Biostax Corp. - Quarter Report: 2014 September (Form 10-Q)

tnib_10q.htm

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)

þQUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2014

oTRANSITION REPORT UNDER SECTION 13 OF 15(d) OF THE EXCHANGE ACT OF 1934

From the transition period from ___________ to ____________

Commission File Number __________________

TNI BIOTECH, INC.

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

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

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 þ No o.

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 o		Accelerated Filer o

	Non-Accelerated Filer o		Smaller Reporting Company þ

Indicate by a check mark whether the company is a shell company (as defined by Rule 12b-2 of the Exchange Act: Yes oNo þ

As of November 13, 2014 there were 132,929,195 shares of Common Stock outstanding.

TABLE OF CONTENTS

PART I FINANCIAL STATEMENTS

Item 1	Financial Statements	5

Item 2	Management's Discussion and Analysis of Financial Conditions and Results of Operations	21

Item 3	Quantitative and Qualitative Disclosures About Market Risk	35

Item 4	Controls and Procedures	35

PART II OTHER INFORMATION

Item 1	Legal Proceedings	36

Item 1A	Risk Factors	36

Item 2	Unregistered Sales of Equity Securities and Use of Proceeds	36

Item 3	Default upon Senior Securities	36

Item 4	Mine Safety Disclosures	37

Item 5	Other Information	37

Item 6	Exhibits	38

JUMPSTART OUR BUSINESS STARTUPS ACT

TNI BioTech, Inc. (“we” or 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, 2013, 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 quarterly 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 last day of our fiscal year following the fifth anniversary of the date of first sale of our common stock pursuant to an effective registration statement under the Securities Act of 1933, as amended; (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 as of the last business day of our most recently completed second fiscal quarter.

As an emerging growth company we are exempt from Section 404(b) of the Sarbanes-Oxley Act and Section 14A(a) and (b) of the Securities Exchange Act of 1934, as amended (the "Exchange Act"). Such sections are provided below:

Section 404(b) of the Sarbanes-Oxley Act of 2002 requires a public company’s auditor to attest to, and report on, management’s assessment of its internal controls.

Sections 14A(a) and (b) of the Exchange Act, implemented by Section 951 of the Dodd-Frank Wall Street Reform and Consumer Protection Act, require companies to hold shareholder advisory votes on executive compensation and golden parachute compensation.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

Certain statements contained or incorporated by reference in this 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 U.S. Food and Drug Administration 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 in the Company’s Annual Report on Form 10-K for the fiscal year ending December 31, 2013 under "Risk Factors" and in this report and in our other public reports filed with the U.S. 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.

By their nature, forward-looking statements involve risks and uncertainties because they relate to events, competitive dynamics and industry change, and depend on the economic circumstances that may or may not occur in the future or may occur on longer or shorter timelines than anticipated. Although forward-looking statements contained in this report 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, we caution you that forward-looking statements 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 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;
●	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 governmental 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 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 report.

PART I FINANCIAL INFORMATION

ITEM 1. FINANCIAL STATEMENTS

TNI BIOTECH, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited)

	September 30, 2014			December 31, 2013
ASSETS
Current Assets:
Cash and cash equivalents	$	58,586			$	406,596
Prepaids and other current assets		49,700				215,900
Total current assets		108,286				622,496

Fixed Assets:
Computer equipment, net of accumulated depreciation
of $3,110 and $1,293 respectively		4,903				5,607
Software development in process		41,390				-

Intangible Assets:
Patents and licenses, net of accumulated amortization
of $6,579,501 and $4,422,375, respectively (Note 6)		16,446,762				18,546,548

Deposits		10,183				17,435
Total assets	$	16,611,524			$	19,192,086

LIABILITIES AND STOCKHOLDERS' EQUITY

Current Liabilities:
Accounts payable	$	1,803,010			$	839,909
Payable to officer		-				76,000
Accrued liabilities		824,126				588,271
Current portion patent liability		-				118,333
Notes payable		100,000				817,197
Total current liabilities		2,727,136				2,439,710

Non-current Liabilities:
Notes payable related party		-				121,128
Total non-current liabilities		-				121,128

Total Liabilities		2,727,136				2,560,838
Commitments and contingencies (Note 7)
Stockholders' Equity:
Common stock - par value $0.001; 500,000,000 shares authorized;
129,015,249 and 74,161,639 shares issued and outstanding respectively		129,013				74,160
Additional paid in capital		338,391,746				308,113,375
Stock issuances due		157,804				4,893,499
Prepaid services		(6,337,235	)			(13,447,109	)
Accumulated deficit		(318,456,940	)			(283,002,677	)
Total stockholders' equity		13,884,388				16,631,248
Total liabilities and stockholders' equity	$	16,611,524			$	19,192,086

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

TNI BIOTECH, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

	Three Months ended						Nine Months ended
	September 30, 2014			September 30, 2013			September 30, 2014			September 30, 2013

Revenues, net	$	-		$	-		$	-		$	-

Operating expenses:
Selling, general and administrative		901,746			1,290,292			3,264,342			4,141,601
Research and development expense		401,424			640,696			1,471,934			1,579,226
Stock issued for services G&A		4,946,639			11,329,950			17,021,025			22,388,033
Stock issued for services R&D		-			5,772,015			5,036,250			13,931,084
Warrant valuation expense		114,939			(11,841)			2,101,866			6,932,056
Depreciation and amortization expense		720,369			719,040			2,158,943			2,134,231
Total operating expenses		7,085,117			19,740,152			31,054,360			51,106,231

Loss from operations		(7,085,117	)		(19,740,152	)		(31,054,360	)		(51,106,231	)

Other income (expense):
Interest expense		(94,101	)		(205,416	)		(376,163	)		(1,098,868	)
Exchange loss		-			-			(783	)		-
Loss on settlement of debt		(4,022,957	)		-			(4,022,957	)		(7,108,495	)
Total other income (expense)		(4,117,058	)		(205,416	)		(4,399,903	)		(8,207,363	)

Net loss	$	(11,202,175	)	$	(19,945,568	)	$	(35,454,263	)	$	(59,313,594	)

Basic and diluted loss per share	$	(0.12	)	$	(0.34	)	$	(0.40	)	$	(1.08	)

Weighted average number of shares outstanding		94,316,453			59,334,545			87,875,552			55,127,859

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

TNI BIOTECH, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY

FOR THE PERIOD ENDED SEPTEMBER 30, 2014

(Unaudited)

	Common Stock						Additional Paid			Stock to			Prepaid			Accumulated
	Shares			Amount			in Capital			Be Issued			Services			Deficit			Total
Balance, December 31, 2013		74,161,639		$	74,160		$	308,113,375		$	4,893,499		$	(13,447,109	)	$	(283,002,677	)	$	16,631,248

Issuance of common stock for prepaid services		16,390,000			16,390			12,435,610			210,001			(12,662,001	)		-			-

Return of stock issued for charitable contributions		(100,000	)		(100	)		(749,900	)		-			-			-			(750,000	)

Amortization of prepaid services		-			-			-			-			19,771,875			-			19,771,875

Issuance of common stock for license		1,600,000			1,600			466,400			-			-			-			468,000

Issuance of common stock for legal settlement		650,000			650			447,850			-			-			-			448,500

Issuance of common stock to employees and consultants		6,329,000			6,329			3,170,728			(1,028,157	)		-			-			2,148,900

Issuance of common stock in exchange for debt		22,037,450			22,037			7,650,763			(1,252,000	)		--			-			6,420,800

Issuance of common stock for loan expenses and interest		655,000			655			522,345			(224,800	)		-			-			298,200

Issuance of common stock for cash and exercise of warrants		7,292,160			7,292			4,232,719			(2,440,739	)		-			-			1,799,272

Issuance and modification of common stock warrants		-			-			2,101,856			-			-			-			2,101,856



Net loss		-			-			-			-			-			(35,454,263	)		(35,454,263	)

Balance, September 30, 2014		129,015,249		$	129,013		$	338,391,746		$	157,804		$	(6,337,235	)	$	(318,456,940	)	$	13,884,388

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

TNI BIOTECH, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

	Nine Months Ended
	September 30, 2014			September 30, 2013
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss	$	(35,454,263	)	$	(59,313,594	)
Adjustments to reconcile net loss to net cash flows used in operating activities:
Depreciation		1,817			682
Amortization		2,157,125			2,133,549
Stock issued, and amortization of stock issued, for prepaid services		19,771,875			36,318,767
Loss on settlement of debt		4,022,957			7,055,994
Stock issued for services		2,148,900			-
Stock issued for license		468,000			-
Stock issued for legal settlement		448,500			-
Debt discount		25,000			-
Stock warrant expense		2,101,866			6,932,057
Stock (returned) issued for donation		(750,000	)		750,000
Stock issued for interest		298,200			1,133,162
Changes in operating assets and liabilities:
Accounts payable		1,101,734			343,098
Accrued liabilities		342,550			227,681
Prepaid expenses and deposits		226,642			(37,507	)

Net cash used in operating activities		(3,089,097	)		(4,456,111	)

CASH FLOWS FROM INVESTING ACTIVITIES
Purchase of computer equipment		(42,503	)		(4,350	)
Purchase of License		(57,340	)		(160,539	)
Net cash used in investing activities		(99,843	)		(164,889	)

CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from sale of stock and exercise of warrants		1,799,262			4,171,613
Proceeds from issuance of notes payable		1,210,000			449,001
Payments made on patent liability		(50,000	)		-
Payments made on Bihari patent		(118,333	)		(155,000	)

Net cash provided by financing activities		2,840,929			4,515,614

Net decrease in cash and cash equivalents		(348,011	)		(105,386	)
Cash and cash equivalents at beginning of period		406,596			313,095
Cash and cash equivalents at end of period	$	58,585		$	207,709

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

TNI BIOTECH, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

	Nine Months Ended
	September 30, 2014		September 30, 2013
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION:

Cash paid for interest	$	-	$	-

SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING AND FINANCING ACTIVITIES:

Common stock issued for loan expense and interest	$	298,200	$	1,133,162

Common stock issued for prepaid services	$	12,662,000	$	53,356

Common stock issued for prepaid assets	$	53,190	$	0

Common stock issued (returned) from foundation	$	(750,000)	$	750,000

Common stock issued for notes payable and accrued interest	$	2,159,248	$	0

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

TNI BioTech, Inc. and Subsidiaries

Notes to the Condensed Consolidated Financial Statements

September 30, 2014

(Unaudited)

1. Organization and Description of Business

TNI BioTech, Inc. (“we” or the “Company”) is a biopharmaceutical company focused on developing and commercializing therapeutics to treat cancer, HIV/AIDS and autoimmune diseases by combating these chronic and often life-threatening diseases through the activation and rebalancing of the body’s immune system. We were initially incorporated in Florida on December 2, 1993 as Resort Clubs International, Inc. (“Resort Clubs”) to manage and market golf course properties in resort markets throughout the United States. Galliano International Ltd. (“Galliano”) was incorporated in Delaware on May 27, 1998 and began trading in November 1999 through the filing of a 15C-211. On November 10, 2004, Galliano merged with Resort Clubs. Resort Clubs was the surviving corporation. On August 23, 2010, Resort Clubs changed its name to pH Environmental Inc. (“pH Environmental”).

On April 23, 2012, pH Environmental completed a name change to TNI BioTech, Inc., and on April 24, 2012, we executed a share exchange agreement for the acquisition of all of the outstanding shares of TNI BioTech IP, Inc. The Company currently operates out of Orlando, Florida and Frederick, Maryland. In July 2012, the Company’s focus turned to acquiring patents that would protect and advance the development of new uses of opioid-related immune- therapies, such as low-dose naltrexone (“LDN”) and Methionine [Met5]-enkephalin (“MENK”). The Company’s therapies are believed to stimulate and/or regulate the immune system in such a way that they provide the potential to treat a variety of diseases. We believe our therapies may be able to correct abnormalities or deficiencies in the immune system in diseases such as HIV infection, autoimmune disease, immune disorders, or cancer; all of which can lead to disease progression and life-threatening situations when the immune system is not functioning optimally.

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

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

In December 2013, the Company formed a new subsidiary, Cytocom Inc. (“Cytocom”), to focus on conducting LDN and MENK clinical trials in the United States. We expect that the manufacturing of our therapies and their subsequent distribution into emerging nations will continue to be operated directly through the Company. We initially entered into consultant arrangements with Dr. Graham Burton, M.D., Ph.D., and Mr. Gary G. Gemignani, to focus on the clinical advancement of LDN and MENK through Cytocom. Effective April 1, 2014, Dr. Burton was appointed President and Chief Executive Officer of Cytocom. On the same date, Mr. Gemignani was appointed Chief Operating Officer, Chief Financial Officer and Executive Vice President of Cytocom. Dr. Burton will be responsible for leading Cytocom’s global development, clinical research and medical initiatives. Mr. Gemignani was expected to handle the operational and business development activities and financial management of Cytocom; however, he resigned from his positions with Cytocom.

On May 1, 2014, the Company announced a plan to spin-off Cytocom. Following the spin-off, Cytocom will initially focus on developing LDN and MENK. The Company will continue to retain rights to certain intellectual property assets, and will focus on manufacturing, distribution and marketing of LDN and MENK therapies for the treatment of both humans and animals in certain territories.

To affect the spin-off distribution (the “Distribution”), the Company took certain reorganizational steps, which are expected to result in Cytocom independently developing LDN and MENK in the United States. At the time of the Distribution, each Company shareholder received one common share of Cytocom for every one share of Company common stock held by such Company shareholder as of September 30, 2014, the record date. The Financial Industry Regulatory Authority declared October 31, 2014 as the payable date for the Distribution. Company shareholders were not required to pay any consideration to participate in the Distribution and, as of the record date, continued to own shares in the Company in the same form and in the same quantity as owned on the record date. The Company continues to be quoted on the OTCQB Market.

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

The Company’s growth strategy includes the near-term commercialization of its existing immunotherapies targeting cancer, Crohn’s disease and/or HIV/AIDS.

Going Concern

The Company has incurred significant net losses since inception and has relied on its ability to fund its operations through private equity financings and short-term debt. Management expects operating losses and negative cash flows to continue at more significant levels in the future. As the Company continues to incur losses, transition to profitability is dependent upon the successful development, approval, and commercialization of its products and achieving a level of revenues adequate to support the Company’s cost structure. The Company may never achieve profitability, and unless and until it does, the Company will continue to need to raise additional cash. Management intends to fund future operations through additional private or public debt or equity offerings, and may seek additional capital through arrangements with strategic partners or from other sources. Based on the Company’s operating plan, existing working capital at September 30, 2014 was not sufficient to meet the cash requirements to fund planned operations through December 31, 2014 without additional sources of cash. These conditions raise substantial doubt about the Company’s ability to continue as a going concern. The accompanying financial statements have been prepared assuming that the Company will continue as a going concern and do not include adjustments that might result from the outcome of this uncertainty. This basis of accounting contemplates the recovery of the Company’s assets and the satisfaction of liabilities in the normal course of business.

The Company experienced a net loss from operations of $35,454,263 and used cash and cash equivalents for operations in the amount of $3,089,097 during the nine months ended September 30, 2014, resulting in stockholders’ equity of $13,884,388.

2. Summary of Significant Accounting Policies

Basis of Presentation

The accompanying unaudited interim financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) and the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”), as amended for interim financial information. The financial information as of September 30, 2014 and September 30, 2013 is derived from the audited financial statements presented in the Company’s Annual Report on Form 10-K for the year ended December 31, 2013 ("2013 10-K"). The unaudited interim financial statements should be read in conjunction with the 2013 10-K, which contains the audited financial statements and notes thereto, together with Management’s Discussion and Analysis of Financial Condition and Results of Operations, for the years ended December 31, 2013 and 2012.

Certain information or footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted, pursuant to the rules and regulations of the SEC for interim financial reporting. Accordingly, they do not include all the information and footnotes necessary for a comprehensive presentation of financial position, results of operations, or cash flows. It is management’s opinion, however, that all material adjustments (consisting of normal recurring adjustments) have been made which are necessary for a fair financial statement presentation. The interim results for the nine months ended September 30, 2014 are not necessarily indicative of results for the full fiscal year.

Use of Estimates

The preparation of the Company’s financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from such estimates.

Cash, Cash Equivalents, and Short-Term Investments

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

Concentration of Credit Risk

Financial instruments that potentially subject the Company to concentrations of credit risk are primarily cash and cash equivalents. The Company is exposed to credit risk, subject to federal deposit insurance, in the event of a default by the financial institutions holding its cash and cash equivalents to the extent of amounts recorded on the balance sheets.

Fair Value of Financial Instruments

In accordance with the reporting requirements of the Financial Accounting Standards Board, ("FASB") Accounting Standards Codification ("ASC") Topic 825, “Financial Instruments,” the Company calculates the fair value of its assets and liabilities which qualify as financial instruments under this standard and includes this additional information in the notes to the financial statements when the fair value is different than the carrying value of those financial instruments.

Computer Equipment

Computer equipment is stated at cost, less accumulated depreciation. Depreciation is determined on a straight-line basis over the estimated useful lives of the assets, which generally range from three to five years. Maintenance and repairs are charged against expense as incurred. Depreciation expense for the nine months ended September 30, 2014 and 2013 was $1,817 and $682, respectively.

Intangible Assets

Costs incurred to acquire and/or develop the Company’s product licenses and patents are capitalized and amortized by straight-line methods over estimated useful lives of seven to sixteen years. Intangible assets are stated at the lower of cost or estimated fair value. Amortization expense for the nine months ended September 30, 2014 and 2013 was $2,158,943 and $2,134,231, respectively. The Company estimates its amortization expense related to these assets will approximate $2,800,000 each year for the next five years.

Impairment of Long-Lived Assets

The Company evaluates long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable as prescribed by ASC Topic 360, “Property, Plant and Equipment.” If the carrying amount of the asset, including any intangible assets associated with that asset, exceeds its estimated undiscounted net cash flow, before interest, the Company will recognize an impairment loss equal to the difference between its carrying amount and its estimated fair value. No impairment losses were recognized for the nine months ended September 30, 2014 or for the corresponding period in 2013.

Research and Development Costs

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

Income Taxes

Management considers the likelihood of changes by taxing authorities in its filed income tax returns, and recognizes a liability for or discloses potential changes that management believes are more likely than not to occur upon examination by tax authorities. Management has not identified any uncertain tax positions in filed income tax returns that require recognition or disclosure. The Company’s income tax returns for the past three years are subject to examination by tax authorities, and may change upon examination.

We follow ASC 740-10, Accounting for Uncertainty in Income Taxes. This interpretation requires recognition and measurement of uncertain income tax positions using a “more-likely-than-not” approach. ASC 740-10 is effective for fiscal years beginning after December 15, 2006. The Company has adopted ASC 740-10 and evaluates its tax positions on an annual basis.

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

The Company measures and recognizes compensation expense for all share-based payment awards made to employees and directors, including employee stock options, based on estimated fair values equaling either the market value of the shares issued or the value of consideration received, whichever is more readily determinable.

The Company’s accounting policy for equity instruments issued to consultants and vendors in exchange for goods and services follows the provisions of ASC Topic 505-50, “Equity-Based Payments to Non-Employees.” The measurement date for the fair value of the equity instruments issued is determined at the earlier of (i) the date at which a commitment for performance by the consultant or vendor is reached or (ii) the date at which the consultant or vendor’s performance is complete.

Net Loss per Share

Basic net loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted average number of common shares outstanding for the period, without consideration for common stock equivalents. Diluted net loss per share is calculated by dividing the net loss by the weighted-average number of common share equivalents outstanding for the period determined using the treasury-stock method and the if-converted method. Dilutive common stock equivalents are comprised of common stock purchase warrants and options outstanding. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding due to the Company’s net loss position.

Basic and diluted net loss per share is as follows:

	For the three months ended September 30,						For the nine months ended September 30,
	2014			2013			2014			2013
Historical net loss per share:
Numerator
Net loss	$	(11,202,175	)	$	(19,945,568	)	$	(35,454,263	)	$	(59,313,594	)
Net loss attributed to Common stockholders	$	(11,202,175	)	$	(19,945,568	)	$	(35,454,263	)	$	(59,313,594	)

Denominator
Weighted-average common shares outstanding—
Denominator for basic and diluted net loss per share		94,316,453			59,334,545			87,875,552			55,127,859
Basic and diluted net loss per share attributed
to common stockholders	$	(0.12	)	$	(0.34	)	$	(0.40	)	$	(1.08	)

The Company’s potential dilutive securities which include stock and warrants have been excluded from the computation of diluted net loss per share as the effect would be to reduce the net loss per share. Therefore, the weighted-average common stock outstanding used to calculate both basic and diluted net loss per share is the same.

The following shares of potentially dilutive securities have been excluded from the computations of diluted weighted average shares outstanding as the effect of including such securities would be antidilutive:

	As of September 30,
	2014		2013
Warrants to purchase common stock		8,986,750		6,503,750

Recent Accounting Standards

Any new accounting pronouncements issued by the FASB, as applicable, have been or will be adopted by the Company upon or before the expiration of the extended transition period provided under Section 102(b)(1) of the JOBS Act.

3. Promissory Notes

At June 30, 2014, the Company had promissory notes outstanding totaling $1,442,197. The promissory notes had maturity dates ranging between September 2007 and July 2014. The notes bore interest at rates between two and six percent per annum. As of June 30, 2014, the Company had accrued $67,863 in unpaid interest on those notes.

During the three months ended September 30, 2014, the Company settled all of the notes that had been outstanding at June 30, 2014, together with accrued interest owing on the notes, by issuing 20,731,601 shares, at a range of $0.10 to $0.25 per share, as repayment of principal, and interest. The Company recognized a loss of $3,621,643 on the settlement of these notes.

On July 29, 2014, the Company issued a note payable to Ira Gaines. The balance outstanding as of September 30, 2014 and 2013 was $100,000 and $0, respectively. The note matures on January 27, 2015 and earns interest at a rate of 18% per annum.

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

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

As of September 30, 2014 and 2013, the Company was authorized to issue 500,000,000 common shares at a par value of $0.001 per share.

Stock Warrants

Using the Black-Scholes Model, the Company calculated the fair value of $2,101,856 for common stock purchase warrants issued and modified during the nine months ended September 30, 2014. Variables used in the Black-Scholes option-pricing model, include (1) a discount rate of 0.98%, (2) an expected remaining life of 5 years and (3) expected volatility of 130%.

During the first nine months of 2014, the Company issued 918,750 shares of its restricted common stock through the exercise of common stock purchase warrants. The warrants were exercised at a price of $0.50 per share and the Company received net proceeds of $459,375 for equity from the exercise of the warrants.

Following is a summary of outstanding stock warrants at September 30, 2014 and activity during the period then ended:

	Number of Shares		Exercise Price		Weighted Average Price

Warrants as of December 31, 2013		7,957,500	$	1.00 – 15.00	$	1.77

Issued in the nine months ended September 30, 2014		1,948,000	$	0.50-1.50	$	1.27


Exercised		(918,750)	$	0.50	$	0.50

Warrants as of September 30, 2014		8,986,750	$	0.50-15.00	$	1.58

Summary of outstanding warrants as of September 30, 2014:

Expiration Date	Number of Shares		Exercise Price		Remaining Life (years)
Third Quarter 2015		407,500	$	1.50-2.00		1.00
Fourth Quarter 2015		268,750	$	1.50		1.25
Second Quarter 2016		37,500	$	3.00-5.00		1.75
Third Quarter 2016		525,000	$	0.50-5.00		2.00
Third Quarter 2017		1,500,000	$	1.00-1.50		3.00
Fourth Quarter 2017		2,941,666	$	1.00-9.00		3.25
First Quarter 2018		127,500	$	15.00		3.50
Second Quarter 2018		33,334	$	15.00		3.75
Third Quarter 2018		400,000	$	1.00-1.50		4.00
Fourth Quarter 2018		1,197,500	$	1.00-1.50		4.25
First Quarter 2019		1,048,000	$	1.50		4.50
Third Quarter 2019		250,000	$	0.50		5.00

5. Stock Compensation

Shares Issued for Services

During the nine months ended September 30, 2014, the Company issued 16,390,000 shares of common stock for prepaid services (10,228,000 for the corresponding period in 2013). The Company valued these shares based upon the fair value of the common stock at the date of the agreements. The consulting fees are amortized over the contract periods, which are typically twelve months. The Company issued common stock for prepaid services of $12,662,001 and $51,204,100 for the nine months ended September 30, 2014 and 2013, respectively. The amortization of prepaid services totaled $19,771,875 and $36,319,117 for the nine months ended September 30, 2014 and 2013, respectively.

6. Licenses and Supply Agreements

Patent License Agreements

On March 4, 2012, the Company entered into a Sale of Technology Agreement with Dr. Nicholas P. Plotnikoff wherein Dr. Plotnikoff agreed to transfer and assign all of his rights, title and interest in certain patents he developed. The Company received all the production formulations and technology designs from Dr. Plotnikoff necessary for the manufacturing, formulation, production and protocols of the MENK treatment of cancer and HIV/AIDS. As consideration for entering into the Sale of Technology Agreement, Dr. Plotnikoff received 8,000,000 shares of the Company’s common stock, a royalty on all sales of MENK and was granted the position of Non-Executive Chairman of our Board of Directors.

On August 13, 2012, the Company signed an exclusive License Agreement with Ms. Jacqueline Young (the “Young Agreement”) for the intellectual property developed by Dr. Bernard Bihari relating to treatments with opioid antagonists such as naltrexone and Met-enkephalin for a variety of diseases and conditions. The Bihari patents were acquired in exchange for 540,000 shares of the Company’s common stock with a fair value of $972,000 and assumed liabilities of $400,000, which is payable to Ms. Young over a twenty-four month period in equal installments to reimburse her for the costs of a New York City office in accordance with the Young Agreement. The patent liability at September 30, 2014 totaled $0.00. The cost of the patent totaled $1,372,000.

Pursuant to the Young Agreement, the Company must pay Ms. Young a royalty payment of 1% of gross MENK sales and provide Ms. Young a position as non-executive chairman of the Company. The Young Agreement is valid for the life of the patents and expires on a country by country basis in each country where patent rights exist, upon the expiration of the last patent to expire in each country or in the event the patent in such country is held to be invalid and/or unenforceable or admitted to be invalid or unenforceable. Additionally, the Company can cancel the Young Agreement upon 120 days’ written notice and, upon cancellation, must pay all royalties and fees that have accrued. The Company has the exclusive rights to the intellectual property; however, Ms. Young retains a right to practice the patents licensed under the Young Agreement solely for noncommercial, academic research purposes.

On December 18, 2012, the Company signed an agreement for the acquisition of patent rights (the “Smith Agreement”) for the intellectual property of Dr. Jill Smith and LDN Research Group LLC (collectively, the “Licensor Parties”), whose members are Dr. Ian S. Zagon, Dr. Patricia J. McLaughlin and Moshe Rogosnitzky and orphan drug designation by the U.S. Food and Drug Administration (“FDA”) to a novel late-stage drug, trademarked “LDN,” for the treatment of Pediatric Crohn’s disease. The patent covers methods and formulations for treatment of the inflammatory and ulcerative diseases of the bowel, using naltrexone in low doses as an opioid antagonist. These patents were acquired in exchange for 300,000 shares of the Company’s common stock with a fair value of $2,715,000 and payment of $165,384 (consisting of an initial license fee and payment of $65,384 of expenses), which totaled $2,880,384.

The Smith Agreement requires the Company to (i) use commercially reasonable efforts to develop, commercialize, market and sell licensed products in a manner consistent with a business plan, (ii) expend a minimum amount of funds per annum to develop and commercialize licensed products as soon as practicable, (iii) obtain all requisite regulatory approvals needed to use or sell licensed products in the field of use, and (iv) make the first commercial sale of a licensed product by March of 2017.

The Company is required to pay an annual license fee, an annual running royalty on net sales of each licensed product or a minimum royalty, whichever is greater, and a sublicense fee on payments received by the Company from sublicensees. The Company has an exclusive, worldwide license to make, have made, use, lease, import, offer for sale and sell licensed products and to use the method under the patent rights. The Smith Agreement will terminate on the expiration or abandonment of the last patent to expire or ten years after the sale of the first licensed product. The Company may terminate the Smith Agreement upon 90 days’ written notice, provided all sublicenses are terminated and all amounts due and owing are paid to the Licensor Parties. The Licensor Parties may terminate the agreement ten days' after notice to the Company if the Company is ten days late in payment or there is a breach that remains uncured for ten days after written notice of such breach.

The Company is also required to pay milestone payments after substantial achievement of certain milestone events for each licensed product including payment: upon initiation of each Phase III trial; upon positive completion of each Phase III clinical trial of the therapeutic use of an LDN compound in the field of use; when a New Drug Application (“NDA”) is accepted for review by the FDA; and when FDA approval to market the NDA is approved. The Company will issue shares upon reaching certain milestones including upon the first dosing of the first patient in a Phase III clinical trial for each licensed product, upon the first sale of each licensed product, and upon the achievement of a set dollar amount in cumulative sales for each licensed product covered by NDAs.

As part of the Smith Agreement, the Company has the right to apply to the FDA for the transfer of the orphan drug status for the use of naltrexone for the treatment of pediatric Crohn’s disease and ulcerative colitis, the Investigation New Drug Application (“IND”), and the right to acquire the relevant clinical data set from Dr. Jill Smith. Dr. Jill Smith made arrangements to transfer the IND to the Company as well as the relevant clinical data set, and the FDA has acknowledged that the Company is now the sponsor for this IND.

On September 24, 2014, the Company and the Licensor Parties jointly agreed to terminate the Smith Agreement, and in place thereof, have the Licensor Parties grant a similar license in their patent rights to Cytocom pursuant to a Patent License Agreement between the Licensor Parties, Cytocom and the Company with substantially similar terms as set forth in the Smith Agreement. Pursuant to this agreement, the Company issued 1,000,000 shares of its common stock valued at $270,000, upon execution to the Licensor Parties and the Company guaranteed the obligations of Cytocom to the Licensor Parties under the agreement.

On January 18, 2013, the Company signed an exclusive licensing agreement with The Penn State Research Foundation to license all of the intellectual property developed by Dr. Ian S. Zagon, Dr. Patricia J. McLaughlin and Dr. Jill P. Smith for the treatment of cancer titled “Opioid Growth Factor and Cancer” and “Combination Therapy with Opioid Growth Factor and Taxanes for the Treatment of Cancer” (the “Foundation Agreement”).

The Foundation Agreement requires the Company to: (a) use commercially reasonable efforts to develop, commercialize, market and sell licensed products in a manner consistent with a business plan; (b) expend a minimum amount of funds per annum to develop and commercialize licensed products as soon as practicable; (c) obtain all requisite regulatory approvals needed to use or sell licensed products in the field of use; and (d) make the first commercial sale of a licensed product by December 31, 2016.

The Foundation Agreement provides that the Company must pay to the licensor an initial license fee, a license maintenance fee on each anniversary of the effective date of the Foundation Agreement, and an annual running royalty on net sales for each licensed product or a minimum royalty, whichever is greater. In addition, the Company must pay a sublicense fee on payments received by the Company from sublicensees.

The Foundation Agreement also requires the Company to make payments upon the achievement of certain milestone events including: initiation of each Phase II trial; initiation of each Phase III trial; when the NDA is accepted for review by the FDA; and when FDA approval to market is approved. The Company must also issue shares upon certain milestones including upon the first dosing of the first patient in a Phase II clinical trial for each licensed product, upon the first dosing of the first patient in a Phase III clinical trial for each licensed product, upon the first sale of each licensed product, and upon the achievement of a set dollar amount of cumulative sales for each licensed product covered by NDAs.

The Foundation Agreement terminates on the expiration or abandonment of the last patent to expire or become abandoned. The Company may terminate the Foundation Agreement at any time upon 60 days’ prior written notice and ceasing to make and sell all licensed products, the termination of all sublicenses and payment of all monies owed under the Foundation Agreement. The licensor may terminate the agreement 30 days after notice to the Company if the Company is 30 days late in payment or a breach that remains uncured for 45 days after written notice of such breach.

In May of 2013, the Company executed a Patent License Agreement with Professor Fengping Shan (the “Shan Agreement”) pursuant to which it obtained exclusive rights to develop and commercialize the licensed technology. The licensed technology is the intellectual property developed and owned by Professor Shan (i) relating to the treatment of a variety of diseases and conditions with MENK including multiple forms of lymphoma and cancer and (ii) a treatment method for humans infected with the HLTV-III (AIDS) virus including AIDS and AIDS related complex (ARC). The licensed technology includes the methods and formulations for these treatments including all INDs, communications with regulatory agencies, patient data, and letters relating to these treatments. The licensed technology also includes certain patents developed by Professor Shan. Under the Shan Agreement, the Company must issue 500,000 shares to Professor Shan upon final transfer of the licenses, and reimburse Professor Shan for all out of pocket expenses in connection with the patents. The Company will pay Professor Shan a running royalty on gross sales subject to decreases if third party intellectual property is needed to complete such sale or product. The Shan Agreement lasts for the duration of each of the licensed patents however the Company may terminate the Shan Agreement on 120 days' written notice to Professor Shan.

On August 6, 2014, Professor Fengping Shan executed an Assignment pursuant to which he transferred to the Company his entire right, title and interest in and to the licensed patents under the Shan Agreement and CN 201210302259 Application of combination of low-dose naltrexone and methionine-enkephalin to preparation of anti-cancer drug for the consideration of 500,000 shares of common stock valued at $140,000.

7. Commitments and Contingencies

Malawi Treatment Facilities

On July 14, 2012, GB Oncology and Imaging Group LTD (“GBOIG”) in partnership with the Company signed a letter of intent to collaborate with the Government of Malawi to assist in expanding the treatment of cancer, HIV/AIDS and other infectious diseases.

The Company and GBOIG will work in connection with the government of Malawi to open and operate clinics that provide treatments for HIV/AIDS, cancer and other infectious diseases. GBOIG and the Company originally expected to have the oncology and infectious disease clinic fully operational within 12 months of the signing of the letter of intent, and to begin treatment for HIV patients within 180 days thereafter. However, delays in obtaining approvals required for the importation of the Company’s products have delayed the start of the project until the second half of 2014. Under the letter of intent, the Company and GBOIG will begin by providing HIV/AIDS treatment to 10,000 patients and hopefully expanding to 500,000 within 24 months of project start. The Company shall contribute $1,000 in initial capital to the venture. The Company shall be allocated 50% of the net income from the venture. Either party may terminate the venture with 180 days’ notice to the other party prior to the one-year anniversary of the letter of intent. After the one-year anniversary, the letter of intent may only be terminated with 180 days' notice to the other party if the other party has breached the letter of intent.

GBOIG, a subsidiary of GB Energie LLC, is a Washington D.C. based minority woman-owned business managed by Dr. Gloria B. Herndon. Dr. Herndon is a former director of the Company.

Oncology and Infectious Disease Center in Malawi at Queen Elizabeth Central Hospital

On September 25, 2012, GBOIG in partnership with the Company, signed an agreement with the Government of Malawi to open an outpatient clinic at Queen Elizabeth Central Hospital (in Malawi) for the treatment of cancer and infectious disease. The duration of the agreement is for 25 years with an optional 10-year renewal to be indicated by the Government of Malawi at least three years prior to the expiration of the term. The Government of Malawi will bear the upfront costs for the agreement of $2,500,000.

Distribution Agreements in Nigeria

Effective November 9, 2012, the Company signed an exclusive Distribution Agreement with G-Ex Technologies/St. Maris Pharma and GB Pharma Holdings, LLC for the Federal Republic of Nigeria (the “Distribution Agreement”). Under the terms of the Distribution Agreement, G-Ex Technologies/St. Maris Pharma and GB Pharma Holdings LLC will have exclusive marketing and distribution rights to IRT-103 LDN and IRT-104 LDN cream in Nigeria until the end of the term of the Distribution Agreement on December 31, 2017. The Company will be responsible for the manufacture and supply of IRT-103 LDN and IRT-104 LDN cream. As part of the Distribution Agreement, G-Ex Technologies/St. Maris Pharma will provide the Company with a revolving letter of credit for the minimum purchase of 750,000 doses monthly of IRT-103 LDN or IRT-104 LDN cream priced at $1.00 per dose. There are no upfront fees.

The Distribution Agreement calls for G-Ex Technologies/St. Maris Pharma and GB Pharma Holdings, LLC to purchase a minimum of 15,000,000 doses monthly within 24 months to maintain the exclusivity of the Distribution Agreement. Once G-Ex Technologies/St. Maris Pharma and GB Pharma Holdings, LLC reach sales of 1,000,000 doses per day, the Company has agreed to joint venture a factory in the Federal Republic of Nigeria to meet local demands.

G-Ex Technologies/St. Maris Pharma is a consortium of companies organized under the laws of the Republic of Nigeria operated by management, a consultant, general pharmaceutical, clinical pharmacy and marketing executives, each with over 25 years of industry experience and well versed in the changing dynamics of the prescription and over-the-counter drug international marketplace. G-Ex Technologies/St. Maris Pharma has been actively supported by medical practice professionals in business and academia who have been involved in the management of related drug therapies for many years.

The parties have been unable to perform under the Distribution Agreement because a certificate of free sale was not obtained by the Company until November of 2013, and no extension has been granted.

In October 2013, the Company announced the signing of a distribution agreement with AHAR Pharma, a Nigerian company to market LDN under the trademark Lodonal™, in Nigeria for the treatment of autoimmune diseases and cancer. AHAR Pharma intends to distribute Lodonal™ through a local distributor network, an Internet client base and directly to hospitals, pharmacists and doctors in Nigeria. The Company expects to implement the agreement in 2014, and expects to treat up to 500,000 patients per day by March 2015. Under the agreement, the Company is obligated to provide delivery of an initial supply of between 1 million and 1.5 million doses of Lodonal™ product to cover AHAR Pharma’s first-year purchase commitment.

Agreements with Hubei Qianjiang Pharmaceutical Company

On October 18, 2012, the Company and Hubei Qianjiang Pharmaceutical Co., Ltd. (“Qianjiang Pharmaceutical”), signed a Venture Cooperation Agreement on New Drug Methionine Enkephalin (the “Venture Agreement”) pursuant to which Qianjiang Pharmaceutical acquired an exclusive license for the production of MENK in China. The Venture Agreement requires that Qianjiang Pharmaceutical conduct drug research and pilot testing for MENK, organize pre-clinical studies, and apply for clinical trials for MENK with the Chinese State Food and Drug Administration. Under the Venture Agreement, Qianjiang Pharmaceutical must open a co-administration account for the development of MENK in China. Qianjiang Pharmaceutical must pay the Company, upon the marketing of MENK products, a half-year amount equaling 6% of its gross sales from MENK of the preceding half year. The Company may cancel the Venture Agreement if Qianjiang Pharmaceutical does not pay expenses for a period exceeding six months or does not commence clinical trials within 12-months after receiving certain approvals. Qianjiang Pharmaceutical may cancel the Venture Agreement if the Company fails to perform its obligations for a period of six months or the failure to receive approval of clinical trials is due to the Company’s MENK technologies. The Venture Agreement was amended on February 24, 2013 to expand the clinical trials from pancreatic to both pancreatic and liver cancer and amended on March 6, 2014 to require Qianjiang Pharmaceutical to commence studies and clinical trials in China and place funds in the co-administration account.

On August 6, 2014, the Company entered into a Supplementary Agreement on New Drug Methionine – Enkephalin Cooperation (the “Amendment”) with Qianjiang Pharmaceutical, amending the Venture Agreement, as amended. The Company and Qianjiang Pharmaceutical executed the Amendment to accelerate clinical trials in both the United States and China, and agreed to immediately initiate three month Good Laboratory Practice (“GLP”) Toxicology Studies (rat and dog) within 30 days of signing the Amendment. The Amendment requires that the GLP Toxicology Studies Trials are conducted in China in accordance with international standards and standards acceptable to the FDA and that the studies include the following:

Exploratory Toxicology (nGLP)

· Dose range finding studies

· Different species and methods of administration

· Multiple dosing regimens

· Estimate the response vs. dose given

Definitive Toxicology (GLP)

· Performed in collaboration with Calvert Laboratories (USA) and MPI/Medicillon (China)

· General toxicology studies

· Different species and methods of administration

· Immunogenicity study with NHPs

Special Toxicology Studies (planned)

Pursuant to the Amendment, Qianjiang Pharmaceutical will make certain funds available from the co-administrative account opened by Qianjiang Pharmaceutical under the Venture Agreement, in accordance with an approved budget and timeline set forth in the Amendment. A portion of these funds are expected to be used by Cytocom to run PK and Dosing trials for MENK in the United States. The Amendment requires Cytocom and Qianjiang Pharmaceutical to meet with the China State Food and Drug Administration to determine that PK and Dosing Trials completed in the United States will be acceptable. All developments and trials run by Cytocom in the U.S. or the European Union will be used for requesting registration approval in China.

In February 2013, the Company signed a Strategic Framework Agreement for Cooperation with Qianjiang Pharmaceutical. Under the agreement, the parties will work together to further the development of new products and conduct research and development on the Company’s licensed patented technology. Specifically, the parties aim to co-invest to develop and market products focusing on HIV, cancer and related autoimmune system therapies, develop co-ventured manufacturing facilities in China, and develop co-ventured distribution of the developed products in China and Africa. The agreement does not have a definitive term, as each new agreement resulting from the cooperation will set forth the material terms, including, but not limited to, fees, duration and termination therein.

Supervision and Inspection of Manufacturing in Nicaragua

On April 23, 2013, the Company signed a Contract with ViPharma for the Supervision and Inspection of Manufacturing Processes as part of its negotiations for a contract for the manufacturing of LDN in a tablet, capsule and/or cream. The contract sets out the terms and conditions under which ViPharma will carry out the services of inspecting and supervising the manufacturing and packaging processes of LDN and ensure compliance with the FDA’s Current Good Manufacturing Practice regulations (“cGMP”) and the Company’s specifications. ViPharma will carry out its obligations in whatever Latin American country the Company ultimately decides to manufacture LDN. Under the contract, ViPharma has the exclusive rights to supervise and inspect all manufacturing processes of LDN in Latin America. The initial term of the agreement is ten years commencing in September 2013, with automatic five-year renewal terms provided neither party is in breach. The agreement may be terminated by (i) mutual agreement, (ii) in the event of a breach after a 45 day cure period or (iii) by either party upon provision of written notice at least 90 days before the end of the agreement, provided however that if the Company terminates the contract without cause it will be required to pay ViPharma a $10 million penalty.

Operating Leases

The Company leases office space in White Plains, New York, Frederick, Maryland, and Orlando, Florida. Rental expense for the nine months ended September 30, 2014 and 2013 was $116,638 and $65,660, respectively.

8. Related Party Transactions

In 2012, Webfoot, Inc. provided a loan to the Company in the amount of $121,128. Webfoot, Inc. is owned by the son of Noreen Griffin, the Company's CEO. On February 21, 2013, the Company entered into a formal loan agreement to evidence the amount owed by the Company. In the nine months ended September 30, 2014, the Company repaid $40,000 of the loan. On September 30, 2014, the remaining balance of $71,128 owed under the agreement, together with accrued and unpaid interest totaling $10,212, was converted into 813,404 shares of the Company’s common stock in full and final settlement of the loan. The loss on conversion was $162,681.

In 2012, Noreen Griffin made payments totaling $30,000 on the Company's behalf covering the costs of incorporation and merger-related expenses. On February 13, 2013, the Company entered into a formal loan agreement to evidence repayment of the amount owed on December 31, 2012. On September 30, 2014, the full balance of the loan, together with accrued and unpaid interest totaling $2,870, was converted into 328,701 shares of the Company’s common stock in full and final settlement of the loan. The loss on conversion was $65,740.

In 2012, Griffin Enterprises, Inc. made payments totaling $46,000 on the Company's behalf covering the cost of incorporation and merger-related expenses. Griffin Enterprises, Inc. is wholly owned by Noreen Griffin. On February 13, 2013, the Company entered into a formal loan agreement to evidence repayment of the amount owed on December 31, 2012. On September 30, 2014, the full balance of the loan, together with accrued and unpaid interest totaling $4,401, was converted into 504,009 shares of the Company’s common stock in full and final settlement of the loan. The loss on conversion was $100,802.

On January 3, 2013, the Company formalized the terms under which Kelly O’Brien Wilson, the daughter-in-law of the Company's Chief Executive Officer is employed. Ms. Wilson had been working with the Company in 2012 and her three-year employment agreement is effective as of December 1, 2012. The terms of the agreement define her base salary, a grant of a common stock, and health insurance coverage. Ms. Wilson was issued 500,000 shares of common stock of the Company in January 2014. For the nine months ended September 30, 2014, the Company paid compensation to Ms. Wilson totaling $115,735.

9. Subsequent Events

The following is a schedule of shares issued subsequent to September 30, 2014.

		Shares
Shares issued for consulting expenses			333,334

On September 4, 2014 at the Company’s annual meeting, a majority of stockholders approved an amendment to our Amended and Restated Articles of Incorporation, as amended, to change the Company’s name to Immune Therapeutics, Inc. (the “Name Change Amendment”). The Name Change Amendment was approved by our Board of Directors as the Board believed the new name would better (i) represent the business of the Company as a global manufacturer, distributor and seller of immune therapies, and (ii) reflect the Company’s presence and focus on affordable and sustainable health-care for an underserved and growing population facing opportunistic infections and cancer with very affordable treatments available. The Name Change Amendment was filed with the Secretary of State of Florida on October 28, 2014 changing the Company’s name to Immune Therapeutics, Inc. (the “Name Change”). As of the date of the filing of this report, the Company has filed the appropriate documentation with the Financial Industry Regulatory Authority in order to effectuate the Name Change in the OTC Markets. We anticipate that the Name Change will be effected by the Financial Industry Regulatory Authority during the fourth quarter.

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

This report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. The Company’s actual results could differ materially from those set forth on the forward-looking statements as a result of the risks set forth in the Company’s filings with the Securities and Exchange Commission, general economic conditions, and changes in the assumptions used in making such forward-looking statements.

General

TNI BioTech, Inc. ("we" or the “Company”) was initially incorporated in Florida on December 2, 1993 as Resort Clubs International, Inc. (“Resort Clubs”) to manage and market golf course properties in resort markets throughout the United States. Galliano International Ltd. (“Galliano”) was incorporated in Delaware on May 27, 1998 and began trading in November 1999 through the filing of a 15C-211. On November 10, 2004, Galliano merged with Resort Clubs. Resort Clubs was the surviving corporation. On August 23 2010, Resort Clubs changed its name to pH Environmental, Inc. (“pH Environmental”). On April 23, 2012, pH Environmental completed a name change to TNI BioTech, Inc., and on April 24, 2012 the Company executed a share exchange agreement for the acquisition of all of the outstanding shares of TNI BioTech IP, Inc.

The Company is a biopharmaceutical company focused on developing and commercializing therapeutics to treat cancer, HIV/AIDS and autoimmune diseases by combating these chronic and often life-threatening diseases through the activation and rebalancing of the body’s immune system. The Company has been developing active and adoptive forms of immunotherapies through the acquisition of patents, Investigational New Drug applications and clinical data and all proprietary technical information, know-how, procedures, protocols, methods, prototypes, designs, data and reports, which are not readily available to others through public means, and which are owned, generated or developed through experiments or testing by Dr. Plotnikoff, Professor Shan, Dr. Bernard Bihari, Dr. Ian Zagon, Dr. Jill Smith, Dr. Patricia J. McLaughlin and Moshe Rogosnitzky. The Company currently has offices in Frederick, Maryland, White Plains, New York and Orlando, Florida.

Business Strategy

The Company’s short-term business strategy focuses on several key areas described below, all of which are being undertaken simultaneously.

●	Commencing by the end of the third quarter of 2014, the distribution of low-dose naltrexone ("IRT 103 LDN") to support the large scale treatment in emerging nations, initially in Africa and Central/South America as an immune-stimulating therapy for HIV/AIDS, cancer, autoimmune disease and immune disorders;

●	Commencing by the end of the second quarter of 2014, the distribution of IRT-103 LDN marketed under the name Lodonal™ through various distribution agreements;

●	Outsourcing of the manufacturing of IRT-103 LDN to Laboratorios Ramos in Managua, Nicaragua to provide IRT 103 LDN in capsule, tablet and/or cream form, throughout Africa and expanding to other developing nations (Laboratorios Ramos has already produced IRT 103 LDN, and the Company will commence shipments when all regulatory approvals have been received in Africa for the importation of IRT 103 LDN); and

●	Continuing the cooperative venture with the Hubei Qianjiang Pharmaceutical Company (“Qianjiang Pharmaceutical”) pursuant to which Qianjiang Pharmaceutical will provide the funding required for the clinical trials of the Company’s products in China in exchange for the Company providing exclusive licensing rights in China (with the Company expecting to receive 6% of the gross revenue from sales of those products in China).

To further the business strategy, the Company has entered into relationships with a number of groups to promote the sale of its products outside the U.S., focusing initially on countries in Africa and Central/South America. They include: the Brewer Group, Inc. (the “Brewer Group”); GB Oncology & Imaging Group, LLC (“GBOIG”); American Hospitals and Resorts Limited (“AHAR”), an advanced surgical and medical facility, as well as a number of U.S. doctors that own and operate clinics in the U.S. and Nigeria.

The Brewer Group is an international business advisory firm engaged in the business of identifying and capitalizing on opportunities with international governments, non-government organizations and professional athletes. The CEO of The Brewer Group is also the founder and Executive Director of The Jack Brewer Foundation. The Jack Brewer Foundation seeks to provide the Company with medical equipment where it is needed. Under the Engagement Agreement for Corporate Advisory Services dated February 5, 2013 (the “Engagement Agreement”), the Brewer Group agreed to evaluate the Company’s options for expansion and growth into certain international markets, including Africa and, upon request, markets in Haiti, the Dominican Republic and/or Panama. Pursuant to the Engagement Agreement, the Brewer Group agreed to endorse the Company publicly and assist the Company in securing strategic partnership deals to enhance brand and market awareness. The initial term of the Engagement Agreement was 12 months, with an option for either party to terminate upon 30 calendar days with written notice to the other party. The Engagement Agreement has been extended through February 2015. The Company issued the Brewer Group 500,000 shares of its common stock in accordance with the Engagement Agreement.

GBOIG, a subsidiary of GB Energie LLC, is a Washington D.C. based business managed by Dr. Gloria B. Herndon, a former director of the Company. Dr. Herndon is committed to sourcing sustainable solutions in the field of health care in Africa, and has been involved since the 1990s on health-care related issues in Africa. The Company and GBOIG are working with the ministries of health in African countries to provide better access to and public awareness of the prevention, diagnosis and treatment of cancer and chronic infectious diseases. The Company plans to work with onsite clinics to complete patient assessments at little or no cost and prescribe treatments used to stimulate the immune system of the patients with various chronic diseases, especially HIV/AIDS and/or cancer.

In September 2012, the Company announced an agreement to open an outpatient's clinic at Queen Elizabeth Central Hospital in Malawi for the treatment of cancer and infectious diseases with GBOIG. Once the facility is operational, AHAR has agreed to assist in the operation of the clinic in Malawi and the implementation of the Company’s therapies. The contract with the Republic of Malawi calls for delivery of 25,000 pills a day, increasing to 500,000 pills a day within 24 months. On April 16, 2014, The Malawi Pharmacy, Medicines and Poisons Board, the drug regulator authority of the government of Malawi, approved the marketing and sale of the Company’s LDN product in Malawi. The Company expects to commence sales and operations in Malawi before the end of 2014.

In October 2013, the Company announced the signing of an exclusive distribution agreement with AHAR Pharma, a Nigerian company, to market Lodonal™, in Nigeria for the treatment of autoimmune diseases and cancer. Dr. Richard Afonja formed AHAR Pharma in 2013 for the sole purpose of marketing the Company’s therapies. Dr. Afonja is a Hematologist/Oncologist and the Founder and CEO of a number of medical operations in both the United States and Nigeria for the treatment of cancer and blood disorders. AHAR Pharma intends to distribute Lodonal™ through a local distributor network, an Internet client base and directly to hospitals, pharmacists and doctors in Nigeria. The Company expects to implement the agreement in 2014, and expects to treat up to 500,000 patients per day within a year of implementation.

On October 18, 2012, the Company and Qianjiang Pharmaceutical signed a Venture Cooperation Agreement on New Drug Methionine Enkephalin (the “Venture Agreement”) pursuant to which Qianjiang Pharmaceutical acquired an exclusive license for the production of MENK in China. The Venture Agreement requires that Qianjiang Pharmaceutical conduct drug research and pilot testing for MENK, organize pre-clinical studies, and apply for clinical trials for MENK with the Chinese State Food and Drug Administration. Under the Venture Agreement, Qianjiang Pharmaceutical must open a co-administration account for the development of MENK in China. Qianjiang Pharmaceutical must pay the Company, upon the marketing of MENK products, a half-year amount equaling 6% of its gross sales from MENK of the preceding half year. The Company signed a Supplementary Agreement in March 2014, obligating the Company to provide to Qianjiang Pharmaceutical the Company’s research materials, data and trial results to date so that Qianjiang Pharmaceutical can begin conducting basic studies and clinical trials in China. Under the Venture Agreement, as amended, Qianjiang Pharmaceutical will fund the subsequent studies in China. On August 6, 2014, the Company entered into a Supplementary Agreement on New Drug Methionine – Enkephalin Cooperation (the “Amendment”) with Qianjiang Pharmaceutical, amending the Venture Agreement, as amended. The parties executed the Amendment to accelerate clinical trials in both the United States and China, and agreed to immediately initiate three month Good Laboratory Practice (“GLP”) Toxicology Studies (rat and dog) within 30 days of signing the Amendment. The Amendment requires that the GLP Toxicology Studies Trials are conducted in China in accordance with international standards and standards acceptable to the U.S. Food and Drug Administration Pursuant to the Amendment, Qianjiang Pharmaceutical will make certain funds available from the co-administrative account, opened by Qianjiang Pharmaceutical pursuant to the Venture Agreement, in accordance with an approved budget and timeline set forth in the Amendment. A portion of these funds are expected to be used by Cytocom Inc. to run PK and Dosing trials for MENK in the United States.

In February 2013, the Company entered into a Strategic Framework Agreement with Qianjiang Pharmaceutical. The agreement calls for the parties to co-develop new cancer drugs based on the Company’s patents and licenses involving MENK, which when approved will be marketed in China under the brand name IRT-101 and IRT-102.

On August 6, 2014, Professor Fengping Shan Ph.D., a former member of the Company’s Board of Directors, executed an Assignment pursuant to which he transferred his entire right, title and interest in and to the following listed Patents and/or Patent Applications in China to the Company: (1) CN 200710158742.7 Met-enkephalin, its application in in treating leukemia and other blood cancers; (2) CN 200710051586.4 Met-enkephalin, its application in preparation of human and animal vaccine; (3) CN 200610046249.1 A nasal spray formulation containing Met-enkephalin; (4) CN 201210290150.1 Low dose naltrexone, combined with MENK, its application in preparation of anticancer drug; (5) CN 201210302259.2 Low dose naltrexone, combined with MENK, its application in preparation of leukophoresis for anticancer; (6) CN 200810229085.5 Conpound met-enkephalin as a drug for colon cancer and pancreatic cancer using a method of by isolating and enriching a patient’s own immune cells and following an enriching external incubation are transfused back into the patient thereby providing the patient with a passive immunity containing large amounts of auto-amplified immune cells that combat cancer cells; (7) CN 200910011030.1 Naltrexone; and (8) CN 201210302259 Application of combination of low-dose naltrexone and methionine-enkephalin to preparation of anti-cancer drug.

The Company is focused on our lead therapies designed for the treatment of cancer, HIV/AIDS, Crohn’s disease, fibromyalgia and multiple sclerosis. Management believes the pharmaceutical industry is eager to acquire advanced clinical-phase and approved products. However, despite the strong demand for advanced clinical-phase products, nearly 4,000 known compounds have had their development suspended in phase II or earlier. Many of these are promising therapeutic drug candidates, but their development was discontinued because of strategic or financial constraints rather than for clinical reasons. Therefore, management believes there are clear market opportunities with a significant amount of unmet needs and a robust potential for partnering activities.

Distribution and Production

The Company has entered into a contract for the supervision and inspection of manufacturing processes with ViPharma. The supervision and manufacturing agreement provides ViPharma with exclusive rights to supervise and inspect all manufacturing processes of IRT-103 LDN in Latin America. The initial term of the agreement is ten years commencing in September 2013, with automatic five-year renewal terms provided neither party is in breach. The agreement may be terminated by (i) mutual agreement, (ii) in the event of a breach after a 45 day cure period or (iii) by either party upon provision of written notice at least 90 days before the end of the agreement, provided however that if the Company terminates the agreement without cause it will be required to pay ViPharma a $10 million penalty.

The Company executed a manufacturing agreement with Laboratorios Ramos, a facility meeting the U.S. Food and Drug Administration enforced Current Good Manufacturing Practice regulations (“cGMP”), for IRT-103 LDN effective August 16, 2013. Under the agreement, Laboratorios Ramos will produce IRT 103 LDN tablets, capsules and/or cream in accordance with the technical specifications provided by the Company, cGMPs and the practices of Nicaragua and of any other regulatory body of the countries where the products will be exported. Laboratorios Ramos has obtained all permits and licenses necessary to carry out the manufacturing of IRT 103 LDN.

The manufacturing agreement has a five-year term, renewable by a signed agreement by the parties at least 60 days before the expiration of the agreement. The agreement may be terminated earlier through mutual agreement or upon expiration of a 30-day cure period following notice from the non-breaching party to the breaching party of a material failure of the obligations under the agreement. Additionally, the Company may terminate the agreement upon at least 30 days written notice if Laboratorios Ramos does not act in strict accordance with the technical specifications provided by the Company and with cGMPs or those of any regulatory body of the importing countries. The Company will pay Laboratorios Ramos a low single digit cent amount per tablet or capsule and a low double-digit cent amount per each cream produced.

In October 2013, the Company announced the signing of a distribution agreement with AHAR Pharma, a Nigerian company, to market Lodonal™, in Nigeria for the treatment of autoimmune diseases and cancer. The agreement gives AHAR Pharma exclusive rights to sell to customers in the private sector, and non-exclusive rights to sell to customers in the public sector, AHAR Pharma intends to distribute Lodonal™ through a local distributor network, an Internet client base and directly to hospitals, pharmacists and doctors in Nigeria. Under the agreement, the Company is obligated to provide delivery of an initial supply of between 0.5 million and 1.0 million doses of Lodonal™ product per day to cover AHAR Pharma’s purchase commitments in 2015.

On June 11, 2014, the Company’s wholly-owned subsidiary, Airmed Biopharma Limited (“Airmed”), entered into a Distribution Agreement with PanAm Global Logistics, Inc. (“Distributor”) pursuant to which Distributor will purchase from Airmed low-dose naltrexone under the name Lodonal™ for resale in Brazil, Colombia, Costa Rica, Dominican Republic, Ecuador, Guatemala, Panama, Venezuela, Republic of Malawi, and Egypt, and such other countries as may be added in accordance with the agreement. Pursuant to the agreement, Airmed agreed to supply Lodonal™ to Distributor for a price of $1.00 per pill ($30 per carton) at a twenty-five percent discount. The term of the agreement is five years and may be extended for an additional five-year period, subject to agreement between the parties on certain target sales requirements for the additional five-year term. Simultaneously with the execution of the agreement, Distributor purchased five thousand cartons of Lodonal™ for $150,000.

Subsidiaries

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

In 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 low dose naltrexone (“LDN”) in those countries we have been able to obtain approval.

In December 2013, the Company formed a new subsidiary, Cytocom Inc. ("Cytocom"), to focus on conducting LDN and Methionine [Met5]-enkephalin (“MENK”) clinical trials in the United States. The Company expects that the manufacturing of our therapies and their subsequent distribution into emerging nations will continue to be operated directly through the Company. The Company initially entered into consulting arrangements with Dr. Graham Burton, M.D., Ph.D., and Mr. Gary G. Gemignani, to focus on the clinical advancement of LDN and MENK through Cytocom. Effective April 1, 2014, Dr. Burton was appointed President and Chief Executive Officer of Cytocom. On the same date, Mr. Gemignani was appointed Chief Operating Officer, Chief Financial Officer and Executive Vice President of Cytocom. Dr. Burton will be responsible for leading Cytocom’s global development, clinical research and medical initiatives. Mr. Gemignani was expected to be responsible for operational and business development activities and financial management of Cytocom; however, he resigned from his positions with Cytocom.

In March 2014, the Company incorporated Airmed, which was set up to benefit from incentives granted by the Irish government for the establishment of pharmaceutical companies (8 out of 10 of the world’s leading pharmaceutical companies have located in Ireland), and because Ireland is a member of the European Union and the European Economic Area (the “Euro Zone”). 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.

Research and Development

The Company's research and development ("R&D") activities commenced in the third quarter of 2012, the Company having only completed the initial acquisition of MENK-related patents required for research in the second quarter of that year. In 2013 we continued to build R&D organization and capabilities focusing primarily on new uses for opioid-related immuno-therapies, such as LDN and MENK. Those activities continued in the first quarter of 2014.

Our R&D priorities include development of IRT-101 or MENK, a small synthetic peptide that is naturally occurring in the body, and IRT-103 LDN, an opioid receptor antagonist. Our pipeline provides two therapies with a wide range of indications that can be pursued. We believe that both molecules have the ability to stimulate the immune system in order to treat a variety of autoimmune diseases including multiple sclerosis, immune disorders such as Crohn’s disease, cancer, and viral infections such as HIV/AIDS.

Our R&D is overseen and managed internally, working with individuals, universities, and contract research organizations in order to utilize patents that we have licensed or acquired since our inception. We continue to seek to expand our pipeline of patents by reviewing other compounds, technologies or capabilities. We also seek out promising compounds and innovative technologies developed by third parties to incorporate into our discovery and development processes or projects.

Drug discovery and development is time-consuming, expensive and unpredictable. According to PhRMA, out of 5,000-10,000 screened compounds, only 250 enter preclinical testing, five enter human clinical trials and one is approved by the FDA. The process from early discovery or design to development to regulatory approval can take more than 10 years. Drug candidates can fail at any stage of the process, and candidates may not receive regulatory approval even after many years of research.

As of September 30, 2014, we had two compounds (IRT-101 and IRT-103) in research and development. We currently have two active development programs in oncology and Crohn’s disease; both of which are expected to move into Phase 3 clinical trials in the first half of 2014.

Results of Operations – Three Months Ended September 30, 2014

Revenue

The Company reported no revenues in the three months ended September 30, 2014 and 2013.

The Company expects to derive revenues in 2014 from the sale of its products in Malawi and Nigeria under distribution and partnership agreements previously announced.

Direct Expenses and Gross Margin

The Company incurred no direct expenses in the three months ended September 30, 2014 and 2013. In the future, direct expenses will include the cost of finished products to be purchased from the Company’s contract manufacturers, sales incentives, associated travel, and inventory return charges.

Gross margin, which is gross profit as a percent of revenue, will be affected by a number of factors, including the type of product sold and the geographic region in which the sale is made.

Research and Development

The Company makes significant investments in R&D in support of ongoing proprietary product development programs to support our pipeline of new drug candidates.

R&D expenses consist of salaries and benefits paid to employees directly engaged in research, payments made in cash or in kind to contractors for services directly related to research and product development, product development costs, payments made for patents and licenses to which the Company has acquired rights to use, and travel, telecommunications, facilities and external legal costs incurred in relation to research activities.

We do not collect costs on a product basis or for any category of product involved in carrying out research projects. While we do perform cost calculations to facilitate our internal evaluation of individual products, these calculations include significant estimations and allocations that are not relevant to, or included in, our external financial reporting mechanisms. As a consequence, we do not report research and development costs at the product level.

Operating Expenses

Selling, general and administrative expenses primarily include salary and benefit costs for employees and contractors included in our sales, marketing, finance, legal and administrative organizations, professional services, insurance, unallocated travel expenses, telecommunications, and office expenses. Professional services consist principally of recruiting costs, external legal, audit, tax and other consulting services.

Other Expenses, Net

Other expenses, net consists primarily of interest income on cash balances, interest expense on borrowings. Interest expense will vary periodically depending on prevailing short-term interest rates.

Loss on settlement of debt

Loss on settlement of debt comprises the cost of issuance of common stock for the retirement of principal and accrued interest on promissory notes.

Critical Accounting Policies

The preparation of financial statements and related disclosures in conformity with U.S. generally accepted accounting principles (“GAAP”) and the Company’s discussion and analysis of its financial condition and operating results require the Company’s management to make judgments, assumptions, and estimates that affect the amounts reported in its consolidated financial statements and accompanying notes. Note 1, “Summary of Significant Accounting Policies” of the Notes to Consolidated Financial Statements in this Form 10-Q describes the significant accounting policies and methods used in the preparation of the Company’s consolidated financial statements. Management bases its estimates on historical experience and on various other assumptions it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities.

We have identified the policies below as critical to our business operations and the understanding of its results of operations. The Company’s senior management has reviewed these critical accounting policies and related disclosures with the Company’s Board of Directors. The impact and any associated risks related to these policies on our business operations are discussed throughout this section where such policies affect our reported and expected financial results. Our preparation of financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of our financial statements, and the reported amounts of revenues and expenses during the reporting period. There can be no assurance that actual results will not differ from those estimates and such differences may be material.

Cash and Cash Equivalents

We consider all highly liquid debt instruments and other short-term investments with a maturity of three months or less to be cash equivalents.

Net Loss Per Share of Common Stock

The basic net loss per common share is computed by dividing the net loss by the weighted average number of common shares outstanding. Diluted net loss per share gives effect to all dilutive potential common shares outstanding during the period using the “as if converted” basis.

Uncertainty in Income Taxes

We follow Accounting Standards Codification (“ASC”) 740-10, Accounting for Uncertainty in Income Taxes (“ASC 740-10”). This interpretation requires recognition and measurement of uncertain income tax positions using a “more-likely-than-not” approach. ASC 740-10 is effective for fiscal years beginning after December 15, 2006. The Company has adopted ASC 740-10 and evaluates its tax positions on an annual basis.

Three Months Ended September 30, 2014 Compared to Three Months Ended September 30, 2013

Revenues

We had no revenues from operations for the three months ended September 30, 2014 and 2013. We anticipate having revenues in the fourth quarter of 2014.

Operating Expenses

Selling, general and administrative

Selling, general and administrative expenses and related percentages for the three months ended September 30, 2014 and 2013 were as follows (dollar amounts in thousands):

	2014			2013
Selling, general and administrative	$	902		$	1,290
Increase/(decrease) from prior year	$	(388)		$	1,013
Percent increase/(decrease) from prior year		(30)	%		100	%

For the three months ended September 30, 2014 and 2013, selling, general and administrative expenses were made up as follows (dollar amounts in thousands):

	2014		2013
Stock listing and investor relations expenses	$	93	$	18
Consulting and contractors		196		467
Payroll		304		316
Professional fees		94		298
Travel		61		78
Insurance		23		-
Other expenses		131		113
Charitable donations		-		-
	$	902	$	1,290

In the three months ended September 30, 2014, total cash and cash accruals for selling, general and administrative expense was $902 compared to $1,290 for the corresponding period in 2013, a decrease of $388 or 30%. Significant cash items included:

●	consulting and contactor services obtained to assist the Company in raising capital, manage investor relations, and develop business in new markets, in the amount of $196 in 2014, a decrease of $271 or 58% over the $467 spent in 2013;
●	professional fees for legal, tax and accounting services in the amount of $94 in 2014, a decrease of $204 or 68% over the $298 spent in 2013;
●	payroll in the amount of $304 in 2014, a decrease of $12 or 4% over the $316 spent in 2013; and
●	travel in the amount of $61 in 2014, a decrease of $17 or 22% over the $78 spent in 2013.

Research and development

R&D expenses and related percentages for the three months ended September 30, 2014 and 2013 were as follows (dollar amounts in thousands):

	2014			2013
Research and development	$	401		$	641
Increase/ (decrease) from prior year	$	(240)		$	614
Percent increase / (decrease) from prior year		(37%	)		100%

Expenses for research and development in the three months ended September 30, 2014 decreased by 37% compared to expenses in the same period in 2013. The decrease occurred mainly as a result a reduction in the cost of stock payments for licenses, purchases of materials for R&D, and legal fees paid to maintain patents and licenses.

In the three months ended September 30, 2014, total cash spent on R&D was $401, a decrease of $240 or 37% over the $641 spent in the same period in 2013. Significant cash items included:

●	payments for contracted technical services, $122 in 2014, a decrease of $299 or 71% over the $421 spent in 2013, reflecting the decreased use of contractors to perform some of our research activities;
●	payments for professional fees $22 in 2014, a decrease of $39 or 76% over the $51 spent in 2013;
●	payroll $65 in 2014, a decrease of $9 or 12% over the $74 spent in 2013, reflecting loss of our chief research officer in 2013.

Approximately 75% of the R&D spending in both 2014 and 2013 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 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.

Amortization of accrued liabilities for stock issued for services G&A and related percentages for the three months ended September 30, 2014 and 2013 were as follows (dollar amounts in thousands):

	2014			2013
Prepaid consulting services G&A	$	4,947		$	11,330
Percentage increase/(decrease) from prior year		(56%	)		100%

The decline in expense reflects the decrease in the price of the Company’s stock year over year and the fact that the cost of shares issued for services had been fully amortized prior to the third quarter of 2014.

The number of shares issued for prepaid consulting services G&A in the three months ending September 30, 2014 was 9,250,000 (2,595,000 in the corresponding period in 2013).

Prepaid consulting services G&A in the three months ended September 30, 2014 consisted of the following:
Amortization of cost of stock issued prior to 2014 under G&A consulting contracts	$	1,414
Amortization of cost incurred for new stock issued in the three months ended September 30, 2014 under G&A consulting contracts entered into in 2013		653
Amortization of cost incurred for new stock issued in the three months ended September 30, 2014 under consulting contracts entered into in 2014		2,880

Amortization of stock issued for services R&D and related percentages for the three months ended September 30, 2014 and 2013 were as follows (dollar amounts in thousands):

	2014			2013
Prepaid consulting services R&D	$	-		$	5,772
Percentage increase/(decrease) from prior year		(100%	)		100%

The decline in expense reflects the fact that the cost of shares issued for services have 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, 2014 (400,000 issued in the corresponding period in 2013).

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, 2014, the Company issued 500,000 warrants to stockholders at an exercise price range of $0.50 to $1.50, for which it recorded an expense of $115. In the three months ended September 30, 2013, the Company issued 2,272,809 warrants to stockholders at an exercise price rangeof $1.00 to $1.50, for which it recorded an expense of $2,521.

Depreciation and amortization

The Company amortizes the costs incurred to acquire patents and licenses over the period of the related agreements. The increase year over year in depreciation and amortization expense reflects the fact that most of the Company's patents and licenses were acquired after October 1, 2012.

Depreciation and amortization expenses for the three months ended September 30, 2014 and 2013 were as follows (dollar amounts in thousands):

	2014		2013
Depreciation expense	$	1	$	0
Amortization expense	$	719	$	719
Increase from prior year	$	1	$	708
Percentage increase/(decrease) from prior year		0%		100%

Interest Expense

Interest expense for the three months ended September 30, 2014 and 2013 were as follows (dollar amounts in thousands):

	2014		2013
Interest expense	$	94	$	205
Increase/(decrease) from prior year	$	(111)	$	205
Percentage decrease from prior year		(54)%		100%

Interest expenses are comprised of loan origination fees and interest owed by the Company. In 2013, interest expense included origination fees of $90. There were no origination fees paid in 2014.

Loss on settlement of debt

In three months ended September 30, 2014, 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 $4,022,957, reflecting the fair value of the shares of common stock issued in exchange for the debt. There was no corresponding expense in three months ended September 30, 2013.

Nine months Ended September 30, 2014 Compared to Nine months Ended September 30, 2013

Revenues

We had no revenues from operations for the nine months ended September 30, 2014 and 2013. We anticipate having revenues in the second half of 2014.

Operating Expenses

Selling, general and administrative

Selling, general and administrative expenses and related percentages for the nine months ended September 30, 2014 and 2013 were as follows (dollar amounts in thousands):

	2014			2013
Selling, general and administrative	$	3,264		$	4,142
Increase/(decrease) from prior year	$	(878	)	$	3,550
Percent increase/(decrease) from prior year		(21	)%		100	%

For the nine months ended September 30, 2014 and 2013, selling, general and administrative expenses were made up as follows (dollar amounts in thousands):

	2014			2013
Stock listing and investor relations expenses	$	429		$	55
Consulting and contractors		1,171			1,131
Payroll		915			795
Professional fees		805			827
Travel		229			311
Insurance		86			-
Other expenses		379			273
Charitable donations		(750	)		750
	$	3,264		$	4,142

The decrease year over year in selling, general and administrative expense was attributable primarily to the return of stock previously issued for charitable donations.

In the nine months ended September 30, 2014, total cash and cash accruals for selling, general and administrative expense was $3,264 compared to $4,142 for the corresponding period in 2013, a decrease of $878 or 21%. 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 $1,171 in 2014, an increase of $40 or 4% over the $1,131 spent in 2013;
●	professional fees for legal, tax and accounting services in the amount of $805 in 2014, a decrease of $22 or 3% over the $827 spent in 2013;
●	payroll in the amount of $915 in 2014, an increase of $120 or 15% over the $795 spent in 2013; and
●	travel in the amount of $229 in 2014, a decrease of $82 or 26% over the $311 spent in 2013.

Research and development

R&D expenses and related percentages for the nine months ended September 30, 2014 and 2013 were as follows (dollar amounts in thousands):

	2014			2013
Research and development	$	1,472		$	1,579
Increase/(decrease) from prior year	$	(107)		$	118
Percentage increase/(decrease) from prior year		(7)	%		8%

Expenses for research and development in the nine months ended September 30, 2014 decreased by 7% compared to expenses in the same period in 2013. The decrease occurred mainly as a result decreases in the cost of stock payments for licenses, purchases of materials for R&D, and legal fees paid to maintain patents and licenses.

In the nine months ended September 30, 2014, total cash spent on R&D was $1,472, a decrease of $107 or 7% over the $1,579 spent in the same period in 2013. Significant cash items included:

●	payments for contracted technical services, 441 in 2014, a decrease of $416 or 49% over the $857 spent in 2013, reflecting the decreased use of contractors to perform some of our research activities;
●	purchases of supplies and materials used in research activities, $181 in 2014, an increase of $181 or 100% over the $0 spent in 2013; and
●	payroll, $251 in 2014, a decrease of $76 or 23% over the $327 spent in 2013, reflecting loss of our chief research officer in 2013.

Approximately 75% of the R&D spending in both 2014 and 2013 was on the development of LDN; the balance was spent on MENK.

Stock issued for services

Amortization of accrued liabilities for stock issued for services G&A and related percentages for the nine months ended September 30, 2014 and 2013 were as follows (dollar amounts in thousands):

	2014			2013
Prepaid consulting services G&A	$	17,021		$	22,388
Percentage increase/(decrease) from prior year		(24%	)		100%

The number of shares issued for prepaid consulting services G&A in the nine months ending September 30, 2014 was 16,390,000 (6,528,000 in the corresponding period in 2013).

Prepaid consulting services G&A in the nine months ended September 30, 2014 consisted of the following:
Amortization of cost of stock issued prior to 2014 under G&A consulting contracts	$	7,857
Amortization of cost incurred for new stock issued in thenine months ended September 30, 2014 under G&A consulting contracts entered into in 2013		2,979
Amortization of cost incurred for new stock issued in the nine months ended September 30, 2014 under G&A consulting contracts entered into in 2014		6,185

Amortization of accrued liabilities for stock issued for services R&D and related percentages for the nine months ended September 30, 2014 and 2013 were as follows (dollar amounts in thousands):

	2014			2013
Prepaid consulting services R&D	$	5,036		$	13,931
Percentage increase/(decrease) from prior year		(64%	)		100%

The decline in expense in 2014 reflects the reduction of the accrued liability of all shares issued for services that had been fully amortized prior to 2014.

There were no new shares issued for prepaid consulting services R&D in the nine months ending September 30, 2014 (3,700,000 issued in the corresponding period in 2013).

Prepaid consulting services R&D in the nine months ended September 30, 2014 consisted of the following:
Amortization of cost of stock issued prior to 2014 under R&D consulting contracts	$		5,036
Amortization of cost incurred for new stock issued in the three months ended September 30, 2014 under R&D consulting contracts entered into in 2013		-
Amortization of cost incurred for new stock issued in the three months ended September 30, 2014 under R&D consulting contracts entered into in 2014		-

Warrant valuation expense

In the nine months ended September 30, 2014, the Company issued 1,948,000 warrants to stockholders at an exercise price range of $0.50 to $1.50, for which it recorded an expense of $2,102. In the nine months ended September 30, 2013, the Company issued 2,567,918 warrants to stockholders at an exercise price range of $1.00 to $1.50, for which it recorded an expense of $6,932.

Depreciation and amortization

Depreciation and amortization expenses for the nine months ended September 30, 2014 and 2013 were as follows (dollar amounts in thousands):

	2014			2013
Depreciation expense	$	2		$	1
Amortization expense	$	2,157		$	2,133
Increase from prior year	$	24		$	2,122
Percentage increase/(decrease) from prior year		1	%		100	%

Interest Expense

Interest expense for the nine months ended September 30, 2014 and 2013 were as follows (dollar amounts in thousands):

	2014			2013
Interest expense	$	376		$	1,099
Increase/(decrease) from prior year	$	(635)		$	1,099
Percentage increase/(decrease) from prior year		(58)	%		100	%

Interest expenses are comprised of loan origination fees and interest owed by the Company. In 2013, interest expense included origination fees of $223. There were no origination fees paid in 2014.

Loss on settlement of debt

In nine months ended September 30, 2014, 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 $4,022,957, reflecting the fair value of the shares of common stock issued in exchange for the debt. There was no corresponding expense in three months ended September 30, 2013.

Liquidity

Liquidity is measured by our ability to secure enough cash to meet our contractual and operating needs as they arise. We do not anticipate generating sufficient net positive cash flows from our operations to fund the next twelve months. We had cash of $58,585 at September 30, 2014, compared to $207,709 at September 30, 2013.

We do not expect that our cash reserves will be sufficient to meet our operational needs and we will need to raise additional capital to pay for our operational expenses and provide for capital expenditures. In addition to the Company's operational expenses, which are estimated at $450,000 per month, we estimate that we need approximately $7-15 million in the next twelve months to fully develop our products and for Phase III clinical trials for Crohn’s disease. If we are not able to raise additional working capital, we may have to cease operations altogether.

For the nine months ended September 30, 2014 and 2013, net cash used in operating activities from operations was $3,089,097 and $4,456,111, respectively. For the nine months ended September 30, 2014 and 2013, net cash used in investing activities from operations was $99,843 and $164,889, respectively. In the nine months ended September 30, 2013, the Company spent $160,539 in payments for licenses from Penn State University

During the nine months ended September 30, 2014 proceeds from the sale of stock and exercise of stock warrants totaled $1,799,262 compared to $4,171,613 for the corresponding period in 2013. We also received $1,210,000 from the issuance of notes payable in nine months ended September 30, 2014, compared to $449,000 in 2013.

Our ability to continue as a going concern is dependent entirely on raising funds through the sale of equity or debt. We anticipate that we will continue our attempt to raise capital through private equity and debt transactions, develop a credit facility with a lender, or the exercise of options and warrants; however, such additional capital may not be available to us at acceptable terms or available at all. In the event that we are unable to obtain additional capital, we would be forced to cease operations altogether.

Off-Balance Sheet Arrangements

During the nine months ended September 30, 2014 and 2013, 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, 2014, 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, 2014, 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

In February 2014, a claim was filed for breach of contract and unjust enrichment in the Circuit Court for Montgomery County, Maryland, E.J. Krause & Associates, Inc. v. TNI BioTech, Inc., in which the named plaintiff claims that the Company breached a sub-sublease. The plaintiff seeks damages in excess of $75,000, along with costs, attorneys’ fees, pre-judgment interest, post-judgment interest, and any further relief the court finds appropriate. The Company is currently in settlement negotiations with the plaintiff regarding these claims.

ITEM 1A. RISK FACTORS

Not Applicable.

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

Between January 1, 2014 and September 30, 2014, various warrant holders exercised their warrants for an aggregate of 918,750 shares of the Company at an exercise price of $0.50 per share. In addition, the Company sold an aggregate 6,373,410 shares of its common stock at $0.28 per share. In total, the Company received $2,474 as consideration for the exercise of the previously-issued warrants and $1,758 for the purchase of common stock under the Private Placement, for an aggregate sum of $4,232.

The issuances of the Company’s securities in connection with the warrants exercises and Private Placement 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 purchased pursuant to the warrant exercises and the shares and warrants purchased in the Private Placement were issued bearing restrictive legend and may not be resold by the purchasers 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.

In the nine months ended September 30, 2014, the Company issued a total of 22,719,000 shares, at an average price of $0.65 per share, and five-year warrants, with an average exercise price of $1.00, in accordance with consulting agreements entered into in 2013 and 2014. The consulting agreements cover the provision of product and market development services, business development and strategy services, and investor and media relations services to the Company.

The issuances of the Company’s common stock and warrants for consulting services 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. The securities were issued bearing restrictive legend and may not be resold by the holders unless such shares are registered or an exemption from registration is available.

In the nine months ended September 30, 2014, the Company issued a total of $20,848,767 shares, at a price range of $0.10 to $0.25 per share settle amounts owed under notes payable, including accrued and unpaid interest as applicable, to common stock as repayment of the notes.

In the nine months ended September 30, 2014, the Company issued a total of 1,838,683 shares, at prices between $0.08 and $0.25 per share settle amounts owed to certain of the Company’s vendors.

The issuances of the Company’s common stock for conversion of notes payable and amounts owing to vendors 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. The securities were issued bearing restrictive legend and may not be resold by the holders unless such shares are registered or an exemption from registration is available.

ITEM 3. DEFAULTS UPON SENIOR SECURITIES

None.

ITEM 4. MINE SAFETY DISCLOSURES

Not applicable.

ITEM 5. OTHER INFORMATION

On December 18, 2012, the Company signed an agreement for the acquisition of patent rights (the “Smith Agreement”) for the intellectual property of Dr. Jill Smith and LDN Research Group LLC (collectively, the “Licensor Parties”) and orphan drug designation by the U.S. Food and Drug Administration to a novel late-stage drug, trademarked “LDN,” for the treatment of Pediatric Crohn’s disease. The patent covers methods and formulations for treatment of the inflammatory and ulcerative diseases of the bowel, using naltrexone in low doses as an opioid antagonist. On September 24, 2014, the Company and the Licensor Parties jointly agreed to terminate the Smith Agreement, and in place thereof, have the Licensor Parties grant a similar license in their patent rights to Cytocom pursuant to a Patent License Agreement between the Licensor Parties, Cytocom and the Company with substantially similar terms as set forth in the Smith Agreement. Pursuant to this agreement, the Company issued 1,000,000 shares of its common stock and guaranteed the obligations of Cytocom to the Licensor Parties under the agreement.

ITEM 6. EXHIBITS

Exhibit Number		Name of Exhibit

10.1		Supplementary Agreement on New Drug Methionine-Enkephalin Cooperation between Hubei Qianjiang Pharmaceutical Co., Ltd, TNI Biotech, Inc. and Cytocom Inc. dated August 6, 2014 (incorporated by reference to Exhibit 1.1 to the Company’s Current Report on Form 8-K filed with the SEC on August 13, 2014).

10.2		Assignment by Professor Fengping Shan Ph.D. to TNI BioTech, Inc. dated August 6, 2014 (incorporated by reference to Exhibit 1.2 to the Company’s Current Report on Form 8-K filed with the SEC on August 13, 2014).

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.

31.2		Certification of Chief Financial 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.

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.

	TNI BioTech, Inc.

Date: November 14, 2014	By:	/s/ Noreen Griffin
		Noreen Griffin
		Chief Executive Officer

	TNI BioTech, Inc.

Date: November 14, 2014	By:	/s/ Peter Aronstam
		Peter Aronstam
		Chief Financial Officer