Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2017 | Aug. 14, 2017 | |
Document And Entity Information | ||
Entity Registrant Name | Immune Therapeutics, Inc. | |
Entity Central Index Key | 1,559,356 | |
Document Type | 10-Q | |
Document Period End Date | Jun. 30, 2017 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Smaller Reporting Company | |
Entity Common Stock, Shares Outstanding | 335,538,005 | |
Trading Symbol | IMUN | |
Document Fiscal Period Focus | Q2 | |
Document Fiscal Year Focus | 2,017 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) | Jun. 30, 2017 | Dec. 31, 2016 |
Current Assets: | ||
Cash and cash equivalents | $ 44,987 | $ 74,389 |
Total current assets | 44,987 | 74,389 |
Fixed Assets: | ||
Computer equipment, net of accumulated depreciation of $8,176 and $7,888 respectively | 3,067 | 1,850 |
Deposits | 200 | 200 |
Total assets | 48,254 | 76,439 |
Current Liabilities: | ||
Accounts payable | 1,794,948 | 1,818,605 |
Accrued liabilities | 1,799,387 | 3,156,759 |
Notes payable, net of debt discount | 4,311,366 | 4,225,419 |
Total current liabilities | 7,905,701 | 9,200,783 |
Total liabilities | 7,905,701 | 9,200,783 |
Stockholders' Deficit: | ||
Common stock - par value $0.0001; 500,000,000 shares authorized; 332,689,818 and 250,428,133 shares issued and outstanding respectively | 33,269 | 25,043 |
Additional paid in capital | 364,754,705 | 360,420,026 |
Stock issuances due | 617,884 | 962,429 |
Prepaid services | (996,665) | (822,500) |
Accumulated deficit | (368,008,192) | (365,718,976) |
Deficit attributable to common stockholders | (3,598,999) | (5,133,978) |
Non-controlling interest | (4,258,448) | (3,990,366) |
Total stockholders' deficit | (7,857,447) | (9,124,344) |
Total liabilities and stockholders' deficit | $ 48,254 | $ 76,439 |
Condensed Consolidated Balance3
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - USD ($) | Jun. 30, 2017 | Dec. 31, 2016 |
Statement of Financial Position [Abstract] | ||
Accumulated depreciation | $ 8,176 | $ 7,888 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 500,000,000 | 500,000,000 |
Common stock, shares issued | 332,689,818 | 250,428,133 |
Common stock, shares outstanding | 332,689,818 | 250,428,133 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Income Statement [Abstract] | ||||
Revenues, net | $ 3,463 | |||
Operating expenses | ||||
Selling, general and administrative | 555,782 | 893,917 | 1,221,873 | 1,833,258 |
Research and development expense | 134,115 | 67,262 | 252,770 | 48,420 |
Stock issued for services G&A | 360,001 | 1,194,761 | 1,091,290 | 3,178,598 |
Warrant valuation | 317,898 | 490,355 | 317,898 | 2,568,554 |
Depreciation and amortization expense | 144 | 434 | 288 | 981 |
Total operating expenses | 1,367,940 | 2,646,729 | 2,884,119 | 7,629,811 |
Loss from operations | (1,367,940) | (2,646,729) | (2,884,119) | (7,626,348) |
Other income (expense): | ||||
Interest expense | (128,082) | (1,051,576) | (703,911) | (1,353,020) |
Gain/(Loss) on settlement of debt | 1,644,657 | (340,343) | 1,030,732 | (1,704,683) |
Total other income (expense) | 1,516,575 | (1,391,919) | 326,821 | (3,057,703) |
Net income/(loss) before income taxes | 148,635 | (4,038,648) | (2,557,298) | (10,684,051) |
Income taxes | ||||
Net income/(loss | 148,635 | (4,038,648) | (2,557,298) | (10,684,051) |
Net income/(loss) attributable to non-controlling interest | (131,519) | (109,929) | (268,082) | (154,049) |
Net income/(loss) attributable to common shareholders | $ 280,154 | $ (3,928,719) | $ (2,289,216) | $ (10,530,002) |
Basic and diluted loss per share attributable to common shareholders | $ 0 | $ (0.02) | $ (0.01) | $ (0.05) |
Weighted average number of shares outstanding | 313,578,281 | 207,229,469 | 281,886,367 | 199,076,428 |
Condensed Consolidated Stateme5
Condensed Consolidated Statements of Stockholders' Deficit (Unaudited) - 6 months ended Jun. 30, 2017 - 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 | $ 2,555 | 1,757,446 | (494,545) | (1,060,000) | $ 205,456 | ||
Issuance of common stock for prepaid services, shares | 25,545,460 | 25,545,460 | |||||
Amortization of prepaid services | 885,835 | $ 885,835 | |||||
Issuance of common stock for accrued interest | $ 300 | 161,700 | 162,000 | ||||
Issuance of common stock for accrued interest,shares | 3,000,000 | ||||||
Issuance of common stock in exchange for debt | $ 3,779 | 1,749,227 | 1,753,006 | ||||
Issuance of common stock in exchange for debt, shares | 37,793,111 | ||||||
Issuance of common stock for sale and exercise of warrants | $ 1,592 | 348,408 | 150,000 | 500,000 | |||
Issuance of common stock for sale and exercise of warrants, shares | 15,923,114 | ||||||
Issuance and modification of common stock warrants | 317,898 | 317,898 | |||||
Net loss | (2,289,216) | (268,082) | (2,557,298) | ||||
Balance at Jun. 30, 2017 | $ 33,269 | $ 364,754,705 | $ 617,884 | $ (996,665) | $ (368,008,192) | $ (4,258,448) | $ (7,857,447) |
Balance, shares at Jun. 30, 2017 | 332,689,818 |
Condensed Consolidated Stateme6
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 6 Months Ended | |
Jun. 30, 2017 | Jun. 30, 2016 | |
CASH FLOWS FROM OPERATING ACTIVITIES | ||
Net loss | $ (2,557,298) | $ (10,684,051) |
Adjustments to reconcile net loss to net cash flows used in operating activities: | ||
Depreciation | 288 | 981 |
Stock issued, and amortization of stock issued, for prepaid services | 885,835 | 1,539,928 |
(Gain)/ loss on settlement of debt | (1,030,732) | 1,704,683 |
Stock issued for services | 523,354 | 1,661,169 |
Amortization of debt discount | 60,347 | 385,288 |
Stock warrant expense | 2,568,554 | |
Stock issued for interest | 149,000 | |
Changes in operating assets and liabilities: | ||
Accounts payable | 239,789 | 104,131 |
Accounts receivable | 13,536 | |
Accrued liabilities | 647,366 | 1,168,324 |
Prepaid expenses and deposits | (11,272) | |
Net cash used in operating activities | (1,231,051) | (1,399,729) |
CASH FLOWS FROM INVESTING ACTIVITIES | ||
Purchase of computer equipment | (1,505) | |
Net cash used in investing activities | (1,505) | |
CASH FLOWS FROM FINANCING ACTIVITIES | ||
Proceeds from sale of stock and exercise of warrants | 500,000 | 50,000 |
Payment of notes payable | (321,846) | |
Proceeds from issuance of notes payable | 1,025,000 | 1,390,869 |
Net cash provided by financing activities | 1,203,154 | 1,440,869 |
Net increase (decrease) in cash | (29,402) | 41,140 |
Cash and cash equivalents at beginning of period | 74,389 | 23,149 |
Cash and cash equivalents at end of period | 44,987 | 64,289 |
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION: | ||
Cash paid for interest | 9,000 | 10,137 |
SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING AND FINANCING ACTIVITIES: | ||
Debt discount | 50,000 | |
Conversion of debt and accrued interest to common stock | 2,906,000 | 3,064,259 |
Shares issued for accounts payable and accrued expenses | 254,738 | |
Cashless exercise of warrants | 260 | |
Estimated gain/(loss) on debt conversion | 215,000 | |
Accounts payable paid directly by lender | 263,446 | |
Settlement paid by lender | $ 150,000 |
Organization and Description of
Organization and Description of Business | 6 Months Ended |
Jun. 30, 2017 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Description of Business | 1. Organization and Description of Business Immune Therapeutics, Inc. (the “Company”) 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 operates out of 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”). The Company’s therapies are believed to stimulate and/or regulate the immune system in such a way that they provide the potential to treat a variety of diseases. We believe our therapies may be able to correct abnormalities or deficiencies in the immune system in diseases such as HIV infection, autoimmune disease, immune disorders, or cancer; all of which can lead to disease progression and life-threatening situations when the immune system is not functioning optimally. 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 determine whether or not to apply to obtain EMA benefits once funding becomes available. In December 2013, the Company formed a new subsidiary, Cytocom Inc., to focus on conducting LDN and MENK clinical trials in the United States. In December 2014, the Company finalized the distribution of common stock of Cytocom Inc. to its shareholders. As part of the transaction, the Company retained exclusive rights to all international patents, in-country approvals, formulations, trademarks, manufacturing, marketing, sales, and distributions rights in emerging nations, including Africa, Central America, South America, Russia, India, China, Far East, and The Commonwealth of Independent States (former Soviet Union). The Company will continue to have access to existing clinical data as well as any new data generated by Cytocom Inc. during drug development. On December 8, 2014, the number of Cytocom Inc. shares of common stock that were issued to our shareholders totaled 113,242,522 shares. In connection with the transaction, Cytocom Inc. issued 140,100,000 shares of its common stock to the Company, which gave the Company a 55.3% stake in Cytocom Inc. on that date. In April 2016, the Board of Directors and a majority of shareholders of Cytocom approved a reverse stock split of Cytocom’s outstanding common stock with one new share of stock for each twenty old shares of common stock. Cytocom effectuated and finalized the reverse split in June 2016. At June 30, 2017, the Company’s equity interest had been further reduced to 12.8%, by subsequent issuances of Cytocom common stock to shareholders in settlement of notes payable. In March 2014, the Company incorporated Airmed Biopharma Limited, an Irish corporation with an address in Dublin, Ireland, and Airmed Holdings Limited, an Irish company domiciled in Bermuda. The Irish companies were set up to benefit from incentives granted by the Irish government for the establishment of pharmaceutical companies (many of the world’s leading pharmaceutical companies have located in Ireland), and so that the Company could take advantage of Ireland’s status as a member of the European Union and the European Economic Area. An Irish limited liability company enjoys a low corporate income tax rate of 12.5%, one of the lowest in the world. The Irish-domiciled company hopes to qualify for tax incentives for Irish holding/headquartered companies and to benefit from the network of double tax treaties that reduce withholding taxes. TNI BioTech International, Ltd. will manage our international distribution, using product that is manufactured in Ireland and elsewhere. Today, Immune Therapeutics is focused on the commercialization of affordable non-toxic immunotherapies focused on the activation and rebalancing of the body’s immune system. We believe that stimulating the body’s immune system remains one of the most promising approaches in the treatment of Cancers, HIV, Autoimmune Diseases, inflammatory conditions and other opportunistic infections for chronic often life-threatening diseases through the mobilization of the body’s immune system in Emerging Nations using existing clinical data. Cytocom Inc, is a clinical-stage pharmaceutical company focused on the development of the first affordable non-toxic immunodulator for the treatment of inflammatory diseases, immune-related disorders, and cancer and is responsible for the development of our patented therapies with the FDA and EMA. As of this date, neither we nor our collaboration partners are permitted to market our drug candidates in the United States until we receive approval of a New Drug Application from the FDA. Neither we nor our collaboration partners have submitted an application for or received marketing approval for any of our drug candidates. Obtaining approval of an NDA can be a lengthy, expensive and uncertain process. Going Concern The Company experienced a net loss from operations of $2,557,298, and used cash and cash equivalents for operations in the amount of $1,231,051 during the six months ended June 30, 2017, resulting in stockholder’s deficit of $7,857,447 at that date. 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 the sale of products, additional private or public debt or equity offerings, and it may also seek additional capital through arrangements with strategic partners or from other sources. Based on the Company’s operating plan, existing working capital at June 30, 2017 was not sufficient to meet the cash requirements to fund planned operations through June 30, 2018 without additional sources of cash. These conditions raise substantial doubt about the Company’s ability to continue as a going concern. The accompanying consolidated 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. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2017 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The consolidated financial statements included herein have been prepared by the Company, without audit, pursuant to the rules and regulations of the Securities and Exchange Commission. Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. generally accepted accounting principles have been omitted. However, in the opinion of management, all adjustments (which include only normal recurring adjustments, unless otherwise indicated) necessary to present fairly the financial position and results of operations for the periods presented have been made. The results for interim periods are not necessarily indicative of trends or of results to be expected for the full year. These financial statements should be read in conjunction with the financial statements of the Company for the year ended December 31, 2016 (including the notes thereto) set forth in Form 10-K. The Company qualifies as an “emerging growth company” as defined in Section 101 of the Jumpstart our Business Startups Act (“JOBS Act”) as we do not have more than $1,000,000,000 in annual gross revenue for the year ended December 31, 2016. We are electing to use the extended transition period for complying with new or revised accounting standards under Section 102(b)(1) of the JOBS Act. Revenue Recognition 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. In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606). This standard provides a single set of guidelines for revenue recognition to be used across all industries and requires additional disclosures. It is effective for annual and interim reporting periods beginning after December 15, 2017. This standard permits early adoption and permits the use of either the retrospective or cumulative effect transition method. We are currently evaluating the potential impact of this standard on our financial position and results of operations, as well as our selected transition method. Based on our preliminary assessment, we believe the new standard will not have a material impact on our financial position and results of operations, as we do not expect to change the manner or timing of recognizing revenue on a majority of our revenue transactions once we commence revenue-generating activities. 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). This standard will be effective for our interim and annual periods beginning January 1, 2019, and must be applied 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. We are currently evaluating the timing of adoption and the potential impact of this standard on our financial position, but we do not expect it to have a material impact on our results of operations. 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 June 30, 2017, the Company has no cash balances in excess of insured limits. Segment and Geographic Information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one operating segment and does not segment the business for internal reporting or decision making. Fair Value of Financial Instruments In accordance with the reporting requirements of Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) Topic 825, “ Financial Instruments” Fair Value Measurements The ASC Topic 820, Fair Value Measurement, Fixed Assets Fixed assets are stated at cost, less accumulated depreciation. Depreciation is determined on a straight-line basis over the estimated useful lives of the assets, which generally range from three to five years. Maintenance and repairs are charged against expense as incurred. Depreciation expense for the three months ended June 30, 2017 and June 30, 2016 was $144 and $434, 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 June 30, 2017 and 2016, 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 June 30, 2017, and 2016, the Company has not accrued any interest or penalties related to uncertain tax positions. Stock-Based Compensation and Issuance of Stock for Non-Cash Consideration The Company measures and recognizes compensation expense for all share-based payment awards made to employees and directors, including employee stock options, based on estimated fair values equaling either the market value of the shares issued or the value of consideration received, whichever is more readily determinable. The majority of the non-cash consideration pertains to services rendered by consultants and others and has been valued at the fair value of the Company’s common stock at the date of the agreement. The Company’s accounting policy for equity instruments issued to consultants and vendors in exchange for goods and services follows the provisions of ASC Topic 505-50, “ Equity-Based Payments to Non-Employees Non-controlling Interest In accordance with ASC Topic 810, Consolidation Net Income (Loss) per Share Basic net income (loss) per share (“EPS”) is calculated in accordance with Accounting Standards Codification (“ASC”) 260, “Earnings Per Share.” Basic net income or 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. Dilutive common stock equivalents are comprised of common stock purchase warrants outstanding. A calculation of basic net income (loss) per share follows: For the three months ended June 30, For the six months ended June 30, 2017 2016 2017 2016 Net Profit/(Loss) $ 148,635 $ (4,038,648) $ (2,557,298) $ (10,684,051) Weighted-average common shares outstanding Basic: 304,232,895 207,229,469 281,886,367 199,076,428 Weighted-average common stock Equivalents Stock options - - - - Warrants 9,345,386 - - - Convertible notes - - - - Weighted-average common shares outstanding Diluted 313,578,281 207,229,469 281,886.367 199,076,428 Profit/(Loss) per share outstanding Basic and diluted $ 0.00 $ (0.02 ) $ (0.01 ) $ (0.05 ) The Company’s potential dilutive securities, which include 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. The following shares of potentially dilutive securities have been excluded from the computations of diluted weighted average shares outstanding: As of June 30, 2017 2016 Warrants to purchase Common stock 44,619,000 32,748,908 44,619,000 32,748,908 Recent Accounting Standards During the quarter ended June 30, 2017, there were several new accounting pronouncements issued by the Financial Accounting Standards Board. Each of these pronouncements, as applicable, has been or will be adopted by the Company. Management does not believe the adoption of any of these accounting pronouncements has had or will have a material impact on the Company’s consolidated financial statements. In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606). This standard provides a single set of guidelines for revenue recognition to be used across all industries and requires additional disclosures. It is effective for annual and interim reporting periods beginning after December 15, 2017. This standard permits early adoption and permits the use of either the retrospective or cumulative effect transition method. We are currently evaluating the potential impact of this standard on our financial position and results of operations, as well as our selected transition method. Based on our preliminary assessment, we believe the new standard will not have a material impact on our financial position and results of operations, as we do not expect to change the manner or timing of recognizing revenue on a majority of our revenue transactions. 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). This standard will be effective for our interim and annual periods beginning January 1, 2019, and must be applied 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. We are currently evaluating the timing of adoption and the potential impact of this standard on our financial position, but we do not expect it to have a material impact on our results of operations. |
Fixed Assets
Fixed Assets | 6 Months Ended |
Jun. 30, 2017 | |
Fixed Assets: | |
Fixed Assets | 3. Fixed Assets June 30, 2017 December 31, 2016 Fixed Assets: Computer equipment $ 11,243 $ 9,738 Less accumulated depreciation (8,176 ) (7,888 ) Property and equipment, net $ 3,067 $ 1,850 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 | 6 Months Ended |
Jun. 30, 2017 | |
Payables and Accruals [Abstract] | |
Accrued Liabilities | 4. Accrued Liabilities Accrued expenses and other liabilities consist of the following: June 30, 2017 December 31, 2016 Accrued payroll to officers and others $ 1,169,883 $ 1,126,261 Accrued interest and penalties - notes payable 517,467 1,902,018 Estimated legal settlement 111,644 128,087 Other accrued liabilities 393 393 Total accrued expenses and other liabilities $ 1,799,387 $ 3,156,759 |
Notes Payable
Notes Payable | 6 Months Ended |
Jun. 30, 2017 | |
Debt Disclosure [Abstract] | |
Notes Payable | 5. Notes Payable Notes payable consist of the following: June 30, 2017 December 31, 2016 Promissory note issued July 29, 2014 to Ira Gaines. In 2016, the maturity date on the note was extended to December 1, 2017. The note earns interest at a rate of 18% per annum. $ 100,000 $ 100,000 Promissory notes issued between November 26, 2014 and September 30, 2015, to raise up to $2,000,000 in debt. Lenders earn interest at a rate of 10% per annum, plus a pro-rata share of two percent of the Company’s gross receipts for sales of IRT-103-LDN in perpetuity. Notes will be repaid in 36 monthly installments of principal and interest commencing no later than October 15, 2015. Notes aggregating $286,000 were in default at June 30, 2017, as the Company was unable to pay installments on those notes on their due dates. No demands for repayment have been made by the lenders. 286,000 286,000 Promissory notes issued between May 1, 2015 and December 31, 2016, and maturing between June 14, 2015 and September 30, 2017. Lenders on loans aggregating $505,994 earn interest at rates between 2% and 18% per annum. On loans aggregating $198,500, interest is payable in a fixed amount not tied to a specific interest rate. Notes aggregating $555,494 were in default at June 30, 2017, as the Company was unable to repay those notes on their due dates. No demands for repayment have been made by the lenders. 704,494 704,494 Promissory notes issued by Cytocom Inc. between April 29, 2015 and December 31, 2015. Lenders earn interest at rates between 5% and 10% per annum. These notes mature on September 30, 2016. At June 30, 2017, the notes were in default, although no demand for repayment has been made by the lenders. 425,000 425,000 Promissory note issued in December 2015. The lender earns interest at a rate of 10% per month. The note is repayable on March 9, 2016. At June 30, 2017, the note was in default, although no demand for repayment has been made by the lender. On April 3, 2017, the Company settled the obligation. - 100,000 Promissory notes issued between May 5, 2016 and June 2, 2016 that mature between October 1, 2016 and January 31, 2017, and include stock conversion features, warrants and original issue debt discounts. The notes were repaid or converted into stock in the quarter ended June 30, 2017. - 554,882 Promissory notes issued to an officer of the Company effective November 3, 2015 and maturing November 3, 2016 for settlement of accrued payroll, bearing interest at 10% per annum and including a stock conversion feature. The Company was unable to repay the note at maturity and the note is in default. 102,737 112,737 Promissory note issued in July 2016. The note was repayable on October 5, 2016 but was extended to December 31, 2016. The note earns interest at 6% per month. The Company was unable to repay the note at maturity and the note is in default. 50,000 50,000 Promissory note issued in July 2016 with an original issuance discount of $30,000. Net proceeds were $150,000. The note is repayable on April 7, 2017. $66,000 of the note was converted to stock. The Company was unable to repay the note at maturity and the note is in default. 114,000 180,000 Promissory notes issued in August 2016 for $149,854 as a settlement of amounts owed to a law firm. The notes accrue interest at 5% per annum and are payable in 18 equal monthly installments of $8,641.88. The note was in default on June 30, 2017. 69,135 120,987 Promissory notes issued between July 1, 2016 and December 31, 2016. Lenders earn interest at 2% per annum. The notes mature on September 30, 2017. 256,000 256,000 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. 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 June 30, 2018. 500,000 - Promissory note issued January 25, 2017. The lenders earn interest at 7% per month. The note matures on July 5, 2017. 50,000 - Notes aggregating $300,000 issued in the second quarter of 2017. The notes accrue interest at 2% per annum and mature between January 12, 2018 and June 30, 2018. 300,000 - Less: Original issue discounts on notes payable and warrants issued with notes. - (18,681 ) Total $ 4,311,366 $ 4,225,419 As of June 30, 2017, the Company had accrued $517,467 in unpaid interest and default penalties. During the quarter ended June 30, 2017, 20,282,473 shares with a fair value of $874,024 were issued by the Company for settlement of promissory notes. |
Capital Structure - Common Stoc
Capital Structure - Common Stock and Common Stock Purchase Warrants | 6 Months Ended |
Jun. 30, 2017 | |
Equity [Abstract] | |
Capital Structure - Common Stock and Common Stock Purchase Warrants | 6. Capital Structure—Common Stock and Common Stock Purchase Warrants Each holder of common stock is entitled to vote on all matters and is entitled to one vote for each share held. No holder of shares of stock of any class shall be entitled as a matter of right to subscribe for or purchase or receive any part of any new or additional issue of shares of stock of any class, or of securities convertible into shares of stock or any class, whether now hereafter authorized or whether issued for money, for consideration other than money, or by way of dividend. As of June 30, 2017 and 2016, the Company was authorized to issue 500,000,000 common shares at a par value of $0.0001 per share. As of June 30, 2017, the Company had 332,689,818 shares of common stock outstanding, and 250,428,133 outstanding as of December 31, 2016. Stock Warrants In the quarter ended June 30, 2017, there were 14,750,000 new warrants issued by the Company. There were no modifications of the terms of any warrants issued by the Company in the quarters ended June 30, 2017. In the quarter ended June 30, 2016, the Company extended to December 31, 2018 the maturity dates on 5,006,666 existing warrants that were originally issued with expiration dates between July 25, 2016 to December 17, 2018. These warrants were originally issued with 3 to 5 year terms, with exercise prices ranging between $0.75 and $1.00. Following is a summary of outstanding stock warrants at June 30, 2017 and activity during the six months then ended: 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 14,750,000 $ 0.05-0.20 $ 0.08 Expired and forfeited in 2017 - $ - $ - Exercised in 2017 5,600,000 $ - $ - Warrants as of June 30, 2017 68,341,904 $ 0.03-15.00 $ 0.31 Summary of outstanding warrants as of June 30, 2017: Expiration Date Number of Shares Exercise Price Remaining Life (years) Fourth Quarter 2017 350,000 $ 1.50-9.00 0.25 First Quarter 2018 127,500 $ 15.00 0.50 Second Quarter 2018 33,334 $ 15.00 0.75 Third Quarter 2018 250,000 $ 1.50 1.00 Fourth Quarter 2018 6,089,166 $ 1.00-1.50 1.25 First Quarter 2019 4,024,000 $ 0.50-2.00 1.50 Second Quarter 2019 135,000 $ 0.07-0.23 1.75 Third Quarter 2019 260,000 $ 0.50-1.50 2.00 Fourth Quarter 2019 400,000 $ 0.14 2.25 Second Quarter 2020 300,000 $ 0.50 2.75 Fourth Quarter 2020 1,000,000 $ 0.20 3.25 First Quarter 2021 12,600,000 $ 0.20 3.50 Second Quarter 2021 21,206,237 $ 0.03-0.20 3.75 Third Quarter 2021 6,816,667 $ 0.03-0.20 4.00 Second Quarter 2022 3,250,000 $ 0.20 4.75 Second Quarter 2032 11,500,000 $ 0.05 14.75 |
Stock Compensation
Stock Compensation | 6 Months Ended |
Jun. 30, 2017 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock Compensation | 7. Stock Compensation Shares Issued for Services During the six months ended June 30, 2017 and 2016, the Company issued 25,545,460 and 23,643,000 shares of common stock respectively for consulting fees. The Company valued these shares at $1,265,456 and $4,543,170 respectively, 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 $885,835 and $1,539,928 for the six months ended June 30, 2017 and 2016. |
Income Taxes - Results of Opera
Income Taxes - Results of Operations | 6 Months Ended |
Jun. 30, 2017 | |
Income Tax Disclosure [Abstract] | |
Income Taxes - Results of Operations | 8. Income Taxes - Results of Operations The Company considers the likelihood of changes by tax authorities in its filed income tax returns and recognizes a liability for or discloses potential significant changes that management believes are more likely than not to occur upon examination by tax authorities. Management has not identified any uncertain tax positions in income tax returns filed that require recognition or disclosure in the accompanying financial statements. The Company’s income tax returns for the past three years are subject to examination by tax authorities, and may change upon examination. For financial reporting purposes, for the six months ending June 30, 2017 and 2016, income before income taxes includes the following components: June 30, 2017 June 30, 2016 United States $ (2,557,298 ) $ (10,684,051 ) Foreign - - Total $ (2,557,298 ) $ (10,684,051 ) The expense (benefit) for income taxes consist of: 2017 2016 Current: Federal $ - $ - State $ - $ - Foreign $ - $ - Total $ - $ - Deferred and other: Federal $ - $ - State $ - $ - Foreign $ - $ - $ - $ - Total tax expense $ - $ - The Company has recognized no tax benefit for the losses generated for the periods through December 31, 2016. ASC Topic 740 requires that a valuation allowance be provided if it is more likely than not that some portion or all of a deferred tax asset will not be realized. The Company’s ability to realize the benefit of its deferred tax asset will depend on the generation of future taxable income. Because the Company has yet to recognize revenue, we believe that the full valuation allowance should be provided. Our effective tax rate for fiscal years 2016 and 2015 was 0%. Our tax rate can be affected by recurring items, such as tax rates in foreign jurisdictions and the relative amount of income we earn in jurisdictions. It may also be affected by discrete items that may occur in any given year, but are not consistent from year to year. As of December 31, 2016, we had estimated federal and state income tax net operating loss (“NOL”) carry-forwards of approximately $79,900,000, which will expire in 2032-2035. |
Licenses and Supply Agreements
Licenses and Supply Agreements | 6 Months Ended |
Jun. 30, 2017 | |
Licenses And Supply Agreements | |
Licenses and Supply Agreements | 9. Licenses and Supply Agreements Patent and Subsidiary Acquisition The Company entered into a share exchange agreement on April 24, 2012 to acquire all of the outstanding shares of TNI BioTech IP, Inc. (“TNI IP”), a biotechnology firm incorporated in Florida and formed to acquire patents related to the treatment of cancer and HIV/AIDS and autoimmune diseases, using Met-enkephalin (“MENK”) and Naltrexone (“LDN”). The goal of TNI IP’s management was to enable mankind and civilization to combat fatal diseases by activating and mobilizing the body’s own immune system using TNI IP’s patented use of MENK. The first patents acquired by TNI IP were acquired from Dr. Nicholas P. Plotnikoff and Professor Fengping Shan in 2012. TNI IP was acquired in exchange for 20,250,000 shares of the Company’s common stock, of which 8,000,000 shares were issued to Dr. Plotnikoff for the acquisition of patents and the remaining 12,250,000 shares were issued to the founders of TNI IP in exchange for all of their right, title and interest in their TNI IP shares. The goodwill arising on the acquisition of TNI BioTech IP, Inc. was valued at $98,000,000 and license agreements arising from the acquisition of TNI IP were valued at $16,006,000. In connection with the share exchange, we entered into a Sale of Technology Agreement with Dr. Nicholas P. Plotnikoff on March 4, 2012, wherein Dr. Plotnikoff agreed to transfer and assign all of his rights, title and interest in: European Patent United Kingdom, Germany, France, Ireland EP 1401471 BI Methods for inducing sustained immune response; Russian Patent Russian Federation patent number 2313364; The Patent Office of the People’s Republic of China, Application No.: 200810165784.8 China Patent CN1015113407 A The Patent Office of the People’s Republic of China ISSN: 1006-2858 CN 21-1349/R; Patent Agencies Government of India Patent, Application number 1627/KOLNP/2003 number 220265 an Enkephalin Peptide Composition; and the US Patent Pending, US Patent Application 10/146.999 e. The Company received all the production formulations and technology designs from Dr. Plotnikoff necessary for the manufacturing, formulation, production and protocols of the MENK treatment of cancer and HIV/AIDS. As consideration for entering into the Sale of Technology Agreement, Dr. Plotnikoff received 8,000,000 shares of common stock, a royalty of a single-digit percentage on all sales of MENK and was granted the position of Non-Executive Chairman of the Board of Directors. At the time of the acquisition, the valuation of goodwill and other intangible assets were determined using the fair market price for the Company’s common stock, which were exchanged for shares of TNI IP. In the fourth quarter of 2012, the Company performed an annual valuation to determine whether any goodwill or intangible assets that had been acquired by the Company were impaired. The result of this valuation was that material impairments were identified. The Company recognized an impairment of the goodwill arising on the acquisition of TNI IP of $98,000,000. Patent License Agreements On August 13, 2012, the Company signed an exclusive License Agreement with Ms. Jacqueline Young (the “Young Agreement”) for the intellectual property developed by Dr. Bernard Bihari relating to treatments with opioid antagonists such as naltrexone and Met-enkephalin for a variety of diseases and conditions including malignant lymphoma, chronic lymphocytic leukemia, Hodgkin’s lymphoma, and non-Hodgkin’s lymphoma, chronic herpes virus infections, chronic herpes viral infections such as chronic genital herpes caused by the herpes simplex virus Type 2 and chronic infections due to the Epstein-Barr virus and a treatment method for humans infected with HTLV-III (AIDS) virus, including patients clinically diagnosed as suffering from AIDS and those suffering from AIDS-related complex (ARC). The Bihari patents were acquired in exchange for 540,000 shares of the Company’s common stock with a fair value of $972,000 and assumed liabilities of $400,000, which is payable to Ms. Young over a twenty-four month period in equal installments to reimburse her for the costs of a New York City office in accordance with the Young Agreement. The patent liability at December 31, 2013 totaled $118,333. The cost of the patent totaled $1,372,000. Additionally, the Company will pay the licensor a royalty payment of 1% of gross MENK sales and provide the licensor a position as non-executive chairman of the Company. The Young Agreement is valid for the life of the patents and expires on a country by country basis in each country where patent rights exist, upon the expiration of the last to expire patent in each country or in the event the patent in such country is held to be invalid and/or unenforceable (by a court or government body of competent jurisdiction) or admitted to be invalid or unenforceable. Additionally, we can cancel the Young Agreement upon 120 days’ written notice and shall pay all royalties and fees that have accrued under the Young Agreement. We have the exclusive rights to the intellectual property; however, Ms. Young retains a right to practice the patents licensed under the Young Agreement solely for noncommercial, academic research purposes. On December 24, 2012, the Company signed an agreement for the acquisition of patent rights (the “Smith Agreement”) for the intellectual property of Dr. Jill Smith and LDN Research Group, LLC (collectively, the “Licensor Parties”), whose members are Dr. Ian S. Zagon, Dr. Patricia J. McLaughlin and Moshe Rogosnitzky and orphan drug designation by the FDA to a novel late-stage drug, trademarked “LDN,” for the treatment of Pediatric Crohn’s disease. The patent covers methods and formulations for treatment of the inflammatory and ulcerative diseases of the bowel, using naltrexone in low doses as an opioid antagonist. These patents were acquired in exchange for 300,000 shares of our common stock with a fair value of $2,715,000 and payment of $165,384 (consisting of a $100,000 initial license fee and payment of $65,384 of expenses), which totaled $2,880,384. The Smith Agreement requires the Company to (i) use commercially reasonable efforts to develop, commercialize, market and sell licensed products in a manner consistent with a business plan, (ii) expend a minimum amount of funds per annum to develop and commercialize licensed products as soon as practicable, (iii) obtain all requisite regulatory approvals needed to use or sell licensed products in the field of use, and (iv) make the first commercial sale of a licensed product by March of 2017. As of June 30, 2017, the Company had not made a commercial sale of licensed product. Under the Smith Agreement, if the licensors determine that the Company has not fulfilled its obligations, they may furnish the Company with written notice of such determination, in which case the Company must either fulfill the obligation or negotiate a mutually acceptable revised commitment. As of the date of the filing of this Form 10-Q, the licensors had not provided any such notice of determination under the agreement. The Company is required to pay an annual license fee, an annual running royalty on net sales of each licensed product or a minimum royalty, whichever is greater, and a sublicense fee on payments received by the Company from sublicensees. The Company has an exclusive, worldwide license to make, have made, use, lease, import, offer for sale and sell licensed products and to use the method under the patent rights. The Smith Agreement will terminate on the expiration or abandonment of the last patent to expire or ten years after the sale of the first licensed product. The Company may terminate the Smith Agreement upon 90 days’ written notice, provided all sublicenses are terminated and all amounts due and owing are paid to the Licensor Parties. The Licensor Parties may terminate the agreement ten days’ after notice to the Company if the Company is ten days late in payment or there is a breach that remains uncured for ten days after written notice of such breach. The Company is also required to pay milestone payments after substantial achievement of certain milestone events for each licensed product including payment: upon initiation of each Phase III trial; upon positive completion of each Phase III clinical trial of the therapeutic use of an LDN compound in the field of use; when a New Drug Application (“NDA”) is accepted for review by the FDA; and when FDA approval to market the NDA is approved. The Company will issue shares upon reaching certain milestones including upon the first dosing of the first patient in a Phase III clinical trial for each licensed product, upon the first sale of each licensed product, and upon the achievement of a set dollar amount in cumulative sales for each licensed product covered by NDAs. As part of the Smith Agreement, the Company has the right to apply to the FDA for the transfer of the orphan drug status for the use of naltrexone for the treatment of pediatric Crohn’s disease and ulcerative colitis, the Investigation New Drug Application (“IND”), and the right to acquire the relevant clinical data set from Dr. Jill Smith. Dr. Jill Smith made arrangements to transfer the IND to the Company as well as the relevant clinical data set, and the FDA has acknowledged that the Company is now the sponsor for this IND. On September 24, 2014, the Company and the Licensor Parties jointly agreed to terminate the Smith Agreement, and in place thereof, have the Licensor Parties grant a similar license in their patent rights to Cytocom Inc. pursuant to a Patent License Agreement between the Licensor Parties, Cytocom Inc. and the Company with substantially similar terms as set forth in the Smith Agreement. Pursuant to this agreement, the Company issued 1,000,000 shares of its common stock valued at $270,000, upon execution to the Licensor Parties and the Company guaranteed the obligations of Cytocom Inc. to the Licensor Parties under the agreement. On January 18, 2013, the Company signed an exclusive licensing agreement with The Penn State Research Foundation to license all of the intellectual property developed by Dr. Ian S. Zagon, Dr. Patricia J. McLaughlin and Dr. Jill P. Smith for the treatment of cancer titled “Opioid Growth Factor and Cancer” and “Combination Therapy with Opioid Growth Factor and Taxanes for the Treatment of Cancer” (the “Foundation Agreement”). The Foundation Agreement requires the Company to: (a) use commercially reasonable efforts to develop, commercialize, market and sell licensed products in a manner consistent with a business plan; (b) expend a minimum amount of funds per annum to develop and commercialize licensed products as soon as practicable; (c) obtain all requisite regulatory approvals needed to use or sell licensed products in the field of use; and (d) make the first commercial sale of a licensed product by December 31, 2016. As of June 30, 2017, the Company had not made a commercial sale of licensed product. Under the Foundation Agreement, if the licensor determines that the Company has not fulfilled its obligations, it may furnish the Company with written notice of such determination, in which case the Company must either fulfill the obligation or negotiate a mutually acceptable revised commitment. As of the date of the filing of this Form 10-Q, the licensor had not provided any such notice of determination under the agreement. The Foundation Agreement provides that the Company must pay to the licensor an initial license fee, a license maintenance fee on each anniversary of the effective date of the Foundation Agreement, and an annual running royalty on net sales for each licensed product or a minimum royalty, whichever is greater. In addition, the Company must pay a sublicense fee on payments received by the Company from sublicensees. The Foundation Agreement also requires the Company to make payments upon the achievement of certain milestone events including: initiation of each Phase II trial; initiation of each Phase III trial; when the NDA is accepted for review by the FDA; and when FDA approval to market is approved. The Company must also issue shares upon certain milestones including upon the first dosing of the first patient in a Phase II clinical trial for each licensed product, upon the first dosing of the first patient in a Phase III clinical trial for each licensed product, upon the first sale of each licensed product, and upon the achievement of a set dollar amount of cumulative sales for each licensed product covered by NDAs. The Foundation Agreement terminates on the expiration or abandonment of the last patent to expire or become abandoned. The Company may terminate the Foundation Agreement at any time upon 60 days’ prior written notice and ceasing to make and sell all licensed products, the termination of all sublicenses and payment of all monies owed under the Foundation Agreement. The licensor may terminate the agreement 30 days after notice to the Company if the Company is 30 days late in payment or a breach that remains uncured for 45 days after written notice of such breach. In May of 2013, the Company executed a Patent License Agreement with Professor Fengping Shan (the “Shan Agreement”) pursuant to which it obtained exclusive rights to develop and commercialize the licensed technology. The licensed technology is the intellectual property developed and owned by Professor Shan (i) relating to the treatment of a variety of diseases and conditions with MENK including multiple forms of lymphoma and cancer and (ii) a treatment method for humans infected with the HLTV-III (AIDS) virus including AIDS and AIDS related complex (ARC). The licensed technology includes the methods and formulations for these treatments including all INDs, communications with regulatory agencies, patient data, and letters relating to these treatments. The licensed technology also includes certain patents developed by Professor Shan. Under the Shan Agreement, the Company must issue 500,000 shares to Professor Shan upon final transfer of the licenses, and reimburse Professor Shan for all out of pocket expenses in connection with the patents. The Company will pay Professor Shan a running royalty on gross sales subject to decreases if third party intellectual property is needed to complete such sale or product. The Shan Agreement lasts for the duration of each of the licensed patents however the Company may terminate the Shan Agreement on 120 days’ written notice to Professor Shan. On August 6, 2014, Professor Fengping Shan executed an Assignment pursuant to which he transferred to the Company his entire right, title and interest in and to the licensed patents under the Shan Agreement and CN 201210302259 Application of combination of low-dose naltrexone and methionine-enkephalin to preparation of anti-cancer drug for the consideration of 500,000 shares of common stock valued at $140,000. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2017 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 10. Commitments and Contingencies Malawi Treatment Facilities On July 14, 2012, GB Oncology and Imaging Group LTD (“GBOIG”) in partnership with the Company signed a letter of intent agreement to collaborate with the Government of Malawi to assist in expanding the treatment of cancer, HIV/AIDS and other infectious diseases. In December of 2014, the Government of Malawi completed an oncology clinic at the Queen Elizabeth Central Hospital in Blantyre, Malawi for the treatment of cancer and infectious diseases. In 2015, the Company submitted protocols seeking permission from the College of Medicine Research and Ethics Committee of Malawi (“COMREC”) to conduct two trials involving Lodonal™ in Malawi: a. The first protocol, submitted jointly with The Jack Brewer Foundation (“JBF Worldwide”), received COMREC approval on November 11, 2015. The protocol covers a 12-month trial for a “Single Visit Approach to Cervical Cancer Prevention.” The approach is designed to deliver a preventive and simple procedure that can be performed in a clinical setting without the use of a laboratory and to allow for immediate treatment of any precancerous lesions utilizing Wallach LL100 Cryosurgical systems. The protocol provides for 50% of the patient group to be put on Lodonal™ to determine if the drug lowers the number of opportunistic infections during the year, and if it can be shown that Lodonal™ increases CD4, CE8, NK and T cell count, which would show that the incidence rates of opportunistic infection could decrease with Lodonal™ and that Lodonal™ could be used as a prophylaxis to prevent substantial HIV-related morbidity in Malawi. COMREC approved the trial in late 2016. Enrollment of study subjects began in late 2016, and the study commenced in January 2017. Due to the fact that enrollment to date in the study has been low, we now expect to reach the target sample size only by the end of the third quarter of 2017. The trial is ongoing with subjects recruited so far, but it cannot be completed until an acceptable sample subject size is reached. b. The second protocol, which has not yet been approved, covers a trial using Lodonal™ for the treatment of cancer. The Company has put this trial on hold as it may not be required now that the Company has received approval in Nigeria for in addition to the pending approval in Kenya and Senegal for Lodonal™ for the treatment of cancer. Distribution Agreements in Nigeria Effective November 9, 2012, the Company signed an exclusive Distribution Agreement with G-Ex Technologies/St. Maris Pharma and GB Pharma Holdings, LLC for the Federal Republic of Nigeria. The parties have been unable to perform under the agreement because a certificate of free sale was not obtained by the Company until November of 2013, and no extension has been granted. In October 2013, the Company announced the signing of a Distribution Agreement with AHAR Pharma, a Nigerian company, to market Lodonal™, in Nigeria for the treatment of autoimmune diseases and cancer. AHAR intends to distribute Lodonal™ through a local distributor network, an Internet client base and directly to hospitals, pharmacists and doctors in Nigeria. The agreement expires in December 2018. Under the agreement, the Company is obligated to provide delivery of an initial supply of between 1 million and 1.5 million doses of Lodonal™ product to cover AHAR Pharma’s first-year purchase commitment. In August 2015, the Company announced the signing of a letter of intent with GB Pharma/AHAR and Fidson Healthcare Plc., in terms of which Fidson will promote Lodonal TM TM In May 2017, the Company received approval from the National Agency for Food and Drug Administration and Control of Nigeria (“NAFDAC”) to market and distribute Lodonal TM Agreements in Kenya In March 2017, the Company signed a Memorandum of Understanding (“MOU”) for distribution of Lodonal™ in Kenya. The MOU is a three-way distribution agreement between the Company, Kenya-based Omaera Pharmaceuticals Limited, a leading Kenyan pharmaceutical importer and distributor, and GB Pharma Holdings. The MOU sets forth standard terms and conditions for distributing Lodonal™ in Kenya. In April 2017, the Company submitted a New Drug Application (“NDA”) to the Pharmacy and Poison Board (“PPB”) in Kenya for Lodonal TM Agreements with Hubei Qianjiang Pharmaceutical Company On October 18, 2012, the Company and Hubei Qianjiang Pharmaceutical Co., Ltd. (“Qianjiang Pharmaceutical”), signed a Venture Cooperation Agreement on New Drug Methionine Enkephalin (the “Venture Agreement”) pursuant to which Qianjiang Pharmaceutical acquired an exclusive license for the production of MENK in China. The Venture Agreement requires that Qianjiang Pharmaceutical conduct drug research and pilot testing for MENK, organize pre-clinical studies, and apply for clinical trials for MENK with the Chinese State Food and Drug Administration. Under the Venture Agreement, Qianjiang Pharmaceutical must open a co-administration account for the development of MENK in China. Qianjiang Pharmaceutical must pay the Company, upon the marketing of MENK products, a half-year amount equaling 6% of its gross sales from MENK of the preceding half year. The Company may cancel the Venture Agreement if Qianjiang Pharmaceutical does not pay expenses for a period exceeding six months or does not commence clinical trials within 12-months after receiving certain approvals. Qianjiang Pharmaceutical may cancel the Venture Agreement if the Company fails to perform its obligations for a period of six months or the failure to receive approval of clinical trials is due to the Company’s MENK technologies. The Venture Agreement was amended on February 24, 2013 to expand the clinical trials from pancreatic to both pancreatic and liver cancer and amended on March 6, 2014 to require Qianjiang Pharmaceutical to commence studies and clinical trials in China and place funds in the co-administration account. On August 6, 2014, the Company entered into a Supplementary Agreement on New Drug Methionine – Enkephalin Cooperation (the “Amendment”) with Qianjiang Pharmaceutical, amending the Venture Agreement, as amended. The Company and Qianjiang Pharmaceutical executed the Amendment to accelerate clinical trials in both the United States and China, and agreed to immediately initiate three month Good Laboratory Practice (“GLP”) Toxicology Studies (rat and dog) within 30 days of signing the Amendment. The Amendment requires that the GLP Toxicology Studies Trials are conducted in China in accordance with international standards and standards acceptable to the FDA and that the studies include the following: Exploratory Toxicology (nGLP) ● Dose range finding studies ● Different species and methods of administration ● Multiple dosing regimens ● Estimate the response vs. dose given Definitive Toxicology (GLP) ● Performed in collaboration with Calvert Laboratories (USA) and MPI/Medicillon (China) ● General toxicology studies ● Different species and methods of administration ● Immunogenicity study with NHPs Special Toxicology Studies (planned) Pursuant to the Amendment, Qianjiang Pharmaceutical has made certain funds available from the co-administrative account opened by Qianjiang Pharmaceutical under the Venture Agreement, in accordance with an approved budget and timeline set forth in the Amendment. A portion of these funds are expected to be used by Cytocom to run PK and Dosing trials for MENK in the United States in 2016. The Amendment requires Cytocom and Qianjiang Pharmaceutical to meet with the China State Food and Drug Administration to determine that PK and Dosing Trials completed in the United States will be acceptable. All developments and trials run by Cytocom in the U.S. or the European Union will be used for requesting registration approval in China. In February 2013, the Company signed a Strategic Framework Agreement for Cooperation with Qianjiang Pharmaceutical. Under the agreement, the parties will work together to further the development of new products and conduct research and development on the Company’s licensed patented technology. Specifically, the parties aim to co-invest to develop and market products focusing on HIV, cancer and related autoimmune system therapies, develop co-ventured manufacturing facilities in China, and develop co-ventured distribution of the developed products in China and Africa. The agreement does not have a definitive term, as each new agreement resulting from the cooperation will set forth the material terms, including, but not limited to, fees, duration and termination therein. In December of 2016 Qianjiang Pharmaceutical completed the following documents: Exploratory Toxicology (nGLP) ● Dose range finding studies ● Different species and methods of administration ● Multiple dosing regimens ● Estimate the response vs. dose given Definitive Toxicology (GLP) ● Performed in collaboration with Calvert Laboratories (USA) and MPI/Medicillon (China) ● General toxicology studies ● Different species and methods of administration ● Immunogenicity study with NHPs In addition to the pharmacology and toxicology studies, Qianjiang Pharmaceutical and China Peptide completed the formulation and CMC necessary to scale up manufacturing of MENK. Contract Manufacturing Agreements On May 16, 2016, the Company entered into an agreement with Complete Pharmacy and Medical Solutions, LLC (“CPMS”) to compound, package and distribute the LDN tablets, capsules and/or creams in the United States. The initial term of the agreement is three years, with the option to renew for an additional year. The agreement may be terminated by (i) mutual agreement, (ii) in the event of a breach, provided however that if the Company terminates the agreement, the Company will be required to reimburse CPMS for all unused packaging materials for the LDN, which unused packaging materials CPMS will provide to IMUN. If CPMS does not receive and ship at least 1,000 orders (prescriptions) during the term of the agreement, the Company will be required to reimburse CPMS for 100% of the “ramp up costs” (defined as all costs and expenses of labor and materials related to the testing, and required FDA and other governmental documentation/approvals of test data) of providing and producing the LDN, even where the Company cancels/terminates the agreement, which provision shall survive the cancellation/termination of the agreement. On October 25, 2016, the Company and Acromax Dominicana, SA (“Acromax”) entered into a contract for manufacturing of LDN tablets, capsules and/or creams (“Agreement”). In accordance with 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 its terms. In January 2017, Acromax obtained from the Ministry of Public Health and Social Assistance a Medications and Specialized Pharmaceuticals Registration Certification for Lodonal TM TM TM Operating Leases At June 30, 2017, the Company was a party to an agreement to lease office space in Orlando, Florida. Rent expense for the quarters ended June 30, 2017 and 2016 was $4,221 and $4,011, respectively Legal Proceedings None. |
Subsequent Events
Subsequent Events | 6 Months Ended |
Jun. 30, 2017 | |
Subsequent Events [Abstract] | |
Subsequent Events | 11. Subsequent Events The Company issued 2,848,187 shares of common stock between June 30, 2017 and August 12, 2017, of which 560,617 shares were for a cashless exercise of a warrant, 2,287,570 shares were for debt conversions and settlements. Between July 1, 2017 and August 11, 2017, the company received $50,000 in debt financing and $50,000 in equity. As of August 12, 2017, the Company had outstanding 335,538,005 shares of common stock. |
Summary of Significant Accoun18
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2017 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The consolidated financial statements included herein have been prepared by the Company, without audit, pursuant to the rules and regulations of the Securities and Exchange Commission. Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. generally accepted accounting principles have been omitted. However, in the opinion of management, all adjustments (which include only normal recurring adjustments, unless otherwise indicated) necessary to present fairly the financial position and results of operations for the periods presented have been made. The results for interim periods are not necessarily indicative of trends or of results to be expected for the full year. These financial statements should be read in conjunction with the financial statements of the Company for the year ended December 31, 2016 (including the notes thereto) set forth in Form 10-K. The Company qualifies as an “emerging growth company” as defined in Section 101 of the Jumpstart our Business Startups Act (“JOBS Act”) as we do not have more than $1,000,000,000 in annual gross revenue for the year ended December 31, 2016. We are electing to use the extended transition period for complying with new or revised accounting standards under Section 102(b)(1) of the JOBS Act. |
Revenue Recognition | Revenue Recognition 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. In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606). This standard provides a single set of guidelines for revenue recognition to be used across all industries and requires additional disclosures. It is effective for annual and interim reporting periods beginning after December 15, 2017. This standard permits early adoption and permits the use of either the retrospective or cumulative effect transition method. We are currently evaluating the potential impact of this standard on our financial position and results of operations, as well as our selected transition method. Based on our preliminary assessment, we believe the new standard will not have a material impact on our financial position and results of operations, as we do not expect to change the manner or timing of recognizing revenue on a majority of our revenue transactions once we commence revenue-generating activities. |
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). This standard will be effective for our interim and annual periods beginning January 1, 2019, and must be applied 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. We are currently evaluating the timing of adoption and the potential impact of this standard on our financial position, but we do not expect it to have a material impact on our results of operations. |
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 June 30, 2017, the Company has no cash balances in excess of insured limits. |
Segment and Geographic Information | Segment and Geographic Information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one operating segment and does not segment the business for internal reporting or decision making. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments In accordance with the reporting requirements of Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) Topic 825, “ Financial Instruments” |
Fair Value Measurements | Fair Value Measurements The ASC Topic 820, Fair Value Measurement, |
Fixed Assets | Fixed Assets Fixed assets are stated at cost, less accumulated depreciation. Depreciation is determined on a straight-line basis over the estimated useful lives of the assets, which generally range from three to five years. Maintenance and repairs are charged against expense as incurred. Depreciation expense for the three months ended June 30, 2017 and June 30, 2016 was $144 and $434, 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 June 30, 2017 and 2016, 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 June 30, 2017, and 2016, the Company has not accrued any interest or penalties related to uncertain tax positions. |
Stock-Based Compensation and Issuance of Stock for Non-Cash Consideration | Stock-Based Compensation and Issuance of Stock for Non-Cash Consideration The Company measures and recognizes compensation expense for all share-based payment awards made to employees and directors, including employee stock options, based on estimated fair values equaling either the market value of the shares issued or the value of consideration received, whichever is more readily determinable. The majority of the non-cash consideration pertains to services rendered by consultants and others and has been valued at the fair value of the Company’s common stock at the date of the agreement. The Company’s accounting policy for equity instruments issued to consultants and vendors in exchange for goods and services follows the provisions of ASC Topic 505-50, “ Equity-Based Payments to Non-Employees |
Non-controlling Interest | Non-controlling Interest In accordance with ASC Topic 810, Consolidation |
Net Income (Loss) per Share | Net Income (Loss) per Share Basic net income (loss) per share (“EPS”) is calculated in accordance with Accounting Standards Codification (“ASC”) 260, “Earnings Per Share.” Basic net income or 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. Dilutive common stock equivalents are comprised of common stock purchase warrants outstanding. A calculation of basic net income (loss) per share follows: For the three months ended June 30, For the six months ended June 30, 2017 2016 2017 2016 Net Profit/(Loss) $ 148,635 $ (4,038,648) $ (2,557,298) $ (10,684,051) Weighted-average common shares outstanding Basic: 304,232,895 207,229,469 281,886,367 199,076,428 Weighted-average common stock Equivalents Stock options - - - - Warrants 9,345,386 - - - Convertible notes - - - - Weighted-average common shares outstanding Diluted 313,578,281 207,229,469 281,886.367 199,076,428 Profit/(Loss) per share outstanding Basic and diluted $ 0.00 $ (0.02 ) $ (0.01 ) $ (0.05 ) The Company’s potential dilutive securities, which include 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. The following shares of potentially dilutive securities have been excluded from the computations of diluted weighted average shares outstanding: As of June 30, 2017 2016 Warrants to purchase Common stock 44,619,000 32,748,908 44,619,000 32,748,908 |
Recent Accounting Standards | Recent Accounting Standards During the quarter ended June 30, 2017, there were several new accounting pronouncements issued by the Financial Accounting Standards Board. Each of these pronouncements, as applicable, has been or will be adopted by the Company. Management does not believe the adoption of any of these accounting pronouncements has had or will have a material impact on the Company’s consolidated financial statements. In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606). This standard provides a single set of guidelines for revenue recognition to be used across all industries and requires additional disclosures. It is effective for annual and interim reporting periods beginning after December 15, 2017. This standard permits early adoption and permits the use of either the retrospective or cumulative effect transition method. We are currently evaluating the potential impact of this standard on our financial position and results of operations, as well as our selected transition method. Based on our preliminary assessment, we believe the new standard will not have a material impact on our financial position and results of operations, as we do not expect to change the manner or timing of recognizing revenue on a majority of our revenue transactions. 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). This standard will be effective for our interim and annual periods beginning January 1, 2019, and must be applied 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. We are currently evaluating the timing of adoption and the potential impact of this standard on our financial position, but we do not expect it to have a material impact on our results of operations. |
Summary of Significant Accoun19
Summary of Significant Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
Accounting Policies [Abstract] | |
Schedule of Basic and Diluted Net Loss Per Share | A calculation of basic net income (loss) per share follows: For the three months ended June 30, For the six months ended June 30, 2017 2016 2017 2016 Net Profit/(Loss) $ 148,635 $ (4,038,648) $ (2,557,298) $ (10,684,051) Weighted-average common shares outstanding Basic: 304,232,895 207,229,469 281,886,367 199,076,428 Weighted-average common stock Equivalents Stock options - - - - Warrants 9,345,386 - - - Convertible notes - - - - Weighted-average common shares outstanding Diluted 313,578,281 207,229,469 281,886.367 199,076,428 Profit/(Loss) per share outstanding Basic and diluted $ 0.00 $ (0.02 ) $ (0.01 ) $ (0.05 ) |
Schedule of Antidilutive Securities | The following shares of potentially dilutive securities have been excluded from the computations of diluted weighted average shares outstanding: As of June 30, 2017 2016 Warrants to purchase Common stock 44,619,000 32,748,908 44,619,000 32,748,908 |
Fixed Assets (Tables)
Fixed Assets (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
Fixed Assets: | |
Schedule of Fixed Assets | June 30, 2017 December 31, 2016 Fixed Assets: Computer equipment $ 11,243 $ 9,738 Less accumulated depreciation (8,176 ) (7,888 ) Property and equipment, net $ 3,067 $ 1,850 |
Accrued Liabilities (Tables)
Accrued Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Liabilities | Accrued expenses and other liabilities consist of the following: June 30, 2017 December 31, 2016 Accrued payroll to officers and others $ 1,169,883 $ 1,126,261 Accrued interest and penalties - notes payable 517,467 1,902,018 Estimated legal settlement 111,644 128,087 Other accrued liabilities 393 393 Total accrued expenses and other liabilities $ 1,799,387 $ 3,156,759 |
Notes Payable (Tables)
Notes Payable (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
Debt Disclosure [Abstract] | |
Schedule of Notes Payable | Notes payable consist of the following: June 30, 2017 December 31, 2016 Promissory note issued July 29, 2014 to Ira Gaines. In 2016, the maturity date on the note was extended to December 1, 2017. The note earns interest at a rate of 18% per annum. $ 100,000 $ 100,000 Promissory notes issued between November 26, 2014 and September 30, 2015, to raise up to $2,000,000 in debt. Lenders earn interest at a rate of 10% per annum, plus a pro-rata share of two percent of the Company’s gross receipts for sales of IRT-103-LDN in perpetuity. Notes will be repaid in 36 monthly installments of principal and interest commencing no later than October 15, 2015. Notes aggregating $286,000 were in default at June 30, 2017, as the Company was unable to pay installments on those notes on their due dates. No demands for repayment have been made by the lenders. 286,000 286,000 Promissory notes issued between May 1, 2015 and December 31, 2016, and maturing between June 14, 2015 and September 30, 2017. Lenders on loans aggregating $505,994 earn interest at rates between 2% and 18% per annum. On loans aggregating $198,500, interest is payable in a fixed amount not tied to a specific interest rate. Notes aggregating $555,494 were in default at June 30, 2017, as the Company was unable to repay those notes on their due dates. No demands for repayment have been made by the lenders. 704,494 704,494 Promissory notes issued by Cytocom Inc. between April 29, 2015 and December 31, 2015. Lenders earn interest at rates between 5% and 10% per annum. These notes mature on September 30, 2016. At June 30, 2017, the notes were in default, although no demand for repayment has been made by the lenders. 425,000 425,000 Promissory note issued in December 2015. The lender earns interest at a rate of 10% per month. The note is repayable on March 9, 2016. At June 30, 2017, the note was in default, although no demand for repayment has been made by the lender. On April 3, 2017, the Company settled the obligation. - 100,000 Promissory notes issued between May 5, 2016 and June 2, 2016 that mature between October 1, 2016 and January 31, 2017, and include stock conversion features, warrants and original issue debt discounts. The notes were repaid or converted into stock in the quarter ended June 30, 2017. - 554,882 Promissory notes issued to an officer of the Company effective November 3, 2015 and maturing November 3, 2016 for settlement of accrued payroll, bearing interest at 10% per annum and including a stock conversion feature. The Company was unable to repay the note at maturity and the note is in default. 102,737 112,737 Promissory note issued in July 2016. The note was repayable on October 5, 2016 but was extended to December 31, 2016. The note earns interest at 6% per month. The Company was unable to repay the note at maturity and the note is in default. 50,000 50,000 Promissory note issued in July 2016 with an original issuance discount of $30,000. Net proceeds were $150,000. The note is repayable on April 7, 2017. $66,000 of the note was converted to stock. The Company was unable to repay the note at maturity and the note is in default. 114,000 180,000 Promissory notes issued in August 2016 for $149,854 as a settlement of amounts owed to a law firm. The notes accrue interest at 5% per annum and are payable in 18 equal monthly installments of $8,641.88. The note was in default on June 30, 2017. 69,135 120,987 Promissory notes issued between July 1, 2016 and December 31, 2016. Lenders earn interest at 2% per annum. The notes mature on September 30, 2017. 256,000 256,000 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. 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 June 30, 2018. 500,000 - Promissory note issued January 25, 2017. The lenders earn interest at 7% per month. The note matures on July 5, 2017. 50,000 - Notes aggregating $300,000 issued in the second quarter of 2017. The notes accrue interest at 2% per annum and mature between January 12, 2018 and June 30, 2018. 300,000 - Less: Original issue discounts on notes payable and warrants issued with notes. - (18,681 ) Total $ 4,311,366 $ 4,225,419 |
Capital Structure - Common St23
Capital Structure - Common Stock and Common Stock Purchase Warrants (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
Equity [Abstract] | |
Schedule of Outstanding Stock Warrants | Following is a summary of outstanding stock warrants at June 30, 2017 and activity during the six months then ended: 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 14,750,000 $ 0.05-0.20 $ 0.08 Expired and forfeited in 2017 - $ - $ - Exercised in 2017 5,600,000 $ - $ - Warrants as of June 30, 2017 68,341,904 $ 0.03-15.00 $ 0.31 |
Summary of Outstanding Warrants | Summary of outstanding warrants as of June 30, 2017: Expiration Date Number of Shares Exercise Price Remaining Life (years) Fourth Quarter 2017 350,000 $ 1.50-9.00 0.25 First Quarter 2018 127,500 $ 15.00 0.50 Second Quarter 2018 33,334 $ 15.00 0.75 Third Quarter 2018 250,000 $ 1.50 1.00 Fourth Quarter 2018 6,089,166 $ 1.00-1.50 1.25 First Quarter 2019 4,024,000 $ 0.50-2.00 1.50 Second Quarter 2019 135,000 $ 0.07-0.23 1.75 Third Quarter 2019 260,000 $ 0.50-1.50 2.00 Fourth Quarter 2019 400,000 $ 0.14 2.25 Second Quarter 2020 300,000 $ 0.50 2.75 Fourth Quarter 2020 1,000,000 $ 0.20 3.25 First Quarter 2021 12,600,000 $ 0.20 3.50 Second Quarter 2021 21,206,237 $ 0.03-0.20 3.75 Third Quarter 2021 6,816,667 $ 0.03-0.20 4.00 Second Quarter 2022 3,250,000 $ 0.20 4.75 Second Quarter 2032 11,500,000 $ 0.05 14.75 |
Income Taxes - Results of Ope24
Income Taxes - Results of Operations (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
Income Taxes - Results Of Operations Tables | |
Schedule of Components of Loss Before Income Taxes | For financial reporting purposes, for the six months ending June 30, 2017 and 2016, income before income taxes includes the following components: June 30, 2017 June 30, 2016 United States $ (2,557,298 ) $ (10,684,051 ) Foreign - - Total $ (2,557,298 ) $ (10,684,051 ) |
Schedule of Provision for Income Taxes | The expense (benefit) for income taxes consist of: 2017 2016 Current: Federal $ - $ - State $ - $ - Foreign $ - $ - Total $ - $ - Deferred and other: Federal $ - $ - State $ - $ - Foreign $ - $ - $ - $ - Total tax expense $ - $ - |
Organization and Description 25
Organization and Description of Business (Details Narrative) - USD ($) | Dec. 08, 2014 | Apr. 30, 2016 | Jun. 30, 2014 | Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | Dec. 31, 2013 | Dec. 31, 2016 |
Net loss | $ (148,635) | $ 4,038,648 | $ 2,557,298 | $ 10,684,051 | |||||
Cash and cash equivalents | 1,231,051 | 1,231,051 | |||||||
Stockholder's deficit | $ 7,857,447 | $ 7,857,447 | $ 9,124,344 | ||||||
Cytocom Inc., [Member] | |||||||||
Number of shares issued during period | 113,242,522 | 140,100,000 | |||||||
Percentage of stake issued during period | 12.80% | 55.30% | |||||||
Reserve stock split description | The Board of Directors and a majority of shareholders of Cytocom approved a reverse stock split of Cytocoms outstanding common stock with one new share of stock for each twenty old shares of common stock. | ||||||||
Irish Limited Liability [Member] | |||||||||
Percentage of low corporate income tax rate | 12.50% |
Summary of Significant Accoun26
Summary of Significant Accounting Policies (Details Narrative) | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2017USD ($) | Jun. 30, 2016USD ($) | Jun. 30, 2017USD ($)Segment | Jun. 30, 2016USD ($) | Dec. 31, 2016USD ($) | |
Maximum of annual gross revenue | $ 1,000,000,000 | ||||
Federal deposit insurance corporation value | $ 250,000 | $ 250,000 | |||
Depreciation expense | 144 | $ 434 | $ 288 | $ 981 | |
Number of operating segment | Segment | 1 | ||||
Accrued interest or penalties related to uncertain tax positions | |||||
Minimum [Member] | |||||
Property and equipment useful lives | 3 years | ||||
Minimum [Member] | Intangible Assets [Member] | |||||
Intangible assets useful lives | 10 years | ||||
Maximum [Member] | |||||
Property and equipment useful lives | 5 years | ||||
Maximum [Member] | Intangible Assets [Member] | |||||
Intangible assets useful lives | 16 years | ||||
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 |
Summary of Significant Accoun27
Summary of Significant Accounting Policies - Schedule of Basic and Diluted Net Loss Per Share (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Net Profit/(Loss) | $ 148,635 | $ (4,038,648) | $ (2,557,298) | $ (10,684,051) |
Weighted-average common shares outstanding Basic: | 304,232,895 | 207,229,469 | 281,886,367 | 199,076,428 |
Net Profit/(Loss) Weighted-average common shares outstanding | 313,578,281 | 207,229,469 | 281,886,367 | 199,076,428 |
Denominator, Basic net loss per share attributed to common stockholders | $ 0 | $ (0.02) | $ (0.01) | $ (0.05) |
Stock Options [Member] | ||||
Weighted-average common stock Equivalents | ||||
Warrant [Member] | ||||
Weighted-average common stock Equivalents | 9,345,386 | |||
Convertible Notes [Member] | ||||
Weighted-average common stock Equivalents |
Summary of Significant Accoun28
Summary of Significant Accounting Policies - Schedule of Antidilutive Securities (Details) - shares | 6 Months Ended | |
Jun. 30, 2017 | Jun. 30, 2016 | |
Accounting Policies [Abstract] | ||
Potentially dilutive securities | 68,341,904 | 32,784,908 |
Fixed Assets (Details Narrative
Fixed Assets (Details Narrative) | 6 Months Ended |
Jun. 30, 2017 | |
Minimum [Member] | |
Depreciable asset lives | 3 years |
Maximum [Member] | |
Depreciable asset lives | 5 years |
Fixed Assets - Schedule of Fixe
Fixed Assets - Schedule of Fixed Assets (Details) - USD ($) | Jun. 30, 2017 | Dec. 31, 2016 |
Fixed Assets: | ||
Computer equipment | $ 11,243 | $ 9,738 |
Less accumulated depreciation | (8,176) | (7,888) |
Property and equipment, net | $ 3,067 | $ 1,850 |
Accrued Liabilities - Schedule
Accrued Liabilities - Schedule of Accrued Liabilities (Details) - USD ($) | Jun. 30, 2017 | Dec. 31, 2016 |
Payables and Accruals [Abstract] | ||
Accrued payroll to officers and others | $ 1,169,883 | $ 1,126,261 |
Accrued interest and penalties - notes payable | 517,467 | 1,902,018 |
Estimated legal settlement | 111,644 | 128,087 |
Other accrued liabilities | 393 | 393 |
Total accrued expenses and other liabilities | $ 1,799,387 | $ 3,156,759 |
Notes Payable (Details Narrativ
Notes Payable (Details Narrative) | 6 Months Ended |
Jun. 30, 2017USD ($)shares | |
Debt Disclosure [Abstract] | |
Accrued unpaid interest | $ 517,467 |
Issuance of common stock for interest expense, shares | shares | 20,282,473 |
Issuance of common stock for interest expense | $ 874,024 |
Notes Payable - Schedule of Not
Notes Payable - Schedule of Notes Payable (Details) - USD ($) | Jun. 30, 2017 | Dec. 31, 2016 | Jul. 31, 2016 |
Total | $ 4,311,366 | $ 4,225,419 | |
Less: Original issue discounts on notes payable and warrants issued with notes | (18,681) | $ 30,000 | |
Notes Payable One [Member] | |||
Total | 100,000 | 100,000 | |
Notes Payable Two [Member] | |||
Total | 286,000 | 286,000 | |
Notes Payable Three [Member] | |||
Total | 704,494 | 704,494 | |
Notes Payable Four [Member] | |||
Total | 425,000 | 425,000 | |
Notes Payable Five [Member] | |||
Total | 100,000 | ||
Notes Payable Six [Member] | |||
Total | 554,882 | ||
Notes Payable Seven [Member] | |||
Total | 102,737 | 112,737 | |
Notes Payable Eight [Member] | |||
Total | 50,000 | 50,000 | |
Notes Payable Nine [Member] | |||
Total | 114,000 | 180,000 | |
Notes Payable Ten [Member] | |||
Total | 69,135 | 120,987 | |
Notes Payable Eleven [Member] | |||
Total | 256,000 | 256,000 | |
Notes Payable Twelve [Member] | |||
Total | 1,354,000 | 1,354,000 | |
Notes Payable Thirteen [Member] | |||
Total | 500,000 | ||
Notes Payable Fourteen [Member] | |||
Total | 50,000 | ||
Notes Payable Fifteen [Member] | |||
Total | $ 300,000 |
Notes Payable - Schedule of N34
Notes Payable - Schedule of Notes Payable (Details) (Parenthetical) | Jan. 25, 2017 | Aug. 31, 2016USD ($)Installments | Jul. 31, 2016USD ($)shares | Jun. 02, 2016 | Nov. 03, 2015 | Jul. 29, 2014 | Jun. 30, 2017USD ($)Doses | Jun. 30, 2016USD ($) | Dec. 31, 2016USD ($) | Dec. 31, 2015 | Sep. 30, 2015USD ($) |
Note matures date | Apr. 7, 2017 | Nov. 3, 2016 | |||||||||
Percentage of interest rate per annum | 5.00% | 6.00% | 10.00% | 10.00% | |||||||
Maximum amount raise in debt | $ 149,854 | $ 2,000,000 | |||||||||
Number of installments, months | 18 | 36 | |||||||||
Debt instrument maturity date description | October 1, 2016 and January 31, 2017 | ||||||||||
Original issuance discount | $ 30,000 | $ (18,681) | |||||||||
Proceeds from issuance of debt | $ 150,000 | $ 1,025,000 | $ 1,390,869 | ||||||||
Debt instrument, periodic payment, principal | $ 8,642 | ||||||||||
Number of note converted into common stock | shares | 66,000 | ||||||||||
December 31, 2017 [Member] | |||||||||||
Percentage of interest rate per annum | 2.00% | ||||||||||
Notes aggregating default amount | $ 1,354,000 | ||||||||||
Debt instrument maturity date description | November 1, 2017 and December 31, 2017 | ||||||||||
March 31, 2018 [Member] | |||||||||||
Percentage of interest rate per annum | 2.00% | ||||||||||
Notes aggregating default amount | $ 500,000 | ||||||||||
Debt instrument maturity date description | January 12, 2018 and March 31, 2018 | ||||||||||
June 30, 2018 [Member] | |||||||||||
Percentage of interest rate per annum | 2.00% | ||||||||||
Notes aggregating default amount | $ 300,000 | ||||||||||
Lenders [Member] | |||||||||||
Note matures date | Sep. 30, 2017 | ||||||||||
Percentage of interest rate per annum | 2.00% | ||||||||||
Debt instrument maturity date description | July 1, 2016 and December 31, 2016 | ||||||||||
April 29, 2015 [Member] | Cytocom Inc., [Member] | |||||||||||
Note matures date | Sep. 30, 2016 | ||||||||||
April 29, 2015 [Member] | Minimum [Member] | Cytocom Inc., [Member] | |||||||||||
Percentage of interest rate per annum | 5.00% | ||||||||||
April 29, 2015 [Member] | Maximum [Member] | Cytocom Inc., [Member] | |||||||||||
Percentage of interest rate per annum | 10.00% | ||||||||||
Ira Gaines [Member] | |||||||||||
Note matures date | Dec. 1, 2017 | ||||||||||
Percentage of interest rate per annum | 18.00% | ||||||||||
Lenders [Member] | |||||||||||
Note matures date | Jul. 5, 2017 | ||||||||||
Percentage of interest rate per annum | 7.00% | ||||||||||
Notes aggregating default amount | 286,000 | ||||||||||
Lenders [Member] | Minimum [Member] | |||||||||||
Percentage of interest rate per annum | 2.00% | ||||||||||
Lenders [Member] | Maximum [Member] | |||||||||||
Percentage of interest rate per annum | 18.00% | ||||||||||
Lenders [Member] | May 1, 2015 [Member] | |||||||||||
Note matures date | Sep. 30, 2017 | ||||||||||
Notes aggregating default amount | $ 555,494 | ||||||||||
Aggregating loan | 505,994 | ||||||||||
Accrued interest | $ 198,500 | ||||||||||
Lenders [Member] | |||||||||||
Notes aggregating default amount | $ 100,000 | ||||||||||
Lender [Member] | |||||||||||
Percentage of interest rate per annum | 10.00% |
Capital Structure - Common St35
Capital Structure - Common Stock and Common Stock Purchase Warrants (Details Narrative) - $ / shares | 6 Months Ended | |
Jun. 30, 2017 | Dec. 31, 2016 | |
Common stock, shares authorized | 500,000,000 | 500,000,000 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares issued | 332,689,818 | 250,428,133 |
Common stock, shares outstanding | 332,689,818 | 250,428,133 |
Number of warrants issued during period | 14,750,000 | |
Number of warrants issued | 5,006,666 | |
Warrant expiration date, description | expiration dates between July 25, 2016 to December 17, 2018 | |
Minimum [Member] | ||
Warrant term | 3 years | |
Warrant exercise prices | $ 0.75 | |
Maximum [Member] | ||
Warrant term | 5 years | |
Warrant exercise prices | $ 1 |
Capital Structure - Common St36
Capital Structure - Common Stock and Common Stock Purchase Warrants - Schedule of Outstanding Stock Warrants (Details) - Warrant [Member] | 6 Months Ended |
Jun. 30, 2017$ / sharesshares | |
Warrants, Number of Shares Beginning balance | shares | 59,191,904 |
Warrants, Number of Shares Issued | shares | 14,750,000 |
Warrants, Number of Shares Expired and forfeited | shares | |
Warrants, Number of Shares Exercised | shares | 5,600,000 |
Warrants, Number of Shares Ending balance | shares | 68,341,904 |
Exercise Price, Issued | |
Exercise Price, Expired and forfeited | |
Exercise Price, Exercised | |
Weighted average exercise price, Beginning balance | 0.35 |
Weighted average exercise price, Issued | 0.08 |
Weighted average exercise price, Expired and forfeited | |
Weighted average exercise price, Exercised | |
Weighted average exercise price, Ending balance | 0.31 |
Minimum [Member] | |
Exercise Price, Beginning balance | 0.03 |
Exercise Price, Issued | .05 |
Exercise Price, Ending balance | 0.03 |
Maximum [Member] | |
Exercise Price, Beginning balance | 15 |
Exercise Price, Issued | .20 |
Exercise Price, Ending balance | $ 15 |
Capital Structure - Common St37
Capital Structure - Common Stock and Common Stock Purchase Warrants - Summary of Outstanding Warrants (Details) | 6 Months Ended |
Jun. 30, 2017$ / sharesshares | |
Fourth Quarter 2017 [Member] | |
Number of Shares | shares | 350,000 |
Exercise Price Lower Limit | $ 1.50 |
Exercise Price Upper Limit | $ 9 |
Remaining Life (years) | 2 months 30 days |
First Quarter 2018 [Member] | |
Number of Shares | shares | 127,500 |
Exercise Price Upper Limit | $ 15 |
Remaining Life (years) | 6 months |
Second Quarter 2018 [Member] | |
Number of Shares | shares | 33,334 |
Exercise Price Upper Limit | $ 15 |
Remaining Life (years) | 9 months |
Third Quarter 2018 [Member] | |
Number of Shares | shares | 250,000 |
Exercise Price Upper Limit | $ 1.50 |
Remaining Life (years) | 1 year |
Fourth Quarter 2018 [Member] | |
Number of Shares | shares | 6,089,166 |
Exercise Price Lower Limit | $ 1 |
Exercise Price Upper Limit | $ 1.50 |
Remaining Life (years) | 1 year 2 months 30 days |
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) | 1 year 6 months |
Second Quarter 2019 [Member] | |
Number of Shares | shares | 135,000 |
Exercise Price Lower Limit | $ 0.07 |
Exercise Price Upper Limit | $ 0.23 |
Remaining Life (years) | 1 year 9 months |
Third Quarter 2019 [Member] | |
Number of Shares | shares | 260,000 |
Exercise Price Lower Limit | $ 0.50 |
Exercise Price Upper Limit | $ 1.50 |
Remaining Life (years) | 2 years |
Fourth Quarter 2019 [Member] | |
Number of Shares | shares | 400,000 |
Exercise Price Upper Limit | $ 0.14 |
Remaining Life (years) | 2 years 2 months 30 days |
Second Quarter 2020 [Member] | |
Number of Shares | shares | 300,000 |
Exercise Price Upper Limit | $ 0.50 |
Remaining Life (years) | 2 years 9 months |
Fourth Quarter 2020 [Member] | |
Number of Shares | shares | 1,000,000 |
Exercise Price Upper Limit | $ 0.20 |
Remaining Life (years) | 3 years 2 months 30 days |
First Quarter 2021 [Member] | |
Number of Shares | shares | 12,600,000 |
Exercise Price Upper Limit | $ 0.20 |
Remaining Life (years) | 3 years 6 months |
Second Quarter 2021 [Member] | |
Number of Shares | shares | 21,206,237 |
Exercise Price Lower Limit | $ 0.03 |
Exercise Price Upper Limit | $ 0.20 |
Remaining Life (years) | 3 years 9 months |
Third Quarter 2021 [Member] | |
Number of Shares | shares | 6,816,667 |
Exercise Price Lower Limit | $ 0.03 |
Exercise Price Upper Limit | $ 0.20 |
Remaining Life (years) | 4 years |
Second Quarter 2022 [Member] | |
Number of Shares | shares | 3,250,000 |
Exercise Price Upper Limit | $ .20 |
Remaining Life (years) | 4 years 9 months |
Second Quarter 2032 [Member] | |
Number of Shares | shares | 11,500,000 |
Exercise Price Upper Limit | $ .05 |
Remaining Life (years) | 14 years 9 months |
Stock Compensation (Details Nar
Stock Compensation (Details Narrative) - USD ($) | 6 Months Ended | |
Jun. 30, 2017 | Jun. 30, 2016 | |
Number of common stock issued for consulting fees | 25,545,460 | 23,643,000 |
Number of common stock issued for consulting fees, value | $ 205,456 | |
Amortization of prepaid services | $ 885,835 | $ 1,539,928 |
Common Stock [Member] | ||
Number of common stock issued for consulting fees | 25,545,460 | |
Number of common stock issued for consulting fees, value | $ 2,555 | |
Common Stock [Member] | Date of Agreements [Member] | ||
Number of common stock issued for consulting fees, value | $ 1,265,456 | $ 4,543,170 |
Minimum [Member] | ||
Consulting fees amortized period | 12 months | |
Maximum [Member] | ||
Consulting fees amortized period | 24 months |
Income Taxes - Results of Ope39
Income Taxes - Results of Operations (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Income Tax Disclosure [Abstract] | ||
Effective tax rate | 0.00% | 0.00% |
Operating loss carryforwards | $ 79,900,000 | |
Operating loss carryforwards expire term | Expire in 2032-2035. |
Income Taxes - Results of Ope40
Income Taxes - Results of Operations - Schedule of Components of Loss Before Income Taxes (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Income Tax Disclosure [Abstract] | ||||
United States | $ (2,557,298) | $ (10,684,051) | ||
Foreign | ||||
Total | $ 148,635 | $ (4,038,648) | $ (2,557,298) | $ (10,684,051) |
Income Taxes - Results of Ope41
Income Taxes - Results of Operations - Schedule of Provision for Income Taxes (Details) - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | Apr. 30, 2017 | Apr. 30, 2016 | |
Income Tax Disclosure [Abstract] | ||||||
Current: Federal | ||||||
Current: Local | ||||||
Current:Foreign | ||||||
Total | ||||||
Deferred and other: Federal | ||||||
Deferred and other: Local | ||||||
Deferred and other: Foreign | ||||||
Income tax expense |
Licenses and Supply Agreements
Licenses and Supply Agreements (Details Narrative) - USD ($) | Sep. 24, 2014 | Aug. 06, 2014 | Dec. 24, 2012 | Aug. 13, 2012 | Apr. 24, 2012 | May 31, 2013 | Dec. 31, 2013 |
Young Agreement [Member] | |||||||
Patent liability | $ 118,333 | ||||||
Cost of patent | $ 1,372,000 | ||||||
Percentage of royalty payment | 1.00% | ||||||
Smith Agreement [Member] | |||||||
Number of shares acquired in exchange for common stock | 1,000,000 | 300,000 | |||||
Acquisition value | $ 270,000 | $ 2,880,384 | |||||
Fair market value acquired | 2,715,000 | ||||||
Payments to acquire patents | 165,384 | ||||||
Smith Agreement [Member] | Initial License Fee [Member] | |||||||
Payments to acquire patents | 100,000 | ||||||
Smith Agreement [Member] | Expenses [Member] | |||||||
Payments to acquire patents | $ 65,384 | ||||||
Shan Agreement [Member] | |||||||
Number of shares issue upon final transfer of licenses | 500,000 | ||||||
Number of common stock shares issued during period | 500,000 | ||||||
TNI BioTech IP, Inc. [Member] | |||||||
Number of shares acquired in exchange for common stock | 20,250,000 | ||||||
Acquisition value | $ 98,000,000 | ||||||
Dr. Plotnikoff [Member] | |||||||
Number of shares acquired in exchange for common stock | 8,000,000 | ||||||
TNI IP's Management [Member] | |||||||
Number of shares acquired in exchange for common stock | 12,250,000 | ||||||
Acquisition value | $ 16,006,000 | ||||||
Dr. Bernard Bihari [Member] | Young Agreement [Member] | |||||||
Number of shares acquired in exchange for common stock | 540,000 | ||||||
Acquisition value | $ 972,000 | ||||||
Assumed liabilities | $ 400,000 |
Commitments and Contingencies (
Commitments and Contingencies (Details Narrative) - USD ($) | Oct. 18, 2012 | Oct. 31, 2013 | Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 |
Cash rental expense | $ 4,221 | $ 4,011 | |||
Complete Pharmacy and Medical Solutions, LLC [Member] | |||||
Ramp up costs, percentage | 100.00% | ||||
AHAR Pharma [Member] | |||||
Distribution agreement, description | the Company is obligated to provide delivery of an initial supply of between 1 million and 1.5 million doses of Lodonal product to cover AHAR Pharmas first-year purchase commitment. | ||||
Agreements With Hubei Qianjiang Pharmaceutical Company [Member] | |||||
Percentage of gross sales | 6.00% |
Subsequent Events (Details Narr
Subsequent Events (Details Narrative) - USD ($) | 1 Months Ended | 6 Months Ended | ||
Aug. 12, 2017 | Aug. 11, 2017 | Jun. 30, 2017 | Dec. 31, 2016 | |
Number of shares for debt conversion and settlements | 20,282,473 | |||
Common stock, shares outstanding | 332,689,818 | 250,428,133 | ||
Subsequent Event [Member] | ||||
Number of common stock issued | 2,848,187 | |||
Number of shares for debt conversion and settlements | 2,287,570 | |||
Proceeds from debt financing | $ 50,000 | |||
Proceeds from equity financing | $ 50,000 | |||
Common stock, shares outstanding | 335,538,005 | |||
Subsequent Event [Member] | Warrant [Member] | ||||
Number of common stock issued | 560,617 |