Biostax Corp. - Quarter Report: 2023 June (Form 10-Q)

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)

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

For the quarterly period ended June 30, 2023

OR

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

From the transition period from ___________ to ____________

Commission File Number 000-54933

IMMUNE THERAPEUTICS, INC.

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

Securities registered pursuant to Section 12(b) of the Act: None

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 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 ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted 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 such files). Yes ☒ No ☐

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

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

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

APPLICABLE ONLY TO CORPORATE ISSUERS:

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.

As of August 18, 2023, there were 83,620,764 shares of common stock, $0.0001 par value per share, outstanding.

TABLE OF CONTENTS

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:

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, and elsewhere in this Quarterly 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:

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 Quarterly Report are based on information available to us on the date of this Quarterly 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 because 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 Quarterly Report.

PART I – FINANCIAL INFORMATION

ITEM 1. FINANCIAL STATEMENTS

IMMUNE THERAPEUTICS, INC. AND SUBSIDIARIES

UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

IMMUNE THERAPEUTICS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

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

IMMUNE THERAPEUTICS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS

(Unaudited)

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

IMMUNE THERAPEUTICS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY/(DEFICIT)

FOR THE PERIODS ENDED JUNE 30, 2023 AND 2022

(Unaudited)

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

IMMUNE THERAPEUTICS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS

FOR THE PERIODS ENDED JUNE 30, 2023 AND 2022

(Unaudited)

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

Immune Therapeutics, Inc.

Notes to the Condensed Consolidated Financial Statements

June 30, 2023

(Unaudited)

1. Company Overview

Immune Therapeutics Inc. (the “Company” or “IMUN”) is a Florida corporation trading on the OTC-Pink. The Company is a drug development and commercialization company. We identify, evaluate, and seek to acquire technologies in the medical device and drug development sectors with the intent to further develop them and move them to commercialization. On February 28, 2023, we received a written consent from a majority of our outstanding shareholders to change the name of our Company to “Biostax Corp.” On March 27, 2023, we filed a definitive information statement on Schedule 14C and mailed the information statement to shareholders on record as of the date of the filing. We plan to file our name change amendment with the Secretary of State of Florida at least twenty calendar days after the Financial Industry Regulatory Authority, Inc. processes our name change.

Going Concern

As of June 30, 2023, the Company had $17,426 in cash on hand, negative working capital of $3,843,596 and accumulated stockholders’ deficit of $383,888,844. For the six months ended June 30, 2023, the Company reported a net loss attributable to common shareholders of $920,350. For the six months ended June 30, 2022, the Company reported net loss attributable to common shareholders of $763,697.

Historically the Company has relied on the funding of operations through private equity financing and management expects operating losses and negative cash flows to continue at more significant levels in the future. As the Company continues to incur losses, its transition to profitability is dependent upon the successful development, approval, and commercialization of its current or future product candidates as they become available and the achievement of a level of revenues adequate to support the Company’s cost structure. The Company may never achieve profitability, and unless and until it does, the Company will continue to need to raise additional cash. Management intends to fund future operations through additional private or public debt or equity offerings and may seek additional capital through arrangements with strategic partners or from other sources.

Working capital at June 30, 2023 is not sufficient to meet the cash requirements to fund planned operations through the next twelve months without additional sources of cash. These conditions raise substantial doubt about the Company’s ability to continue as a going concern. The accompanying financial statements have been prepared assuming that the Company will continue as a going concern and do not include adjustments that might result from the outcome of this uncertainty. This basis of accounting contemplates the recovery of the Company’s assets and the satisfaction of liabilities in the normal course of business.

Management is continuing to develop strategies to re-capitalize the Company and position it for future growth. Key steps to this process include:

There can be no guarantee that the Company will be successful in securing adequate capital to continue operations and in identifying and acquiring assets for future development.

If the Company is unable to secure new working capital, other alternative strategies will be required.

Historically, the Company’s strategy has been to acquire and develop assets; potentially spin them out and retain both an equity stake and royalties and milestone payments. In so doing, the Company would act as an incubator for late-stage drug development. Management believes that this strategy can be successful. At this time, the Company is reviewing several opportunities which it may pursue as soon as funding is available. At present, no definitive action has been taken.

There can be no guarantees that the Company will be successful in:

Company History

Immune Therapeutics, Inc. (the “Company” or “Immune”) 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 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. On February 28, 2023, we received a written consent from a majority of our outstanding shareholders to change the name of our Company to “Biostax Corp.” On March 27, 2023, we filed a definitive information statement on Schedule 14C and mailed the information statement to shareholders on record as of the date of the filing. We plan to file our name change amendment with the Secretary of State of Florida at least twenty calendar days after the Financial Industry Regulatory Authority, Inc. processes our name change.

2. Summary of Significant Accounting Policies

Basis of Presentation

The condensed 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, 2022 (including the notes thereto) set forth in the Company’s Annual Report on Form 10- K for that period.

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. At June 30, 2023 and December 31, 2022, the Company had cash and cash equivalents of $17,426 and $150,491, respectively.

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 condensed consolidated balance sheets. The cash accounts are insured by the Federal Deposit Insurance Corporation up to $250,000.

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, cash equivalents 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 the Company’s investment in the common stock of Statera BioPharma, Inc. (“STAB”) reflects an asset impairment charge taken in the second quarter of 2022 and is carried at zero in the consolidated balance sheet. The carrying value of notes payable approximate fair value since they bear market rates of interest and other terms. None of these instruments are held for trading purposes.

Research and Development Costs

Research and development costs are charged to expense as incurred and are typically comprised of expenses associated with advancing the commercialization of our technologies. The Company incurred $356,132 of research and development costs during the six months ended June 30, 2023, which includes legal fees related to the maintenance and prosecution of licensed and owned intellectual property as well as the fair value of common stock issued to extend the payment terms of the Company’s license agreement with TaiwanJ Pharmaceuticals. The Company did not incur any research and development costs during the six months ended June 30, 2022.

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 June 30, 2023 and 2022, 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 June 30, 2023, and 2022, the Company does not have any interest or penalties related to uncertain tax positions.

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

The Company measures and recognizes compensation expense for share-based awards 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. Generally, 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 718, “Compensation-Stock Compensation.” 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.

The Company did not issue any stock-based compensation awards during the six months ended June 30, 2023 and 2022.

Net Income (Loss) per Share

For the six month period ended June 30, 2023, basic and diluted net loss per share is calculated by dividing the net loss by the weighted average number of common shares outstanding for the period, without consideration for common stock equivalents.

Diluted net income (loss) per share is calculated by adjusting weighted average shares outstanding for the dilutive effect of common stock equivalents outstanding for the period, using the treasury-stock method. For purposes of the diluted net income (loss) per share calculation, shares to be issued pursuant to convertible debt and warrants are considered to be common stock equivalents but are excluded from the calculation of diluted net income (loss) per share in 2023 and 2022 because their effect would be anti-dilutive. A total of 33,495 warrants 736,732 shares, resulting from the conversion of principal and interest on convertible notes, have been excluded from this calculation for the six month period ended June 30, 2023.

For the six month period ended June 30, 2023, diluted income per share was calculated by dividing the net income by the weighted-average number of common shares outstanding for the period determined using the treasury-stock method. A reconciliation of the weighted average shares outstanding used in basic and diluted earnings per share for the periods ended June 30, 2023 and 2022 are as follows:

Schedule of Basic and Diluted Earnings per Share 

Recent Accounting Standards

The Company has reviewed the accounting pronouncements issued by the Financial Accounting Standards Board during the six months ended June 30, 2023. Applicable pronouncements will be adopted by the Company in accordance with the accounting guidance and definition. 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.

Management does not believe there are other significant accounting pronouncements which have had or will have a material impact on the Company’s consolidated financial statements.

Note 3. Notes payable

During the three-month period ended June 30, 2023, the Company reported the following activity in notes and accrued interest:

On April 13, 2023, the Company issued a $250,000 promissory note to TaiwanJ Pharmaceuticals, pursuant to the Second Extension Agreement to the Intellectual Property License Agreement. The note accrues interest at 18% annually and matured on May 30, 2023. This note is presently in default.

On June 2, 2023, the Company issued a $15,000 promissory note to one lender. The note matures in 90 days and accrues interest of 8% annually.

Notes Payable on June 30, 2023 and December 31, 2022 are as follows:

 Schedule of Notes Payable

At June 30, 2023 and December 31, 2022, the Company had accrued $104,062 and $64,455, respectively, in unpaid interest on notes payable.

4. Capital Structure – Common Stock and 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.

Stock Warrants

During the six month period ended June 30, 2023 no common stock warrants were issued, exercised or modified.

On June 29, 2022, the Company’s board of directors approved a resolution to clarify the anti-dilution protection granted to certain note and warrant holders. In connection with this board action, the Company recognized a non-cash charge of $1,011,625 in the Statement of Operations for the three- and six-month periods ended June 30, 2022. The fair value of the re-measured warrants was determined using the Black Scholes model and used the following assumptions:

 Schedule of Fair Value of the Remeasured Warrants

The average risk-free interest rate was based on the U.S. Treasury security rate in effect on June 29, 2022. We determined expected volatility using the historical closing stock price. The expected life was determined using the simplified method as we do not believe we had sufficient historical warrant exercise experiences on which to base the expected term.

Warrant holders exercised 12,565,000 common stock warrants during the second quarter of 2022. An additional 31,899 warrants were forfeited or cancelled during the second quarter of 2022.

The following is a summary of outstanding common stock warrants as of June 30, 2023.

Schedule of Outstanding Common Stock Warrants

Following is a summary of stock warrant activity for the six months ended June 30, 2023:

Schedule of Stock Outstanding Warrants Activity

5. Income Taxes – Results of Operations

There was no income tax expense reflected in the results of operations for the periods ended June 30, 2023 and 2022 because the Company has significant net loss operating carryforwards available to offset the potential tax liabilities. 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.

For U.S. federal purposes the corporate statutory income tax rate was 21%, for 2023 and 2022 tax years. The Company has recognized no tax benefit for the losses generated for the periods through June 30, 2023.

ASC Topic 740 requires that a valuation allowance be provided if it is more likely than not that some portion or all 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.

6. Subsequent Events

Amendment 2 to License with Cytocom Inc. (which is now Statera Biopharma Inc.)

In December 2013, the Company formed Cytocom Inc., which changed its name to Statera Biopharma Inc. (“Statera”) or STAB, on September 1, 2021, as a subsidiary of the Company, and transferred rights, titles and interests to the Company as follows:

On May 1, 2018, the Company entered into an amended and restated licensing agreement (the “Restated Agreement”) with STAB. The Restated Agreement restates the licensing arrangement between the Company and STAB and grants the Company distribution and marketing rights for Lodonal™ and meta enkephalin (MENK) for humans in certain emerging markets. In addition, the Company was granted the rights to distribute and market Lodonal™ and MENK for animal use in the United States. The royalty due to STAB was reduced from 5% to 1% of net sales in the Restated Agreement, and the Company no longer would have any ongoing obligations to pay for costs in connection with the assets of STAB. While the Company formalized the agreement in May 1 2018, Penn State University, a licensor that was part of the group of intellectual property that was to be moved, did not consent the move of their license or payables to STAB at the time of the Restated Agreement.

On April 8, 2019, the Company signed a second amendment to its licensing agreement (the “Second Amendment”) with STAB. The Second Amendment confirmed that, (as of its effective date December 31, 2018) the Company owned 15.57% of the STAB common shares issued and outstanding on that date. The Company agreed to assume responsibility to repay all accounts payable obligations and accrued liabilities owed by STAB as of the effective date, except those accounts payable obligations and accrued liabilities as specified in the Second Amendment. The Company also assumed the responsibility to repay all notes payable, together with any interest or fees payable thereon, owed by STAB as of the effective date, except those notes payable obligations, together with any interest or fees payable thereon, as specified by the Second Amendment. The parties further agreed that in the event of a change of control of STAB, and at the option of STAB, the Company would have the right to purchase outright the Company’s licensing rights to emerging markets for humans under the License Agreement at a price equal to value of those licensing rights as determined by and independent valuator acceptable to the Company and STAB.

On May 13, 2020, the Company and STAB entered into an Amendment to the Second Amendment (“Third Amendment”) that was effective December 31, 2018. The Third Amendment provides STAB with the Company’s previously licensed rights for LDN and MENK in emerging markets. The original terms for consideration for the sublicense were not finalized until August 12, 2020, at which time STAB and the Company signed a letter agreement in which STAB agreed to assume a combination of defaulted notes plus certain other liabilities. Such terms were amended, and the Company agreed to transfer all the rights, title, and interests to STAB in technology licensed from Penn State Research Foundation (“PSU”) in exchange for STAB assuming all past due and future obligations under the PSU license. While the Company formalized the agreement to assign all outstanding liabilities due to PSU, a vendor of the Company, PSU did not consent to the assignment of the payables to STAB. As of December 31, 2021, the Company had no outstanding accounts payable balances due to PSU.

On July 20, 2021, STAB and the Company agreed to modify the terms of the original sublicense. The renegotiated terms are presented below. The assignment of the notes and associated accrued interest and penalties in default was fully executed in the third quarter of 2020 with the transfer of the notes upon the creditors’ signoff. The Company recognized a gain upon the assignment of these notes in the third quarter of 2020.

Consideration for License to STAB as of December 31, 2022:

Schedule of Consideration

As of December 31, 2022, the Notes transaction has not been fully executed. The notes in default have been assigned and the transfer signed off by the creditors, but STAB still has not completed the assumption of the agreed upon obligations.

On March 24, 2023, the Company and STAB entered into an amendment to the licensing agreement (“Third License Amendment”). This agreement is subject to approval of the United States Bankruptcy Court for the District of Colorado, which is the process of reviewing the involuntary petition commenced against STAB on August 16, 2022.

The Third License Amendment:

Schedule of Royalty Rate

The Company anticipates the Third License Amendment to be approved by the United States Bankruptcy Court.

Second Extension to License Agreement with TaiwanJ Pharmaceuticals

On September 30, 2022, the Company entered into an Intellectual Property License Agreement (the “Agreement”) with TaiwanJ Pharmaceuticals Co. Ltd., a Taiwanese corporation (“TaiwanJ”), pursuant to which TaiwanJ granted the Company an exclusive, royalty-bearing license, including the right to grant sublicenses, to commercialize and sell TaiwanJ’s pharmaceutical products including naltrexone, or any other small molecule composition that either alone or in combination can be formulated and used in humans to show anti-fibrotic, immune-modulating, and/or anti-inflammatory effects for the treatments of various diseases, (the “Products”).

Pursuant to the terms of the Agreement, the Company was to provide a non-refundable, up-front payment of $500,000 by December 31, 2022. The Company did not provide this payment by the due date.

On January 5, 2023, the Company entered into an agreement to extend the up-front payment due date under the Intellectual Property Licensing Agreement (the “Extension”) with TaiwanJ Pharmaceuticals Co. Ltd. Pursuant to the Extension, the Company issued 250,000 shares of common stock to TaiwainJ, in return for a 30-day extension of payment terms.

On March 27, 2023, the Company paid $150,000 of the $500,000 license payment due.

On April 13, 2023, The Company entered into a second extension to the Intellectual Property License Agreement (the “Second Extension”) with TaiwanJ Pharmaceuticals Co. Ltd. Pursuant to the Second Extension, the Company has agreed to make a $100,000 cash payment to TaiwanJ Pharmaceuticals by April 30, 2023 and issue a promissory note for the remaining $250,000 license fee. The $250,000 promissory note was issued on April 14, 2023, matures on May 31, 2023 and pays an interest rate of 1.5% per month. This note is currently in default.

Other Subsequent Events

On April 11, 2023, The Company entered into a second amendment to the promissory note agreement with investor Ira Gaines. Pursuant to the Second Amendment, the Company has agreed to make an additional $10,000 cash payment and issue an additional 50,000 shares of common stock to Mr. Gaines, in exchange for extending the term of the original amendment to the promissory note.

On July 14^th, the Company received a $7,500 loan from Global Reverb Corporation, a related party of which Noreen Griffin is the sole beneficial owner.

On July 20, 2023, the board of directors of the Company appointed Ms. Noreen Griffin, age 70, as the Chief Executive Officer of the Company. Ms. Griffin is the mother of Robert Wilson, a Director of the Company. Ms. Griffin replaces Kelly Wilson who was serving as the interim Chief Executive Officer. Ms. Wilson resigned as the interim Chief Executive Officer effective as of the same date. Ms. Wilson’s resignation as interim Chief Executive Officer was not due to any disagreement with the Company on any matter. Ms. Wilson remains the Company’s Chief Operating Officer.

On August 2, 2023, the Company entered into a consulting agreement with Noreen Griffin, following her appointment as Chief Executive Officer. Pursuant to the terms of the consulting agreement, we agreed to pay Ms. Griffin a monthly fee of $20,834 and a monthly insurance stipend of $1,200, in return for 40 hours of weekly services. Pursuant to the terms of the agreement, Ms. Griffin agrees to accrue her salary from the commencement of the agreement until the Company has raised funding of $1,000,000. The salary accrual shall earn interest at 8.5% per year.

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

The following management’s discussion and analysis of financial condition and results of operations provides information that management believes is relevant to an assessment and understanding of our plans and financial condition. The following financial information is derived from our condensed consolidated financial statements and should be read in conjunction with such condensed consolidated financial statements and notes thereto and set forth elsewhere herein.

Use of Terms

Except as otherwise indicated by the context and for the purposes of this report only, references in this report to “we,” “us,” “our” and the “Company” refer to Immune Therapeutics, Inc. a Florida corporation and its consolidated subsidiaries.

FORWARD-LOOKING STATEMENTS AND ASSOCIATED RISKS

The Private Securities Litigation Reform Act of 1995 provides a “safe harbor” for forward-looking statements. This report contains certain forward-looking statements that are based on the beliefs of management as well as assumptions made by and currently available to management. The statements contained in this report relating to matters that are not historical facts are forward-looking statements that involve risks and uncertainties, including, but not limited to, future demand for our products and services, the successful commercialization of our products, general domestic and global economic conditions, government and environmental conditions and regulations, competition and customer strategies, changes in our business strategy or development plans, capital deployment, business disruptions, including those by fires, raw material supplies, environmental regulations, and other risks and uncertainties, certain of which are beyond our control. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may differ materially from those forward-looking statements. For further discussion of certain of the matters described above see the Cautionary Note Regarding Forward-Looking Statements included in our 2022 Annual Report on Form 10-K.

Undue reliance should not be placed on our forward-looking statements. Except as required by law, we disclaim an obligation to update any factors or to publicly announce the results of any revisions to any of the forward-looking statements contained in this quarterly report on Form 10-Q to reflect new information, future events, or other developments. The following discussion and analysis should be read in conjunction with the accompanying condensed consolidated financial statements and notes thereto appearing elsewhere in this Form 10-Q.

Forward-looking statements 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 a guarantee of future performance and the Company’s actual results may differ significantly from the results discussed in the forward-looking statements. 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.

COMPANY OVERVIEW

Immune Therapeutics Inc. is a Florida corporation trading on the OTC-Pink. The Company is a drug development and commercialization company. We identify, evaluate, and seek to acquire technologies in the medical device and drug development sectors with the intent to further develop them and move them to commercialization.

Our strategy has been limited due to lack of capital. Management is seeking to secure new investment capital with which to continue to pursue the Company’s strategy. There is no guarantee that the Company will be successful in securing additional capital.

GOING CONCERN

As of June 30, 2023, the Company had $17,426 in cash on hand, negative working capital of $3,843,596 and accumulated deficit of $383,888,844. For the six months ended June 30, 2023, the Company reported a net loss attributable to common shareholders of $920,350. For the six months ended June 30, 2022, the Company reported net loss attributable to common shareholders of $763,697.

Historically the Company has relied on the funding of operations through private equity financing and 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 current or future product candidates as they become available and the achievement of a level of revenues adequate to support the Company’s cost structure. The Company may never achieve profitability, and unless and until it does, the Company will continue to need to raise additional cash. Management intends to fund future operations through additional private or public debt or equity offerings and may seek additional capital through arrangements with strategic partners or from other sources.

Working capital at June 30, 2023 is not sufficient to meet the cash requirements to fund planned operations through the next twelve months without additional sources of cash. These conditions raise substantial doubt about the Company’s ability to continue as a going concern. The accompanying financial statements have been prepared assuming that the Company will continue as a going concern and do not include adjustments that might result from the outcome of this uncertainty. This basis of accounting contemplates the recovery of the Company’s assets and the satisfaction of liabilities in the normal course of business.

Management is continuing to develop strategies to re-capitalize the Company and position it for future growth. Key steps to this process include:

There can be no guarantee that the Company will be successful in securing adequate capital to continue operations and in identifying and acquiring assets for future development.

If the Company is unable to secure new working capital, other alternative strategies will be required.

Historically, the Company has been able to acquire and develop assets, spin them out and retain both an equity stake and royalties and milestone payments. In so doing, the Company has acted as an incubator for late-stage drug development. Management believes that this strategy can continue to be successful. At this time, the Company is reviewing several opportunities which it may pursue as soon as funding is available. At present no definitive actions have been taken.

There can be no guarantees that the Company will be successful in:

Recent Developments

On April 11, 2023, The Company entered into a second amendment to the promissory note agreement with investor Ira Gaines. Pursuant to the Second Amendment, the Company has agreed to make an additional $10,000 cash payment and issue an additional 50,000 shares of common stock to Mr. Gaines, in exchange for extending the term of the original amendment to the promissory note.

On July 14^th, the company received a $7,500 loan from Global Reverb Corporation, a related party of which Noreen Griffin is the sole beneficial owner.

On August 3, 2023, the board of directors of the Company appointed Ms. Noreen Griffin, age 70, as the Chief Executive Officer of the Company. Ms. Griffin is the mother of Robert Wilson, a Director of the Company. Ms. Griffin replaces Kelly Wilson who was serving as the interim Chief Executive Officer. Ms. Wilson resigned as the interim Chief Executive Officer effective as of the same date. Ms. Wilson’s resignation as interim Chief Executive Officer was not due to any disagreement with the Company on any matter. Ms. Wilson remains the Company’s Chief Operating Officer.

On August 3, 2023, the Company entered into a consulting agreement with Noreen Griffin, following her appointment as Chief Executive Officer. Pursuant to the terms of the consulting agreement, we agreed to pay Ms. Griffin a monthly fee of $20,834 and a monthly insurance stipend of $1,200, in return for 40 hours of weekly services. Pursuant to the terms of the agreement, Ms. Griffin agrees to accrue her salary from the commencement of the agreement until the Company has raised funding of $1,000,000. The salary accrual shall earn interest at 8.5%.

RESULTS OF OPERATIONS

COMPARISON OF THE THREE MONTHS ENDED JUNE 30, 2023

TO THE THREE MONTHS ENDED JUNE 30, 2022

Revenues

We had no revenues from operations for the three months ended June 30, 2023 and 2022.

Operating Expenses

Selling, General and Administrative Expenses

Selling, general and administrative expenses for the three months ended June 30, 2023 and 2022 were as follows:

During the three months ended June 30, 2023, the Company has focused on the negotiation and finalization of certain licensing transactions and business development opportunities.

For the three months ended June 30, 2023 and 2022, selling, general and administrative expenses were compromised of the following:

The decrease in selling, general and administrative expenses for the three months ended June 30, 2023 over the same period in 2022 was primarily due to the Company focusing on internal operations after its completion of its recapitalization during the second and third quarters of 2022 and reflect the following:

Research and Development Expenses

R&D expenses and related percentages for the three months ended June 30, 2023 and 2022 were as follows:

Research and development expense for the three months ended June 30, 2023 was $175,209, compared to no expenses incurred in the same period in 2022. The increase in research and development expenses for the three months ended June 30, 2023 over the same period of 2022 was primarily due to an increase in amounts payable to TaiwanJ for our license to use certain intellectual property.

The research and development expenses for the three months ended June 30, 2023 reflect the following:

Interest Expense

Interest expense for the three months ended June 30, 2023 and 2022 were as follows:

Interest expense is comprised of accrued interest on notes payable owed by the Company. The increase from 2022 to 2023 reflects the increase in the amount of notes payable, increases in interest rates and payments of additional penalties and interest accrued on defaulted notes.

LIQUIDITY AND CAPITAL RESOURCES

Overview

Liquidity is measured by our ability to secure enough cash to meet our contractual and operating needs as they arise. The Company does not anticipate generating sufficient cash flows from our operations to fund the next twelve months. We had cash on hand of $17,426 at June 30, 2023, compared to $150,491 at December 31, 2022.

Summary of Cash Flows

Net cash used in operating activities was $579,519 for the six months ended June 30, 2023, compared to $222,352 for the corresponding period in 2022. The use of cash in 2023 resulted primarily from our loss from operations and a reclassification of legacy accounts payable to other income, offset by other changes in our working capital accounts. The reclassified accounts payable had been outstanding for more than five years, and have been deemed no longer valid payables.

For the six months ended June 30, 2022, the Company used $222,352 in cash to support operating activities. Included in net income for the six months ended June 30, 2022, are non-cash gains of: $3,165,151 recognized upon the assignment of notes and other obligations in connection with a license agreement, $297,579 recognized upon the settlement with owners of the obligations, offset by non-cash charges upon the recognition of an asset impairment of the STAB common shares held by the Company, and a charge for the market value from the modification of certain warrant provisions.

The Company had no cash used or provided from investing activities during the six month periods ended June 30, 2023 and 2022.

For the six months ended June 30, 2023 and 2022, the Company received $446,453 and $338,416 in financing activities from issued notes payable, respectively.

The Company does not expect to generate revenues in the foreseeable future. If the Company is unable to raise additional working capital to meet its operating obligations and expenditures, the Company will be required to modify its business plan.

CONTRACTUAL OBLIGATIONS

Promissory Notes

The notes payable on the Company’s Condensed Consolidated Balance Sheet above contains, at June 30, 2023, certain promissory notes on which the Company was in arrears on payment of principal as follows:

Promissory notes were issued in 2019 accruing interest at 6% with a balance due of $291,809 due as of June 30, 2022.

Promissory notes accruing interest at 8% and maturing in 2023 were issued in the second quarter of 2023. The note reflect all principal, interest and penalties associated with the original instrument. The promissory notes have a balance due of $153,258 as of June 30, 2022.

Promissory note issued in 2023 accruing interest at 18% with a balance due of $259,625 due as of May 31, 2023.

Please refer to Note 3 to the Condensed Consolidated Financial Statements of Part I Item 1, which is incorporated by reference, for additional details regarding these promissory notes.

OFF BALANCE SHEET ARRANGEMENTS

During the six months ended June 30, 2023 and 2022, the Company did not engage in any off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial conditions, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources.

CRITICAL ACCOUNTING POLICIES AND ESTIMATES

We have identified the policies below as critical to our business operations and the understanding of its results of operations. The Company’s senior management has reviewed these critical accounting policies and related disclosures with the Company’s board of directors. The impact and any associated risks related to these policies on our business operations are discussed throughout this section where such policies affect our reported and expected financial results.

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, cash equivalents 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 the Company’s investment in the common stock of STAB reflects an asset impairment charge taken in the second quarter of 2022 and is carried at zero in the consolidated balance sheet. The carrying value of notes payable approximate fair value since they bear market rates of interest and other terms. None of these instruments are held for trading purposes.

Research and Development Costs

Research and development costs are charged to expense as incurred and are typically comprised of expenses associated with advancing the commercialization of our technologies.

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.

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

The Company measures and recognizes compensation expense for share-based awards 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. Generally, 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 718, “Compensation-Stock Compensation.” 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.

Recent Accounting Standards

The Company has reviewed the accounting pronouncements issued by the Financial Accounting Standards Board during the six months ended June 30, 2023. Applicable pronouncements will be adopted by the Company in accordance with the accounting guidance and definition. 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.

Management does not believe there are other significant accounting pronouncements which have had or will have a material impact on the Company’s consolidated financial statements.

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

Not Applicable.

ITEM 4. CONTROLS AND PROCEDURES

Changes in Internal Control over Financial Reporting

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

Evaluation of Disclosure Controls and Procedures

As of the end of the period covered by this report, we conducted an evaluation, under the supervision and with the participation of our principal executive officer and principal financial officer, of our disclosure controls and procedures as defined in Rule 13a-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act. Based on this evaluation, the principal executive officer and the principal financial officer concluded that, because of the weakness in internal control 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 our internal controls over financial reporting 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, management concluded that our internal control over financial reporting was 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 the 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 remediate these weaknesses, as well as 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 Disclosure Controls and Procedures and Internal Control Over Financial Reporting

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

We are not party to any material pending legal proceedings. From time to time, we may be involved in legal proceedings which arise during the ordinary course of business.

ITEM 1A. RISK FACTORS

Not applicable.

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

During the quarter ended June 30, 2023, the Company issued the following securities:

The Company issued 250,000 shares of common stock to TaiwanJ Pharmaceuticals Co., Ltd. pursuant to the Second Amendment to the Intellectual Property Licensing Agreement executed on January 12, 2023.

The Company issued 52,906 shares of common stock to Ira Gaines, pursuant to the Second Amendment to Promissory Note issued on October 1, 2019.

We did not repurchase any shares of our common stock during the three months ended June 30, 2023.

The issuances of shares of common stock described above will not be registered under the Securities Act of 1933, as amended, or the Securities Act, in reliance upon the exemption from registration provided by Section 4(a)(2) of the Securities Act, and/or Regulation D promulgated thereunder.

ITEM 3. DEFAULTS UPON SENIOR SECURITIES

Refer to Note 3 to the Condensed Consolidated Financial Statements of Part I Item 1, which is incorporated by reference, for additional details. The notes payable on the Company’s Condensed Consolidated Balance Sheet above contains, at June 30, 2023, certain promissory notes on which the Company was in arrears on payment of principal as follows:

$231,478 promissory note issued in 2019. The note accrued interest at 6% and matured in 2020

$100,000 promissory note issued in March 2023. The note accrued interest at 8% and matured on May 23, 2023.

$50,000 promissory note issued in March 2023. The note accrued interest at 8% and matured on June 22, 2023.

$250,000 promissory note issued in April 2023. The note accrued interest at 18% and matured on May 30, 2023.

ITEM 4. MINE SAFETY DISCLOSURES

None.

ITEM 5. OTHER INFORMATION

None.

ITEM 6. EXHIBITS

The following exhibits are filed with this Quarterly Report: