Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2016 | May. 12, 2016 | |
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 | Mar. 31, 2016 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Smaller Reporting Company | |
Entity Common Stock, Shares Outstanding | 206,913,301 | |
Document Fiscal Period Focus | Q1 | |
Document Fiscal Year Focus | 2,016 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) | Mar. 31, 2016 | Dec. 31, 2015 |
Current Assets: | ||
Cash and cash equivalents | $ 132,817 | $ 23,149 |
Accounts receivable | 19,660 | $ 16,197 |
Prepaids and other current assets | 1,594 | |
Total current assets | 153,441 | $ 39,346 |
Fixed Assets: | ||
Computer equipment, net of accumulated depreciation of $6,878 and $6,331 respectively | 1,135 | 1,682 |
Deposits | 200 | 200 |
Total assets | 154,776 | 41,228 |
Current Liabilities: | ||
Accounts payable | 1,860,361 | 1,924,672 |
Accrued liabilities | 1,641,351 | 1,281,039 |
Current portion of notes payable | 2,838,200 | 2,793,701 |
Total current liabilities | 6,339,912 | 5,999,412 |
Total liabilities | 6,339,912 | 5,999,412 |
Stockholders’ Deficit: | ||
Common stock - par value $0.0001; 500,000,000 shares authorized; 205,127,530 and 174,850,047 shares issued and outstanding respectively | 20,513 | 17,485 |
Additional paid in capital | 351,290,136 | 343,434,786 |
Stock issuances due | 1,173,244 | 1,140,303 |
Prepaid services | (2,133,286) | (660,417) |
Accumulated deficit | (354,391,171) | (347,789,889) |
Equity attributable to common stockholders | (4,040,564) | (3,857,732) |
Non-controlling interest | (2,144,572) | (2,100,452) |
Total stockholders’ deficit | (6,185,136) | (5,958,184) |
Total liabilities and stockholders’ deficit | $ 154,776 | $ 41,228 |
Condensed Consolidated Balance3
Condensed Consolidated Balance Sheets (Parenthetical) - USD ($) | Mar. 31, 2016 | Dec. 31, 2015 |
Statement of Financial Position [Abstract] | ||
Accumulated depreciation | $ 6,878 | $ 6,331 |
Common Stock, Par Value | $ 0.0001 | $ 0.0001 |
Common Stock, Shares Authorized | 500,000,000 | 500,000,000 |
Common Stock, Shares Issued | 205,127,530 | 174,850,047 |
Common Stock, Shares Outstanding | 205,127,530 | 174,850,047 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | |
Income Statement [Abstract] | ||
Revenues, net | $ 3,463 | $ 2,070 |
Operating expenses: | ||
Selling, general and administrative | 939,341 | 401,988 |
Research and development expense | (18,842) | 177,157 |
Stock issued for services G&A | $ 1,983,837 | $ 2,161,559 |
Stock issued for services R&D | ||
Warrant valuation expense | $ 2,078,199 | |
Depreciation and amortization expense | 547 | $ 148,727 |
Total operating expenses | 4,983,082 | 2,889,431 |
Loss from operations | (4,979,619) | (2,887,361) |
Other income (expense): | ||
Interest expense | (301,444) | $ (18,045) |
Loss on settlement of debt | (1,364,339) | |
Total other income (expense) | (1,665,783) | $ (18,045) |
Net loss | (6,645,402) | (2,905,406) |
Net loss attributable to non-controlling interest | (44,120) | (124,065) |
Net loss attributable to common shareholders | $ (6,601,282) | $ (2,781,341) |
Basic and diluted loss per share to common shareholders | $ (0.03) | $ (0.02) |
Weighted average number of shares outstanding | 190,923,381 | 138,795,044 |
Condensed Consolidated Stateme5
Condensed Consolidated Statements of Stockholders’ Deficit (Unaudited) - 3 months ended Mar. 31, 2016 - USD ($) | Common Stock [Member] | Additional Paid-In Capital [Member] | Stock To Be Issued [Member] | Prepaid Service [Member] | Accumulated Deficit [Member] | Non-controlling Interest [Member] | Total |
Balance at Dec. 31, 2015 | $ 17,485 | $ 343,434,786 | $ 1,140,303 | $ (660,417) | $ (347,789,889) | $ (2,100,452) | $ (5,958,184) |
Balance, shares at Dec. 31, 2015 | 174,850,047 | ||||||
Issuance of common stock for prepaid services | $ 1,904 | $ 3,724,266 | $ (269,466) | (2,142,535) | 1,314,169 | ||
Issuance of common stock for prepaid services, shares | 19,043,000 | ||||||
Amortization of prepaid services | $ 669,667 | 669,667 | |||||
Issuance of common stock in exchange for debt | $ 1,093 | $ 2,027,915 | $ 277,407 | 2,306,415 | |||
Issuance of common stock in exchange for debt, shares | 10,921,983 | ||||||
Issuance of common stock for cash and exercise of warrants | $ 31 | 24,969 | $ 25,000 | 50,000 | |||
Issuance of common stock for cash and exercise of warrants, shares | 312,500 | ||||||
Issuance of common stock warrants | $ 2,078,199 | 2,078,199 | |||||
Net loss | $ (6,601,282) | $ (44,120) | (6,645,402) | ||||
Balance at Mar. 31, 2016 | $ 20,513 | $ 351,290,136 | $ 1,173,244 | $ (2,133,286) | $ (354,391,171) | $ (2,144,572) | $ (6,185,136) |
Balance, shares at Mar. 31, 2016 | 205,127,530 |
Condensed Consolidated Stateme6
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 3 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | |
CASH FLOWS FROM OPERATING ACTIVITIES | ||
Net loss | $ (6,645,402) | $ (2,905,406) |
Adjustments to reconcile net loss to net cash flows used in operating activities: | ||
Depreciation | $ 547 | 668 |
Amortization | 148,060 | |
Amortization of stock issued for prepaid services | $ 669,667 | $ 2,161,559 |
Stock issued for services | 1,314,169 | |
Stock warrant expense | 2,078,199 | |
Loss on settlement of debt | 1,364,339 | |
Changes in operating assets and liabilities: | ||
Accounts receivable | (3,463) | $ (2,070) |
Accounts payable | 139,203 | (192,521) |
Accrued liabilities | 486,373 | $ 32,600 |
Prepaid expenses and other current assets | (1,594) | |
Net cash used in operating activities | $ (597,962) | $ (757,110) |
CASH FLOWS FROM INVESTING ACTIVITIES | ||
Net cash used in investing activities | ||
CASH FLOWS FROM FINANCING ACTIVITIES | ||
Proceeds from sale of stock and exercise of warrants | $ 50,000 | $ 95,000 |
Proceeds from issuance of notes payable | 657,000 | 500,975 |
Net cash provided by financing activities | 707,000 | 595,975 |
Net decrease in cash and cash equivalents | 109,038 | (161,135) |
Cash and cash equivalents at beginning of period | 23,149 | 191,987 |
Cash and cash equivalents at end of period | 132,817 | 30,852 |
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION: | ||
Cash paid for interest | 7,050 | $ 4,500 |
SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING AND FINANCING ACTIVITIES: | ||
Issuance of common stock in exchange for debt and accrued interest | $ 2,306,415 |
Organization and Description of
Organization and Description of Business | 3 Months Ended |
Mar. 31, 2016 | |
Accounting Policies [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 Companys 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 Companys 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 Companys 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 Crohns Disease. The EMA granted the UK Subsidiary a meeting that took place on September 27, 2013. The UK Subsidiary is eligible to benefit from the provisions for administrative and financial assistance for SMEs set out in Regulation (EC) No 2049/2005. The Company will apply to obtain EMA benefits once funding becomes available. In December 2013, the Company formed a new subsidiary, Cytocom Inc., to focus on conducting LDN and MENK clinical trials in the United States. In December 2014, the Company 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% equity interest in Cytocom Inc. on that date. The Companys equity interest has since been reduced to 50.2% at March 31, 2016, by subsequent issuances of Cytocom common stock to shareholders. 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 worlds leading pharmaceutical companies have located in Ireland), and so that the Company could take advantage of Irelands status as a member of the European Union and the European Economic Area. An Irish limited liability company enjoys a low corporate income tax rate of 12.5%, one of the lowest in the world. The Irish-domiciled company hopes to qualify for tax incentives for Irish holding/headquartered companies and to benefit from the network of double tax treaties that reduce withholding taxes. TNI BioTech International, Ltd. will manage our international distribution, using product that is manufactured in Ireland and elsewhere. We are focused on the development and commercialization of therapeutic treatments for cancer, HIV/AIDS and autoimmune diseases and immune disorders by combating these severe and fatal diseases through the stimulation and/or regulation of the bodys immune system. Our growth strategy includes the near-term commercialization of our existing immunotherapies targeting cancer, Crohns disease and/or HIV/AIDS. Going Concern The Company has incurred significant net losses since inception and has relied on its ability to fund its operations through private equity financings. Management expects operating losses and negative cash flows to continue at more significant levels in the future. As the Company continues to incur losses, transition to profitability is dependent upon the successful development, approval, and commercialization of its product candidate and the achievement of a level of revenues adequate to support the Companys cost structure. The Company may never achieve profitability, and unless and until it does, the Company will continue to need to raise additional cash. Management intends to fund future operations through additional private or public debt or equity offerings, and may seek additional capital through arrangements with strategic partners or from other sources. Based on the Companys operating plan, existing working capital at December 31, 2015 was not sufficient to meet the cash requirements to fund planned operations through December 31, 2016 without additional sources of cash. These conditions raise substantial doubt about the Companys ability to continue as a going concern. The accompanying financial statements have been prepared assuming that the Company will continue as a going concern and do not include adjustments that might result from the outcome of this uncertainty. This basis of accounting contemplates the recovery of the Companys assets and the satisfaction of liabilities in the normal course of business. The Company experienced a net loss from operations of $6,645,402, and used cash and cash equivalents for operations in the amount of $497,962 during the quarter ended March 31, 2016, resulting in stockholders deficit of $6,185,136 at that date. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2016 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The accompanying consolidated financial statements have been prepared in accordance with United States (U.S.) generally accepted accounting principles (U.S. GAAP) and include all adjustments (consisting of only normal recurring adjustments, unless otherwise indicated) necessary for the fair presentation of the Companys financial position for the periods presented. The Company qualifies as an emerging growth company as defined in Section 101 of the Jumpstart our Business Startups Act (JOBS Act) as we do not have more than $1,000,000,000 in annual gross revenue for the year ended December 31, 2015. 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. Use of Estimates The preparation of the Companys 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 March 31, 2016, the Company has no uninsured cash balances. 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 Measurements Property and Equipment Property and equipment 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 quarters ended March 31, 2016 and March 31, 2015 was $547 and $668, respectively. Intangible Assets Costs incurred to acquire and/or develop the Companys product licenses and patents are capitalized and amortized by straight-line methods over estimated useful lives of seven to sixteen years. Intangible assets are stated at the lower of cost or estimated fair market value. During the quarters ended March 31, 2016 and March 31, 2015, the Company did not capitalize any such costs. (See Note 10). Amortization expense for the quarters ended March 31, 2016 and March 31, 2015 was $0 and $148,059, respectively. Impairment of Long-Lived Assets The Company evaluates long-lived assets for impairment whenever events or changes 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 Companys 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 FASB ASC Topic 740, Income Taxes, The standard addresses the determination of whether tax benefits claimed or expected to be claimed on a tax return should be recorded in the financial statements. Under ASC Topic 740, the Company may recognize the tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination by the tax authorities, based on the technical merits of the position. The tax benefits recognized in the financial statements from such a position should be measured based on the largest benefit that has a greater than fifty percent likelihood of being realized upon ultimate settlement. ASC Topic 740 also provides guidance on de-recognition, classification, interest and penalties on income taxes, accounting in interim periods and requires increased disclosures. At the date of adoption, and as of December 31, 2015, and 2014, the Company does not have a liability for unrecognized tax uncertainties. The Companys policy is to record interest and penalties on uncertain tax positions as income tax expense. At the end of the quarters ended March 31, 2016 and March 31, 2015, the Company had 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 Companys common stock at the date of the agreement. The Companys 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 810, Consolidation Net Loss per Share Basic net loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted average number of common shares outstanding for the period, without consideration for common stock equivalents. Diluted net loss per share is calculated by dividing the net loss by the weighted-average number of common share equivalents outstanding for the period determined using the treasury-stock method and the if-converted method. Dilutive common stock equivalents are comprised of common stock purchase warrants and options outstanding. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding due to the Companys net loss position. A calculation of basic and diluted net loss per share follows: For the three months ended March 31, 2016 2015 Historical net loss per share: Numerator Net loss $ (6,645,402 ) $ (2,905,406 ) Non-controlling interest (44,120 ) (124,065 ) Net loss attributed to Common stockholders $ (6,601,282 ) $ (2,781,341 ) Denominator Weighted-average common shares outstandingDenominator for basic and diluted net loss per share 190,923,381 138,795,044 Basic and diluted net loss per share attributed to common stockholders $ (0.03 ) $ (0.02 ) The Companys potential dilutive securities which include stock and warrants have been excluded from the computation of diluted net loss per share as the effect would be to reduce the net loss per share. Therefore, the weighted-average Common stock outstanding used to calculate both basic and diluted net loss per share is the same. The following shares of potentially dilutive securities have been excluded from the computations of diluted weighted average shares outstanding as the effect of including such securities would be antidilutive: For the three months ended March 31, 2016 2015 Warrants to purchase Common stock 24,731,500 9,372,750 Recent Accounting Standards During the quarter ended March 31, 2016, 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 Companys consolidated financial statements. |
Property and Equipment
Property and Equipment | 3 Months Ended |
Mar. 31, 2016 | |
Fixed Assets: | |
Property and Equipment | 3. Property and Equipment March 31, 2016 December 31, 2015 Property and equipment: Computer equipment $ 8,013 $ 8,013 Less accumulated depreciation (6,878 ) (6,331 ) Property and equipment, net $ 1,135 $ 1,682 The Company utilizes the straight-line method for depreciation, using three to five-year depreciable asset lives. Depreciation expense was not material for all periods presented. |
Accrued Liabilities
Accrued Liabilities | 3 Months Ended |
Mar. 31, 2016 | |
Payables and Accruals [Abstract] | |
Accrued Liabilities | 4. Accrued Liabilities Accrued expenses and other liabilities consist of the following: March 31, 2016 December 31, 2015 (in thousands) Accrued payroll to officers and others $ 1,077,640 $ 758,342 Accrued interest - notes payable 365,006 236,671 Estimated legal settlement 198,312 282,136 Other accrued liabilities 393 323 State payroll taxes - 3,567 Total accrued expenses and other liabilities $ 1,641,351 $ 1,281,039 |
Notes Payable
Notes Payable | 3 Months Ended |
Mar. 31, 2016 | |
Debt Disclosure [Abstract] | |
Notes Payable | 5. Notes Payable Notes payable consist of the following: March 31, 2016 December 31, 2015 Promissory note issued July 29, 2014 to Ira Gaines. The note matures on January 27, 2015 and earns interest at a rate of 18% per annum. The Company was unable to repay the note at maturity and the note is in default, although no demand for repayment has been made by the lender. $ 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 Companys 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 $346,000 were in default at March 31, 2016, as the Company was unable to pay installments on those notes on their due dates. No demands for repayment have been made by the lenders. In the quarter ended March 31, 2016, $365,500 of these notes and their accompanying interest were converted into 5,191,909 shares of Immune Therapeutics common stock. 346,000 711,500 Promissory note issued October 17, 2014 to Roger Bozarth. The note matures on October 17, 2015 and earns interest at a rate of 2% per annum. The Company was unable to repay the note at maturity and the note is in default, although no demand for repayment has been made by the lender. In the quarter ended March 31, 2016, this note and the accompanying interest was converted into 89,639 shares of Immune Therapeutics common stock. - 7,000 Promissory notes issued between May 1, 2015 and September 30, 2015, and maturing between June 14, 2015 and December 31, 2015. Lenders on loans aggregating $356,432 earn interest at rates between 10% and 18% per annum. On loans aggregating $223,500, interest is payable in a fixed amount not tied to a specific interest rate. Notes aggregating $223,500 were in default at March 31, 2016, as the Company was unable to repay those notes on their due dates. No demands for repayment have been made by the lenders. In the quarter ended March 31, 2016, $140,001 of these notes and their accompanying interest were converted into 2,420,377 shares of Immune Therapeutics common stock. 579,932 669,933 Promissory note issued January 26, 2015 to Robert J. Dailey. The note is senior to, and has priority in right of payment over, all indebtedness of the Company. The note earns interest at a rate of 2% per annum and was due on July 30, 2015. The Company was unable to repay the note at maturity and the note is in default, although no demand for repayment has been made by the lender. 200,000 200,000 Promissory notes issued by Cytocom Inc. between April 29, 2015 and December 31, 2015. Lenders earn interest at rates between 5% and 10% per annum. These notes mature on September 30, 2016. 750,000 800,000 Promissory notes issued in December 2015. Lenders earn interest at a rate of 10% per month. Notes are repayable on March 9, 2016. The Company was unable to repay the note at maturity and the note is in default. The Company is obligated to pay late-payment penalties totaling $6,667 per day. 130,000 130,000 Promissory note issued November 24, 2015 as settlement of amounts owing to a law firm. The Lender earns interest at the rate of 10% per annum. The note is repayable in full on December 1, 2016. 175,268 175,268 Promissory notes issued between January 1, 2016 and March 31, 2016. Lenders earn interest at a rate of 10% per month. Notes are repayable in one year. 312,000 Promissory note issued February 3, 2016, payable in 90 days which includes an original issue discount of $40,000 and expenses of $5,000, resulting in net proceeds of $200,000. 245,000 Total 2,838,200 2,793,701 Less: Current Portion (2,838,200 ) (2,793,701 ) Long-Term debt, less current portion $ - $ - As of March 31, 2016, the Company had accrued $365,006 in unpaid interest, compared to $236,671 as of December 31, 2015 |
Capital Structure - Common Stoc
Capital Structure - Common Stock and Common Stock Purchase Warrants | 3 Months Ended |
Mar. 31, 2016 | |
Notes to Financial Statements | |
Capital Structure - Common Stock and Common Stock Purchase Warrants | 6. Capital StructureCommon 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 March 31, 2016 and 2015, the Company was authorized to issue 500,000,000 common shares at a par value of $0.0001 per share. As of March 31, 2016, the Company had 205,127,530 shares of common stock outstanding and 178,850,047 outstanding as of December 31, 2015. Stock Warrants In the quarter ended March 31, 2016, the Company issued 15,600,000 warrants. There were no modifications of the terms of any warrants issued by the Company in the quarters ended March 31, 2016 and 2015. Following is a summary of outstanding stock warrants at March 31, 2016 and activity during the three months then ended: Number of Shares Exercise Price Weighted Average Price Warrants as of December 31, 2015 9,131,500 $ 0.07-15.00 $ 1.47 Issued in 2016 15,600,000 $ .020-2.00 $ 0.39 Expired - $ - $ - Exercised - $ - $ - Warrants as of March 31, 2016 24,731,500 $ 0.07-15.00 $ 0.79 Summary of outstanding warrants as of March 31, 2016: Expiration Date Number of Shares Exercise Price Remaining Life (years) Second Quarter 2016 37,500 $ 5.00 .25 Third Quarter 2016 525,000 $ 1.00-5.00 .50 Third Quarter 2017 1,500,000 $ 1.00 1.50 Fourth Quarter 2017 2,941,666 $ 1.00-9.00 1.75 First Quarter 2018 127,500 $ 15.00 2.00 Second Quarter 2018 33,334 $ 15.00 2.25 Third Quarter 2018 650,000 $ 1.00-1.50 2.50 Fourth Quarter 2018 1,197,500 $ 1.00-1.50 2.75 First Quarter 2019 4,024,000 $ 0.50-2.00 3.00 Second Quarter 2019 135,000 $ 0.070.23 3.25 Third Quarter 2019 260,000 $ 0.50 3.50 Fourth Quarter 2019 400,000 $ 0.14 3.75 Second Quarter 2020 300,000 $ 0.50 4.25 First Quarter 2021 12,600,000 $ 0.20 5.00 |
Stock Compensation
Stock Compensation | 3 Months Ended |
Mar. 31, 2016 | |
Equity [Abstract] | |
Stock Compensation | 7. Stock Compensation Shares Issued for Services During the quarters ended March 31, 2016 and 2015, the Company issued 19,043,000 and 9,272,502 shares of common stock respectively for consulting fees. The Company valued these shares at $1,314,169 and $1,712,876 respectively, based upon the fair market 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 $669,667 and $2,161,559 for the quarters ended March 31, 2016 and 2015. |
Income Taxes - Results of Opera
Income Taxes - Results of Operations | 3 Months Ended |
Mar. 31, 2016 | |
Income Tax Disclosure [Abstract] | |
Income Taxes - Results of Operations | 8. Income Taxes - Results of Operations There was no income tax expense reflected in the results of operations for the quarters ended March 31, 2016 and 2015 because the Company incurred a net loss in both quarters. The Company has recognized no tax benefit for the losses generated for the periods through December 31, 2015. 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 Companys 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 2015 and 2014 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, 2015, we have estimated federal and state income tax net operating loss (NOL) carry-forwards of approximately $66,500,000, which will expire in 2032-2035. |
Licenses and Supply Agreements
Licenses and Supply Agreements | 3 Months Ended |
Mar. 31, 2016 | |
Notes to Financial Statements | |
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 Naltraxone (LDN). The goal of TNI IPs management was to enable mankind and civilization to combat fatal diseases by activating and mobilizing the bodys own immune system using TNI IPs 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 Companys 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 IP 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 Peoples Republic of China, Application No.: 200810165784.8 China Patent CN1015113407 A The Patent Office of the Peoples 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 Companys 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, Hodgkins lymphoma, and non-Hodgkins 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 Companys common stock with a fair market 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. 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. In addition, we are required to make a minimum royalty in the amount of $100,000 for each year after 2014 until such time as we make a first commercial sale. 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 Crohns 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 market value of $2,715,000 and payment of $165,384 (consisting of a $100,000 initial license fee and payment of $65,384 of expenses), which totaled $2,880,384. The Smith Agreement requires the Company to (i) use commercially reasonable efforts to develop, commercialize, market and sell licensed products in a manner consistent with a business plan, (ii) expend a minimum amount of funds per annum to develop and commercialize licensed products as soon as practicable, (iii) obtain all requisite regulatory approvals needed to use or sell licensed products in the field of use, and (iv) make the first commercial sale of a licensed product by March of 2017. The Company is required to pay an annual license fee, an annual running royalty on net sales of each licensed product or a minimum royalty, whichever is greater, and a sublicense fee on payments received by the Company from sublicensees. The Company has an exclusive, worldwide license to make, have made, use, lease, import, offer for sale and sell licensed products and to use the method under the patent rights. The Smith Agreement will terminate on the expiration or abandonment of the last patent to expire or ten years after the sale of the first licensed product. The Company may terminate the Smith Agreement upon 90 days written notice, provided all sublicenses are terminated and all amounts due and owing are paid to the Licensor Parties. The Licensor Parties may terminate the agreement ten days after notice to the Company if the Company is ten days late in payment or there is a breach that remains uncured for ten days after written notice of such breach. The Company is also required to pay milestone payments after substantial achievement of certain milestone events for each licensed product including payment: upon initiation of each Phase III trial; upon positive completion of each Phase III clinical trial of the therapeutic use of an LDN compound in the field of use; when a New Drug Application (NDA) is accepted for review by the FDA; and when FDA approval to market the NDA is approved. The Company will issue shares upon reaching certain milestones including upon the first dosing of the first patient in a Phase III clinical trial for each licensed product, upon the first sale of each licensed product, and upon the achievement of a set dollar amount in cumulative sales for each licensed product covered by NDAs. As part of the Smith Agreement, the Company has the right to apply to the FDA for the transfer of the orphan drug status for the use of naltrexone for the treatment of pediatric Crohns disease and ulcerative colitis, the Investigation New Drug Application (IND), and the right to acquire the relevant clinical data set from Dr. Jill Smith. Dr. Jill Smith made arrangements to transfer the IND to the Company as well as the relevant clinical data set, and the FDA has acknowledged that the Company is now the sponsor for this IND. On September 24, 2014, the Company and the Licensor Parties jointly agreed to terminate the Smith Agreement, and in place thereof, have the Licensor Parties grant a similar license in their patent rights to Cytocom Inc. pursuant to a Patent License Agreement between the Licensor Parties, Cytocom Inc. and the Company with substantially similar terms as set forth in the Smith Agreement. Pursuant to this agreement, the Company issued 1,000,000 shares of its common stock valued at $270,000, upon execution to the Licensor Parties and the Company guaranteed the obligations of Cytocom Inc. to the Licensor Parties under the agreement. On January 18, 2013, the Company signed an exclusive licensing agreement with The Penn State Research Foundation to license all of the intellectual property developed by Dr. Ian S. Zagon, Dr. Patricia J. McLaughlin and Dr. Jill P. Smith for the treatment of cancer titled Opioid Growth Factor and Cancer and Combination Therapy with Opioid Growth Factor and Taxanes for the Treatment of Cancer (the Foundation Agreement). The Foundation Agreement requires the Company to: (a) use commercially reasonable efforts to develop, commercialize, market and sell licensed products in a manner consistent with a business plan; (b) expend a minimum amount of funds per annum to develop and commercialize licensed products as soon as practicable; (c) obtain all requisite regulatory approvals needed to use or sell licensed products in the field of use; and (d) make the first commercial sale of a licensed product by December 31, 2016. The Foundation Agreement provides that the Company must pay to the licensor an initial license fee, a license maintenance fee on each anniversary of the effective date of the Foundation Agreement, and an annual running royalty on net sales for each licensed product or a minimum royalty, whichever is greater. In addition, the Company must pay a sublicense fee on payments received by the Company from sublicensees. The Foundation Agreement also requires the Company to make payments upon the achievement of certain milestone events including: initiation of each Phase II trial; initiation of each Phase III trial; when the NDA is accepted for review by the FDA; and when FDA approval to market is approved. The Company must also issue shares upon certain milestones including upon the first dosing of the first patient in a Phase II clinical trial for each licensed product, upon the first dosing of the first patient in a Phase III clinical trial for each licensed product, upon the first sale of each licensed product, and upon the achievement of a set dollar amount of cumulative sales for each licensed product covered by NDAs. The Foundation Agreement terminates on the expiration or abandonment of the last patent to expire or become abandoned. The Company may terminate the Foundation Agreement at any time upon 60 days prior written notice and ceasing to make and sell all licensed products, the termination of all sublicenses and payment of all monies owed under the Foundation Agreement. The licensor may terminate the agreement 30 days after notice to the Company if the Company is 30 days late in payment or a breach that remains uncured for 45 days after written notice of such breach. In May of 2013, the Company executed a Patent License Agreement with Professor Fengping Shan (the Shan Agreement) pursuant to which it obtained exclusive rights to develop and commercialize the licensed technology. The licensed technology is the intellectual property developed and owned by Professor Shan (i) relating to the treatment of a variety of diseases and conditions with MENK including multiple forms of lymphoma and cancer and (ii) a treatment method for humans infected with the HLTV-III (AIDS) virus including AIDS and AIDS related complex (ARC). The licensed technology includes the methods and formulations for these treatments including all INDs, communications with regulatory agencies, patient data, and letters relating to these treatments. The licensed technology also includes certain patents developed by Professor Shan. Under the Shan Agreement, the Company must issue 500,000 shares to Professor Shan upon final transfer of the licenses, and reimburse Professor Shan for all out of pocket expenses in connection with the patents. The Company will pay Professor Shan a running royalty on gross sales subject to decreases if third party intellectual property is needed to complete such sale or product. The Shan Agreement lasts for the duration of each of the licensed patents however the Company may terminate the Shan Agreement on 120 days written notice to Professor Shan. On August 6, 2014, Professor Fengping Shan executed an Assignment pursuant to which he transferred to the Company his entire right, title and interest in and to the licensed patents under the Shan Agreement and CN 201210302259 Application of combination of low-dose naltrexone and methionine-enkephalin to preparation of anti-cancer drug for the consideration of 500,000 shares of common stock valued at $140,000. |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2016 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 10. Commitments and Contingencies Malawi Treatment Facilities On July 14, 2012, GB Oncology and Imaging Group LTD (GBOIG) in partnership with the Company signed a letter of intent agreement to collaborate with the Government of Malawi to assist in expanding the treatment of cancer, HIV/AIDS and other infectious diseases. In December of 2014, the Government of Malawi completed an oncology clinic at the Queen Elizabeth Central Hospital in Blantyre, Malawi for the treatment of cancer and infectious diseases. In 2015, the Company submitted protocols seeking permission from the Pharmacy, Medicines and Poisons Board of Malawi (PMPB) to conduct two trials involving Lodonal in Malawi: a. The first protocol, submitted jointly with The Jack Brewer Foundation (JBF Worldwide), received PMPB approval on November 11, 2015. The protocol covers a 12-month trial for a Single Visit Approach to Cervical Cancer Prevention. The approach is designed to deliver a preventive and simple procedure that can be performed in a clinical setting without the use of a laboratory and to allow for immediate treatment of any precancerous lesions utilizing Wallach LL100 Cryosurgical systems. The protocol provides for 50% of the patient group to be put on Lodonal to determine if the drug lowers the number of opportunistic infections during the year, and if it can be shown that LDN increases CD4, CE8, NK and T cell count, which would show that the incidence rates of opportunistic infection could decrease with Lodonal and that Lodonal could be used as a prophylaxis to prevent substantial HIV-related morbidity in Malawi. The final trial agreement with PMPB was signed in February 2016. Lodonal pills have been produced in Nicaragua in anticipation of the trial. Shipments will commence once the trial is approved. b. The second protocol, which has not yet been approved, covers a trial using Lodonal for the treatment of cancer. The Company and GBOIG will work with the government of Malawi to open and operate other clinics that provide treatments for HIV/AIDS, cancer and other infectious diseases. Under the letter of intent, the Company and GBOIG intend to provide HIV/AIDS treatment to 25,000 patients and hopefully expanding to 500,000 within 24 months. The Company shall contribute $1,000 in initial capital to the venture. The Company shall be allocated 50% of the net income from the venture. Either party may terminate the venture with 180 days notice to the other party prior to the one-year anniversary of the Agreement. After the one-year anniversary, the agreement may only be terminated with 180 days notice to the other party if the other party has breached the Agreement. GBOIG, a subsidiary of GB Energie LLC, is a Washington D.C. based minority woman-owned business managed by Dr. Gloria B. Herndon. Dr. Herndon is a former director of the Company. Dr. Herndons directorship with the Company ended September 4, 2014. Open an Oncology and Infectious Disease Center in Malawi at Queen Elizabeth Central Hospital On September 25, 2012, GBOIG, in partnership with the Company, signed an agreement with the Government of Malawi to open an outpatient clinic at Queen Elizabeth Central Hospital (in Malawi) for the treatment of cancer and infectious disease. The duration of the Agreement shall be for 25 years with an optional 10-year renewal to be indicated by the Government of Malawi at least three years prior to the expiration of the term. The Government of Malawi will bear the upfront costs for the agreement of $2,500,000. Distribution Agreements in Nigeria In October 2013, the Company announced the signing of a Distribution Agreement with AHAR Pharma, a Nigerian company, to market Lodonal in Nigeria for the treatment of autoimmune diseases and cancer. AHAR intends to distribute Lodonal through a local distributor network, an Internet client base and directly to hospitals, pharmacists and doctors in Nigeria. 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 Pharmas 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 LodonalTM upon execution of a definitive agreement between the companies. In April 2016, the Company announced that Nigerias National Agency for Food and Drug Administration and Control (NAFDAC) had approved its LodonalTM as an over the counter, non-toxic adjunct therapy in the treatment of HIV/AIDS and immune system regulator. NAFDAC is the Nigerian agency under the Federal Ministry of Health that is responsible for regulating and controlling the manufacture, import/export, distribution, sale and use of food and drugs. Its approval clears the way for the Company and its distribution partners to complete the registration of LodonalTM for sale in Nigeria. 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 Companys 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 will make 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. 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 Companys 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. Supervision and Inspection of Manufacturing in Nicaragua On April 23, 2013, the Company signed a Contract with ViPharma for the Supervision and Inspection of Manufacturing Processes as part of its negotiations for a contract for the manufacturing of LDN in a tablet, capsule and/or cream. The contract sets out the terms and conditions under which ViPharma will carry out the services of inspecting and supervising the manufacturing and packaging processes of LDN and ensure compliance with the FDAs Current Good Manufacturing Practice regulations (cGMP) and the Companys specifications. ViPharma will carry out its obligations in whatever Latin American country the Company ultimately decides to manufacture LDN. Under the contract, ViPharma has the exclusive rights to supervise and inspect all manufacturing processes of LDN in Latin America. The initial term of the agreement is ten years commencing in September 2013, with automatic five-year renewal terms provided neither party is in breach. The agreement may be terminated by (i) mutual agreement, (ii) in the event of a breach after a 45 day cure period or (iii) by either party upon provision of written notice at least 90 days before the end of the agreement, provided however that if the Company terminates the contract without cause it will be required to pay ViPharma a $10 million penalty. Operating Leases At March 31, 2016, the Company was a party to an agreement to lease office space in Orlando, Florida. Rent expense for the quarters ended March 31, 2016 and 2015 was $(114,794) and $18,319, respectively. The 2016 expense reflects the reversal of accruals for rent expense in prior years, including the settlement with E.J. Krause & Associates, Inc. referred to in Legal Proceedings below. Legal Proceedings In October 2014, a claim was filed for breach of contract and unjust enrichment in the United States District Court, Middle District of Florida, Orlando Division, QS Pharma, LLC v. TNI BioTech, Inc. n/k/a Immune Therapeutics, Inc., In February 2015, a claim was filed for breach of contract and unjust enrichment in the Circuit Court for Montgomery County, Maryland, E.J. Krause & Associates, Inc. v. TNI BioTech, Inc. |
Subsequent Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2016 | |
Subsequent Events [Abstract] | |
Subsequent Events | 11. Subsequent Events On May 1, 2016, the Company entered into a one-year employment agreement with Robert Wilson, the son of the Companys Chief Executive Officer, as the Companys Senior Content and Web Developer. The terms of the agreement provide for payment to Mr. Wilson of an annual base salary of $120,000, and health insurance coverage. On May 9, 2016, the Company and KRS Global Bio Technology, Inc. mutually agreed to terminate their Contract for the Compounding of Pharmaceutical Products dated December 8, 2014. Between March 31, 2016 and May 16, 2016 the Company issued promissory notes aggregating $961,250 and paid off notes totaling $245,000. The Company issued 1,786,285 shares of common stock between March 31, 2016 and May 16, 2016, of which, 450,000 shares are for consulting fees, 836,285 shares are for debt conversions and 500,000 shares are for loan origination fees. As of May 16, 2016, the Company had outstanding 206,913,301 shares of common stock. |
Summary of Significant Accoun18
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2016 | |
Summary Of Significant Accounting Policies Policies | |
Basis of Presentation | Basis of Presentation The accompanying consolidated financial statements have been prepared in accordance with United States (U.S.) generally accepted accounting principles (U.S. GAAP) and include all adjustments (consisting of only normal recurring adjustments, unless otherwise indicated) necessary for the fair presentation of the Companys financial position for the periods presented. The Company qualifies as an emerging growth company as defined in Section 101 of the Jumpstart our Business Startups Act (JOBS Act) as we do not have more than $1,000,000,000 in annual gross revenue for the year ended December 31, 2015. 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. |
Use of Estimates | Use of Estimates The preparation of the Companys 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 March 31, 2016, the Company has no uninsured cash balances. |
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 Measurements |
Property and Equipment | Property and Equipment Property and equipment 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 quarters ended March 31, 2016 and March 31, 2015 was $547 and $668, respectively. |
Intangible Assets | Intangible Assets Costs incurred to acquire and/or develop the Companys product licenses and patents are capitalized and amortized by straight-line methods over estimated useful lives of seven to sixteen years. Intangible assets are stated at the lower of cost or estimated fair market value. During the quarters ended March 31, 2016 and March 31, 2015, the Company did not capitalize any such costs. (See Note 10). Amortization expense for the quarters ended March 31, 2016 and March 31, 2015 was $0 and $148,059, respectively. |
Impairment of Long-lived Assets | Impairment of Long-Lived Assets The Company evaluates long-lived assets for impairment whenever events or changes 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 Companys 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 FASB ASC Topic 740, Income Taxes, The standard addresses the determination of whether tax benefits claimed or expected to be claimed on a tax return should be recorded in the financial statements. Under ASC Topic 740, the Company may recognize the tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination by the tax authorities, based on the technical merits of the position. The tax benefits recognized in the financial statements from such a position should be measured based on the largest benefit that has a greater than fifty percent likelihood of being realized upon ultimate settlement. ASC Topic 740 also provides guidance on de-recognition, classification, interest and penalties on income taxes, accounting in interim periods and requires increased disclosures. At the date of adoption, and as of December 31, 2015, and 2014, the Company does not have a liability for unrecognized tax uncertainties. The Companys policy is to record interest and penalties on uncertain tax positions as income tax expense. At the end of the quarters ended March 31, 2016 and March 31, 2015, the Company had 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 Companys common stock at the date of the agreement. The Companys 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 810, Consolidation |
Net Loss Per Share | Net Loss per Share Basic net loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted average number of common shares outstanding for the period, without consideration for common stock equivalents. Diluted net loss per share is calculated by dividing the net loss by the weighted-average number of common share equivalents outstanding for the period determined using the treasury-stock method and the if-converted method. Dilutive common stock equivalents are comprised of common stock purchase warrants and options outstanding. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding due to the Companys net loss position. A calculation of basic and diluted net loss per share follows: For the three months ended March 31, 2016 2015 Historical net loss per share: Numerator Net loss $ (6,645,402 ) $ (2,905,406 ) Non-controlling interest (44,120 ) (124,065 ) Net loss attributed to Common stockholders $ (6,601,282 ) $ (2,781,341 ) Denominator Weighted-average common shares outstandingDenominator for basic and diluted net loss per share 190,923,381 138,795,044 Basic and diluted net loss per share attributed to common stockholders $ (0.03 ) $ (0.02 ) The Companys potential dilutive securities which include stock and warrants have been excluded from the computation of diluted net loss per share as the effect would be to reduce the net loss per share. Therefore, the weighted-average Common stock outstanding used to calculate both basic and diluted net loss per share is the same. The following shares of potentially dilutive securities have been excluded from the computations of diluted weighted average shares outstanding as the effect of including such securities would be antidilutive: For the three months ended March 31, 2016 2015 Warrants to purchase Common stock 24,731,500 9,372,750 |
Recent Accounting Standards | Recent Accounting Standards During the quarter ended March 31, 2016, 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 Companys consolidated financial statements. |
Summary of Significant Accoun19
Summary of Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2016 | |
Summary Of Significant Accounting Policies Tables | |
Schedule of Basic and Diluted Net Loss Per Share | A calculation of basic and diluted net loss per share follows: For the three months ended March 31, 2016 2015 Historical net loss per share: Numerator Net loss $ (6,645,402 ) $ (2,905,406 ) Non-controlling interest (44,120 ) (124,065 ) Net loss attributed to Common stockholders $ (6,601,282 ) $ (2,781,341 ) Denominator Weighted-average common shares outstandingDenominator for basic and diluted net loss per share 190,923,381 138,795,044 Basic and diluted net loss per share attributed to common stockholders $ (0.03 ) $ (0.02 ) |
Schedule of Antidilutive Securities | The following shares of potentially dilutive securities have been excluded from the computations of diluted weighted average shares outstanding as the effect of including such securities would be antidilutive: For the three months ended March 31, 2016 2015 Warrants to purchase Common stock 24,731,500 9,372,750 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 3 Months Ended |
Mar. 31, 2016 | |
Property And Equipment Tables | |
Schedule of Property and Equipment | March 31, 2016 December 31, 2015 Property and equipment: Computer equipment $ 8,013 $ 8,013 Less accumulated depreciation (6,878 ) (6,331 ) Property and equipment, net $ 1,135 $ 1,682 |
Accrued Liabilities (Tables)
Accrued Liabilities (Tables) | 3 Months Ended |
Mar. 31, 2016 | |
Accrued Liabilities Tables | |
Schedule of Accrued Liabilities | Accrued expenses and other liabilities consist of the following: March 31, 2016 December 31, 2015 (in thousands) Accrued payroll to officers and others $ 1,077,640 $ 758,342 Accrued interest - notes payable 365,006 236,671 Estimated legal settlement 198,312 282,136 Other accrued liabilities 393 323 State payroll taxes - 3,567 Total accrued expenses and other liabilities $ 1,641,351 $ 1,281,039 |
Notes Payable (Tables)
Notes Payable (Tables) | 3 Months Ended |
Mar. 31, 2016 | |
Notes Payable Tables | |
Schedule of Notes Payable | Notes payable consist of the following: March 31, 2016 December 31, 2015 Promissory note issued July 29, 2014 to Ira Gaines. The note matures on January 27, 2015 and earns interest at a rate of 18% per annum. The Company was unable to repay the note at maturity and the note is in default, although no demand for repayment has been made by the lender. $ 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 Companys 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 $346,000 were in default at March 31, 2016, as the Company was unable to pay installments on those notes on their due dates. No demands for repayment have been made by the lenders. In the quarter ended March 31, 2016, $365,500 of these notes and their accompanying interest were converted into 5,191,909 shares of Immune Therapeutics common stock. 346,000 711,500 Promissory note issued October 17, 2014 to Roger Bozarth. The note matures on October 17, 2015 and earns interest at a rate of 2% per annum. The Company was unable to repay the note at maturity and the note is in default, although no demand for repayment has been made by the lender. In the quarter ended March 31, 2016, this note and the accompanying interest was converted into 89,639 shares of Immune Therapeutics common stock. - 7,000 Promissory notes issued between May 1, 2015 and September 30, 2015, and maturing between June 14, 2015 and December 31, 2015. Lenders on loans aggregating $356,432 earn interest at rates between 10% and 18% per annum. On loans aggregating $223,500, interest is payable in a fixed amount not tied to a specific interest rate. Notes aggregating $223,500 were in default at March 31, 2016, as the Company was unable to repay those notes on their due dates. No demands for repayment have been made by the lenders. In the quarter ended March 31, 2016, $140,001 of these notes and their accompanying interest were converted into 2,420,377 shares of Immune Therapeutics common stock. 579,932 669,933 Promissory note issued January 26, 2015 to Robert J. Dailey. The note is senior to, and has priority in right of payment over, all indebtedness of the Company. The note earns interest at a rate of 2% per annum and was due on July 30, 2015. The Company was unable to repay the note at maturity and the note is in default, although no demand for repayment has been made by the lender. 200,000 200,000 Promissory notes issued by Cytocom Inc. between April 29, 2015 and December 31, 2015. Lenders earn interest at rates between 5% and 10% per annum. These notes mature on September 30, 2016. 750,000 800,000 Promissory notes issued in December 2015. Lenders earn interest at a rate of 10% per month. Notes are repayable on March 9, 2016. The Company was unable to repay the note at maturity and the note is in default. The Company is obligated to pay late-payment penalties totaling $6,667 per day. 130,000 130,000 Promissory note issued November 24, 2015 as settlement of amounts owing to a law firm. The Lender earns interest at the rate of 10% per annum. The note is repayable in full on December 1, 2016. 175,268 175,268 Promissory notes issued between January 1, 2016 and March 31, 2016. Lenders earn interest at a rate of 10% per month. Notes are repayable in one year. 312,000 Promissory note issued February 3, 2016, payable in 90 days which includes an original issue discount of $40,000 and expenses of $5,000, resulting in net proceeds of $200,000. 245,000 Total 2,838,200 2,793,701 Less: Current Portion (2,838,200 ) (2,793,701 ) Long-Term debt, less current portion $ - $ - |
Capital Structure - Common St23
Capital Structure - Common Stock and Common Stock Purchase Warrants (Tables) | 3 Months Ended |
Mar. 31, 2016 | |
Capital Structure - Common Stock And Common Stock Purchase Warrants Tables | |
Schedule of Outstanding Stock Warrants | Following is a summary of outstanding stock warrants at March 31, 2016 and activity during the three months then ended: Number of Shares Exercise Price Weighted Average Price Warrants as of December 31, 2015 9,131,500 $ 0.07-15.00 $ 1.47 Issued in 2016 15,600,000 $ .020-2.00 $ 0.39 Expired - $ - $ - Exercised - $ - $ - Warrants as of March 31, 2016 24,731,500 $ 0.07-15.00 $ 0.79 |
Summary of Outstanding Warrants | Summary of outstanding warrants as of March 31, 2016: Expiration Date Number of Shares Exercise Price Remaining Life (years) Second Quarter 2016 37,500 $ 5.00 .25 Third Quarter 2016 525,000 $ 1.00-5.00 .50 Third Quarter 2017 1,500,000 $ 1.00 1.50 Fourth Quarter 2017 2,941,666 $ 1.00-9.00 1.75 First Quarter 2018 127,500 $ 15.00 2.00 Second Quarter 2018 33,334 $ 15.00 2.25 Third Quarter 2018 650,000 $ 1.00-1.50 2.50 Fourth Quarter 2018 1,197,500 $ 1.00-1.50 2.75 First Quarter 2019 4,024,000 $ 0.50-2.00 3.00 Second Quarter 2019 135,000 $ 0.070.23 3.25 Third Quarter 2019 260,000 $ 0.50 3.50 Fourth Quarter 2019 400,000 $ 0.14 3.75 Second Quarter 2020 300,000 $ 0.50 4.25 First Quarter 2021 12,600,000 $ 0.20 5.00 |
Organization and Description 24
Organization and Description of Business (Details Narrative) - USD ($) | Dec. 08, 2014 | Mar. 31, 2014 | Mar. 31, 2016 | Mar. 31, 2015 | Dec. 31, 2015 |
Net loss | $ 6,645,402 | $ 2,905,406 | |||
Cash equivalents | 497,962 | ||||
Stockholders equity | $ 6,185,136 | $ 5,958,184 | |||
Cytocom Inc., [Member] | |||||
Number of shares issued druing period | 113,242,522 | 140,100,000 | |||
Percentage of stake issued during period | 55.30% | 50.20% | |||
Irish Limited Liability [Member] | |||||
Percentage of low corporate income tax rate | 12.50% |
Summary of Significant Accoun25
Summary of Significant Accounting Policies (Details Narrative) - USD ($) | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | Dec. 31, 2015 | |
Summary Of Significant Accounting Policies Details Narrative | |||
Maximum of annual gross revenue | $ 1,000,000,000 | ||
Federal deposit insurance corporation value | $ 250,000 | ||
Depreciation expense | 547 | $ 668 | |
Amortization expense | $ 0 | $ 148,059 | |
Impairment loss |
Summary of Significant Accoun26
Summary of Significant Accounting Policies - Schedule of Basic and Diluted Net Loss Per Share (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | |
Summary Of Significant Accounting Policies - Schedule Of Basic And Diluted Net Loss Per Share Details | ||
Numerator, Net loss | $ (6,645,402) | $ (2,905,406) |
Numerator, Non-controlling interest | (44,120) | (124,065) |
Numerator, Net loss attributed to Common stockholders | $ (6,601,282) | $ (2,781,341) |
Denominator, Weighted-average common shares outstanding-Denominator for basic and diluted net loss per share | 190,923,381 | 138,795,044 |
Denominator, Basic and diluted net loss per share attributed to common stockholders | $ (0.03) | $ (0.02) |
Summary of Significant Accoun27
Summary of Significant Accounting Policies - Schedule of Antidilutive Securities (Details) - shares | 3 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | |
Summary Of Significant Accounting Policies - Schedule Of Basic And Diluted Net Loss Per Share Details | ||
Warrants to purchase Common stock | 24,731,500 | 9,372,750 |
Property and Equipment (Details
Property and Equipment (Details Narrative) | 3 Months Ended |
Mar. 31, 2016 | |
Property And Equipment Details Narrative | |
Depreciable asset lives | 5 years |
Property and Equipment - Schedu
Property and Equipment - Schedule of Property and Equipment (Details) - USD ($) | Mar. 31, 2016 | Dec. 31, 2015 |
Property And Equipment - Schedule Of Property And Equipment Details | ||
Computer equipment | $ 8,013 | $ 8,013 |
Less accumulated depreciation | (6,878) | (6,331) |
Property and equipment, net | $ 1,135 | $ 1,682 |
Accrued Liabilities - Schedule
Accrued Liabilities - Schedule of Accrued Liabilities (Details) - USD ($) | Mar. 31, 2016 | Dec. 31, 2015 |
Accrued Liabilities - Schedule Of Accrued Liabilities Details | ||
Accrued payroll to officers and others | $ 1,077,640,000 | $ 758,342,000 |
Accrued interest - notes payable | 365,006,000 | 236,671,000 |
Estimated legal settlement | 198,312,000 | 282,136,000 |
Other accrued liabilities | $ 393,000 | 323,000 |
State payroll taxes | 3,567,000 | |
Total accrued expenses and other liabilities | $ 1,641,351,000 | $ 1,281,039,000 |
Notes Payable (Details Narrativ
Notes Payable (Details Narrative) - USD ($) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2016 | Dec. 31, 2015 | |
Notes Payable Details Narrative | ||
Accrued unpaid interest | $ 365,006 | $ 236,671 |
Notes Payable - Schedule of Not
Notes Payable - Schedule of Notes Payable (Details) - USD ($) | Mar. 31, 2016 | Dec. 31, 2015 |
Total | $ 2,838,200 | $ 2,793,701 |
Less: Current portion | (2,838,200) | (2,793,701) |
Notes Payable One [Member] | ||
Total | 100,000 | 100,000 |
Notes Payable Two [Member] | ||
Total | $ 346,000 | 711,500 |
Notes Payable Three [Member] | ||
Total | 7,000 | |
Notes Payable Four [Member] | ||
Total | $ 579,932 | 669,933 |
Notes Payable Five [Member] | ||
Total | 200,000 | 200,000 |
Notes Payable Six [Member] | ||
Total | 750,000 | 800,000 |
Notes Payable Seven [Member] | ||
Total | 130,000 | 130,000 |
Notes Payable Eight [Member] | ||
Total | 175,268 | $ 175,268 |
Notes Payable Nine [Member] | ||
Total | 312,000 | |
Notes Payable Ten [Member] | ||
Total | $ 245,000 |
Notes Payable - Schedule of N33
Notes Payable - Schedule of Notes Payable (Details) (Parenthetical) | Feb. 03, 2016USD ($) | Nov. 24, 2015 | Jan. 26, 2015 | Oct. 17, 2014 | Jul. 29, 2014 | Dec. 31, 2015USD ($) | Mar. 31, 2016USD ($)shares | Mar. 31, 2015 | Sep. 30, 2015USD ($)Installments | Dec. 31, 2015USD ($)shares |
Percentage of interest rate per annum | 10.00% | 10.00% | ||||||||
Maximum amount raise in debt | $ 2,000,000 | |||||||||
Number of installments, months | Installments | 36 | |||||||||
Original issue discount | $ 40,000 | |||||||||
Debt issuance cost | 5,000 | |||||||||
Net proceeds from notes payable | $ 200,000 | |||||||||
Cytocom Inc., [Member] | ||||||||||
Note matures date | Sep. 30, 2016 | |||||||||
Minimum [Member] | Cytocom Inc., [Member] | ||||||||||
Percentage of interest rate per annum | 5.00% | |||||||||
Maximum [Member] | Cytocom Inc., [Member] | ||||||||||
Percentage of interest rate per annum | 10.00% | |||||||||
Ira Gaines [Member] | ||||||||||
Note matures date | Jan. 27, 2015 | |||||||||
Percentage of interest rate per annum | 18.00% | |||||||||
Lenders [Member] | ||||||||||
Notes aggregating default amount | $ 346,000 | |||||||||
Value of notes that converted into shares | $ 365,500 | |||||||||
Notes and interest converted into shares | shares | 5,191,909 | |||||||||
Aggregating loan | $ 356,432 | |||||||||
Interest payable | $ 223,500 | |||||||||
Lenders [Member] | Minimum [Member] | ||||||||||
Percentage of interest rate per annum | 10.00% | |||||||||
Lenders [Member] | Maximum [Member] | ||||||||||
Percentage of interest rate per annum | 18.00% | |||||||||
Roger Bozarth [Member] | ||||||||||
Note matures date | Oct. 17, 2015 | |||||||||
Percentage of interest rate per annum | 2.00% | |||||||||
Notes and interest converted into shares | shares | 89,639 | |||||||||
Lenders [Member] | ||||||||||
Maximum amount raise in debt | $ 140,001 | |||||||||
Notes aggregating default amount | $ 223,500 | |||||||||
Notes and interest converted into shares | shares | 2,420,377 | |||||||||
Robert J. Dailey [Member] | ||||||||||
Note matures date | Jul. 30, 2015 | |||||||||
Percentage of interest rate per annum | 2.00% | |||||||||
Lender [Member] | ||||||||||
Note matures date | Mar. 9, 2016 | |||||||||
Percentage of interest rate per annum | 10.00% | 10.00% | ||||||||
Pay late-payment penalties per day | $ 6,667 | $ 6,667 | ||||||||
Lender [Member] | ||||||||||
Note matures date | Dec. 1, 2016 | |||||||||
Percentage of interest rate per annum | 10.00% |
Capital Structure - Common St34
Capital Structure - Common Stock and Common Stock Purchase Warrants (Details Narrative) - $ / shares | 3 Months Ended | ||
Mar. 31, 2016 | Dec. 31, 2015 | Mar. 31, 2015 | |
Capital Structure - Common Stock And Common Stock Purchase Warrants Details Narrative | |||
Common Stock, Par Value | $ 0.0001 | $ 0.0001 | $ 0.0001 |
Common Stock, Shares Authorized | 500,000,000 | 500,000,000 | 500,000,000 |
Common Stock, Shares Issued | 205,127,530 | 174,850,047 | |
Common Stock, Shares Outstanding | 205,127,530 | 174,850,047 | |
Number of warrants issued during period | 15,600,000 |
Capital Structure - Common St35
Capital Structure - Common Stock and Common Stock Purchase Warrants - Schedule of Outstanding Stock Warrants (Details) - Warrant [Member] | 3 Months Ended |
Mar. 31, 2016$ / sharesshares | |
Warrants, Number of shares Beginning balance | shares | 9,131,500 |
Warrants, Number of shares Issued | shares | 15,600,000 |
Warrants, Number of shares Expired | shares | |
Warrants, Number of shares Exercised | shares | |
Warrants, Number of shares Ending balance | shares | 24,731,500 |
Exercise Price, Expired | $ 1.50 |
Exercise Price, Exercised | .50 |
Weighted average exercise price, Beginning balance | 1.47 |
Weighted average exercise price, Issued | $ 0.39 |
Weighted average exercise price, Expired | |
Weighted average exercise price, Exercised | |
Weighted average exercise price, Ending balance | $ 0.79 |
Minimum [Member] | |
Exercise Price, Beginning balance | 0.07 |
Exercise Price, Issued | 0.20 |
Exercise Price, Ending balance | 0.07 |
Maximum [Member] | |
Exercise Price, Beginning balance | 15 |
Exercise Price, Issued | .50 |
Exercise Price, Ending balance | $ 15 |
Capital Structure - Common St36
Capital Structure - Common Stock and Common Stock Purchase Warrants - Summary of Outstanding Warrants (Details) | 3 Months Ended |
Mar. 31, 2016$ / sharesshares | |
Second Quarter 2016 [Member] | |
Number of Shares | shares | 37,500 |
Exercise Price Lower Limit | $ 5 |
Remaining Life (years) | 6 months |
Third Quarter 2016 [Member] | |
Number of Shares | shares | 525,000 |
Exercise Price Lower Limit | $ 1 |
Exercise Price Upper Limit | $ 5 |
Remaining Life (years) | 6 months |
Third Quarter 2017 [Member] | |
Number of Shares | shares | 1,500,000 |
Exercise Price Lower Limit | $ 1 |
Remaining Life (years) | 1 year 6 months |
Fourth Quarter 2017 [Member] | |
Number of Shares | shares | 2,941,666 |
Exercise Price Lower Limit | $ 1 |
Exercise Price Upper Limit | $ 9 |
Remaining Life (years) | 1 year 9 months |
First Quarter 2018 [Member] | |
Number of Shares | shares | 127,500 |
Exercise Price Lower Limit | $ 15 |
Remaining Life (years) | 2 years |
Second Quarter 2018 [Member] | |
Number of Shares | shares | 33,334 |
Exercise Price Lower Limit | $ 15 |
Remaining Life (years) | 2 years 3 months |
Third Quarter 2018 [Member] | |
Number of Shares | shares | 650,000 |
Exercise Price Lower Limit | $ 1 |
Exercise Price Upper Limit | $ 1.50 |
Remaining Life (years) | 2 years 6 months |
Fourth Quarter 2018 [Member] | |
Number of Shares | shares | 1,197,500 |
Exercise Price Lower Limit | $ 1 |
Exercise Price Upper Limit | $ 1.50 |
Remaining Life (years) | 2 years 9 months |
First Quarter 2019 [Member] | |
Number of Shares | shares | 4,024,000 |
Exercise Price Lower Limit | $ 1.50 |
Exercise Price Upper Limit | $ 2 |
Remaining Life (years) | 3 years |
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) | 3 years 3 months |
Third Quarter 2019 [Member] | |
Number of Shares | shares | 260,000 |
Exercise Price Lower Limit | $ .50 |
Remaining Life (years) | 3 years 6 months |
Fourth Quarter 2019 [Member] | |
Number of Shares | shares | 400,000 |
Exercise Price Lower Limit | $ .14 |
Remaining Life (years) | 3 years 9 months |
Second Quarter 2020 [Member] | |
Number of Shares | shares | 300,000 |
Exercise Price Lower Limit | $ .50 |
Remaining Life (years) | 4 years 3 months |
Second Quarter 2021 [Member] | |
Number of Shares | shares | 12,600,000 |
Exercise Price Lower Limit | $ 0.20 |
Remaining Life (years) | 5 years |
Stock Compensation (Details Nar
Stock Compensation (Details Narrative) - USD ($) | 3 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | |
Number of common stock issued for consulting fees | 19,043,000 | 9,272,502 |
Fair value of common stock | $ 1,314,169 | $ 1,712,876 |
Amortization of prepaid services | $ 669,667 | $ 2,161,559 |
Minimum [Member] | ||
Consulting fees amortized period | 12 months | |
Maximum [Member] | ||
Consulting fees amortized period | 24 months |
Income Taxes - Results of Ope38
Income Taxes - Results of Operations (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Income Taxes - Results Of Operations Details Narrative | ||
Effective tax rate | 0.00% | 0.00% |
Deferred tax assets | ||
Operating loss carryforwards | $ 66,500,000 | |
Operating loss carryforwards expire term | expire in 2032-2035. |
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 | Mar. 31, 2016 | Dec. 31, 2014 | Dec. 31, 2013 |
Minimum royalty amount | $ 100,000 | ||||||||
Issued common stock value | $ 1,314,169 | ||||||||
Young Agreement [Member] | |||||||||
Patent liability | $ 118,333 | ||||||||
Cost of the patent | $ 1,372,000 | ||||||||
Smith Agreement [Member] | |||||||||
Number of shares acquired in exchange for common stock | 300,000 | ||||||||
Acquisition value | $ 2,880,384 | ||||||||
Fair market value acquired | 2,715,000 | ||||||||
Payments for expenses | 165,384 | ||||||||
Number of common stock shares issued during period | 1,000,000 | ||||||||
Issued common stock value | $ 270,000 | ||||||||
Smith Agreement [Member] | Initial License Fee [Member] | |||||||||
Payments for expenses | 100,000 | ||||||||
Smith Agreement [Member] | Expenses [Member] | |||||||||
Payments for expenses | $ 65,384 | ||||||||
Shan Agreement [Member] | |||||||||
Number of common stock shares issued during period | 500,000 | ||||||||
Issued common stock value | $ 140,000 | ||||||||
Number of shares issue upon final transfer of licenses | 500,000 | ||||||||
Dr. Plotnikoff [Member] | |||||||||
Number of shares acquired in exchange for common stock | 8,000,000 | ||||||||
TNI IPs 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 | ||||||||
TNI BioTech IP, Inc. [Member] | |||||||||
Number of shares acquired in exchange for common stock | 20,250,000 | ||||||||
Acquisition value | $ 98,000,000 |
Commitments and Contingencies (
Commitments and Contingencies (Details Narrative) - USD ($) | Apr. 23, 2013 | Oct. 18, 2012 | Sep. 25, 2012 | Jul. 14, 2012 | Oct. 31, 2014 | Feb. 28, 2014 | Oct. 31, 2013 | Mar. 31, 2016 | Mar. 31, 2015 | Oct. 31, 2015 | Dec. 31, 2015 |
Letter of intent, description | the letter of intent, the Company and GBOIG intend to provide HIV/AIDS treatment to 25,000 patients and hopefully expanding to 500,000 within 24 months. | ||||||||||
Initial capital to venture | $ 1,000 | ||||||||||
Percentage of allocated income from venture | 50.00% | ||||||||||
Cash rental expense | $ 53,205 | $ 147,236 | |||||||||
May 15, 2016 [Member] | |||||||||||
Debt instruments installment | 198,312 | ||||||||||
Orlando, Florida [Member] | |||||||||||
Cash rental expense | $ (114,794) | $ 18,319 | |||||||||
Plaintiff Claims [Member] | |||||||||||
Seeking damages in excess | $ 75,000 | ||||||||||
Default judgment entered in favor of legal party amount | $ 80,000 | ||||||||||
Accrued for claim | $ 210,452 | ||||||||||
Withdrew from bank account towards settlement of claim | $ 92,590 | ||||||||||
Plaintiff EK Krause & Associates [Member] | |||||||||||
Default judgment entered in favor of legal party amount | 259,894 | ||||||||||
Accrued for claim | $ 279,000 | ||||||||||
GBOIG [Member] | |||||||||||
Upfornt costs | $ 2,500,000 | ||||||||||
Distribution Agreements In Nigeria [Member] | |||||||||||
Initial supply, description | 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 Pharmas first-year purchase commitment. | ||||||||||
Agreements With Hubei Qianjiang Pharmaceutical Company [Member] | |||||||||||
Percentage of gross sales | 6.00% | ||||||||||
Agreements With Hubei Qianjiang Pharmaceutical Company [Member] | |||||||||||
Initial supply, description | By either party upon provision of written notice at least 90 days before the end of the agreement, provided however that if the Company terminates the contract without cause it will be required to pay ViPharma a $10 million penalty. |
Subsequent Events (Details Narr
Subsequent Events (Details Narrative) - USD ($) | May. 01, 2016 | Feb. 03, 2016 | May. 16, 2016 | Mar. 31, 2016 | Dec. 31, 2015 |
Proceeds fom notes payable | $ 200,000 | ||||
Common stock outstanding | 205,127,530 | 174,850,047 | |||
Subsequent Event [Member] | |||||
Proceeds fom notes payable | $ 961,250 | ||||
Repayments of notes payable | $ 245,000 | ||||
Number of stock issued for debt conversion | 1,786,285 | ||||
Number of shares issued for consulting fees | 450,000 | ||||
Number of shares issued for debt conversion | 836,285 | ||||
Number of shares issued for loan orignation fees | 500,000 | ||||
Common stock outstanding | 206,913,301 | ||||
Mr. Wilson [Member] | Subsequent Event [Member] | |||||
Annual base salary | $ 120,000 |