UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

(Mark One)

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

 

For the quarterly period ended March 31, 2018

 

OR

 

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

 

From the transition period from ___________ to ____________

 

Commission File Number __________________

 

IMMUNE THERAPEUTICS, INC.

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

 

Florida   59-3226705

(State or other jurisdiction of

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 [X] No [  ]

 

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

 

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

 

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

 

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

 

As of May 15, 2018 there were 395,726,040 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 27
     
Item 3. Quantitative and Qualitative Disclosures About Market Risk 32
     
Item 4. Controls and Procedures 32
     
  PART II - OTHER INFORMATION  
Item 1. Legal Proceedings 33
     
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 33
     
Item 3. Default upon Senior Securities 34
     
Item 6. Exhibits 36

 

2

 

 

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

 

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

 

  strategy;
  new product discovery and development;
  current or pending clinical trials;
  our products’ ability to demonstrate efficacy or an acceptable safety profile;
  actions by the FDA and other regulatory authorities;
  product manufacturing, including our arrangements with third-party suppliers;
  product introduction and sales;
  royalties and contract revenues;
  expenses and net income;
  credit and foreign exchange risk management;
  liquidity;
  asset and liability risk management;
  the outcome of litigation and other proceedings;
  intellectual property rights and protection;
  economic factors;
  competition; and
  legal risks.

 

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

 

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

 

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

 

  our lack of operating history;
  our current and future capital requirements and our ability to satisfy our capital needs;
  our inability to keep up with industry competition;

 

3

 

 

  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;
  our reliance on key personnel, including our ability to attract and retain scientists;
  legislation or regulation that may increase the cost of our business or limit our service and product offerings;
  risks related to our intellectual property, including our ability to adequately protect intellectual property rights;
  risks related to government regulation, including our ability to obtain approvals for the commercialization of some or all of our drug candidates, and ongoing regulatory obligations and continued regulatory review which may result in significant additional expense and subject us to penalties if we fail to comply with applicable regulatory requirements; and
  our ability to obtain regulatory approvals in foreign jurisdictions to allow us to market our products internationally.

 

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

 

JUMPSTART OUR BUSINESS STARTUPS ACT

 

We qualify as an “emerging growth company” as defined in Section 101 of the Jumpstart our Business Startups Act (“JOBS Act”) as we do not have more than $1,000,000,000 in annual gross revenue and did not have such amount as of December 31, 2018, the last day of our last fiscal year. We are electing to use the extended transition period for complying with new or revised accounting standards under Section 102(b)(1) of the JOBS Act.

 

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

 

  being permitted to present only two years of audited financial statements and only two years of related “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in this annual report;
  not being requested to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, as amended (“Sarbanes-Oxley Act”);
  reduced disclosure obligations regarding executive compensation in our periodic reports, proxy statements and registration statements; and
  exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved.

 

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

 

4

 

 

PART I - FINANCIAL INFORMATION

 

ITEM 1. FINANCIAL STATEMENTS

 

IMMUNE THERAPEUTICS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited)

 

    March 31, 2018     December 31, 2017  
ASSETS                
                 
Current Assets:                
Cash and cash equivalents   $ 30,401     $ 14,718  
Inventories     158,648       178,098  
Total current assets     189,049       192,816  
                 
Fixed Assets:                
Computer equipment, net of accumulated depreciation of $9,148 and $8,714 respectively     4,066       2,529  
Deposits     200       200  
                 
Total assets   $ 193,315     $ 195,545  
                 
LIABILITIES AND STOCKHOLDERS’ DEFICIT                
                 
Current Liabilities:                
Accounts payable   $ 2,411,809     $ 2,319,932  
Accrued liabilities     2,842,822       2,489,404  
Notes payable, net of debt discount     5,166,047       4,820,063  
Derivative liability     931,519       1,669,532  
Total current liabilities     11,352,197       11,298,931  
                 
Total liabilities     11,352,197       11,298,931  
                 
Commitments and Contingencies (Note 11)                
                 
Stockholders’ Deficit:                
Common stock - par value $0.0001; 500,000,000 shares authorized; 389,846,113 and 386,782,473 shares issued and outstanding respectively     38,985       38,679  
Additional paid in capital     367,247,514       366,625,144  
Stock issuances due     31,992       103,226  
Prepaid services     (101,667 )     (226,667 )
Accumulated deficit     (373,645,836 )     (373,035,183 )
                 
Deficit attributable to common stockholders     (6,429,012 )     (6,494,801 )
Non-controlling interest     (4,729,870 )     (4,608,585 )
Total stockholders’ deficit     (11,158,882 )     (11,103,386 )
Total liabilities and stockholders’ deficit   $ 193,315     $ 195,545  

 

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

 

5

 

 

IMMUNE THERAPEUTICS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

 

    Three Months ended  
    March 31, 2018     March 31, 2017  
Revenues, net   $ 65,013     $ -  
Cost of products sold     33,172       -  
Gross profit     31,841       -  
Operating expenses:                
Selling, general and administrative     638,228       666,091  
Research and development expense     129,191       118,656  
Stock issued for services G&A     252,244       731,288  
Depreciation and amortization expense     433       144  
Total operating expenses     1,020,096       1,516,179  
                 
Loss from operations     (988,255 )     (1,516,179 )
                 
Other income (expense):                
Interest expense     (220,461 )     (575,828 )
Gain on Derivative Liability Revaluation     494,814          
Loss on settlement of debt     (18,036 )     (613,926  
Total other income (expense)     256,317 )     (1,189,754 )
Net loss   $ (731,938 )   $ (2,705,933 )
Net loss attributable to non-controlling interest     (121,285 )     (136,563 )
Net loss attributable to common shareholders     (610,653 )     (2,569,370 )
Basic loss per share to common shareholders   $ (0.00 )   $ (0.01 )
Weighted average number of shares outstanding     387,621,835       259,291,541  

 

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

 

6

 

 

IMMUNE THERAPEUTICS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ DEFICIT

FOR THE PERIOD ENDED MARCH 31, 2018

(Unaudited)

 

    Common Stock     Additional Paid-in     Stock To     Prepaid     Accumulated     Non-Controlling        
    Shares     Amount     Capital     Be Issued     Services     Deficit     Interest     Total  
                                                 
Balance December 31, 2017     386,782,473     $ 38,679     $ 366,625,144     $ 103,226     $ (226,667 )   $ (373,035,183 )   $ (4,608,585 )   $ (11,103,386 )
                                                                 
Issuance of common stock for services     2,863,640       286       198,191       (71,234 )     -       -       -       127,243  
                                                                 
Amortization of prepaid services     -       -       -               125,000       -       -       125,000  
                                                                 
Issuance of common stock in exchange for debt     -       -       243,199       -       -       -       -       243,199  
                                                                 
Issuance of common stock for interest     200,000       20       5,980       -       -       -       -       6,000  
                                                                 
Issuance of Cytocom common stock for sale and exercise of warrants     -       -       50,000       -       -       -       -       50,000  
                                                                 
Issuance and modification of common stock warrants     -       -       125,000       -       -       -       -       125,000  
                                                                 
Net loss     -       -       -       -       -       (610,653 )     (121,285 )     (731,938 )
                                                                 
Balance as of March 31, 2018     389,846,113       38,985       367,247,514       31,992       (101,667 )     (373,645,836 )     (4,729,870 )     (11,158,882 )

 

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

 

7

 

 

IMMUNE THERAPEUTICS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

 

    Three Months Ended  
    March 31, 2018     March 31, 2017  
CASH FLOWS FROM OPERATING ACTIVITIES                
Net loss   $ (731,938 )   $ (2,705,933 )
Adjustments to reconcile net loss to net cash flows used in operating activities:                
Depreciation     434       144  
Amortization of debt discount     100,318       35,346  
Amortization of stock issued for prepaid services     125,000       365,834  
Stock issued for services     127,243       365,455  
Change in value of derivative     (494,814 )     -  
Loss on settlement of debt     18,036       613,926  
Stock issued for origination fees and interest expense     6,000       -  
Expenses paid by lender     54,661       -  
                 
Changes in operating assets and liabilities:                
Inventories     19,450       -  
Accounts payable     78,199       138,840  
Accrued liabilities     241,595       656,958  
                 
Net cash used in operating activities     (455,816 )     (529,430 )
                 
CASH FLOWS FROM INVESTING ACTIVITIES                
Purchase of computer equipment     (1,971 )     -  
                 
 Net cash used in investing activities     (1,971 )     -  
                 
CASH FLOWS FROM FINANCING ACTIVITIES                
Proceeds from sale of stock and exercise of warrants     50,000       -  
Payment of notes payable     -       (321,846 )
Proceeds from issuance of notes payable     423,470       875,000  
                 
Net cash provided by financing activities     473,470       553,154  
                 
Net increase in cash and cash equivalents     15,683       23,724  
Cash and cash equivalents at beginning of period     14,718       74,389  
Cash and cash equivalents at end of period   $ 30,401     $ 98,113  

 

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

 

8

 

 

IMMUNE THERAPEUTICS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

 

    Three Months Ended  
    March 31, 2018     March 31, 2017  
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION:            
             
Cash paid for interest   $ 15,210     $ 13,000  
                 
SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING AND FINANCING ACTIVITIES:                
                 
Debt discount   $ 125,000     $ 50,000  
                 
Accrue shares to be issued for debt and accrued interest   $ 108,216     $ 362,700  
                 
Settlement of derivative liability   $ 243,199     $ -  
                 
Shares issued for accounts payable and accrued expenses   $ -     $ 339,339  
                 
Reclassification from debt to accounts payable   $ 17,284     $ -  
                 
Cashless exercise of warrants   $ -     $ 165  
                 
Estimated loss on debt conversion   $ -     $ 215,000  
                 
Loss on debt conversion   $ 18,036     $ -  

 

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

 

9

 

 

Immune Therapeutics, Inc. and Subsidiaries

Notes to the Condensed Consolidated Financial Statements

March 31, 2018

(Unaudited)

 

1. Organization and Description of Business

 

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

 

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

 

The Company currently operates out of Orlando, Florida. In July 2012, the Company’s focus turned to acquiring patents that would protect and advance the development of new uses of opioid-related immune- therapies, such as low dose naltrexone (“LDN”) and Methionine [Met5]-enkephalin (“MENK”). The Company’s therapies are believed to stimulate and/or regulate the immune system in such a way that they provide the potential to treat a variety of diseases. We believe our therapies may be able to correct abnormalities or deficiencies in the immune system in diseases such as HIV infection, autoimmune disease, immune disorders, or cancer; all of which can lead to disease progression and life-threatening situations when the immune system is not functioning optimally.

 

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

 

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

 

In December 2013, the Company formed a subsidiary, Cytocom Inc., to focus on conducting LDN and MENK clinical trials in the United States. In December 2014, the Company finalized the distribution of common stock of Cytocom Inc. to its shareholders. As part of the transaction, the Company transferred to Cytocom certain of its rights, title and interest in or relating to intellectual property (i) patents, patent applications, and all divisional, continuations and continuations-in-part thereof, together with all reissues, reexaminations, renewals and extensions thereof and all rights to obtain such divisionals, continuations and continuations-in-part, reissues, reexaminations, renewals and extensions, and all utility models and statutory invention registrations and any other such analogous rights, (ii) trademarks, service marks, Internet domain names, trade dress, trade styles, logos, trade names, services names, brand names, corporate names, assumed business names and general intangibles and other source identifiers of a like nature, together with the goodwill associated with any of the foregoing, and all registrations and applications for registrations thereof, together with all renewals and extensions thereof and all rights to obtain such renewals and extensions, (iii) copyrights, mask work rights, database and design rights, moral rights and rights in Internet websites, whether registered or unregistered and whether published or unpublished, all registrations and recordings thereof and all applications in connection therewith, together with all renewals, continuations, reversions and extensions thereof and all rights to obtain such renewals, continuations, reversions and extensions, and (iv) confidential and proprietary information, including, trade secrets and know-how. Cytocom licensed back to the Company a perpetual, non-exclusive, royalty-free right and license to use the assigned intellectual property for veterinary indications and for the marketing rights to emerging markets, access to all clinical data, use of the formulation for LDN and MENK. The parties have informally agreed that until such time as Cytocom was funded, the Company would be responsible for all payments to employees, ongoing general and administrative expenses, licensing fees, patent fees, and drug development costs. When Cytocom becomes self-sustaining and fully funded, it expects to reimburse the Company for all funds spent by the Company since the spin-out.

 

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On December 8, 2014, the number of Cytocom Inc. shares of common stock that were issued to our shareholders totaled 113,242,522 shares. In connection with the transaction, Cytocom Inc. issued 140,100,000 shares of its common stock to the Company, which gave the Company a 55.3% stake in Cytocom Inc. on that date. In April 2016, the Board of Directors and a majority of shareholders of Cytocom approved a reverse stock split of Cytocom’s outstanding common stock with one new share of stock for each twenty old shares of common stock. Cytocom effectuated and finalized the reverse split in June 2016. At December 31, 2017, the Company’s equity interest had been further reduced to 9.3%, by subsequent issuances of Cytocom common stock.

 

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

 

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

 

Cytocom Inc, is a clinical-stage pharmaceutical company focused on the development of the first affordable non-toxic immunodulator for the treatment of inflammatory diseases, immune-related disorders, and cancer and is responsible for the development of our patented therapies with the FDA and EMA.

 

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

 

Going Concern

 

The Company experienced a net loss from operations of $988,255, and used cash and cash equivalents for operations in the amount of $455,816 during the quarter ended March 31, 2018, resulting in stockholder’s deficit of $11,158,882 at that date.

 

The Company has incurred significant net losses since inception and has relied on its ability to fund its operations through private equity financings. Management expects operating losses and negative cash flows to continue at more significant levels in the future. As the Company continues to incur losses, transition to profitability is dependent upon the successful development, approval, and commercialization of its product candidate and the achievement of a level of revenues adequate to support the Company’s cost structure. The Company may never achieve profitability, and unless and until it does, the Company will continue to need to raise additional cash. Management intends to fund future operations through the sale of products, additional private or public debt or equity offerings, and it may also seek additional capital through arrangements with strategic partners or from other sources. Based on the Company’s operating plan, existing working capital at March 31, 2018 was not sufficient to meet the cash requirements to fund planned operations for the next 12 months without additional sources of cash. These conditions raise substantial doubt about the Company’s ability to continue as a going concern. The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern and do not include adjustments that might result from the outcome of this uncertainty. This basis of accounting contemplates the recovery of the Company’s assets and the satisfaction of liabilities in the normal course of business.

 

11

 

 

2. Summary of Significant Accounting Policies

 

Basis of Presentation

 

The consolidated financial statements included herein have been prepared by the Company, without audit, pursuant to the rules and regulations of the Securities and Exchange Commission. Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. generally accepted accounting principles have been omitted. However, in the opinion of management, all adjustments (which include only normal recurring adjustments, unless otherwise indicated) necessary to present fairly the financial position and results of operations for the periods presented have been made. The results for interim periods are not necessarily indicative of trends or of results to be expected for the full year. These financial statements should be read in conjunction with the financial statements of the Company for the year ended December 31, 2017 (including the notes thereto) set forth in Form 10-K.

 

The Company qualifies as an “emerging growth company” as defined in Section 101 of the Jumpstart our Business Startups Act (“JOBS Act”) as we do not have more than $1,000,000,000 in annual gross revenue for the year ended December 31, 2016. We are electing to use the extended transition period for complying with new or revised accounting standards under Section 102(b)(1) of the JOBS Act.

 

Revenue Recognition

 

We recognize revenue on sales to customers and distributors upon satisfaction of our performance obligations when the goods are shipped. For consignment sales, we recognize revenue when the goods are pulled from consignment inventory.

 

In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606). This standard provides a single set of guidelines for revenue recognition to be used across all industries and requires additional disclosures. It is effective for annual and interim reporting periods beginning after December 15, 2017. We believe the new standard will not have a material impact on our consolidated financial position and consolidated results of operations, as we do not expect to change the manner or timing of recognizing revenue on a majority of our revenue transactions once we commence revenue-generating activities.

 

Leases

 

In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842). This standard requires all leases that have a term of over 12 months to be recognized on the balance sheet with the liability for lease payments and the corresponding right-of-use asset initially measured at the present value of amounts expected to be paid over the term. Recognition of the costs of these leases on the income statement will be dependent upon their classification as either an operating or a financing lease. Costs of an operating lease will continue to be recognized as a single operating expense on a straight-line basis over the lease term. Costs for a financing lease will be disaggregated and recognized as both an operating expense (for the amortization of the right-of-use asset) and interest expense (for interest on the lease liability). This standard will be effective for our interim and annual periods beginning January 1, 2019, and must be applied on a modified retrospective basis to leases existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements. Early adoption is permitted. We are currently evaluating the timing of adoption and the potential impact of this standard on our financial position, but we do not expect it to have a material impact on our results of operations.

 

12

 

 

Use of Estimates

 

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

 

Cash, Cash Equivalents, and Short-Term Investments

 

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

 

Concentration of Credit Risk

 

Financial instruments that potentially subject the Company to concentrations of credit risk are primarily cash and cash equivalents. The Company is exposed to credit risk, subject to federal deposit insurance, in the event of a default by the financial institutions holding its cash and cash equivalents to the extent of amounts recorded on the balance sheets. The cash accounts are insured by the Federal Deposit Insurance Corporation up to $250,000. At March 31, 2018, the Company had no cash balances in excess of insured limits.

 

Segment and Geographic Information

 

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

 

Fair Value of Financial Instruments

 

In accordance with the reporting requirements of Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) Topic 825, “ Financial Instruments” , the Company calculates the fair value of its assets and liabilities which qualify as financial instruments under this standard and includes this additional information in the notes to the financial statements when the fair value is different than the carrying value of those financial instruments. Cash and accounts payable are accounted for at cost which approximates fair value due to the relatively short maturity of these instruments. The carrying value of notes payable also approximate fair value since they bear market rates of interest and other terms. None of these instruments are held for trading purposes.

 

Fair Value Measurements

 

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

 

Inventory

 

Inventories are stated at the lower of cost or market with cost based on the first-in, first-out (FIFO) method. Inventory that can be used in either the production of clinical or commercial products is expensed as research and development costs when identified for use in a clinical trials or clinical manufacturing campaigns.

 

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Fixed Assets

 

Fixed assets are stated at cost, less accumulated depreciation. Depreciation is determined on a straight-line basis over the estimated useful lives of the assets, which generally range from three to five years. Maintenance and repairs are charged against expense as incurred. Depreciation expense for the three months ended March 31, 2018 and March 31, 2017 was $433 and $144, respectively.

 

Impairment of Long-Lived Assets

 

The Company evaluates long-lived assets for impairment whenever events or change in circumstances indicate that the carrying amount of an asset may not be recoverable as prescribed by ASC Topic 360-10-05, “ Property, Plant and Equipment .” 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.

 

Research and Development Costs

 

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

 

Income Taxes

 

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

 

The standard addresses the determination of whether tax benefits claimed or expected to be claimed on a tax return should be recorded in the financial statements. Under ASC Topic 740, the Company may recognize the tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination by the tax authorities, based on the technical merits of the position. The tax benefits recognized in the financial statements from such a position should be measured based on the largest benefit that has a greater than fifty percent likelihood of being realized upon ultimate settlement. ASC Topic 740 also provides guidance on de-recognition, classification, interest and penalties on income taxes, accounting in interim periods and requires increased disclosures. At the date of adoption, and as of March 31, 2018 and 2017, the Company does not have a liability for unrecognized tax uncertainties.

 

The Company’s policy is to record interest and penalties on uncertain tax positions as income tax expense. As of March 31, 2018, and 2017, the Company has not accrued any interest or penalties related to uncertain tax positions.

 

In February 2018, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update No. 2018-02, Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income , which amends ASC Topic 220, Income Statement - Reporting Comprehensive Income. This ASU allows for tax effects in accumulated other comprehensive income resulting from the Tax Cuts and Jobs Act to be reclassified as retained earnings. This ASU is effective for fiscal years, and interim periods within those years, beginning after December 15, 2018. Early adoption is permitted. The Company is currently evaluating the effect this guidance may have on its financial position, results of operations, comprehensive income, cash flows and disclosures.

 

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

 

The Company measures and recognizes compensation expense for all share-based payment awards made to employees and directors, including employee stock options, based on estimated fair values equaling either the market value of the shares issued or the value of consideration received, whichever is more readily determinable. The majority of the non-cash consideration pertains to services rendered by consultants and others and has been valued at the fair value of the Company’s common stock at the date of the agreement.

 

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

 

Non-controlling Interest

 

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

 

Net Loss per Share of Common Stock

 

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

 

A calculation of basic net loss per share follows:

 

    For the three months ended
March 31,
 
    2018     2017  
Historical net loss per share:                
Numerator                
Net loss   $ (731,938 )   $ (2,705,933 )
Non-controlling interest     (121,285 )     (136,563 )
Net loss attributed to Common stockholders   $ (610,653 )   $ (2,569,370 )
                 
Denominator                
Weighted-average common shares outstanding—Denominator for basic net loss per share     387,621,835       259,291,541  
Basic net loss per share attributed to common stockholders   $ (0.00 )   $ (0.01 )

 

The Company’s potential dilutive securities, which include warrants, have been excluded from the computation of diluted net loss per share as the effect would be to reduce the net loss per share.

 

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

 

15

 

 

    For the three months ended
March 31,
 
    2018     2017  
Warrants to purchase Common stock     126,670,720       52,525,237  

 

Recent Accounting Standards

 

During the quarter ended March 31, 2018, there were several new accounting pronouncements issued by the Financial Accounting Standards Board. Each of these pronouncements, as applicable, has been or will be adopted by the Company. Management does not believe the adoption of any of these accounting pronouncements has had or will have a material impact on the Company’s consolidated financial statements.

 

3. Fixed Assets

 

    March 31, 2018     December 31, 2017  
Fixed Assets:                
Computer equipment   $ 13,214     $ 11,243  
Less accumulated depreciation     (9,148 )     (8,714 )
Fixed assets, net   $ 4,066     $ 2,529  

 

The Company utilizes the straight-line method for depreciation, using three to five-year depreciable asset lives. Depreciation expense was not material for all periods presented.

 

4. Accrued Liabilities

 

Accrued expenses and other liabilities consist of the following:

 

    March 31, 2018     December 31, 2017  
Accrued payroll to officers and others     1,693,945       1,539,777  
Accrued interest and penalties - notes payable     792,919       703,141  
Estimated legal settlements     136,057       136,057  
Other accrued liabilities     1,650       393  
Estimated loss on note conversions     218,251       110,036  
Derivative Liability     931,519       1,669,532  
                 
Total accrued expenses and other liabilities   $ 3,774,341     $ 4,158,936  

 

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5. Notes Payable

 

Notes payable consist of the following:

 

    March 31, 2018     December 31, 2017  
Promissory note issued July 29, 2014 to Ira Gaines. In 2016, the maturity date on the note was extended to December 1, 2017. As of March 31, 2018, the note is in default. The note earns interest at a rate of 18% per annum.   $ 100,000     $ 100,000  
                 
Promissory notes issued between November 26, 2014 and December 31, 2015, to raise up to $2,000,000 in debt. Lenders earn interest at a rate of 10% per annum, plus a pro-rata share of two percent of the Company’s gross receipts for sales of IRT-103-LDN in perpetuity. Notes will be repaid in 36 monthly installments of principal and interest commencing no later than October 15, 2015. Notes aggregating $286,000 were in default at March 31, 2018, as the Company was unable to pay installments on those notes on their due dates.     286,000       286,000  
                 
Promissory notes issued between May 1, 2015 and December 31, 2016, and maturing between June 14, 2015 and December 1, 2017. Lenders on loans aggregating $505,994 earn interest at rates between 2% and 18% per annum. On loans aggregating $200,000, interest is payable in a fixed amount not tied to a specific interest rate. Notes aggregating $705,994 were in default at March 31, 2018, as the Company was unable to repay those notes on their due dates.     705,994       705,994  
                 
Promissory notes issued by Cytocom Inc. between April 29, 2015 and December 31, 2015. Lenders earn interest at rates between 5% and 10% per annum. These notes mature on December 31, 2016. At March 31, 2018, the notes were in default.     425,000       425,000  
                 
Promissory notes issued to an officer of the Company effective November 3, 2015 and maturing November 3, 2016 for settlement of accrued payroll, bearing interest at 10% per annum and including a stock conversion feature. The Company was unable to repay the note at maturity and at March 31, 2018 the note was in default.     97,737       97,737  
                 
Promissory note issued in July 2016. The note was repayable on October 5, 2016 but was extended to December 31, 2016. The note earns interest at 6% per month. The Company was unable to repay the note at maturity and at March 31, 2018 the note was in default.     50,000       50,000  
                 
Promissory note for $180,000 was issued in July 2016 with an original issue discount of $30,000. The note is repayable on April 7, 2017. The Company was unable to repay the note at maturity and at March 31, 2018 the note was in default. Under the terms of the note, the principal amount was increased in 2017 to $243,000, and interest accrued at 25% per annum. $161,976 of principal and $20,025 of accrued interest were converted into 7,447,448 shares, of which 5,500,000 shares were issued at year end. The Company has accrued a $243,199 derivative liability for the $81,024 principal balance attributable to the conversion feature contained in this note. The Note was settled in the quarter ended March 31, 2018.     -       81,024  
                 
Promissory notes issued in August 2016 for $149,854 as a settlement of amounts owed to a law firm. The notes accrue interest at 5% per annum and are payable in 18 equal monthly installments of $8,642. The note was in default on March 31, 2018. The balance due was moved to accounts payable.     -         17,284  
                 
Promissory notes issued between July 1, 2016 and December 31, 2016. Lenders earn interest at 2% per annum. The notes mature on December 31, 2017 and at March 31, 2018 the notes were in default.     206,000       206,000  
                 
Notes aggregating $1,354,000 issued in the fourth quarter of 2016. The notes accrue interest at 2% per annum and mature between November 1, 2017 and December 31, 2017. As of March 31, 2018 the notes were in default     1,354,000       1,354,000  
                 
Notes aggregating $500,000 issued in the first quarter of 2017. The notes accrue interest at 2% per annum and mature between January 12, 2018 and March 31, 2018. At March 31, 2018, the notes were in default     500,000       500,000  
                 
Promissory note issued January 25, 2017. The lenders earn interest at 7% per month. The note matures on July 5, 2017 and at March 31, 2018 the note was in default.     50,000       50,000  
                 
Notes aggregating $300,000 issued in the second quarter of 2017. The notes accrue interest at 2% per annum and mature between April 3, 2018 and May 31, 2018.     300,000       300,000  
                 
Notes aggregating $191,800 issued in the third quarter of 2017. The notes accrue interest at 2% per annum and mature between June 16, 2018 and December 31, 2018.     191,800       191,800  
                 
Promissory note for $425,000 was issued in October 2017 with an original issue discount of $70,000. The note is in default, giving the Holder an option to convert the note to stock. The Company has accrued a $931,519 derivative liability for the conversion right.     425,000       425,000  
                 
Notes aggregating $108,500 issued in the fourth quarter of 2017. The notes accrue interest at 2% per annum and mature on December 31, 2018.     105,500       105,500  
                 
Notes aggregating $47,975 issued in the first quarter of 2018. The notes accrue interest at 2% per annum and mature between May 2018 and January 2019.     47,975       -    
                 
Notes aggregating $125,000 issued in the first quarter of 2018. The notes accrue interest between 2% and 12% per annum and mature between April 2018 and June 2018. These notes include warrants between 5,000,000 and 20,000,000 shares with an exercise price of $0.005.     125,000       -    
                 
Promissory notes issued by Cytocom Inc. aggregating $296,000 issued in the first quarter of 2018. The notes accrue interest at 5% per annum and mature March 31, 2019.     296,000       -    
                 
Less: Original issue discounts on notes payable and warrants issued with notes.     (99,959 )     (75,277 )
                 
Total   $ 5,166,047     $ 4,820,062  

 

As of March 31, 2018, the Company had accrued $792,919 in unpaid interest and default penalties. During the quarter ended March 31, 2018, 0 shares with a fair value of $0 were issued by the Company for settlement of promissory notes.

 

As of March 31, 2017, the Company had accrued $2,412,535 in unpaid interest and default penalties. During the quarter ended March 31, 2017, 17,510,638 shares with a fair value of $809,925 were issued by the Company for settlement of promissory notes.

 

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6. DERIVATIVE LIABILITIES

 

During the quarter ended March 31, 2018, notes payable aggregating $0 were issued as convertible debt or became convertible and qualified as a derivative liability under FASB ASC 815. In the first quarter 2018, notes payable with a derivative liability of $243,199 were converted, and the derivative liability on other notes payable was revalued from $1,426,333 to $931,519.

 

As of March 31, 2018, and December 31, 2017, the aggregate fair value of the outstanding derivative liability was $931,519 and $1,669,532 respectively. The Company estimated the fair value of the derivative liability using the Black-Scholes option pricing model using the following key assumptions during the quarter ended March 31, 2018:

 

    Three months ended
March 31, 2018
 
Volatility     431.57 %
Risk-free interest rate     2.30 %
Expected dividends     - %
Expected term     1 year  

 

The Company determines the fair market values of its financial instruments based on the fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. The following three levels of inputs may be used to measure fair value:

 

Level 1 Quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date.
   
Level 2 Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
   
Level 3 Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

 

The Company uses Level 3 inputs to estimate the fair value of its derivative liabilities.

 

The following schedule summarizes the valuation of financial instruments at fair value in the balance sheets as of March 31, 2018:

 

    Fair Value Measurements as of
March 31, 2018
 
    Level 1     Level 2     Level 3  
Assets                        
None   $ -     $ -     $ -  
Total assets     -       -       -  
Liabilities                        
Conversion option derivative liability     -       -       931,519  
Total liabilities   $ -     $ -     $ 931,519  

 

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The following table sets forth a reconciliation of changes in the fair value of derivative liabilities classified as Level 3 in the fair value hierarchy:

 

    Significant
Unobservable
Inputs (Level 3)
 
Beginning balance   $ 1,669,532  
Change in fair value     738,013  
Ending balance   $ 931,519  

 

7. 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 March 31, 2018 and 2017, the Company was authorized to issue 500,000,000 common shares at a par value of $0.0001 per share.

 

As of March 31, 2018, the Company had 389,846,113 shares of common stock outstanding, and 386,782,473 outstanding as of December 31, 2017.

 

Stock Warrants

 

In the quarter ended March 31, 2018, there were 42,510,818 new warrants issued by the Company.

 

There were no modifications of the terms of any warrants issued by the Company in the quarters ended March 31, 2018 and 2017.

 

Following is a summary of outstanding stock warrants at March 31, 2018 and activity during the three months then ended:

 

    Number of
Shares
    Exercise
Price
    Weighted
Average
Price
 
Warrants as of December 31, 2017     84,287,402     $ 0.01-15.00     $ 0.33  
                         
Issued in 2018     42,510,818     $ 0.01-3.74     $ 0.22  
                         
Expired and forfeited     127,500     $ 15.00     $ 15.00  
                         
Exercised     -     $ -       $  
                         
Warrants as of March 31, 2018     126,670,720     $ 0.01-15.00     $ 0.20  

 

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Summary of outstanding warrants as of March 31, 2018:

 

Expiration Date   Number of
Shares
    Exercise
Price
    Remaining
Life (years)
 
                   
Second Quarter 2018     33,334     $ 15.00       0.25  
Third Quarter 2018     250,000     $ 1.50       0.50  
Fourth Quarter 2018     6,089,166     $ 1.00-1.50       0.75  
First Quarter 2019     4,024,000     $ 0.50-2.00       1.00  
Second Quarter 2019     135,000     $ 0.07-0.23       1.25  
Third Quarter 2019     260,000     $ 0.50-1.50       1.50  
Fourth Quarter 2019     17,131,090     $ 0.05-3.74       1.75  
Second Quarter 2020     300,000     $ 0.50       2.25  
Fourth Quarter 2020     1,000,000     $ 0.20       2.75  
First Quarter 2021     12,600,000     $ 0.20       3.00  
Second Quarter 2021     5,812,252     $ 0.01-0.20       3.25  
Third Quarter 2021     5,016,667     $ 0.03-0.20       3.50  
Second Quarter 2022     1,750,000     $ 0.15       4.25  
Third Quarter 2022     2,650,000     $ 0.05-0.10       4.50  
Fourth Quarter 2022     9,811,422     $ 0.08-0.29       4.75  
First Quarter 2023     1,000,000     $ 0.03       5.00  
Second Quarter 2023     2,000,000     $ 0.20       5.25  
First Quarter 2024     35,000,000     $ 0.01       6.00  
Second Quarter 2032     21,807,789     $ 0.01-0.07       14.25  
                         
      126,670,720     $ 0.01-15.00       0.20  

 

8. Stock Compensation

 

Shares Issued for Services

 

During the quarters ended March 31, 2018 and 2017, the Company issued 2,863,640 and 6,045,460 shares of common stock respectively for consulting fees. The Company valued these shares at $198,477 and $365,455 respectively, based upon the fair market value of the common stock at the dates of the agreements. The consulting fees are amortized over the contract periods which are typically between 12 and 24 months. The amortization of prepaid services totaled $125,000 and $365,834 for the quarters ended March 31, 2018 and 2017.

 

9. Income Taxes - Results of Operations

 

There was no income tax expense reflected in the results of operations for the quarters ended March 31, 2018 and 2017 because the Company incurred a net loss in both quarters.

 

On December 22, 2017, the President of the United States signed the Tax Cuts and Jobs Act (“U.S. Tax Reform”), which enacts a wide range of changes to the U.S. corporate income tax system. The impact of U.S. Tax Reform primarily represents the Company’s estimates of revaluing the Company’s U.S. deferred tax assets and liabilities based on the rates at which they are expected to be recognized in the future. For U.S. federal purposes the corporate statutory income tax rate was reduced from 35% to 21%, effective for the 2018 tax year. Based on the Company’s historical financial performance, at December 31, 2017, the net deferred tax asset position was re-measured at the lower corporate rate of 21% and a tax expense was recognized to adjust net deferred tax assets to the reduced value.

 

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Deferred tax assets:

 

    March 31, 2018     December 31, 2017  
             
Net operating losses   $ 17,899,000     $ 18,102,000  
Stock based compensation     39,134,000       39,054,000  
Amortization, depreciation, and impairment     4,178,000       4,178,000  
Capitalization of start-up costs for tax purposes     1,145,000       1,145,000  
Loss on debt conversion of debt     573,000       569,000  
Total deferred tax assets     62,929,000       63,048,000  
                 
Valuation allowance     (62,929,000 )     (63,048,000 )
                 
Total deferred tax assets, net   $ -     $ -  

 

The Company has recognized no tax benefit for the losses generated for the periods through March, 2018. ASC Topic 740 requires that a valuation allowance be provided if it is more likely than not that some portion or all of a deferred tax asset will not be realized. The Company’s ability to realize the benefit of its deferred tax asset will depend on the generation of future taxable income. Because the Company has yet to recognize revenue, we believe that the full valuation allowance should be provided.

 

Our effective tax rate for fiscal years 2018 and 2017 was 0%. Our tax rate can be affected by recurring items, such as tax rates in foreign jurisdictions and the relative amount of income we earn in jurisdictions. It may also be affected by discrete items that may occur in any given year, but are not consistent from year to year.

 

At December 31, 2017, we had estimated federal and state income tax net operating loss (“NOL”) carry-forwards of approximately $86,000,000, which will expire in 2032-2037.

 

    2018     2017  
    Amount     Percent     Amount     Percent  
Benefits for income tax at federal statutory rate   $ 128,000       21 %   $ 874,000       34 %
Permanent differences     104,000       17- %     137,000       -  
Change in estimates     (232,000 )     -       (1,011,000 )     -  
    $ -       - %   $ -       - %

 

10. Licenses and Supply Agreements

 

Patent and Subsidiary Acquisition

 

The Company entered into a share exchange agreement on April 24, 2012 to acquire all of the outstanding shares of TNI BioTech IP, Inc. (“TNI IP”), a biotechnology firm incorporated in Florida and formed to acquire patents related to the treatment of cancer and HIV/AIDS and autoimmune diseases, using Met-enkephalin (“MENK”) and Naltrexone (“LDN”). The goal of TNI IP’s management was to enable mankind and civilization to combat fatal diseases by activating and mobilizing the body’s own immune system using TNI IP’s patented use of MENK. The first patents acquired by TNI IP were acquired from Dr. Nicholas P. Plotnikoff and Professor Fengping Shan in 2012. TNI IP was acquired in exchange for 20,250,000 shares of the Company’s common stock, of which 8,000,000 shares were issued to Dr. Plotnikoff for the acquisition of patents and the remaining 12,250,000 shares were issued to the founders of TNI IP in exchange for all of their right, title and interest in their TNI IP shares. The goodwill arising on the acquisition of TNI BioTech IP, Inc. was valued at $98,000,000 and license agreements arising from the acquisition of TNI IP were valued at $16,006,000.

 

In connection with the share exchange, we entered into a Sale of Technology Agreement with Dr. Nicholas P. Plotnikoff on March 4, 2012, wherein Dr. Plotnikoff agreed to transfer and assign all of his rights, title and interest in: European Patent United Kingdom, Germany, France, Ireland EP 1401471 BI Methods for inducing sustained immune response; Russian Patent Russian Federation patent number 2313364; The Patent Office of the People’s Republic of China, Application No.: 200810165784.8 China Patent CN1015113407 A The Patent Office of the People’s Republic of China ISSN: 1006-2858 CN 21-1349/R; Patent Agencies Government of India Patent, Application number 1627/KOLNP/2003 number 220265 an Enkephalin Peptide Composition; and the US Patent Pending, US Patent Application 10/146.999 e. The Company received all the production formulations and technology designs from Dr. Plotnikoff necessary for the manufacturing, formulation, production and protocols of the MENK treatment of cancer and HIV/AIDS. As consideration for entering into the Sale of Technology Agreement, Dr. Plotnikoff received 8,000,000 shares of common stock, a royalty of a single-digit percentage on all sales of MENK and was granted the position of Non-Executive Chairman of the Board of Directors.

 

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At the time of the acquisition, the valuation of goodwill and other intangible assets were determined using the fair market price for the Company’s common stock, which were exchanged for shares of TNI IP. In the fourth quarter of 2012, the Company performed an annual valuation to determine whether any goodwill or intangible assets that had been acquired by the Company were impaired. The result of this valuation was that material impairments were identified. The Company recognized an impairment of the goodwill arising on the acquisition of TNI IP of $98,000,000.

 

Patent License Agreements

 

On August 13, 2012, the Company signed an exclusive License Agreement with Ms. Jacqueline Young (the “Young Agreement”) for the intellectual property developed by Dr. Bernard Bihari relating to treatments with opioid antagonists such as naltrexone and Met-enkephalin for a variety of diseases and conditions including malignant lymphoma, chronic lymphocytic leukemia, Hodgkin’s lymphoma, and non-Hodgkin’s lymphoma, chronic herpes virus infections, chronic herpes viral infections such as chronic genital herpes caused by the herpes simplex virus Type 2 and chronic infections due to the Epstein-Barr virus and a treatment method for humans infected with HTLV-III (AIDS) virus, including patients clinically diagnosed as suffering from AIDS and those suffering from AIDS-related complex (ARC). The Bihari patents were acquired in exchange for 540,000 shares of the Company’s common stock with a fair value of $972,000 and assumed liabilities of $400,000, which is payable to Ms. Young over a twenty-four month period in equal installments to reimburse her for the costs of a New York City office in accordance with the Young Agreement. The cost of the patent totaled $1,372,000. Additionally, the Company will pay the licensor a royalty payment of 1% of gross MENK sales and provide the licensor a position as non-executive chairman of the Company. The Young Agreement is valid for the life of the patents and expires on a country by country basis in each country where patent rights exist, upon the expiration of the last to expire patent in each country or in the event the patent in such country is held to be invalid and/or unenforceable (by a court or government body of competent jurisdiction) or admitted to be invalid or unenforceable. Additionally, we can cancel the Young Agreement upon 120 days’ written notice and shall pay all royalties and fees that have accrued under the Young Agreement. We have the exclusive rights to the intellectual property; however, Ms. Young retains a right to practice the patents licensed under the Young Agreement solely for noncommercial, academic research purposes.

 

On December 24, 2012, the Company signed an agreement for the acquisition of patent rights (the “Smith Agreement”) for the intellectual property of Dr. Jill Smith and LDN Research Group, LLC (collectively, the “Licensor Parties”), whose members are Dr. Ian S. Zagon, Dr. Patricia J. McLaughlin and Moshe Rogosnitzky and orphan drug designation by the FDA to a novel late-stage drug, trademarked “LDN,” for the treatment of Pediatric Crohn’s disease. The patent covers methods and formulations for treatment of the inflammatory and ulcerative diseases of the bowel, using naltrexone in low doses as an opioid antagonist. These patents were acquired in exchange for 300,000 shares of our common stock with a fair value of $2,715,000 and payment of $165,384 (consisting of a $100,000 initial license fee and payment of $65,384 of expenses), which totaled $2,880,384.

 

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

 

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.

 

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

 

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

 

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

 

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

 

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.

 

23

 

 

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.

 

11. Commitments and Contingencies

 

Malawi Treatment Facilities

 

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

 

In December of 2014, the Government of Malawi completed an oncology clinic at the Queen Elizabeth Central Hospital in Blantyre, Malawi for the treatment of cancer and infectious diseases. In 2015, the Company submitted protocols seeking permission from the Pharmacy, Medicines and Poisons Board of Malawi (“PMPB”) to conduct two trials involving Lodonal™ in Malawi:

 

a. The first protocol, submitted jointly with The Jack Brewer Foundation (“JBF Worldwide”), received PMPB approval on November 11, 2015. The protocol covers a 12-month trial for a “Single Visit Approach to Cervical Cancer Prevention.” The approach is designed to deliver a preventive and simple procedure that can be performed in a clinical setting without the use of a laboratory and to allow for immediate treatment of any precancerous lesions utilizing Wallach LL100 Cryosurgical systems. The protocol provides for 50% of the patient group to be put on Lodonal™ to determine if the drug lowers the number of opportunistic infections during the year, and if it can be shown that LDN increases CD4, CE8, NK and T cell count, which would show that the incidence rates of opportunistic infection could decrease with Lodonal™ and that Lodonal™ could be used as a prophylaxis to prevent substantial HIV-related morbidity in Malawi. The PMPB approved the trial in late 2016, recruitment began in late 2016 and the trial is now ongoing.
   
b. The second protocol, which has not yet been approved, covers a trial using Lodonal™ for the treatment of cancer. The Company has put this trial on hold as it may not be necessary with the approval in Nigeria in addition to the pending approval in Kenya and Senegal for Lodonal™ for the treatment of cancer.

 

Distribution Agreements in Nigeria

 

Effective November 9, 2012, we signed an exclusive Distribution Agreement with G-Ex Technologies/St. Maris Pharma and GB Pharma Holdings, LLC for the Federal Republic of Nigeria. The parties were unable to perform under the agreement because a certificate of free sale was not obtained by the Company until November of 2013, and no extension of the contract was granted.

 

In October 2013, the Company announced the signing of a Distribution Agreement with AHAR Pharma, a Nigerian company, to market Lodonal™, in Nigeria for the treatment of autoimmune diseases and cancer. AHAR intends to distribute Lodonal™ through a local distributor network, an Internet client base and directly to hospitals, pharmacists and doctors in Nigeria. The first deliveries under the agreement took place in February 2018. Under the original 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. These commitments are currently under review by the parties.

 

In August 2015, the Company announced the signing of a letter of intent with GB Pharma/AHAR and Fidson Healthcare Plc., in terms of which Fidson will promote Lodonal TM upon execution of a definitive agreement between the companies and receipt of NAFDAC and other approvals to distribute Lodonal TM in Nigeria.

 

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Agreements with Hubei Qianjiang Pharmaceutical Company

 

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

 

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

 

Exploratory Toxicology (nGLP)

 

  Dose range finding studies
  Different species and methods of administration
  Multiple dosing regimens
  Estimate the response vs. dose given

 

Definitive Toxicology (GLP)

 

  Performed in collaboration with Calvert Laboratories (USA) and MPI/Medicillon (China)
  General toxicology studies
  Different species and methods of administration
  Immunogenicity study with NHPs

 

Special Toxicology Studies (planned)

 

Pursuant to the Amendment, Qianjiang Pharmaceutical has made certain funds available from the co-administrative account opened by Qianjiang Pharmaceutical under the Venture Agreement, in accordance with an approved budget and timeline set forth in the Amendment. A portion of these funds are expected to be used by Cytocom to run PK and Dosing trials for MENK in the United States in 2018. 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.

 

25

 

 

In December of 2016 Qianjiang Pharmaceutical completed the following documents:

 

Exploratory Toxicology (nGLP)

 

  Dose range finding studies
  Different species and methods of administration
  Multiple dosing regimens
  Estimate the response vs. dose given

 

Definitive Toxicology (GLP)

 

  Performed in collaboration with Calvert Laboratories (USA) and MPI/Medicillon (China)
  General toxicology studies
  Different species and methods of administration
  Immunogenicity study with NHPs

 

In addition to the pharmacology and toxicology studies, Qianjiang Pharmaceutical and China Peptide completed the formulation and CMC necessary to scale up manufacturing of MENK.

 

Contract Manufacturing Agreements

 

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

 

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

 

Operating Leases

 

At March 31, 2018, the Company was a party to agreements to lease office space in Orlando, Florida. Rental expense for the three months ended March 31, 2018 and 2017 was $4,281 and $4,129 respectively.

 

Legal Proceedings

 

None.

 

12. Subsequent Events

 

The Company issued 5,879,927 shares of common stock between March 31, 2018 and May 15, 2018, all of which were for debt conversions.

 

As of May 15, 2018, the Company had outstanding 395,726,040 shares of common stock.

 

26

 

 

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

 

Forward-Looking Statements and Associated Risks

 

This section and other parts of this Form 10-Q contain forward-looking statements. Forward-looking statements provide current expectations of future events based on certain assumptions and include any statement that does not directly relate to any historical or current fact. Forward-looking statements also can be identified by words such as “future,” “anticipates,” “believes,” “estimates,” “expects,” “intends,” “will,” “would,” “could,” “can,” “may,” and similar terms. Forward-looking statements are not guarantees of future performance and the Company’s actual results may differ significantly from the results discussed in the forward-looking statements. Factors that might cause such differences include, but are not limited to, those discussed in our Annual Report on Form 10-K for the year ended December 31, 2017 filed with the Securities and Exchange Commission on April 2, 2018 (the “2017 Form 10-K”) under the heading “Risk Factors”.

 

The following discussion should be read in conjunction with the 2017 Form 10-K and the consolidated financial statements and notes thereto included elsewhere in this Form 10-Q. All information presented herein is based on the Company’s fiscal calendar. Unless otherwise stated, references in this report to particular years, quarters, months or periods refer to the Company’s fiscal years ended in December and the associated quarters, months, or periods of those fiscal years. Each of the terms the “Company”, “we”, “us” or “our” as used herein refers collectively to Immune Therapeutics, Inc. and its subsidiaries, unless otherwise stated. The Company assumes no obligation to revise or update any forward-looking statements for any reason, except as required by law.

 

General

 

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

 

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

 

The Company currently operates out of Orlando, Florida. In July 2012, the Company’s focus turned to acquiring patents that would protect and advance the development of new uses of opioid-related immune- therapies, such as low dose naltrexone (“LDN”) and Methionine [Met5]-enkephalin (“MENK”). The Company’s therapies are believed to stimulate and/or regulate the immune system in such a way that they provide the potential to treat a variety of diseases. We believe our therapies may be able to correct abnormalities or deficiencies in the immune system in diseases such as HIV infection, autoimmune disease, immune disorders, or cancer; all of which can lead to disease progression and life-threatening situations when the immune system is not functioning optimally.

 

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

 

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

 

27

 

 

In December 2013, the Company formed a subsidiary, Cytocom Inc., to focus on conducting LDN and MENK clinical trials in the United States. In December 2014, the Company finalized the distribution of common stock of Cytocom Inc. to its shareholders. As part of the transaction, the Company transferred to Cytocom certain of its rights, title and interest in or relating to intellectual property (i) patents, patent applications, and all divisional, continuations and continuations-in-part thereof, together with all reissues, reexaminations, renewals and extensions thereof and all rights to obtain such divisionals, continuations and continuations-in-part, reissues, reexaminations, renewals and extensions, and all utility models and statutory invention registrations and any other such analogous rights, (ii) trademarks, service marks, Internet domain names, trade dress, trade styles, logos, trade names, services names, brand names, corporate names, assumed business names and general intangibles and other source identifiers of a like nature, together with the goodwill associated with any of the foregoing, and all registrations and applications for registrations thereof, together with all renewals and extensions thereof and all rights to obtain such renewals and extensions, (iii) copyrights, mask work rights, database and design rights, moral rights and rights in Internet websites, whether registered or unregistered and whether published or unpublished, all registrations and recordings thereof and all applications in connection therewith, together with all renewals, continuations, reversions and extensions thereof and all rights to obtain such renewals, continuations, reversions and extensions, and (iv) confidential and proprietary information, including, trade secrets and know-how. Cytocom licensed back to the Company a perpetual, non-exclusive, royalty-free right and license to use the assigned intellectual property for veterinary indications and for the marketing rights to emerging markets, access to all clinical data, use of the formulation for LDN and MENK. The parties have informally agreed that until such time as Cytocom was funded, the Company would be responsible for all payments to employees, ongoing general and administrative expenses, licensing fees, patent fees, and drug development costs. When Cytocom becomes self-sustaining and fully funded, it expects to reimburse the Company for all funds spent by the Company since the spin-out.

 

On December 8, 2014, the number of Cytocom Inc. shares of common stock that were issued to our shareholders totaled 113,242,522 shares. In connection with the transaction, Cytocom Inc. issued 140,100,000 shares of its common stock to the Company, which gave the Company a 55.3% stake in Cytocom Inc. on that date. In April 2016, the Board of Directors and a majority of shareholders of Cytocom approved a reverse stock split of Cytocom’s outstanding common stock with one new share of stock for each twenty old shares of common stock. Cytocom effectuated and finalized the reverse split in June 2016. At December 31, 2018, the Company’s equity interest had been further reduced to 9.3%, by subsequent issuances of Cytocom common stock.

 

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

 

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

 

Cytocom Inc, is a clinical-stage pharmaceutical company focused on the development of the first affordable non-toxic immunodulator for the treatment of inflammatory diseases, immune-related disorders, and cancer and is responsible for the development of our patented therapies with the FDA and EMA.

 

28

 

 

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

 

Three Months Ended March 31, 2018 Compared to Three Months Ended March 31, 2017

 

Revenues

 

We had revenues from operations of $65,013 for the three months ended March 31, 2018, compared to $0 for the three months ended March 31, 2017. In February 2018, the Company reported the first shipments of Lodonal TM to Nigeria.

 

Operating Expenses

 

Selling, general and administrative

 

Selling, general and administrative expenses and related percentages for the three months ended March 31, 2018 and 2017 were as follows (dollar amounts in thousands):

 

    For the three months ended
March 31,
 
    2018     2017  
Selling, general and administrative   $ 638     $ 666  
Increase/(decrease) from prior year   $ (28 )   $ (273 )
Percent increase/(decrease) from prior year     (4 )%     (29 )%

 

For the three months ended March 31, 2018 and 2017, selling, general and administrative expenses were made up as follows (dollar amounts in thousands):

 

    For the three months ended
March 31,
 
    2018     2017  
Stock listing and investor relations expenses   $ 10     $ 10  
Consulting and contractors     143       189  
Payroll     321       226  
Professional fees     47       108  
Travel     32       12  
Other expenses     85       121  

 

In the three months ended March 31, 2018, total cash and cash accruals for selling, general and administrative expense was $638 compared to $666 for the corresponding period in 2017, a decrease of $28 or 4%. 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 $143 in 2018, a decrease of $46 or 24% over the $189 spent in 2017. The decrease was the result primarily of the expiration of certain consulting contracts by the end of 2017;
     
  professional fees for legal, tax and accounting services in the amount of $47 in 2018, a decrease of $61 or 57% over the $108 spent in 2017. The decrease was primarily due to lower legal fees incurred in the first quarter of 2018;
     
  payroll in the amount of $321 in 2018, an increase of $95 or 42% over the $226 spent in 2017. The increase reflects accruals for compensation accrued to Cytocom executives appointed in 2018; and
     
  travel in the amount of $32 in 2018, an increase of $20 or 167% over the $12 spent in 2017, reflecting increased travel for investor relations in 2018.

 

29

 

 

Research and development

 

R&D expenses and related percentages for the three months ended March 31, 2018 and 2017 were as follows (dollar amounts in thousands):

 

    For the three months ended
March 31,
 
    2018     2017  
Research and development   $ 129     $ 119  
Increase from prior year   $ 10     $ 138  
Percent increase/(decrease) from prior year     9 %     100 %

 

Expenses for research and development in the three months ended March 31, 2018 increased by 9% compared to expenses in the same period in 2017. The increase reflects greater legal fees and an increase in use of contracted services in 2018 to maintain patents and licenses, offset by lower patent expenses.

 

Significant items included:

 

  payments for contracted services, $49 in 2018, an increase of $24 or 92% over the $25 spent in 2017;
     
  payments for professional fees of $55 in 2018, an increase of $16 or 41% over the $39 spent in 2017, reflecting the increased cost in maintaining patents and licenses worldwide;
     
  Patent expenses of $25 in 2018, a decrease of $30 or 55% over the $55 spent in 2017. In 2018, the Company is no longer obligated to pay certain expenses related to the Bihari patents.

 

Approximately 95% of the R&D spending in the first quarter of 2018 was for LDN, unchanged from the same period in 2017.

 

Stock issued for services

 

The Company periodically receives services from consultants under long-term consulting contracts, in terms of which it issues stock to prepay for the services. In such cases, the Company initially accounts for the full cost of these services as Prepaid Services on its balance sheet, calculated by the number of shares issued multiplied by the share price on the contract date. This amount is then amortized as a cost 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 amounts recorded as Prepaid Services for stock issued for services G&A and related percentages for the three months ended March 31, 2018 and 2017 were as follows (dollar amounts in thousands):

 

    For the three months ended
March 31,
 
    2018     2017  
Amortization of prepaid consulting expense G&A   $ 125     $ 481  
Percentage decrease from prior year     (74 )%     (28 )%

 

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 in prior years.

 

The number of shares issued for prepaid consulting services G&A in the three months ending March 31, 2018 was 2,863,640 (6,045,460 in the corresponding period in 2017).

 

30

 

 

Prepaid consulting services G&A in the three months ended March 31, 2018 consisted of the following:

 

Amortization of cost of stock issued prior to 2017   $ 90  
Amortization of cost of stock issued in 2017     35  
Amortization of cost incurred for new stock issued in the three months ended March 31, 2018 under consulting contracts entered into in 2018     -  

 

Warrant valuation expense

 

When the Company sells its stock for cash or settles debt for stock, it periodically issues warrants 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 6. 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 March 31, 2018, the Company issued 42,510,818 warrants to stockholders at an exercise price range of $0.005 to $12.00, for which it recorded an expense of $125,000.

 

In the three months ended March 31, 2017, the Company issued no warrants to stockholders.

 

Depreciation and amortization

 

The Company amortizes the costs incurred to acquire patents and licenses over the period of the related agreements. All of the Company’s patents and licenses were fully amortized by December 31, 2016.

 

Depreciation expense for the three months ended March 31, 2018 and 2017 was as follows (dollar amounts in thousands):

 

    For the three months ended
March 31,
 
    2018     2017  
Depreciation expense   $ -     $ -  
Decrease from prior year   $ -     $ (1 )
Percentage increase/(decrease) from prior year     - %     (100 )%

 

Interest Expense

 

Interest expense for the three months ended March 31, 2018 and 2017 were as follows (dollar amounts in thousands):

 

    For the three months ended
March 31,
 
    2018     2017  
Interest expense   $ 220     $ 576  
Increase from prior year   $ (356 )   $ 275  
Percentage increase from prior year     (62 )%     91 %

 

The decrease in interest expense reflects the elimination of payment of interest on a note as a result of repayment of that note in the second quarter of 2017; the Company had been required to accrue a significant penalty on that note due to late repayment in the first quarter of 2017.

 

31

 

 

Loss on settlement of debt

 

In three months ended March 31, 2018, 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 $18, reflecting the fair value of the shares of common stock issued in exchange for the debt. In three months ended March 31, 2017, the Company recorded an expense of $614, reflecting the fair value of the shares of common stock issued in exchange for the debt.

 

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 $30,401 at March 31, 2018, compared to $98,113 at March 31, 2017.

 

For the three months ended March 31, 2018 and 2017, net cash used in operating activities from operations was $455,816 and $529,430, respectively.

 

$1,971 was used in investing activities for the three months ended March 31, 2018; no cash was used in the corresponding period in 2017.

 

During the three months ended March 31, 2018 proceeds from the sale of stock and exercise of stock warrants totaled $50,000 compared to $0 for the corresponding period in 2017. We also received $468,975 from the issuance of notes payable in three months ended March 31, 2018, compared to $875,000 in 2017. There were $0 of loan repayments made in cash in the three months ended March 31, 2018 ($321,846 in 2017).

 

The Company generated revenues from sales in the first quarter of 2018. If the Company is unable to generate sufficient cash flows from future sales, or if it does not raise additional working capital to meet all of its operating obligations and expenditures, the Company may have to modify its business plan.

 

In addition to the cost of its ongoing operations, the Company expects it will incur future research and development expenditures in the next 12 months through Cytocom. Cytocom plans to conduct Phase II and Phase IIB trials for the treatment of Crohn’s disease. Cytocom will need approximately $7-$15 million to fully develop products and for Phase III clinical trials for Crohn’s disease. We expect that two-thirds of this amount will be spent by Cytocom in the USA, the balance for international trials. Cytocom trials are expected to be split evenly between LDN and MENK. The international trials will focus the use of MENK for treatment of cancer in Africa.

 

If the trials do not commence before the end of 2018, the Company will be required to make a payment of $100,000 in December 2018 under its license agreements. In prior years, the Company has been able to raise funds through sales of notes payable to cover this obligation, and it expects to do the same if the payment becomes due in December 2018.

 

Off-Balance Sheet Arrangements

 

During the three months ended March 31, 2018 and 2017, 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.

 

32

 

 

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 March 31, 2018, 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 March 31, 2018, 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

 

The legal proceedings described in Note 11 of the “Notes to the Condensed Consolidated Financial Statements” are incorporated in this “Item 1: Legal Proceedings” by reference.

 

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

 

In the quarter ended March 31, 2018, the Company issued a total of 3,063,640 shares of common stock (net of stock cancellations. 25,212,545 shares of common stock were issued in the same period in 2017). 200,000 of those shares were issued to settle amounts owed under notes payable, including accrued and unpaid interest as applicable, to common stock as repayment of the notes (17,510,638 in 2017). 0 shares were issued to settle amounts owed to certain of the Company’s vendors and employees (0 in 2017).

 

In total, the Company received $0 as consideration for the exercise of previously-issued warrants ($0 in 2017) and $50,000 for the purchase of common stock ($25,000 in 2017), for an aggregate sum of $50,000.

 

33

 

 

The following table lists all securities issued during in the three months ended March 31, 2018 without registering the securities under the Securities Act of 1933, as amended (the “Securities Act”):

 

Date   Description   Number     Purchaser     Proceeds     Consideration   Exemption  
1/24/2018   Common Stock Purchase     200,000       Consultant     $ Nil     Advisory Services     Sec. 4(a)(2)  
                                         
2/9/2018   Common Stock Purchase     181,820       Consultant     $ Nil     Advisory Services     Sec. 4(a)(2)  
                                         
2/9/2018   Common Stock Purchase     181,820       Consultant     $ Nil     Advisory Services     Sec. 4(a)(2)  
                                         
3/13/2018   Common Stock Purchase     500,000       Consultant     $ Nil     Advisory Services     Sec. 4(a)(2)  
                                         
3/13/2018   Common Stock Purchase     500,000       Consultant     $ Nil     Advisory Services     Sec. 4(a)(2)  
                                         
3/13/2018   Common Stock Purchase     1,500,000       Consultant     $ Nil     Advisory Services     Sec. 4(a)(2)  

 

The issuances of the Company’s securities 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 purchased 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.

 

ITEM 3. DEFAULTS UPON SENIOR SECURITIES

 

The current portion of notes payable on the Company’s Condensed Consolidated Balance Sheets above contains, at March 31, 2018, certain promissory notes on which the Company was in arrears on payments of principal as follows:

 

1. Promissory note issued July 29, 2014 for $100,000. As of March 31, 2018, the note is in default. The note earns interest at a rate of 18% per annum.
   
2. Promissory notes issued between November 26, 2014 and December 31, 2015. Lenders earn interest at a rate of 10% per annum, plus a pro-rata share of two percent of the Company’s gross receipts for sales of IRT-103-LDN in perpetuity. Notes will be repaid in 36 monthly installments of principal and interest commencing no later than October 15, 2015. Notes aggregating $286,000 were in default at March 31, 2018, as the Company was unable to pay installments on those notes on their due dates.

 

34

 

 

3. Promissory notes issued between May 1, 2015 and December 31, 2016, and maturing between June 14, 2015 and December 1, 2017. Lenders on loans aggregating $505,994 earn interest at rates between 2% and 18% per annum. On loans aggregating $200,000, interest is payable in a fixed amount not tied to a specific interest rate. Notes aggregating $705,994 were in default at March 31, 2018, as the Company was unable to repay those notes on their due dates.
   
4. Promissory notes issued by Cytocom Inc. between April 29, 2015 and December 31, 2015 totaling $425,000. Lenders earn interest at rates between 5% and 10% per annum. These notes mature on December 31, 2016. At March 31, 2018, the notes were in default.
   
5. Promissory notes totaling $97,737 issued to an officer of the Company effective November 3, 2015 and maturing November 3, 2016 for settlement of accrued payroll, bearing interest at 10% per annum and including a stock conversion feature. The Company was unable to repay the note at maturity and at March 31, 2018 the notes were in default.
   
6. Promissory note issued in July 2016 for $50,000. The note was repayable on October 5, 2016 but was extended to December 31, 2016. The note earns interest at 6% per month. The Company was unable to repay the note at maturity and at March 31, 2018 the note was in default.
   
7. Promissory notes for $206,000 issued between July 1, 2016 and December 31, 2016 The notes mature on December 31, 2017. Lenders earn an interest rate of 2% per annum The Company was unable to repay the note at maturity and at March 31, 2018 the notes were in default.
   
8.

Promissory notes totaling $1,354,000 issued in the fourth quarter of 2016. The lenders earn interest at 2% per annum and mature between November 1, 2017 and December 31, 2017. The Company was unable to repay the note at maturity and at March 31, 2018 the notes were in default.

 

9.

Promissory note for $50,000 issued January 25, 2017. The lenders earn interest at 7% per month. The note matures on July 15, 2017. The Company was unable to repay the note at maturity and at March 31, 2018 the note was in default.

 

10. Promissory note for $425,000 was issued in October 2017 with an original issue discount of $70,000. The note is in default, giving the Holder an option to convert the note to stock. The Company has accrued a $931,519 derivative liability for the conversion right.

 

At March 31, 2018, the Company had insufficient cash on hand to repay these notes.

 

35

 

 

ITEM 6. EXHIBITS

 

Exhibit Number   Name of Exhibit
     
10.23   Loan agreement and promissory note with Joel Yanowitz, dated January 9, 2018, for $50,000.
     
10.24   Loan agreement and promissory note with Rogoff Family Trust, dated February 13, 2018, for $50,000.
     
31.1   Certification of Chief Executive Officer, pursuant to Rule 13a-14(a) of the Exchange Act, as enacted by Section 302 of the Sarbanes-Oxley Act of 2002.
     
32.1   Certification of Chief Executive Officer and Chief Financial Officer, pursuant to 18 United States Code Section 1350, as enacted by Section 906 of the Sarbanes-Oxley Act of 2002.
     
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

 

36

 

 

SIGNATURES

 

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

 

  Immune Therapeutics, Inc.
     
Date: May 15, 2018 By: /s/ Noreen Griffin
    Noreen Griffin
    Chief Executive Officer
     
  Immune Therapeutics, Inc.
     
Date: May 15, 2018 By: /s/ Peter Aronstam
    Peter Aronstam
    Chief Financial Officer

 

37

 

 

 

LOAN AGREEMENT

 

This LOAN AGREEMENT (this “Agreement”), dated January 9, 2018 (the “Effective Date”), is entered into by and between Immune Therapeutics, Inc., a Florida corporation (“Borrower”), and Joel Yanowitz (‘‘Lender”).

 

RECITALS

 

WHEREAS, Borrower has requested that Lender provide Borrower with a term loan bearing interest at a fixed rate as more particularly described in this Agreement; and

 

WHEREAS, Lender has agreed to make such a loan, subject to the terms and conditions set forth herein and in the other Loan Documents (as defined below).

 

NOW, THEREFORE, in consideration of the foregoing, the mutual covenants and agreements herein contained and other good and valuable consideration the receipt and sufficiency of which is hereby acknowledged, the parties agree as follows:

 

1. AMOUNT AND TERMS OF THE LOAN

 

1. The Loan . The “Loan” hereunder shall mean the loan by Lender to Borrower in the total principal amount of fifty thousand dollars ($50,000).

 

1.2 The Note. The Loan shall be evidenced by a Promissory Note in substantially the form attached hereto as Exhibit A (the “Note”), which Note shall be executed by Borrower as of the Effective Date.

 

1.3 Payment of Principal and Interest .

 

(a) The outstanding principal balance of the Loan shall bear interest at the rate of twelve percent (12%) per annum. Interest on the Loan shall be calculated based on a 360-day year and the actual number of days elapsed.

 

(b) The principal balance of the Loan and all accrued interest shall become due and payable ninety (90) from the Effective Date (the “Term”); provided however, that the principal balance of the Loan and all accrued interest shall be paid earlier as follows:

 

(i) If Borrower receives investment capital in an amount equal to or greater than one million five hundred thousand dollars ($1,500,000) during the Term, principal and accrued interest under the Loan shall become immediately due and payable;

 

(ii) Upon the receipt of gross revenues by borrower equaling or greater than one million five hundred thousand dollars ($1,500,000) during the Term, Borrower shall pay Lender in monthly installments five percent (5%) of gross revenues received on the outstanding principal and accrued interest on the last day of each month beginning the first month after the Borrower has received total gross revenues of $1,500,000 or more.

 

(c) Nothing contained herein shall be deemed to require the payment of interest at a rate in excess of the maximum rate permitted by applicable law. In the event that the amount required to be paid hereunder for any calendar month exceeds the maximum rate permitted by law, such amounts shall be automatically reduced for such month to the maximum rate permitted by applicable law.

 

 Page 1 of 6   _________ / ________
 

 

1.5 Prepayment . Upon three (3) business days’ prior written notice to Lender, Borrower may prepay all or any part of the Loan, including interest, without penalty or premium at any time and from time to time.

 

1.6 Acceleration . Immediately upon the occurrence of any Event of Default (as defined in Section 6.1) and during any continuance thereof, Lender may declare the Loan, all interest thereon and all other amounts and obligations payable to be forthwith due and payable to Lender or may take any other action as provided in Section 6.2 herein.

 

1.7 Payment Procedures . All payments made by Borrower under this Agreement shall be made to Lender by wire transfer in U.S. dollars in immediately available funds to such bank account as shall be designated by Lender in writing from time to time.

 

2. EFFECTIVENESS

 

2.1 Effectiveness . This Agreement and the Note and (collectively: the “Loan Documents”) shall not become effective until (a) all parties hereto have executed and delivered a counterpart hereof (including by way of facsimile transmission or by electronic transmission in PDF format), and (b) the conditions precedent set forth in Section 4 hereof shall have been satisfied.

 

3. REPRESENTATIONS AND WARRANTIES OF BORROWER

 

Borrower represents and warrants to Lender the following:

 

3.1 Authority . Borrower has the requisite legal capacity to borrow money, to execute, deliver and perform each of the Loan Documents to which it is a party and all other documents, certificates and instruments delivered in connection therewith, and to effect and carry out the transactions contemplated herein and therein. Each Loan Document has been duly authorized and, when executed and delivered, will be a valid and legally binding instrument enforceable against Borrower in accordance with its terms. The execution and delivery of the Loan Documents and the consummation of the transactions contemplated thereby will not (immediately or with the passage of time, or the giving of notice) violate (a) any law, order, rule or regulation or deten11ination of an arbitrator, a court, or other governmental agency, applicable or binding upon Borrower or any of Borrower’s property or as to which Borrower or any of Borrower s property is subject (collectively, “Requirement of Law”), or (b) any provision of any agreement, instrument, or undertaking to which Borrower is a party. No consents, approvals or other authorizations or notices, other than those which have been obtained and are in full force and effect, are required by any state or federal regulatory authority or other person or entity (“Person”) in connection with the execution and delivery of the Loan Documents and the performance of any obligations contemplated thereby.

 

3.2 Litigation . There are no actions, suits, proceedings or governmental investigations or inquiries pending, or to the best knowledge of Borrower threatened, against Borrower or Lender, that could, if adversely determined, have a material adverse effect on the performance of any obligation contemplated in or arising under the Loan Documents (“Material Adverse Effect”).

 

3.3 Full Disclosure . No written statement prepared or furnished to Lender in connection with the transactions contemplated hereby (including, without limitation, financial statements) by or on behalf of Borrower: when all such statements are taken as a whole, contains any untrue statement of a material fact or omits to state a material fact necessary to make the statements contained therein not misleading. All facts known to Borrower which are material to an understanding of the financial condition, business, properties or prospects of Borrower have been disclosed to Lender.

 

 Page 2 of 6   _________ / ________
 

 

4. CONDITIONS PRECEDENT

 

The effectiveness of this Agreement is subject to the satisfaction of the following conditions precedent:

 

4.1 Documents . Lender shall have received the following, validly executed to the satisfaction of the Lender: (a) this Agreement; and (b) the Note.

 

4.2 Compliance with Covenants . Borrower shall have complied with and performed all of Borrower’s covenants and obligations under the Loan Documents.

 

4.3 Related Information . Borrower shall have provided to Lender in form satisfactory to Lender such other financial information relating to Borrower as requested by Lender.

 

5. COVENANTS OF BORROWER

 

5.1 Certain Affirmative Covenants . Borrower covenants and agrees that until full and complete performance by Borrower of all obligations arising under the Loan and the Loan Documents, Borrower shall:

 

(a) Cooperate with Lender and execute such further instruments and documents as Lender shall reasonably request to can-y out to its satisfaction of the transactions contemplated by the Loan Documents;

 

(b) As soon as possible and in any event within two (2) business days after acquiring knowledge thereof notify Lender in writing of the occurrence of any Event of Default; and

 

(c) Promptly provide Lender with such other information respecting condition or operations, financial or othe1wise, of Borrower as Lender may from time to time reasonably request.

 

5.2 Compliance with Laws . Borrower shall comply in all material respects with all Requirements of Law, contractual obligations, commitments, instruments, licenses, and permits.

 

5.3 Reporting Requirements . Borrower shall furnish to Lender, promptly after the commencement thereof notice of all actions, suits and proceedings before any domestic or foreign governmental authority or arbitrator, affecting Borrower, except those which in the aggregate, if adversely determined, would have no Material Adverse Effect;

 

6. EVENTS OF DEFAULT; ACCELERATION

 

6.1 Events of Default . Each of the following shall constitute an “Event of Default”

 

(a) Borrower shall fail to make any payment of principal or interest on the Loan or other amounts due under the Loan Documents within fifteen (15) days of the date, which such payment is due;

 

(b) Borrower shall fail to perform any terms, covenant or agreement contained herein or in any Loan Document and such failure shall continue for thirty (30) days after the earlier of the date on which (x) Borrower becomes aware of such failure, or (y) written notice of such failure has been given to Borrower by Lender;

 

(c) Any representation or warranty of Borrower in any Loan Document shall prove to have been false in any material respect upon the date when made;

 

 Page 3 of 6   _________ / ________
 

 

(d) Borrower shall (i) apply for or consent to the appointment of, or the taking of possession by, a receiver, custodian, trustee or liquidator, (ii) make a general assignment for the benefit of Borrower creditors, (iii) commence a voluntary case under the United States Bankruptcy Code (as now or hereafter in effect), (iv) file a petition seeking to take advantage of any other law of any jurisdiction relating to bankruptcy, insolvency, or composition or readjustment of debts, (v) fail to controvert in a timely and appropriate manner, or acquiesce in writing to, any petition filed against Borrower in an involuntary case under the United States Bankruptcy Code, or (vi) take any action for the purpose of effecting any of the foregoing; or

 

(e) A proceeding or case shall be commenced, without the application or consent of Borrower, in any court of competent jurisdiction, seeking (i) the liquidation of Borrower’s assets, or the composition or readjustment of Borrower’s debts, (ii) the appointment of a trustee, receiver, custodian, liquidator or the like of any substantial part of Borrower’s assets, or (iii) similar relief in respect of Borrower under any law of any jurisdiction relating to bankruptcy, insolvency, or the composition or readjustment of debts, and such proceedings or case shall continue undismissed, or an order, judgment or decree approving or ordering any of the foregoing shall be entered and continue unstayed and in effect for a period of sixty (60) days; or an order for relief against the Borrower shall be entered in an involuntary case under any bankruptcy, insolvency, composition, readjustment of debt, liquidation of assets or similar law of any jurisdiction.

 

6.2 Remedies Upon Default . Immediately upon the occurrence of any Event of Default and during the continuance thereof, Lender may declare the Loan, all interest thereon and all other amounts and obligations payable under any Loan Document to be due and payable, without presentment, demand, protest or further notice of any kind, all of which are expressly waived by Borrower.

 

6.3 Default Penalty . Not-with-standing any other remedy, if Borrower shall fail to make to make any payment of principal or interest on the Loan or other amounts due under the Loan Documents within fifteen (15) days of the date, which such payment is due, then there shall be an additional penalty of 5% per month of the outstanding balance then due.

 

7. ARBITRATION

 

7.1 AGREEMENT TO BINDING ARBITRATION . THE PARTIES AGREE THAT ANY

 

CONTROVERSY OR CLAIM ARISING OUT OF OR RELATING TO THIS AGREEMENT OR ANY OTHER LOAN DOCUMENT OR THE BREACH THEREOF SHALL AT EITHER PARTIES ELECTION, BE SUBMITTED TO ARBITRATION BEFORE THE AMERICAN ARBITRATION ASSOCIATION IN ACCORDANCE WITH THE COMMERCIAL ARBITRATION RULES OF THE AMERICAN ARBITRATION ASSOCIATION, AND JUDGMENT ON THE AWARD RENDERED BY THE ARBITRATOR MAY BE ENTERED IN ANY COURT HAVING JURISDICTION THEREOF. EITHER PARTY MAY OBTAIN PROVISIONAL OR ANCILLARY REMEDIES SUCH AS INJUNCTIVE RELIEF OR THE APPOINTMENT OF A RECEIVER, OR EXERCISE SELF-HELP, AT ANY TIME WITHOUT WAIVING ITS RIGHT TO ARBITRATION.

 

8. MISCELLANEOUS

 

8.1 Governing Law; Submission to Jurisdiction . This Agreement and the Note are contracts under the laws of the State of Florida and shall for all purposes be governed by and construed in accordance with the laws of the State of Florida, without regard to its principals of conflicts of laws. Borrower and Lender hereby submit to the nonexclusive jurisdiction of any Florida state or federal court sitting in Orlando for the purposes of all legal proceedings arising out of or relating to this Agreement or the transactions contemplated hereby. Borrower and Lender irrevocably waive, to the fullest extent pern1itted by applicable law, any objection that Borrower or Lender may now or hereafter have to laying of the venue of any such proceedings brought in such a court and any claim that any such proceeding brought in such a court has been brought in an inconvenient forum.

 

 Page 4 of 6   _________ / ________
 

 

8.2 Waiver of Jury Trial . BORROWER AND LENDER HEREBY IRREVOCABLY WAIVE, TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW ANY AND ALL RIGHT TO TRIAL BY JURY IN ANY LEGAL PROCEEDING ARISING OUT OF OR RELATING TO THIS AGREEMENT OR THE TRANSACTIONS CONTEMPLATED HEREBY.

 

8.3 Further Assurances . Borrower shall, at any time, and from time to time, upon the written request of Lender, execute and deliver such further documents and do such further acts and things as Lender may reasonably request to effect the purposes of this Agreement.

 

8.4 Waivers . No course of dealing between Borrower and Lender, nor any failure to exercise, nor any delay in exercising, any right, power or privilege of Lender hereunder shall operate as a waiver thereof, nor shall any single or partial exercise of any right, power, or privilege hereunder preclude any other or further exercise thereof or the exercise of any other right, power or privilege.

 

8.5 Rights Cumulative . The rights and remedies provided herein, and under the Note, and in all other agreements, instruments, and documents delivered pursuant to or in connection with this Agreement, and by applicable law are cumulative and are in addition to and not exclusive of any other rights or remedies provided by law.

 

8.6 Severability . The provisions of this Agreement are severable. If any clause or provision hereof shall be held invalid or unenforceable in whole or in part in any jurisdiction, then such invalidity or unenforceability shall affect only such clause or provision or pa1t thereof in such jurisdiction and shall not in any manner affect such clause or provision in any other jurisdiction or any other clause or provision in this Agreement in any jurisdiction.

 

8.7 Notices . All notices and other communications made or required to be given pursuant to the Loan Documents shall be in writing and shall be deemed given if delivered personally, by facsimile transmission or by electronic transmission in PDF format, or delivered by overnight courier service, or mailed by registered or ce11ified mail {return receipt requested), postage prepaid, to the parties at the following addresses (or at such other address for a party as shall be specified by like notice; provided that notices of a change of address shall be effective only upon receipt thereat):

 

If to Borrower:

 

Immune Therapeutics, Inc.
37 North Orange Ave., Suite 607
Orlando, Florida 32801

Fax number: (866) 514-4807

Phone: (888) 613-8802

 

If to Lender:

  ____________________________

  ____________________________

  ____________________________

 

 Page 5 of 6   _________ / ________
 

 

8.8 Successors and Assign . This Agreement shall inure to the benefit of and shall be binding upon the successors and assigns of the parties hereto; provided, however, that Borrower may not assign any rights or obligations hereunder without the written consent of Lender.

 

8.9 Counterparts . This Agreement may be executed in counterparts, each of which shall be deemed to be an original and all of which shall constitute one document.

 

8.10 Termination . This Agreement shall terminate upon iI1·evocable payment in cash in full of all obligations hereby.

 

8.11 Entire Agreement . This Agreement and the other Loan Documents executed and delivered contemporaneously herewith, together with the exhibits and schedules attached hereto and thereto, constitute the entire understanding of the parties with respect to the subject matter hereof, and any other prior or contemporaneous agreements, whether written or oral, with respect thereto are expressly superseded hereby. In the event that the provisions of this Agreement shall conflict with provisions of any of the other Loan Documents, the provisions of this Agreement shall control.

 

IN WITNESS WHEREOF, the parties hereby have caused this Agreement to be duly executed and delivered as of the day and year first above written.

 

Borrower: Immune Therapeutics, Inc.   Lender: Joel Yanowitz
       
By:      
  Noreen Griffin, Chief Executive Officer    

 

 Page 6 of 6   _________ / ________
 

 

Exhibit A

 

PROMISSORY NOTE

 

$50,000 January 9, 2018

 

FOR VALUE RECEIVED, the undersigned, Immune Therapeutics, Inc., a Florida corporation (“Borrower”), promises to pay to the order of Joel Yanowitz (“Lender”), the principal sum of fifty thousand dollars ($50,000), together with interest upon the unpaid principal balance (the “Loan”), at the rate hereinafter specified, said principal and interest being payable as follows:

 

The outstanding principal balance of the Loan shall bear interest at the rate of twelve percent (12%) per annum. Interest on the Loan shall be calculated on the basis of a 360-day year and the actual number of days elapsed.

 

The principal balance of the Loan and all accrued interest shall become due and payable ninety (90) days from the Effective Date, without extension; provided, however, that the principal balance of the Loan and all accrued interest shall be paid earlier as follows:

 

(i) If Borrower receives investment capital in an amount equal to or greater than one million five hundred thousand dollars ($1,500,000) during the Term, principal and accrued interest under the Loan shall become immediately due and payable;

 

(ii) If Borrower uplists its common stock to a global or national exchange for buying and selling its common stock during the Term, principal and accrued interest under the Loan shall become immediately due and payable; or

 

(iii) Upon the receipt of gross revenues by Borrower equaling or greater than one million five hundred thousand dollars ($ 1,500,000) during the Term, Borrower shall pay Lender in monthly installments five percent (5%) of gross revenues received on the outstanding principal and accrued interest on the last day of each month beginning the first month after the Borrower has received total gross revenues of $1,500,000 or more.

 

This Promissory Note (the “Note’’) is being issued pursuant to that certain Loan Agreement, dated of even date herewith, between Borrower and Lender (the “Loan Agreement”). Capitalized terms not otherwise defined herein shall have the meaning ascribed to such terms in the Loan Agreement.

 

All interest and the principal hereof shall be paid to Lender by wire transfer in U.S. dollars in immediately available funds to such bank account as shall be designated by Lender in writing from time to time.

 

If Borrower shall fail to make payment of any installment of principal and interest, within fifteen (15) days of its due date, or upon the occurrence of any other Event of Default under the Loan Agreement or this Note, then and in any such event, the entire unpaid principal balance of the indebtedness evidenced hereby, together with all interest then accrued, shall, at the absolute option of Lender, at once become due and payable, without demand or notice, the same being expressly waived and Lender may exercise any right, power or remedy permitted by law or equity, or as set forth herein or in the Loan Agreement or any other Loan Document. Further, if Borrower shall fail to make to make any payment of principal or interest on the Loan or other amounts due under the Loan Documents within fifteen (15) days of the date, which such payment is due, then there shall be an additional penalty of 5% per month of the outstanding balance then due.

 

Lender and Borrower hereby waive the right to any jury trial in any action, proceeding, or counterclaim brought by either Lender or Borrower against the other. Borrower waives protest, demand, presentment, and notice of dishonor, and agrees that this Note may be extended, in whole or in part, without limit as to the number of such extensions or the period or periods thereof, without notice to it and without affecting its liability thereon. The liability of Borrower shall be absolute and unconditional and without regard to the liability of any other party hereto.

 

 Promissory Note Page 1 of 2   _________ / ________
 

 

It is the intention of Lender and Borrower to comply strictly with applicable usury laws; and, accordingly, in no event and upon no contingency shall Lender ever be entitled to receive, collect, or apply as interest any interest, fees, charges or other payments equivalent to interest, in excess of the maximum effective contract rate which Lender may lawfully charge under applicable statutes and laws from time to time in effect; and in the event that Lender ever receives, collects, or applies as interest any such excess, such amount which, but for this provision, would be excessive interest, shall be applied to the reduction of the principal amount of the indebtedness hereby evidenced; and if the principal amount of the indebtedness evidenced hereby, all lawful interest thereon and all lawful fees and charges in connection therewith, are paid in full, any remaining excess shall forthwith be paid to Borrower, or other party lawfully entitled thereto. All interest paid or agreed to be paid by Borrower shall, to the maximum extent permitted under applicable law, be amortized, prorated, allocated and spread throughout the full period until payment in full of the principal so that the interest hereon for such full period shall not exceed the maximum amount permitted by applicable law. The provisions of this paragraph shall be given precedence over any other provision contained herein or in any other agreement between Lender and Borrower that is in conflict with the provisions of this paragraph.

 

This Note shall be governed and construed according to the statutes and laws of the State of Florida from time to time in effect.

 

Upon three (3) business days’ prior written notice to Lender, Borrower shall have the right to prepay the indebtedness evidenced hereby in whole or in part by paying the principal amount being prepaid plus accrued interest.

 

The invalidity or unenforceability of any one or more provisions of this Note shall not render any other provision invalid or unenforceable. The parties hereto shall negotiate in good faith to replace such invalid or unenforceable provision with a valid and enforceable provision to effect the original intent of the parties in a mutually acceptable manner; provided, however, that if the parties cannot agree on such provision after negotiating in good faith within a reasonable period of time under the circumstances, in lieu of any invalid or unenforceable provision, there shall be added automatically a valid and enforceable provision as similar in terms to such invalid or unenforceable provision as may be possible.

 

The covenants, conditions, waivers, releases and agreements contained in this Note shall bind, and the benefits thereof shall inure to, the parties hereto and their respective heirs, executors, administrators, successors and assigns; provided, however, that this Note cannot be assigned by Borrower without the prior written consent of Lender, and any such assignment or attempted assignment by Borrower without consent shall be void and of no effect with respect to Lender.

 

Subject to the Loan Agreement, Lender may from time to time assign, in whole or in part, this Note and/or the obligations evidenced hereby. The holder of any such assignment, if the applicable agreement between Lender and such holder so provides, shall be entitled to all of the rights, obligations and benefits of Lender as fully as though Borrower were directly indebted to such holder.

 

Borrower irrevocably appoints each and every officer of Borrower as its attorneys upon whom may be served, by certified mail at the address set forth in the Loan Agreement, or such other address as may be directed by Borrower, in writing, any notice, process or pleading in any action or proceeding against it arising out of or in connection with this Note or any other Loan Document; and Borrower hereby consents that any action or proceeding against it be commenced and maintained in any state or federal court sitting in Orlando, Orange County, Florida, by service of process on any such officer; and Borrower agrees that such courts of the State shall have jurisdiction with respect to the subject matter hereof and the person of Borrower. Borrower agrees not to assert any defense to any action or proceeding initiated by Lender in any such court based upon improper venue or inconvenient forum.

 

Borrower:

 

Immune Therapeutics, Inc.  
     
By:    
  Noreen Griffin, Chief Executive  

 

 Promissory Note Page 2 of 2   _________ / ________
 

 

 

 

 

 

LOAN AGREEMENT

 

This LOAN AGREEMENT (this “Agreement”), dated February 13, 2018 (the “Effective Date”), is entered into by and between Immune Therapeutics, Inc., a Florida corporation (“Borrower”), and Rogoff Family Trust (“Lender”).

 

RECITALS

 

WHEREAS, Borrower has requested that Lender provide Borrower with a term loan bearing interest at a fixed rate as more particularly described in this Agreement; and

 

WHEREAS, Lender has agreed to make such a loan, subject to the terms and conditions set forth herein and in the other Loan Documents (as defined below).

 

NOW, THEREFORE, in consideration of the foregoing, the mutual covenants and agreements herein contained and other good and valuable consideration the receipt and sufficiency of which is hereby acknowledged, the parties agree as follows:

 

1. AMOUNT AND TERMS OF THE LOAN

 

1. The Loan . The “Loan” hereunder shall mean the loan by Lender to Borrower in the total principal amount of Fifty Thousand Dollars ($50,000).

 

1.2 The Note The Loan shall be evidenced by a Promissory Note in substantially the form attached hereto as Exhibit A (the “Note”), which Note shall be executed by Borrower as of the Effective Date.

 

1.3 Payment of Principal and Interest.

 

(a) The outstanding principal balance of the Loan shall bear interest at the rate of two percent (2%) per annum. Interest on the Loan shall be calculated on the basis of a 360-day year and the actual number of days elapsed.

 

(b) The principal balance of the Loan and all accrued interest shall become due and payable one hundred and twenty days (120) from the Effective Date (the “Term”); provided however, that the principal balance of the Loan and all accrued interest shall be paid earlier as follows:

 

(i) If Borrower receives investment capital in an amount equal to or greater than one million five hundred thousand dollars ($1,500,000) during the Term, principal and accrued interest under the Loan shall become immediately due and payable;

 

(ii) Upon the receipt of gross revenues by borrower equaling or greater than one million five hundred thousand dollars ($1,500,000) during the Term, Borrower shall pay Lender in monthly installments five percent (5%) of gross revenues received on the outstanding principal and accrued interest on the last day of each month beginning the first month after the Borrower has received total gross revenues of $1,500,000 or more.

 

(c) Nothing contained herein shall be deemed to require the payment of interest at a rate in excess of the maximum rate permitted by applicable law. In the event that the amount required to be paid hereunder for any calendar month exceeds the maximum rate permitted by law, such amounts shall be automatically reduced for such month to the maximum rate permitted by applicable law.

 

Page 1 of 6  

_________ / ________

 

 

1.5 Prepayment . Upon three (3) business days’ prior written notice to Lender, Borrower may prepay all or any part of the Loan, including interest, without penalty or premium at any time and from time to time.

 

1.6 Acceleration . Immediately upon the occurrence of any Event of Default (as defined in Section 6.1) and during any continuance thereof, Lender may declare the Loan, all interest thereon and all other amounts and obligations payable to be forthwith due and payable to Lender or may take any other action as provided in Section 6.2 herein.

 

1.7 Payment Procedures . All payments made by Borrower under this Agreement shall be made to Lender by wire transfer in U.S. dollars in immediately available funds to such bank account as shall be designated by Lender in writing from time to time.

 

2. EFFECTIVENESS

 

2.1 Effectiveness . This Agreement and the Note and (collectively: the “Loan Documents”) shall not become effective until (a) all parties hereto have executed and delivered a counterpart hereof (including by way of facsimile transmission or by electronic transmission in PDF format), and (b) the conditions precedent set forth in Section 4 hereof shall have been satisfied.

 

3. REPRESENTATIONS AND WARRANTIES OF BORROWER

 

Borrower represents and warrants to Lender the following:

 

3.1 Authority . Borrower has the requisite legal capacity to borrow money, to execute, deliver and perform each of the Loan Documents to which it is a party and all other documents, certificates and instruments delivered in connection therewith, and to effect and carry out the transactions contemplated herein and therein. Each Loan Document has been duly authorized and, when executed and delivered, will be a valid and legally binding instrument enforceable against Borrower in accordance with its terms. The execution and delivery of the Loan Documents and the consummation of the transactions contemplated thereby will not (immediately or with the passage of time, or the giving of notice) violate (a) any law, order, rule or regulation or deten11ination of an arbitrator, a court, or other governmental agency, applicable or binding upon Borrower or any of Borrower’s property or as to which Borrower or any of Borrower s property is subject (collectively, “Requirement of Law”), or (b) any provision of any agreement, instrument, or undertaking to which Borrower is a party. No consents, approvals or other authorizations or notices, other than those which have been obtained and are in full force and effect, are required by any state or federal regulatory authority or other person or entity (“Person”) in connection with the execution and delivery of the Loan Documents and the performance of any obligations contemplated thereby.

 

3.2 Litigation . There are no actions, suits, proceedings or governmental investigations or inquiries pending, or to the best knowledge of Borrower threatened, against Borrower or Lender, that could, if adversely determined, have a material adverse effect on the performance of any obligation contemplated in or arising under the Loan Documents (“Material Adverse Effect”).

 

3.3 Full Disclosure . No written statement prepared or furnished to Lender in connection with the transactions contemplated hereby (including, without limitation, financial statements) by or on behalf of Borrower:- when all such statements are taken as a whole, contains any untrue statement of a material fact or omits to state a material fact necessary to make the statements contained therein not misleading. All facts known to Borrower which are material to an understanding of the financial condition, business, properties or prospects of Borrower have been disclosed to Lender.

 

Page 2 of 6  

_________ / ________

 

 

4. CONDITIONS PRECEDENT

 

The effectiveness of this Agreement is subject to the satisfaction of the following conditions precedent:

 

4.1 Documents . Lender shall have received the following, validly executed to the satisfaction of the Lender: (a) this Agreement; and (b) the Note.

 

4.2 Compliance with Covenants . Borrower shall have complied with and performed all of Borrower’s covenants and obligations under the Loan Documents.

 

4.3 Related Information . Borrower shall have provided to Lender in form satisfactory to Lender such other financial information relating to Borrower as requested by Lender.

 

5. COVENANTS OF BORROWER

 

5.1 Certain Affirmative Covenants . Borrower covenants and agrees that until full and complete performance by Borrower of all obligations arising under the Loan and the Loan Documents, Borrower shall:

 

(a) Cooperate with Lender and execute such further instruments and documents as Lender shall reasonably request to can-y out to its satisfaction of the transactions contemplated by the Loan Documents;

 

(b) As soon as possible and in any event within two (2) business days after acquiring knowledge thereof notify Lender in writing of the occurrence of any Event of Default; and

 

(c) Promptly provide Lender with such other information respecting condition or operations, financial or othe1wise, of Borrower as Lender may from time to time reasonably request.

 

5.2 Compliance with Laws . Borrower shall comply in all material respects with all Requirements of Law, contractual obligations, commitments, instruments, licenses, and permits.

 

5.3 Reporting Requirements . Borrower shall furnish to Lender, promptly after the commencement thereof notice of all actions, suits and proceedings before any domestic or foreign governmental authority or arbitrator, affecting Borrower, except those which in the aggregate, if adversely determined, would have no Material Adverse Effect;

 

6. EVENTS OF DEFAULT; ACCELERATION

 

6.1 Events of Default . Each of the following shall constitute an “Event of Default”

 

(a) Borrower shall fail to make any payment of principal or interest on the Loan or other amounts due under the Loan Documents within fifteen (15) days of the date, which such payment is due;

 

(b) Borrower shall fail to preform any terms, covenant or agreement contained herein or in any Loan Document and such failure shall continue for thirty (30) days after the earlier of the date on which (x) Borrower becomes aware of such failure, or (y) written notice of such failure has been given to Borrower by Lender;

 

(c) Any representation or warranty of Borrower in any Loan Document shall prove to have been false in any material respect upon the date when made;

 

(d) Borrower shall (i) apply for or consent to the appointment of, or the taking of possession by, a receiver, custodian, trustee or liquidator, (ii) make a general assignment for the benefit of Borrower creditors, (iii) commence a voluntary case under the United States Bankruptcy Code (as now or hereafter in effect), (iv) file a petition seeking to take advantage of any other law of any jurisdiction relating to bankruptcy, insolvency, or composition or readjustment of debts, (v) fail to controvert in a timely and appropriate manner, or acquiesce in writing to, any petition filed against Borrower in an involuntary case under the United States Bankruptcy Code, or (vi) take any action for the purpose of effecting any of the foregoing; or

 

Page 3 of 6  

_________ / ________

 

 

(e) A proceeding or case shall be commenced, without the application or consent of Borrower, in any court of competent jurisdiction, seeking (i) the liquidation of Borrower’s assets, or the composition or readjustment of Borrower’s debts, (ii) the appointment of a trustee, receiver, custodian, liquidator or the like of any substantial part of Borrower’s assets, or (iii) similar relief in respect of Borrower under any law of any jurisdiction relating to bankruptcy, insolvency, or the composition or readjustment of debts, and such proceedings or case shall continue undismissed, or an order, judgment or decree approving or ordering any of the foregoing shall be entered and continue unstayed and in effect for a period of sixty (60) days; or an order for relief against the Borrower shall be entered in an involuntary case under any bankruptcy, insolvency, composition, readjustment of debt, liquidation of assets or similar law of any jurisdiction.

 

6.2 Remedies Upon Default . Immediately upon the occurrence of any Event of Default and during the continuance thereof, Lender may declare the Loan, all interest thereon and all other amounts and obligations payable under any Loan Document to be due and payable, without presentment, demand, protest or further notice of any kind, all of which are expressly waived by Borrower.

 

7. ARBITRATION

 

7.1 AGREEMENT TO BINDING ARBITRATION . THE PARTIES AGREE THAT ANY

 

CONTROVERSY OR CLAIM ARISING OUT OF OR RELATING TO THIS AGREEMENT OR ANY OTHER LOAN DOCUMENT OR THE BREACH THEREOF SHALL AT EITHER PARTIES ELECTION, BE SUBMITTED TO ARBITRATION BEFORE THE AMERICAN ARBITRATION ASSOCIATION IN ACCORDANCE WITH THE COMMERCIAL ARBITRATION RULES OF THE AMERICAN ARBITRATION ASSOCIATION, AND JUDGMENT ON THE AWARD RENDERED BY THE ARBITRATOR MAY BE ENTERED IN ANY COURT HAVING JURISDICTION THEREOF. EITHER PARTY MAY OBTAIN PROVISIONAL OR ANCILLARY REMEDIES SUCH AS INJUNCTIVE RELIEF OR THE APPOINTMENT OF A RECEIVER, OR EXERCISE SELF-HELP, AT ANY TIME WITHOUT WAIVING ITS RIGHT TO ARBITRATION.

 

8. MISCELLANEOUS

 

8.1 Governing Law; Submission to Jurisdiction . This Agreement and the Note are contracts under the laws of the State of Florida and shall for all purposes be governed by and construed in accordance with the laws of the State of Florida, without regard to its principals of conflicts of laws. Borrower and Lender hereby submit to the nonexclusive jurisdiction of any Florida state or federal court sitting in Orlando for the purposes of all legal proceedings arising out of or relating to this Agreement or the transactions contemplated hereby. Borrower and Lender irrevocably waive, to the fullest extent pern1itted by applicable law, any objection that Borrower or Lender may now or hereafter have to laying of the venue of any such proceedings brought in such a court and any claim that any such proceeding brought in such a court has been brought in an inconvenient forum.

 

8.2 Waiver of Jury Trial . BORROWER AND LENDER HEREBY IRREVOCABLY WAIVE, TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW ANY AND ALL RIGHT TO TRIAL BY JURY IN ANY LEGAL PROCEEDING ARISING OUT OF OR RELATING TO THIS AGREEMENT OR THE TRANSACTIONS CONTEMPLATED HEREBY.

 

8.3 Further Assurances . Borrower shall, at any time, and from time to time, upon the written request of Lender, execute and deliver such further documents and do such further acts and things as Lender may reasonably request to effect the purposes of this Agreement.

 

8.4 Waivers . No course of dealing between Borrower and Lender, nor any failure to exercise, nor any delay in exercising, any right, power or privilege of Lender hereunder shall operate as a waiver thereof, nor shall any single or partial exercise of any right, power, or privilege hereunder preclude any other or further exercise thereof or the exercise of any other right, power or privilege.

 

Page 4 of 6  

_________ / ________

 

 

8.5 Rights Cumulative . The rights and remedies provided herein, and under the Note, and in all other agreements, instruments, and documents delivered pursuant to or in connection with this Agreement, and by applicable law are cumulative and are in addition to and not exclusive of any other rights or remedies provided by law.

 

8.6 Severability . The provisions of this Agreement are severable. If any clause or provision hereof shall be held invalid or unenforceable in whole or in part in any jurisdiction, then such invalidity or unenforceability shall affect only such clause or provision or pa1t thereof in such jurisdiction and shall not in any manner affect such clause or provision in any other jurisdiction or any other clause or provision in this Agreement in any jurisdiction.

 

8.7 Notices . All notices and other communications made or required to be given pursuant to the Loan Documents shall be in writing and shall be deemed given if delivered personally, by facsimile transmission or by electronic transmission in PDF format, or delivered by overnight courier service, or mailed by registered or ce11ified mail {return receipt requested), postage prepaid, to the parties at the following addresses (or at such other address for a party as shall be specified by like notice; provided that notices of a change of address shall be effective only upon receipt thereat):

 

If to Borrower:

 

Immune Therapeutics, Inc.
37 North Orange Ave., Suite 607
Orlando, Florida 32801

Fax number: (407) 894-5567

Phone: (407) 902-7904

 

If to Lender:

 

Lofton Family Trust

 

8.8 Successors and Assign. This Agreement shall inure to the benefit of and shall be binding upon the successors and assigns of the parties hereto; provided, however, that Borrower may not assign any rights or obligations hereunder without the written consent of Lender.

 

8.9 Counterparts . This Agreement may be executed in counterparts, each of which shall be deemed to be an original and all of which shall constitute one document.

 

8.10 Termination . This Agreement shall terminate upon iI1·evocable payment in cash in full of all obligations hereby.

 

8.11 Entire Agreement . This Agreement and the other Loan Documents executed and delivered contemporaneously herewith, together with the exhibits and schedules attached hereto and thereto, constitute the entire understanding of the parties with respect to the subject matter hereof, and any other prior or contemporaneous agreements, whether written or oral, with respect thereto are expressly superseded hereby. In the event that the provisions of this Agreement shall conflict with provisions of any of the other Loan Documents, the provisions of this Agreement shall control.

 

Signatures Appear on the Following Page

 

Page 5 of 6  

_________ / ________

 

 

IN WITNESS WHEREOF, the parties hereby have caused this Agreement to be duly executed and delivered as of the day and year first above written.

 

Borrower: Immune Therapeutics, Inc.   Lender: Rogoff Family Trust
       
By:      
  Noreen Griffin    
       
Its: CEO    

 

[Signature Page to Loan Agreement]

 

Page 6 of 6  

_________ / ________

 

 

Exhibit A

 

PROMISSORY NOTE

 

$50,000 February 13, 2018

 

 

FOR VALUE RECEIVED, the undersigned, Immune Therapeutics, Inc., a Florida corporation (“Borrower”), promises to pay to the order of Rogoff Family Trust (“Lender”), the principal sum of Fifty Thousand dollars ($50,000), together with interest upon the unpaid principal balance (the “Loan”), at the rate hereinafter specified, said principal and interest being payable as follows:

 

The outstanding principal balance of the Loan shall bear interest at the rate of two percent (2%) per annum. Interest on the Loan shall be calculated on the basis of a 360-day year and the actual number of days elapsed.