,706 |
Schedule of Reconciliation of Changes in the Fair Value of Derivative Liabilities | The following table sets forth a reconciliation of changes in the fair value of derivative liabilities classified as Level 3 in the fair value hierarchy: Significant Unobservable Inputs (Level 3) Beginning balance $ 1,669,532 Settlement of liability (243,199 ) Change in fair value (494,445 ) Partial settlements of liability (145,182 ) Ending balance $ 786,706 |
Capital Structure - Common St_2
Capital Structure - Common Stock and Common Stock Purchase Warrants (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Equity [Abstract] | |
Schedule of Outstanding Stock Warrants | Following is a summary of outstanding stock warrants at December 31, 2018: Number of Shares Exercise Price Weighted Average Price Warrants as of December 31, 2016 59,191,904 $ 0.03-15.00 $ 0.35 Issued in 2017 66,789,711 $ 0.01-3.74 $ 0.14 Expired and forfeited in 2017 11,053,762 $ 0.01-9.00 $ 0.13 Exercised in 2017 30,640,451 $ 0.01-0.20 $ 0.01 Warrants as of December 31, 2017 84,287,402 $ 0.01-15.00 $ 0.33 Issued in 2018 203,995,454 $ 0.01-3.74 $ 0.11 Expired and forfeited in 2018 6,500,000 $ 15.00 $ 1.45 Exercised in 2018 - $ - $ - Warrants as of December 31, 2018 281,782,856 $ 0.01-3.74 $ 0.09 |
Summary of Outstanding Warrants | Summary of outstanding warrants as of December 31, 2018: Expiration Date Number of Shares Exercise Price Remaining Life (years) First Quarter 2019 4,024,000 $ 0.50-2.00 0.25 Second Quarter 2019 135,000 $ 0.07-0.23 0.50 Third Quarter 2019 260,000 $ 0.50-1.50 0.75 Fourth Quarter 2019 22,690,908 $ 0.05-3.74 1.00 Second Quarter 2020 300,000 $ 0.50 1.50 Fourth Quarter 2020 1,000,000 $ 0.20 2.00 First Quarter 2021 12,600,000 $ 0.20 2.25 Second Quarter 2021 5,812,252 $ 0.01408-0.20 2.50 Third Quarter 2021 5,166,667 $ 0.03-0.20 2.75 Fourth Quarter 2021 300,000 $ 0.10 3.00 Second Quarter 2022 1,750,000 $ 0.15 3.50 Third Quarter 2022 2,650,000 $ 0.05-0.10 3.75 Fourth Quarter 2022 9,811,422 $ 0.08-0.29 4.00 First Quarter 2023 8,000,000 $ 0.005-0.0 4 4.25 Second Quarter 2023 15,000,000 $ 0.005-0.20 4.50 Third Quarter 2023 76,700,000 $ 0.005-0.10 4.75 Fourth Quarter 2023 60,774,818 $ 0.005 5.00 First Quarter 2024 30,000,000 $ 0.005 5.25 Third Quarter 2028 3,000,000 $ 0.07 9.75 Second Quarter 2032 21,807,789 $ 0.01-0.0679 13.50 281,782,856 $ 0.005-15.00 |
Income Taxes - Results of Ope_2
Income Taxes - Results of Operations (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Schedule of Deferred Tax Assets | Deferred tax assets: 2018 2017 Net operating losses $ 19,671,000 $ 18,102,000 Stock based compensation 39,256,000 39,054,000 Amortization, depreciation, and impairment 4,178,000 4,178,000 Capitalization of start-up costs for tax purposes 1,145,000 1,145,000 Gain/(loss) on conversion of debt 713,000 569,000 Total deferred tax assets 64,963,000 63,048,000 Valuation allowance (64,963,000 ) (63,048,000 ) Total deferred tax assets, net $ - $ - |
Schedule of Income Taxes Net Operating Loss | As of December 31, 2018, we have estimated federal and state income tax net operating loss (“NOL”) carry-forwards of approximately $93,206,000, which will expire in 2032-2037. 2018 2017 Amount Percent Amount Percent Benefits for income tax at federal statutory rate $ 1,811,000 21 % $ 1,666,000 34 % Change in valuation allowance (2,000 ) $ 36,334,000 - Permanent differences - - - - Change in estimates (1,809,000 ) (38,000,000 ) - $ - - % $ - - % |
Subsequent Events (Tables)
Subsequent Events (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Subsequent Events [Abstract] | |
Schedule of Number of Shares Issued | Between January 1, 2019 and April 16, 2019, the Company issued shares as follows: Number of Shares Issuance of common stock to employees and consultants 3,000,000 Issuance of common stock for conversion of debt 18,255,739 |
Organization and Description _2
Organization and Description of Business (Details Narrative) - USD ($) | 1 Months Ended | 12 Months Ended | ||
Mar. 31, 2014 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Net loss attributable to common shareholders | $ 8,175,228 | $ 7,316,207 | ||
Cash and cash equivalents used in operating activities | 1,369,503 | 2,053,263 | ||
Stockholder's deficit | $ 11,250,638 | $ 11,103,386 | $ 9,124,344 | |
Irish Limited Liability [Member] | ||||
Percentage of low corporate income tax rate | 12.50% |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Details Narrative) | Jun. 04, 2018USD ($) | Dec. 31, 2018USD ($)Segment | Dec. 31, 2017USD ($) |
Maximum of annual gross revenue | $ 1,000,000,000 | $ 1,000,000,000 | |
Federal deposit insurance corporation value | 250,000 | ||
Inventory | 82,801 | 178,098 | |
Decrease in inventory | $ (95,297) | 178,098 | |
Percentage on decrease in inventory | 54.00% | ||
Number of operating segment | Segment | 1 | ||
Depreciation expense | $ 1,734 | 826 | |
Accrued interest or penalties related to uncertain tax positions | |||
Property and Equipment [Member] | Minimum [Member] | |||
Property and equipment useful lives | 3 years | ||
Property and Equipment [Member] | Maximum [Member] | |||
Property and equipment useful lives | 5 years | ||
Cytocom Inc., [Member] | |||
Percentage of equity ownership | 15.50% | ||
Cytocom Inc., [Member] | |||
Amount of debt converted into common stock | $ 4,000,000 | ||
Percentage of common stock issued in exchange of debt | 10.00% |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Schedule of Antidilutive Securities (Details) - shares | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Common Stock Purchase Warrants [Member] | ||
Potentially dilutive securities | 281,251,038 | 84,287,402 |
Convertible Debt [Member] | ||
Potentially dilutive securities | 180,603,978 | 81,880,906 |
Fixed Assets - Schedule of Fixe
Fixed Assets - Schedule of Fixed Assets (Details) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Fixed Assets: | ||
Computer equipment | $ 13,213 | $ 11,243 |
Less accumulated depreciation | (10,447) | (8,714) |
Fixed assets, net | $ 2,766 | $ 2,529 |
Investments_ Deconsolidation of
Investments: Deconsolidation of Cytocom (Details Narrative) - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | May 01, 2018 | Dec. 31, 2017 | |
Notes payable | $ 506,024 | ||
Cytocom Inc., [Member] | |||
Notes payable | $ 1,193,500 | ||
Cytocom Inc., [Member] | |||
Equity method investments | $ 1,189 | ||
Loss on investment | $ 0 |
Accrued Liabilities - Schedule
Accrued Liabilities - Schedule of Accrued Liabilities (Details) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Payables and Accruals [Abstract] | ||
Accrued payroll to officers and others | $ 2,010,570 | $ 1,539,777 |
Accrued interest and penalties - notes payable | 877,571 | 703,141 |
Estimated legal settlements | 136,057 | 136,057 |
Other accrued liabilities | 15,512 | 393 |
Estimated loss on note conversions | 110,036 | |
Derivative Liability | 786,706 | 1,669,532 |
Total accrued expenses and other liabilities | $ 3,826,416 | $ 4,158,936 |
Notes Payable (Details Narrativ
Notes Payable (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Accrued unpaid interest and default penalties | $ 877,571 | $ 703,141 |
Issuance of common stock for conversion of debt | $ 671,597 | $ 2,171,849 |
Promissory Notes [Member] | ||
Issuance of common stock for conversion of debt, shares | 30,351,461 | 8,147,570 |
Issuance of common stock for conversion of debt | $ 318,182 | $ 394,562 |
Settlement of promissory notes | $ 175,000 |
Notes Payable - Schedule of Not
Notes Payable - Schedule of Notes Payable (Details) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 | Oct. 31, 2017 | Jul. 31, 2016 |
Total | $ 5,187,727 | $ 4,820,063 | ||
Less: Original issue discounts on notes payable and warrants issued with notes | (149,256) | (75,277) | ||
Notes Payable One [Member] | ||||
Total | 100,000 | 100,000 | ||
Notes Payable Two [Member] | ||||
Total | 286,000 | 286,000 | ||
Notes Payable Three [Member] | ||||
Total | 725,994 | 705,994 | ||
Notes Payable Four [Member] | ||||
Total | 425,000 | |||
Notes Payable Five [Member] | ||||
Total | 97,737 | 97,737 | ||
Notes Payable Six [Member] | ||||
Total | 50,000 | |||
Notes Payable Seven [Member] | ||||
Total | 81,024 | |||
Less: Original issue discounts on notes payable and warrants issued with notes | $ (30,000) | |||
Notes Payable Eight [Member] | ||||
Total | 17,284 | |||
Notes Payable Nine [Member] | ||||
Total | 206,000 | 206,000 | ||
Notes Payable Ten [Member] | ||||
Total | 1,354,000 | 1,354,000 | ||
Notes Payable Eleven [Member] | ||||
Total | 500,000 | 500,000 | ||
Notes Payable Twelve [Member] | ||||
Total | 50,000 | 50,000 | ||
Notes Payable Thirteen [Member] | ||||
Total | 300,000 | 300,000 | ||
Notes Payable Fourteen [Member] | ||||
Total | 191,800 | 191,800 | ||
Notes Payable Fifteen [Member] | ||||
Total | 455,122 | 425,000 | ||
Less: Original issue discounts on notes payable and warrants issued with notes | $ (70,000) | |||
Notes Payable Sixteen [Member] | ||||
Total | 105,500 | 105,500 | ||
Notes Payable Seventeen [Member] | ||||
Total | 47,975 | |||
Notes Payable Eighteen [Member] | ||||
Total | 125,000 | |||
Notes Payable Nineteen [Member] | ||||
Total | 65,000 | |||
Notes Payable Twenty [Member] | ||||
Total | 193,000 | |||
Notes Payable Twenty One [Member] | ||||
Total | $ 533,855 |
Notes Payable - Schedule of N_2
Notes Payable - Schedule of Notes Payable (Details) (Parenthetical) | Jan. 25, 2017 | Aug. 31, 2016USD ($)Installments | Jul. 31, 2016USD ($) | Nov. 03, 2015 | Jul. 29, 2014 | Jul. 31, 2018USD ($) | Jul. 31, 2016USD ($) | Dec. 31, 2018USD ($)$ / sharesshares | Sep. 30, 2018USD ($)$ / sharesshares | Jun. 30, 2018USD ($)$ / sharesshares | Mar. 31, 2018USD ($)$ / sharesshares | Sep. 30, 2017USD ($) | Jun. 30, 2017USD ($) | Mar. 31, 2017USD ($) | Dec. 31, 2016USD ($) | Dec. 31, 2016USD ($) | Dec. 31, 2015USD ($) | Dec. 31, 2018USD ($)$ / sharesshares | Dec. 31, 2017USD ($)shares | Dec. 31, 2015USD ($)Installments | Dec. 31, 2016USD ($) | Oct. 31, 2017USD ($) |
Accrued interest | $ 877,571 | $ 877,571 | $ 703,141 | |||||||||||||||||||
Original issuance discount | 149,256 | 149,256 | 75,277 | |||||||||||||||||||
Number of shares converted into common stock | 671,597 | $ 2,171,849 | ||||||||||||||||||||
Notes Payable Two [Member] | ||||||||||||||||||||||
Percentage of interest rate per annum | 10.00% | 10.00% | ||||||||||||||||||||
Number of installments, months | Installments | 36 | |||||||||||||||||||||
Notes Payable Two [Member] | Maximum [Member] | ||||||||||||||||||||||
Maximum amount raise in debt | $ 2,000,000 | $ 2,000,000 | ||||||||||||||||||||
Notes Payable Four [Member] | Cytocom Inc., [Member] | ||||||||||||||||||||||
Note matures date | Dec. 31, 2016 | |||||||||||||||||||||
Notes Payable Four [Member] | Maximum [Member] | Cytocom Inc., [Member] | ||||||||||||||||||||||
Percentage of interest rate per annum | 10.00% | 10.00% | ||||||||||||||||||||
Notes Payable Four [Member] | Minimum [Member] | Cytocom Inc., [Member] | ||||||||||||||||||||||
Percentage of interest rate per annum | 5.00% | 5.00% | ||||||||||||||||||||
Notes Payable Five [Member] | ||||||||||||||||||||||
Note matures date | Nov. 3, 2016 | |||||||||||||||||||||
Percentage of interest rate per annum | 10.00% | |||||||||||||||||||||
Notes Payable Six [Member] | ||||||||||||||||||||||
Note matures date | Oct. 5, 2016 | |||||||||||||||||||||
Percentage of interest rate per annum | 6.00% | 6.00% | ||||||||||||||||||||
Debt maturity date extended | Dec. 31, 2016 | |||||||||||||||||||||
Notes Payable Seven [Member] | ||||||||||||||||||||||
Note matures date | Apr. 7, 2017 | |||||||||||||||||||||
Percentage of interest rate per annum | 25.00% | |||||||||||||||||||||
Accrued interest | $ 20,025 | |||||||||||||||||||||
Notes aggregating default amount | $ 180,000 | $ 180,000 | $ 161,976 | |||||||||||||||||||
Original issuance discount | $ 30,000 | $ 30,000 | ||||||||||||||||||||
Issuance of common stock for conversion of debt | shares | 7,447,448 | |||||||||||||||||||||
Number of shares issued | shares | 5,500,000 | |||||||||||||||||||||
Derivative liability | $ 243,199 | |||||||||||||||||||||
Principal balance attributable to the conversion feature | 81,024 | |||||||||||||||||||||
Notes Payable Seven [Member] | Maximum [Member] | ||||||||||||||||||||||
Notes aggregating default amount | $ 243,000 | |||||||||||||||||||||
Notes Payable Eight [Member] | ||||||||||||||||||||||
Percentage of interest rate per annum | 5.00% | |||||||||||||||||||||
Number of installments, months | Installments | 18 | |||||||||||||||||||||
Notes aggregating default amount | $ 149,854 | |||||||||||||||||||||
Debt instrument, periodic payment, principal | $ 8,642 | |||||||||||||||||||||
Notes Payable Nine [Member] | Lenders [Member] | ||||||||||||||||||||||
Note matures date | Dec. 31, 2017 | |||||||||||||||||||||
Percentage of interest rate per annum | 2.00% | 2.00% | 2.00% | |||||||||||||||||||
Notes Payable Ten [Member] | ||||||||||||||||||||||
Percentage of interest rate per annum | 2.00% | 2.00% | 2.00% | |||||||||||||||||||
Debt instrument maturity date description | November 1, 2017 and December 31, 2017 | |||||||||||||||||||||
Notes aggregating default amount | $ 1,354,000 | $ 1,354,000 | $ 1,354,000 | |||||||||||||||||||
Notes Payable Eleven [Member] | ||||||||||||||||||||||
Percentage of interest rate per annum | 2.00% | |||||||||||||||||||||
Debt instrument maturity date description | January 12, 2018 and March 31, 2018 | |||||||||||||||||||||
Notes aggregating default amount | $ 500,000 | |||||||||||||||||||||
Notes Payable Thirteen [Member] | ||||||||||||||||||||||
Percentage of interest rate per annum | 2.00% | |||||||||||||||||||||
Debt instrument maturity date description | April 3, 2018 and May 31, 2018 | |||||||||||||||||||||
Notes aggregating default amount | $ 300,000 | |||||||||||||||||||||
Notes Payable Fourteen [Member] | ||||||||||||||||||||||
Percentage of interest rate per annum | 2.00% | |||||||||||||||||||||
Debt instrument maturity date description | June 16, 2018 and December 31, 2018 | |||||||||||||||||||||
Notes aggregating default amount | $ 191,800 | |||||||||||||||||||||
Notes Payable Fifteen [Member] | ||||||||||||||||||||||
Accrued interest | 455,122 | 455,122 | ||||||||||||||||||||
Notes aggregating default amount | $ 425,000 | |||||||||||||||||||||
Original issuance discount | $ 70,000 | |||||||||||||||||||||
Derivative liability | 786,706 | 786,706 | ||||||||||||||||||||
Number of shares converted into common stock | 60,000 | |||||||||||||||||||||
Notes Payable Sixteen [Member] | ||||||||||||||||||||||
Percentage of interest rate per annum | 2.00% | |||||||||||||||||||||
Notes aggregating default amount | $ 105,500 | |||||||||||||||||||||
Notes Payable Seventeen [Member] | ||||||||||||||||||||||
Percentage of interest rate per annum | 2.00% | |||||||||||||||||||||
Maximum amount raise in debt | $ 10,000 | 10,000 | ||||||||||||||||||||
Debt instrument maturity date description | May 2018 and January 2019 | |||||||||||||||||||||
Notes aggregating default amount | $ 47,975 | |||||||||||||||||||||
Notes Payable Eighteen [Member] | ||||||||||||||||||||||
Debt instrument maturity date description | April 2018 and June 2018 | |||||||||||||||||||||
Notes aggregating default amount | $ 125,000 | |||||||||||||||||||||
Warrant exercise price per share | $ / shares | $ 0.005 | |||||||||||||||||||||
Notes Payable Eighteen [Member] | Maximum [Member] | ||||||||||||||||||||||
Percentage of interest rate per annum | 12.00% | |||||||||||||||||||||
Number of warrants | shares | 20,000,000 | |||||||||||||||||||||
Notes Payable Eighteen [Member] | Minimum [Member] | ||||||||||||||||||||||
Percentage of interest rate per annum | 2.00% | |||||||||||||||||||||
Number of warrants | shares | 5,000,000 | |||||||||||||||||||||
Notes Payable Nineteen [Member] | ||||||||||||||||||||||
Percentage of interest rate per annum | 2.00% | |||||||||||||||||||||
Debt instrument maturity date description | July 2018 and October 2018 | |||||||||||||||||||||
Notes aggregating default amount | $ 65,000 | |||||||||||||||||||||
Warrant exercise price per share | $ / shares | $ 0.005 | |||||||||||||||||||||
Notes Payable Nineteen [Member] | Maximum [Member] | ||||||||||||||||||||||
Number of warrants | shares | 5,000,000 | |||||||||||||||||||||
Notes Payable Nineteen [Member] | Minimum [Member] | ||||||||||||||||||||||
Number of warrants | shares | 1,000,000 | |||||||||||||||||||||
Notes Payable Twenty [Member] | ||||||||||||||||||||||
Percentage of interest rate per annum | 2.00% | |||||||||||||||||||||
Debt instrument maturity date description | November 2018 and January 2019 | |||||||||||||||||||||
Notes aggregating default amount | $ 193,000 | |||||||||||||||||||||
Warrant exercise price per share | $ / shares | $ 0.005 | |||||||||||||||||||||
Notes Payable Twenty [Member] | Maximum [Member] | ||||||||||||||||||||||
Number of warrants | shares | 5,000,000 | |||||||||||||||||||||
Notes Payable Twenty [Member] | Minimum [Member] | ||||||||||||||||||||||
Number of warrants | shares | 600,000 | |||||||||||||||||||||
Notes Payable Twenty One [Member] | ||||||||||||||||||||||
Debt instrument maturity date description | February 2019 and December 2019 | |||||||||||||||||||||
Notes aggregating default amount | $ 533,855 | $ 533,855 | ||||||||||||||||||||
Notes Payable Twenty One [Member] | Maximum [Member] | ||||||||||||||||||||||
Percentage of interest rate per annum | 3.50% | 3.50% | ||||||||||||||||||||
Number of warrants | shares | 39,500,000 | 39,500,000 | ||||||||||||||||||||
Warrant exercise price per share | $ / shares | $ 0.04 | $ 0.04 | ||||||||||||||||||||
Notes Payable Twenty One [Member] | Minimum [Member] | ||||||||||||||||||||||
Percentage of interest rate per annum | 2.00% | 2.00% | ||||||||||||||||||||
Number of warrants | shares | 200,000 | 200,000 | ||||||||||||||||||||
Warrant exercise price per share | $ / shares | $ 0.005 | $ 0.005 | ||||||||||||||||||||
Ira Gaines [Member] | Notes Payable One [Member] | ||||||||||||||||||||||
Note matures date | Dec. 1, 2017 | |||||||||||||||||||||
Percentage of interest rate per annum | 18.00% | |||||||||||||||||||||
Lenders [Member] | Notes Payable Three [Member] | ||||||||||||||||||||||
Maximum amount raise in debt | $ 130,000 | $ 130,000 | ||||||||||||||||||||
Debt instrument maturity date description | June 14, 2015 and December 1, 2017 | |||||||||||||||||||||
Aggregating loan | 375,994 | 375,994 | $ 375,994 | |||||||||||||||||||
Accrued interest | $ 100,000 | $ 100,000 | $ 100,000 | |||||||||||||||||||
Notes aggregating default amount | $ 725,994 | $ 725,994 | ||||||||||||||||||||
Extinguishment of debt, amount | $ 150,000 | |||||||||||||||||||||
Lenders [Member] | Notes Payable Three [Member] | Maximum [Member] | ||||||||||||||||||||||
Percentage of interest rate per annum | 18.00% | 18.00% | 18.00% | |||||||||||||||||||
Lenders [Member] | Notes Payable Three [Member] | Minimum [Member] | ||||||||||||||||||||||
Percentage of interest rate per annum | 2.00% | 2.00% | 2.00% | |||||||||||||||||||
Lenders [Member] | Notes Payable Twelve [Member] | ||||||||||||||||||||||
Note matures date | Jul. 5, 2017 | |||||||||||||||||||||
Percentage of interest rate per annum | 7.00% |
Derivative Liabilities (Details
Derivative Liabilities (Details Narrative) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Derivative Instruments and Hedging Activities Disclosure [Abstract] | ||
Notes payable | $ 506,024 | |
Derivative liabilities | $ 786,706 | $ 1,669,532 |
Schedule of Estimated Fair Valu
Schedule of Estimated Fair Value of Derivative Liability Valuation Assumptions (Details) - Black-Scholes Option Pricing Model [Member] | 12 Months Ended |
Dec. 31, 2018 | |
Volatility [Member] | |
Fair value assumptions, measurement input, percentages | 311.78% |
Risk-Free Interest Rate [Member] | |
Fair value assumptions, measurement input, percentages | 2.8054% |
Expected Dividends [Member] | |
Fair value assumptions, measurement input, percentages | 0.00% |
Expected Term [Member] | Minimum [Member] | |
Fair value assumptions, measurement input, term | 1 year |
Expected Term [Member] | Maximum [Member] | |
Fair value assumptions, measurement input, term | 5 years |
Derivative Liabilities - Schedu
Derivative Liabilities - Schedule of Valuation of Financial Instruments (Details) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Total assets | $ 91,626 | $ 195,545 |
Total liabilities | 11,342,264 | $ 11,298,931 |
Level 1 [Member] | ||
Total assets | ||
Conversion option derivative liability | ||
Total liabilities | ||
Level 2 [Member] | ||
Total assets | ||
Conversion option derivative liability | ||
Total liabilities | ||
Level 3 [Member] | ||
Total assets | ||
Conversion option derivative liability | 786,706 | |
Total liabilities | $ 786,706 |
Derivative Liabilities - Sche_2
Derivative Liabilities - Schedule of Reconciliation of Changes in the Fair Value of Derivative Liabilities (Details) | 12 Months Ended |
Dec. 31, 2018USD ($) | |
Derivative liabilities beginning balance | $ 1,669,532 |
Derivative liabilities ending balance | 786,706 |
Level 3 [Member] | |
Derivative liabilities beginning balance | 1,669,532 |
Settlement of liability | (243,199) |
Change in fair value | (494,445) |
Partial settlements of liability | (145,182) |
Derivative liabilities ending balance | $ 786,706 |
Capital Structure - Common St_3
Capital Structure - Common Stock and Common Stock Purchase Warrants (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Common stock, shares authorized | 500,000,000 | 500,000,000 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares outstanding | 434,322,574 | 386,782,473 |
Warrant [Member] | ||
Number of warrants issued during period | 203,995,454 | |
Warrant expiration date description | Exercisable into one share of common stock of the Company for each warrant at prices between $0.01 and $3.74 per share. The warrants expire between December 2019 and June 2032. | |
Warrant valuation expense | $ 0 | $ 4,730,726 |
Warrant [Member] | Minimum [Member] | ||
Warrant exercise price | $ 0.01 | |
Warrant [Member] | Maximum [Member] | ||
Warrant exercise price | $ 3.74 |
Capital Structure - Common St_4
Capital Structure - Common Stock and Common Stock Purchase Warrants - Schedule of Outstanding Stock Warrants (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Number of Shares Warrants, Beginning balance | 84,287,402 | 59,191,904 |
Number of Shares Warrants, Issued | 203,995,454 | 66,789,711 |
Number of Shares Warrants, Expired and forfeited | 6,500,000 | 11,053,762 |
Number of Shares Warrants, Exercised | 30,640,451 | |
Number of Shares Warrants, Ending balance | 281,782,856 | 84,287,402 |
Exercise Price, Expired and forfeited | $ 15 | |
Exercise Price, Exercised | ||
Weighted average price, Beginning balance | 0.33 | $ 0.35 |
Weighted average price, Issued | 0.11 | 0.14 |
Weighted average price, Expired and forfeited | 1.45 | 0.13 |
Weighted average price, Exercised | 0.01 | |
Weighted average price, Ending balance | 0.09 | 0.33 |
Minimum [Member] | ||
Exercise Price, Beginning balance | 0.01 | 0.03 |
Exercise Price, Issued | 0.01 | 0.01 |
Exercise Price, Expired and forfeited | 0.01 | |
Exercise Price, Exercised | 0.01 | |
Exercise Price, Ending balance | 0.01 | 0.01 |
Maximum [Member] | ||
Exercise Price, Beginning balance | 15 | 15 |
Exercise Price, Issued | 3.74 | 3.74 |
Exercise Price, Expired and forfeited | 9 | |
Exercise Price, Exercised | 0.20 | |
Exercise Price, Ending balance | $ 3.74 | $ 15 |
Capital Structure - Common St_5
Capital Structure - Common Stock and Common Stock Purchase Warrants - Summary of Outstanding Warrants (Details) | 12 Months Ended |
Dec. 31, 2018$ / sharesshares | |
Number of Shares | shares | 281,782,856 |
Exercise Price Lower Limit | $ 0.005 |
Exercise Price Upper Limit | $ 15 |
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 months 30 days |
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) | 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) | 9 months |
Fourth Quarter 2019 [Member] | |
Number of Shares | shares | 22,690,908 |
Exercise Price Lower Limit | $ 0.05 |
Exercise Price Upper Limit | $ 3.74 |
Remaining Life (years) | 1 year |
Second Quarter 2020 [Member] | |
Number of Shares | shares | 300,000 |
Exercise Price Upper Limit | $ 0.50 |
Remaining Life (years) | 1 year 6 months |
Fourth Quarter 2020 [Member] | |
Number of Shares | shares | 1,000,000 |
Exercise Price Upper Limit | $ 0.20 |
Remaining Life (years) | 2 years |
First Quarter 2021 [Member] | |
Number of Shares | shares | 12,600,000 |
Exercise Price Upper Limit | $ 0.20 |
Remaining Life (years) | 2 years 2 months 30 days |
Second Quarter 2021 [Member] | |
Number of Shares | shares | 5,812,252 |
Exercise Price Lower Limit | $ 0.01408 |
Exercise Price Upper Limit | $ 0.20 |
Remaining Life (years) | 2 years 6 months |
Third Quarter 2021 [Member] | |
Number of Shares | shares | 5,166,667 |
Exercise Price Lower Limit | $ 0.03 |
Exercise Price Upper Limit | $ 0.20 |
Remaining Life (years) | 2 years 9 months |
Fourth Quarter 2021 [Member] | |
Number of Shares | shares | 300,000 |
Exercise Price Upper Limit | $ 0.10 |
Remaining Life (years) | 3 years |
Second Quarter 2022 [Member] | |
Number of Shares | shares | 1,750,000 |
Exercise Price Upper Limit | $ 0.15 |
Remaining Life (years) | 3 years 6 months |
Third Quarter 2022 [Member] | |
Number of Shares | shares | 2,650,000 |
Exercise Price Lower Limit | $ 0.05 |
Exercise Price Upper Limit | $ 0.10 |
Remaining Life (years) | 3 years 9 months |
Fourth Quarter 2022 [Member] | |
Number of Shares | shares | 9,811,422 |
Exercise Price Lower Limit | $ 0.08 |
Exercise Price Upper Limit | $ 0.29 |
Remaining Life (years) | 4 years |
First Quarter 2023 [Member] | |
Number of Shares | shares | 8,000,000 |
Exercise Price Lower Limit | $ 0.005 |
Exercise Price Upper Limit | $ 0.04 |
Remaining Life (years) | 4 years 2 months 30 days |
Second Quarter 2023 [Member] | |
Number of Shares | shares | 15,000,000 |
Exercise Price Lower Limit | $ 0.005 |
Exercise Price Upper Limit | $ 0.20 |
Remaining Life (years) | 4 years 6 months |
Third Quarter 2023 [Member] | |
Number of Shares | shares | 76,700,000 |
Exercise Price Lower Limit | $ 0.005 |
Exercise Price Upper Limit | $ 0.10 |
Remaining Life (years) | 4 years 9 months |
Fourth Quarter 2023 [Member] | |
Number of Shares | shares | 60,774,818 |
Exercise Price Upper Limit | $ 0.005 |
Remaining Life (years) | 5 years |
First Quarter 2024 [Member] | |
Number of Shares | shares | 30,000,000 |
Exercise Price Upper Limit | $ 0.005 |
Remaining Life (years) | 5 years 2 months 30 days |
Third Quarter 2028 [Member] | |
Number of Shares | shares | 3,000,000 |
Exercise Price Upper Limit | $ 0.07 |
Remaining Life (years) | 9 years 9 months |
Second Quarter 2032 [Member] | |
Number of Shares | shares | 21,807,789 |
Exercise Price Lower Limit | $ 0.01 |
Exercise Price Upper Limit | $ 0.0679 |
Remaining Life (years) | 13 years 6 months |
Stock Compensation (Details Nar
Stock Compensation (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Amortization of prepaid services | $ 226,667 | $ 1,655,834 |
Vision Pharmaceutica SA [Member] | ||
Number of common stock issued for services | 3,000,000 | |
Contract term | 10 years | |
Contract term description | If the Company terminates the contract without cause before its expiration date, the Company is obligated to pay to Vision Pharmaceutica SA the greater of $10,000,000 or 10 times the gross fee to be earned by to Vision Pharmaceutica SA for the remaining term of the contract, calculated on a present value. | |
Minimum [Member] | ||
Consulting fees amortized period | 12 months | |
Maximum [Member] | ||
Consulting fees amortized period | 24 months | |
Common Stock [Member] | ||
Number of common stock issued for services | 16,988,640 | 28,995,460 |
Amortization of prepaid services |
Income Taxes - Results of Ope_3
Income Taxes - Results of Operations (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | ||
Income tax examination, description | The impact of U.S. Tax Reform primarily represents the Company's estimates of revaluing the Company's U.S. deferred tax assets and liabilities based on the rates at which they are expected to be recognized in the future. For U.S. federal purposes the corporate statutory income tax rate was reduced from 35% to 21% | |
Percentage of statutory income tax rate | 21.00% | 34.00% |
Lower corporate tax rate | 21.00% | |
Effective tax rate | 0.00% | 0.00% |
Operating loss carryforwards | $ 93,206,000 | |
Operating loss carryforwards expire term | Expire in 2032-2037 |
Income Taxes - Results of Ope_4
Income Taxes - Results of Operations - Schedule of Deferred Tax Assets (Details) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Income Tax Disclosure [Abstract] | ||
Net operating losses | $ 19,671,000 | $ 18,102,000 |
Stock based compensation | 39,256,000 | 39,054,000 |
Amortization, depreciation, and impairment | 4,178,000 | 4,178,000 |
Capitalization of start-up costs for tax purposes | 1,145,000 | 1,145,000 |
Gain/(loss) on conversion of debt | 713,000 | 569,000 |
Total deferred tax assets | 64,963,000 | 63,048,000 |
Valuation allowance | (64,963,000) | (63,048,000) |
Total deferred tax assets, net |
Income Taxes - Results of Ope_5
Income Taxes - Results of Operations - Schedule of Income Taxes Net Operating Loss (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | ||
Benefits for income tax at federal statutory rate | $ 1,811,000 | $ 1,666,000 |
Change in valuation allowance | (2,000) | 36,334,000 |
Permanent differences | ||
Change in estimates | (1,809,000) | (38,000,000) |
Net operating loss | ||
Benefits for income tax at federal statutory rate, percent | 21.00% | 34.00% |
Change in valuation allowance, percent | 0.00% | 0.00% |
Permanent differences, percent | 0.00% | 0.00% |
Change in estimates, percent | 0.00% | 0.00% |
Effective income tax rate reconciliation, percent | 0.00% | 0.00% |
Licenses and Supply Agreements
Licenses and Supply Agreements (Details Narrative) - Cytocom Inc., [Member] | May 01, 2018 | Dec. 31, 2014 |
Royalty percentage | 5.00% | |
Maximum [Member] | ||
Royalty percentage | 5.00% | |
Minimum [Member] | ||
Royalty percentage | 1.00% |
Commitments and Contingencies (
Commitments and Contingencies (Details Narrative) - USD ($) | Apr. 18, 2018 | Oct. 31, 2013 | Dec. 31, 2018 | Dec. 31, 2017 |
Rental expense | $ 11,775 | $ 16,777 | ||
AHAR Pharma [Member] | ||||
Distribution agreement, description | In October 2018, the Company shipped 250,000 pills to Fidson to support the product launch in the coming months. | 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. |
Related Party Transactions (Det
Related Party Transactions (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Notes payable | $ 506,024 | |
Value of common stock issued for services | $ 545,828 | $ 435,996 |
Two Notes Payable [Member] | Raster Investments, Inc [Member] | ||
Notes payable | 210,000 | |
Robert Wilson [Member] | ||
Compensation paid | $ 100,000 | |
Number of stock options issued | 500,000 | |
Number of stock options issued value | $ 24,998 | |
Kelly O'Brien Wilson [Member] | ||
Compensation paid | $ 136,158 | |
Number of stock options issued | 1,200,000 | |
Number of stock options issued value | $ 59,995 | |
Peter Aronstam [Member] | ||
Compensation paid | 70,000 | |
Edward Teraskiewicz [Member] | Two Notes Payable [Member] | Raster Investments, Inc [Member] | ||
Notes payable | 150,000 | |
Repayment of other liabilities | $ 60,000 | |
Interest rate | 2.00% | |
Dr. Roscoe Moore [Member] | ||
Compensation paid | $ 1,500 | |
Number of common stock issued for services | 1,875,000 | |
Value of common stock issued for services | $ 37,500 |
Subsequent Events (Details Narr
Subsequent Events (Details Narrative) - USD ($) | Feb. 27, 2019 | Apr. 16, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Common stock, shares outstanding | 434,322,574 | 386,782,473 | ||
Proceeds from notes payable and equity | $ 859,470 | $ 1,608,440 | ||
Subsequent Event [Member] | ||||
Common stock, shares outstanding | 455,577,799 | |||
Proceeds from notes payable and equity | $ 85,000 | |||
Issuance of common stock for conversion of debt | 231,478 | 18,255,739 | ||
Interest rate | 6.00% | |||
Debt maturity date | Feb. 27, 2020 |
Subsequent Events - Schedule of
Subsequent Events - Schedule of Number of Shares Issued (Details) - Subsequent Event [Member] - shares | Feb. 27, 2019 | Apr. 16, 2019 |
Issuance of common stock to employees and consultants | 3,000,000 | |
Issuance of common stock for conversion of debt | 231,478 | 18,255,739 |