0001493152-16-015067.txt : 20161121 0001493152-16-015067.hdr.sgml : 20161121 20161115135127 ACCESSION NUMBER: 0001493152-16-015067 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 55 CONFORMED PERIOD OF REPORT: 20160930 FILED AS OF DATE: 20161114 DATE AS OF CHANGE: 20161121 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Immune Therapeutics, Inc. CENTRAL INDEX KEY: 0001559356 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 593226705 STATE OF INCORPORATION: FL FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 000-54933 FILM NUMBER: 161999028 BUSINESS ADDRESS: STREET 1: 37 NORTH ORANGE AVENUE STREET 2: SUITE 607 CITY: ORLANDO STATE: FL ZIP: 32801 BUSINESS PHONE: (888) 613-8802 MAIL ADDRESS: STREET 1: 37 NORTH ORANGE AVENUE STREET 2: SUITE 607 CITY: ORLANDO STATE: FL ZIP: 32801 FORMER COMPANY: FORMER CONFORMED NAME: TNI BIOTECH, INC. DATE OF NAME CHANGE: 20121001 10-Q 1 form10-q.htm

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)

[X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2016

[ ] TRANSITION REPORT UNDER SECTION 13 OF 15(d) OF THE EXCHANGE ACT OF 1934

From the transition period from ___________ to ____________

Commission File Number __________________

IMMUNE THERAPEUTICS, INC.

(Exact name of small business issuer as specified in its charter)

Florida		59-3226705
(State or other jurisdiction of		(IRS Employer
incorporation or organization)		Identification No.)

37 North Orange Ave, Suite 607, Orlando, FL 32801

(Address of principal executive offices)

888-613-8802

(Issuer’s telephone number)

(Former name, former address and former fiscal year, if changed since last report)

Indicate by check mark whether the registrant (1) filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act during the past 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days: Yes [X] No [ ].

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes [X] No [ ].

Indicate by a check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.

	Large Accelerated Filer [ ]		Accelerated Filer [ ]

	Non-Accelerated Filer [ ]		Smaller Reporting Company [X]

Indicate by a check mark whether the company is a shell company (as defined by Rule 12b-2 of the Exchange Act: Yes [ ] No [X]

As of November 14, 2016 there were 241,128,131 shares of Common Stock outstanding.

TABLE OF CONTENTS

PART I FINANCIAL STATEMENTS

Item 1	Financial Statements	6

Item 2	Management’s Discussion and Analysis of Financial Conditions and Results of Operations	23

Item 3	Quantitative and Qualitative Disclosures About Market Risk	32

Item 4	Controls and Procedures	32

PART II OTHER INFORMATION

Item 1	Legal Proceedings	33

Item 1A	Risk Factors

Item 2	Unregistered Sales of Equity Securities and Use of Proceeds	33

Item 3	Default upon Senior Securities	33

Item 4	Mine Safety Disclosures	34

Item 5	Other Information	34

Item 6	Exhibits	34

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

Certain statements contained or incorporated by reference in this Quarterly Report on Form 10-Q are considered forward-looking statements (within the meaning of the Private Securities Litigation Reform Act of 1995) concerning our business, results of operations, economic performance and/or financial condition, based on management’s current expectations, plans, estimates, assumptions and projections. Forward-looking statements are included, for example, in the discussions about:

	●	strategy;

	●	new product discovery and development;

	●	current or pending clinical trials;

	●	our products’ ability to demonstrate efficacy or an acceptable safety profile;

	●	actions by the FDA and other regulatory authorities;

	●	product manufacturing, including our arrangements with third-party suppliers;

	●	product introduction and sales;

	●	royalties and contract revenues;

	●	expenses and net income;

	●	credit and foreign exchange risk management;

	●	liquidity;

	●	asset and liability risk management;

	●	the outcome of litigation and other proceedings;

	●	intellectual property rights and protection;

	●	economic factors;

	●	competition; and

	●	legal risks.

Any statements contained in this report that are not statements of historical fact may be deemed forward-looking statements. Forward-looking statements generally are identified by the words “expects,” “anticipates,” “believes,” “intends,” “estimates,” “aims,” “plans,” “may,” “could,” “will,” “will continue,” “seeks,” “should,” “predict,” “potential,” “outlook,” “guidance,” “target,” “forecast,” “probable,” “possible” or the negative of such terms and similar expressions. Forward-looking statements are subject to change and may be affected by risks and uncertainties, most of which are difficult to predict and are generally beyond our control. Forward-looking statements speak only as of the date they are made, and we undertake no obligation to update any forward-looking statement in light of new information or future events, except as required by law, although we intend to continue to meet our ongoing disclosure obligations under the U.S. securities laws and other applicable laws.

We caution you that a number of important factors could cause actual results or outcomes to differ materially from those expressed in, or implied by, the forward-looking statements, and therefore you should not place too much reliance on them. These factors include, among others, those described herein, under “Risk Factors” and elsewhere in this Annual Report and in our other public reports filed with the Securities and Exchange Commission. It is not possible to predict or identify all such factors, and therefore the factors that are noted are not intended to be a complete discussion of all potential risks or uncertainties that may affect forward-looking statements. If these or other risks and uncertainties materialize, or if the assumptions underlying any of the forward-looking statements prove incorrect, our actual performance and future actions may be materially different from those expressed in, or implied by, such forward-looking statements. We can offer no assurance that our estimates or expectations will prove accurate or that we will be able to achieve our strategic and operational goals.

Forward-looking statements are based on information we have when those statements are made or management’s good faith belief as of that time with respect to future events, and are subject to significant risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. Important factors that could cause such differences include, but are not limited to:

	●	our lack of operating history;

	●	our current and future capital requirements and our ability to satisfy our capital needs;

	●	our inability to keep up with industry competition;

	●	interpretations of current laws and the passages of future laws;

	●	acceptance of our business model by investors and our ability to raise capital;

	●	our drug discovery and development activities may not result in products that are approved by the applicable regulatory authorities. Even if our drug candidates do obtain regulatory approval they may never achieve market acceptance or commercial success;

	●	our reliance on key personnel, including our ability to attract and retain scientists;

	●	our reliance on third party manufacturing, some of which is outside the United States and may therefore be subject to political, economic and other uncertainties, to supply drugs for clinical trials and sales;

	●	our limited distribution organization with no sales and marketing staff;

	●	our being subject to product liability claims;

	●	our reliance on key personnel, including our ability to attract and retain scientists;

	●	legislation or regulation that may increase the cost of our business or limit our service and product offerings;

	●	risks related to our intellectual property, including our ability to adequately protect intellectual property rights;

	●	risks related to government regulation, including our ability to obtain approvals for the commercialization of some or all of our drug candidates, and ongoing regulatory obligations and continued regulatory review which may result in significant additional expense and subject us to penalties if we fail to comply with applicable regulatory requirements; and

	●	our ability to obtain regulatory approvals in foreign jurisdictions to allow us to market our products internationally.

Moreover, new risks regularly emerge and it is not possible for our management to predict or articulate all risks we face, nor can we assess the impact of all risks on our business or the extent to which any risk, or combination of risks, may cause actual results to differ from those contained in any forward-looking statements. All forward-looking statements included in this prospectus are based on information available to us on the date of this Annual Report. Except to the extent required by applicable laws or rules, we undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. All subsequent written and oral forward-looking statements attributable to us or persons acting on our behalf are expressly qualified in their entirety by the cautionary statements contained above and throughout this Annual Report.

JUMPSTART OUR BUSINESS STARTUPS ACT

We qualify as an “emerging growth company” as defined in Section 101 of the Jumpstart our Business Startups Act (“JOBS Act”) as we do not have more than $1,000,000,000 in annual gross revenue and did not have such amount as of December 31, 2015, the last day of our last fiscal year. We are electing to use the extended transition period for complying with new or revised accounting standards under Section 102(b)(1) of the JOBS Act.

As an emerging growth company, we are permitted to, and intend to, rely on exemptions from certain disclosure requirements that are otherwise applicable to public companies. These provisions include, but are not limited to:

	●	being permitted to present only two years of audited financial statements and only two years of related “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in this annual report;

	●	not being requested to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, as amended (“Sarbanes-Oxley Act”);

	●	reduced disclosure obligations regarding executive compensation in our periodic reports, proxy statements and registration statements; and

	●	exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved.

We will remain an emerging growth company until the earliest to occur of: (i) our reporting $1 billion or more in annual gross revenues; (ii) the end of fiscal year 2019; (iii) our issuance, in a three year period, of more than $1 billion in non-convertible debt; and (iv) the end of the fiscal year in which the market value of our common stock held by non-affiliates exceeded $700 million on the last business day of our second fiscal quarter

PART I FINANCIAL INFORMATION

ITEM 1. FINANCIAL STATEMENTS

IMMUNE THERAPEUTICS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

	September 30, 2016			December 31, 2015
	(Unaudited)			(Audited)
ASSETS
Current Assets:
Cash and cash equivalents	$	22,152		$	23,149
Accounts receivable		-			16,197
Total current assets		22,152			39,346

Fixed Assets:
Computer equipment, net of accumulated depreciation of $7,611 and $6,331 respectively		402			1,682

Deposits		200			200

Total assets	$	22,754		$	41,228

LIABILITIES AND STOCKHOLDERS’ DEFICIT

Current Liabilities:
Accounts payable	$	1,516,812		$	1,924,672
Accrued liabilities		2,397,013			1,281,039
Current portion of notes payable		3,573,698			2,793,701

Total current liabilities		7,487,523			5,999,412

Non-current liabilities:
Notes payable, less current portion		-			-
Total non-current liabilities		-			-
Total liabilities		7,487,523			5,999,412

Commitments and Contingencies (Note 10)

Stockholders’ Deficit:
Common stock - par value $0.0001; 500,000,000 shares authorized; 235,831,298 and 174,850,047 shares issued and outstanding respectively		23,583			17,485
Additional paid in capital		357,436,906			343,434,786
Stock issuances due		845,838			1,140,303
Prepaid services		(1,252,762	)		(660,417	)
Accumulated deficit		(362,256,392	)		(347,789,889	)

Deficit attributable to common shareholders		(5,202,827	)		(3,857,732	)
Non-controlling interest		(2,261,942	)		(2,100,452	)
Total stockholders’ deficit		(7,464,769	)		(5,958,184	)
Total liabilities and stockholders’ deficit	$	22,754		$	41,228

The accompanying footnotes are an integral part of these condensed consolidated financial statements.

IMMUNE THERAPEUTICS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

	Three months ended						Nine months ended
	September 30, 2016			September 30, 2015			September 30, 2016			September 30, 2015

Revenues, net	$	-		$	4,958		$	3,463		$	12,676

Operating expenses
Selling, general and administrative		1,031,075			865,335			2,864,333			1,689,188
Research and development expense		247,019			111,361			295,438			703,011
Stock issued for services G&A		1,225,353			1,393,500			4,403,951			5,005,393
Warrant valuation		187,850			37,451			2,756,404			37,451
Depreciation and amortization expense		299			148,696			1,280			446,148
Total operating expenses		2,691,596			2,556,343			10,321,406			7,881,191

Loss from operations		(2,691,596	)		(2,551,385	)		(10,317,943	)		(7,868,515	)

Other income (expense):
Interest expense		(978,275	)		(79,924	)		(2,331,296	)		(148,681	)
Loss on settlement of debt		(274,071	)		(1,394,000	)		(1,978,754	)		(1,482,445	)
Total other income (expense)		(1,252,346	)		(1,473,924	)		(4,310,050	)		(1,631,126	)

Net (loss)	$	(3,943,942	)	$	(4,025,309	)	$	(14,627,993	)	$	(9,499,641	)
Net (loss) attributable to non-controlling interest		(7,441	)		(165,759	)		(161,490	)		(428,715	)
Net (loss) attributable to common shareholders	$	(3,936,501	)	$	(3,859,550	)	$	(14,466,503	)	$	(9,070,926	)

Basic and diluted loss per share attributable to common shareholders	$	(0.02	)	$	(0.02	)	$	(0.07	)	$	(0.06	)

Weighted average number of shares outstanding		226,843,113			156,814,094			208,399,547			147,365,571

The accompanying notes are an integral part of these condensed consolidated financial statements.

IMMUNE THERAPEUTICS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ DEFICIT

FOR THE PERIOD ENDED SEPTEMBER 30, 2016

(Unaudited)

	Common Stock				Additional Paid		Stock to			Prepaid			Accumulated			Non-Controlling
	Shares		Amount		in Capital		Be Issued			Services			Deficit			Interest			Total
Balance, December 31, 2015		174,850,047	$	17,485	$	343,434,786	$	1,140,303		$	(660,417	)	$	(347,789,889	)	$	(2,100,452	)	$	(5,958,184	)

Issuance of common stock for prepaid services		29,283,910		2,927		5,417,833		(424,466	)		(2,907,535	)		-			-			2,088,759

Amortization of prepaid services		-		-		-		-			2,315,190			-			-			2,315,190

Issuance of common stock for interest expense		1,121,296		113		191,637		-			-			-			-			191,750

Discount on warrants issued in connection with notes payable		-				682,665		-			—			-			-			682,665

Issuance of common stock for legal fees		150,000		15		22,485		-			-			-			-			22,500

Issuance of common stock in exchange for debt		28,488,545		2,850		4,706,289		155,001			-			-			-			4,864,140

Issuance of common stock for cash and exercise of warrants		1,937,500		193		224,807		(25,000	)		-			-			-			200,000

Issuance and modification of stock warrants		-		-		2,756,404		-			-			-			-			2,756,404

Net loss		-		-		-		-			-			(14,466,503	)		(161,490	)		(14,627,993	)

Balance, September 30, 2016		235,831,298	$	23,583	$	357,436,906	$	845,838		$	(1,252,762	)	$	(362,256,392	)	$	(2,261,942	)	$	(7,464,769	)

The accompanying notes are an integral part of these condensed consolidated financial statements.

IMMUNE THERAPEUTICS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

	Nine months Ended
	September 30, 2016			September 30, 2015
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss	$	(14,627,993	)	$	(9,499,641	)
Adjustments to reconcile net loss to net cash flows used in operating activities:
Depreciation		1,280			1,974
Amortization		-			444,175
Stock issued, and amortization of stock issued, for prepaid services		2,315,190			3,895,018
Loss on settlement of debt		1,978,754			1,482,444
Stock issued for services		2,111,259			1,029,375
Stock issued for legal settlement		-			81,000
Stock warrant expense		2,756,404			37,452
Stock issued for interest		191,750			15,625
Amortization of debt discount		727,612			-
Accounts receivable write off		2,661
Changes in operating assets and liabilities:
Accounts payable		103,155			605,634
Accounts receivable		13,536			(12,676	)
Accrued liabilities		2,093,015			31,427
Prepaid expenses and deposits		-			(15,401	)

Net cash used in operating activities		(2,333,377	)		(1,903,594	)

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		200,000			587,500
Proceeds from issuance of notes payable		2,132,380			1,277,975

Net cash provided by financing activities		2,332,380			1,865,475
Net increase (decrease) in cash		(997	)		(38,119	)
Cash and cash equivalents at beginning of period		23,149			191,987
Cash and cash equivalents at end of period	$	22,152		$	153,868

The accompanying notes are an integral part of these condensed consolidated financial statements.

IMMUNE THERAPEUTICS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

	Nine months Ended
	September 30, 2016		September 30, 2015
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION:

Cash paid for interest	$	18,667	$	12,000

SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING AND FINANCING ACTIVITIES:

Common stock issued for loan expense and interest	$	191,750		$ 15,625

Common stock issued for prepaid services	$	2,088,759		$ 1,029,376

The accompanying notes are an integral part of these condensed consolidated financial statements.

Immune Therapeutics, Inc. and Subsidiaries

Notes to the Condensed Consolidated Financial Statements

September 30, 2016

(Unaudited)

1. Organization and Description of Business

Immune Therapeutics, Inc. (the “Company”) was initially incorporated in Florida on December 2, 1993 as Resort Clubs International, Inc. (“Resort Clubs”). It was formed to manage and market golf course properties in resort markets throughout the United States. Galliano International Ltd. (“Galliano”) was incorporated in Delaware on May 27, 1998 and began trading in November 1999 through the filing of a 15C-211. On November 10, 2004, Galliano merged with Resort Clubs. Resort Clubs was the surviving corporation. On August 23, 2010, Resort Clubs changed its name to pH Environmental Inc. (“pH Environmental”).

On April 23, 2012, pH Environmental completed a name change to TNI BioTech, Inc., and on April 24, 2012, we executed a share exchange agreement for the acquisition of all of the outstanding shares of TNI BioTech IP, Inc. On September 4, 2014, a majority of our shareholders approved an amendment to our Amended and Restated Articles of Incorporation, as amended, to change our name to Immune Therapeutics, Inc. We filed our name change amendment with the Secretary of State of Florida on October 27, 2014 changing our name to Immune Therapeutics, Inc.

The Company currently operates out of Orlando, Florida. In July 2012, the Company’s focus turned to acquiring patents that would protect and advance the development of new uses of opioid-related immune- therapies, such as low dose naltrexone (“LDN”) and Methionine [Met5]-enkephalin (“MENK”). Today, the Company is focused on the development and commercialization of therapeutic treatments for cancer, HIV/AIDS, malaria, and opportunistic infections arising from their treatment, and commercializing affordable, non-toxic therapies in Africa, to be followed by Asia and South America, and autoimmune diseases and immune disorders by combating these severe and fatal diseases through the stimulation and/or regulation of the body’s immune system. The Company’s therapies are believed to stimulate and/or regulate the immune system in such a way that they provide the potential to treat a variety of diseases. We believe our therapies may be able to correct abnormalities or deficiencies in the immune system in diseases such as HIV infection, autoimmune disease, immune disorders, or cancer; all of which can lead to disease progression and life-threatening situations when the immune system is not functioning optimally.

In October 2012, the Company formed TNI BioTech International, Ltd., a BVI company in Tortola, British Virgin Islands, which was set up to allow the Company to market and sell LDN in those countries outside the U.S. in which we have been able to obtain approval to sell the Company’s products.

In August 2013, the Company formed its United Kingdom subsidiary, TNI BioTech, LTD (the “UK Subsidiary”). The UK Subsidiary received approval to be considered a micro, small or medium-sized enterprise (“SME”) with the European Medicines Agency (“EMA”) on August 21, 2013. The designation provides the UK Subsidiary with significant discounts when holding meetings or submitting filings to the EMA. On September 19, 2013, the UK Subsidiary submitted a pre-submission package to the EMA regarding Crohn’s Disease. The EMA granted the UK Subsidiary a meeting that took place on September 27, 2013. The UK Subsidiary is eligible to benefit from the provisions for administrative and financial assistance for SMEs set out in Regulation (EC) No 2049/2005. The Company will apply to obtain EMA benefits once funding becomes available.

In December 2013, the Company formed a new subsidiary, Cytocom Inc. (“Cytocom”). Cytocom is a clinical-stage pharmaceutical company focused on the development of the first affordable non-toxic immunodulator for the treatment of inflammatory diseases, immune-related disorders, and cancer, and is responsible for the development of the Company’s patented therapies under the auspices of the FDA and EMA. In December 2014, the Company finalized the distribution of common stock of Cytocom 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 during drug development. On December 8, 2014, the number of Cytocom shares of common stock that were issued to our shareholders totaled 113,242,522 shares. In connection with the transaction, Cytocom issued 140,100,000 shares of its common stock to the Company, which gave the Company a 55.3% equity interest in Cytocom on that date. In April 2016, the Board of Directors and a majority of shareholders of Cytocom approved a reverse stock split of Cytocom’s outstanding common stock with one new share of stock for each twenty old shares of common stock. Cytocom effectuated and finalized the reverse split in June 2016. At September 30, 2016, the Company’s equity interest had been further reduced to 17%, by subsequent issuances of Cytocom common stock to shareholders in settlement of notes payable.

In March 2014, the Company incorporated Airmed Biopharma Limited, an Irish corporation with an address in Dublin, Ireland, and Airmed Holdings Limited, an Irish company domiciled in Bermuda. The Irish companies were set up to benefit from incentives granted by the Irish government for the establishment of pharmaceutical companies (many of the world’s leading pharmaceutical companies have located in Ireland), and so that the Company could take advantage of Ireland’s status as a member of the European Union and the European Economic Area. An Irish limited liability company enjoys a low corporate income tax rate of 12.5%, one of the lowest in the world. The Irish-domiciled company hopes to qualify for tax incentives for Irish holding/headquartered companies and to benefit from the network of double tax treaties that reduce withholding taxes. TNI BioTech International, Ltd. will manage our international distribution, using product that is manufactured in Ireland and elsewhere.

Immune Therapeutics is commercializing affordable non-toxic immunotherapies focused on the activation and rebalancing of the body’s immune system. Stimulating the body’s immune system remains one of the most promising approaches in the treatment of cancers, HIV, autoimmune diseases, inflammatory conditions and other opportunistic infections, and for treating chronic, often life-threatening, diseases in Emerging Nations through the mobilization of the body’s immune system using existing clinical data.

As of this date, neither we nor our collaboration partners are permitted to market our drug candidates in the United States until we receive approval of a New Drug Application from the FDA. Neither we nor our collaboration partners have submitted an application for or received marketing approval for any of our drug candidates. Obtaining approval of an NDA can be a lengthy, expensive and uncertain process.

Going Concern

The Company has incurred significant net losses since inception and has relied on its ability to fund its operations through private equity financings. Management expects operating losses and negative cash flows to continue at more significant levels in the future. As the Company continues to incur losses, transition to profitability is dependent upon the successful development, approval, and commercialization of its product candidate and the achievement of a level of revenues adequate to support the Company’s cost structure. The Company may never achieve profitability, and unless and until it does, the Company will continue to need to raise additional cash. Management intends to fund future operations through additional private or public debt or equity offerings, and may seek additional capital through arrangements with strategic partners or from other sources. Based on the Company’s operating plan, existing working capital at December 31, 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 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 $(14,627,993) and used cash and cash equivalents from operations in the amount of $2,333,377 during the nine months ended September 30, 2016, resulting in stockholders deficit of $(7,464,769) at September 30, 2016.

2. Summary of Significant Accounting Policies

Basis of Presentation

The consolidated financial statements included herein have been prepared by the Company, without audit, pursuant to the rules and regulations of the Securities and Exchange Commission. Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. generally accepted accounting principles have been omitted. However, in the opinion of management, all adjustments (which include only normal recurring adjustments, unless otherwise indicated) necessary to present fairly the financial position and results of operations for the periods presented have been made. The results for interim periods are not necessarily indicative of trends or of results to be expected for the full year. These financial statements should be read in conjunction with the financial statements of the Company for the year ended December 31, 2015 (including the notes thereto) set forth in Form 10-K/A.

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 Company’s financial statements in conformity with U.S. generally accepted accounting principles requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from such estimates.

Cash, Cash Equivalents, and Short-Term Investments

The Company considers all highly liquid investments with original maturities at the date of purchase of three months or less to be cash equivalents. Cash and cash equivalents include bank demand deposits, marketable securities with maturities of three months or less at purchase, and money market funds that invest primarily in certificates of deposits, commercial paper and U.S. government and U.S. government agency obligations. Cash equivalents are reported at fair value.

Concentration of Credit Risk

Financial instruments that potentially subject the Company to concentrations of credit risk are primarily cash and cash equivalents. The Company is exposed to credit risk, subject to federal deposit insurance, in the event of a default by the financial institutions holding its cash and cash equivalents to the extent of amounts recorded on the balance sheets. The cash accounts are insured by the Federal Deposit Insurance Corporation up to $250,000. At September 30, 2016, the Company has no uninsured cash balances.

Segment and Geographic Information

Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one operating segment and does not segment the business for internal reporting or decision making.

Fair Value of Financial Instruments

In accordance with the reporting requirements of Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) Topic 825, “Financial Instruments”, 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. Cash and cash equivalents, accounts receivable and accounts payable are accounted for at cost which approximates fair value due to the relatively short maturity of these instruments. The carrying value of notes payable also approximates fair value since they bear market rates of interest and other terms. None of these instruments are held for trading purposes.

Fair Value Measurements

The ASC Topic 820, Fair Value Measurements, defines fair value, establishes a framework for measuring fair value in accordance with U.S. generally accepted accounting principles, and requires certain disclosures about fair value measurements. In general, fair values of financial instruments are based upon quoted market prices, where available. If such quoted market prices are not available, fair value is based upon internally developed models that primarily use, as inputs, observable market-based parameters. Valuation adjustments may be made to ensure that financial instruments are recorded at fair value. These adjustments may include amounts to reflect counterparty credit quality and the customer’s creditworthiness, among other things, as well as unobservable parameters. Any such valuation adjustments are applied consistently over time.

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 September 30, 2016 and September 30, 2015 was $299 and $638, 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 market value. At the end of 2015, the Company determined that the unamortized carrying amount recorded for the acquisition of licenses and patents related to LDN were impaired, and recorded an impairment loss of $5,226,352. In 2014, the Company determined that the carrying amount recoded for the acquisition of licenses and patents related to MENK were impaired, and recorded an impairment loss of $9,908,477.

During the quarters ended September 30, 2016 and September 30, 2015, the Company did not capitalize any costs to acquire and/or develop the Company’s product licenses and patents. (See Note 10). Amortization expense for the quarters ended September 30, 2016 and September 30, 2015 was $0 and $444,175, 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.” 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 quarters ended September 30, 2016 and September 30, 2015.

Research and Development Costs

Research and development costs are charged to expense as incurred and are typically comprised of salaries and benefits, pre-clinical studies, clinical trial activities, drug development and manufacturing, fees paid to consultants and other entities that conduct certain research and development activities on the Company’s behalf and third-party service fees, including clinical research organizations and investigative sites. Costs for certain development activities, such as clinical trials are recognized based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations, or information provided by vendors on their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the financial statements as operating expenses.

Income Taxes

The Company follows FASB ASC Topic 740, “Income Taxes,” which requires recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements or tax returns. Under this method, deferred tax assets and liabilities are based on the differences between the financial statements and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Deferred tax assets are reduced by a valuation allowance to the extent management concludes it is more likely than not that the asset will not be realized. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled.

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 September 30, 2016, the Company does not have a liability for unrecognized tax uncertainties.

The Company’s policy is to record interest and penalties on uncertain tax positions as income tax expense. At the end of the quarters ended September 30, 2016 and September 30, 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 market value of the Company’s common stock at the date of the agreement.

The Company’s accounting policy for equity instruments issued to consultants and vendors in exchange for goods and services follows the provisions of ASC Topic 505-50, “Equity-Based Payments to Non-Employees.” 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.

Non-controlling Interest

In accordance with ASC 810, Consolidation, the Company consolidates Cytocom, Inc. The non-controlling interests in Cytocom represent the interests of outside shareholders in the equity and results of operations of Cytocom.

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.

A calculation of basic and diluted net loss per share follows:

	For the three months ended September 30,						For the six months ended September 30,
	2016			2015			2016			2015
Net loss per share:
Numerator
Net loss	$	(3,943,942	)	$	(4,025,309	)	$	(14,627,993	)	$	(9,499,641	)
Net loss attributed to Common stockholders	$	(3,936,501	)	$	(3,859,550	)	$	(14,466,503	)	$	(9,070,926	)

Denominator
Weighted-average common shares outstanding—
Denominator for basic and diluted net loss per share		226,843,113			156,814,094			208,399,547			147,365,571
Basic and diluted net loss per share attributed to common stockholders	$	(0.02	)	$	(0.02	)	$	(0.07	)	$	(0.06	)

The Company’s potential dilutive securities which include stock, stock warrants and convertible debt 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,
	2016		2015
Warrants to purchase Common stock		32,623,908		9,355,250
		32,623,908		9,355,250

Recent Accounting Standards

During the quarter ended September 30, 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 Company’s consolidated financial statements.

The Company qualifies as an “emerging growth company” as defined in Section 101 of the Jumpstart our Business Startups Act (“JOBS Act”) as we do not have more than $1,000,000,000 in annual gross revenue and did not have such amount as of December 31, 2015, our last fiscal year. We are electing to use the extended transition period for complying with new or revised accounting standards under Section 102(b)(1) of the JOBS Act.

3. Property and Equipment

	September 30, 2016			December 31, 2015
Property and equipment:
Computer equipment	$	8,013		$	8,013

Less accumulated depreciation		(7,611	)		(6,331	)

Property and equipment, net	$	402		$	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.

4. Accrued Liabilities

Accrued expenses and other liabilities consist of the following:

	September 30, 2016		December 31, 2015
	(in thousands)
Accrued payroll to officers and others	$	934	$	758
Accrued interest and penalties - notes payable		1,319		237
Accrued legal settlements		143		282
Other accrued liabilities		1		4
Total accrued expenses and other liabilities	$	2,397	$	1,281

5. Notes Payable

Notes payable consist of the following:

	September 30, 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 Company’s gross receipts for sales of IRT-103-LDN in perpetuity. Notes will be repaid in 36 monthly installments of principal and interest commencing no later than October 15, 2015. Principal of $425,500 and accrued interest of $37,427 were converted to 5,309,092 shares of common stock in the nine months ended September 30, 2016, Notes aggregating $286,000 were in default at September 30, 2016, as the Company was unable to pay installments on those notes on their due dates. No demands for repayment have been made by the lenders.		286,000		711,500

Promissory note issued October 17, 2014 to Roger Bozarth. The note matures on October 17, 2015 and earns interest at a rate of 2% per annum. The lender converted this note and $2,139 in accrued interest to 114,237 shares of common stock in January 2016.		-		7,000

Promissory notes issued between May 1, 2015 and September 30, 2016, and maturing between June 14, 2015 and June 30, 2017. Lenders on loans aggregating $535,994 earn interest at rates between 10% and 18% per annum. On loans aggregating $198,500, interest is payable in a fixed amount not tied to a specific interest rate. Notes aggregating $198,500 were in default at September 30, 2016, as the Company was unable to repay those notes on their due dates. No demands for repayment have been made by the lenders.		734,494		669,933

Promissory note issued January 26, 2015 to Robert J. Dailey. The note is senior to, and has priority in right of payment over, all indebtedness of the Company. The note earns interest at a rate of 2% per annum and was due on July 30, 2015. Principal of $200,000 and accrued interest of $4,778 was converted to 3,722,015 shares of common stock in the nine months ending September 30, 2016.		-		200,000

Promissory notes issued by Cytocom Inc. between April 29, 2015 and December 31, 2015. Lenders earn interest at rates between 5% and 10% per annum. These notes mature on September 30, 2016. $375,000 of principal and $12,036 in accrued interest was converted to 4,837,960 shares of common stock in the nine months ending September 30, 2016. The Company was unable to repay the remaining notes at maturity and the notes are in default, although no demand for repayment has been made by the lenders.		425,000		800,000

Promissory notes issued in December 2015. Lenders earn interest at a rate of 10% per month. Notes are repayable on March 9, 2016. . $30,000 of principal and $49,000 of interest and penalties were converted to 987,500 shares of common stock in the nine months ended September 30, 2016. The Company was unable to repay the remaining note at maturity and the note is in default The Company is obligated to pay late-payment penalties totaling $5,000 per day on the remaining obligation.		100,000		130,000

Promissory note issued November 24, 2015 as settlement of amounts owing to a law firm. The Lender earns interest at the rate of 10% per annum. The note and $10,036 in interest was converted to 1,235,536 shares of common stock in July 2016.		-			175,268

Promissory notes issued between May 5, 2016 and June 2, 2016 that mature between October 1, 2016 and January 31, 2017, and include stock conversion features, warrants and original issue debt discounts. Notes aggregating $305,000 were in default at November 14, 2016. No demand for repayment has been made by the lenders.		555,000			-

Promissory notes issued to an officer of the Company effective November 3, 2015 and maturing November 3, 2016 for settlement of accrued payroll, bearing interest at 10% per annum and including a stock conversion feature.		112,737			-

Promissory note issued in July 2016. The note is repayable on October 5, 2016. The note earns interest at 6% per month. The Company was unable to repay the note at maturity and the note is in default.		50,000			-

Promissory note dated April 2016, issued to JM Financial (“JMJ”), pursuant to which JMJ loaned the Company $525,000 and was issued the promissory note, 500,000 shares of common stock, and a warrant exercisable for 3,515,621 additional common shares at a rate of $0.14 per share. The note matures on January 6, 2017. The note was repaid on November 4, 2016.		656,250			-

Promissory note issued in July 2016 with an original issuance discount of $30,000. Net proceeds were $150,000. The note is repayable on April 7, 2017.		180,000			-

Promissory notes issued in August 2016 for $149,854 as a settlement of amounts owed to a law firm. The notes accrue interest at 5% per annum and are payable in 18 equal monthly installments of $8,641.88.		146,912			-

Promissory notes issued between July 1, 2016 and September 30, 2016. Lenders earn interest at 12% per annum. The notes mature between January 1, 2017 and March 31, 2017.		495,000			-

Less: Original issue discounts on notes payable and warrants issued with notes.		(267,695	)		-

Total		3,573,698			2,793,701

Less: Current Portion	$	(3,573,698	)	$	(2,793,701	)

Long-Term debt, less current portion	$	-		$	-

As of September 30, 2016, the Company had accrued $278,089 in unpaid interest and $1,041,502 in unpaid default penalties, compared to $217,717 and 18,954, respectively, as of December 31, 2015. During the three months ended September 30, 2016, 225,000 shares with a fair value of $42,750 were issued by the Company for interest expense under promissory notes.

6. Capital Structure—Common Stock and Common Stock Purchase Warrants

Each holder of common stock is entitled to vote on all matters and is entitled to one vote for each share held. No holder of shares of stock of any class shall be entitled as a matter of right to subscribe for or purchase or receive any part of any new or additional issue of shares of stock of any class, or of securities convertible into shares of stock or any class, whether now hereafter authorized or whether issued for money, for consideration other than money, or by way of dividend.

As of September 30, 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 September 30, 2016, the Company had 235,831,298 shares of common stock outstanding, and 174,850,047 outstanding as of December 31, 2015.

Stock Warrants

In the quarter ended September 30, 2016, the Company issued 2,000,000 warrants.

There were no modifications of the terms of any warrants issued by the Company in the quarter ended September 30, 2015.

Following is a summary of outstanding stock warrants at September 30, 2016 and activity during the nine 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		25,654,908		$	0.14-2.00	$	0.31

Expired		(162,500	)	$	5.00	$	5.00

Exercised		(0	)	$	0	$	0

Warrants as of September 30, 2016		34,623,908		$	0.07-15.00	$	0..50

Summary of outstanding warrants as of September 30, 2016:

Expiration Date	Number of Shares		Exercise Price		Remaining Life (years)

Fourth Quarter 2017		350,000	$	1.50-9.00		1.25
First Quarter 2018		127,500	$	15.00		1.50
Second Quarter 2018		33,334	$	15.00		1.75
Third Quarter 2018		250,000	$	1.50		2.00
Fourth Quarter 2018		6,089,166	$	1.00-1.50		2.25
First Quarter 2019		4,024,000	$	0.50-2.00		2.50
Second Quarter 2019		135,000	$	0.07–0.23		2.75
Third Quarter 2019		260,000	$	0.50-1.50		3.00
Fourth Quarter 2019		400,000	$	0.14		3.25
Second Quarter 2020		300,000	$	0.50		3.75
Fourth Quarter 2020		1,000,000	$	0.20		4.00
First Quarter 2021		12,650,000	$	0.20		4.25
Second Quarter 2021		6,004,908	$	0.10-0.20		4.50
Third Quarter 2021		3,000,000	$	0.20		4.75

7. Stock Compensation

Shares Issued for Services

During the nine months ended September 30, 2016 and 2015, the Company issued 29,283,910 and 16,922,504 shares of common stock respectively for consulting fees. The Company valued these shares at $5,420,760 and $1,029,375 respectively, based upon the fair value of the common stock at the dates of the agreements. The consulting fees are amortized over the contract periods, which are typically between 12 and 24 months. The amortization of prepaid services totaled $2,315,190 and $3,895,018 for the nine months ended September 30, 2016 and 2015. In the nine months ended September 30, 2016, the company also issued and expensed $2,088,759 of stock for services.

8. Income Taxes - Results of Operations

There was no income tax expense reflected in the results of operations for the quarters ended September 30, 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 Company’s ability to realize the benefit of its deferred tax asset will depend on the generation of future taxable income. Because the Company has yet to recognize revenue, we believe that the full valuation allowance should be provided.

The Company’s effective tax rate for fiscal years 2015 and 2013 was 0%. The Company’s 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, the Company has estimated federal and state income tax net operating loss (“NOL”) carry-forwards of approximately $66,500,000, which will expire in 2032-2035.

9. Licenses and Supply Agreements

Patent and Subsidiary Acquisition

The Company has not entered into any new licenses or supply agreements during quarter ending September 30, 2016. All prior licenses, supply agreements, and patents remain unchanged from the prior quarter.

10. Commitments and Contingencies

Except as described below, the Company has not created any new commitments or contingency obligations during quarter ending September 30, 2016. All other prior commitments and contingent obligations remain unchanged from the prior quarter.

Distribution of Lodonal^TM in Nigeria

Through its wholly-owned subsidiary, TNI BioTech International, Ltd., in December 2015 the Company completed a 90-day bridging trial for the treatment of patients with HIV/AIDS. The trial consisted of a total of 150 patients of both genders between the ages of 18-60, each of whom was infected HIV/AIDS. The primary objective of this bridging trial was to confirm that Lodonal^TM has a beneficial effect on the immune system of immune deficient patients and that it is safe. The trial separated patients into a Control (placebo) Group and a Treatment Group (which was administered Lodonal^TM). The efficacy of increasing CD4 count [cell/mm3] between Day-1 and Day-90 by at least 25% was set as the criteria for demonstrating beneficial effect on the immune system. Safety was demonstrated through quality of life assessment and vitals both of which were not adversely affected. Treatment Group patients were given a daily dose of 4.5-mg/kg of Lodonal.

In April 2016, the Company announced that Nigeria’s National Agency for Food and Drug Administration and Control (“NAFDAC”) had approved its Lodonal^TM 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. The NAFDAC approval clears the way for the Company and its distribution partners to complete the registration of Lodonal^TM for sale in Nigeria. The Company is currently completing the registration process to allow it to import the drug into Nigeria.

Other Distribution Agreements

Contract Manufacturing Agreements

On May 16, 2016, the Company entered into an agreement with Complete Pharmacy and Medical Solutions, LLC (“CPMS”) to compound, package and distribute the LDN tablets, capsules and/or creams in the United States. The initial term of the agreement is three years, with the option to renew for an additional year. The agreement may be terminated by (i) mutual agreement, (ii) in the event of a breach, provided however that if the Company terminates the agreement, the Company will be required to reimburse CPMS for all unused packaging materials for the LDN, which unused packaging materials CPMS will provide to IMUN. If CPMS does not receive and ship at least 1,000 orders (prescriptions) during the term of the agreement, the Company will be required to reimburse CPMS for 100% of the “ramp up costs” (defined as all costs and expenses of labor and materials related to the testing, and required FDA and other governmental documentation/approvals of test data) of providing and producing the LDN, even where the Company cancels/terminates the agreement, which provision shall survive the cancellation/termination of the agreement.

On October 25, 2016, the Company and Acromax Dominicana, SA ("Acromax") entered into a contract for manufacturing of LDN tablets, capsules and/or creams ("Agreement"). Subject to the terms and conditions of the Agreement, Acromax will obtain all necessary licenses and permits to carry out the manufacturing and packaging of LDN in exchange for a fixed fee per tablet plus an additional fee for packaging, shipping and customs clearance. The Agreement has an initial term of five years unless terminated by either party in accordance with the terms.

Operating Leases

At September 30, 2016, the Company was a party to an agreement to lease office space in Orlando, Florida. Rent expense for the quarters ended September 30, 2016 and 2015 was $4,009 and $4,988, respectively.

Legal Proceedings

None.

11. Subsequent Events

In October 2016, the Company and its wholly owned subsidiary, TNI BioTech International, Ltd., and GB Pharma Holdings, LLC (“GBPH”), entered into an exclusive agency agreement (“Agency Agreement”) that replaced the agency agreement originally entered into in June 2014 between GBPH and Airmed Biopharma Limited. Subject to the terms and conditions of the Agency Agreement, the Company appointed GBPH as its exclusive agent to (i) assist the Company in obtaining governmental approvals for the sale of LDN and MENK (“Products”) in countries specified in the agreement, (ii) facilitate the registration of the Products in those countries, (iii) identify and present to the Company distributors for the Products in those countries, and (iv) subject to GBPH meeting certain requirements, enter into distribution agreements with the specified organizations to distribute the Products in the countries. The Company has agreed pay GBPH a commission of 12.5% of funds received by the Company from such sales. The Agency Agreement has an initial term of five years, and will automatically renew for additional one year terms unless terminated by either party in accordance with its terms. If the Company sells or disposes of all or substantially all of its assets, whether by purchase, merger or otherwise, the Company shall have the right to terminate the Agency Agreement immediately, whereupon the Company will be obligated to pay Agent a royalty in perpetuity in an amount equal to one percent of funds actually received by the Company from the sale of the Products in the specified countries, after the deduction of certain costs of sale.

In October 2016, the Company amended a promissory note dated July 6, 2015, and settled a portion of the principal owed under the note and accrued and unpaid interest to the date of the amendment. In accordance with the amendment, the Company repaid $50,000 of the $100,000 principal owed, issued 2,000,000 shares of the Company’s common stock to the note holder in full satisfaction of the accrued and unpaid interest to the date of the amendment, and caused Cytocom to issue 250,000 shares of its common stock in return for the note holder’s agreement to reduce the annual interest rate on the note from 18% to 10% and to extend the maturity date of the note from September 6, 2016 to December 31, 2016.

In October 2016, the company borrowed an additional $165,000.

In October 2016, the Company issued 1,300,000 shares of common stock for consulting services.

In October 2016, the company issued 300,000 shares of common stock for lending fees.

On or around October 25, 2016, the Company issued a promissory note in the principal amount of $25,000.00 to Noreen Griffin in consideration for past payroll due Ms. Griffin. Ms. Griffin sold the note to a minority shareholder for $25,000.00 on October 25, 2016. This note was subsequently converted to 500,000 shares of common stock.

On November 1, 2016, the Company issued promissory notes for $750,000, paying interest at 2% per month, and maturing on November 1, 2017. $656,250 of the proceeds were used to pay off the JMJ Financial note, with the remainder to be used for general obligations.

As of November 14, 2016, the Company had outstanding 241,128,131 shares of common stock.

ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATION

Forward-Looking Statements and Associated Risks

This section and other parts of this Form 10-Q contain forward-looking statements. Forward-looking statements provide current expectations of future events based on certain assumptions and include any statement that does not directly relate to any historical or current fact. Forward-looking statements also can be identified by words such as “future,” “anticipates,” “believes,” “estimates,” “expects,” “intends,” “will,” “would,” “could,” “can,” “may,” and similar terms. Forward-looking statements are not guarantees of future performance and the Company’s actual results may differ significantly from the results discussed in the forward-looking statements. Factors that might cause such differences include, but are not limited to, those discussed in our Annual Report on Form 10-K/A for the year ended December 31, 2015 filed with the Securities and Exchange Commission on May 16, 2016 (the “2015 Form 10-K/A”) under the heading “Risk Factors”.

The following discussion should be read in conjunction with the 2015 Form 10-K/A and the consolidated financial statements and notes thereto included elsewhere in this Form 10-Q. All information presented herein is based on the Company’s fiscal calendar. Unless otherwise stated, references in this report to particular years, quarters, months or periods refer to the Company’s fiscal years ended in December and the associated quarters, months, or periods of those fiscal years. Each of the terms the “Company”, “we”, “us” or “our” as used herein refers collectively to Immune Therapeutics, Inc. and its subsidiaries, unless otherwise stated. The Company assumes no obligation to revise or update any forward-looking statements for any reason, except as required by law.

General

Three Months Ended September 30, 2016 Compared to Three Months Ended September 30, 2015 (all dollar amounts and numbers in $000s, except percentages or where otherwise indicated)

Revenues

We had revenues from operations of $0 for the three months ended September 30, 2016, compared to revenues of $4,958 for three months ended September 30, 2015. The decrease in revenues was the result of the Company’s termination of its manufacturing agreement with KRS Global Bio Technology, Inc. (“KRS”), which was cancelled by mutual agreement of the parties in May 2016. Shipments under the agreement with Complete Pharmacy and Medical Solutions, LLC, which will replace KRS as the Company’s manufacturer and distributor of LDN tablets, have not yet commenced.

Operating Expenses

Selling, general and administrative

Selling, general and administrative expenses and related percentages for the three months ended September 30, 2016 and 2015 were as follows (dollar amounts in thousands):

	For the three months ended September 30,
	2016			2015
Selling, general and administrative	$	1,031		$	865
Increase/(decrease) from prior year	$	166		$	(37	)
Percent increase/(decrease) from prior year		19	%		(4	)%

For the three months ended September 30, 2016 and 2015, selling, general and administrative expenses were made up as follows (dollar amounts in thousands):

	For the three months ended September 30,
	2016		2015
Consulting and contractors	$	161	$	388
Payroll		583		262
Professional fees		37		75
Travel		107		9
Other expenses		143		131

	$	1,031	$	865

In the three months ended September 30, 2016, total cash and accruals for selling, general and administrative expense was $1,031 compared to $865 for the corresponding period in 2015, an increase of $166 or 19%. Significant cash items included:

	●	consulting and contactor services obtained to assist the Company in raising capital, manage investor relations, manage financial reporting and compliance, and develop business in new markets, in the amount of $161 in 2016, a decrease of $227 or 58 % over the $388 spent in 2015. The decrease was the result primarily of the conversion in 2015 of amounts owed from prior periods into equity, which resulted in a $200 charge to this expense category;

	●	professional fees for legal, tax and accounting services in the amount of $37 in 2016, a decrease of $38 or 51% over the $75 spent in 2015. The decrease was the primarily the result of $40 in legal fees incurred in 2015 related to Cytocom, which were not repeated in 2016;

	●	payroll in the amount of $583 in 2016, an increase of $321 or 123% over the $262 reported in 2015. The increase reflects higher headcount in 2016, together with the accrual of payroll for Cytocom employees, which was only instituted in July, 2016; and

	●	travel in the amount of $107 in 2016, an increase of $98 or 1,075% over the $9 spent in 2015. 2016 travel was related mostly to sales and marketing activities in Africa.

Research and development

R&D expenses and related percentages for the three months ended September 30, 2016 and 2015 were as follows (dollar amounts in thousands):

	For the three months ended September 30,
	2016			2015
Research and development	$	247		$	111
Increase/ (decrease) from prior year	$	136		$	(290	)
Percent decrease from prior year		122	%		(72	)%

Expenses for research and development in the three months ended September 30, 2016 increased by 122% compared to the same period in 2015. The increase occurred mainly as a result of (i) the commencement of new trials in Malawi and Senegal ($124), which were offset by a $24 decrease in the cost trials in Nigeria, and (ii) an increase of $36 in legal fees paid to maintain patents and licenses.

In the three months ended September 30, 2016, significant items included:

	●	payments for contracted technical services, $26 in 2016, a decrease of $3 or 10% over the $29 spent in 2015, reflecting the decreased use of contractors to perform research activities;

	●	payments for professional fees $45 in 2016, an increase of $36 or 400% over the $9 spent in 2015;

	●	patent expenses of $39 in 2016, an increase of $3 or 9% over the $36 spent in 2015, reflecting payments for certain rights to use LDN.

All of the R&D spending in 2016 was on LDN. In 2015, 75% of R&D spending was on the development of LDN; the balance was spent on MENK.

Stock issued for services

The Company periodically issues stock to consultants who provide services to the Company under consulting contracts. The Company records an expense for the cost of these services, calculated by the number of shares issued for the services multiplied by the price of the Company’s stock on the effective date of the consulting contract. If the period over which services are to be provided extends beyond the date of the Company’s financial report, the portion of the cost applicable to the future services is accrued as a liability, which is then amortized over the period in which the services are provided to the Company. The Company reports these costs separately from Selling, general and administrative costs, and Research and development costs, to better demonstrate the true costs of Selling, general and administrative activities, and Research and development.

Cost of stock issued for services G&A and related percentages for the three months ended September 30, 2016 and 2015 were as follows (dollar amounts in thousands):

	For the three months ended September 30,
	2016			2015
Stock for services and Prepaid consulting services expense G&A	$	1225		$	1,394
Percentage increase/(decrease) from prior year		12	%		(72	)%

The decrease reflects the decrease in amount of stock that was issued for services.

The number of shares issued for prepaid consulting services G&A in the three months ending September 30, 2016 was 5,790,910 (6,683,334 in the corresponding period in 2015).

Amortization of prepaid consulting services G&A in the three months ended September 30, 2016 consisted of the following:

Amortization of cost of stock issued prior to 2016	$	110
Amortization of cost of stock issued in the first half of 2016		620
Amortization of cost incurred for new stock issued third quarter of 2016 under consulting contracts entered into in 2016		45

Total third quarter amortization of prepaid consulting	$	775

There was no expense for amortization of stock issued for services R&D for the three months ended September 30, 2016 and 2015, due to the fact that the cost of shares issued for R&D services had been fully amortized prior to the third quarter of 2014.

There were no new shares issued for prepaid consulting services R&D in the three months ending September 30, 2016 or 2015.

Warrant valuation expense

When the Company sells its stock to stockholders for cash, it periodically issues warrants to those stockholders to acquire additional stock at prices agreed at the date of the original sale. The Company incurs a cost for the rights attached to the warrants, which is calculated using the Black-Scholes Model (see above 4. Capital Structure—Common Stock and Common Stock Purchase Warrants.) This expense is reported in the Condensed Consolidated Statements of Operations above as the Warrant valuation expense.

In the three months ended September 30, 2016, the Company issued 2,000,000 warrants. In the three months ended September 30, 2015, the Company issued 390,000 warrants to stockholders.

Depreciation and amortization

The Company amortizes the costs incurred to acquire patents and licenses over the period of the related agreements. The decrease year over year in depreciation and amortization expense reflects the fact that, at the end of 2015, the Company determined that the unamortized carrying amount recorded for the acquisition of licenses and patents related to LDN were impaired, and recorded an impairment loss of $5,226,352. In 2014, the Company determined that the carrying amount recoded for the acquisition of licenses and patents related to MENK were impaired, and recorded an impairment loss of $9,908,477.

Depreciation and amortization expenses for the three months ended September 30, 2016 and 2015 were as follows (dollar amounts in thousands):

	For the three months ended September 30,
	2016			2015
Depreciation expense	$	1		$	1
Amortization expense	$	-		$	148
Decrease from prior year	$	(148	)	$	(571	)
Percentage decrease from prior year		(99	)%		(79	)%

The decrease reflects the fact that all patents were fully amortized by the end of 2015.

Interest Expense

Interest expense for the three months ended September 30, 2016 and 2015 were as follows (dollar amounts in thousands):

	For the three months ended September 30,
	2016			2015
Interest expense	$	978		$	80
Increase/(decrease) from prior year	$	898		$	(14	)
Percentage increase/(decrease) from prior year		1,124	%		(16	)%

The increase reflects the higher levels of interest-bearing debt in the third quarter of 2016. Interest expense for the quarter ended September 30, 2016 included $460 of penalties for late interest and principal payments ($0 for the quarter ended September 30, 2015).

Loss on settlement of debt (dollar amounts in thousands)

In three months ended September 30, 2016, certain lenders to the Company settled all or a portion of their notes or accounts payable by converting them to equity. The Company recorded an expense of $274, reflecting the fair value of the shares of common stock issued in exchange for the debt.

In three months ended September 30, 2015, certain lenders to the Company settled all or a portion of their notes payable or accounts payable by converting them to equity, for which the Company recorded an expense of $1,394, reflecting the fair value of the shares of common stock issued in exchange for the debt less the carrying value of the debt.

Nine months ended September 30, 2016 compared to nine months ended September 30, 2015 (all dollar amounts and numbers in $000s, except percentages or where otherwise indicated)

Revenues

We had revenues from operations of $3 for the nine months ended September 30, 2016, compared to $13 for the nine months ended September 30, 2015. The decrease in revenues was the result of the Company’s termination of its manufacturing agreement with KRS Global Bio Technology, Inc. (“KRS”), which was cancelled by mutual agreement of the parties in May 2016. Shipments under the agreement with Complete Pharmacy and Medical Solutions, LLC, which will replace KRS as the Company’s manufacturer and distributor of LDN tablets, have not yet commenced.

Operating Expenses

Selling, general and administrative

Selling, general and administrative expenses and related percentages for the nine months ended September 30, 2016 and 2015 were as follows (dollar amounts in thousands):

	For the nine months ended September 30,
	2016			2015
Selling, general and administrative	$	2,864		$	1,689
Increase/(decrease) from prior year	$	1,175		$	(1,575	)
Percent increase/(decrease) from prior year		70	%		(48	)%

For the nine months ended September 30, 2016 and 2015, selling, general and administrative expenses were made up as follows (dollar amounts in thousands):

	For the nine months ended September 30,
	2016		2015

Stock listing and investor relations expenses	$	210	$	73
Consulting and contractors		645		722
Payroll		1,350		441
Professional fees		173		179
Travel		152		131
Insurance		-		(107	)
Other expenses		334		250

	$	2,864	$	1,689

In the nine months ended September 30, 2016, total cash and cash accruals for selling, general and administrative expense was $2,864 compared to $1,689 for the corresponding period in 2015, an increase of $1,175 or 70%. Significant cash items included:

	●	consulting and contractor services obtained to assist the Company in raising capital, manage investor relations, and develop business in new markets, in the amount of $645 in 2016, a decrease of 77 or 11% over the $722 spent in 2015. The decrease was the result of the conversion to equity of amounts owed to contractors from prior periods, and lower fees paid to advisors who are assisting the Company with manufacturing and marketing activities in the United States and Africa;

	●	professional fees for legal, tax and accounting services in the amount of $173 in 2016, a decrease of $6 or 4% over the $179 spent in 2015. The decrease was primarily the result of lower spending on accounting fees for non-US subsidiaries;

	●	payroll in the amount of $1,350 in 2016, an increase of $909 or 206% over the $441 spent in 2015. The increase is primarily attributable to $345 in accruals for Cytocom payrolls, an increase in headcount, contractually-mandated payroll increases for officers, and the conversion in 2015 of $282 of deferred payroll owed to a Company officer into an agreement to pay the officer a royalty on future product sales; and

	●	travel in the amount of $152 in 2016, an increase of $21 or 16% over the $131 spent in 2015, reflecting increased travel to Africa in 2016.

Research and development

R&D expenses and related percentages for the nine months ended September 30, 2016 and 2015 were as follows (dollar amounts in thousands):

	For the nine months ended September 30,
	2016			2015
Research and development	$	295		$	703
Decrease from prior year	$	(408	)	$	(769	)
Percent decrease from prior year		(58	)%		(52	)%

In the nine months ended September 30, 2016, total spending on R&D was $295, a decrease of $408 or 58% over the $703 spent in the same period in 2015. Expenses for research and development in the nine months ended September 30, 2016 decreased by 58% compared to expenses in the same period in 2015. The decrease occurred mainly as a result a lower spending on R&D-related technical services, the completion of most trial activity in Nigeria at the end of 2015, the settlement of a rent dispute related to premises that were to be used to conduct R&D, and the reduction in expenses recorded to settle payables related to amounts owing for R&D contracted technical services in 2016, offset by higher legal fees to maintain patents and licenses, and higher travel fees for trials in Africa.

Significant cash items included:

●	expenses for contracted technical services, ($22) in 2016, a decrease of $190 or 113% over the $168 spent in 2015, reflecting the settlement of payables related to R&D contracted technical services;

●	payments for contracted services of $37 in 2016, an increase of $37 or 100% over the $0 spent in 2015, related to meetings with the FDA for resumption of trials by Cytocom;

●	expenses recorded for patent and license payments totaling $140, an increase of $29 or 27% over the $111 recorded in 2015, reflecting timing of accruals under license agreements;

●	rent expense of $(83) in 2016, a decrease of 102 or 546% over the $19 spent in 2015, reflecting (i) the closure of all R&D offices by the end of 2015 and (ii) the settlement of a rent dispute with a landlord in Maryland;

●	payments for professional fees of $72 in 2016, an increase of $47 or 189% over the $25 spent in 2015, reflecting the higher fees incurred to protect patent and intellectual property rights worldwide in 2016; and

●	Spending on trials of $145 in 2016, a decrease of $228 or 61% over the $373 spent in 2015, reflecting the fact that the Nigerian trial activity had mostly concluded in 2015.

All of the R&D spending in 2016 was for the development of LDN, compared to 75% of spending on LDN in 2015.

Stock issued for services

The Company periodically issues stock to consultants who provide services to the Company under consulting contracts. The Company accrues a liability for these services calculated by the number of shares issued for the services multiplied by the price of the Company’s stock on the effective date of the consulting contract. The accrued liability is amortized over the period in which the services are provided to the Company. The Company reports these costs separately from Selling, general and administrative costs, and Research and development costs, to better demonstrate the true costs of Selling, general and administrative activities, and Research and development.

Cost of stock issued for services G&A and related percentages for the nine months ended September 30, 2016 and 2015 were as follows (dollar amounts in thousands):

	For the nine months ended September 30,
	2016			2015
Stock for services and Prepaid consulting services expense G&A	$	4,404		$	5,005
Percentage decrease from prior year		(12	)%		(71	)%

The decrease reflects the decrease in amount of stock that was issued for services.

The number of shares issued for prepaid consulting services G&A in the nine months ending September 30, 2016 was 29,283,910 (16,922,504 in the corresponding period in 2015).

Amortization of prepaid consulting services G&A in the nine months ended September 30, 2016 consisted of the following:

Amortization of cost of stock issued prior to 2016	$	649

Amortization of cost incurred for new stock issued in the nine months ended September 30, 2016 under consulting contracts entered into in 2016		1,666

	$	2,315

There was no expense for amortization of stock issued for services R&D and related percentages for the nine months ended September 30, 2016 and 2015, due to the fact that he cost of shares issued for R&D services had been fully amortized prior to the third quarter of 2014.

There were no new shares issued for prepaid consulting services R&D in the nine months ending September 30, 2016 or 2015.

Warrant valuation expense (dollar amounts in thousands)

In the nine months ended September 30, 2016, the Company issued 25,654,908 warrants to stockholders at an exercise price range of $0.14 to $2.00, for which it recorded an expense of $2,756. In the nine months ended September 30, 2015, the Company issued 390,000 warrants to stockholders at an exercise price range of $0.07 to $0.50, for which it recorded an expense of $37.

	For the nine months ended September 30,
	2016			2015
Warrant valuation expense	$	2,756		$	37
Percentage increase/(decrease) from prior year		7,349	%		1,682	%

Depreciation and amortization

The Company amortizes the costs incurred to acquire patents and licenses over the period of the related agreements.

Depreciation and amortization expenses for the nine months ended September 30, 2016 and 2015 were as follows (dollar amounts in thousands):

	For the nine months ended September 30,
	2016			2015
Depreciation expense	$	1		$	1
Amortization expense	$	-		$	445
Increase/ (decrease) from prior year	$	(445	)	$	(1,713	)
Percentage increase/(decrease) from prior year		(99	)%		(79	)%

The decrease year over year in depreciation and amortization expense reflects the fact that all of the Company’s patents and licenses had been fully amortized by December 31, 2015. At the end of 2015, the Company determined that the unamortized carrying amount recorded for the acquisition of licenses and patents related to LDN were impaired, and recorded an impairment loss of $5,226,352. In 2014, the Company determined that the carrying amount recoded for the acquisition of licenses and patents related to MENK were impaired, and recorded an impairment loss of $9,908,477.

Interest Expense

Interest expense for the nine months ended September 30, 2016 and 2015 was as follows (dollar amounts in thousands):

	For the nine months ended September 30,
	2016			2015
Interest expense	$	2,331		$	149
Increase from prior year	$	2,182		$	(227	)
Percentage decrease from prior year		1,464	%		(60	)%

The increase reflects the increased levels of interest-bearing debt in the first nine months of 2016. Interest expense for the nine months ended September 30, 2016 included $1,042 of penalties for late interest and principal payments ($0 for the nine months ended September 30, 2015).

Loss on settlement of debt (dollar amounts in thousands)

In nine months ended September 30, 2016, certain lenders to the Company settled all or a portion of their notes or accounts payable by converting them to equity. The Company recorded an expense of $1,979, reflecting the fair value of the shares of common stock issued in exchange for the debt. In nine months ended September 30, 2015, the Company recorded an expense of $1,482 to settle all or a portion of notes or accounts payable.

Liquidity

Liquidity is measured by the Company’s ability to secure enough cash to meet its contractual and operating needs as they arise. The Company had cash of $22,152 at September 30, 2016, compared to $23,149 at December 31, 2015. For the nine months ended September 30, 2016 and 2015, net cash used in operating activities was $2,333,377 and $1,903,594, respectively. $0 cash was used in investing activities for the nine months ended September 30, 2016 ($0 was used in 2015).

In May 2016, the Company announced that it had received approval for sale of Lodonal^TM in Nigeria. The Company expects to commence sales to Nigeria by the end of 2016. The Company believes that those sales will generate sufficient cash flows for the next 12 months to pay for operating expenses and to pay off current and past-due obligations. Until such sales commence, the Company expects to fund operations through sales of equity and notes payable, and conversions of exiting obligations into equity. The Company believes it will require between $300,000 and $350,000 monthly to meet its ongoing expenses and obligations.

If the Company is unable to generate sufficient cash flows from sales, or if it does not raise additional working capital to meet all of its operating obligations and expenditures, the Company may have to modify its business plan.

In addition to the cost of its ongoing operations, the Company expects it will incur future research and development expenditures in the next 12 months through Cytocom. Cytocom plans to conduct Phase II and Phase IIB trials for the treatment of Crohn’s disease, at an estimated cost of $3,900,000 and $7,500,000 respectively for each phase. If the trials do not commence before 2017, the Company will be required to make a payment of $100,000 in December 2016 under its license agreements. In prior years, the Company has been able to raise funds through sales of notes payable, and it expects to do the same for the payment due in 2016.

During the nine months ended September 30, 2016 proceeds from the sale of stock and exercise of stock warrants totaled $200,000, compared to $587,500 for the corresponding period in 2015. We also received $2,132,380 from the issuance of notes payable in nine months ended September 30, 2016, compared to $1,277,975 in 2015. There were $0 loan repayments made in cash in the nine months ended September 30, 2016 ($0 in 2015).

Off-Balance Sheet Arrangements

During the three months ended September 30, 2016 and 2015, we did not engage in any off balance sheet arrangements as defined in item 303(a)(4) of the SEC’s Regulation S-K.

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

Not Applicable.

ITEM 4. CONTROLS AND PROCEDURES

Changes in Internal Controls over Financial Reporting

There were no changes in our internal controls over financial reporting that occurred during the period covered by this report on Form 10-Q that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

Evaluation of Disclosure Controls and Procedures

As of the end of the period covered by this report, we conducted an evaluation, under the supervision and with the participation of our principal executive officer and principal financial officer, of our disclosure controls and procedures as defined in Rules 13(a)-15(e) under the Exchange Act. Based on this evaluation, the principal executive officer and principal financial officer concluded that, because of the weakness in internal controls over financial reporting described below, our disclosure controls and procedures are ineffective to ensure that information required to be disclosed by us in the reports we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in Securities and Exchange Commission rules and forms.

Management assessed the effectiveness of the internal controls over financial reporting as of September 30, 2016, using the framework set forth in Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based upon this assessment, our management concluded that, as of September 30, 2016, the internal controls over financial reporting were not effective. The reportable conditions and material weakness relate to a limited segregation of duties and lack of an audit committee. The limited segregation of duties within our company and the lack of an audit committee are due to the small number of employees. Management has determined that this control deficiency constitutes a material weakness. This material weakness could result in material misstatements of significant accounts and disclosures that would result in a material misstatement to our interim or annual financial statements that would not be prevented or detected. In addition, due to limited staffing, we are not always able to detect minor errors or omissions in reporting.

Going forward, management anticipates that additional staff will be necessary to mitigate these weaknesses, as well as to implement other planned improvements. Additional staff will enable us to document and apply transactional and periodic controls procedures, permit a better review and approval process and improve quality of financial reporting. However, the potential addition of new staff is contingent on obtaining additional financing, and there is no assurance that we will be able to do so.

Limitations on the Effectiveness of Internal Controls

Readers are cautioned that our management does not expect that our disclosure controls and procedures or our internal control over financial reporting will necessarily prevent all fraud and material error. An internal control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within our control have been detected. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any control design will succeed in achieving its stated goals under all potential future conditions. Over time, controls may become inadequate because of changes in conditions, or the degree of compliance with the policies or procedures may deteriorate.

PART II OTHER INFORMATION

ITEM 1. LEGAL PROCEEDINGS

On November 11, 2016, the Company received a fax containing a copy of a lawsuit supposedly filed against the Company on November 10, 2016. The Company has not been served and has not been provided a case number or evidence that the suit has been filed and is relying on the information in the facsimile received as the basis for this disclosure. Apparently, Kacem Enterprise, Inc. is suing the Company and certain of its consultants and their related entities for $21,777 plus interest, costs and attorneys’ fees for fees Kacem Enterprise claims it is owed for travel related expenses incurred by certain consultants of the Company. The suit was supposedly filed in the Circuit Court of Arlington, Virginia.

ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

In the quarter ended September 30, 2016, the Company issued a total of 21,383,687 shares of common stock (net of stock cancellations), compared to 26,321,828 in the corresponding period in 2015. 14,055,277 of the shares in 2016 were issued to settle amounts owed under notes payable, including accrued and unpaid interest as applicable, to common stock as repayment of the notes (13,475,480 in 2015). 5,790,910 of the shares were issued to as payment for prepaid services to Company’s vendors (6,683,334 in 2015).

Between July 1, 2016 and September 30, 2016, warrant holders exercised 0 warrants to purchase shares (0 in 2015). The Company sold an aggregate 1,312,500 shares of its common stock at an average of $0.15 per share. In total, the Company received $0 as consideration for the exercise of the previously-issued warrants and $175,000 for the purchase of common stock, for an aggregate sum of $175,000.

The following table lists all securities issued during in the three months ended September 30, 2016 without registering the securities under the Securities Act of 1933, as amended (the “Securities Act”): get details from Rich

Date

Description

Number

Purchaser

Proceeds

Consideration

Exemption

7/7/2016

Common Stock Purchase

2,000,000

Consultant

Nil

Advisory Services

Sec. 4(a)(2)

7/7/2016

Common Stock Purchase

312,500

Investor

25,000

Share Purchase Agreement

Sec. 4(a)(2)

7/14/2016

Common Stock Purchase

1,500,000

Consultant

Nil

Advisory Services

Sec. 4(a)(2)

7/19/2016

Common Stock Purchase

200,000

Consultant

Nil

Advisory Services

Sec. 4(a)(2)

7/19/2016

Common Stock Purchase

1,069,589

Lender

Nil

Debt Settlement

Sec. 4(a)(2)

7/22/2016

Common Stock Purchase

1,235,356

Lender

Nil

Debt Settlement

Sec. 4(a)(2)

7/21/2016

Common Stock Purchase

225,000

Lender

Nil

Origination Fees

Sec. 4(a)(2)

8/12/2016

Common Stock Purchase

3,531,738

Lender

Nil

Debt Settlement

Sec. 4(a)(2)

8/12/2016

Common Stock Purchase

200,000

Lender

Nil

Debt Settlement

Sec. 4(a)(2)

8/12/2016

Common Stock Purchase

250,000

Lender

Nil

Debt Settlement

Sec. 4(a)(2)

8/12/2016

Common Stock Purchase

300,000

Lender

Nil

Debt Settlement

Sec. 4(a)(2)

8/12/2016

Common Stock Purchase

852,292

Lender

Nil

Debt Settlement

Sec. 4(a)(2)

8/12/2016

Common Stock Purchase

4,516,302

Lender

Nil

Debt Settlement

Sec. 4(a)(2)

8/12/2016

Common Stock Purchase

2,000,000

Lender

Nil

Debt Settlement

Sec. 4(a)(2)

8/30/2016

Common Stock Purchase

50,000

Consultant

Nil

Advisory Services

Sec. 4(a)(2)

8/30/2016

Common Stock Purchase

50,000

Consultant

Nil

Advisory Services

Sec. 4(a)(2)

8/30/2016

Common Stock Purchase

1,000,000

Investor

150,000

Share Purchase Agreement

Sec. 4(a)(2)

9/2/2016

Common Stock Purchase

500,000

Consultant

Nil

Advisory Services

Sec. 4(a)(2)

9/22/2016

Common Stock Purchase

545,455

Consultant

Nil

Advisory Services

Sec. 4(a)(2)

9/22/2016

Common Stock Purchase

100,000

Lender

Nil

Debt Settlement

Sec. 4(a)(2)

9/22/2016

Common Stock Purchase

545,455

Consultant

Nil

Advisory Services

Sec. 4(a)(2)

9/22/2016

Common Stock Purchase

400,000

Consultant

Nil

Advisory Services

Sec. 4(a)(2)

The issuances of the Company’s securities in connection with the above issuances were completed in private transactions by the Company not involving any public offering pursuant to Section 4(a)(2) and Rule 506 of Regulation D of the Securities Act of 1933, as amended (the “Securities Act”). The shares were issued bearing a restrictive legend and may not be resold by the holders unless such securities are registered or an exemption from registration is available. The Company determined, based on representations of the investors, that the investors were “accredited investors” as defined under Rule 501(a) of the Securities Act.

ITEM 3. DEFAULTS UPON SENIOR SECURITIES

The Current portion of notes payable on the Company’s Condensed Consolidated Balance Sheets above contains, at September 30, 2016, certain promissory notes on which the Company was in arrears on payments of principal as follows:

	1.	Repayment of a promissory note for $100,000 issued July 29, 2014 to Ira Gaines. The note matured on January 27, 2015. The note earns interest at a rate of 18% per annum. The Company has continued to pay monthly interest on the note since the maturity date.

	2.	Payment of principal aggregating $286,000 on certain promissory notes issued between November 26, 2014 and September 30, 2015, to raise up to $2,000,000 in debt, on which lenders earn interest at a rate of 10% per annum, plus a pro-rata share of 2 percent of the Company’s gross receipts for sales of IRT-103-LDN in perpetuity

	3.	Payment of principal aggregating $198,500 on certain promissory notes issued between May 1, 2015 and September 30, 2015, and maturing between June 14, 2015 and December 31, 2015. Interest is payable in a fixed amount not tied to a specific interest rate.

	4.	Repayment of a promissory note for $400,000 issued September 30, 2015 to Richard Gostanian. The note matured on September 30, 2016. The note earns an interest rate of 8% per annum.

	5.	Repayment of a promissory note for $100,000 issued in December 2015. Lenders earn interest at a rate of 10% per month. Notes were 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 $5,000 per day.

	6.	Repayment of promissory note for $77,500 issued on July 1, 2015. The note matured on July 1, 2016. The note earns interest at 5% per annum.

	7.	Repayment of a promissory note for $656,500 to JMJ Financial. This note was repaid on November 4, 2016.

At September 30, 2016, the Company had insufficient cash on hand to repay these notes.

ITEM 4. MINE SAFETY DISCLOSURES

None

ITEM 5. OTHER INFORMATION

None.

ITEM 6. EXHIBITS

Exhibit Number			Name of Exhibit
31.1			Certification of Chief Executive Officer, pursuant to Rule 13a-14(a) of the Exchange Act, as enacted by Section 302 of the Sarbanes-Oxley Act of 2002.

32.1			Certification of Chief Executive Officer and Chief Financial Officer, pursuant to 18 United States Code Section 1350, as enacted by Section 906 of the Sarbanes-Oxley Act of 2002.

10.1			Employment Agreement between Immune Therapeutics, Inc. and Robert Wilson dated May 1, 2016.

101.INS			XBRL Instance Document

101.SCH			XBRL Taxonomy Extension Schema

101.CAL			XBRL Taxonomy Extension Calculation Linkbase

101.DEF			XBRL Taxonomy Extension Definition Linkbase

101.LAB			XBRL Taxonomy Extension Label Linkbase

101.PRE			XBRL Taxonomy Extension Presentation Linkbase

SIGNATURES

In accordance with the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this Report to be signed on its behalf by the undersigned, thereunto duly authorized.

	Immune Therapeutics, Inc.

Date: November 14, 2016	By:	/s/ Noreen Griffin
		Noreen Griffin
		Chief Executive Officer

	Immune Therapeutics, Inc.

Date: November 14, 2016	By:	/s/ Peter Aronstam
		Peter Aronstam
		Chief Financial Officer

EX-31.1 2 ex31-1.htm

CERTIFICATION

I, Noreen Griffin, certify that:

1.	I have reviewed this quarterly report on Form 10-Q of Immune Therapeutics, Inc.;

2.	Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3.	Based on my knowledge, the financial statements and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4.	The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15-d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

	a)	Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

	b)	Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

	c)	Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

	d)	Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5.	The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

	a)	All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

	b)	Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: November 14, 2016	By:	/s/ Noreen Griffin
		Noreen Griffin
		Chief Executive Officer
		(Principal Executive Officer)

EX-31.2 3 ex31-2.htm

I, Peter Aronstam, certify that:

1.	I have reviewed this quarterly report on Form 10-Q of Immune Therapeutics, Inc.;

2.	Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3.	Based on my knowledge, the financial statements and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4.	The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15-d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

	a)	Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

	b)	Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

	c)	Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

	d)	Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5.	The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

	a)	All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

	b)	Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: November 14, 2016	By:	/s/ Peter Aronstam
		Peter Aronstam
		Chief Financial Officer
		(Principal Financial and Accounting Officer)

EX-32.1 4 ex32-1.htm

CERTIFICATION

In connection with the periodic report of Immune Therapeutics, Inc. (the “Company”) on Form 10-Q for the quarter ending September 30, 2016 as filed with the Securities and Exchange Commission (the “Report”), we, Noreen Griffin, Chief Executive Officer (Principal Executive Officer) and Peter Aronstam, Chief Financial Officer (Principal Financial and Accounting Officer) of the Company, hereby certify as of the date hereof, solely for purposes of Title 18, Chapter 63, Section 1350 of the United States Code, that to the best of our knowledge:

(1) The Report fully complies with the requirements of Section 13(a) or 15(d), as applicable, of the Securities Exchange Act of 1934, and

(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company at the dates and for the periods indicated.

Date: November 14, 2016	By:	/s/ Noreen Griffin
		Noreen Griffin
		Chief Executive Officer
		(Principal Executive Officer)

	By:	/s/ Peter Aronstam
		Peter Aronstam
		Chief Financial Officer
		(Principal Financial and Accounting Officer)

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9. Licenses and Supply Agreements   Patent and Subsidiary Acquisition   The Company has not entered into any new licenses or supply agreements during quarter ending September 30, 2016. All prior licenses, supply agreements, and patents remain unchanged from the prior quarter.

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). Today, the Company is focused on the development and commercialization of therapeutic treatments for cancer, HIV/AIDS, malaria, and opportunistic infections arising from their treatment, and commercializing affordable, non-toxic therapies in Africa, to be followed by Asia and South America, and autoimmune diseases and immune disorders by combating these severe and fatal diseases through the stimulation and/or regulation of the bodys immune system. 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. (Cytocom). Cytocom is a clinical-stage pharmaceutical company focused on the development of the first affordable non-toxic immunodulator for the treatment of inflammatory diseases, immune-related disorders, and cancer, and is responsible for the development of the Companys patented therapies under the auspices of the FDA and EMA. In December 2014, the Company finalized the distribution of common stock of Cytocom 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 during drug development. On December 8, 2014, the number of Cytocom shares of common stock that were issued to our shareholders totaled 113,242,522 shares. In connection with the transaction, Cytocom issued 140,100,000 shares of its common stock to the Company, which gave the Company a 55.3% equity interest in Cytocom on that date. In April 2016, the Board of Directors and a majority of shareholders of Cytocom approved a reverse stock split of Cytocoms outstanding common stock with one new share of stock for each twenty old shares of common stock. Cytocom effectuated and finalized the reverse split in June 2016. At September 30, 2016, the Companys equity interest had been further reduced to 17%, by subsequent issuances of Cytocom common stock to shareholders in settlement of notes payable.   In March 2014, the Company incorporated Airmed Biopharma Limited, an Irish corporation with an address in Dublin, Ireland, and Airmed Holdings Limited, an Irish company domiciled in Bermuda. The Irish companies were set up to benefit from incentives granted by the Irish government for the establishment of pharmaceutical companies (many of the 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.   Immune Therapeutics is commercializing affordable non-toxic immunotherapies focused on the activation and rebalancing of the bodys immune system. Stimulating the bodys immune system remains one of the most promising approaches in the treatment of cancers, HIV, autoimmune diseases, inflammatory conditions and other opportunistic infections, and for treating chronic, often life-threatening, diseases in Emerging Nations through the mobilization of the bodys immune system using existing clinical data.   As of this date, neither we nor our collaboration partners are permitted to market our drug candidates in the United States until we receive approval of a New Drug Application from the FDA. Neither we nor our collaboration partners have submitted an application for or received marketing approval for any of our drug candidates. Obtaining approval of an NDA can be a lengthy, expensive and uncertain process.   Going Concern   The Company 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 $(14,627,993) and used cash and cash equivalents from operations in the amount of $2,333,377 during the nine months ended September 30, 2016, resulting in stockholders deficit of $(7,464,769) at September 30, 2016.

2. Summary of Significant Accounting Policies   Basis of Presentation   The consolidated financial statements included herein have been prepared by the Company, without audit, pursuant to the rules and regulations of the Securities and Exchange Commission. Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. generally accepted accounting principles have been omitted. However, in the opinion of management, all adjustments (which include only normal recurring adjustments, unless otherwise indicated) necessary to present fairly the financial position and results of operations for the periods presented have been made. The results for interim periods are not necessarily indicative of trends or of results to be expected for the full year. These financial statements should be read in conjunction with the financial statements of the Company for the year ended December 31, 2015 (including the notes thereto) set forth in Form 10-K/A.   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 September 30, 2016, the Company has no uninsured cash balances.   Segment and Geographic Information   Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one operating segment and does not segment the business for internal reporting or decision making.   Fair Value of Financial Instruments   In accordance with the reporting requirements of Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) Topic 825, Financial Instruments, 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. Cash and cash equivalents, accounts receivable and accounts payable are accounted for at cost which approximates fair value due to the relatively short maturity of these instruments. The carrying value of notes payable also approximates fair value since they bear market rates of interest and other terms. None of these instruments are held for trading purposes.   Fair Value Measurements   The ASC Topic 820, Fair Value Measurements, defines fair value, establishes a framework for measuring fair value in accordance with U.S. generally accepted accounting principles, and requires certain disclosures about fair value measurements. In general, fair values of financial instruments are based upon quoted market prices, where available. If such quoted market prices are not available, fair value is based upon internally developed models that primarily use, as inputs, observable market-based parameters. Valuation adjustments may be made to ensure that financial instruments are recorded at fair value. These adjustments may include amounts to reflect counterparty credit quality and the customers creditworthiness, among other things, as well as unobservable parameters. Any such valuation adjustments are applied consistently over time.   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 September 30, 2016 and September 30, 2015 was $299 and $638, 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. At the end of 2015, the Company determined that the unamortized carrying amount recorded for the acquisition of licenses and patents related to LDN were impaired, and recorded an impairment loss of $5,226,352. In 2014, the Company determined that the carrying amount recoded for the acquisition of licenses and patents related to MENK were impaired, and recorded an impairment loss of $9,908,477.   During the quarters ended September 30, 2016 and September 30, 2015, the Company did not capitalize any costs to acquire and/or develop the Companys product licenses and patents. (See Note 10). Amortization expense for the quarters ended September 30, 2016 and September 30, 2015 was $0 and $444,175, 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. 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 quarters ended September 30, 2016 and September 30, 2015.   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, which requires recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements or tax returns. Under this method, deferred tax assets and liabilities are based on the differences between the financial statements and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Deferred tax assets are reduced by a valuation allowance to the extent management concludes it is more likely than not that the asset will not be realized. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled.   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 September 30, 2016, 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 September 30, 2016 and September 30, 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 market 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. 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 vendors performance is complete.   Non-controlling Interest   In accordance with ASC 810, Consolidation, the Company consolidates Cytocom, Inc. The non-controlling interests in Cytocom represent the interests of outside shareholders in the equity and results of operations of Cytocom.   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:   <table cellspacing="0" cellpadding="0" style="font: 11pt Calibri, Helvetica, Sans-Serif; width: 100%; border-collapse: collapse"> <tr style="vertical-align: bottom"> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td colspan="6" style="border-bottom: black 1.5pt solid; text-align: center; line-height: 115%">For the three months ended September 30,</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td colspan="6" style="border-bottom: black 1.5pt solid; text-align: center; line-height: 115%">For the six months ended September 30,</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom"> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center; line-height: 115%">2016</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center; line-height: 115%">2015</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center; line-height: 115%">2016</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center; line-height: 115%">2015</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="line-height: 115%">Net loss per share:</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="line-height: 115%">Numerator</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="width: 44%; line-height: 115%">Net loss</td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 1%; line-height: 115%">$</td> <td style="width: 11%; text-align: right; line-height: 115%">(3,943,942</td> <td style="width: 1%; line-height: 115%">)</td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 1%; line-height: 115%">$</td> <td style="width: 11%; text-align: right; line-height: 115%">(4,025,309</td> <td style="width: 1%; line-height: 115%">)</td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 1%; line-height: 115%">$</td> <td style="width: 11%; text-align: right; line-height: 115%">(14,627,993</td> <td style="width: 1%; line-height: 115%">)</td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 1%; line-height: 115%">$</td> <td style="width: 11%; text-align: right; line-height: 115%">(9,499,641</td> <td style="width: 1%; line-height: 115%">)</td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="line-height: 115%">Net loss attributed to Common stockholders</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%">$</td> <td style="text-align: right; line-height: 115%">(3,936,501</td> <td style="line-height: 115%">)</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%">$</td> <td style="text-align: right; line-height: 115%">(3,859,550</td> <td style="line-height: 115%">)</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%">$</td> <td style="text-align: right; line-height: 115%">(14,466,503</td> <td style="line-height: 115%">)</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%">$</td> <td style="text-align: right; line-height: 115%">(9,070,926</td> <td style="line-height: 115%">)</td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="line-height: 115%">Denominator</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="line-height: 115%">Weighted-average common shares outstanding</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="line-height: 115%">Denominator for basic and diluted net loss per share</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">226,843,113</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">156,814,094</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">208,399,547</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">147,365,571</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="line-height: 115%">Basic and diluted net loss per share attributed to common stockholders</td> <td style="line-height: 115%"> </td> <td style="border-bottom: black 2.25pt double; line-height: 115%">$</td> <td style="border-bottom: black 2.25pt double; text-align: right; line-height: 115%">(0.02</td> <td style="line-height: 115%">)</td> <td style="line-height: 115%"> </td> <td style="border-bottom: black 2.25pt double; line-height: 115%">$</td> <td style="border-bottom: black 2.25pt double; text-align: right; line-height: 115%">(0.02</td> <td style="line-height: 115%">)</td> <td style="line-height: 115%"> </td> <td style="border-bottom: black 2.25pt double; line-height: 115%">$</td> <td style="border-bottom: black 2.25pt double; text-align: right; line-height: 115%">(0.07</td> <td style="line-height: 115%">)</td> <td style="line-height: 115%"> </td> <td style="border-bottom: black 2.25pt double; line-height: 115%">$</td> <td style="border-bottom: black 2.25pt double; text-align: right; line-height: 115%">(0.06</td> <td style="line-height: 115%">)</td></tr> </table>    The Companys potential dilutive securities which include stock, stock warrants and convertible debt 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:   <table cellspacing="0" cellpadding="0" style="font: 11pt Calibri, Helvetica, Sans-Serif; width: 100%; border-collapse: collapse"> <tr style="vertical-align: bottom"> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td colspan="6" style="border-bottom: black 1.5pt solid; text-align: center; line-height: 115%">As of September 30,</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom"> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center; line-height: 115%">2016</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center; line-height: 115%">2015</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="width: 62%; line-height: 115%">Warrants to purchase Common stock</td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 1%; border-bottom: black 1.5pt solid; line-height: 115%"> </td> <td style="width: 16%; border-bottom: black 1.5pt solid; text-align: right; line-height: 115%">32,623,908</td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 1%; border-bottom: black 1.5pt solid; line-height: 115%"> </td> <td style="width: 16%; border-bottom: black 1.5pt solid; text-align: right; line-height: 115%">9,355,250</td> <td style="width: 1%; line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="border-bottom: black 2.25pt double; line-height: 115%"> </td> <td style="border-bottom: black 2.25pt double; text-align: right; line-height: 115%">32,623,908</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="border-bottom: black 2.25pt double; line-height: 115%"> </td> <td style="border-bottom: black 2.25pt double; text-align: right; line-height: 115%">9,355,250</td> <td style="line-height: 115%"> </td></tr> </table>   Recent Accounting Standards   During the quarter ended September 30, 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.   The Company qualifies as an emerging growth company as defined in Section 101 of the Jumpstart our Business Startups Act (JOBS Act) as we do not have more than $1,000,000,000 in annual gross revenue and did not have such amount as of December 31, 2015, our last fiscal year. We are electing to use the extended transition period for complying with new or revised accounting standards under Section 102(b)(1) of the JOBS Act.

3. Property and Equipment   <table cellspacing="0" cellpadding="0" style="font: 11pt Calibri, Helvetica, Sans-Serif; width: 100%; border-collapse: collapse"> <tr style="vertical-align: bottom"> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center; line-height: 115%">September 30, 2016</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center; line-height: 115%">December 31, 2015</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="line-height: 115%">Property and equipment:</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="width: 62%; line-height: 115%">Computer equipment</td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 1%; line-height: 115%">$</td> <td style="width: 16%; text-align: right; line-height: 115%">8,013</td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 1%; line-height: 115%">$</td> <td style="width: 16%; text-align: right; line-height: 115%">8,013</td> <td style="width: 1%; line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="line-height: 115%">Less accumulated depreciation</td> <td style="line-height: 115%"> </td> <td style="border-bottom: black 1.5pt solid; line-height: 115%"> </td> <td style="border-bottom: black 1.5pt solid; text-align: right; line-height: 115%">(7,611</td> <td style="line-height: 115%">)</td> <td style="line-height: 115%"> </td> <td style="border-bottom: black 1.5pt solid; line-height: 115%"> </td> <td style="border-bottom: black 1.5pt solid; text-align: right; line-height: 115%">(6,331</td> <td style="line-height: 115%">)</td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="line-height: 115%">Property and equipment, net</td> <td style="line-height: 115%"> </td> <td style="border-bottom: black 1.5pt solid; line-height: 115%">$</td> <td style="border-bottom: black 1.5pt solid; text-align: right; line-height: 115%">402</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="border-bottom: black 1.5pt solid; line-height: 115%">$</td> <td style="border-bottom: black 1.5pt solid; text-align: right; line-height: 115%">1,682</td> <td style="line-height: 115%"> </td></tr> </table>   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.

4. Accrued Liabilities   Accrued expenses and other liabilities consist of the following:   <table cellspacing="0" cellpadding="0" style="font: 11pt Calibri, Helvetica, Sans-Serif; width: 100%; border-collapse: collapse"> <tr style="vertical-align: bottom"> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center; line-height: 115%">September 30, 2016</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center; line-height: 115%">December 31, 2015</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom"> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td colspan="6" style="text-align: center; line-height: 115%">(in thousands)</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="width: 62%; line-height: 115%">Accrued payroll to officers and others</td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 1%; line-height: 115%">$</td> <td style="width: 16%; text-align: right; line-height: 115%">934</td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 1%; line-height: 115%">$</td> <td style="width: 16%; text-align: right; line-height: 115%">758</td> <td style="width: 1%; line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="line-height: 115%">Accrued interest and penalties - notes payable</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">1,319</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">237</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="line-height: 115%">Accrued legal settlements</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">143</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">282</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="line-height: 115%">Other accrued liabilities</td> <td style="line-height: 115%"> </td> <td style="border-bottom: black 1.5pt solid; line-height: 115%"> </td> <td style="border-bottom: black 1.5pt solid; text-align: right; line-height: 115%">1</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="border-bottom: black 1.5pt solid; line-height: 115%"> </td> <td style="border-bottom: black 1.5pt solid; text-align: right; line-height: 115%">4</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="line-height: 115%">Total accrued expenses and other liabilities</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%">$</td> <td style="text-align: right; line-height: 115%">2,397</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%">$</td> <td style="text-align: right; line-height: 115%">1,281</td> <td style="line-height: 115%"> </td></tr> </table>

5. Notes Payable   Notes payable consist of the following:   <table cellspacing="0" cellpadding="0" style="font: 11pt Calibri, Helvetica, Sans-Serif; width: 100%; border-collapse: collapse"> <tr style="vertical-align: bottom"> <td style="text-align: justify; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center; line-height: 115%"> September 30, 2016</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center; line-height: 115%"> December 31, 2015 </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="width: 62%; text-align: justify; line-height: 115%">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.</td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 1%; line-height: 115%">$</td> <td style="width: 16%; text-align: right; line-height: 115%">100,000</td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 1%; line-height: 115%">$</td> <td style="width: 16%; text-align: right; line-height: 115%">100,000</td> <td style="width: 1%; line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="text-align: justify; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="text-align: justify; line-height: 115%">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. Principal of $425,500 and accrued interest of $37,427 were converted to 5,309,092 shares of common stock in the nine months ended September 30, 2016, Notes aggregating $286,000 were in default at September 30, 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.</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">286,000</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">711,500</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="text-align: justify; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="text-align: justify; line-height: 115%">Promissory note issued October 17, 2014 to Roger Bozarth. The note matures on October 17, 2015 and earns interest at a rate of 2% per annum. The lender converted this note and $2,139 in accrued interest to 114,237 shares of common stock in January 2016.</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">-</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">7,000</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="text-align: justify; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="text-align: justify; line-height: 115%">Promissory notes issued between May 1, 2015 and September 30, 2016, and maturing between June 14, 2015 and June 30, 2017. Lenders on loans aggregating $535,994 earn interest at rates between 10% and 18% per annum. On loans aggregating $198,500, interest is payable in a fixed amount not tied to a specific interest rate. Notes aggregating $198,500 were in default at September 30, 2016, as the Company was unable to repay those notes on their due dates. No demands for repayment have been made by the lenders.</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">734,494</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">669,933</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="text-align: justify; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="text-align: justify; line-height: 115%">Promissory note issued January 26, 2015 to Robert J. Dailey. The note is senior to, and has priority in right of payment over, all indebtedness of the Company. The note earns interest at a rate of 2% per annum and was due on July 30, 2015. Principal of $200,000 and accrued interest of $4,778 was converted to 3,722,015 shares of common stock in the nine months ending September 30, 2016.</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">-</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">200,000</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="text-align: justify; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="text-align: justify; line-height: 115%">Promissory notes issued by Cytocom Inc. between April 29, 2015 and December 31, 2015. Lenders earn interest at rates between 5% and 10% per annum. These notes mature on September 30, 2016. $375,000 of principal and $12,036 in accrued interest was converted to 4,837,960 shares of common stock in the nine months ending September 30, 2016. The Company was unable to repay the remaining notes at maturity and the notes are in default, although no demand for repayment has been made by the lenders.</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">425,000</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">800,000</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="text-align: justify; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="text-align: justify; line-height: 115%">Promissory notes issued in December 2015. Lenders earn interest at a rate of 10% per month. Notes are repayable on March 9, 2016. . $30,000 of principal and $49,000 of interest and penalties were converted to 987,500 shares of common stock in the nine months ended September 30, 2016. The Company was unable to repay the remaining note at maturity and the note is in default The Company is obligated to pay late-payment penalties totaling $5,000 per day on the remaining obligation.</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">100,000</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">130,000</td> <td style="line-height: 115%"> </td></tr> </table>   <table cellspacing="0" cellpadding="0" style="font: 11pt Calibri, Helvetica, Sans-Serif; width: 100%; border-collapse: collapse"> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="width: 62%; text-align: justify; line-height: 115%">Promissory note issued November 24, 2015 as settlement of amounts owing to a law firm. The Lender earns interest at the rate of 10% per annum. The note and $10,036 in interest was converted to 1,235,536 shares of common stock in July 2016.</td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 16%; text-align: right; line-height: 115%">-</td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 16%; text-align: right; line-height: 115%">175,268</td> <td style="width: 1%; line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="text-align: justify; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="text-align: justify; line-height: 115%">Promissory notes issued between May 5, 2016 and June 2, 2016 that mature between October 1, 2016 and January 31, 2017, and include stock conversion features, warrants and original issue debt discounts. Notes aggregating $305,000 were in default at November 14, 2016. No demand for repayment has been made by the lenders.</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">555,000</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">-</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="text-align: justify; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="text-align: justify; line-height: 115%">Promissory notes issued to an officer of the Company effective November 3, 2015 and maturing November 3, 2016 for settlement of accrued payroll, bearing interest at 10% per annum and including a stock conversion feature.</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">112,737</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">-</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="text-align: justify; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="text-align: justify; line-height: 115%">Promissory note issued in July 2016. The note is repayable on October 5, 2016. The note earns interest at 6% per month. The Company was unable to repay the note at maturity and the note is in default.</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">50,000</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">-</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="text-align: justify; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="text-align: justify; line-height: 115%">Promissory note dated April 2016, issued to JM Financial (JMJ), pursuant to which JMJ loaned the Company $525,000 and was issued the promissory note, 500,000 shares of common stock, and a warrant exercisable for 3,515,621 additional common shares at a rate of $0.14 per share. The note matures on January 6, 2017. The note was repaid on November 4, 2016.</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">656,250</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">-</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="text-align: justify; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="text-align: justify; line-height: 115%">Promissory note issued in July 2016 with an original issuance discount of $30,000. Net proceeds were $150,000. The note is repayable on April 7, 2017.</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">180,000</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">-</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="text-align: justify; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="text-align: justify; line-height: 115%">Promissory notes issued in August 2016 for $149,854 as a settlement of amounts owed to a law firm. The notes accrue interest at 5% per annum and are payable in 18 equal monthly installments of $8,641.88.</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">146,912</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">-</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="text-align: justify; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="text-align: justify; line-height: 115%">Promissory notes issued between July 1, 2016 and September 30, 2016. Lenders earn interest at 12% per annum. The notes mature between January 1, 2017 and March 31, 2017.</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">495,000</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">-</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="text-align: justify; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="text-align: justify; line-height: 115%">Less: Original issue discounts on notes payable and warrants issued with notes.</td> <td style="line-height: 115%"> </td> <td style="border-bottom: black 1.5pt solid; line-height: 115%"> </td> <td style="border-bottom: black 1.5pt solid; text-align: right; line-height: 115%">(267,695</td> <td style="line-height: 115%">)</td> <td style="line-height: 115%"> </td> <td style="border-bottom: black 1.5pt solid; line-height: 115%"> </td> <td style="border-bottom: black 1.5pt solid; text-align: right; line-height: 115%">-</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="text-align: justify; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="text-align: justify; line-height: 115%">Total</td> <td style="line-height: 115%"> </td> <td style="border-bottom: black 1.5pt solid; line-height: 115%"> </td> <td style="border-bottom: black 1.5pt solid; text-align: right; line-height: 115%">3,573,698</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="border-bottom: black 1.5pt solid; line-height: 115%"> </td> <td style="border-bottom: black 1.5pt solid; text-align: right; line-height: 115%">2,793,701</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="text-align: justify; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="text-align: justify; line-height: 115%">Less: Current Portion</td> <td style="line-height: 115%"> </td> <td style="border-bottom: black 2.25pt double; line-height: 115%">$</td> <td style="border-bottom: black 2.25pt double; text-align: right; line-height: 115%">(3,573,698</td> <td style="line-height: 115%">)</td> <td style="line-height: 115%"> </td> <td style="border-bottom: black 2.25pt double; line-height: 115%">$</td> <td style="border-bottom: black 2.25pt double; text-align: right; line-height: 115%">(2,793,701</td> <td style="line-height: 115%">)</td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="text-align: justify; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="text-align: justify; line-height: 115%">Long-Term debt, less current portion</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%">$</td> <td style="text-align: right; line-height: 115%">-</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%">$</td> <td style="text-align: right; line-height: 115%">-</td> <td style="line-height: 115%"> </td></tr> </table>   As of September 30, 2016, the Company had accrued $278,089 in unpaid interest and $1,041,502 in unpaid default penalties, compared to $217,717 and 18,954, respectively, as of December 31, 2015. During the three months ended September 30, 2016, 225,000 shares with a fair value of $42,750 were issued by the Company for interest expense under promissory notes.

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 September 30, 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 September 30, 2016, the Company had 235,831,298 shares of common stock outstanding, and 174,850,047 outstanding as of December 31, 2015.   Stock Warrants   In the quarter ended September 30, 2016, the Company issued 2,000,000 warrants.   There were no modifications of the terms of any warrants issued by the Company in the quarter ended September 30, 2015.   Following is a summary of outstanding stock warrants at September 30, 2016 and activity during the nine months then ended:   <table cellspacing="0" cellpadding="0" style="font: 11pt Calibri, Helvetica, Sans-Serif; width: 100%; border-collapse: collapse"> <tr style="vertical-align: bottom"> <td style="text-align: center; line-height: 115%"> </td> <td style="text-align: center; line-height: 115%"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center; line-height: 115%">Number of Shares</td> <td style="text-align: center; line-height: 115%"> </td> <td style="text-align: center; line-height: 115%"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center; line-height: 115%">Exercise Price</td> <td style="text-align: center; line-height: 115%"> </td> <td style="text-align: center; line-height: 115%"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center; line-height: 115%">Weighted Average Price</td> <td style="text-align: center; line-height: 115%"> </td></tr> <tr style="vertical-align: bottom"> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td colspan="2" style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td colspan="2" style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td colspan="2" style="line-height: 115%"> </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="width: 55%; line-height: 115%">Warrants as of December 31, 2015</td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 12%; text-align: right; line-height: 115%">9,131,500</td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 1%; line-height: 115%">$</td> <td style="width: 12%; text-align: right; line-height: 115%"> 0.07-15.00 </td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 1%; line-height: 115%">$</td> <td style="width: 12%; text-align: right; line-height: 115%">1.47</td> <td style="width: 1%; line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="line-height: 115%">Issued in 2016</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">25,654,908</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%">$</td> <td style="text-align: right; line-height: 115%">  0.14-2.00 </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%">$</td> <td style="text-align: right; line-height: 115%">0.31</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="line-height: 115%">Expired</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">(162,500</td> <td style="line-height: 115%">)</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%">$</td> <td style="text-align: right; line-height: 115%">5.00</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%">$</td> <td style="text-align: right; line-height: 115%">5.00</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="line-height: 115%">Exercised</td> <td style="line-height: 115%"> </td> <td style="border-bottom: black 1.5pt solid; line-height: 115%"> </td> <td style="border-bottom: black 1.5pt solid; text-align: right; line-height: 115%">(0</td> <td style="line-height: 115%">)</td> <td style="line-height: 115%"> </td> <td style="border-bottom: black 1.5pt solid; line-height: 115%">$</td> <td style="border-bottom: black 1.5pt solid; text-align: right; line-height: 115%">0</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="border-bottom: black 1.5pt solid; line-height: 115%">$</td> <td style="border-bottom: black 1.5pt solid; text-align: right; line-height: 115%">0</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="line-height: 115%">Warrants as of September 30, 2016</td> <td style="line-height: 115%"> </td> <td style="border-bottom: black 2.25pt double; line-height: 115%"> </td> <td style="border-bottom: black 2.25pt double; text-align: right; line-height: 115%">34,623,908</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="border-bottom: black 2.25pt double; line-height: 115%">$</td> <td style="border-bottom: black 2.25pt double; text-align: right; line-height: 115%">    0.07-15.00 </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="border-bottom: black 2.25pt double; line-height: 115%">$</td> <td style="border-bottom: black 2.25pt double; text-align: right; line-height: 115%">0..50</td> <td style="line-height: 115%"> </td></tr> </table>   Summary of outstanding warrants as of September 30, 2016:   <table cellspacing="0" cellpadding="0" style="font: 11pt Calibri, Helvetica, Sans-Serif; width: 100%; border-collapse: collapse"> <tr style="vertical-align: bottom"> <td style="border-bottom: black 1.5pt solid; line-height: 115%">Expiration Date</td> <td style="line-height: 115%"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center; line-height: 115%">Number of Shares</td> <td style="text-align: center; line-height: 115%"> </td> <td style="text-align: center; line-height: 115%"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center; line-height: 115%">Exercise Price</td> <td style="text-align: center; line-height: 115%"> </td> <td style="text-align: center; line-height: 115%"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center; line-height: 115%">Remaining Life (years)</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom"> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td colspan="2" style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td colspan="2" style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td colspan="2" style="line-height: 115%"> </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="width: 58%; line-height: 115%">Fourth Quarter 2017</td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 11%; text-align: right; line-height: 115%">350,000</td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 1%; line-height: 115%">$ </td> <td style="width: 11%; text-align: right; line-height: 115%">1.50-9.00 </td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 11%; text-align: right; line-height: 115%">1.25</td> <td style="width: 1%; line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="line-height: 115%">First Quarter 2018</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">127,500</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%">$</td> <td style="text-align: right; line-height: 115%">15.00</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">1.50</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="line-height: 115%">Second Quarter 2018</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">33,334</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%">$</td> <td style="text-align: right; line-height: 115%">15.00</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">1.75</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="line-height: 115%">Third Quarter 2018</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">250,000</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%">$</td> <td style="text-align: right; line-height: 115%">1.50</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">2.00</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="line-height: 115%">Fourth Quarter 2018</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">6,089,166</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%">$</td> <td style="text-align: right; line-height: 115%">1.00-1.50</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">2.25</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="line-height: 115%">First Quarter 2019</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">4,024,000</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%">$</td> <td style="text-align: right; line-height: 115%">0.50-2.00</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">2.50</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="line-height: 115%">Second Quarter 2019</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">135,000</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%">$</td> <td style="text-align: right; line-height: 115%">0.070.23 </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">2.75</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="line-height: 115%">Third Quarter 2019</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">260,000</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%">$</td> <td style="text-align: right; line-height: 115%">0.50-1.50 </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">3.00</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="line-height: 115%">Fourth Quarter 2019</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">400,000</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%">$</td> <td style="text-align: right; line-height: 115%">0.14</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">3.25</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="line-height: 115%">Second Quarter 2020</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">300,000</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%">$</td> <td style="text-align: right; line-height: 115%">0.50</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">3.75</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="line-height: 115%">Fourth Quarter 2020</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">1,000,000</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%">$</td> <td style="text-align: right; line-height: 115%">0.20</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">4.00</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="line-height: 115%">First Quarter 2021</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">12,650,000</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%">$</td> <td style="text-align: right; line-height: 115%">0.20</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">4.25</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="line-height: 115%">Second Quarter 2021</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">6,004,908</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%">$</td> <td style="text-align: right; line-height: 115%">0.10-0.20 </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">4.50</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="line-height: 115%">Third Quarter 2021</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">3,000,000</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%">$</td> <td style="text-align: right; line-height: 115%">0.20</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">4.75</td> <td style="line-height: 115%"> </td></tr> </table>

8. Income Taxes - Results of Operations   There was no income tax expense reflected in the results of operations for the quarters ended September 30, 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.   The Companys effective tax rate for fiscal years 2015 and 2013 was 0%. The Companys 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, the Company has estimated federal and state income tax net operating loss (NOL) carry-forwards of approximately $66,500,000, which will expire in 2032-2035.

10. Commitments and Contingencies   Except as described below, the Company has not created any new commitments or contingency obligations during quarter ending September 30, 2016. All other prior commitments and contingent obligations remain unchanged from the prior quarter.   Distribution of LodonalTM in Nigeria   Through its wholly-owned subsidiary, TNI BioTech International, Ltd., in December 2015 the Company completed a 90-day bridging trial for the treatment of patients with HIV/AIDS. The trial consisted of a total of 150 patients of both genders between the ages of 18-60, each of whom was infected HIV/AIDS. The primary objective of this bridging trial was to confirm that LodonalTM has a beneficial effect on the immune system of immune deficient patients and that it is safe. The trial separated patients into a Control (placebo) Group and a Treatment Group (which was administered LodonalTM). The efficacy of increasing CD4 count [cell/mm3] between Day-1 and Day-90 by at least 25% was set as the criteria for demonstrating beneficial effect on the immune system. Safety was demonstrated through quality of life assessment and vitals both of which were not adversely affected. Treatment Group patients were given a daily dose of 4.5-mg/kg of Lodonal.   In April 2016, the Company announced that Nigeria’s 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. The NAFDAC approval clears the way for the Company and its distribution partners to complete the registration of LodonalTM for sale in Nigeria. The Company is currently completing the registration process to allow it to import the drug into Nigeria.   Other Distribution Agreements   Contract Manufacturing Agreements   On May 16, 2016, the Company entered into an agreement with Complete Pharmacy and Medical Solutions, LLC (“CPMS”) to compound, package and distribute the LDN tablets, capsules and/or creams in the United States. The initial term of the agreement is three years, with the option to renew for an additional year. The agreement may be terminated by (i) mutual agreement, (ii) in the event of a breach, provided however that if the Company terminates the agreement, the Company will be required to reimburse CPMS for all unused packaging materials for the LDN, which unused packaging materials CPMS will provide to IMUN. If CPMS does not receive and ship at least 1,000 orders (prescriptions) during the term of the agreement, the Company will be required to reimburse CPMS for 100% of the “ramp up costs” (defined as all costs and expenses of labor and materials related to the testing, and required FDA and other governmental documentation/approvals of test data) of providing and producing the LDN, even where the Company cancels/terminates the agreement, which provision shall survive the cancellation/termination of the agreement.   On October 25, 2016, the Company and Acromax Dominicana, SA ("Acromax") entered into a contract for manufacturing of LDN tablets, capsules and/or creams ("Agreement"). Subject to the terms and conditions of the Agreement, Acromax will obtain all necessary licenses and permits to carry out the manufacturing and packaging of LDN in exchange for a fixed fee per tablet plus an additional fee for packaging, shipping and customs clearance. The Agreement has an initial term of five years unless terminated by either party in accordance with the terms.   Operating Leases   At September 30, 2016, the Company was a party to an agreement to lease office space in Orlando, Florida. Rent expense for the quarters ended September 30, 2016 and 2015 was $4,009 and $4,988, respectively.   Legal Proceedings   None.

11. Subsequent Events   In October 2016, the Company and its wholly owned subsidiary, TNI BioTech International, Ltd., and GB Pharma Holdings, LLC (GBPH), entered into an exclusive agency agreement (Agency Agreement) that replaced the agency agreement originally entered into in June 2014 between GBPH and Airmed Biopharma Limited. Subject to the terms and conditions of the Agency Agreement, the Company appointed GBPH as its exclusive agent to (i) assist the Company in obtaining governmental approvals for the sale of LDN and MENK (Products) in countries specified in the agreement, (ii) facilitate the registration of the Products in those countries, (iii) identify and present to the Company distributors for the Products in those countries, and (iv) subject to GBPH meeting certain requirements, enter into distribution agreements with the specified organizations to distribute the Products in the countries. The Company has agreed pay GBPH a commission of 12.5% of funds received by the Company from such sales. The Agency Agreement has an initial term of five years, and will automatically renew for additional one year terms unless terminated by either party in accordance with its terms. If the Company sells or disposes of all or substantially all of its assets, whether by purchase, merger or otherwise, the Company shall have the right to terminate the Agency Agreement immediately, whereupon the Company will be obligated to pay Agent a royalty in perpetuity in an amount equal to one percent of funds actually received by the Company from the sale of the Products in the specified countries, after the deduction of certain costs of sale.   In October 2016, the Company amended a promissory note dated July 6, 2015, and settled a portion of the principal owed under the note and accrued and unpaid interest to the date of the amendment. In accordance with the amendment, the Company repaid $50,000 of the $100,000 principal owed, issued 2,000,000 shares of the Companys common stock to the note holder in full satisfaction of the accrued and unpaid interest to the date of the amendment, and caused Cytocom to issue 250,000 shares of its common stock in return for the note holders agreement to reduce the annual interest rate on the note from 18% to 10% and to extend the maturity date of the note from September 6, 2016 to December 31, 2016.   In October 2016, the company borrowed an additional $165,000.   In October 2016, the Company issued 1,300,000 shares of common stock for consulting services.   In October 2016, the company issued 300,000 shares of common stock for lending fees.   On or around October 25, 2016, the Company issued a promissory note in the principal amount of $25,000.00 to Noreen Griffin in consideration for past payroll due Ms. Griffin. Ms. Griffin sold the note to a minority shareholder for $25,000.00 on October 25, 2016. This note was subsequently converted to 500,000 shares of common stock.   On November 1, 2016, the Company issued promissory notes for $750,000, paying interest at 2% per month, and maturing on November 1, 2017. $656,250 of the proceeds were used to pay off the JMJ Financial note, with the remainder to be used for general obligations.   As of November 14, 2016, the Company had outstanding 241,128,131 shares of common stock.

A calculation of basic and diluted net loss per share follows:   <table cellspacing="0" cellpadding="0" style="font: 11pt Calibri, Helvetica, Sans-Serif; width: 100%; border-collapse: collapse"> <tr style="vertical-align: bottom"> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td colspan="6" style="border-bottom: black 1.5pt solid; text-align: center; line-height: 115%">For the three months ended September 30,</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td colspan="6" style="border-bottom: black 1.5pt solid; text-align: center; line-height: 115%">For the six months ended September 30,</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom"> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center; line-height: 115%">2016</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center; line-height: 115%">2015</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center; line-height: 115%">2016</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center; line-height: 115%">2015</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="line-height: 115%">Net loss per share:</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="line-height: 115%">Numerator</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="width: 44%; line-height: 115%">Net loss</td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 1%; line-height: 115%">$</td> <td style="width: 11%; text-align: right; line-height: 115%">(3,943,942</td> <td style="width: 1%; line-height: 115%">)</td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 1%; line-height: 115%">$</td> <td style="width: 11%; text-align: right; line-height: 115%">(4,025,309</td> <td style="width: 1%; line-height: 115%">)</td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 1%; line-height: 115%">$</td> <td style="width: 11%; text-align: right; line-height: 115%">(14,627,993</td> <td style="width: 1%; line-height: 115%">)</td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 1%; line-height: 115%">$</td> <td style="width: 11%; text-align: right; line-height: 115%">(9,499,641</td> <td style="width: 1%; line-height: 115%">)</td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="line-height: 115%">Net loss attributed to Common stockholders</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%">$</td> <td style="text-align: right; line-height: 115%">(3,936,501</td> <td style="line-height: 115%">)</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%">$</td> <td style="text-align: right; line-height: 115%">(3,859,550</td> <td style="line-height: 115%">)</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%">$</td> <td style="text-align: right; line-height: 115%">(14,466,503</td> <td style="line-height: 115%">)</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%">$</td> <td style="text-align: right; line-height: 115%">(9,070,926</td> <td style="line-height: 115%">)</td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="line-height: 115%">Denominator</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="line-height: 115%">Weighted-average common shares outstanding</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="line-height: 115%">Denominator for basic and diluted net loss per share</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">226,843,113</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">156,814,094</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">208,399,547</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">147,365,571</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="line-height: 115%">Basic and diluted net loss per share attributed to common stockholders</td> <td style="line-height: 115%"> </td> <td style="border-bottom: black 2.25pt double; line-height: 115%">$</td> <td style="border-bottom: black 2.25pt double; text-align: right; line-height: 115%">(0.02</td> <td style="line-height: 115%">)</td> <td style="line-height: 115%"> </td> <td style="border-bottom: black 2.25pt double; line-height: 115%">$</td> <td style="border-bottom: black 2.25pt double; text-align: right; line-height: 115%">(0.02</td> <td style="line-height: 115%">)</td> <td style="line-height: 115%"> </td> <td style="border-bottom: black 2.25pt double; line-height: 115%">$</td> <td style="border-bottom: black 2.25pt double; text-align: right; line-height: 115%">(0.07</td> <td style="line-height: 115%">)</td> <td style="line-height: 115%"> </td> <td style="border-bottom: black 2.25pt double; line-height: 115%">$</td> <td style="border-bottom: black 2.25pt double; text-align: right; line-height: 115%">(0.06</td> <td style="line-height: 115%">)</td></tr> </table>

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:   <table cellspacing="0" cellpadding="0" style="font: 11pt Calibri, Helvetica, Sans-Serif; width: 100%; border-collapse: collapse"> <tr style="vertical-align: bottom"> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td colspan="6" style="border-bottom: black 1.5pt solid; text-align: center; line-height: 115%">As of September 30,</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom"> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center; line-height: 115%">2016</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center; line-height: 115%">2015</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="width: 62%; line-height: 115%">Warrants to purchase Common stock</td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 1%; border-bottom: black 1.5pt solid; line-height: 115%"> </td> <td style="width: 16%; border-bottom: black 1.5pt solid; text-align: right; line-height: 115%">32,623,908</td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 1%; border-bottom: black 1.5pt solid; line-height: 115%"> </td> <td style="width: 16%; border-bottom: black 1.5pt solid; text-align: right; line-height: 115%">9,355,250</td> <td style="width: 1%; line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="border-bottom: black 2.25pt double; line-height: 115%"> </td> <td style="border-bottom: black 2.25pt double; text-align: right; line-height: 115%">32,623,908</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="border-bottom: black 2.25pt double; line-height: 115%"> </td> <td style="border-bottom: black 2.25pt double; text-align: right; line-height: 115%">9,355,250</td> <td style="line-height: 115%"> </td></tr> </table>

<table cellspacing="0" cellpadding="0" style="font: 11pt Calibri, Helvetica, Sans-Serif; width: 100%; border-collapse: collapse"> <tr style="vertical-align: bottom"> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center; line-height: 115%">September 30, 2016</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center; line-height: 115%">December 31, 2015</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="line-height: 115%">Property and equipment:</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="width: 62%; line-height: 115%">Computer equipment</td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 1%; line-height: 115%">$</td> <td style="width: 16%; text-align: right; line-height: 115%">8,013</td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 1%; line-height: 115%">$</td> <td style="width: 16%; text-align: right; line-height: 115%">8,013</td> <td style="width: 1%; line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="line-height: 115%">Less accumulated depreciation</td> <td style="line-height: 115%"> </td> <td style="border-bottom: black 1.5pt solid; line-height: 115%"> </td> <td style="border-bottom: black 1.5pt solid; text-align: right; line-height: 115%">(7,611</td> <td style="line-height: 115%">)</td> <td style="line-height: 115%"> </td> <td style="border-bottom: black 1.5pt solid; line-height: 115%"> </td> <td style="border-bottom: black 1.5pt solid; text-align: right; line-height: 115%">(6,331</td> <td style="line-height: 115%">)</td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="line-height: 115%">Property and equipment, net</td> <td style="line-height: 115%"> </td> <td style="border-bottom: black 1.5pt solid; line-height: 115%">$</td> <td style="border-bottom: black 1.5pt solid; text-align: right; line-height: 115%">402</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="border-bottom: black 1.5pt solid; line-height: 115%">$</td> <td style="border-bottom: black 1.5pt solid; text-align: right; line-height: 115%">1,682</td> <td style="line-height: 115%"> </td></tr> </table>

Accrued expenses and other liabilities consist of the following:   <table cellspacing="0" cellpadding="0" style="font: 11pt Calibri, Helvetica, Sans-Serif; width: 100%; border-collapse: collapse"> <tr style="vertical-align: bottom"> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center; line-height: 115%">September 30, 2016</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center; line-height: 115%">December 31, 2015</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom"> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td colspan="6" style="text-align: center; line-height: 115%">(in thousands)</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="width: 62%; line-height: 115%">Accrued payroll to officers and others</td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 1%; line-height: 115%">$</td> <td style="width: 16%; text-align: right; line-height: 115%">934</td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 1%; line-height: 115%">$</td> <td style="width: 16%; text-align: right; line-height: 115%">758</td> <td style="width: 1%; line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="line-height: 115%">Accrued interest and penalties - notes payable</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">1,319</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">237</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="line-height: 115%">Accrued legal settlements</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">143</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">282</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="line-height: 115%">Other accrued liabilities</td> <td style="line-height: 115%"> </td> <td style="border-bottom: black 1.5pt solid; line-height: 115%"> </td> <td style="border-bottom: black 1.5pt solid; text-align: right; line-height: 115%">1</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="border-bottom: black 1.5pt solid; line-height: 115%"> </td> <td style="border-bottom: black 1.5pt solid; text-align: right; line-height: 115%">4</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="line-height: 115%">Total accrued expenses and other liabilities</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%">$</td> <td style="text-align: right; line-height: 115%">2,397</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%">$</td> <td style="text-align: right; line-height: 115%">1,281</td> <td style="line-height: 115%"> </td></tr> </table>

Notes payable consist of the following:   <table cellspacing="0" cellpadding="0" style="font: 11pt Calibri, Helvetica, Sans-Serif; width: 100%; border-collapse: collapse"> <tr style="vertical-align: bottom"> <td style="text-align: justify; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center; line-height: 115%"> September 30, 2016</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center; line-height: 115%"> December 31, 2015 </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="width: 62%; text-align: justify; line-height: 115%">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.</td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 1%; line-height: 115%">$</td> <td style="width: 16%; text-align: right; line-height: 115%">100,000</td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 1%; line-height: 115%">$</td> <td style="width: 16%; text-align: right; line-height: 115%">100,000</td> <td style="width: 1%; line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="text-align: justify; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="text-align: justify; line-height: 115%">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. Principal of $425,500 and accrued interest of $37,427 were converted to 5,309,092 shares of common stock in the nine months ended September 30, 2016, Notes aggregating $286,000 were in default at September 30, 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.</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">286,000</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">711,500</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="text-align: justify; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="text-align: justify; line-height: 115%">Promissory note issued October 17, 2014 to Roger Bozarth. The note matures on October 17, 2015 and earns interest at a rate of 2% per annum. The lender converted this note and $2,139 in accrued interest to 114,237 shares of common stock in January 2016.</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">-</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">7,000</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="text-align: justify; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="text-align: justify; line-height: 115%">Promissory notes issued between May 1, 2015 and September 30, 2016, and maturing between June 14, 2015 and June 30, 2017. Lenders on loans aggregating $535,994 earn interest at rates between 10% and 18% per annum. On loans aggregating $198,500, interest is payable in a fixed amount not tied to a specific interest rate. Notes aggregating $198,500 were in default at September 30, 2016, as the Company was unable to repay those notes on their due dates. No demands for repayment have been made by the lenders.</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">734,494</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">669,933</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="text-align: justify; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="text-align: justify; line-height: 115%">Promissory note issued January 26, 2015 to Robert J. Dailey. The note is senior to, and has priority in right of payment over, all indebtedness of the Company. The note earns interest at a rate of 2% per annum and was due on July 30, 2015. Principal of $200,000 and accrued interest of $4,778 was converted to 3,722,015 shares of common stock in the nine months ending September 30, 2016.</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">-</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">200,000</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="text-align: justify; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="text-align: justify; line-height: 115%">Promissory notes issued by Cytocom Inc. between April 29, 2015 and December 31, 2015. Lenders earn interest at rates between 5% and 10% per annum. These notes mature on September 30, 2016. $375,000 of principal and $12,036 in accrued interest was converted to 4,837,960 shares of common stock in the nine months ending September 30, 2016. The Company was unable to repay the remaining notes at maturity and the notes are in default, although no demand for repayment has been made by the lenders.</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">425,000</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">800,000</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="text-align: justify; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="text-align: justify; line-height: 115%">Promissory notes issued in December 2015. Lenders earn interest at a rate of 10% per month. Notes are repayable on March 9, 2016. . $30,000 of principal and $49,000 of interest and penalties were converted to 987,500 shares of common stock in the nine months ended September 30, 2016. The Company was unable to repay the remaining note at maturity and the note is in default The Company is obligated to pay late-payment penalties totaling $5,000 per day on the remaining obligation.</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">100,000</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">130,000</td> <td style="line-height: 115%"> </td></tr> </table>   <table cellspacing="0" cellpadding="0" style="font: 11pt Calibri, Helvetica, Sans-Serif; width: 100%; border-collapse: collapse"> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="width: 62%; text-align: justify; line-height: 115%">Promissory note issued November 24, 2015 as settlement of amounts owing to a law firm. The Lender earns interest at the rate of 10% per annum. The note and $10,036 in interest was converted to 1,235,536 shares of common stock in July 2016.</td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 16%; text-align: right; line-height: 115%">-</td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 16%; text-align: right; line-height: 115%">175,268</td> <td style="width: 1%; line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="text-align: justify; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="text-align: justify; line-height: 115%">Promissory notes issued between May 5, 2016 and June 2, 2016 that mature between October 1, 2016 and January 31, 2017, and include stock conversion features, warrants and original issue debt discounts. Notes aggregating $305,000 were in default at November 14, 2016. No demand for repayment has been made by the lenders.</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">555,000</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">-</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="text-align: justify; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="text-align: justify; line-height: 115%">Promissory notes issued to an officer of the Company effective November 3, 2015 and maturing November 3, 2016 for settlement of accrued payroll, bearing interest at 10% per annum and including a stock conversion feature.</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">112,737</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">-</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="text-align: justify; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="text-align: justify; line-height: 115%">Promissory note issued in July 2016. The note is repayable on October 5, 2016. The note earns interest at 6% per month. The Company was unable to repay the note at maturity and the note is in default.</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">50,000</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">-</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="text-align: justify; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="text-align: justify; line-height: 115%">Promissory note dated April 2016, issued to JM Financial (JMJ), pursuant to which JMJ loaned the Company $525,000 and was issued the promissory note, 500,000 shares of common stock, and a warrant exercisable for 3,515,621 additional common shares at a rate of $0.14 per share. The note matures on January 6, 2017. The note was repaid on November 4, 2016.</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">656,250</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">-</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="text-align: justify; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="text-align: justify; line-height: 115%">Promissory note issued in July 2016 with an original issuance discount of $30,000. Net proceeds were $150,000. The note is repayable on April 7, 2017.</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">180,000</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">-</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="text-align: justify; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="text-align: justify; line-height: 115%">Promissory notes issued in August 2016 for $149,854 as a settlement of amounts owed to a law firm. The notes accrue interest at 5% per annum and are payable in 18 equal monthly installments of $8,641.88.</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">146,912</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">-</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="text-align: justify; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="text-align: justify; line-height: 115%">Promissory notes issued between July 1, 2016 and September 30, 2016. Lenders earn interest at 12% per annum. The notes mature between January 1, 2017 and March 31, 2017.</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">495,000</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">-</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="text-align: justify; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="text-align: justify; line-height: 115%">Less: Original issue discounts on notes payable and warrants issued with notes.</td> <td style="line-height: 115%"> </td> <td style="border-bottom: black 1.5pt solid; line-height: 115%"> </td> <td style="border-bottom: black 1.5pt solid; text-align: right; line-height: 115%">(267,695</td> <td style="line-height: 115%">)</td> <td style="line-height: 115%"> </td> <td style="border-bottom: black 1.5pt solid; line-height: 115%"> </td> <td style="border-bottom: black 1.5pt solid; text-align: right; line-height: 115%">-</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="text-align: justify; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="text-align: justify; line-height: 115%">Total</td> <td style="line-height: 115%"> </td> <td style="border-bottom: black 1.5pt solid; line-height: 115%"> </td> <td style="border-bottom: black 1.5pt solid; text-align: right; line-height: 115%">3,573,698</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="border-bottom: black 1.5pt solid; line-height: 115%"> </td> <td style="border-bottom: black 1.5pt solid; text-align: right; line-height: 115%">2,793,701</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="text-align: justify; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="text-align: justify; line-height: 115%">Less: Current Portion</td> <td style="line-height: 115%"> </td> <td style="border-bottom: black 2.25pt double; line-height: 115%">$</td> <td style="border-bottom: black 2.25pt double; text-align: right; line-height: 115%">(3,573,698</td> <td style="line-height: 115%">)</td> <td style="line-height: 115%"> </td> <td style="border-bottom: black 2.25pt double; line-height: 115%">$</td> <td style="border-bottom: black 2.25pt double; text-align: right; line-height: 115%">(2,793,701</td> <td style="line-height: 115%">)</td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="text-align: justify; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="text-align: justify; line-height: 115%">Long-Term debt, less current portion</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%">$</td> <td style="text-align: right; line-height: 115%">-</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%">$</td> <td style="text-align: right; line-height: 115%">-</td> <td style="line-height: 115%"> </td></tr> </table>

Following is a summary of outstanding stock warrants at September 30, 2016 and activity during the nine months then ended:   <table cellspacing="0" cellpadding="0" style="font: 11pt Calibri, Helvetica, Sans-Serif; width: 100%; border-collapse: collapse"> <tr style="vertical-align: bottom"> <td style="text-align: center; line-height: 115%"> </td> <td style="text-align: center; line-height: 115%"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center; line-height: 115%">Number of Shares</td> <td style="text-align: center; line-height: 115%"> </td> <td style="text-align: center; line-height: 115%"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center; line-height: 115%">Exercise Price</td> <td style="text-align: center; line-height: 115%"> </td> <td style="text-align: center; line-height: 115%"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center; line-height: 115%">Weighted Average Price</td> <td style="text-align: center; line-height: 115%"> </td></tr> <tr style="vertical-align: bottom"> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td colspan="2" style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td colspan="2" style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td colspan="2" style="line-height: 115%"> </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="width: 55%; line-height: 115%">Warrants as of December 31, 2015</td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 12%; text-align: right; line-height: 115%">9,131,500</td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 1%; line-height: 115%">$</td> <td style="width: 12%; text-align: right; line-height: 115%"> 0.07-15.00 </td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 1%; line-height: 115%">$</td> <td style="width: 12%; text-align: right; line-height: 115%">1.47</td> <td style="width: 1%; line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="line-height: 115%">Issued in 2016</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">25,654,908</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%">$</td> <td style="text-align: right; line-height: 115%">  0.14-2.00 </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%">$</td> <td style="text-align: right; line-height: 115%">0.31</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="line-height: 115%">Expired</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">(162,500</td> <td style="line-height: 115%">)</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%">$</td> <td style="text-align: right; line-height: 115%">5.00</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%">$</td> <td style="text-align: right; line-height: 115%">5.00</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="line-height: 115%">Exercised</td> <td style="line-height: 115%"> </td> <td style="border-bottom: black 1.5pt solid; line-height: 115%"> </td> <td style="border-bottom: black 1.5pt solid; text-align: right; line-height: 115%">(0</td> <td style="line-height: 115%">)</td> <td style="line-height: 115%"> </td> <td style="border-bottom: black 1.5pt solid; line-height: 115%">$</td> <td style="border-bottom: black 1.5pt solid; text-align: right; line-height: 115%">0</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="border-bottom: black 1.5pt solid; line-height: 115%">$</td> <td style="border-bottom: black 1.5pt solid; text-align: right; line-height: 115%">0</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="line-height: 115%">Warrants as of September 30, 2016</td> <td style="line-height: 115%"> </td> <td style="border-bottom: black 2.25pt double; line-height: 115%"> </td> <td style="border-bottom: black 2.25pt double; text-align: right; line-height: 115%">34,623,908</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="border-bottom: black 2.25pt double; line-height: 115%">$</td> <td style="border-bottom: black 2.25pt double; text-align: right; line-height: 115%">    0.07-15.00 </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="border-bottom: black 2.25pt double; line-height: 115%">$</td> <td style="border-bottom: black 2.25pt double; text-align: right; line-height: 115%">0..50</td> <td style="line-height: 115%"> </td></tr> </table>

Summary of outstanding warrants as of September 30, 2016:   <table cellspacing="0" cellpadding="0" style="font: 11pt Calibri, Helvetica, Sans-Serif; width: 100%; border-collapse: collapse"> <tr style="vertical-align: bottom"> <td style="border-bottom: black 1.5pt solid; line-height: 115%">Expiration Date</td> <td style="line-height: 115%"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center; line-height: 115%">Number of Shares</td> <td style="text-align: center; line-height: 115%"> </td> <td style="text-align: center; line-height: 115%"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center; line-height: 115%">Exercise Price</td> <td style="text-align: center; line-height: 115%"> </td> <td style="text-align: center; line-height: 115%"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center; line-height: 115%">Remaining Life (years)</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom"> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td colspan="2" style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td colspan="2" style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td colspan="2" style="line-height: 115%"> </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="width: 58%; line-height: 115%">Fourth Quarter 2017</td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 11%; text-align: right; line-height: 115%">350,000</td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 1%; line-height: 115%">$ </td> <td style="width: 11%; text-align: right; line-height: 115%">1.50-9.00 </td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 11%; text-align: right; line-height: 115%">1.25</td> <td style="width: 1%; line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="line-height: 115%">First Quarter 2018</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">127,500</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%">$</td> <td style="text-align: right; line-height: 115%">15.00</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">1.50</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="line-height: 115%">Second Quarter 2018</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">33,334</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%">$</td> <td style="text-align: right; line-height: 115%">15.00</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">1.75</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="line-height: 115%">Third Quarter 2018</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">250,000</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%">$</td> <td style="text-align: right; line-height: 115%">1.50</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">2.00</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="line-height: 115%">Fourth Quarter 2018</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">6,089,166</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%">$</td> <td style="text-align: right; line-height: 115%">1.00-1.50</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">2.25</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="line-height: 115%">First Quarter 2019</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">4,024,000</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%">$</td> <td style="text-align: right; line-height: 115%">0.50-2.00</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">2.50</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="line-height: 115%">Second Quarter 2019</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">135,000</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%">$</td> <td style="text-align: right; line-height: 115%">0.070.23 </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">2.75</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="line-height: 115%">Third Quarter 2019</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">260,000</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%">$</td> <td style="text-align: right; line-height: 115%">0.50-1.50 </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">3.00</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="line-height: 115%">Fourth Quarter 2019</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">400,000</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%">$</td> <td style="text-align: right; line-height: 115%">0.14</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">3.25</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="line-height: 115%">Second Quarter 2020</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">300,000</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%">$</td> <td style="text-align: right; line-height: 115%">0.50</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">3.75</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="line-height: 115%">Fourth Quarter 2020</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">1,000,000</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%">$</td> <td style="text-align: right; line-height: 115%">0.20</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">4.00</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="line-height: 115%">First Quarter 2021</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">12,650,000</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%">$</td> <td style="text-align: right; line-height: 115%">0.20</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">4.25</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="line-height: 115%">Second Quarter 2021</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">6,004,908</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%">$</td> <td style="text-align: right; line-height: 115%">0.10-0.20 </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">4.50</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="line-height: 115%">Third Quarter 2021</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">3,000,000</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%">$</td> <td style="text-align: right; line-height: 115%">0.20</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">4.75</td> <td style="line-height: 115%"> </td></tr> </table>

4009

4988

5226352

9908477

39346

22152

16197

41228

22754

200

1682

402

5999412

7487523

2793701

3573698

1281039

2397013

1924672

1516812

5999412

7487523

41228

22754

-2100452

-2261942

-3857732

-5202827

-347789889

-362256392

-660417 -1252762 1140303 845838

343434786

357436906

17485

23583

3463

12676

4958

10321406

7881191

2691596

2556343

1280

446148

299

148696

2756404 37451 187850 37451 4403951 5005393 1225353 1393500

295438

703011

247019

111361

2864333

1689188

1031075

865335

-10317943

-7868515

-2691596

-2551385

-4310050

-1631126

-1252346

-1473924

-1978754

-1482445

-274071

-1394000

2331296

148681

978275

79924

208399547

147365571

226843113

156814094

-0.07

-0.06

-0.02

-14466503

-9070926

-3936501

-3859550

-161490

-428715

-7441

-165759

2132380

1277975

150000

656250

Basis of Presentation   The consolidated financial statements included herein have been prepared by the Company, without audit, pursuant to the rules and regulations of the Securities and Exchange Commission. Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. generally accepted accounting principles have been omitted. However, in the opinion of management, all adjustments (which include only normal recurring adjustments, unless otherwise indicated) necessary to present fairly the financial position and results of operations for the periods presented have been made. The results for interim periods are not necessarily indicative of trends or of results to be expected for the full year. These financial statements should be read in conjunction with the financial statements of the Company for the year ended December 31, 2015 (including the notes thereto) set forth in Form 10-K/A.   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 September 30, 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, 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. Cash and cash equivalents, accounts receivable and accounts payable are accounted for at cost which approximates fair value due to the relatively short maturity of these instruments. The carrying value of notes payable also approximates fair value since they bear market rates of interest and other terms. None of these instruments are held for trading purposes.

Fair Value Measurements   The ASC Topic 820, Fair Value Measurements, defines fair value, establishes a framework for measuring fair value in accordance with U.S. generally accepted accounting principles, and requires certain disclosures about fair value measurements. In general, fair values of financial instruments are based upon quoted market prices, where available. If such quoted market prices are not available, fair value is based upon internally developed models that primarily use, as inputs, observable market-based parameters. Valuation adjustments may be made to ensure that financial instruments are recorded at fair value. These adjustments may include amounts to reflect counterparty credit quality and the customers creditworthiness, among other things, as well as unobservable parameters. Any such valuation adjustments are applied consistently over time.

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 September 30, 2016 and September 30, 2015 was $299 and $638, 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. At the end of 2015, the Company determined that the unamortized carrying amount recorded for the acquisition of licenses and patents related to LDN were impaired, and recorded an impairment loss of $5,226,352. In 2014, the Company determined that the carrying amount recoded for the acquisition of licenses and patents related to MENK were impaired, and recorded an impairment loss of $9,908,477.   During the quarters ended September 30, 2016 and September 30, 2015, the Company did not capitalize any costs to acquire and/or develop the Companys product licenses and patents. (See Note 10). Amortization expense for the quarters ended September 30, 2016 and September 30, 2015 was $0 and $444,175, 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. 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 quarters ended September 30, 2016 and September 30, 2015.

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, which requires recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements or tax returns. Under this method, deferred tax assets and liabilities are based on the differences between the financial statements and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Deferred tax assets are reduced by a valuation allowance to the extent management concludes it is more likely than not that the asset will not be realized. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled.   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 September 30, 2016, 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 September 30, 2016 and September 30, 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 market 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. 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 vendors performance is complete.

Non-controlling Interest   In accordance with ASC 810, Consolidation, the Company consolidates Cytocom, Inc. The non-controlling interests in Cytocom represent the interests of outside shareholders in the equity and results of operations of Cytocom.

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:   <table cellspacing="0" cellpadding="0" style="font: 11pt Calibri, Helvetica, Sans-Serif; width: 100%; border-collapse: collapse"> <tr style="vertical-align: bottom"> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td colspan="6" style="border-bottom: black 1.5pt solid; text-align: center; line-height: 115%">For the three months ended September 30,</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td colspan="6" style="border-bottom: black 1.5pt solid; text-align: center; line-height: 115%">For the six months ended September 30,</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom"> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center; line-height: 115%">2016</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center; line-height: 115%">2015</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center; line-height: 115%">2016</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center; line-height: 115%">2015</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="line-height: 115%">Net loss per share:</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="line-height: 115%">Numerator</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="width: 44%; line-height: 115%">Net loss</td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 1%; line-height: 115%">$</td> <td style="width: 11%; text-align: right; line-height: 115%">(3,943,942</td> <td style="width: 1%; line-height: 115%">)</td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 1%; line-height: 115%">$</td> <td style="width: 11%; text-align: right; line-height: 115%">(4,025,309</td> <td style="width: 1%; line-height: 115%">)</td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 1%; line-height: 115%">$</td> <td style="width: 11%; text-align: right; line-height: 115%">(14,627,993</td> <td style="width: 1%; line-height: 115%">)</td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 1%; line-height: 115%">$</td> <td style="width: 11%; text-align: right; line-height: 115%">(9,499,641</td> <td style="width: 1%; line-height: 115%">)</td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="line-height: 115%">Net loss attributed to Common stockholders</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%">$</td> <td style="text-align: right; line-height: 115%">(3,936,501</td> <td style="line-height: 115%">)</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%">$</td> <td style="text-align: right; line-height: 115%">(3,859,550</td> <td style="line-height: 115%">)</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%">$</td> <td style="text-align: right; line-height: 115%">(14,466,503</td> <td style="line-height: 115%">)</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%">$</td> <td style="text-align: right; line-height: 115%">(9,070,926</td> <td style="line-height: 115%">)</td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="line-height: 115%">Denominator</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="line-height: 115%">Weighted-average common shares outstanding</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%"> </td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="line-height: 115%">Denominator for basic and diluted net loss per share</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">226,843,113</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">156,814,094</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">208,399,547</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="text-align: right; line-height: 115%">147,365,571</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="line-height: 115%">Basic and diluted net loss per share attributed to common stockholders</td> <td style="line-height: 115%"> </td> <td style="border-bottom: black 2.25pt double; line-height: 115%">$</td> <td style="border-bottom: black 2.25pt double; text-align: right; line-height: 115%">(0.02</td> <td style="line-height: 115%">)</td> <td style="line-height: 115%"> </td> <td style="border-bottom: black 2.25pt double; line-height: 115%">$</td> <td style="border-bottom: black 2.25pt double; text-align: right; line-height: 115%">(0.02</td> <td style="line-height: 115%">)</td> <td style="line-height: 115%"> </td> <td style="border-bottom: black 2.25pt double; line-height: 115%">$</td> <td style="border-bottom: black 2.25pt double; text-align: right; line-height: 115%">(0.07</td> <td style="line-height: 115%">)</td> <td style="line-height: 115%"> </td> <td style="border-bottom: black 2.25pt double; line-height: 115%">$</td> <td style="border-bottom: black 2.25pt double; text-align: right; line-height: 115%">(0.06</td> <td style="line-height: 115%">)</td></tr> </table>    The Companys potential dilutive securities which include stock, stock warrants and convertible debt 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:   <table cellspacing="0" cellpadding="0" style="font: 11pt Calibri, Helvetica, Sans-Serif; width: 100%; border-collapse: collapse"> <tr style="vertical-align: bottom"> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td colspan="6" style="border-bottom: black 1.5pt solid; text-align: center; line-height: 115%">As of September 30,</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom"> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center; line-height: 115%">2016</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center; line-height: 115%">2015</td> <td style="line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="width: 62%; line-height: 115%">Warrants to purchase Common stock</td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 1%; border-bottom: black 1.5pt solid; line-height: 115%"> </td> <td style="width: 16%; border-bottom: black 1.5pt solid; text-align: right; line-height: 115%">32,623,908</td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 1%; line-height: 115%"> </td> <td style="width: 1%; border-bottom: black 1.5pt solid; line-height: 115%"> </td> <td style="width: 16%; border-bottom: black 1.5pt solid; text-align: right; line-height: 115%">9,355,250</td> <td style="width: 1%; line-height: 115%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="border-bottom: black 2.25pt double; line-height: 115%"> </td> <td style="border-bottom: black 2.25pt double; text-align: right; line-height: 115%">32,623,908</td> <td style="line-height: 115%"> </td> <td style="line-height: 115%"> </td> <td style="border-bottom: black 2.25pt double; line-height: 115%"> </td> <td style="border-bottom: black 2.25pt double; text-align: right; line-height: 115%">9,355,250</td> <td style="line-height: 115%"> </td></tr> </table>

Recent Accounting Standards   During the quarter ended September 30, 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.   The Company qualifies as an emerging growth company as defined in Section 101 of the Jumpstart our Business Startups Act (JOBS Act) as we do not have more than $1,000,000,000 in annual gross revenue and did not have such amount as of December 31, 2015, our last fiscal year. We are electing to use the extended transition period for complying with new or revised accounting standards under Section 102(b)(1) of the JOBS Act.

250000

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66500000

expire in 2032-2035.

Through its wholly-owned subsidiary, TNI BioTech International, Ltd., in December 2015 the Company completed a 90-day bridging trial for the treatment of patients with HIV/AIDS. The trial consisted of a total of 150 patients of both genders between the ages of 18-60, each of whom was infected HIV/AIDS. The primary objective of this bridging trial was to confirm that LodonalTM has a beneficial effect on the immune system of immune deficient patients and that it is safe. The trial separated patients into a Control (placebo) Group and a Treatment Group (which was administered LodonalTM). The efficacy of increasing CD4 count [cell/mm3] between Day-1 and Day-90 by at least 25% was set as the criteria for demonstrating beneficial effect on the immune system. Safety was demonstrated through quality of life assessment and vitals both of which were not adversely affected. Treatment Group patients were given a daily dose of 4.5-mg/kg of Lodonal.

191750 113 191637 22500 15 22485 150000

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Segment and Geographic Information   Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one operating segment and does not segment the business for internal reporting or decision making.

15401

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3573698

30000

37427

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12036

10536

42750

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1.00

0.50

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0.14

0.50

0.20

0.10

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1.50

2.00

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P1Y3M

P1Y6M

P1Y9M

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P2Y6M

P2Y9M

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P3Y3M

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3515621

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October 1, 2016 and January 31, 2017

mature between January 1, 2017 and March 31, 2017

October 1, 2016 and January 31, 2017

2315190

3895018

250000

7. Stock Compensation   Shares Issued for Services   During the nine months ended September 30, 2016 and 2015, the Company issued 29,283,910 and 16,922,504 shares of common stock respectively for consulting fees. The Company valued these shares at $5,420,760 and $1,029,375 respectively, based upon the fair value of the common stock at the dates of the agreements. The consulting fees are amortized over the contract periods, which are typically between 12 and 24 months. The amortization of prepaid services totaled $2,315,190 and $3,895,018 for the nine months ended September 30, 2016 and 2015. In the nine months ended September 30, 2016, the company also issued and expensed $2,088,759 of stock for services.

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Disclosure - Income Taxes - Results of Operations (Details Narrative) link:presentationLink link:calculationLink link:definitionLink 00000039 - Disclosure - Commitments and Contingencies (Details Narrative) link:presentationLink link:calculationLink link:definitionLink 00000040 - Disclosure - Subsequent Events (Details Narrative) link:presentationLink link:calculationLink link:definitionLink EX-101.CAL 7 imun-20160930_cal.xml XBRL CALCULATION FILE EX-101.DEF 8 imun-20160930_def.xml XBRL DEFINITION FILE EX-101.LAB 9 imun-20160930_lab.xml XBRL LABEL FILE Common Stock [Member] Equity Components [Axis] Additional Paid-In Capital [Member] Stock to Be Issued [Member] Prepaid Service [Member] Accumulated Deficit [Member] Non-controlling Interest [Member] Cytocom Inc., [Member] Legal Entity [Axis] Irish Limited Liability [Member] Notes Payable One [Member] Debt Instrument [Axis] Notes Payable Two [Member] Notes Payable Three [Member] Notes Payable Four [Member] Notes Payable Five [Member] Notes Payable Six [Member] Notes Payable Seven [Member] Notes Payable Eight [Member] Ira Gaines [Member] Related Party [Axis] Lenders [Member] Roger Bozarth [Member] May 1, 2015 [Member] Award Date [Axis] Minimum [Member] Range [Axis] Maximum [Member] Lenders [Member] Robert J. Dailey [Member] December Thirty First Two Thousand Fifteen [Member] Lender [Member] Lender [Member] Warrant [Member] Fourth Quarter 2020 [Member] Class of Warrant or Right [Axis] Fourth Quarter 2017 [Member] First Quarter 2018 [Member] Second Quarter 2018 [Member] Third Quarter 2018 [Member] Fourth Quarter 2018 [Member] First Quarter 2019 [Member] Second Quarter 2019 [Member] Third Quarter 2019 [Member] Fourth Quarter 2019 [Member] Second Quarter 2020 [Member] Notes Payable Nine [Member] Notes Payable Ten [Member] First Quarter 2021 [Member] Orlando, Florida [Member] Lease Arrangement, Type [Axis] LDN [Member] Indefinite-lived Intangible Assets [Axis] MENK [Member] Notes Payable Eleven [Member] Complete Pharmacy and Medical Solutions, LLC [Member] Notes Payable Twelve [Member] Notes Payable Thirteen [Member] Notes Payable Fourteen [Member] Notes Payable Fifteen [Member] JM Financial [Member] Lender [Member] Title of Individual [Axis] Second Quarter 2021 [Member] Third Quarter 2021 [Member] Subsequent Event [Member] Subsequent Event Type [Axis] GB Pharma Holdings, LLC [Member] Note Holder[Member] Cytocom[Member] Property and Equipment [Member] Property, Plant and Equipment, Type [Axis] Warrants To Purchase Common Stock [Member] Antidilutive Securities [Axis] Noreen Griffin [Member] Ms. Griffin [Member] Document And Entity Information Entity Registrant Name Entity Central Index Key Document Type Document Period End Date Amendment Flag Current Fiscal Year End Date Entity Filer Category Entity Common Stock, Shares Outstanding Trading Symbol Document Fiscal Period Focus Document Fiscal Year Focus Statement of Financial Position [Abstract] ASSETS Current Assets: Cash and cash equivalents Accounts receivable Total current assets Fixed Assets: Computer equipment, net of accumulated depreciation of $7,611 and $6,331 respectively Deposits Total assets LIABILITIES AND STOCKHOLDERS' DEFICIT Current Liabilities: Accounts payable Accrued liabilities Current portion of notes payable Total current liabilities Non-current liabilities: Notes payable, less current portion Total non-current liabilities Total liabilities Commitments and Contingencies (Note 10) Stockholders' Deficit: Common stock - par value $0.0001; 500,000,000 shares authorized; 235,831,298 and 174,850,047 shares issued and outstanding respectively Additional paid in capital Stock issuances due Prepaid services Accumulated deficit Deficit attributable to common shareholders Non-controlling interest Total stockholders' deficit Total liabilities and stockholders' deficit Accumulated depreciation Common stock, par value Common stock, shares authorized Common stock, shares issued Common stock, shares outstanding Income Statement [Abstract] Revenues, net Operating expenses Selling, general and administrative Research and development expense Stock issued for services G&A Warrant valuation Depreciation and amortization expense Total operating expenses Loss from operations Other income (expense): Interest expense Loss on settlement of debt Total other income (expense) Net (loss) Net (loss) attributable to non-controlling interest Net (loss) attributable to common shareholders Basic and diluted loss per share attributable to common shareholders Weighted average number of shares outstanding Statement [Table] Statement [Line Items] Balance Balance, shares Issuance of common stock for prepaid services Issuance of common stock for prepaid services, shares Amortization of prepaid services Issuance of common stock for interest expense Issuance of common stock for interest expense, shares Discount on warrants issued in connection with notes payable Issuance of common stock for legal fees Issuance of common stock for legal fees, shares Issuance of common stock in exchange for debt Issuance of common stock in exchange for debt, shares Issuance of common stock for cash and exercise of warrants Issuance of common stock for cash and exercise of warrants, shares Issuance and modification of stock warrants Net loss Balance Balance, shares Statement of Cash Flows [Abstract] CASH FLOWS FROM OPERATING ACTIVITIES Adjustments to reconcile net loss to net cash flows used in operating activities: Depreciation Amortization Stock issued, and amortization of stock issued, for prepaid services Loss on settlement of debt Stock issued for services Stock issued for legal settlement Stock warrant expense Stock issued for interest Amortization of debt discount Accounts receivable write off Changes in operating assets and liabilities: Accounts payable Accounts receivable Accrued liabilities Prepaid expenses and deposits Net cash used in operating activities 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 Proceeds from issuance of notes payable Net cash provided by financing activities Net increase (decrease) in cash Cash and cash equivalents at beginning of period Cash and cash equivalents at end of period SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION: Cash paid for interest SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING AND FINANCING ACTIVITIES: EX-101.PRE 10 imun-20160930_pre.xml XBRL PRESENTATION FILE XML 11 R1.htm IDEA: XBRL DOCUMENT

Document and Entity Information - shares	9 Months Ended
Document and Entity Information - shares	Sep. 30, 2016	Nov. 14, 2016
Document And Entity Information
Entity Registrant Name	Immune Therapeutics, Inc.
Entity Central Index Key	0001559356
Document Type	10-Q
Document Period End Date	Sep. 30, 2016
Amendment Flag	false
Current Fiscal Year End Date	--12-31
Entity Filer Category	Smaller Reporting Company
Entity Common Stock, Shares Outstanding		241,128,131
Trading Symbol	IMUN
Document Fiscal Period Focus	Q3
Document Fiscal Year Focus	2016

XML 12 R2.htm IDEA: XBRL DOCUMENT

Condensed Consolidated Balance Sheets - USD ($)	Sep. 30, 2016	Dec. 31, 2015
Current Assets:
Cash and cash equivalents	$ 22,152	$ 23,149
Accounts receivable		16,197
Total current assets	22,152	39,346
Fixed Assets:
Computer equipment, net of accumulated depreciation of $7,611 and $6,331 respectively	402	1,682
Deposits	200	200
Total assets	22,754	41,228
Current Liabilities:
Accounts payable	1,516,812	1,924,672
Accrued liabilities	2,397,013	1,281,039
Current portion of notes payable	3,573,698	2,793,701
Total current liabilities	7,487,523	5,999,412
Non-current liabilities:
Notes payable, less current portion
Total non-current liabilities
Total liabilities	7,487,523	5,999,412
Commitments and Contingencies (Note 10)
Stockholders' Deficit:
Common stock - par value $0.0001; 500,000,000 shares authorized; 235,831,298 and 174,850,047 shares issued and outstanding respectively	23,583	17,485
Additional paid in capital	357,436,906	343,434,786
Stock issuances due	845,838	1,140,303
Prepaid services	(1,252,762)	(660,417)
Accumulated deficit	(362,256,392)	(347,789,889)
Deficit attributable to common shareholders	(5,202,827)	(3,857,732)
Non-controlling interest	(2,261,942)	(2,100,452)
Total stockholders' deficit	(7,464,769)	(5,958,184)
Total liabilities and stockholders' deficit	$ 22,754	$ 41,228

XML 13 R3.htm IDEA: XBRL DOCUMENT

Condensed Consolidated Balance Sheets (Parenthetical) - USD ($)	Sep. 30, 2016	Dec. 31, 2015
Statement of Financial Position [Abstract]
Accumulated depreciation	$ 7,611	$ 6,331
Common stock, par value	$ 0.0001	$ 0.0001
Common stock, shares authorized	500,000,000	500,000,000
Common stock, shares issued	235,831,298	174,850,047
Common stock, shares outstanding	235,831,298	174,850,047

XML 14 R4.htm IDEA: XBRL DOCUMENT

Condensed Consolidated Statements of Operations (Unaudited) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2016	Sep. 30, 2015	Sep. 30, 2016	Sep. 30, 2015
Income Statement [Abstract]
Revenues, net		$ 4,958	$ 3,463	$ 12,676
Operating expenses
Selling, general and administrative	1,031,075	865,335	2,864,333	1,689,188
Research and development expense	247,019	111,361	295,438	703,011
Stock issued for services G&A	1,225,353	1,393,500	4,403,951	5,005,393
Warrant valuation	187,850	37,451	2,756,404	37,451
Depreciation and amortization expense	299	148,696	1,280	446,148
Total operating expenses	2,691,596	2,556,343	10,321,406	7,881,191
Loss from operations	(2,691,596)	(2,551,385)	(10,317,943)	(7,868,515)
Other income (expense):
Interest expense	(978,275)	(79,924)	(2,331,296)	(148,681)
Loss on settlement of debt	(274,071)	(1,394,000)	(1,978,754)	(1,482,445)
Total other income (expense)	(1,252,346)	(1,473,924)	(4,310,050)	(1,631,126)
Net (loss)	(3,943,942)	(4,025,309)	(14,627,993)	(9,499,641)
Net (loss) attributable to non-controlling interest	(7,441)	(165,759)	(161,490)	(428,715)
Net (loss) attributable to common shareholders	$ (3,936,501)	$ (3,859,550)	$ (14,466,503)	$ (9,070,926)
Basic and diluted loss per share attributable to common shareholders	$ (0.02)	$ (0.02)	$ (0.07)	$ (0.06)
Weighted average number of shares outstanding	226,843,113	156,814,094	208,399,547	147,365,571

XML 15 R5.htm IDEA: XBRL DOCUMENT

Condensed Consolidated Statements of Stockholders' Deficit (Unaudited) - 9 months ended Sep. 30, 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	$ 2,927	5,417,833	(424,466)	(2,907,535)			2,088,759
Issuance of common stock for prepaid services, shares	29,283,910
Amortization of prepaid services				2,315,190			2,315,190
Issuance of common stock for interest expense	$ 113	191,637					$ 191,750
Issuance of common stock for interest expense, shares	1,121,296						225,000
Discount on warrants issued in connection with notes payable		682,665					$ 682,665
Issuance of common stock for legal fees	$ 15	22,485					22,500
Issuance of common stock for legal fees, shares	150,000
Issuance of common stock in exchange for debt	$ 2,850	4,706,289	155,001				4,864,140
Issuance of common stock in exchange for debt, shares	28,488,545
Issuance of common stock for cash and exercise of warrants	$ 193	224,807	(25,000)				200,000
Issuance of common stock for cash and exercise of warrants, shares	1,937,500
Issuance and modification of stock warrants		2,756,404					2,756,404
Net loss					(14,466,503)	(161,490)	(14,627,993)
Balance at Sep. 30, 2016	$ 23,583	$ 357,436,906	$ 845,838	$ (1,252,762)	$ (362,256,392)	$ (2,261,942)	$ (7,464,769)
Balance, shares at Sep. 30, 2016	235,831,298

XML 16 R6.htm IDEA: XBRL DOCUMENT

Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($)	9 Months Ended
	Sep. 30, 2016	Sep. 30, 2015
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss	$ (14,627,993)	$ (9,499,641)
Adjustments to reconcile net loss to net cash flows used in operating activities:
Depreciation	1,280	1,974
Amortization		444,175
Stock issued, and amortization of stock issued, for prepaid services	2,315,190	3,895,018
Loss on settlement of debt	1,978,754	1,482,444
Stock issued for services	2,111,259	1,029,375
Stock issued for legal settlement		81,000
Stock warrant expense	2,756,404	37,452
Stock issued for interest	191,750	15,625
Amortization of debt discount	727,612
Accounts receivable write off	2,661
Changes in operating assets and liabilities:
Accounts payable	103,155	605,634
Accounts receivable	13,536	(12,676)
Accrued liabilities	2,093,015	31,427
Prepaid expenses and deposits		(15,401)
Net cash used in operating activities	(2,333,377)	(1,903,594)
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	200,000	587,500
Proceeds from issuance of notes payable	2,132,380	1,277,975
Net cash provided by financing activities	2,332,380	1,865,475
Net increase (decrease) in cash	(997)	(38,119)
Cash and cash equivalents at beginning of period	23,149	191,987
Cash and cash equivalents at end of period	22,152	153,868
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION:
Cash paid for interest	18,667	12,000
SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING AND FINANCING ACTIVITIES:
Common stock issued for loan expense and interest	191,750	15,625
Common stock issued for prepaid services	$ 2,088,759	$ 1,029,376

XML 17 R7.htm IDEA: XBRL DOCUMENT

Organization and Description of Business

9 Months Ended

Sep. 30, 2016

Accounting Policies [Abstract]

Organization and Description of Business

1. Organization and Description of Business

Going Concern

XML 18 R8.htm IDEA: XBRL DOCUMENT

Summary of Significant Accounting Policies

9 Months Ended

Sep. 30, 2016

Accounting Policies [Abstract]

Summary of Significant Accounting Policies

2. Summary of Significant Accounting Policies

Basis of Presentation

Use of Estimates

Cash, Cash Equivalents, and Short-Term Investments

Concentration of Credit Risk

Segment and Geographic Information

Fair Value of Financial Instruments

Fair Value Measurements

Property and Equipment

Intangible Assets

Impairment of Long-Lived Assets

Research and Development Costs

Income Taxes

Stock-Based Compensation and Issuance of Stock for Non-Cash Consideration

Non-controlling Interest

Net Loss per Share

A calculation of basic and diluted net loss per share follows:

	For the three months ended September 30,						For the six months ended September 30,
	2016			2015			2016			2015
Net loss per share:
Numerator
Net loss	$	(3,943,942	)	$	(4,025,309	)	$	(14,627,993	)	$	(9,499,641	)
Net loss attributed to Common stockholders	$	(3,936,501	)	$	(3,859,550	)	$	(14,466,503	)	$	(9,070,926	)

Denominator
Weighted-average common shares outstanding—
Denominator for basic and diluted net loss per share		226,843,113			156,814,094			208,399,547			147,365,571
Basic and diluted net loss per share attributed to common stockholders	$	(0.02	)	$	(0.02	)	$	(0.07	)	$	(0.06	)

	As of September 30,
	2016		2015
Warrants to purchase Common stock		32,623,908		9,355,250
		32,623,908		9,355,250

Recent Accounting Standards

The Company qualifies as an “emerging growth company” as defined in Section 101 of the Jumpstart our Business Startups Act (“JOBS Act”) as we do not have more than $1,000,000,000 in annual gross revenue and did not have such amount as of December 31, 2015, our last fiscal year. We are electing to use the extended transition period for complying with new or revised accounting standards under Section 102(b)(1) of the JOBS Act.

XML 19 R9.htm IDEA: XBRL DOCUMENT

Property and Equipment

9 Months Ended

Sep. 30, 2016

Fixed Assets:

Property and Equipment

3. Property and Equipment

	September 30, 2016			December 31, 2015
Property and equipment:
Computer equipment	$	8,013		$	8,013

Less accumulated depreciation		(7,611	)		(6,331	)

Property and equipment, net	$	402		$	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.

XML 20 R10.htm IDEA: XBRL DOCUMENT

Accrued Liabilities

9 Months Ended

Sep. 30, 2016

Payables and Accruals [Abstract]

Accrued Liabilities

4. Accrued Liabilities

Accrued expenses and other liabilities consist of the following:

	September 30, 2016		December 31, 2015
	(in thousands)
Accrued payroll to officers and others	$	934	$	758
Accrued interest and penalties - notes payable		1,319		237
Accrued legal settlements		143		282
Other accrued liabilities		1		4
Total accrued expenses and other liabilities	$	2,397	$	1,281

XML 21 R11.htm IDEA: XBRL DOCUMENT

Notes Payable

9 Months Ended

Sep. 30, 2016

Debt Disclosure [Abstract]

Notes Payable

5. Notes Payable

Notes payable consist of the following:

	September 30, 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 Company’s gross receipts for sales of IRT-103-LDN in perpetuity. Notes will be repaid in 36 monthly installments of principal and interest commencing no later than October 15, 2015. Principal of $425,500 and accrued interest of $37,427 were converted to 5,309,092 shares of common stock in the nine months ended September 30, 2016, Notes aggregating $286,000 were in default at September 30, 2016, as the Company was unable to pay installments on those notes on their due dates. No demands for repayment have been made by the lenders.		286,000		711,500

Promissory note issued October 17, 2014 to Roger Bozarth. The note matures on October 17, 2015 and earns interest at a rate of 2% per annum. The lender converted this note and $2,139 in accrued interest to 114,237 shares of common stock in January 2016.		-		7,000

Promissory notes issued between May 1, 2015 and September 30, 2016, and maturing between June 14, 2015 and June 30, 2017. Lenders on loans aggregating $535,994 earn interest at rates between 10% and 18% per annum. On loans aggregating $198,500, interest is payable in a fixed amount not tied to a specific interest rate. Notes aggregating $198,500 were in default at September 30, 2016, as the Company was unable to repay those notes on their due dates. No demands for repayment have been made by the lenders.		734,494		669,933

Promissory note issued January 26, 2015 to Robert J. Dailey. The note is senior to, and has priority in right of payment over, all indebtedness of the Company. The note earns interest at a rate of 2% per annum and was due on July 30, 2015. Principal of $200,000 and accrued interest of $4,778 was converted to 3,722,015 shares of common stock in the nine months ending September 30, 2016.		-		200,000

Promissory notes issued by Cytocom Inc. between April 29, 2015 and December 31, 2015. Lenders earn interest at rates between 5% and 10% per annum. These notes mature on September 30, 2016. $375,000 of principal and $12,036 in accrued interest was converted to 4,837,960 shares of common stock in the nine months ending September 30, 2016. The Company was unable to repay the remaining notes at maturity and the notes are in default, although no demand for repayment has been made by the lenders.		425,000		800,000

Promissory notes issued in December 2015. Lenders earn interest at a rate of 10% per month. Notes are repayable on March 9, 2016. . $30,000 of principal and $49,000 of interest and penalties were converted to 987,500 shares of common stock in the nine months ended September 30, 2016. The Company was unable to repay the remaining note at maturity and the note is in default The Company is obligated to pay late-payment penalties totaling $5,000 per day on the remaining obligation.		100,000		130,000

Promissory note issued November 24, 2015 as settlement of amounts owing to a law firm. The Lender earns interest at the rate of 10% per annum. The note and $10,036 in interest was converted to 1,235,536 shares of common stock in July 2016.		-			175,268

Promissory notes issued between May 5, 2016 and June 2, 2016 that mature between October 1, 2016 and January 31, 2017, and include stock conversion features, warrants and original issue debt discounts. Notes aggregating $305,000 were in default at November 14, 2016. No demand for repayment has been made by the lenders.		555,000			-

Promissory notes issued to an officer of the Company effective November 3, 2015 and maturing November 3, 2016 for settlement of accrued payroll, bearing interest at 10% per annum and including a stock conversion feature.		112,737			-

Promissory note issued in July 2016. The note is repayable on October 5, 2016. The note earns interest at 6% per month. The Company was unable to repay the note at maturity and the note is in default.		50,000			-

Promissory note dated April 2016, issued to JM Financial (“JMJ”), pursuant to which JMJ loaned the Company $525,000 and was issued the promissory note, 500,000 shares of common stock, and a warrant exercisable for 3,515,621 additional common shares at a rate of $0.14 per share. The note matures on January 6, 2017. The note was repaid on November 4, 2016.		656,250			-

Promissory note issued in July 2016 with an original issuance discount of $30,000. Net proceeds were $150,000. The note is repayable on April 7, 2017.		180,000			-

Promissory notes issued in August 2016 for $149,854 as a settlement of amounts owed to a law firm. The notes accrue interest at 5% per annum and are payable in 18 equal monthly installments of $8,641.88.		146,912			-

Promissory notes issued between July 1, 2016 and September 30, 2016. Lenders earn interest at 12% per annum. The notes mature between January 1, 2017 and March 31, 2017.		495,000			-

Less: Original issue discounts on notes payable and warrants issued with notes.		(267,695	)		-

Total		3,573,698			2,793,701

Less: Current Portion	$	(3,573,698	)	$	(2,793,701	)

Long-Term debt, less current portion	$	-		$	-

XML 22 R12.htm IDEA: XBRL DOCUMENT

Capital Structure - Common Stock and Common Stock Purchase Warrants

9 Months Ended

Sep. 30, 2016

Equity [Abstract]

Capital Structure - Common Stock and Common Stock Purchase Warrants

6. Capital Structure—Common Stock and Common Stock Purchase Warrants

As of September 30, 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 September 30, 2016, the Company had 235,831,298 shares of common stock outstanding, and 174,850,047 outstanding as of December 31, 2015.

Stock Warrants

In the quarter ended September 30, 2016, the Company issued 2,000,000 warrants.

There were no modifications of the terms of any warrants issued by the Company in the quarter ended September 30, 2015.

Following is a summary of outstanding stock warrants at September 30, 2016 and activity during the nine 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		25,654,908		$	0.14-2.00	$	0.31

Expired		(162,500	)	$	5.00	$	5.00

Exercised		(0	)	$	0	$	0

Warrants as of September 30, 2016		34,623,908		$	0.07-15.00	$	0..50

Summary of outstanding warrants as of September 30, 2016:

Expiration Date	Number of Shares		Exercise Price		Remaining Life (years)

Fourth Quarter 2017		350,000	$	1.50-9.00		1.25
First Quarter 2018		127,500	$	15.00		1.50
Second Quarter 2018		33,334	$	15.00		1.75
Third Quarter 2018		250,000	$	1.50		2.00
Fourth Quarter 2018		6,089,166	$	1.00-1.50		2.25
First Quarter 2019		4,024,000	$	0.50-2.00		2.50
Second Quarter 2019		135,000	$	0.07–0.23		2.75
Third Quarter 2019		260,000	$	0.50-1.50		3.00
Fourth Quarter 2019		400,000	$	0.14		3.25
Second Quarter 2020		300,000	$	0.50		3.75
Fourth Quarter 2020		1,000,000	$	0.20		4.00
First Quarter 2021		12,650,000	$	0.20		4.25
Second Quarter 2021		6,004,908	$	0.10-0.20		4.50
Third Quarter 2021		3,000,000	$	0.20		4.75

XML 23 R13.htm IDEA: XBRL DOCUMENT

Stock Compensation

9 Months Ended

Sep. 30, 2016

Disclosure of Compensation Related Costs, Share-based Payments [Abstract]

Stock Compensation

7. Stock Compensation

Shares Issued for Services

- Definition

The entire disclosure for compensation-related costs for equity-based compensation, which may include disclosure of policies, compensation plan details, allocation of equity compensation, incentive distributions, equity-based arrangements to obtain goods and services, deferred compensation arrangements, employee stock ownership plan details and employee stock purchase plan details.

+ References+ Details

XML 24 R14.htm IDEA: XBRL DOCUMENT

Income Taxes - Results of Operations

9 Months Ended

Sep. 30, 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 September 30, 2016 and 2015 because the Company incurred a net loss in both quarters.

As of December 31, 2015, the Company has estimated federal and state income tax net operating loss (“NOL”) carry-forwards of approximately $66,500,000, which will expire in 2032-2035.

XML 25 R15.htm IDEA: XBRL DOCUMENT

Licenses and Supply Agreements

9 Months Ended

Sep. 30, 2016

Licenses And Supply Agreements

Licenses and Supply Agreements

9. Licenses and Supply Agreements

Patent and Subsidiary Acquisition

XML 26 R16.htm IDEA: XBRL DOCUMENT

Commitments and Contingencies

9 Months Ended

Sep. 30, 2016

Commitments and Contingencies Disclosure [Abstract]

Commitments and Contingencies

10. Commitments and Contingencies

Distribution of Lodonal^TM in Nigeria

Other Distribution Agreements

Contract Manufacturing Agreements

Operating Leases

Legal Proceedings

None.

XML 27 R17.htm IDEA: XBRL DOCUMENT

Subsequent Events

9 Months Ended

Sep. 30, 2016

Subsequent Events [Abstract]

Subsequent Events

11. Subsequent Events

In October 2016, the company borrowed an additional $165,000.

In October 2016, the Company issued 1,300,000 shares of common stock for consulting services.

In October 2016, the company issued 300,000 shares of common stock for lending fees.

As of November 14, 2016, the Company had outstanding 241,128,131 shares of common stock.

XML 28 R18.htm IDEA: XBRL DOCUMENT

Summary of Significant Accounting Policies (Policies)

9 Months Ended

Sep. 30, 2016

Accounting Policies [Abstract]

Basis of Presentation

Basis of Presentation

Use of Estimates

Use of Estimates

Cash, Cash Equivalents, and Short-term Investments

Cash, Cash Equivalents, and Short-Term Investments

Concentration of Credit Risk

Concentration of Credit Risk

Segment and Geographic Information

Segment and Geographic Information

Fair Value of Financial Instruments

Fair Value of Financial Instruments

Fair Value Measurements

Fair Value Measurements

Property and Equipment

Property and Equipment

Intangible Assets

Intangible Assets

Impairment of Long-lived Assets

Impairment of Long-Lived Assets

Research and Development Costs

Research and Development Costs

Income Taxes

Income Taxes

Stock-Based Compensation and Issuance of Stock for Non-Cash Consideration

Stock-Based Compensation and Issuance of Stock for Non-Cash Consideration

Non-controlling Interest

Non-controlling Interest

Net Loss Per Share

Net Loss per Share

A calculation of basic and diluted net loss per share follows:

	For the three months ended September 30,						For the six months ended September 30,
	2016			2015			2016			2015
Net loss per share:
Numerator
Net loss	$	(3,943,942	)	$	(4,025,309	)	$	(14,627,993	)	$	(9,499,641	)
Net loss attributed to Common stockholders	$	(3,936,501	)	$	(3,859,550	)	$	(14,466,503	)	$	(9,070,926	)

Denominator
Weighted-average common shares outstanding—
Denominator for basic and diluted net loss per share		226,843,113			156,814,094			208,399,547			147,365,571
Basic and diluted net loss per share attributed to common stockholders	$	(0.02	)	$	(0.02	)	$	(0.07	)	$	(0.06	)

	As of September 30,
	2016		2015
Warrants to purchase Common stock		32,623,908		9,355,250
		32,623,908		9,355,250

Recent Accounting Standards

Recent Accounting Standards

The Company qualifies as an “emerging growth company” as defined in Section 101 of the Jumpstart our Business Startups Act (“JOBS Act”) as we do not have more than $1,000,000,000 in annual gross revenue and did not have such amount as of December 31, 2015, our last fiscal year. We are electing to use the extended transition period for complying with new or revised accounting standards under Section 102(b)(1) of the JOBS Act.

XML 29 R19.htm IDEA: XBRL DOCUMENT

Summary of Significant Accounting Policies (Tables)

9 Months Ended

Sep. 30, 2016

Accounting Policies [Abstract]

Schedule of Basic and Diluted Net Loss Per Share

A calculation of basic and diluted net loss per share follows:

	For the three months ended September 30,						For the six months ended September 30,
	2016			2015			2016			2015
Net loss per share:
Numerator
Net loss	$	(3,943,942	)	$	(4,025,309	)	$	(14,627,993	)	$	(9,499,641	)
Net loss attributed to Common stockholders	$	(3,936,501	)	$	(3,859,550	)	$	(14,466,503	)	$	(9,070,926	)

Denominator
Weighted-average common shares outstanding—
Denominator for basic and diluted net loss per share		226,843,113			156,814,094			208,399,547			147,365,571
Basic and diluted net loss per share attributed to common stockholders	$	(0.02	)	$	(0.02	)	$	(0.07	)	$	(0.06	)

Schedule of Antidilutive Securities

	As of September 30,
	2016		2015
Warrants to purchase Common stock		32,623,908		9,355,250
		32,623,908		9,355,250

XML 30 R20.htm IDEA: XBRL DOCUMENT

Property and Equipment (Tables)

9 Months Ended

Sep. 30, 2016

Fixed Assets:

Schedule of Property and Equipment

	September 30, 2016			December 31, 2015
Property and equipment:
Computer equipment	$	8,013		$	8,013

Less accumulated depreciation		(7,611	)		(6,331	)

Property and equipment, net	$	402		$	1,682

XML 31 R21.htm IDEA: XBRL DOCUMENT

Accrued Liabilities (Tables)

9 Months Ended

Sep. 30, 2016

Payables and Accruals [Abstract]

Schedule of Accrued Liabilities

Accrued expenses and other liabilities consist of the following:

	September 30, 2016		December 31, 2015
	(in thousands)
Accrued payroll to officers and others	$	934	$	758
Accrued interest and penalties - notes payable		1,319		237
Accrued legal settlements		143		282
Other accrued liabilities		1		4
Total accrued expenses and other liabilities	$	2,397	$	1,281

XML 32 R22.htm IDEA: XBRL DOCUMENT

Notes Payable (Tables)

9 Months Ended

Sep. 30, 2016

Debt Disclosure [Abstract]

Schedule of Notes Payable

Notes payable consist of the following:

	September 30, 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 Company’s gross receipts for sales of IRT-103-LDN in perpetuity. Notes will be repaid in 36 monthly installments of principal and interest commencing no later than October 15, 2015. Principal of $425,500 and accrued interest of $37,427 were converted to 5,309,092 shares of common stock in the nine months ended September 30, 2016, Notes aggregating $286,000 were in default at September 30, 2016, as the Company was unable to pay installments on those notes on their due dates. No demands for repayment have been made by the lenders.		286,000		711,500

Promissory note issued October 17, 2014 to Roger Bozarth. The note matures on October 17, 2015 and earns interest at a rate of 2% per annum. The lender converted this note and $2,139 in accrued interest to 114,237 shares of common stock in January 2016.		-		7,000

Promissory notes issued between May 1, 2015 and September 30, 2016, and maturing between June 14, 2015 and June 30, 2017. Lenders on loans aggregating $535,994 earn interest at rates between 10% and 18% per annum. On loans aggregating $198,500, interest is payable in a fixed amount not tied to a specific interest rate. Notes aggregating $198,500 were in default at September 30, 2016, as the Company was unable to repay those notes on their due dates. No demands for repayment have been made by the lenders.		734,494		669,933

Promissory note issued January 26, 2015 to Robert J. Dailey. The note is senior to, and has priority in right of payment over, all indebtedness of the Company. The note earns interest at a rate of 2% per annum and was due on July 30, 2015. Principal of $200,000 and accrued interest of $4,778 was converted to 3,722,015 shares of common stock in the nine months ending September 30, 2016.		-		200,000

Promissory notes issued by Cytocom Inc. between April 29, 2015 and December 31, 2015. Lenders earn interest at rates between 5% and 10% per annum. These notes mature on September 30, 2016. $375,000 of principal and $12,036 in accrued interest was converted to 4,837,960 shares of common stock in the nine months ending September 30, 2016. The Company was unable to repay the remaining notes at maturity and the notes are in default, although no demand for repayment has been made by the lenders.		425,000		800,000

Promissory notes issued in December 2015. Lenders earn interest at a rate of 10% per month. Notes are repayable on March 9, 2016. . $30,000 of principal and $49,000 of interest and penalties were converted to 987,500 shares of common stock in the nine months ended September 30, 2016. The Company was unable to repay the remaining note at maturity and the note is in default The Company is obligated to pay late-payment penalties totaling $5,000 per day on the remaining obligation.		100,000		130,000

Promissory note issued November 24, 2015 as settlement of amounts owing to a law firm. The Lender earns interest at the rate of 10% per annum. The note and $10,036 in interest was converted to 1,235,536 shares of common stock in July 2016.		-			175,268

Promissory notes issued between May 5, 2016 and June 2, 2016 that mature between October 1, 2016 and January 31, 2017, and include stock conversion features, warrants and original issue debt discounts. Notes aggregating $305,000 were in default at November 14, 2016. No demand for repayment has been made by the lenders.		555,000			-

Promissory notes issued to an officer of the Company effective November 3, 2015 and maturing November 3, 2016 for settlement of accrued payroll, bearing interest at 10% per annum and including a stock conversion feature.		112,737			-

Promissory note issued in July 2016. The note is repayable on October 5, 2016. The note earns interest at 6% per month. The Company was unable to repay the note at maturity and the note is in default.		50,000			-

Promissory note dated April 2016, issued to JM Financial (“JMJ”), pursuant to which JMJ loaned the Company $525,000 and was issued the promissory note, 500,000 shares of common stock, and a warrant exercisable for 3,515,621 additional common shares at a rate of $0.14 per share. The note matures on January 6, 2017. The note was repaid on November 4, 2016.		656,250			-

Promissory note issued in July 2016 with an original issuance discount of $30,000. Net proceeds were $150,000. The note is repayable on April 7, 2017.		180,000			-

Promissory notes issued in August 2016 for $149,854 as a settlement of amounts owed to a law firm. The notes accrue interest at 5% per annum and are payable in 18 equal monthly installments of $8,641.88.		146,912			-

Promissory notes issued between July 1, 2016 and September 30, 2016. Lenders earn interest at 12% per annum. The notes mature between January 1, 2017 and March 31, 2017.		495,000			-

Less: Original issue discounts on notes payable and warrants issued with notes.		(267,695	)		-

Total		3,573,698			2,793,701

Less: Current Portion	$	(3,573,698	)	$	(2,793,701	)

Long-Term debt, less current portion	$	-		$	-

XML 33 R23.htm IDEA: XBRL DOCUMENT

Capital Structure - Common Stock and Common Stock Purchase Warrants (Tables)

9 Months Ended

Sep. 30, 2016

Accounting Policies [Abstract]

Schedule of Outstanding Stock Warrants

Following is a summary of outstanding stock warrants at September 30, 2016 and activity during the nine 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		25,654,908		$	0.14-2.00	$	0.31

Expired		(162,500	)	$	5.00	$	5.00

Exercised		(0	)	$	0	$	0

Warrants as of September 30, 2016		34,623,908		$	0.07-15.00	$	0..50

Summary of Outstanding Warrants

Summary of outstanding warrants as of September 30, 2016:

Expiration Date	Number of Shares		Exercise Price		Remaining Life (years)

Fourth Quarter 2017		350,000	$	1.50-9.00		1.25
First Quarter 2018		127,500	$	15.00		1.50
Second Quarter 2018		33,334	$	15.00		1.75
Third Quarter 2018		250,000	$	1.50		2.00
Fourth Quarter 2018		6,089,166	$	1.00-1.50		2.25
First Quarter 2019		4,024,000	$	0.50-2.00		2.50
Second Quarter 2019		135,000	$	0.07–0.23		2.75
Third Quarter 2019		260,000	$	0.50-1.50		3.00
Fourth Quarter 2019		400,000	$	0.14		3.25
Second Quarter 2020		300,000	$	0.50		3.75
Fourth Quarter 2020		1,000,000	$	0.20		4.00
First Quarter 2021		12,650,000	$	0.20		4.25
Second Quarter 2021		6,004,908	$	0.10-0.20		4.50
Third Quarter 2021		3,000,000	$	0.20		4.75

- Definition

Tabular disclosure of warrants or rights issued. Warrants and rights outstanding are derivative securities that give the holder the right to purchase securities (usually equity) from the issuer at a specific price within a certain time frame. Warrants are often included in a new debt issue to entice investors by a higher return potential. The main difference between warrants and call options is that warrants are issued and guaranteed by the company, whereas options are exchange instruments and are not issued by the company. Also, the lifetime of a warrant is often measured in years, while the lifetime of a typical option is measured in months. Disclose the title of issue of securities called for by warrants and rights outstanding, the aggregate amount of securities called for by warrants and rights outstanding, the date from which the warrants or rights are exercisable, and the price at which the warrant or right is exercisable.

+ References+ Details

XML 34 R24.htm IDEA: XBRL DOCUMENT

Organization and Description of Business (Details Narrative) - USD ($)		1 Months Ended	3 Months Ended		9 Months Ended		12 Months Ended
	Dec. 08, 2014	Sep. 30, 2014	Sep. 30, 2016	Sep. 30, 2015	Sep. 30, 2016	Sep. 30, 2015	Dec. 31, 2013	Dec. 31, 2015
Net loss			$ (3,943,942)	$ (4,025,309)	$ (14,627,993)	$ (9,499,641)
Cash equivalents			2,333,377		2,333,377
Stockholders equity			$ (7,464,769)		$ (7,464,769)			$ (5,958,184)
Cytocom Inc., [Member]
Number of shares issued during period	113,242,522						140,100,000
Percentage of stake issued during period	55.30%				17.00%
Irish Limited Liability [Member]
Percentage of low corporate income tax rate		12.50%

XML 35 R25.htm IDEA: XBRL DOCUMENT

Summary of Significant Accounting Policies (Details Narrative) - USD ($)	9 Months Ended		12 Months Ended
	Sep. 30, 2016	Sep. 30, 2015	Dec. 31, 2015	Dec. 31, 2014
Maximum of annual gross revenue			$ 1,000,000,000
Federal deposit insurance corporation value	$ 250,000
Depreciation expense	1,280	$ 1,974
Impairment loss
Amortization expense	$ 0	$ 444,175
LDN [Member]
Impairment loss			$ 5,226,352
MENK [Member]
Impairment loss				$ 9,908,477
Minimum [Member]
Property and equipment useful lives	1 year
Minimum [Member] \| Property and Equipment [Member]
Property and equipment useful lives	3 years
Maximum [Member]
Property and equipment useful lives	5 years
Maximum [Member] \| Property and Equipment [Member]
Property and equipment useful lives	5 years

XML 36 R26.htm IDEA: XBRL DOCUMENT

Summary of Significant Accounting Policies - Schedule of Basic and Diluted Net Loss Per Share (Details) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2016	Sep. 30, 2015	Sep. 30, 2016	Sep. 30, 2015
Accounting Policies [Abstract]
Numerator, Net loss	$ (3,943,942)	$ (4,025,309)	$ (14,627,993)	$ (9,499,641)
Numerator, Net loss attributed to Common stockholders	$ (3,936,501)	$ (3,859,550)	$ (14,466,503)	$ (9,070,926)
Denominator, Weighted-average common shares outstanding-Denominator for basic and diluted net loss per share	226,843,113	156,814,094	208,399,547	147,365,571
Denominator, Basic and diluted net loss per share attributed to common stockholders	$ (0.02)	$ (0.02)	$ (0.07)	$ (0.06)

XML 37 R27.htm IDEA: XBRL DOCUMENT

Summary of Significant Accounting Policies - Schedule of Antidilutive Securities (Details) - shares	9 Months Ended
	Sep. 30, 2016	Sep. 30, 2015
Potentially dilutive securities	32,623,908	9,355,250
Warrants To Purchase Common Stock [Member]
Potentially dilutive securities	32,623,908	9,355,250

XML 38 R28.htm IDEA: XBRL DOCUMENT

Property and Equipment (Details Narrative)	9 Months Ended
Property and Equipment (Details Narrative)	Sep. 30, 2016
Minimum [Member]
Depreciable asset lives	1 year
Maximum [Member]
Depreciable asset lives	5 years

XML 39 R29.htm IDEA: XBRL DOCUMENT

Property and Equipment - Schedule of Property and Equipment (Details) - USD ($)	Sep. 30, 2016	Dec. 31, 2015
Fixed Assets:
Computer equipment	$ 8,013	$ 8,013
Less accumulated depreciation	(7,611)	(6,331)
Property and equipment, net	$ 402	$ 1,682

XML 40 R30.htm IDEA: XBRL DOCUMENT

Accrued Liabilities - Schedule of Accrued Liabilities (Details) - USD ($)	Sep. 30, 2016	Dec. 31, 2015
Payables and Accruals [Abstract]
Accrued payroll to officers and others	$ 934,000	$ 758,000
Accrued interest and penalties - notes payable	1,319,000	237,000
Accrued legal settlements	143,000	282,000
Other accrued liabilities	1,000	4,000
Total accrued expenses and other liabilities	$ 2,397,000	$ 1,281,000

XML 41 R31.htm IDEA: XBRL DOCUMENT

Notes Payable (Details Narrative) - USD ($)	3 Months Ended	9 Months Ended	12 Months Ended
Notes Payable (Details Narrative) - USD ($)	Sep. 30, 2016	Sep. 30, 2016	Dec. 31, 2015
Debt Disclosure [Abstract]
Accrued unpaid interest		$ 278,089	$ 217,717
Penalties		$ 1,041,502	$ 18,954
Issuance of common stock for interest expense, shares	225,000
Issuance of common stock for interest expense	$ 42,750

XML 42 R32.htm IDEA: XBRL DOCUMENT

Notes Payable - Schedule of Notes Payable (Details) - USD ($)	Sep. 30, 2016	Jul. 31, 2016	Dec. 31, 2015
Total	$ (267,695)		$ 2,793,701
Less: Original issue discounts on notes payable and warrants issued with notes	3,573,698	$ 30,000
Less: Current portion	(3,573,698)		(2,793,701)
Long-Term debt, less current portion
Notes Payable One [Member]
Total	100,000		100,000
Notes Payable Two [Member]
Total	286,000		711,500
Notes Payable Three [Member]
Total			7,000
Notes Payable Four [Member]
Total	734,494		669,933
Notes Payable Five [Member]
Total			200,000
Notes Payable Six [Member]
Total	425,000		800,000
Notes Payable Seven [Member]
Total	100,000		130,000
Notes Payable Eight [Member]
Total			175,268
Notes Payable Nine [Member]
Total	555,000
Notes Payable Ten [Member]
Total	112,737
Notes Payable Eleven [Member]
Total	50,000
Notes Payable Twelve [Member]
Total	656,250
Notes Payable Thirteen [Member]
Total	180,000
Notes Payable Fourteen [Member]
Total	146,912
Notes Payable Fifteen [Member]
Total	$ 495,000

XML 43 R33.htm IDEA: XBRL DOCUMENT

Notes Payable - Schedule of Notes Payable (Details) (Parenthetical)												1 Months Ended	3 Months Ended	9 Months Ended		10 Months Ended
	Aug. 31, 2016 USD ($) Installments	Jul. 31, 2016 USD ($)	Jun. 02, 2016	May 05, 2016 USD ($)	Apr. 30, 2016 USD ($) $ / shares shares	Jan. 31, 2016 USD ($) shares	Nov. 24, 2015 USD ($) shares	Nov. 03, 2015	Jan. 26, 2015 USD ($) shares	Oct. 17, 2014	Jul. 29, 2014	Dec. 31, 2015 USD ($)	Sep. 30, 2016 USD ($) shares	Sep. 30, 2016 USD ($) shares	Sep. 30, 2015 USD ($)	Sep. 30, 2015 USD ($) Installments
Note matures date		Apr. 07, 2017						Nov. 03, 2016
Percentage of interest rate per annum	5.00%	6.00%						10.00%							10.00%	10.00%
Maximum amount raise in debt	$ 149,854			$ 305,000											$ 2,000,000	$ 2,000,000
Number of installments, months \| Installments	18															36
Debt instrument, periodic payment, principal	$ 8,642
Notes aggregating default amount													$ 0	$ 0
Debt instrument maturity date description			October 1, 2016 and January 31, 2017	October 1, 2016 and January 31, 2017
Value of notes that converted into shares													$ 42,750
Notes and interest converted into shares \| shares													225,000
Original issuance discount		$ 30,000											$ 3,573,698	3,573,698
Proceeds from issuance of debt		$ 150,000												$ 2,132,380	$ 1,277,975
Lender [Member]
Percentage of interest rate per annum													12.00%	12.00%
Debt instrument maturity date description													mature between January 1, 2017 and March 31, 2017
JM Financial [Member]
Note matures date					Jan. 06, 2017
Notes and interest converted into shares \| shares					500,000
Aggregating loan					$ 525,000
Warrant exercisable \| shares					3,515,621
Price per share \| $ / shares					$ 0.14
Minimum [Member] \| Cytocom Inc., [Member]
Percentage of interest rate per annum													5.00%	5.00%
Maximum [Member] \| Cytocom Inc., [Member]
Percentage of interest rate per annum													10.00%	10.00%
December Thirty First Two Thousand Fifteen [Member] \| Cytocom Inc., [Member]
Note matures date														Sep. 30, 2016
Debt instrument, periodic payment, principal														$ 375,000
Value of notes that converted into shares														$ 12,036
Notes and interest converted into shares \| shares														4,837,960
Ira Gaines [Member]
Note matures date											Jan. 27, 2015
Percentage of interest rate per annum											18.00%
Lender [Member]
Debt instrument, periodic payment, principal														$ 425,500
Notes aggregating default amount													$ 286,000	286,000
Accrued interest						$ 2,139							$ 37,427	$ 37,427
Notes and interest converted into shares \| shares						114,237								5,309,092
Lender [Member] \| Minimum [Member]
Percentage of interest rate per annum													10.00%	10.00%
Lender [Member] \| Maximum [Member]
Percentage of interest rate per annum													18.00%	18.00%
Lender [Member] \| May 1, 2015 [Member]
Note matures date														Jun. 30, 2017
Aggregating loan													$ 535,994	$ 535,994
Interest payable													198,500	198,500
Roger Bozarth [Member]
Note matures date										Oct. 17, 2015
Percentage of interest rate per annum										2.00%
Lenders [Member]
Notes aggregating default amount													198,500	198,500
Robert J. Dailey [Member]
Note matures date									Jul. 30, 2015
Percentage of interest rate per annum									2.00%
Debt instrument, periodic payment, principal									$ 200,000
Accrued interest									$ 4,778
Notes and interest converted into shares \| shares									3,722,015
Lender [Member]
Note matures date												Mar. 09, 2016
Percentage of interest rate per annum												10.00%
Debt instrument, periodic payment, principal														30,000
Accrued interest													49,000	$ 49,000
Notes and interest converted into shares \| shares														987,500
Pay late-payment penalties per day													$ 5,000	$ 5,000
Lender [Member]
Percentage of interest rate per annum							10.00%
Value of notes that converted into shares							$ 10,536
Notes and interest converted into shares \| shares							1,235,356

XML 44 R34.htm IDEA: XBRL DOCUMENT

Capital Structure - Common Stock and Common Stock Purchase Warrants (Details Narrative) - $ / shares	9 Months Ended
	Sep. 30, 2016	Dec. 31, 2015	Sep. 30, 2015
Equity [Abstract]
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	235,831,298	174,850,047
Common Stock, Shares Outstanding	235,831,298	174,850,047
Number of warrants issued during period	2,000,000

XML 45 R35.htm IDEA: XBRL DOCUMENT

Capital Structure - Common Stock and Common Stock Purchase Warrants - Schedule of Outstanding Stock Warrants (Details) - Warrant [Member]	9 Months Ended
	Sep. 30, 2016 $ / shares shares
Warrants, Number of shares Beginning balance \| shares	9,131,500
Warrants, Number of shares Issued \| shares	25,654,908
Warrants, Number of shares Expired \| shares	(162,500)
Warrants, Number of shares Exercised \| shares	0
Warrants, Number of shares Ending balance \| shares	34,623,908
Exercise Price, Expired	$ 5.00
Exercise Price, Exercised	0
Weighted average exercise price, Beginning balance	1.47
Weighted average exercise price, Issued	0.31
Weighted average exercise price, Expired	5.00
Weighted average exercise price, Exercised	0
Weighted average exercise price, Ending balance	0.50
Minimum [Member]
Exercise Price, Beginning balance	0.07
Exercise Price, Issued	0.14
Exercise Price, Ending balance	0.07
Maximum [Member]
Exercise Price, Beginning balance	15.00
Exercise Price, Issued	2.00
Exercise Price, Ending balance	$ 15.00

XML 46 R36.htm IDEA: XBRL DOCUMENT

Capital Structure - Common Stock and Common Stock Purchase Warrants - Summary of Outstanding Warrants (Details)	9 Months Ended
	Sep. 30, 2016 $ / shares shares
Fourth Quarter 2017 [Member]
Number of Shares \| shares	350,000
Exercise Price Lower Limit	$ 1.50
Exercise Price Upper Limit	$ 9.00
Remaining Life (years)	1 year 3 months
First Quarter 2018 [Member]
Number of Shares \| shares	127,500
Exercise Price Lower Limit	$ 15.00
Remaining Life (years)	1 year 6 months
Second Quarter 2018 [Member]
Number of Shares \| shares	33,334
Exercise Price Lower Limit	$ 15.00
Remaining Life (years)	1 year 9 months
Third Quarter 2018 [Member]
Number of Shares \| shares	250,000
Exercise Price Lower Limit	$ 1.50
Remaining Life (years)	2 years
Fourth Quarter 2018 [Member]
Number of Shares \| shares	6,089,166
Exercise Price Lower Limit	$ 1.00
Exercise Price Upper Limit	$ 1.50
Remaining Life (years)	2 years 3 months
First Quarter 2019 [Member]
Number of Shares \| shares	4,024,000
Exercise Price Lower Limit	$ 0.50
Exercise Price Upper Limit	$ 2.00
Remaining Life (years)	2 years 6 months
Second Quarter 2019 [Member]
Number of Shares \| shares	135,000
Exercise Price Lower Limit	$ 0.07
Exercise Price Upper Limit	$ 0.23
Remaining Life (years)	2 years 9 months
Third Quarter 2019 [Member]
Number of Shares \| shares	260,000
Exercise Price Lower Limit	$ 0.50
Exercise Price Upper Limit	$ 1.50
Remaining Life (years)	3 years
Fourth Quarter 2019 [Member]
Number of Shares \| shares	400,000
Exercise Price Lower Limit	$ 0.14
Remaining Life (years)	3 years 3 months
Second Quarter 2020 [Member]
Number of Shares \| shares	300,000
Exercise Price Lower Limit	$ 0.50
Remaining Life (years)	3 years 9 months
Fourth Quarter 2020 [Member]
Number of Shares \| shares	1,000,000
Exercise Price Lower Limit	$ 0.20
Remaining Life (years)	4 years
First Quarter 2021 [Member]
Number of Shares \| shares	12,650,000
Exercise Price Lower Limit	$ 0.20
Remaining Life (years)	4 years 3 months
Second Quarter 2021 [Member]
Number of Shares \| shares	6,004,908
Exercise Price Lower Limit	$ 0.10
Exercise Price Upper Limit	$ 0.20
Remaining Life (years)	4 years 6 months
Third Quarter 2021 [Member]
Number of Shares \| shares	3,000,000
Exercise Price Lower Limit	$ 0.20
Remaining Life (years)	4 years 9 months

XML 47 R37.htm IDEA: XBRL DOCUMENT

Stock Compensation (Details Narrative) - USD ($)	9 Months Ended
Stock Compensation (Details Narrative) - USD ($)	Sep. 30, 2016	Sep. 30, 2015
Number of common stock issued for consulting fees	29,283,910	16,922,504
Fair value of common stock	$ 5,420,760	$ 1,029,375
Amortization of prepaid services	2,315,190	$ 3,895,018
Stock issued during period, value, issued for services	$ 2,088,759
Minimum [Member]
Consulting fees amortized period	12 months
Maximum [Member]
Consulting fees amortized period	24 months

XML 48 R38.htm IDEA: XBRL DOCUMENT

Income Taxes - Results of Operations (Details Narrative) - USD ($)	12 Months Ended
	Dec. 31, 2015	Dec. 31, 2013
Income Tax Disclosure [Abstract]
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.

XML 49 R39.htm IDEA: XBRL DOCUMENT

Commitments and Contingencies (Details Narrative) - USD ($)	9 Months Ended
	Sep. 30, 2016	Sep. 30, 2015
Initial supply, description	Through its wholly-owned subsidiary, TNI BioTech International, Ltd., in December 2015 the Company completed a 90-day bridging trial for the treatment of patients with HIV/AIDS. The trial consisted of a total of 150 patients of both genders between the ages of 18-60, each of whom was infected HIV/AIDS. The primary objective of this bridging trial was to confirm that LodonalTM has a beneficial effect on the immune system of immune deficient patients and that it is safe. The trial separated patients into a Control (placebo) Group and a Treatment Group (which was administered LodonalTM). The efficacy of increasing CD4 count [cell/mm3] between Day-1 and Day-90 by at least 25% was set as the criteria for demonstrating beneficial effect on the immune system. Safety was demonstrated through quality of life assessment and vitals both of which were not adversely affected. Treatment Group patients were given a daily dose of 4.5-mg/kg of Lodonal.
Initial capital to venture	$ 1,000
Percentage of allocated income from venture	25.00%
Orlando, Florida [Member]
Cash rental expense	$ 4,009	$ 4,988
Complete Pharmacy and Medical Solutions, LLC [Member]
Percentage of allocated income from venture	100.00%

XML 50 R40.htm IDEA: XBRL DOCUMENT

Subsequent Events (Details Narrative) - USD ($)						9 Months Ended
Subsequent Events (Details Narrative) - USD ($)	Nov. 02, 2016	Oct. 31, 2016	Oct. 25, 2016	Jul. 31, 2016	Nov. 03, 2015	Sep. 30, 2016	Sep. 30, 2015	Nov. 14, 2016	Aug. 31, 2016	May 05, 2016	Dec. 31, 2015
Debt instrument, face amount							$ 2,000,000		$ 149,854	$ 305,000
Maturity date				Apr. 07, 2017	Nov. 03, 2016
Consulting services						29,283,910	16,922,504
Proceeds from issuance of debt				$ 150,000		$ 2,132,380	$ 1,277,975
Common stock, shares outstanding						235,831,298					174,850,047
Subsequent Event [Member]
Repayments of debt		$ 50,000
Debt instrument, face amount	$ 750,000	100,000
Common stock, shares issued			500,000
Interest rate	2.00%
Maturity date	Nov. 01, 2017
Borrowings		$ 165,000
Consulting services		1,300,000
Lending fees		300,000
Proceeds from issuance of debt	$ 656,250
Common stock, shares outstanding								241,128,131
Subsequent Event [Member] \| Noreen Griffin [Member]
Debt instrument, face amount			$ 25,000
Subsequent Event [Member] \| Ms. Griffin [Member]
Debt instrument, face amount			$ 25,000
Subsequent Event [Member] \| Note Holder[Member]
Common stock, shares issued		2,000,000
Subsequent Event [Member] \| Note Holder[Member] \| Minimum [Member]
Interest rate		18.00%
Maturity date		Sep. 06, 2016
Subsequent Event [Member] \| Note Holder[Member] \| Maximum [Member]
Interest rate		10.00%
Maturity date		Dec. 31, 2016
Subsequent Event [Member] \| GB Pharma Holdings, LLC [Member]
Concentration risk, percentage		12.50%
Subsequent Event [Member] \| Cytocom[Member] \| Note Holder[Member]
Common stock in return		250,000

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