Document_and_Entity_Informatio
Document and Entity Information | 9 Months Ended | |
Sep. 30, 2014 | Nov. 13, 2014 | |
Document And Entity Information | ' | ' |
Entity Registrant Name | 'Immune Therapeutics, Inc. | ' |
Entity Central Index Key | '0001559356 | ' |
Document Type | '10-Q | ' |
Document Period End Date | 30-Sep-14 | ' |
Amendment Flag | 'false | ' |
Current Fiscal Year End Date | '--12-31 | ' |
Is Entity a Well-known Seasoned Issuer? | 'No | ' |
Is Entity a Voluntary Filer? | 'No | ' |
Is Entity's Reporting Status Current? | 'Yes | ' |
Entity Filer Category | 'Smaller Reporting Company | ' |
Entity Common Stock, Shares Outstanding | ' | 132,929,195 |
Document Fiscal Period Focus | 'Q3 | ' |
Document Fiscal Year Focus | '2014 | ' |
Condensed_Consolidated_Balance
Condensed Consolidated Balance Sheets (Unaudited) (USD $) | Sep. 30, 2014 | Dec. 31, 2013 |
Current Assets: | ' | ' |
Cash and cash equivalents | $58,586 | $406,596 |
Prepaids and Other Current assets | 49,700 | 215,900 |
Total current assets | 108,286 | 622,496 |
Fixed Assets: | ' | ' |
Computer equipment, net of accumulated depreciation of $3,110 and $1,293 respectively | 4,903 | 5,607 |
Software development in process | 41,390 | 0 |
Intangible Assets: | ' | ' |
Patents and licenses, net of amortization of $6,579,501 and $4,422,375, respectively (Note 6) | 16,446,762 | 18,546,548 |
Deposits | 10,183 | 17,435 |
Total assets | 16,611,524 | 19,192,086 |
Current Liabilities: | ' | ' |
Accounts payable | 1,803,010 | 839,909 |
Payable to officer | 0 | 76,000 |
Accrued liabilities | 824,126 | 588,271 |
Current portion patent liability | 0 | 118,333 |
Notes payable - net of discount of $125,000 and $0 respectively | 100,000 | 817,197 |
Total current liabilities | 2,727,136 | 2,439,710 |
Non-current Liabilities: | ' | ' |
Notes payable related party | 0 | 121,128 |
Total non-current liabilities | 0 | 121,128 |
Commitments and contingencies (Note 7) | 0 | 0 |
Total Liabilities | 2,727,136 | 2,560,838 |
Stockholders' Equity: | ' | ' |
Common stock - par value $0.001; 500,000,000 shares authorized; 129,015,249 and 74,161,639 shares issued and outstanding respectively | 129,013 | 74,160 |
Additional paid in capital | 338,391,746 | 308,113,375 |
Stock issuances due | 157,804 | 4,893,499 |
Prepaid services | -6,337,235 | -13,447,109 |
Accumulated deficit | -318,456,940 | -283,002,677 |
Total stockholders' equity | 13,884,388 | 16,631,248 |
Total liabilities and stockholders' equity | $16,611,524 | $19,192,086 |
Condensed_Consolidated_Balance1
Condensed Consolidated Balance Sheets (Parenthetical) (USD $) | Sep. 30, 2014 | Dec. 31, 2013 |
Statement of Financial Position [Abstract] | ' | ' |
Accumulated depreciation | $3,110 | $1,293 |
Amortization | $6,579,501 | $4,422,375 |
Common Stock, Par Value | $0.00 | $0.00 |
Common Stock, Shares Authorized | 500,000,000 | 500,000,000 |
Common Stock, Shares Issued | 129,015,249 | 74,161,639 |
Common Stock, Shares Outstanding | 129,015,249 | 74,161,639 |
Condensed_Consolidated_Stateme
Condensed Consolidated Statements of Operations (Unaudited) (USD $) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | |
Income Statement [Abstract] | ' | ' | ' | ' |
Revenues, net | ' | ' | ' | ' |
Operating expenses: | ' | ' | ' | ' |
Selling, general and administrative | 901,746 | 1,290,292 | 3,264,342 | 4,141,601 |
Research and development expense | 401,424 | 640,696 | 1,471,934 | 1,579,226 |
Stock issued for services G&A | 4,946,639 | 11,329,950 | 17,021,025 | 22,388,033 |
Stock issued for services R&D | ' | 5,772,015 | 5,036,250 | 13,931,084 |
Warrant valuation expense | 114,939 | -11,841 | 2,101,866 | 6,932,056 |
Depreciation and amortization expense | 720,369 | 719,040 | 2,158,943 | 2,134,231 |
Total operating expenses | 7,085,117 | 19,740,152 | 31,054,360 | 51,106,231 |
Loss from operations | -7,085,117 | -19,740,152 | -31,054,360 | -51,106,231 |
Other income (expense): | ' | ' | ' | ' |
Interest expense | -94,101 | -205,416 | -376,163 | -1,098,868 |
Exchange (loss) | ' | ' | -783 | ' |
Loss on settlement of debt | -4,022,957 | ' | -4,022,957 | -7,108,495 |
Total other income (expense) | -4,117,058 | -205,416 | -4,399,903 | -8,207,363 |
Net loss | ($11,202,175) | ($19,945,568) | ($35,454,263) | ($59,313,594) |
Basic and diluted loss per share: | ' | ' | ' | ' |
Basic and diluted loss per share | ($0.12) | ($0.34) | ($0.40) | ($1.08) |
Weighted average number of shares outstanding | 94,316,453 | 59,334,545 | 87,875,552 | 55,127,859 |
Condensed_Consolidated_Stateme1
Condensed Consolidated Statements of Stockholders Equity (Unaudited) (USD $) | Common Stock | Additional Paid-In Capital | Stock To Be Issued | Prepaid Services | Accumulated Deficit | Total |
Beginning Balance, Amount at Dec. 31, 2013 | $74,160 | $308,113,375 | $4,893,499 | ($13,447,109) | ($283,002,677) | $16,631,248 |
Beginning Balance, Shares at Dec. 31, 2013 | 74,161,639 | ' | ' | ' | ' | ' |
Issuance of common stock for prepaid services, Shares | 16,390,000 | ' | ' | ' | ' | ' |
Issuance of common stock for prepaid services, Amount | 16,390 | 12,435,610 | 210,001 | -12,662,001 | ' | ' |
Return of stock issued for charitable contributions, Shares | -100,000 | ' | ' | ' | ' | ' |
Return of stock issued for charitable contributions, Amount | -100 | -749,900 | ' | ' | ' | -750,000 |
Amortization of prepaid services | ' | ' | ' | 19,771,875 | ' | 19,771,875 |
Issuance of common stock for license, Shares | 1,600,000 | ' | ' | ' | ' | ' |
Issuance of common stock for license, Amount | 1,600 | 466,400 | ' | ' | ' | 468,000 |
Issuance of common stock for legal settlement, Shares | 650,000 | ' | ' | ' | ' | ' |
Issuance of common stock for legal settlement, Amount | 650 | 447,850 | ' | ' | ' | 448,500 |
Issuance of common stock to employees and consultants, Shares | 6,329,000 | ' | ' | ' | ' | ' |
Issuance of common stock to employees and consultants, Amount | 6,329 | 3,170,728 | -1,028,157 | ' | ' | 2,148,900 |
Issuance of common stock in exchange for debt, Shares | 22,037,450 | ' | ' | ' | ' | ' |
Issuance of common stock in exchange for debt, Amount | 22,037 | 7,650,763 | -1,252,000 | ' | ' | 6,420,800 |
Issuance of common stock for loan expenses and interest, Shares | 655,000 | ' | ' | ' | ' | ' |
Issuance of common stock for loan expenses and interest, Amount | 655 | 522,345 | -224,800 | ' | ' | 298,200 |
Issuance of common stock for cash and exercise of warrants, Shares | 7,292,160 | ' | ' | ' | ' | ' |
Issuance of common stock for cash and exercise of warrants, Amount | 7,292 | 4,232,719 | -2,440,739 | ' | ' | 1,799,272 |
Issuance and modification of common stock warrants | ' | 2,101,856 | ' | ' | ' | 2,101,856 |
Net loss | ' | ' | ' | ' | -35,454,263 | -35,454,263 |
Ending Balance, Amount at Sep. 30, 2014 | $129,013 | $338,391,746 | $157,804 | ($6,337,235) | ($318,456,940) | $13,884,388 |
Ending Balance, Shares at Sep. 30, 2014 | 129,015,249 | ' | ' | ' | ' | ' |
Condensed_Consolidated_Stateme2
Condensed Consolidated Statements of Cash Flows (Unaudited) (USD $) | 9 Months Ended | |
Sep. 30, 2014 | Sep. 30, 2013 | |
CASH FLOWS FROM OPERATING ACTIVITIES | ' | ' |
Net loss | ($35,454,263) | ($59,313,594) |
Adjustments to reconcile loss from continuing operations to net cash flows used in operating activities: | ' | ' |
Depreciation | 1,817 | 682 |
Amortization | 2,157,125 | 2,133,549 |
Stock issued, and amortization of stock issued, for prepaid services | 19,771,875 | 36,318,767 |
Loss on settlement of debt | 4,022,957 | 7,055,994 |
Stock issued for services | 2,148,900 | ' |
Stock issued for license | 468,000 | ' |
Stock issued for legal settlement | 448,500 | ' |
Debt discount | 25,000 | ' |
Stock warrant expense | 2,101,866 | 6,932,057 |
Stock (returned) issued for donation | -750,000 | 750,000 |
Stock issued for interest | 298,200 | 1,133,162 |
Changes in operating assets and liabilities: | ' | ' |
Accounts payable | 1,101,734 | 343,098 |
Accrued liabilities | 342,550 | 227,681 |
Prepaid expenses and deposits | 226,642 | -37,507 |
Net cash used in operating activities from continuing operations | -3,089,097 | -4,456,111 |
CASH FLOWS FROM INVESTING ACTIVITIES | ' | ' |
Purchase of computer equipment | -42,503 | -4,350 |
Purchase of License | -57,340 | -160,539 |
Net cash used in investing activities from continuing operations | -99,843 | -164,889 |
CASH FLOWS FROM FINANCING ACTIVITIES | ' | ' |
Proceeds from sale of stock and exercise of warrants | 1,799,262 | 4,171,613 |
Proceeds from issuance of notes payable | 1,210,000 | 449,001 |
Payments made on patent liability | -50,000 | ' |
Payments made on Bihari patent | -118,333 | -155,000 |
Net cash provided by financing activities from continuing operations | 2,840,929 | 4,515,614 |
Net decrease iin cash | -348,011 | -105,386 |
Cash, beginning of period | 406,596 | 313,095 |
Cash, end of period | 58,585 | 207,709 |
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION: | ' | ' |
Cash paid for interest | ' | ' |
SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING AND FINANCING ACTIVITIES: | ' | ' |
Common stock issued for loan expense and interest | 298,200 | 1,133,162 |
Common stock issued for prepaid services | 12,662,000 | 53,356 |
Common stock issued for prepaid assets | 53,190 | 0 |
Common stock issued (returned) from foundation | -750,000 | 750,000 |
Common stock issued for notes payable and accrued interest | $2,159,248 | $0 |
1_Organization_and_Description
1. Organization and Description of Business | 9 Months Ended |
Sep. 30, 2014 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ' |
1. Organization and Description of Business | ' |
TNI BioTech, Inc. (“we” or the “Company”) is a biopharmaceutical company focused on developing and commercializing therapeutics to treat cancer, HIV/AIDS and autoimmune diseases by combating these chronic and often life-threatening diseases through the activation and rebalancing of the body’s immune system. We were initially incorporated in Florida on December 2, 1993 as Resort Clubs International, Inc. (“Resort Clubs”) 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. The Company currently operates out of Orlando, Florida and Frederick, Maryland. In July 2012, the Company’s focus turned to acquiring patents that would protect and advance the development of new uses of opioid-related immune- therapies, such as low-dose naltrexone (“LDN”) and Methionine [Met5]-enkephalin (“MENK”). The Company’s therapies are believed to stimulate and/or regulate the immune system in such a way that they provide the potential to treat a variety of diseases. We believe our therapies may be able to correct abnormalities or deficiencies in the immune system in diseases such as HIV infection, autoimmune disease, immune disorders, or cancer; all of which can lead to disease progression and life-threatening situations when the immune system is not functioning optimally. | |
In October 2012, the Company formed TNI BioTech International, Ltd., a BVI company in Tortola, British Virgin Islands, which was set up to allow the Company to market and sell LDN in those countries outside the U.S. in which we have been able to obtain approval to sell the Company’s products. | |
In August 2013, the Company formed its United Kingdom subsidiary, TNI BioTech, LTD (the “UK Subsidiary”). The UK Subsidiary received approval to be considered a micro, small or medium-sized enterprise (“SME”) with the European Medicines Agency (“EMA”) on August 21, 2013. The designation provides the UK Subsidiary with significant discounts when holding meetings or submitting filings to the EMA. On September 19, 2013, the UK Subsidiary submitted a pre-submission package to the EMA regarding Crohn’s disease. The EMA granted the UK Subsidiary a meeting that took place on September 27, 2013. The UK Subsidiary is eligible to benefit from the provisions for administrative and financial assistance for SMEs set out in Regulation (EC) No 2049/2005. | |
In December 2013, the Company formed a new subsidiary, Cytocom Inc. (“Cytocom”), to focus on conducting LDN and MENK clinical trials in the United States. We expect that the manufacturing of our therapies and their subsequent distribution into emerging nations will continue to be operated directly through the Company. We initially entered into consultant arrangements with Dr. Graham Burton, M.D., Ph.D., and Mr. Gary G. Gemignani, to focus on the clinical advancement of LDN and MENK through Cytocom. Effective April 1, 2014, Dr. Burton was appointed President and Chief Executive Officer of Cytocom. On the same date, Mr. Gemignani was appointed Chief Operating Officer, Chief Financial Officer and Executive Vice President of Cytocom. Dr. Burton will be responsible for leading Cytocom’s global development, clinical research and medical initiatives. Mr. Gemignani was expected to handle the operational and business development activities and financial management of Cytocom; however, he resigned from his positions with Cytocom. | |
On May 1, 2014, the Company announced a plan to spin-off Cytocom. Following the spin-off, Cytocom will initially focus on developing LDN and MENK. The Company will continue to retain rights to certain intellectual property assets, and will focus on manufacturing, distribution and marketing of LDN and MENK therapies for the treatment of both humans and animals in certain territories. | |
To affect the spin-off distribution (the “Distribution”), the Company took certain reorganizational steps, which are expected to result in Cytocom independently developing LDN and MENK in the United States. At the time of the Distribution, each Company shareholder received one common share of Cytocom for every one share of Company common stock held by such Company shareholder as of September 30, 2014, the record date. The Financial Industry Regulatory Authority declared October 31, 2014 as the payable date for the Distribution. Company shareholders were not required to pay any consideration to participate in the Distribution and, as of the record date, continued to own shares in the Company in the same form and in the same quantity as owned on the record date. The Company continues to be quoted on the OTCQB Market. | |
In March 2014, the Company incorporated Airmed Biopharma Limited, an Irish corporation with an address in Dublin, Ireland. Airmed Biopharma Limited was set up to benefit from incentives granted by the Irish government for the establishment of pharmaceutical companies (many of the world’s leading pharmaceutical companies have located in Ireland), and so that the Company could take advantage of Ireland's status as a member of the European Union and the European Economic Area. An Irish limited liability company enjoys a low corporate income tax rate of 12.5%, one of the lowest in the world. Airmed Biopharma Limited 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. | |
The Company’s growth strategy includes the near-term commercialization of its existing immunotherapies targeting cancer, Crohn’s disease and/or HIV/AIDS. | |
Going Concern | |
The Company has incurred significant net losses since inception and has relied on its ability to fund its operations through private equity financings and short-term debt. 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 products and achieving a level of revenues adequate to support the Company’s cost structure. The Company may never achieve profitability, and unless and until it does, the Company will continue to need to raise additional cash. Management intends to fund future operations through additional private or public debt or equity offerings, and may seek additional capital through arrangements with strategic partners or from other sources. Based on the Company’s operating plan, existing working capital at September 30, 2014 was not sufficient to meet the cash requirements to fund planned operations through December 31, 2014 without additional sources of cash. These conditions raise substantial doubt about the Company’s ability to continue as a going concern. The accompanying financial statements have been prepared assuming that the Company will continue as a going concern and do not include adjustments that might result from the outcome of this uncertainty. This basis of accounting contemplates the recovery of the Company’s assets and the satisfaction of liabilities in the normal course of business. | |
The Company experienced a net loss from operations of $35,454,263 and used cash and cash equivalents for operations in the amount of $3,089,097 during the nine months ended September 30, 2014, resulting in stockholders’ equity of $13,884,388. |
2_Summary_of_Significant_Accou
2. Summary of Significant Accounting Policies | 9 Months Ended | ||||||||||||||||
Sep. 30, 2014 | |||||||||||||||||
Accounting Policies [Abstract] | ' | ||||||||||||||||
2. Summary of Significant Accounting Policies | ' | ||||||||||||||||
Basis of Presentation | |||||||||||||||||
The accompanying unaudited interim financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) and the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”), as amended for interim financial information. The financial information as of September 30, 2014 and September 30, 2013 is derived from the audited financial statements presented in the Company’s Annual Report on Form 10-K for the year ended December 31, 2013 ("2013 10-K"). The unaudited interim financial statements should be read in conjunction with the 2013 10-K, which contains the audited financial statements and notes thereto, together with Management’s Discussion and Analysis of Financial Condition and Results of Operations, for the years ended December 31, 2013 and 2012. | |||||||||||||||||
Certain information or footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted, pursuant to the rules and regulations of the SEC for interim financial reporting. Accordingly, they do not include all the information and footnotes necessary for a comprehensive presentation of financial position, results of operations, or cash flows. It is management’s opinion, however, that all material adjustments (consisting of normal recurring adjustments) have been made which are necessary for a fair financial statement presentation. The interim results for the nine months ended September 30, 2014 are not necessarily indicative of results for the full fiscal year. | |||||||||||||||||
Use of Estimates | |||||||||||||||||
The preparation of the Company’s financial statements in conformity with GAAP 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. | |||||||||||||||||
Fair Value of Financial Instruments | |||||||||||||||||
In accordance with the reporting requirements of the Financial Accounting Standards Board, ("FASB") Accounting Standards Codification ("ASC") Topic 825, “Financial Instruments,” the Company calculates the fair value of its assets and liabilities which qualify as financial instruments under this standard and includes this additional information in the notes to the financial statements when the fair value is different than the carrying value of those financial instruments. | |||||||||||||||||
Computer Equipment | |||||||||||||||||
Computer equipment is 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 nine months ended September 30, 2014 and 2013 was $1,817 and $682, respectively. | |||||||||||||||||
Intangible Assets | |||||||||||||||||
Costs incurred to acquire and/or develop the Company’s product licenses and patents are capitalized and amortized by straight-line methods over estimated useful lives of seven to sixteen years. Intangible assets are stated at the lower of cost or estimated fair value. Amortization expense for the nine months ended September 30, 2014 and 2013 was $2,158,943 and $2,134,231, respectively. The Company estimates its amortization expense related to these assets will approximate $2,800,000 each year for the next five years. | |||||||||||||||||
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, “Property, Plant and Equipment.” If the carrying amount of the asset, including any intangible assets associated with that asset, exceeds its estimated undiscounted net cash flow, before interest, the Company will recognize an impairment loss equal to the difference between its carrying amount and its estimated fair value. No impairment losses were recognized for the nine months ended September 30, 2014 or for the corresponding period in 2013. | |||||||||||||||||
Research and Development Costs | |||||||||||||||||
Research and development costs are charged to expense as incurred and are typically comprised of salaries and benefits, pre-clinical studies, clinical trial activities, drug development and manufacturing, fees paid to consultants and other entities that conduct certain research and development activities on the Company’s behalf and third-party service fees, including clinical research organizations and investigative sites. Costs for certain development activities, such as clinical trials are recognized based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations, or information provided by vendors on their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the financial statements as operating expenses. | |||||||||||||||||
Income Taxes | |||||||||||||||||
Management considers the likelihood of changes by taxing authorities in its filed income tax returns, and recognizes a liability for or discloses potential changes that management believes are more likely than not to occur upon examination by tax authorities. Management has not identified any uncertain tax positions in filed income tax returns that require recognition or disclosure. The Company’s income tax returns for the past three years are subject to examination by tax authorities, and may change upon examination. | |||||||||||||||||
We follow ASC 740-10, Accounting for Uncertainty in Income Taxes. This interpretation requires recognition and measurement of uncertain income tax positions using a “more-likely-than-not” approach. ASC 740-10 is effective for fiscal years beginning after December 15, 2006. The Company has adopted ASC 740-10 and evaluates its tax positions on an annual basis. | |||||||||||||||||
Share-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 Company’s accounting policy for equity instruments issued to consultants and vendors in exchange for goods and services follows the provisions of ASC Topic 505-50, “Equity-Based Payments to Non-Employees.” The measurement date for the fair value of the equity instruments issued is determined at the earlier of (i) the date at which a commitment for performance by the consultant or vendor is reached or (ii) the date at which the consultant or vendor’s performance is complete. | |||||||||||||||||
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 Company’s net loss position. | |||||||||||||||||
Basic and diluted net loss per share is as follows: | |||||||||||||||||
For the three months ended September 30, | For the nine months ended September 30, | ||||||||||||||||
2014 | 2013 | 2014 | 2013 | ||||||||||||||
Historical net loss per share: | |||||||||||||||||
Numerator | |||||||||||||||||
Net loss | $ | (11,202,175 | ) | $ | (19,945,568 | ) | $ | (35,454,263 | ) | $ | (59,313,594 | ) | |||||
Net loss attributed to Common stockholders | $ | (11,202,175 | ) | $ | (19,945,568 | ) | $ | (35,454,263 | ) | $ | (59,313,594 | ) | |||||
Denominator | |||||||||||||||||
Weighted-average common shares outstanding— | |||||||||||||||||
Denominator for basic and diluted net loss per share | 94,316,453 | 59,334,545 | 87,875,552 | 55,127,859 | |||||||||||||
Basic and diluted net loss per share attributed | |||||||||||||||||
to common stockholders | $ | (0.12 | ) | $ | (0.34 | ) | $ | (0.40 | ) | $ | (1.08 | ) | |||||
The Company’s potential dilutive securities which include stock and warrants have been excluded from the computation of diluted net loss per share as the effect would be to reduce the net loss per share. Therefore, the weighted-average common stock outstanding used to calculate both basic and diluted net loss per share is the same. | |||||||||||||||||
The following shares of potentially dilutive securities have been excluded from the computations of diluted weighted average shares outstanding as the effect of including such securities would be antidilutive: | |||||||||||||||||
As of September 30, | |||||||||||||||||
2014 | 2013 | ||||||||||||||||
Warrants to purchase common stock | 8,986,750 | 6,503,750 | |||||||||||||||
Recent Accounting Standards | |||||||||||||||||
Any new accounting pronouncements issued by the FASB, as applicable, have been or will be adopted by the Company upon or before the expiration of the extended transition period provided under Section 102(b)(1) of the JOBS Act. |
3_Promissory_Notes
3. Promissory Notes | 9 Months Ended |
Sep. 30, 2014 | |
Debt Disclosure [Abstract] | ' |
3. Promissory Notes | ' |
At June 30, 2014, the Company had promissory notes outstanding totaling $1,442,197. The promissory notes had maturity dates ranging between September 2007 and July 2014. The notes bore interest at rates between two and six percent per annum. As of June 30, 2014, the Company had accrued $67,863 in unpaid interest on those notes. | |
During the three months ended September 30, 2014, the Company settled all of the notes that had been outstanding at June 30, 2014, together with accrued interest owing on the notes, by issuing 20,731,601 shares, at a range of $0.10 to $0.25 per share, as repayment of principal, and interest. The Company recognized a loss of $3,621,643 on the settlement of these notes. | |
On July 29, 2014, the Company issued a note payable to Ira Gaines. The balance outstanding as of September 30, 2014 and 2013 was $100,000 and $0, respectively. The note matures on January 27, 2015 and earns interest at a rate of 18% per annum. |
4_Capital_StructureCommon_Stoc
4. Capital Structure-Common Stock and Common Stock Purchase Warrants | 9 Months Ended | ||||||||||||
Sep. 30, 2014 | |||||||||||||
Notes to Financial Statements | ' | ||||||||||||
4. Capital Structure-Common Stock and Common Stock Purchase Warrants | ' | ||||||||||||
Each holder of common stock is entitled to vote on all matters and is entitled to one vote for each share held. No holder of shares of stock of any class shall be entitled as a matter of right to subscribe for or purchase or receive any part of any new or additional issue of shares of stock of any class, or of securities convertible into shares of stock or any class, whether now hereafter authorized or whether issued for money, for consideration other than money, or by way of dividend. | |||||||||||||
As of September 30, 2014 and 2013, the Company was authorized to issue 500,000,000 common shares at a par value of $0.001 per share. | |||||||||||||
Stock Warrants | |||||||||||||
Using the Black-Scholes Model, the Company calculated the fair value of $2,101,856 for common stock purchase warrants issued and modified during the nine months ended September 30, 2014. Variables used in the Black-Scholes option-pricing model, include (1) a discount rate of 0.98%, (2) an expected remaining life of 5 years and (3) expected volatility of 130%. | |||||||||||||
During the first nine months of 2014, the Company issued 918,750 shares of its restricted common stock through the exercise of common stock purchase warrants. The warrants were exercised at a price of $0.50 per share and the Company received net proceeds of $459,375 for equity from the exercise of the warrants. | |||||||||||||
Following is a summary of outstanding stock warrants at September 30, 2014 and activity during the period then ended: | |||||||||||||
Number of | Exercise | Weighted | |||||||||||
Shares | Price | Average Price | |||||||||||
Warrants as of December 31, 2013 | 7,957,500 | $ | 1.00 – 15.00 | $ | 1.77 | ||||||||
1,948,000 | $ | 0.50-1.50 | $ | 1.27 | |||||||||
Issued in the nine months ended September 30, 2014 | |||||||||||||
Exercised | -918,750 | $ | 0.5 | $ | 0.5 | ||||||||
8,986,750 | $ | 0.50-15.00 | $ | 1.58 | |||||||||
Warrants as of September 30, 2014 | |||||||||||||
Summary of outstanding warrants as of September 30, 2014: | |||||||||||||
Number of | Exercise | Remaining Life (years) | |||||||||||
Expiration Date | Shares | Price | |||||||||||
Third Quarter 2015 | 407,500 | $ | 1.50-2.00 | 1 | |||||||||
Fourth Quarter 2015 | 268,750 | $ | 1.5 | 1.25 | |||||||||
Second Quarter 2016 | 37,500 | $ | 3.00-5.00 | 1.75 | |||||||||
Third Quarter 2016 | 525,000 | $ | 0.50-5.00 | 2 | |||||||||
Third Quarter 2017 | 1,500,000 | $ | 1.00-1.50 | 3 | |||||||||
Fourth Quarter 2017 | 2,941,666 | $ | 1.00-9.00 | 3.25 | |||||||||
First Quarter 2018 | 127,500 | $ | 15 | 3.5 | |||||||||
Second Quarter 2018 | 33,334 | $ | 15 | 3.75 | |||||||||
Third Quarter 2018 | 400,000 | $ | 1.00-1.50 | 4 | |||||||||
Fourth Quarter 2018 | 1,197,500 | $ | 1.00-1.50 | 4.25 | |||||||||
First Quarter 2019 | 1,048,000 | $ | 1.5 | 4.5 | |||||||||
Third Quarter 2019 | 250,000 | $ | 0.5 | 5 |
5_Stock_Compensation
5. Stock Compensation | 9 Months Ended |
Sep. 30, 2014 | |
Equity [Abstract] | ' |
5. Stock Compensation | ' |
Shares Issued for Services | |
During the nine months ended September 30, 2014, the Company issued 16,390,000 shares of common stock for prepaid services (10,228,000 for the corresponding period in 2013). The Company valued these shares based upon the fair value of the common stock at the date of the agreements. The consulting fees are amortized over the contract periods, which are typically twelve months. The Company issued common stock for prepaid services of $12,662,001 and $51,204,100 for the nine months ended September 30, 2014 and 2013, respectively. The amortization of prepaid services totaled $19,771,875 and $36,319,117 for the nine months ended September 30, 2014 and 2013, respectively. | |
6_Lincenses_and_Supply_Agreeme
6. Lincenses and Supply Agreements | 9 Months Ended |
Sep. 30, 2014 | |
Notes to Financial Statements | ' |
6. Lincenses and Supply Agreements | ' |
Patent License Agreements | |
On March 4, 2012, the Company entered into a Sale of Technology Agreement with Dr. Nicholas P. Plotnikoff wherein Dr. Plotnikoff agreed to transfer and assign all of his rights, title and interest in certain patents he developed. 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 the Company’s common stock, a royalty on all sales of MENK and was granted the position of Non-Executive Chairman of our Board of Directors. | |
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. The Bihari patents were acquired in exchange for 540,000 shares of the Company’s common stock with a fair value of $972,000 and assumed liabilities of $400,000, which is payable to Ms. Young over a twenty-four month period in equal installments to reimburse her for the costs of a New York City office in accordance with the Young Agreement. The patent liability at September 30, 2014 totaled $0.00. The cost of the patent totaled $1,372,000. | |
Pursuant to the Young Agreement, the Company must pay Ms. Young a royalty payment of 1% of gross MENK sales and provide Ms. Young a position as non-executive chairman of the Company. The Young Agreement is valid for the life of the patents and expires on a country by country basis in each country where patent rights exist, upon the expiration of the last patent to expire in each country or in the event the patent in such country is held to be invalid and/or unenforceable or admitted to be invalid or unenforceable. Additionally, the Company can cancel the Young Agreement upon 120 days’ written notice and, upon cancellation, must pay all royalties and fees that have accrued. The Company has 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 18, 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 U.S. Food and Drug Administration (“FDA”) to a novel late-stage drug, trademarked “LDN,” for the treatment of Pediatric Crohn’s disease. The patent covers methods and formulations for treatment of the inflammatory and ulcerative diseases of the bowel, using naltrexone in low doses as an opioid antagonist. These patents were acquired in exchange for 300,000 shares of the Company’s common stock with a fair value of $2,715,000 and payment of $165,384 (consisting of an initial license fee and payment of $65,384 of expenses), which totaled $2,880,384. | |
The Smith Agreement requires the Company to (i) use commercially reasonable efforts to develop, commercialize, market and sell licensed products in a manner consistent with a business plan, (ii) expend a minimum amount of funds per annum to develop and commercialize licensed products as soon as practicable, (iii) obtain all requisite regulatory approvals needed to use or sell licensed products in the field of use, and (iv) make the first commercial sale of a licensed product by March of 2017. | |
The Company is required to pay an annual license fee, an annual running royalty on net sales of each licensed product or a minimum royalty, whichever is greater, and a sublicense fee on payments received by the Company from sublicensees. The Company has an exclusive, worldwide license to make, have made, use, lease, import, offer for sale and sell licensed products and to use the method under the patent rights. The Smith Agreement will terminate on the expiration or abandonment of the last patent to expire or ten years after the sale of the first licensed product. The Company may terminate the Smith Agreement upon 90 days’ written notice, provided all sublicenses are terminated and all amounts due and owing are paid to the Licensor Parties. The Licensor Parties may terminate the agreement ten days' after notice to the Company if the Company is ten days late in payment or there is a breach that remains uncured for ten days after written notice of such breach. | |
The Company is also required to pay milestone payments after substantial achievement of certain milestone events for each licensed product including payment: upon initiation of each Phase III trial; upon positive completion of each Phase III clinical trial of the therapeutic use of an LDN compound in the field of use; when a New Drug Application (“NDA”) is accepted for review by the FDA; and when FDA approval to market the NDA is approved. The Company will issue shares upon reaching certain milestones including upon the first dosing of the first patient in a Phase III clinical trial for each licensed product, upon the first sale of each licensed product, and upon the achievement of a set dollar amount in cumulative sales for each licensed product covered by NDAs. | |
As part of the Smith Agreement, the Company has the right to apply to the FDA for the transfer of the orphan drug status for the use of naltrexone for the treatment of pediatric Crohn’s disease and ulcerative colitis, the Investigation New Drug Application (“IND”), and the right to acquire the relevant clinical data set from Dr. Jill Smith. Dr. Jill Smith made arrangements to transfer the IND to the Company as well as the relevant clinical data set, and the FDA has acknowledged that the Company is now the sponsor for this IND. | |
On September 24, 2014, the Company and the Licensor Parties jointly agreed to terminate the Smith Agreement, and in place thereof, have the Licensor Parties grant a similar license in their patent rights to Cytocom pursuant to a Patent License Agreement between the Licensor Parties, Cytocom 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 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. |
7_Commitments_and_Contingencie
7. Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2014 | |
Commitments and Contingencies Disclosure [Abstract] | ' |
7. 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 to collaborate with the Government of Malawi to assist in expanding the treatment of cancer, HIV/AIDS and other infectious diseases. | |
The Company and GBOIG will work in connection with the government of Malawi to open and operate clinics that provide treatments for HIV/AIDS, cancer and other infectious diseases. GBOIG and the Company originally expected to have the oncology and infectious disease clinic fully operational within 12 months of the signing of the letter of intent, and to begin treatment for HIV patients within 180 days thereafter. However, delays in obtaining approvals required for the importation of the Company’s products have delayed the start of the project until the second half of 2014. Under the letter of intent, the Company and GBOIG will begin by providing HIV/AIDS treatment to 10,000 patients and hopefully expanding to 500,000 within 24 months of project start. 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 letter of intent. After the one-year anniversary, the letter of intent may only be terminated with 180 days' notice to the other party if the other party has breached the letter of intent. | |
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. | |
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 is 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 | |
Effective November 9, 2012, the Company signed an exclusive Distribution Agreement with G-Ex Technologies/St. Maris Pharma and GB Pharma Holdings, LLC for the Federal Republic of Nigeria (the “Distribution Agreement”). Under the terms of the Distribution Agreement, G-Ex Technologies/St. Maris Pharma and GB Pharma Holdings LLC will have exclusive marketing and distribution rights to IRT-103 LDN and IRT-104 LDN cream in Nigeria until the end of the term of the Distribution Agreement on December 31, 2017. The Company will be responsible for the manufacture and supply of IRT-103 LDN and IRT-104 LDN cream. As part of the Distribution Agreement, G-Ex Technologies/St. Maris Pharma will provide the Company with a revolving letter of credit for the minimum purchase of 750,000 doses monthly of IRT-103 LDN or IRT-104 LDN cream priced at $1.00 per dose. There are no upfront fees. | |
The Distribution Agreement calls for G-Ex Technologies/St. Maris Pharma and GB Pharma Holdings, LLC to purchase a minimum of 15,000,000 doses monthly within 24 months to maintain the exclusivity of the Distribution Agreement. Once G-Ex Technologies/St. Maris Pharma and GB Pharma Holdings, LLC reach sales of 1,000,000 doses per day, the Company has agreed to joint venture a factory in the Federal Republic of Nigeria to meet local demands. | |
G-Ex Technologies/St. Maris Pharma is a consortium of companies organized under the laws of the Republic of Nigeria operated by management, a consultant, general pharmaceutical, clinical pharmacy and marketing executives, each with over 25 years of industry experience and well versed in the changing dynamics of the prescription and over-the-counter drug international marketplace. G-Ex Technologies/St. Maris Pharma has been actively supported by medical practice professionals in business and academia who have been involved in the management of related drug therapies for many years. | |
The parties have been unable to perform under the Distribution Agreement because a certificate of free sale was not obtained by the Company until November of 2013, and no extension has been granted. | |
In October 2013, the Company announced the signing of a distribution agreement with AHAR Pharma, a Nigerian company to market LDN under the trademark Lodonal™, in Nigeria for the treatment of autoimmune diseases and cancer. AHAR Pharma intends to distribute Lodonal™ through a local distributor network, an Internet client base and directly to hospitals, pharmacists and doctors in Nigeria. The Company expects to implement the agreement in 2014, and expects to treat up to 500,000 patients per day by March 2015. Under the agreement, the Company is obligated to provide delivery of an initial supply of between 1 million and 1.5 million doses of Lodonal™ product to cover AHAR Pharma’s first-year purchase commitment. | |
Agreements with Hubei Qianjiang Pharmaceutical Company | |
On October 18, 2012, the Company and Hubei Qianjiang Pharmaceutical Co., Ltd. (“Qianjiang Pharmaceutical”), signed a Venture Cooperation Agreement on New Drug Methionine Enkephalin (the “Venture Agreement”) pursuant to which Qianjiang Pharmaceutical acquired an exclusive license for the production of MENK in China. The Venture Agreement requires that Qianjiang Pharmaceutical conduct drug research and pilot testing for MENK, organize pre-clinical studies, and apply for clinical trials for MENK with the Chinese State Food and Drug Administration. Under the Venture Agreement, Qianjiang Pharmaceutical must open a co-administration account for the development of MENK in China. Qianjiang Pharmaceutical must pay the Company, upon the marketing of MENK products, a half-year amount equaling 6% of its gross sales from MENK of the preceding half year. The Company may cancel the Venture Agreement if Qianjiang Pharmaceutical does not pay expenses for a period exceeding six months or does not commence clinical trials within 12-months after receiving certain approvals. Qianjiang Pharmaceutical may cancel the Venture Agreement if the Company fails to perform its obligations for a period of six months or the failure to receive approval of clinical trials is due to the Company’s MENK technologies. The Venture Agreement was amended on February 24, 2013 to expand the clinical trials from pancreatic to both pancreatic and liver cancer and amended on March 6, 2014 to require Qianjiang Pharmaceutical to commence studies and clinical trials in China and place funds in the co-administration account. | |
On August 6, 2014, the Company entered into a Supplementary Agreement on New Drug Methionine – Enkephalin Cooperation (the “Amendment”) with Qianjiang Pharmaceutical, amending the Venture Agreement, as amended. The Company and Qianjiang Pharmaceutical executed the Amendment to accelerate clinical trials in both the United States and China, and agreed to immediately initiate three month Good Laboratory Practice (“GLP”) Toxicology Studies (rat and dog) within 30 days of signing the Amendment. The Amendment requires that the GLP Toxicology Studies Trials are conducted in China in accordance with international standards and standards acceptable to the FDA and that the studies include the following: | |
Exploratory Toxicology (nGLP) | |
· Dose range finding studies | |
· Different species and methods of administration | |
· Multiple dosing regimens | |
· Estimate the response vs. dose given | |
Definitive Toxicology (GLP) | |
· Performed in collaboration with Calvert Laboratories (USA) and MPI/Medicillon (China) | |
· General toxicology studies | |
· Different species and methods of administration | |
· Immunogenicity study with NHPs | |
Special Toxicology Studies (planned) | |
Pursuant to the Amendment, Qianjiang Pharmaceutical 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 Company’s licensed patented technology. Specifically, the parties aim to co-invest to develop and market products focusing on HIV, cancer and related autoimmune system therapies, develop co-ventured manufacturing facilities in China, and develop co-ventured distribution of the developed products in China and Africa. The agreement does not have a definitive term, as each new agreement resulting from the cooperation will set forth the material terms, including, but not limited to, fees, duration and termination therein. | |
Supervision andInspectionof 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 FDA’s Current Good Manufacturing Practice regulations (“cGMP”) and the Company’s 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 | |
The Company leases office space in White Plains, New York, Frederick, Maryland, and Orlando, Florida. Rental expense for the nine months ended September 30, 2014 and 2013 was $116,638 and $65,660, respectively. |
8_Related_Party_Transactions
8. Related Party Transactions | 9 Months Ended |
Sep. 30, 2014 | |
Related Party Transactions [Abstract] | ' |
8. Related Party Transactions | ' |
In 2012, Webfoot, Inc. provided a loan to the Company in the amount of $121,128. Webfoot, Inc. is owned by the son of Noreen Griffin, the Company's CEO. On February 21, 2013, the Company entered into a formal loan agreement to evidence the amount owed by the Company. In the nine months ended September 30, 2014, the Company repaid $40,000 of the loan. On September 30, 2014, the remaining balance of $71,128 owed under the agreement, together with accrued and unpaid interest totaling $10,212, was converted into 813,404 shares of the Company’s common stock in full and final settlement of the loan. The loss on conversion was $162,681. | |
In 2012, Noreen Griffin made payments totaling $30,000 on the Company's behalf covering the costs of incorporation and merger-related expenses. On February 13, 2013, the Company entered into a formal loan agreement to evidence repayment of the amount owed on December 31, 2012. On September 30, 2014, the full balance of the loan, together with accrued and unpaid interest totaling $2,870, was converted into 328,701 shares of the Company’s common stock in full and final settlement of the loan. The loss on conversion was $65,740. | |
In 2012, Griffin Enterprises, Inc. made payments totaling $46,000 on the Company's behalf covering the cost of incorporation and merger-related expenses. Griffin Enterprises, Inc. is wholly owned by Noreen Griffin. On February 13, 2013, the Company entered into a formal loan agreement to evidence repayment of the amount owed on December 31, 2012. On September 30, 2014, the full balance of the loan, together with accrued and unpaid interest totaling $4,401, was converted into 504,009 shares of the Company’s common stock in full and final settlement of the loan. The loss on conversion was $100,802. | |
On January 3, 2013, the Company formalized the terms under which Kelly O’Brien Wilson, the daughter-in-law of the Company's Chief Executive Officer is employed. Ms. Wilson had been working with the Company in 2012 and her three-year employment agreement is effective as of December 1, 2012. The terms of the agreement define her base salary, a grant of a common stock, and health insurance coverage. Ms. Wilson was issued 500,000 shares of common stock of the Company in January 2014. For the nine months ended September 30, 2014, the Company paid compensation to Ms. Wilson totaling $115,735. |
9_Subsequent_Events
9. Subsequent Events | 9 Months Ended | ||||
Sep. 30, 2014 | |||||
Subsequent Events [Abstract] | ' | ||||
9. Subsequent Events | ' | ||||
The following is a schedule of shares issued subsequent to September 30, 2014. | |||||
Shares | |||||
Shares issued for consulting expenses | 333,334 | ||||
On September 4, 2014 at the Company’s annual meeting, a majority of stockholders approved an amendment to our Amended and Restated Articles of Incorporation, as amended, to change the Company’s name to Immune Therapeutics, Inc. (the “Name Change Amendment”). The Name Change Amendment was approved by our Board of Directors as the Board believed the new name would better (i) represent the business of the Company as a global manufacturer, distributor and seller of immune therapies, and (ii) reflect the Company’s presence and focus on affordable and sustainable health-care for an underserved and growing population facing opportunistic infections and cancer with very affordable treatments available. The Name Change Amendment was filed with the Secretary of State of Florida on October 28, 2014 changing the Company’s name to Immune Therapeutics, Inc. (the “Name Change”). As of the date of the filing of this report, the Company has filed the appropriate documentation with the Financial Industry Regulatory Authority in order to effectuate the Name Change in the OTC Markets. We anticipate that the Name Change will be effected by the Financial Industry Regulatory Authority during the fourth quarter. |
2_Summary_of_Significant_Accou1
2. Summary of Significant Accounting Policies (Policies) | 9 Months Ended | ||||||||||||||||
Sep. 30, 2014 | |||||||||||||||||
Summary Of Significant Accounting Policies Policies | ' | ||||||||||||||||
Basis of Presentation | ' | ||||||||||||||||
The accompanying unaudited interim financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) and the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”), as amended for interim financial information. The financial information as of September 30, 2014 and September 30, 2013 is derived from the audited financial statements presented in the Company’s Annual Report on Form 10-K for the year ended December 31, 2013 ("2013 10-K"). The unaudited interim financial statements should be read in conjunction with the 2013 10-K, which contains the audited financial statements and notes thereto, together with Management’s Discussion and Analysis of Financial Condition and Results of Operations, for the years ended December 31, 2013 and 2012. | |||||||||||||||||
Certain information or footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted, pursuant to the rules and regulations of the SEC for interim financial reporting. Accordingly, they do not include all the information and footnotes necessary for a comprehensive presentation of financial position, results of operations, or cash flows. It is management’s opinion, however, that all material adjustments (consisting of normal recurring adjustments) have been made which are necessary for a fair financial statement presentation. The interim results for the nine months ended September 30, 2014 are not necessarily indicative of results for the full fiscal year. | |||||||||||||||||
Use of Estimates | ' | ||||||||||||||||
The preparation of the Company’s financial statements in conformity with GAAP 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. | |||||||||||||||||
Fair Value of Financial Instruments | ' | ||||||||||||||||
In accordance with the reporting requirements of the Financial Accounting Standards Board, ("FASB") Accounting Standards Codification ("ASC") Topic 825, “Financial Instruments,” the Company calculates the fair value of its assets and liabilities which qualify as financial instruments under this standard and includes this additional information in the notes to the financial statements when the fair value is different than the carrying value of those financial instruments. | |||||||||||||||||
Computer Equipment | ' | ||||||||||||||||
Computer equipment is 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 nine months ended September 30, 2014 and 2013 was $1,817 and $682, respectively. | |||||||||||||||||
Intangible Assets | ' | ||||||||||||||||
Costs incurred to acquire and/or develop the Company’s product licenses and patents are capitalized and amortized by straight-line methods over estimated useful lives of seven to sixteen years. Intangible assets are stated at the lower of cost or estimated fair value. Amortization expense for the nine months ended September 30, 2014 and 2013 was $2,158,943 and $2,134,231, respectively. The Company estimates its amortization expense related to these assets will approximate $2,800,000 each year for the next five years. | |||||||||||||||||
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, “Property, Plant and Equipment.” If the carrying amount of the asset, including any intangible assets associated with that asset, exceeds its estimated undiscounted net cash flow, before interest, the Company will recognize an impairment loss equal to the difference between its carrying amount and its estimated fair value. No impairment losses were recognized for the nine months ended September 30, 2014 or for the corresponding period in 2013. | |||||||||||||||||
Research and Development Costs | ' | ||||||||||||||||
Research and development costs are charged to expense as incurred and are typically comprised of salaries and benefits, pre-clinical studies, clinical trial activities, drug development and manufacturing, fees paid to consultants and other entities that conduct certain research and development activities on the Company’s behalf and third-party service fees, including clinical research organizations and investigative sites. Costs for certain development activities, such as clinical trials are recognized based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations, or information provided by vendors on their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the financial statements as operating expenses. | |||||||||||||||||
Income Taxes | ' | ||||||||||||||||
Management considers the likelihood of changes by taxing authorities in its filed income tax returns, and recognizes a liability for or discloses potential changes that management believes are more likely than not to occur upon examination by tax authorities. Management has not identified any uncertain tax positions in filed income tax returns that require recognition or disclosure. The Company’s income tax returns for the past three years are subject to examination by tax authorities, and may change upon examination. | |||||||||||||||||
We follow ASC 740-10, Accounting for Uncertainty in Income Taxes. This interpretation requires recognition and measurement of uncertain income tax positions using a “more-likely-than-not” approach. ASC 740-10 is effective for fiscal years beginning after December 15, 2006. The Company has adopted ASC 740-10 and evaluates its tax positions on an annual basis. | |||||||||||||||||
Share-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 Company’s accounting policy for equity instruments issued to consultants and vendors in exchange for goods and services follows the provisions of ASC Topic 505-50, “Equity-Based Payments to Non-Employees.” The measurement date for the fair value of the equity instruments issued is determined at the earlier of (i) the date at which a commitment for performance by the consultant or vendor is reached or (ii) the date at which the consultant or vendor’s performance is complete. | |||||||||||||||||
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 Company’s net loss position. | |||||||||||||||||
Basic and diluted net loss per share is as follows: | |||||||||||||||||
For the three months ended September 30, | For the nine months ended September 30, | ||||||||||||||||
2014 | 2013 | 2014 | 2013 | ||||||||||||||
Historical net loss per share: | |||||||||||||||||
Numerator | |||||||||||||||||
Net loss | $ | (11,202,175 | ) | $ | (19,945,568 | ) | $ | (35,454,263 | ) | $ | (59,313,594 | ) | |||||
Net loss attributed to Common stockholders | $ | (11,202,175 | ) | $ | (19,945,568 | ) | $ | (35,454,263 | ) | $ | (59,313,594 | ) | |||||
Denominator | |||||||||||||||||
Weighted-average common shares outstanding— | |||||||||||||||||
Denominator for basic and diluted net loss per share | 94,316,453 | 59,334,545 | 87,875,552 | 55,127,859 | |||||||||||||
Basic and diluted net loss per share attributed | |||||||||||||||||
to common stockholders | $ | (0.12 | ) | $ | (0.34 | ) | $ | (0.40 | ) | $ | (1.08 | ) | |||||
The Company’s potential dilutive securities which include stock and warrants have been excluded from the computation of diluted net loss per share as the effect would be to reduce the net loss per share. Therefore, the weighted-average common stock outstanding used to calculate both basic and diluted net loss per share is the same. | |||||||||||||||||
The following shares of potentially dilutive securities have been excluded from the computations of diluted weighted average shares outstanding as the effect of including such securities would be antidilutive: | |||||||||||||||||
As of September 30, | |||||||||||||||||
2014 | 2013 | ||||||||||||||||
Warrants to purchase common stock | 8,986,750 | 6,503,750 | |||||||||||||||
Recent Accounting Standards | ' | ||||||||||||||||
Any new accounting pronouncements issued by the FASB, as applicable, have been or will be adopted by the Company upon or before the expiration of the extended transition period provided under Section 102(b)(1) of the JOBS Act. |
2_Summary_of_Significant_Accou2
2. Summary of Significant Accounting Policies (Tables) | 9 Months Ended | ||||||||||||||||
Sep. 30, 2014 | |||||||||||||||||
Summary Of Significant Accounting Policies Tables | ' | ||||||||||||||||
Schedule of basic and diluted net loss per share | ' | ||||||||||||||||
For the three months ended September 30, | For the nine months ended September 30, | ||||||||||||||||
2014 | 2013 | 2014 | 2013 | ||||||||||||||
Historical net loss per share: | |||||||||||||||||
Numerator | |||||||||||||||||
Net loss | $ | (11,202,175 | ) | $ | (19,945,568 | ) | $ | (35,454,263 | ) | $ | (59,313,594 | ) | |||||
Net loss attributed to Common stockholders | $ | (11,202,175 | ) | $ | (19,945,568 | ) | $ | (35,454,263 | ) | $ | (59,313,594 | ) | |||||
Denominator | |||||||||||||||||
Weighted-average common shares outstanding— | |||||||||||||||||
Denominator for basic and diluted net loss per share | 94,316,453 | 59,334,545 | 87,875,552 | 55,127,859 | |||||||||||||
Basic and diluted net loss per share attributed | |||||||||||||||||
to common stockholders | $ | (0.12 | ) | $ | (0.34 | ) | $ | (0.40 | ) | $ | (1.08 | ) | |||||
Schedule of anitdilutive securities | ' | ||||||||||||||||
As of September 30, | |||||||||||||||||
2014 | 2013 | ||||||||||||||||
Warrants to purchase common stock | 8,986,750 | 6,503,750 | |||||||||||||||
4_Capital_StructureCommon_Stoc1
4. Capital Structure-Common Stock and Common Stock Purchase Warrants (Tables) | 9 Months Ended | ||||||||||||
Sep. 30, 2014 | |||||||||||||
Capital Structure-Common Stock And Common Stock Purchase Warrants Tables | ' | ||||||||||||
Schedule of outstanding stock warrants | ' | ||||||||||||
Number of | Exercise | Weighted | |||||||||||
Shares | Price | Average Price | |||||||||||
Warrants as of December 31, 2013 | 7,957,500 | $ | 1.00 – 15.00 | $ | 1.77 | ||||||||
1,948,000 | $ | 0.50-1.50 | $ | 1.27 | |||||||||
Issued in the nine months ended September 30, 2014 | |||||||||||||
Exercised | -918,750 | $ | 0.5 | $ | 0.5 | ||||||||
8,986,750 | $ | 0.50-15.00 | $ | 1.58 | |||||||||
Warrants as of September 30, 2014 | |||||||||||||
Summary of outstanding warrants | ' | ||||||||||||
Number of | Exercise | Remaining Life (years) | |||||||||||
Expiration Date | Shares | Price | |||||||||||
Third Quarter 2015 | 407,500 | $ | 1.50-2.00 | 1 | |||||||||
Fourth Quarter 2015 | 268,750 | $ | 1.5 | 1.25 | |||||||||
Second Quarter 2016 | 37,500 | $ | 3.00-5.00 | 1.75 | |||||||||
Third Quarter 2016 | 525,000 | $ | 0.50-5.00 | 2 | |||||||||
Third Quarter 2017 | 1,500,000 | $ | 1.00-1.50 | 3 | |||||||||
Fourth Quarter 2017 | 2,941,666 | $ | 1.00-9.00 | 3.25 | |||||||||
First Quarter 2018 | 127,500 | $ | 15 | 3.5 | |||||||||
Second Quarter 2018 | 33,334 | $ | 15 | 3.75 | |||||||||
Third Quarter 2018 | 400,000 | $ | 1.00-1.50 | 4 | |||||||||
Fourth Quarter 2018 | 1,197,500 | $ | 1.00-1.50 | 4.25 | |||||||||
First Quarter 2019 | 1,048,000 | $ | 1.5 | 4.5 | |||||||||
Third Quarter 2019 | 250,000 | $ | 0.5 | 5 |
9_Subsequent_Events_Tables
9. Subsequent Events (Tables) | 9 Months Ended | ||||
Sep. 30, 2014 | |||||
Subsequent Events Tables | ' | ||||
Schedule of shares issued | ' | ||||
Shares | |||||
Shares issued for consulting expenses | 333,334 | ||||
- | |||||
- |
2_Summary_of_Significant_Accou3
2. Summary of Significant Accounting Policies (Details) (USD $) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | |
Numerator | ' | ' | ' | ' |
Net loss | ($11,202,175) | ($19,945,568) | ($35,454,263) | ($59,313,594) |
Net loss attributed to Common stockholders | ($11,202,175) | ($19,945,568) | ($35,454,263) | ($59,313,594) |
Denominator | ' | ' | ' | ' |
Weighted-average common shares outstanding-Denominator for basic and diluted net loss per share | 94,316,453 | 59,334,545 | 87,875,552 | 55,127,859 |
Basic and diluted net loss per share attributed to common stockholders | ($0.12) | ($0.34) | ($0.40) | ($1.08) |
2_Summary_of_Significant_Accou4
2. Summary of Significant Accounting Policies (Details 1) | 9 Months Ended | |
Sep. 30, 2014 | Sep. 30, 2013 | |
Summary Of Significant Accounting Policies Tables | ' | ' |
Warrants to purchase Common stock | 8,986,750 | 6,503,750 |
2_Summary_of_Significant_Accou5
2. Summary of Significant Accounting Policies (Details Narrative) (USD $) | 9 Months Ended | |
Sep. 30, 2014 | Sep. 30, 2013 | |
Amortization expense | $2,158,943 | $2,134,231 |
Computer equipment | ' | ' |
Depreciation expense | $1,817 | $682 |
4_Capital_StructureCommon_Stoc2
4. Capital Structure-Common Stock and Common Stock Purchase Warrants (Details) (USD $) | 9 Months Ended |
Sep. 30, 2014 | |
Number of Warrants | ' |
Beginning Balance | 7,957,500 |
Issued | 1,948,000 |
Forfeited | 0 |
Exercised | -918,750 |
Ending Balance | 8,986,750 |
Warrants Price Per Share | ' |
Beginning Balance | '1.00 B 15.00 |
Issued | '0.50 B 1.50 |
Exercised | '0.50 |
Ending Balance | '0.50-15.00 |
Weighted Average Exercise Price | ' |
Beginning Balance | $1.77 |
Issued | $1.27 |
Exercised | 0.5 |
Ending Balance | $1.58 |
4_Capital_StructureCommon_Stoc3
4. Capital Structure-Common Stock and Common Stock Purchase Warrants (Details 1) | Sep. 30, 2014 | Dec. 31, 2013 | Sep. 30, 2014 | Sep. 30, 2014 | Sep. 30, 2014 | Sep. 30, 2014 | Sep. 30, 2014 | Sep. 30, 2014 | Sep. 30, 2014 | Sep. 30, 2014 | Sep. 30, 2014 | Sep. 30, 2014 | Sep. 30, 2014 | Sep. 30, 2014 |
Third Quarter 2015 | Fourth Quarter 2015 | Second Quarter 2016 | Third Quarter 2016 | Third Quarter 2017 | Fourth Quarter 2017 | First Quarter 2018 | Second Quarter 2018 | Third Quarter 2018 | Fourth Quarter 2018 | First Quarter 2019 | Third Quarter 2019 | |||
Number of Shares | 8,986,750 | 7,957,500 | 407,500 | 268,750 | 37,500 | 525,000 | 1,500,000 | 2,941,666 | 127,500 | 33,334 | 400,000 | 1,197,500 | 1,048,000 | 250,000 |
Exercise Price | ' | ' | '1.50-2.00 | '1.50 | '3.00-5.00 | '0.50-5.00 | '1.00-1.50 | '1.00-9.00 | '15.00 | '15.00 | '1.00 | '1.00-1.50 | '1.50 | '0.50 |
Remaining Life (years) | ' | ' | '1 year | '1 year 3 months | '1 year 9 months | '2 years | '3 years | '3 years 3 months | '3 years 6 months | '3 years 9 months | '4 years | '4 years 3 months | '4 years 6 months | '5 years |